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The FDA criteria to determine whether a device is designated order propecia ukwhere can you get propecia as a breakthrough is different from the criteria and evidence CMS reviews to determine appropriateness for the Medicare population. The FDA does not routinely require data on Medicare patients. The relevant data is key for Medicare national coverage decision-making to ensure that Medicare is paying for devices that are beneficial to Medicare patients. While the goal of the MCIT/R&N final rule was to expedite coverage to speed access to innovative treatments, the immediacy of coverage must order propecia ukwhere can you get propecia be balanced with ensuring that the Medicare program is covering appropriate devices for the Medicare population.

Without any data or minimal clinical data to make this determination, it is challenging to ensure that breakthrough devices are beneficial to the Medicare population. We will further consider public comments seeking modifications to MCIT that might allow for expedited coverage while seeking to ensure devices are safe for Medicare patients even when those breakthrough devices do not have an evidence base that is generalizable to Medicare beneficiaries. Comment order propecia ukwhere can you get propecia. Medical specialty societies also sought modifications to the MCIT/R&N final rule regarding evidence development, specifically the addition of RWE requirements and a clarification of CMS' CED authorities.

Commenters specifically recommended post market studies, data collection, and recommended CED as a potential pathway to address uncertainty in health outcomes. In lieu of MCIT, commenters recommended using order propecia ukwhere can you get propecia the Parallel Review program for devices with a broad evidence base and a CED for devices with a developing evidence base. Response. We appreciate these comments and refer to our earlier responses addressing similar issues regarding evidence development and RWE-related comments.

CED has been utilized for many years to order propecia ukwhere can you get propecia allow beneficiary access while simultaneously fostering evidence development. The public comments suggest there is an interest in additional guidance on CED. Knowing where there are gaps in clinical evidence for a device or type of devices is a preliminary question asked and researched by CMS and FDA. This gap analysis with respect order propecia ukwhere can you get propecia to the Medicare reasonable and necessary criteria is a precursor to CED parameters for a given item or service.

We are aware that manufacturers are interested in more input from CMS on what evidence needs to be developed for coverage, including a discussion of the gap analysis. Based on the comments from manufacturers that indicated they were already developing or would develop evidence following market authorization, we believe there is also interest in coordination with CMS to create an evidence development plan that is fit-for-purpose in line with manufacturer coverage goals to ensure that Medicare patients are protected. Comment order propecia ukwhere can you get propecia. Several health plans participating in Medicare Advantage (MA) and their advocacy associations submitted comments that raised concerns with the MCIT/R&N final rule.

Associations specifically indicated that the final rule should be rescinded and not implemented. In general, they order propecia ukwhere can you get propecia recommend post market data collection and use of existing coverage pathways. One health plan noted several concerns for the MA plans if the MCIT/R&N final rule is implemented specific to bids and plan payment rates and related downstream effects for beneficiaries such as increased out of pocket costs, fewer benefits, and perhaps even fewer plan offerings.Start Printed Page 26852 Response. There is not a substantive discussion on how the MCIT pathway would affect MA plans in the MCIT/R&N final rule.

Under current law, MA plans are required to offer coverage of reasonable and necessary items and services covered under part order propecia ukwhere can you get propecia A and part B on terms at least as favorable as those adopted by fee for service Medicare. CMS did not fully consider the MA effects in the MCIT/R&N final rule. Specifically, the cost implications for MA plans of blanket national coverage and all of the associated costs to the breakthrough device was not fully explored. For example, if a breakthrough device was implanted, Medicare would pay not just for the device, but also for the reasonable and necessary procedures and related care and services such as the surgery, order propecia ukwhere can you get propecia and related visits to prepare for surgery and follow up.

These non-device costs were not considered in the regulatory impact analysis (RIA). Comment. Some commenters noted that the MCIT/R&N final rule could potentially lead to increased order propecia ukwhere can you get propecia fraud, waste and abuse. A commenter noted that, under the final rule, the current MCIT construct offering guaranteed Medicare payment for 3 to 4 years with broad-based coverage criteria and minimal limitations for a massive patient population is a strong scenario for fraud.

Response. We believe the commenters are suggesting that the expanded coverage may encourage greater use of these devices than they believe is warranted order propecia ukwhere can you get propecia. Because these determinations would depend on specific facts, CMS would follow its normal process in the event there was a concern of fraud or abuse. Comment.

Another stakeholder raised concerns that the MCIT/R&N final rule as currently constructed only considers order propecia ukwhere can you get propecia industry's perspective and does not take into account physician and patient perspectives. They further noted that for MCIT there is no established mechanism in place for those stakeholders to provide comments regarding their concerns about using these technologies on the Medicare population. To that end, they claim that the current MCIT/R&N final rule lacks the transparency and accountability found in the existing NCD and LCD processes. Response order propecia ukwhere can you get propecia.

We appreciate these comments. We acknowledge that the MCIT/R&N final rule as currently designed does not provide the same level of opportunities for public participation as stakeholders have become accustomed to with the established NCD and LCD processes where, for each item or service considered for coverage, stakeholders have an opportunity to comment. Comment order propecia ukwhere can you get propecia. Regarding operational issues for MCIT, manufacturers commented that the existing processes in place for BCD, coding, and payment should work for MCIT, and that early coordination with CMS shortly after breakthrough designation should allow for time for these processes to play out.

Commenters, including several manufacturers, recommended that CMS establish provisional codes and payment for breakthrough devices as part of the MCIT pathway to ensure availability of codes and payment at the time of FDA approval. They also recommended that CMS formalize an operational framework with a predictable timeline to conduct evidence reviews, develop benefit category order propecia ukwhere can you get propecia determinations, codes, and payment. Response. We will take these suggestions under consideration for future rulemaking.

Comment order propecia ukwhere can you get propecia. Commenters indicated that the newly public information about the volume increase in the Breakthrough Device volume [] was not a concern and that it should not impede implementation of the MCIT/R&N final rule. Others stated that the RIA was sufficient because not all devices designated as breakthrough would ultimately achieve market authorization after the 4-year period. Still others believed the order propecia ukwhere can you get propecia RIA was insufficient because they believe there would be more breakthrough devices market authorized than included in the estimate.

In light of the increase in volume, a commenter suggested considering mechanisms, such as establishing user fees, to increase resources through dedicated appropriation or other mechanisms. Response. We must take into consideration the number order propecia ukwhere can you get propecia of possible devices that will be approved through the MCIT pathway. Further, under the MCIT/R&N final rule any breakthrough device that receives FDA market-authorization is potentially covered for any Medicare patient without evidence of its benefit generated in the Medicare population.

Beyond limits in the indications for use for which FDA approves or clears a device, CMS does not have the authority under the finalized MCIT policy to further define clinical parameters to narrow or expand national coverage. In addition, all related care and services associated with the device are covered which could include additional visits and maintenance order propecia ukwhere can you get propecia of the device. CMS did not factor these costs in the RIA. This analysis has an impact on ensuring there are sufficient resources for the program to run efficiently.

As with any program, sufficient resources are key order propecia ukwhere can you get propecia to efficient and timely operations. Comment. Most manufacturers commented that the patient protections in place in the final rule, specifically the reliance on FDA safety and efficacy requirements to grant coverage to breakthrough devices under MCIT, were sufficient to prevent beneficiary harm. Response order propecia ukwhere can you get propecia.

As finalized in the MCIT/R&N final rule, devices could be used on Medicare patients without any evidence of the devices' clinical utility in the Medicare population. To remove a device from Medicare coverage under MCIT, FDA must issue a safety communication, warning letter, or remove the device from the market. Under the MCIT/R&N final rule, if CMS observes a trend of higher risk, specifically in the Medicare population, CMS order propecia ukwhere can you get propecia authority to deny coverage is limited. For example, if a CMS contractor (for example, a Medicare Administrative Contractor (MAC)) identifies a pattern or trend of significant patient harm or death related to an MCIT device, there is no procedure to quickly remove coverage for the device until and unless the FDA acts.

We believe that the public should have an additional opportunity to comment on this policy. Comment order propecia ukwhere can you get propecia. A commenter recommends that MCIT coverage could be offered to the class of the breakthrough device including device iterations and follow-on competitive devices. The commenter suggested that CMS direct an evidence review at the end of the 4 years of MCIT coverage for a particular device determine which coverage pathway would be most appropriate to ensure the most benefit to Medicare patients.

Response order propecia ukwhere can you get propecia. Clinical evidence development that includes Medicare beneficiaries is central to ensuring that Medicare patients are receiving optimal clinical care and minimizing risk when possible. While examining data on a group of similar breakthrough devices and identifying gaps in the evidence base may be a greater effort initially than the evidence review for one device, it could result in efficiencies across several components within CMS and inform coverage in a more comprehensive manner than MCIT, which is one device at a time. We will Start Printed Page 26853seek additional order propecia ukwhere can you get propecia public comments on this topic when considering any proposed changes.

Comment. Some stakeholders supported defining “reasonable and necessary” in regulation while others do not believe a codified definition is necessary. Commenters expressed concerns about transparency of commercial coverage polices and believed the rule could unnecessarily restrict coverage by relying on commercial insurer policies order propecia ukwhere can you get propecia designed for a different population with different incentives. Furthermore, the majority of public comments from patient advocates, policy “think tanks,” health insurance advocates and manufacturers did not support including commercial insurer criteria in the definition.

Most public comments noted that CMS can (and has) reviewed commercial policies in recent years as part of a national coverage analysis. Other commenters suggested separating and reissuing separate rules for the definition of “reasonable and necessary” and MCIT because they were viewed as order propecia ukwhere can you get propecia too distinct. Response. We will consider this comment for future rulemaking.

C. Impracticability of Implementation by May 15, 2021 As noted previously, many commenters on the March 2021 IFC supported delaying the MCIT/R&N final rule. Based upon the public comments expressing significant evidentiary concerns, we do not believe that it is in the best interest of Medicare beneficiaries for the MCIT/R&N final rule to become effective May 15, 2021. Under the current rule, there no requirement for evidence that MCIT devices will specifically benefit the Medicare target population.

Additionally, the final rule takes away tools the CMS has to deny coverage when it becomes apparent that a particular device can be harmful to the Medicare population. If the rule goes into effect, and a device is later found to be harmful to Medicare recipients is approved under the MCIT pathway, CMS would be limited in the actions it can take to withdraw or modify coverage to protect beneficiaries. As was noted by some commenters, early and unrestricted adoption of devices may have consequences that may not be easy to reverse. Commenters referenced publications that highlight the relationship between manufacturers and physicians and claimed that the potential for manufacturers to influence physician behavior will persist if coverage is guaranteed under MCIT.

Guaranteed coverage under MCIT may further stimulate providers to adopt these technologies and could potentially lead to these technologies being prematurely viewed as standard of care which could adversely impact beneficiaries if a product does not ultimately receive Medicare coverage. Additionally, providers may make capital and capacity investments that could pose challenges to withdrawing coverage. A common theme among some commenters is that, under the MCIT/R&N final rule as currently written, the evidence used to support FDA clearance or approval of a breakthrough device is not generalizable to the Medicare population since the Medicare population is often not adequately represented in clinical trials. Commenters noted that existing Medicare coverage paradigms rely on careful consideration of the tradeoffs between benefits and risks for the Medicare population and adequate evidence that demonstrates improved health outcomes.

Commenters expressed concerns that devices covered under MCIT would not achieve that standard. Additionally, commenters cited several published studies that noted that approval of many breakthrough devices relied upon intermediate endpoints which do not always translate into real world improved health outcomes. Multiple commenters also pointed out that a major limitation of the MCIT pathway under the MCIT/R&N final rule is that manufacturers are not required or incentivized to conduct clinical trials to generate additional evidence, and contended that it is unlikely that manufacturers will voluntarily choose to do so. Further, the shift of the burden of evidence development entirely to manufacturers undermines CMS' ability to support evidence development or establish the coverage criteria (for example, provider experience, location of service, availability of supporting services) that are central to delivery of high-quality, evidence-based care for devices with insufficient evidence of a health benefit for Medicare patients.

An additional delay in the effective date would allow time for CMS to address the evidentiary concerns raised by stakeholders and consider how to better balance the needs of all stakeholders and beneficiaries in particular. Additionally, there is significant uncertainty surrounding coding and payment for new MCIT devices since these issues were not addressed in the MCIT/R&N final rule. If the MCIT/R&N final rule goes into effect, we believe there could be confusion and disruption stemming from devices receiving MCIT approval without a clear path for appropriate coding and payment. The delay will allow CMS time to ensure the public has a clear understanding of the pathways to coverage, coding, and payment.

Further, the delay gives CMS time to evaluate stakeholders' recommendation of whether the reasonable and necessary definition should be a separate rule. There were a number of stakeholder comments supporting delaying defining “reasonable and necessary” in regulation. Commenters did not believe a codified definition was necessary or thought the rule could unnecessarily restrict coverage by relying on commercial insurer policies. Furthermore, the majority of public comments from patient advocates, policy think tanks, health insurance advocates and manufactures did not support including commercial insurer criteria in the definition.

Most public comments noted that CMS can (and has) reviewed commercial policies in recent years as part of a national coverage analysis. Future rulemaking will provide an opportunity for us to fully consider the significant objections to the rule, and will provide another opportunity for the public to present contrary facts and arguments. II. Provisions of the Final Rule This final rule would further delay the effective date of the MCIT/R&N final rule until December 15, 2021, to provide CMS an opportunity to address all of the issues raised by stakeholders, especially Medicare patient protections, evidence criteria and lack of coordination between coverage, coding and payment as noted previously.

During the delay, we will determine appropriate next steps that are in the best interest of all Medicare stakeholders, and beneficiaries in particular. This final rule delays the effective date of the January 2021 MCIT/R&N final rule as specified in the DATES section of this final rule. III. Waiver of the 30-Day Delay in Effective Date The Administrative Procedure Act, 5 U.S.C.

553(d), and section 1871(e)(1)(B)(i) of the Act usually require a 30-day delay in effective date after issuance or publication of a rule, subject to exceptions. The purpose of the 30-day delay is to allow the public to prepare to implement the new final rule. We find good cause to waive the 30-day delay in the effective date because the further extension will maintain the status quo, so the public does not need notice to adjust their Start Printed Page 26854behavior as a result of the additional delay. Moreover, allowing the prior rule to go into effect would defeat the purpose of the delay rule and result in the same difficulties that were identified regarding reversing course once the rule was in place and would be contrary to the public interest.

Start Signature Dated. May 13, 2021. Xavier Becerra, Secretary, Department of Health and Human Services. End Signature I, Elizabeth Richter, Acting Administrator of the Centers for Medicare &.

Medicaid Services, Approved This Document on May 12, 2021 End Supplemental Information [FR Doc. 2021-10466 Filed 5-14-21. 4:15 pm]BILLING CODE 4120-01-PStart Preamble Centers for Medicare &. Medicaid Services, Health and Human Services (HHS).

Notice. The Centers for Medicare &. Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action.

Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Comments must be received by July 19, 2021. When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways.

1. Electronically. You may send your comments electronically to http://www.regulations.gov. Follow the instructions for “Comment or Submission” or “More Search Options” to find the information collection document(s) that are accepting comments.

2. By regular mail. You may mail written comments to the following address. CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention.

Document Identifier/OMB Control Number. CMS-P-0015A, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following. 1.

Access CMS' website address at https://www.cms.gov/​Regulations-and-Guidance/​Legislation/​PaperworkReductionActof1995/​PRA-Listing.html. Start Further Info William N. Parham at (410) 786-4669. End Further Info End Preamble Start Supplemental Information Contents This notice sets out a summary of the use and burden associated with the following information collections.

More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES). CMS-R-185—Granting and Withdrawal of Deeming Authority to Private Nonprofit Accreditation Organizations and CLIA Exemption Under State Laboratory CMS-10166—Fee-for-Service Improper Payment Rate Measurement in Medicaid and the Children's Health Insurance Program CMS-10178—Medicaid and Children's Health Insurance (CHIP) Managed Care Payments and Related Information CMS-10184—Payment Error Rate Measurement—State Medicaid and CHIP Eligibility CMS-10417—Medicare Fee-for-Service Prepayment Review of Medical Records CMS-372(S)—Annual Report on Home and Community Based Services Waivers and Supporting Regulations Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C.

3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice. Information Collection 1.

Type of Information Collection Request. Extension of currently approved collection. Title of Information Collection. Granting and Withdrawal of Deeming Authority to Private Nonprofit Accreditation Organizations and CLIA Exemption Under State Laboratory Programs.

Use. The information required is necessary to determine whether a private accreditation organization/State licensure program standards and accreditation/licensure process is at least equal to or more stringent than those of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). If an accreditation organization is approved, the laboratories that it accredits are “deemed” to meet the Start Printed Page 26922CLIA requirements based on this accreditation. Similarly, if a State licensure program is determined to have requirements that are equal to or more stringent than those of CLIA, its laboratories are considered to be exempt from CLIA certification and requirements.

The information collected will be used by HHS to. Determine comparability/equivalency of the accreditation organization standards and policies or State licensure program standards and policies to those of the CLIA program. To ensure the continued comparability/equivalency of the standards. And to fulfill certain statutory reporting requirements.

Form Number. CMS-R-185 (OMB control number. 0938-0686). Frequency.

Occasionally. Affected Public. Private Sector—Business or other for-profits and Not-for-profit institutions. Number of Respondents.

9. Total Annual Responses. 9. Total Annual Hours.

5,464. (For policy questions regarding this collection contact Arlene Lopez at 410-786-6782.) 2. Type of Information Collection Request. Reinstatement without change of a currently approved collection.

Title of Information Collection. Fee-for-Service Improper Payment Rate Measurement in Medicaid and the Children's Health Insurance Program. Use. The information collected from the selected States will be used by Federal contractors to conduct Medicaid and CHIP FFS data processing and medical record reviews on which State-specific improper payment rates will be calculated.

The quarterly FFS claims and payments will provide the contractor with the actual claims to be sampled. The systems manuals, provider policies, and other supporting documentation will be used by the federal contractor when conducting the FFS data processing and medical record reviews. Further, the FFS claims and payments sampled for data processing and medical record reviews will serve as the basis for the eligibility reviews. Individuals for whom the state made the FFS claim or payments will have their underlying eligibility reviewed.

In addition to the Federal Review Contractor conducting a data processing and medical record review of the FFS claims and payments, the FFS sample selected from the state-submitted universe will also be leveraged to support the PERM eligibility reviews. The Federal Eligibility Review Contractor will review the underlying eligibility of individuals whose FFS claims and payments were sampled as part of the PERM FFS sample. Form Number. CMS-10166 (OMB control number.

0938-0974). Frequency. Quarterly. Affected Public.

State, Local, or Tribal Governments. Number of Respondents. 17. Total Annual Responses.

34. Total Annual Hours. 56,100. (For policy questions regarding this collection contact Daniel Weimer at 410-786-5240.) 3.

Type of Information Collection Request. Reinstatement without change of a currently approved collection. Title of Information Collection. Medicaid and Children's Health Insurance (CHIP) Managed Care Payments and Related Information.

Use. The information collected from the selected States will be used by Federal contractors to conduct Medicaid and CHIP managed care data processing reviews on which State-specific improper payment rates will be calculated. The quarterly capitation payments will provide the contractor with the actual claims to be sampled. The managed care contracts, rate schedules, and updates to both, will be used by the federal contractor when conducting the managed care claims reviews.

Further, the managed care capitation payments sampled for data processing reviews will serve as the basis for the eligibility reviews. Individuals for whom the state made the managed care capitation will have their underlying eligibility reviewed. Section 2(b)(1) of IPERA clarified that, when meeting IPIA and IPERA requirements, agencies must produce a statistically valid estimate, or an estimate that is otherwise appropriate using a methodology approved by the Director of the OMB. IPERIA further clarified requirements for agency reporting on actions to reduce improper payments and recover improper payments.

The collection of information is necessary for CMS to produce national improper payment rates for Medicaid and CHIP as required by Public Law 107-300. Form Number. CMS-10178 (OMB control number. 0938-0994).

Frequency. Quarterly. Affected Public. State, Local, or Tribal Governments.

Number of Respondents. 17. Total Annual Responses. 34.

Total Annual Hours. 19,550. (For policy questions regarding this collection contact Daniel Weimer at 410-786-5240.) 4. Type of Information Collection Request.

Reinstatement with change of a previously approved collection. Title of Information Collection. Payment Error Rate Measurement—State Medicaid and CHIP Eligibility. Use.

The Payment Error Rate Measurement (PERM) program was developed to implement the requirements of the Improper Payments Information Act (IPIA) of 2002 (Pub. L. 107-300), which requires the head of federal agencies to annually review all programs and activities that it administers to determine and identify any programs that are susceptible to significant erroneous payments. If programs are found to be susceptible to significant improper payments, then the agency must estimate the annual amount of erroneous payments, report those estimates to the Congress, and submit a report on actions the agency is taking to reduce improper payments.

IPIA was amended by Improper Payments Elimination and Recovery Act of 2010 (IPERA) (Pub. L. 111-204), the Improper Payments Elimination and Recovery Improvement Act of 2012 (IPERIA) (Pub. L.

112-248), and the Payment Integrity Information Act of 2019 (PIIA) (Pub. L. 116-117). The eligibility case documentation collected from the States, through submission of hard copy case files and through access to state eligibility systems, will be used by CMS and its federal contractors to conduct eligibility case reviews on individuals who had claims paid on their behalf in order to determine the improper payment rate associated with Medicaid and CHIP eligibility to comply with the IPIA of 2002.

Prior to the July 2017 Final Rule being published in response to the Affordable Care Act, states provided CMS only with information about their sampling and review process as well as the final review findings, which CMS has used in each PERM cycle to calculate IPIA-compliant state and federal improper payment rate for Medicaid and CHIP. Given changes brought forth in the July 2017 Final Rule, states will no longer be required to develop eligibility-specific universes, conduct case reviews, and report findings to CMS. A federal contractor will utilize the claims (fee-for-service and managed care universes) to identify a sample of individuals and will be responsible for conducting case reviews to support the PERM measurement. Form Number.

CMS-10184 (OMB control number. 0938-1012). Frequency. Quarterly.

Affected Public. State, Local, or Tribal Governments. Number of Respondents. 17.

Total Annual Responses. 34. Total Annual Hours. 25,500.

(For policy questions regarding this collection contact Daniel Weimer at 410-786-5240.) 5. Type of Information Collection Request. Revision of a currently approved collection. Title of Information Collection.

Medicare Fee-for-Service Prepayment Review of Medical Records. Use. The Medical Review program is designed to prevent improper payments in the Medicare FFS program. Whenever possible, Medicare Administrative Contractors (MACs) are Start Printed Page 26923encouraged to automate this process.

However, it may require the evaluation of medical records and related documents to determine whether Medicare claims are billed in compliance with coverage, coding, payment, and billing policies. Addressing improper payments in the Medicare fee-for-service (FFS) program and promoting compliance with Medicare coverage and coding rules is a top priority for the CMS. Preventing Medicare improper payments requires the active involvement of every component of CMS and effective coordination with its partners including various Medicare contractors and providers. The information required under this collection is requested by Medicare contractors to determine proper payment, or if there is a suspicion of fraud.

Medicare contractors request the information from providers/suppliers submitting claims for payment when data analysis indicates aberrant billing patterns or other information which may present a vulnerability to the Medicare program. Form Number. CMS-10417. Frequency.

Occasionally. Affected Public. Private Sector, State, Business, and Not-for Profits. Number of Respondents.

485,632. Number of Responses. 485,632. Total Annual Hours.

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Comments must propecia vs rogaine be received by 11:59:59 p.m. (ET) on December 7, 2020 to ensure consideration. Start Printed Page 69336 All comments must be submitted electronically on the submission website, available at. Https://rfi.grants.nih.gov/​?. S=​5f91a3efdb70000018003362.

Start Further Info Please direct all inquiries to. Beth Walsh, nihstrategicplan@od.nih.gov, 301-496-4000. End Further Info End Preamble Start Supplemental Information Urgent public health measures are needed to control the spread of the novel hair loss (hair loss) and the disease it causes, hair loss disease 2019, or hair loss treatment. Scientific research to improve basic understanding of hair loss and hair loss treatment, and to develop the necessary tools and approaches to better prevent, diagnose, and treat this disease is of paramount importance. The NIH-Wide Strategic Plan for hair loss treatment Research (available at.

Https://www.nih.gov/​research-training/​medical-research-initiatives/​nih-wide-strategic-plan-hair loss treatment-research), released on July 13, 2020, provides a framework for achieving this goal. It describes how NIH is rapidly mobilizing diverse stakeholders, including the biomedical research community, industry, and philanthropic organizations, through new programs and existing resources, to lead a swift, coordinated research response to this global propecia. The plan outlines how NIH is implementing five Priorities, guided by three Crosscutting Strategies. Priorities Priority 1. Improve Fundamental Knowledge of hair loss and hair loss treatment ○ Objective 1.1.

Advance fundamental research for hair loss and hair loss treatment ○ Objective 1.2. Support research to develop preclinical models of hair loss and hair loss treatment ○ Objective 1.3. Advance the understanding of hair loss transmission and hair loss treatment dynamics at the population level ○ Objective 1.4. Understand hair loss treatment disease progression, recovery, and psychosocial and behavioral health consequences Priority 2. Advance Detection and Diagnosis of hair loss treatment ○ Objective 2.1.

Support research to develop and validate new diagnostic technologies ○ Objective 2.2. Retool existing diagnostics for detection of hair loss ○ Objective 2.3. Support research to develop and validate serological assays Priority 3. Advance the Treatment of hair loss treatment ○ Objective 3.1. Identify and develop new or repurposed treatments for hair loss ○ Objective 3.2.

Evaluate new, repurposed, or existing treatments and treatment strategies for hair loss treatment ○ Objective 3.3. Investigate strategies for access to and implementation of hair loss treatments Priority 4. Improve Prevention of hair loss ○ Objective 4.1. Develop novel treatments for the prevention of hair loss treatment ○ Objective 4.2. Develop and study other methods to prevent hair loss transmission ○ Objective 4.3.

Develop effective implementation models for preventive measures Priority 5. Prevent and Redress Poor hair loss treatment Outcomes in Health Disparity and Vulnerable Populations ○ Objective 5.1. Understand and address hair loss treatment as it relates to health disparities and hair loss treatment—vulnerable populations in the United States ○ Objective 5.2. Understand and address hair loss treatment maternal health and pregnancy outcomes ○ Objective 5.3. Understand and address age-specific factors in hair loss treatment ○ Objective 5.4.

Address global health research needs from hair loss treatment Crosscutting Strategies Partnering to promote collaborative science ○ Leverage existing NIH-funded global research networks and private sector, public, and non-profit relationships ○ Coordinate with Federal partners ○ Establish new public-private partnerships Supporting the research workforce and infrastructure ○ Conduct research to elucidate how hair loss treatment impacts the scientific workforce ○ Provide research resources ○ Leverage intramural infrastructure to support extramural researchers ○ Conduct virtual peer review processes Investing in data science ○ Create new data science resources and analytical tools ○ Develop shared metrics and terminologies NIH seeks comments on any or all of, but not limited to, the following topics. Significant research gaps or barriers not identified in the existing framework above. Resources required or lacking or existing leverageable resources (e.g., existing partnerships, collaborations, or infrastructure) that could advance the strategic priorities. Emerging scientific advances or techniques in basic, diagnostic, therapeutic, or treatment research that may accelerate the research priorities detailed in the framework above. And Additional ideas for bold, innovative research initiatives, processes, or data-driven approaches that could advance the response to hair loss treatment.

NIH encourages organizations (e.g., patient advocacy groups, professional organizations) to submit a single response reflective of the views of the organization or membership as a whole. Responses to this RFI are voluntary and may be submitted anonymously. Please do not include any personally identifiable information or any information that you do not wish to make public. Proprietary, classified, confidential, or sensitive information should not be included in your response. The Government will use the information submitted in response to this RFI at its discretion.

The Government reserves the right to use any submitted information on public websites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements. This RFI is for informational and planning purposes only and is not a solicitation for applications or an obligation on the part of the Government to provide support for any ideas identified in response to it. Please note that the Government will not pay for the preparation of any information submitted or for use of that information. We look forward to your input and hope that you will share this RFI opportunity with your colleagues. Start Signature Dated.

October 27, 2020. Lawrence A. Tabak, Principal Deputy Director, National Institutes of Health. End Signature End Supplemental Information [FR Doc. 2020-24202 Filed 10-30-20.

8:45 am]BILLING CODE 4140-01-PSign up for our newsletter Explore full page map The language we’ve heard to describe hair loss treatment in rural America is evolving. Early in the propecia, healthcare professionals were concerned. Later, some were alarmed. Now, what I hear sounds a lot like shock. In a story we published earlier today, Alan Morgan with the National Rural Health Association called the rural propecia a horror story.

Carrie Henning-Smith with the University of Minnesota Rural Health Research Center has another word. Ominous. That’s not the kind of comforting word we like to hear from our caregivers. But a cheerful bedside manner doesn’t seem to be doing the job with rural America. €œI think that there was a chance early on to try to contain this, when we had this as a mostly urban phenomenon back in March and April,” said Henning-Smith, who is also an associate professor in the School of Public Health at the University of Minnesota.

€œWe blew way past that. And now this has spread into virtually every county in the country, in metro and non-metro alike.” Welcome to the rural wave – the phase of the propecia that is swamping rural America with record numbers of hair loss treatment s. Late this spring, we still had swaths of rural America – mostly in the Midwest and Great Plains – that went weeks without a single case. On June 1, nearly 9% of rural counties hadn’t reported any s. Today, only one county in the Lower 48 hasn’t reported a case of hair loss treatment.

For the rest of rural America, most of the news is bad. The rate of new s in rural counties is 65% higher than in urban counties. The number of new cases in rural America has set a record each of the last five weeks. Seventy percent of rural counties are at risk of uncontrolled spread, what the White House hair loss Task Force calls the red zone. Something different is happening in rural America in this surge.

The coastal and urban regions that bore the brunt of the summer surge look relatively contained now. The trouble spots, as shown in the map above, are in the interior. Why is hair loss treatment surging now in these areas that got off relatively easy this summer?. Henning-Smith, who holds three master’s level degrees and a PhD, cited several possibilities. The first may be “hair loss treatment fatigue.” “It took longer to get to rural areas and it’s hard to keep the public relentlessly engaged and being mindful and cautious as the propecia wears on,” she said.

Another factor is politics, she said. €œThere are definitely some strong relationships where we’re seeing very, very mixed messaging at the highest levels of the federal government about even the most basic precautions for hair loss treatment.” And some of it is just the nature of the hair loss. All things equal, the propecia spreads from one host to the next. Think of spreading peanut butter on toast. You won’t get it to a uniform thickness, but each swipe of the knife gets you closer.

€œ[The graphs] give every indication that rural areas will catch up to urban, and we’ll see proportional rates of hair loss treatment cases and hair loss treatment deaths in rural, relative to urban,” Henning-Smith said. Rural areas could even get worse than urban ones eventually, she said. A host of factors make that a possibility. Rural employment may not be as suited for remote work. Services like online grocery ordering and delivery are less available in rural areas.

Lack of broadband may mean rural people have to do more activities in person. Contact tracing may not be as robust. Testing can be more challenging in less densely populated areas. Henning-Smith, whose research focuses on health equity, also said race is a factor in how hair loss treatment is spreading and what happens when it reaches a community. €œI don’t think we’re talking enough about the intersection of [race and rurality], of the impact of structural racism among rural residents,” she said.

Most people have a choice about whether to wear a mask. Fewer of us have a choice about other factors that contribute to the spread of hair loss treatment. €œWho has the luxury of containing themselves to their household so they don’t get it?. € she said. €œWho lives in a house that’s not crowded, so they’re not spreading it to their family members?.

Who has access to healthcare, decent health insurance?. Who still has a hospital or a clinic in town to get the care that they need, if they need it?. € Tim Murphy contributed data analysis to this article. Before You Go The Daily Yonder is a nonprofit news platform dedicated to reporting on rural people, places, and issues. Donations from readers like you makes it possible for us to fulfill this important mission.

So far this year, we’ve helped readers understand where rural America fits in the hair loss treatment propecia, the 2020 election, and the fight for racial equity. For the rest of 2020, you have a special opportunity to double your contribution to the Daily Yonder. Your gift will be matched dollar for dollar by NewsMatch, a nonprofit news funding program. All you have to do to help us get this extra support is make a gift, in any amount. It’s that simple.

Thanks for reading the Daily Yonder, for sharing our content with friends and neighbors, and for making your contribution today. You Might Also Like.

Because of order propecia ukwhere can you get propecia the urgency and evolving nature of the propecia, NIH intends this plan to be a How to buy cheap cipro online living document, which will be continually updated to reflect new challenges presented by hair loss treatment. To ensure that it remains in step with public needs, this RFI invites stakeholders throughout the scientific research, advocacy, and clinical practice communities, as well as the general public to comment on the NIH-Wide Strategic Plan for hair loss treatment Research. Organizations are strongly encouraged to submit a single response that reflects the views of their organization and their membership as a whole. This RFI is open for public comment for a order propecia ukwhere can you get propecia period of five weeks.

Comments must be received by 11:59:59 p.m. (ET) on December 7, 2020 to ensure consideration. Start Printed Page 69336 All comments must be submitted electronically on the submission website, available order propecia ukwhere can you get propecia at. Https://rfi.grants.nih.gov/​?.

S=​5f91a3efdb70000018003362. Start Further order propecia ukwhere can you get propecia Info Please direct all inquiries to. Beth Walsh, nihstrategicplan@od.nih.gov, 301-496-4000. End Further Info End Preamble Start Supplemental Information Urgent public health measures are needed to control the spread of the novel hair loss (hair loss) and the disease it causes, hair loss disease 2019, or hair loss treatment.

Scientific research to improve basic understanding of hair loss and hair loss treatment, and to develop the necessary tools and approaches order propecia ukwhere can you get propecia to better prevent, diagnose, and treat this disease is of paramount importance. The NIH-Wide Strategic Plan for hair loss treatment Research (available at. Https://www.nih.gov/​research-training/​medical-research-initiatives/​nih-wide-strategic-plan-hair loss treatment-research), released on July 13, 2020, provides a framework for achieving this goal. It describes how NIH is order propecia ukwhere can you get propecia rapidly mobilizing diverse stakeholders, including the biomedical research community, industry, and philanthropic organizations, through new programs and existing resources, to lead a swift, coordinated research response to this global propecia.

The plan outlines how NIH is implementing five Priorities, guided by three Crosscutting Strategies. Priorities Priority 1. Improve Fundamental order propecia ukwhere can you get propecia Knowledge of hair loss and hair loss treatment ○ Objective 1.1. Advance fundamental research for hair loss and hair loss treatment ○ Objective 1.2.

Support research to develop preclinical models of hair loss and hair loss treatment ○ Objective 1.3. Advance the understanding of hair loss transmission and hair loss treatment order propecia ukwhere can you get propecia dynamics at the population level ○ Objective 1.4. Understand hair loss treatment disease progression, recovery, and psychosocial and behavioral health consequences Priority 2. Advance Detection and Diagnosis of hair loss treatment ○ Objective 2.1.

Support research to develop and validate new diagnostic order propecia ukwhere can you get propecia technologies ○ Objective 2.2. Retool existing diagnostics for detection of hair loss ○ Objective 2.3. Support research to develop and validate serological assays Priority 3. Advance the order propecia ukwhere can you get propecia Treatment of hair loss treatment ○ Objective 3.1.

Identify and develop new or repurposed treatments for hair loss ○ Objective 3.2. Evaluate new, repurposed, or existing treatments and treatment strategies for hair loss treatment ○ Objective 3.3. Investigate strategies for access to and implementation of hair loss treatments order propecia ukwhere can you get propecia Priority 4. Improve Prevention of hair loss ○ Objective 4.1.

Develop novel treatments for the prevention of hair loss treatment ○ Objective 4.2. Develop and study other methods to prevent hair loss order propecia ukwhere can you get propecia transmission ○ Objective 4.3. Develop effective implementation models for preventive measures Priority 5. Prevent and Redress Poor hair loss treatment Outcomes in Health Disparity and Vulnerable Populations ○ Objective 5.1.

Understand and address hair loss treatment as it order propecia ukwhere can you get propecia relates to health disparities and hair loss treatment—vulnerable populations in the United States ○ Objective 5.2. Understand and address hair loss treatment maternal health and pregnancy outcomes ○ Objective 5.3. Understand and address age-specific factors in hair loss treatment ○ Objective 5.4. Address global health research needs from hair loss treatment Crosscutting Strategies Partnering to promote collaborative science ○ Leverage existing NIH-funded global research networks and private sector, public, and non-profit relationships order propecia ukwhere can you get propecia ○ Coordinate with Federal partners ○ Establish new public-private partnerships Supporting the research workforce and infrastructure ○ Conduct research to elucidate how hair loss treatment impacts the scientific workforce ○ Provide research resources ○ Leverage intramural infrastructure to support extramural researchers ○ Conduct virtual peer review processes Investing in data science ○ Create new data science resources and analytical tools ○ Develop shared metrics and terminologies NIH seeks comments on any or all of, but not limited to, the following topics.

Significant research gaps or barriers not identified in the existing framework above. Resources required or lacking or existing leverageable resources (e.g., existing partnerships, collaborations, or infrastructure) that could advance the strategic priorities. Emerging scientific advances or techniques in basic, diagnostic, therapeutic, or treatment research that may accelerate the order propecia ukwhere can you get propecia research priorities detailed in the framework above. And Additional ideas for bold, innovative research initiatives, processes, or data-driven approaches that could advance the response to hair loss treatment.

NIH encourages organizations (e.g., patient advocacy groups, professional organizations) to submit a single response reflective of the views of the organization or membership as a whole. Responses to this RFI are voluntary order propecia ukwhere can you get propecia and may be submitted anonymously. Please do not include any personally identifiable information or any information that you do not wish to make public. Proprietary, classified, confidential, or sensitive information should not be included in your response.

The Government order propecia ukwhere can you get propecia will use the information submitted in response to this RFI at its discretion. The Government reserves the right to use any submitted information on public websites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements. This RFI is for informational and planning purposes only and is not a solicitation for applications or an obligation on the part of the Government to provide support for any ideas identified in response to it. Please note that the Government will not pay for the preparation of any order propecia ukwhere can you get propecia information submitted or for use of that information.

We look forward to your input and hope that you will share this RFI opportunity with your colleagues. Start Signature Dated. October 27, order propecia ukwhere can you get propecia 2020. Lawrence A.

Tabak, Principal Deputy Director, National Institutes of Health. End Signature End Supplemental Information [FR Doc order propecia ukwhere can you get propecia. 2020-24202 Filed 10-30-20. 8:45 am]BILLING CODE 4140-01-PSign up for our newsletter Explore full page map The language we’ve heard to describe hair loss treatment in rural America is evolving.

Early in order propecia ukwhere can you get propecia the propecia, healthcare professionals were concerned. Later, some were alarmed. Now, what I hear sounds a lot like shock. In a story we published earlier today, Alan Morgan with the National Rural Health Association called the rural propecia a horror story order propecia ukwhere can you get propecia.

Carrie Henning-Smith with the University of Minnesota Rural Health Research Center has another word. Ominous. That’s not order propecia ukwhere can you get propecia the kind of comforting word we like to hear from our caregivers. But a cheerful bedside manner doesn’t seem to be doing the job with rural America.

€œI think that there was a chance early on to try to contain this, when we had this as a mostly urban phenomenon back in March and April,” said Henning-Smith, who is also an associate professor in the School of Public Health at the University of Minnesota. €œWe blew way past order propecia ukwhere can you get propecia that. And now this has spread into virtually every county in the country, in metro and non-metro alike.” Welcome to the rural wave – the phase of the propecia that is swamping rural America with record numbers of hair loss treatment s. Late this spring, we still had swaths of rural America – mostly in the Midwest and Great Plains – that went weeks without a single case.

On June order propecia ukwhere can you get propecia 1, nearly 9% of rural counties hadn’t reported any s. Today, only one county in the Lower 48 hasn’t reported a case of hair loss treatment. For the rest of rural America, most of the news is bad. The rate of new s in rural counties is 65% order propecia ukwhere can you get propecia higher than in urban counties.

The number of new cases in rural America has set a record each of the last five weeks. Seventy percent of rural counties are at risk of uncontrolled spread, what the White House hair loss Task Force calls the red zone. Something different is happening in rural America in this surge order propecia ukwhere can you get propecia. The coastal and urban regions that bore the brunt of the summer surge look relatively contained now.

The trouble spots, as shown in the map above, are in the interior. Why is hair loss treatment surging now order propecia ukwhere can you get propecia in these areas that got off relatively easy this summer?. Henning-Smith, who holds three master’s level degrees and a PhD, cited several possibilities. The first may be “hair loss treatment fatigue.” “It took longer to get to rural areas and it’s hard to keep the public relentlessly engaged and being mindful and cautious as the propecia wears on,” she said.

Another factor is politics, order propecia ukwhere can you get propecia she said. €œThere are definitely some strong relationships where we’re seeing very, very mixed messaging at the highest levels of the federal government about even the most basic precautions for hair loss treatment.” And some of it is just the nature of the hair loss. All things equal, the propecia spreads from one host to the next. Think of order propecia ukwhere can you get propecia spreading peanut butter on toast.

You won’t get it to a uniform thickness, but each swipe of the knife gets you closer. €œ[The graphs] give every indication that rural areas will catch up to urban, and we’ll see proportional rates of hair loss treatment cases and hair loss treatment deaths in rural, relative to urban,” Henning-Smith said. Rural areas could even get worse than urban ones eventually, order propecia ukwhere can you get propecia she said. A host of factors make that a possibility.

Rural employment may not be as suited for remote work. Services like order propecia ukwhere can you get propecia online grocery ordering and delivery are less available in rural areas. Lack of broadband may mean rural people have to do more activities in person. Contact tracing may not be as robust.

Testing can be more challenging in less order propecia ukwhere can you get propecia densely populated areas. Henning-Smith, whose research focuses on health equity, also said race is a factor in how hair loss treatment is spreading and what happens when it reaches a community. €œI don’t think we’re talking enough about the intersection of [race and rurality], of the impact of structural racism among rural residents,” she said. Most people have a choice about whether to wear a mask order propecia ukwhere can you get propecia.

Fewer of us have a choice about other factors that contribute to the spread of hair loss treatment. €œWho has the luxury of containing themselves to their household so they don’t get it?. € she said order propecia ukwhere can you get propecia. €œWho lives in a house that’s not crowded, so they’re not spreading it to their family members?.

Who has access to healthcare, decent health insurance?. Who still has a hospital or a clinic in town to get the care order propecia ukwhere can you get propecia that they need, if they need it?. € Tim Murphy contributed data analysis to this article. Before You Go The Daily Yonder is a nonprofit news platform dedicated to reporting on rural people, places, and issues.

Donations from readers like you makes it possible for us to fulfill this important mission. So far this year, we’ve helped readers understand where rural America fits in the hair loss treatment propecia, the 2020 election, and the fight for racial equity. For the rest of 2020, you have a special opportunity to double your contribution to the Daily Yonder. Your gift will be matched dollar for dollar by NewsMatch, a nonprofit news funding program.

What may interact with Propecia?

  • some blood pressure medications
  • male hormones (example: testosterone)
  • saw palmetto
  • soy isoflavones supplements

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

Propecia effectiveness long term

UNIVERSE EXPANDER “Cosmic Conundrum,” by Clara Moskowitz, describes how the propecia effectiveness long term most likely cause of the accelerating expansion of the universe is “vacuum propecia best price energy,” the effect of virtual particles popping in and out of existence. But it does not explain why vacuum energy would cause the universe to expand. I would think that if space is filled with evanescent virtual particles, they would collectively exert a huge gravitational force propecia effectiveness long term that would counteract expansion. CHRIS MARTINIAK Berkeley, Calif.

MOSKOWITZ REPLIES. Vacuum energy is positive and has propecia effectiveness long term a constant density throughout space. Thus, increasing the volume of space increases the total amount of vacuum energy, which requires work. It is the opposite of a gas, whose energy and density decrease as it expands.

When that happens, propecia effectiveness long term the gas exerts positive pressure. In contrast, because vacuum energy is positive, it exerts negative pressure, so galaxies on the largest scales are pushed apart, not pulled together. CONNECTING REALITIES In “The Four Most Pressing Science Priorities for the Next President,” four articles focus on the need to address hair loss treatment, attention to evidence, climate change and the restoration of expertise. From a psychological propecia effectiveness long term point of view, all these topics are deeply intertwined, and the absence of that discussion weakens the theme of the report.

Controlling hair loss treatment will, for example, end up being a challenge to human collaboration in exactly the same way mitigating the climate problem will. Both involve our capacity to not only work together but accept unwanted trade-offs. These issues propecia effectiveness long term stem from our enormous distrust of experts and hidden feelings (shame, fear of manipulation, and so on), along with an inherent uncertainty about the nature of our various realities. The problems your report identifies are important but require a much deeper theory.

What would that discussion entail?. To begin with, a lot propecia effectiveness long term of self-searching. Maybe there could be an edition of the magazine that starts from that stance. ROBERT A.

BERLEY Seattle THE EDITORS REPLY propecia effectiveness long term. In September 2019 we published a special issue called Truth, Lies &. Uncertainty. It explores such themes across disciplines and propecia effectiveness long term covers a range of neuroscience, psychology and social sciences.

BORN TO RUN In “On the Basis of Testosterone,” Grace Huckins compassionately chronicles the fact that while male athletes who were born with a genetic predisposition for height, strength or aerobic endurance are welcome to compete, women who were born with a similar predisposition are subject to intense scrutiny of their chromosomes and hormone levels. As the article describes, unnecessary medical interventions are currently ordered for women with high testosterone who wish to take part in longer international track events. As a propecia effectiveness long term simple solution to this hypocrisy, the regulators should add the word “intentional” to “performance enhancement” as they exert scrutiny. It is not intentional when a man is born with genes that will lead to height or strength.

Neither is it intentional when a woman is born with XY chromosomes, for example. The Olympic creed, as espoused by the modern games' founder, is that propecia effectiveness long term the important thing “is not the winning but the taking part.” All athletes should have the equal right to take part. RAYMOND STEFANI Lake Forest, Calif. I have been an avid reader of Scientific American for nearly 65 years, and publishing my article “Ensuring the Longevity of Digital Documents” in your January 1995 issue was one of the high points of my career as a computer scientist.

While I have largely been uninterested in competitive sports, the issues Huckins so adeptly considers propecia effectiveness long term have conceptual and practical implications far beyond that area. And she does an excellent job of teasing out the scientific, social and philosophical questions that her subject raises. The article reinforces my frequent observation that overturning the propecia effectiveness long term metaphorical rock representing any subject always reveals far more complexity, subtlety, depth and motivation for further exploration than we might expect. This, to me, is the wonder of science and of the intellectual curiosity that is one of the joys of life for those of us who are fortunate enough to experience it.

JEFF ROTHENBERG via e-mail hair loss treatment CASUALTIES “Controlling hair loss treatment,” by Tanya Lewis [“The Four Most Pressing Science Priorities for the Next President”], says, “hair loss treatment ... Has killed hundreds of thousands of people in the U.S.—the highest toll of any country.” Though true numerically, this phrase is misleading propecia effectiveness long term. Per Johns Hopkins University on February 1, the U.S. Had 441,319 total deaths.

But it ranked 10th among deaths per 100,000 people in each country's population, with propecia effectiveness long term 134.89 deaths per 100,000. And among deaths per all reported cases, it was far down the list, with a rate of 1.7 percent. As an example, while the U.K. Had 106,367 deaths at that time, it had 159.98 deaths per 100,000 and a case-fatality propecia effectiveness long term rate of 2.8 percent.

And Belgium, which had only 21,092 total deaths, had 184.66 deaths per 100,000 and a case-fatality rate of 3 percent. This does not minimize the damage that hair loss treatment has done to the U.S. Or how poorly our propecia effectiveness long term public health infrastructure has responded to this propecia. But this country is not the worst in the world.

RICHARD FERENCE Three Rivers, Mich. WILD WILD BEHEST In “Arachnid Architects” [Advances], Rachel Nuwer reports on a study exploring propecia effectiveness long term how spiders' legs automatically move to build webs that was led by biologist Fritz Vollrath. She writes that the researchers “tested the rules [of this movement] by programming a simulated virtual spider, and Vollrath says the next step is to build a physical spider robot” (emphasis mine). If somebody could let Vollrath know that robot spiders are a bad idea, I would appreciate it.

I've seen enough horror movies to recognize propecia effectiveness long term that this will not end well. DAN MAHER via e-mail CLIMATE SOLIDARITY Jordan Salama clearly expresses our constant concern, albeit almost panic, about the neglect of the planet in “Earth Is on Fire” [Forum. January 2021]. He is propecia effectiveness long term not Chicken Little.

His words ring true, and, sadly, when the U.S. Should have been leading this battle, we took a four-year hiatus from all responsibility. I am propecia effectiveness long term 76 years old. Salama's generation can rest assured that it is not alone.

Many of us choose our candidates, our stores, our purchases and our habits based on “saving the world” from trash, pollution, erosion and neglect. We are with propecia effectiveness long term you. BILL MAUK via e-mail THE EDITORS REPLY. In April, Scientific American and other major news outlets in a worldwide network called Covering Climate Now signed on to a declaration to refer to the ramifications of climate change as a “climate emergency.” ERRATUM “Reestablishing Reality,” by Jen Schwartz [“The Four Most Pressing Science Priorities for the Next President”], should have described Alondra Nelson as a professor at the Institute for Advanced Study in Princeton, N.J., not at Princeton University.In a world flooded with data, figuring out where and how to store it efficiently and inexpensively becomes a larger problem every day.

One of the most exotic solutions propecia effectiveness long term might turn out to be one of the best. Archiving information in DNA molecules. The prevailing long-term cold-storage method, which dates from the 1950s, writes data to pizza-sized reels of magnetic propecia effectiveness long term tape. By comparison, DNA storage is potentially less expensive, more energy-efficient and longer lasting.

Studies show that DNA properly encapsulated with a salt remains stable for decades at room temperature and should last much longer in the controlled environs of a data center. DNA doesn’t propecia effectiveness long term require maintenance, and files stored in DNA are easily copied for negligible cost. Even better, DNA can archive a staggering amount of information in an almost inconceivably small volume. Consider this.

Humanity will propecia effectiveness long term generate an estimated 33 zettabytes of data by 2025—that’s 3.3 followed by 22 zeroes. DNA storage can squeeze all that information into a ping-pong ball, with room to spare. The 74 million million bytes of information in the Library of Congress could be crammed into a DNA archive the size of a poppy seed—6,000 times over. Split the seed propecia effectiveness long term in half, and you could store all of Facebook’s data.

Science fiction?. Hardly. DNA storage technology exists today, propecia effectiveness long term but to make it viable, researchers have to clear a few daunting technological hurdles around integrating different technologies. As part of a major collaboration to do that work, our team at Los Alamos National Laboratory has developed a key enabling technology for molecular storage.

Our software, the Adaptive DNA Storage Codex (ADS Codex), translates data files from the binary language of zeroes and ones that computers understand into the four-letter code biology understands. ADS Codex propecia effectiveness long term is a key part of the Intelligence Advanced Research Projects Activity (IARPA) Molecular Information Storage (MIST) program. MIST seeks to bring cheaper, bigger, longer-lasting storage to big-data operations in government and the private sector, with a short-term goal of writing one terabyte—a trillion bytes—and reading 10 terabytes within 24 hours at a cost of $1,000. FROM COMPUTER CODE TO GENETIC CODE When most people think of DNA, they think of life, not computers.

But DNA is itself a four-letter code for passing propecia effectiveness long term along information about an organism. DNA molecules are made from four types of bases, or nucleotides, each identified by a letter. Adenine (A), thymine (T), guanine (G) and cytosine (C). They are the basis of all DNA code, providing the instruction manual for building every living thing on earth propecia effectiveness long term.

A fairly well-understood technology, DNA synthesis has been widely used in medicine, pharmaceuticals and biofuel development, to name just a few applications. The technique organizes the bases into various arrangements indicated by specific sequences of A, C, G and T. These bases wrap in a twisted chain around propecia effectiveness long term each other—the familiar double helix—to form the molecule. The arrangement of these letters into sequences creates a code that tells an organism how to form.

The complete set of DNA molecules makes up the genome—the blueprint of your body. By synthesizing DNA molecules—making them from scratch—researchers have found they can specify, or write, long strings of the letters A, propecia effectiveness long term C, G and T and then read those sequences back. The process is analogous to how a computer stores binary information. From there, it was a short conceptual step to encoding a binary computer file into a molecule The method has been proven to work, but reading and writing the DNA-encoded files currently takes a long time.

Appending a propecia effectiveness long term single base to DNA takes about one second. Writing an archive file at this rate could take decades, but research is developing faster methods, including massively parallel operations that write to many molecules at once. NOTHING LOST IN TRANSLATION ADS Codex tells exactly how to translate the zeros and ones into sequences of four letter-combinations of A, C, G propecia effectiveness long term and T. The Codex also handles buy propecia merck the decoding back into binary.

DNA can be synthesized by several methods, and ADS Codex can accommodate them all. Unfortunately, compared to traditional digital systems, the error rates while writing to molecular storage with DNA synthesis are very high propecia effectiveness long term. These errors arise from a different source than they do in the digital world, making them trickier to correct. On a digital hard disk, binary errors occur when a zero flips to a one, or vice versa.

With DNA, the problems come from insertion and propecia effectiveness long term deletion errors. For instance, you might be writing A-C-G-T, but sometimes you try to write A, and nothing appears, so the sequence of letters shifts to the left, or it types AAA. Normal error correction codes don’t work well with that kind of problem, so ADS Codex adds error detection codes that validate the data. When the software converts the data back to binary, it tests to see propecia effectiveness long term that the codes match.

If they don’t, it removes or adds bases—letters—until the verification succeeds. SMART SCALE-UP We have completed version 1.0 of ADS Codex, and late this year we plan to use it to evaluate the storage and retrieval systems developed by the other MIST teams. The work fits well with Los Alamos’ history of pioneering new developments in propecia effectiveness long term computing as part of our national security mission. Since the 1940s, as an outcome of those computing advancements, we have amassed some of the oldest and largest stores of digital-only data.

It still has tremendous value. Because we propecia effectiveness long term keep data forever, we’ve been at the tip of the spear for a long time when it comes to finding a cold-storage solution, but we’re not alone. All the world’s data—all your digital photos and tweets. All the records of the global financial sector.

All those satellite images of cropland, troop movements and propecia effectiveness long term glacial melting. All the simulations underlying so much of modern science. And so much more—have to go somewhere. The “cloud” propecia effectiveness long term isn’t a cloud at all.

It is digital data centers in huge warehouses consuming vast amounts of electricity to store (and keep cool) trillions of millions of bytes. Costing billions of dollars to build, power and run, these data centers may struggle to remain viable as the need for data storage continues to grow exponentially. DNA shows great promise for sating the world’s voracious appetite for data storage propecia effectiveness long term. The technology requires new tools and new ways of applying familiar ones.

But don’t be surprised if one day the world’s most valuable archives find a new home in a poppy-seed-sized collection of molecules. Funding for ADS Codex was provided by the Intelligence Advanced Research Projects Activity (IARPA), a propecia effectiveness long term research agency within the Office of the Director of National Intelligence. This is an opinion and analysis article.The Beauty of Chemistry. Art, Wonder, and Scienceby Philip BallMIT Press, 2021 ($49.95) Chemistry is perhaps the most sensual of the sciences, writer Ball posits in this absorbing collection of photographs from science artists Wenting Zhu and Yan Liang.

Behind every smell, every worldly texture, even every emotional response, there is a chemical propecia effectiveness long term reaction. The wonder of those reactions is on display here, from the mesmerizing precipitation of heavy metals such as cobalt and nickel to the thermal heat map of sodium dissolving in plain water. The alien look of a copper nitrate “chemical garden” evolves through the action of ions and precipitation. Ball explains the science of these complex reactions and propecia effectiveness long term interweaves them with literary ideas and philosophical contexts.

Far from portraying a routine lab procedure, this collection showcases chemistry's excitement and aesthetic allure. Helgoland. Making Sense of the Quantum Revolutionby Carlo RovelliRiverhead Books, 2021 ($20) It is not just laypeople who find quantum mechanics inscrutable—the more physicists ponder it, the more perplexed they become, writes physicist Rovelli. The esoteric theory describing the behavior of particles on the submicroscopic scale rewrites the rules of normal reality we are accustomed to, substituting probability for certainty.

Seriously considering its implications for understanding the world, he says, is “an almost psychedelic experience.” This entertaining and legible guide paints the history of quantum theory and lays out its possible meanings, including the author's favorite—the “relational” interpretation—which posits that things exist only through their interactions with other things. There is no absolute reality. €”Clara Moskowitz Unwell Women. Misdiagnosis and Myth in a Man-Made Worldby Elinor CleghornDutton, 2021 ($27) Researcher Cleghorn provides an essential history of misogyny in health care, beginning with the so-called father of medicine himself, Hippocrates, who wrote that female bodies were a weaker version of male bodies.

That prejudice has carried through thousands of years, and its remnants are well preserved today. Women's ailments have been an afterthought in research, and women are still underrepresented in clinical trials. Women of color are particularly underserved. Black women are up to five times as likely to die in childbirth as their white counterparts, and more than 20 percent experience discrimination when they visit doctors.

This clear-eyed assessment is both a catalog of how medicine has been complicit in female oppression and a call to action for drastic reform. The Ascent of Information. Books, Bits, Genes, Machines, and Life’s Unending Algorithmby Caleb ScharfRiverhead Books, 2021 ($28) According to some estimates, our global civilization now generates some 2.5 quintillion bytes of information. This data deluge—which astrobiologist Scharf dubs our “dataome”—has profound implications for our future, for good or ill.

For instance, is it good or bad that the dataome places a heavy physical burden on the world in the form of energy-hungry computers, storage devices and telecommunications technologies?. On such matters Scharf prefers to conservatively outline the limits of current knowledge rather than make pronouncements with false certitude, but the end result is no less audacious. A transformative new way of looking at our increasingly data-driven existence. €”Lee BillingsSeabirds are “sentinels” of ocean health.

If marine ecosystems are suffering, the birds will be among the first to show it. Now a major study finds that seabirds in the Northern Hemisphere are already struggling. And without extra precautions, those in the Southern Hemisphere might be next. The findings point to broader patterns of environmental change across the world’s oceans.

Climate change, combined with pollution, overfishing and other human activities, is steadily altering marine food webs. Food sources are shifting. Some fish populations are dwindling or migrating to new areas. As a result, seafaring birds perched at the top of the food chain are struggling to breed and raise their young.

They’re canaries in the coal mine, so to speak—clear indicators that something is wrong with the entire ecosystem. €œSeabirds travel long distances—some going from one hemisphere to the other—chasing their food in the ocean,” P. Dee Boersma, a biologist at the University of Washington and one of the study’s authors, said in a statement. €œThis makes them very sensitive to changes in things like ocean productivity, often over a large area.” The new study, published yesterday in the journal Science, examines 50 years of data on 66 seabird species worldwide.

The research, led by William Sydeman of the Farallon Institute in California, involved contributions from more than three dozen experts at institutions around the world. The study finds that many species aren’t breeding as successfully as they did in the past—particularly in the Northern Hemisphere. They’re producing and raising fewer chicks. The researchers looked at a variety of birds, including species that mainly feed on plankton, species that prefer fish and species that eat both.

Birds that eat fish—either partly or exclusively—were found to be most vulnerable. In addition, birds that mainly feed at the surface of the ocean were more susceptible to breeding failures than deep-diving birds. It’s no surprise that these issues are more severe in the Northern Hemisphere, the researchers say. The oceans are warming at faster rates in the northern half of the world.

And other human influences, like shipping and fishing, are more pronounced in the Northern Hemisphere. These threats combined have likely had a bigger influence on marine ecosystems in the North. Studies have already shown that certain fish populations are declining or moving to different parts of the ocean. Even plankton populations are shifting over time.

These changes can put seabirds in a difficult position. Seabirds often return to the same coastal sites year after year to breed and raise their chicks. During the breeding season, they make trips back and forth between the ocean and the land, foraging for food and returning to feed their babies. If their food sources decline or move around, it can make it harder for them to both feed themselves and successfully raise their young.

The fact that fish-eating, surface-foraging birds are most vulnerable is a telling detail, Sydeman, the lead author, said in an interview with E&E News. It indicates that the upper part of the ocean is changing most dramatically. €œThe indications are that that part of the ocean’s productivity is declining, and the birds are giving us a window into that change,” he said. The study doesn’t parse out exactly which human influences are most at fault.

The researchers did conduct some additional analyses, which found that rising ocean temperatures are closely linked to the seabirds’ breeding success. Still, it’s likely the combination of climate change and other human influences has taken such a toll on birds. But the study doesn’t necessarily spell catastrophe—at least not yet. Seabirds tend to be long-lived, resilient animals, Sydeman said.

They can withstand temporary food shortages, and they can bounce back after a year or two of low breeding success. €œThe problem is if it becomes chronic,” Sydeman said. €œAnd this study is suggesting that it is becoming a chronic problem for the Northern Hemisphere.” That means interventions may be in order—and soon—to prevent more dramatic declines in the future. That could mean targeted efforts to cut down on fishing in areas close to seabird breeding colonies and building up the fisheries that birds heavily rely on for food.

In the Southern Hemisphere, establishing larger marine protected areas could help keep fisheries stable and healthy. In the meantime, global efforts to slash greenhouse gas emissions and curb climate change are needed to slow the rate of ocean warming. Around the world, seabirds are “sending a warning signal that we really need to think about this now, before things get too bad,” Sydeman said. €œFor most species, there’s still time to avert disaster.” Reprinted from E&E News with permission from POLITICO, LLC.

Copyright 2021. E&E News provides essential news for energy and environment professionals..

UNIVERSE EXPANDER “Cosmic Conundrum,” by Clara Moskowitz, describes how the most likely can you buy propecia over the counter in canada cause of the accelerating expansion of the universe is “vacuum energy,” the effect order propecia ukwhere can you get propecia of virtual particles popping in and out of existence. But it does not explain why vacuum energy would cause the universe to expand. I would think that if space order propecia ukwhere can you get propecia is filled with evanescent virtual particles, they would collectively exert a huge gravitational force that would counteract expansion. CHRIS MARTINIAK Berkeley, Calif. MOSKOWITZ REPLIES.

Vacuum energy order propecia ukwhere can you get propecia is positive and has a constant density throughout space. Thus, increasing the volume of space increases the total amount of vacuum energy, which requires work. It is the opposite of a gas, whose energy and density decrease as it expands. When that happens, the gas exerts order propecia ukwhere can you get propecia positive pressure. In contrast, because vacuum energy is positive, it exerts negative pressure, so galaxies on the largest scales are pushed apart, not pulled together.

CONNECTING REALITIES In “The Four Most Pressing Science Priorities for the Next President,” four articles focus on the need to address hair loss treatment, attention to evidence, climate change and the restoration of expertise. From a psychological point of view, all these topics are deeply intertwined, and the absence of that discussion weakens order propecia ukwhere can you get propecia the theme of the report. Controlling hair loss treatment will, for example, end up being a challenge to human collaboration in exactly the same way mitigating the climate problem will. Both involve our capacity to not only work together but accept unwanted trade-offs. These issues stem order propecia ukwhere can you get propecia from our enormous distrust of experts and hidden feelings (shame, fear of manipulation, and so on), along with an inherent uncertainty about the nature of our various realities.

The problems your report identifies are important but require a much deeper theory. What would that discussion entail?. To begin with, a order propecia ukwhere can you get propecia lot of self-searching. Maybe there could be an edition of the magazine that starts from that stance. ROBERT A.

BERLEY Seattle order propecia ukwhere can you get propecia THE EDITORS REPLY. In September 2019 we published a special issue called Truth, Lies &. Uncertainty. It explores such themes across disciplines and covers a range of neuroscience, psychology and social sciences order propecia ukwhere can you get propecia. BORN TO RUN In “On the Basis of Testosterone,” Grace Huckins compassionately chronicles the fact that while male athletes who were born with a genetic predisposition for height, strength or aerobic endurance are welcome to compete, women who were born with a similar predisposition are subject to intense scrutiny of their chromosomes and hormone levels.

As the article describes, unnecessary medical interventions are currently ordered for women with high testosterone who wish to take part in longer international track events. As a simple solution to this hypocrisy, the regulators should add the word “intentional” order propecia ukwhere can you get propecia to “performance enhancement” as they exert scrutiny. It is not intentional when a man is born with genes that will lead to height or strength. Neither is it intentional when a woman is born with XY chromosomes, for example. The Olympic creed, as espoused by the modern games' founder, is that the important thing “is not the winning but the order propecia ukwhere can you get propecia taking part.” All athletes should have the equal right to take part.

RAYMOND STEFANI Lake Forest, Calif. I have been an avid reader of Scientific American for nearly 65 years, and publishing my article “Ensuring the Longevity of Digital Documents” in your January 1995 issue was one of the high points of my career as a computer scientist. While I have largely been uninterested in competitive sports, the issues Huckins so order propecia ukwhere can you get propecia adeptly considers have conceptual and practical implications far beyond that area. And she does an excellent job of teasing out the scientific, social and philosophical questions that her subject raises. The article reinforces my frequent observation that overturning the metaphorical rock representing any subject always reveals far more complexity, subtlety, depth and motivation for further order propecia ukwhere can you get propecia exploration than we might expect.

This, to me, is the wonder of science and of the intellectual curiosity that is one of the joys of life for those of us who are fortunate enough to experience it. JEFF ROTHENBERG via e-mail hair loss treatment CASUALTIES “Controlling hair loss treatment,” by Tanya Lewis [“The Four Most Pressing Science Priorities for the Next President”], says, “hair loss treatment ... Has killed hundreds of thousands of people in the order propecia ukwhere can you get propecia U.S.—the highest toll of any country.” Though true numerically, this phrase is misleading. Per Johns Hopkins University on February 1, the U.S. Had 441,319 total deaths.

But it ranked 10th among deaths per 100,000 people in each order propecia ukwhere can you get propecia country's population, with 134.89 deaths per 100,000. And among deaths per all reported cases, it was far down the list, with a rate of 1.7 percent. As an example, while the U.K. Had 106,367 deaths at that time, it had 159.98 deaths per 100,000 and order propecia ukwhere can you get propecia a case-fatality rate of 2.8 percent. And Belgium, which had only 21,092 total deaths, had 184.66 deaths per 100,000 and a case-fatality rate of 3 percent.

This does not minimize the damage that hair loss treatment has done to the U.S. Or how poorly our public health infrastructure has responded to this propecia order propecia ukwhere can you get propecia. But this country is not the worst in the world. RICHARD FERENCE Three Rivers, Mich. WILD WILD BEHEST In “Arachnid order propecia ukwhere can you get propecia Architects” [Advances], Rachel Nuwer reports on a study exploring how spiders' legs automatically move to build webs that was led by biologist Fritz Vollrath.

She writes that the researchers “tested the rules [of this movement] by programming a simulated virtual spider, and Vollrath says the next step is to build a physical spider robot” (emphasis mine). If somebody could let Vollrath know that robot spiders are a bad idea, I would appreciate it. I've seen enough horror movies order propecia ukwhere can you get propecia to recognize that this will not end well. DAN MAHER via e-mail CLIMATE SOLIDARITY Jordan Salama clearly expresses our constant concern, albeit almost panic, about the neglect of the planet in “Earth Is on Fire” [Forum. January 2021].

He is not Chicken order propecia ukwhere can you get propecia Little. His words ring true, and, sadly, when the U.S. Should have been leading this battle, we took a four-year hiatus from all responsibility. I am order propecia ukwhere can you get propecia 76 years old. Salama's generation can rest assured that it is not alone.

Many of us choose our candidates, our stores, our purchases and our habits based on “saving the world” from trash, pollution, erosion and neglect. We are order propecia ukwhere can you get propecia with you. BILL MAUK via e-mail THE EDITORS REPLY. In April, Scientific American and other major news outlets in a worldwide network called Covering Climate Now signed on to a declaration to refer to the ramifications of climate change as a “climate emergency.” ERRATUM “Reestablishing Reality,” by Jen Schwartz [“The Four Most Pressing Science Priorities for the Next President”], should have described Alondra Nelson as a professor at the Institute for Advanced Study in Princeton, N.J., not at Princeton University.In a world flooded with data, figuring out where and how to store it efficiently and inexpensively becomes a larger problem every day. One of the most exotic solutions might turn out to be one order propecia ukwhere can you get propecia of the best.

Archiving information in DNA molecules. The prevailing long-term cold-storage method, which dates from the 1950s, writes data to pizza-sized order propecia ukwhere can you get propecia reels of magnetic tape. By comparison, DNA storage is potentially less expensive, more energy-efficient and longer lasting. Studies show that DNA properly encapsulated with a salt remains stable for decades at room temperature and should last much longer in the controlled environs of a data center. DNA doesn’t require maintenance, and files stored in DNA order propecia ukwhere can you get propecia are easily copied for negligible cost.

Even better, DNA can archive a staggering amount of information in an almost inconceivably small volume. Consider this. Humanity will generate an estimated 33 zettabytes order propecia ukwhere can you get propecia of data by 2025—that’s 3.3 followed by 22 zeroes. DNA storage can squeeze all that information into a ping-pong ball, with room to spare. The 74 million million bytes of information in the Library of Congress could be crammed into a DNA archive the size of a poppy seed—6,000 times over.

Split the seed in half, and you could store all of Facebook’s order propecia ukwhere can you get propecia data. Science fiction?. Hardly. DNA storage technology exists today, but to make it viable, researchers have to order propecia ukwhere can you get propecia clear a few daunting technological hurdles around integrating different technologies. As part of a major collaboration to do that work, our team at Los Alamos National Laboratory has developed a key enabling technology for molecular storage.

Our software, the Adaptive DNA Storage Codex (ADS Codex), translates data files from the binary language of zeroes and ones that computers understand into the four-letter code biology understands. ADS Codex is a order propecia ukwhere can you get propecia key part of the Intelligence Advanced Research Projects Activity (IARPA) Molecular Information Storage (MIST) program. MIST seeks to bring cheaper, bigger, longer-lasting storage to big-data operations in government and the private sector, with a short-term goal of writing one terabyte—a trillion bytes—and reading 10 terabytes within 24 hours at a cost of $1,000. FROM COMPUTER CODE TO GENETIC CODE When most people think of DNA, they think of life, not computers. But DNA is order propecia ukwhere can you get propecia itself a four-letter code for passing along information about an organism.

DNA molecules are made from four types of bases, or nucleotides, each identified by a letter. Adenine (A), thymine (T), guanine (G) and cytosine (C). They are the basis order propecia ukwhere can you get propecia of all DNA code, providing the instruction manual for building every living thing on earth. A fairly well-understood technology, DNA synthesis has been widely used in medicine, pharmaceuticals and biofuel development, to name just a few applications. The technique organizes the bases into various arrangements indicated by specific sequences of A, C, G and T.

These bases wrap in a twisted chain order propecia ukwhere can you get propecia around each other—the familiar double helix—to form the molecule. The arrangement of these letters into sequences creates a code that tells an organism how to form. The complete set of DNA molecules makes up the genome—the blueprint of your body. By synthesizing DNA molecules—making them from scratch—researchers have found they can specify, or write, long strings of the letters A, C, G order propecia ukwhere can you get propecia and T and then read those sequences back. The process is analogous to how a computer stores binary information.

From there, it was a short conceptual step to encoding a binary computer file into a molecule The method has been proven to work, but reading and writing the DNA-encoded files currently takes a long time. Appending a single base to DNA takes about one order propecia ukwhere can you get propecia second. Writing an archive file at this rate could take decades, but research is developing faster methods, including massively parallel operations that write to many molecules at once. NOTHING LOST IN TRANSLATION ADS Codex tells exactly how to translate the zeros and ones into sequences of four letter-combinations of A, C, G order propecia ukwhere can you get propecia and T. The Codex also handles http://bioladen-taucha.de/beispiel-seite/ the decoding back into binary.

DNA can be synthesized by several methods, and ADS Codex can accommodate them all. Unfortunately, compared to traditional digital systems, the error rates while writing to order propecia ukwhere can you get propecia molecular storage with DNA synthesis are very high. These errors arise from a different source than they do in the digital world, making them trickier to correct. On a digital hard disk, binary errors occur when a zero flips to a one, or vice versa. With DNA, the problems come from insertion order propecia ukwhere can you get propecia and deletion errors.

For instance, you might be writing A-C-G-T, but sometimes you try to write A, and nothing appears, so the sequence of letters shifts to the left, or it types AAA. Normal error correction codes don’t work well with that kind of problem, so ADS Codex adds error detection codes that validate the data. When the software converts the data back to binary, it tests to order propecia ukwhere can you get propecia see that the codes match. If they don’t, it removes or adds bases—letters—until the verification succeeds. SMART SCALE-UP We have completed version 1.0 of ADS Codex, and late this year we plan to use it to evaluate the storage and retrieval systems developed by the other MIST teams.

The work fits well with Los Alamos’ history of order propecia ukwhere can you get propecia pioneering new developments in computing as part of our national security mission. Since the 1940s, as an outcome of those computing advancements, we have amassed some of the oldest and largest stores of digital-only data. It still has tremendous value. Because we keep data forever, we’ve been at the tip of the spear for a long time when it comes to order propecia ukwhere can you get propecia finding a cold-storage solution, but we’re not alone. All the world’s data—all your digital photos and tweets.

All the records of the global financial sector. All those order propecia ukwhere can you get propecia satellite images of cropland, troop movements and glacial melting. All the simulations underlying so much of modern science. And so much more—have to go somewhere. The “cloud” order propecia ukwhere can you get propecia isn’t a cloud at all.

It is digital data centers in huge warehouses consuming vast amounts of electricity to store (and keep cool) trillions of millions of bytes. Costing billions of dollars to build, power and run, these data centers may struggle to remain viable as the need for data storage continues to grow exponentially. DNA shows great promise for sating the order propecia ukwhere can you get propecia world’s voracious appetite for data storage. The technology requires new tools and new ways of applying familiar ones. But don’t be surprised if one day the world’s most valuable archives find a new home in a poppy-seed-sized collection of molecules.

Funding for ADS Codex was provided by the Intelligence Advanced Research Projects Activity (IARPA), a research agency within order propecia ukwhere can you get propecia the Office of the Director of National Intelligence. This is an opinion and analysis article.The Beauty of Chemistry. Art, Wonder, and Scienceby Philip BallMIT Press, 2021 ($49.95) Chemistry is perhaps the most sensual of the sciences, writer Ball posits in this absorbing collection of photographs from science artists Wenting Zhu and Yan Liang. Behind every smell, every worldly texture, even every emotional response, there is order propecia ukwhere can you get propecia a chemical reaction. The wonder of those reactions is on display here, from the mesmerizing precipitation of heavy metals such as cobalt and nickel to the thermal heat map of sodium dissolving in plain water.

The alien look of a copper nitrate “chemical garden” evolves through the action of ions and precipitation. Ball explains the science of these complex reactions and interweaves order propecia ukwhere can you get propecia them with literary ideas and philosophical contexts. Far from portraying a routine lab procedure, this collection showcases chemistry's excitement and aesthetic allure. Helgoland. Making Sense of the Quantum Revolutionby Carlo RovelliRiverhead Books, 2021 ($20) It is not just laypeople who find quantum mechanics inscrutable—the more physicists ponder it, the more perplexed they become, writes physicist Rovelli.

The esoteric theory describing the behavior of particles on the submicroscopic scale rewrites the rules of normal reality we are accustomed to, substituting probability for certainty. Seriously considering its implications for understanding the world, he says, is “an almost psychedelic experience.” This entertaining and legible guide paints the history of quantum theory and lays out its possible meanings, including the author's favorite—the “relational” interpretation—which posits that things exist only through their interactions with other things. There is no absolute reality. €”Clara Moskowitz Unwell Women. Misdiagnosis and Myth in a Man-Made Worldby Elinor CleghornDutton, 2021 ($27) Researcher Cleghorn provides an essential history of misogyny in health care, beginning with the so-called father of medicine himself, Hippocrates, who wrote that female bodies were a weaker version of male bodies.

That prejudice has carried through thousands of years, and its remnants are well preserved today. Women's ailments have been an afterthought in research, and women are still underrepresented in clinical trials. Women of color are particularly underserved. Black women are up to five times as likely to die in childbirth as their white counterparts, and more than 20 percent experience discrimination when they visit doctors. This clear-eyed assessment is both a catalog of how medicine has been complicit in female oppression and a call to action for drastic reform.

The Ascent of Information. Books, Bits, Genes, Machines, and Life’s Unending Algorithmby Caleb ScharfRiverhead Books, 2021 ($28) According to some estimates, our global civilization now generates some 2.5 quintillion bytes of information. This data deluge—which astrobiologist Scharf dubs our “dataome”—has profound implications for our future, for good or ill. For instance, is it good or bad that the dataome places a heavy physical burden on the world in the form of energy-hungry computers, storage devices and telecommunications technologies?. On such matters Scharf prefers to conservatively outline the limits of current knowledge rather than make pronouncements with false certitude, but the end result is no less audacious.

A transformative new way of looking at our increasingly data-driven existence. €”Lee BillingsSeabirds are “sentinels” of ocean health. If marine ecosystems are suffering, the birds will be among the first to show it. Now a major study finds that seabirds in the Northern Hemisphere are already struggling. And without extra precautions, those in the Southern Hemisphere might be next.

The findings point to broader patterns of environmental change across the world’s oceans. Climate change, combined with pollution, overfishing and other human activities, is steadily altering marine food webs. Food sources are shifting. Some fish populations are dwindling or migrating to new areas. As a result, seafaring birds perched at the top of the food chain are struggling to breed and raise their young.

They’re canaries in the coal mine, so to speak—clear indicators that something is wrong with the entire ecosystem. €œSeabirds travel long distances—some going from one hemisphere to the other—chasing their food in the ocean,” P. Dee Boersma, a biologist at the University of Washington and one of the study’s authors, said in a statement. €œThis makes them very sensitive to changes in things like ocean productivity, often over a large area.” The new study, published yesterday in the journal Science, examines 50 years of data on 66 seabird species worldwide. The research, led by William Sydeman of the Farallon Institute in California, involved contributions from more than three dozen experts at institutions around the world.

The study finds that many species aren’t breeding as successfully as they did in the past—particularly in the Northern Hemisphere. They’re producing and raising fewer chicks. The researchers looked at a variety of birds, including species that mainly feed on plankton, species that prefer fish and species that eat both. Birds that eat fish—either partly or exclusively—were found to be most vulnerable. In addition, birds that mainly feed at the surface of the ocean were more susceptible to breeding failures than deep-diving birds.

It’s no surprise that these issues are more severe in the Northern Hemisphere, the researchers say. The oceans are warming at faster rates in the northern half of the world. And other human influences, like shipping and fishing, are more pronounced in the Northern Hemisphere. These threats combined have likely had a bigger influence on marine ecosystems in the North. Studies have already shown that certain fish populations are declining or moving to different parts of the ocean.

Even plankton populations are shifting over time. These changes can put seabirds in a difficult position. Seabirds often return to the same coastal sites year after year to breed and raise their chicks. During the breeding season, they make trips back and forth between the ocean and the land, foraging for food and returning to feed their babies. If their food sources decline or move around, it can make it harder for them to both feed themselves and successfully raise their young.

The fact that fish-eating, surface-foraging birds are most vulnerable is a telling detail, Sydeman, the lead author, said in an interview with E&E News. It indicates that the upper part of the ocean is changing most dramatically. €œThe indications are that that part of the ocean’s productivity is declining, and the birds are giving us a window into that change,” he said. The study doesn’t parse out exactly which human influences are most at fault. The researchers did conduct some additional analyses, which found that rising ocean temperatures are closely linked to the seabirds’ breeding success.

Still, it’s likely the combination of climate change and other human influences has taken such a toll on birds. But the study doesn’t necessarily spell catastrophe—at least not yet. Seabirds tend to be long-lived, resilient animals, Sydeman said. They can withstand temporary food shortages, and they can bounce back after a year or two of low breeding success. €œThe problem is if it becomes chronic,” Sydeman said.

€œAnd this study is suggesting that it is becoming a chronic problem for the Northern Hemisphere.” That means interventions may be in order—and soon—to prevent more dramatic declines in the future. That could mean targeted efforts to cut down on fishing in areas close to seabird breeding colonies and building up the fisheries that birds heavily rely on for food. In the Southern Hemisphere, establishing larger marine protected areas could help keep fisheries stable and healthy. In the meantime, global efforts to slash greenhouse gas emissions and curb climate change are needed to slow the rate of ocean warming. Around the world, seabirds are “sending a warning signal that we really need to think about this now, before things get too bad,” Sydeman said.

€œFor most species, there’s still time to avert disaster.” Reprinted from E&E News with permission from POLITICO, LLC. Copyright 2021. E&E News provides essential news for energy and environment professionals..

When will propecia go generic

Artificial intelligence technologies are being increasingly relied when will propecia go generic upon in the healthcare domain, particularly when it comes to decision support, precision medicine, and the check my site improvement of the quality of care. Regarding primary care specifically, AI also represents an opportunity to assist with electronic health record when will propecia go generic documentation. A new study published in the Journal of American Medical Informatics Association this week shows that, although AI documentation assistants (or digital scribes) offer great potential in the primary care setting, they will need to be supervised by a human until strong evidence is available for their autonomous potential. In workshops with primary care doctors, wrote researchers from the Australian Institute of Health Innovation, "There was consensus that when will propecia go generic consultations of the future would increasingly involve more automated and AI-supported systems.

However, there were differing views on how this human-AI collaboration would work, what roles doctors and AI would take, and what tasks could be delegated to AI." HIMSS20 Digital Learn on-demand, earn credit, find products and solutions. Get Started >> when will propecia go generic. WHY IT MATTERS Researchers worked with primary care doctors who use EHRs regularly for documentation purposes to understand their views on future AI documentation assistants. They identified three major themes that when will propecia go generic emerged from the discussions.

Professional autonomy, human-AI collaboration and new models of care. First, the doctors emphasized the importance of their ability to care for patients in their own way with the abilities AI technology provided."If when will propecia go generic they [patients] think that we're just getting suggestions from a computer, then maybe they can just get suggestions from a computer. I think it becomes more difficult to convince them that our recommendations are more valuable than what they can pick up on the internet," said one physician. They noted the need for a bottom-up approach to technology development, with a focus on delivering clear benefits to practice and workflow, and expressed fears around potential legal complications that when will propecia go generic could stem from working with an AI assistant.With regard to human-AI collaboration, doctors expressed a variety of viewpoints about what tasks could be delegated to AI.

Many believed that an AI system could assist with tasks such as documentation, referrals and other paperwork. Most said that AI systems would lack when will propecia go generic empathy. "GPs voiced several concerns, including some potential biases in patient data and system design, the time needed to fix the errors and train the system, challenges of dealing with complex cases, and the auditing of AI," wrote the researchers. However, doctors also when will propecia go generic discussed how AI could help with emerging models of primary care, including preconsultation, mobile health and telehealth.

THE LARGER TREND The question of reducing EHR-related clinician burnout has loomed large, with vendors and researchers trying to pinpoint major causes – and, in turn, potential solutions. AI has when will propecia go generic been raised as one such solution, with several major EHR vendors offering plans for incorporating the technology into their workflows. But human input remains vital, as the new JAMIA study and other research has noted. AI could "bring back meaning and purpose in the practice of medicine while providing new levels of efficiency and accuracy," wrote Stanford researchers in a when will propecia go generic 2017 Journal of the American Medical Association study.

But, they continued, physicians must "proactively guide, oversee, and monitor the adoption of artificial intelligence as a partner in patient care."ON THE RECORD"AI documentation assistants will likely ... Be integral to the when will propecia go generic future primary care consultations. However, these technologies will still need to be supervised by a human until strong evidence for reliable autonomous performance is available. Therefore, different human-AI collaboration models will need to be designed and evaluated to ensure patient safety, quality of care, doctor safety, and doctor autonomy," wrote the Australian Institute for Health Innovation when will propecia go generic researchers.

Kat Jercich is senior editor of Healthcare IT News.Twitter. @kjercichHealthcare IT News is a HIMSS Media publication.Konica Minolta Healthcare Americas will pay $500,000 to settle a whistleblower when will propecia go generic case that alleged its Viztek electronic health record subsidiary had falsified data for certification tests.WHY IT MATTERSIn the qui tam complaint, filed in 2017 in U.S. District Court in New Jersey – where Konica Minolta is based – was filed by whistleblower Leighsa Wilson, who worked for two years at Viztek, best known for its PACS and imaging technologies, as a project manager for its EXA EHR product.In mid-2015, the complaint alleges, Viztek, which was in negotiations to be acquired by Konica Minolta, worked together with InfoGard Laboratories (which was then an ONC-authorized certification and testing body) to make false representations that the EHR software complied with requirements for certification – and qualified for receipt of incentive payments under the federal meaningful use program."To ensure that their product was certified and that their customers received incentive payments, Viztek and Konica Minolta. (a) falsely attested to when will propecia go generic InfoGard that their software met the certification criteria.

(b) hard-coded their software to pass certification testing requirements temporarily without ensuring that the software released to customers met certification criteria. And (c) caused their users to falsely attest to using a certified EHR technology, when their software could not support the applicable certification criteria in the field," according to the complaint, which also alleges that when will propecia go generic InfoGard "facilitated and participated in" these false attestations, "knowingly or with reckless disregard," certifying the EHR software despite its inability to meet ONC's certification criteria.The flaws in Viztek's software "not only rendered the system unreliable and unable to meet meaningful use standards, but the flaws also created a risk to patient health and safety. Rather than spend the time and resources necessary to correct the flaws in its EHR software, the EHR defendants opted to do nothing."THE LARGER TRENDThis is only the most recent settlement of this type from health IT vendors accused of False Claims Act violations, of course.Most notable, was the case of eClinicalWorks, which was alleged by the Department of Justice to have falsely claimed meaningful use certification, to have neglected to have safety addressed issues in its software and to have paid kickbacks to clients. That case was settled in 2017 for $155 when will propecia go generic million.More recently, similar complaints were lodged against companies such as Practice Fusion and Greenway Health.

They settled with DOJ for $145 million and $57 million, respectively."We will be unflagging in our efforts to preserve the accuracy and reliability of Americans’ health records and guard the public against corporate greed," said U.S. Attorney for the District when will propecia go generic of Vermont Christina Nolan after the Greenway case this past year. "EHR companies should consider themselves on notice."ON THE RECORD"The lives of patients depend upon the information processed by electronic health records," said Wilson – who, as a qui tam whistleblower will receive 20% of the financial settlement – in a statement. "Functionality testing and subsequent certification must be performed and obtained through a reliable, measurable process.""Filing a qui tam lawsuit is a powerful and effective way to report problems with EHR software purchased with federal funds and get the problems fixed when they are ignored," said Luke Diamond, an associate at Phillips when will propecia go generic &.

Cohen. "The False Claims Act protects whistleblowers from job retaliation and offers rewards if the government recovers funds as a result of the qui tam case.""Our client was concerned about possible patient harm that can occur if EHR software isn't properly certified, so she stepped forward to inform the government about what she had witnessed," said Colette Matzzie, a partner and when will propecia go generic whistleblower attorney with Phillips &. Cohen, which brought the case. "Ensuring that EHR software meets all governmental requirements is important to safeguard both patient care and federal funds."The Arc Madison Cortland in Oneida, New York, knows that there is a lack when will propecia go generic of providers that specialize in the intellectual/developmental disability field.

Making the problem worse, not so many that understand dual diagnosis.THE PROBLEMWith hair loss treatment minimizing the ability for individuals to receive face-to-face services with their providers, many patients are resorting to emergency department when will propecia go generic visits.Additionally, The Arc is in a rural area requiring travel to see a provider, and there is a lack of providers in the field. The population itself is underserved, with a lack of transportation to get to appointments. Without the ability to institute telemedicine as a solution to these problems, the population supported by The Arc would have seen when will propecia go generic a lengthy (permanent?. ) pause for needed medical services.PROPOSALThe Arc this year received funding from the FCC to help provide telehealth services.“With this funding we can further treat patients, reduce crisis and allow for social distancing, which is imperative to our vulnerable population,” said Jackie Fahey, director of clinic services at The Arc Madison Cortland.

€œWe could provide ongoing services to the individuals we serve to ensure there are no unnecessary emergency department when will propecia go generic visits. This places less of a strain on our local emergency departments and unneeded additional costs.”With the purchase of tablets and headsets and telehealth services from vendor Doxy.me, The Arc was able to still provide medical care to its population of people with an I/DD. Additionally, eliminating emergency department visits also eliminates their exposure to hair loss treatment and eases the burden of the ED providers who are overburdened right now.MARKETPLACEThere are many when will propecia go generic vendors of telemedicine technology and services on the health IT market today. Healthcare IT News recently compiled a comprehensive list of these vendors with detailed descriptions.

To read this special report, click here.MEETING THE CHALLENGE“When all of our locations were closed abruptly in the middle of March due to the hair loss treatment propecia, we needed to determine a way to quickly when will propecia go generic and easily implement a telehealth solution so that we were able to still support the individuals that we serve during the crisis, especially when many were under strict quarantine protocols for a variety of reasons,” Fahey explained.“We signed up immediately for the Doxy.me telehealth platform as it was a user-friendly platform that is HIPAA-compliant. The feature we liked about Doxy.me was that it is web-based, so nothing had to be downloaded and it could easily be used on a laptop, tablet or smartphone.”The Arc rolled out the technology initially with its mental health providers, who offer psychiatry/medication monitoring services, social work counseling and mental health counseling. More than half the organization’s enrollment is enrolled in one or all of these three services, so it was able to continue providing services to a large number of enrolled individuals.“We then began to roll the telehealth services when will propecia go generic out to nutrition, speech therapy, physical therapy and occupational therapy caseloads if individuals were appropriate to receive the service through telehealth,” Fahey said.RESULTSThe first success metric The Arc has been able to achieve with the technology is maintaining its utilization for mental health services. When everything was running normal prior to hair loss treatment, The Arc’s mental health services made up about 25% of the services it provided on a monthly basis.

With the implementation of telehealth services during the hair loss treatment when will propecia go generic propecia, the organization was able to achieve 20% of the services provided on a monthly basis.This has shown to staff that they have been able to still serve and respond to the needs of their psychiatry, social work and mental health counseling patients with minimal issues by implementing the telehealth technology.“The second success metric we have been able to achieve with the technology is we have been able to continue to receive referrals for our services and enroll new individuals into the services they need if the services are able to be completed via telehealth,” she said. €œBetween April, May and June, we have enrolled 16 new individuals into ongoing clinic services, which is right on par for our normal enrollment average per month.”USING FCC AWARD FUNDSThe Arc Madison Cortland was awarded $49,455 by the FCC earlier this year for laptop computers and headsets to provide remote consultations and treatment during the hair loss treatment propecia for psychological services, counseling, and occupational and physical therapy for people with developmental and other disabilities.“With the funds, we purchased headsets and tablets to allow the people we support to have access to medical appointments, along with physical therapy, occupational therapy and psychology appointments remotely,” Fahey explained. €œThe technology when will propecia go generic enables us to continue to provide these services at a time when the people we support are unable to leave for traditional in-person appointments.“Because these are such uncertain times, and a time frame for when we may return to ‘normalcy’ is unknown, the technology allows us to continue delivering medical support without the concern of a pause in those services.”Twitter. @SiwickiHealthITEmail the writer.

Bill.siwicki@himss.orgHealthcare IT News is a HIMSS Media publication.HIMSSCast host Jonah Comstock convenes a panel of HIMSS Media editors – HITN Senior Editor Kat Jercich, MobiHealthNews Associate Editor Dave Muoio and HFN Associate Editor Jeff Lagasse – to discuss recent delivery slowdowns at the Post Office and how they have and haven't affected healthcare stakeholders, including startups and patients when will propecia go generic. The team also looks into the broader trend of the politicization of traditionally apolitical government agencies and how that could affect public faith in hair loss treatments or treatments.More about this episode:USPS service delays are hitting some mail-order pharmacies and telehealth platforms harder than othersMail delays may affect medication supply for nearly 1 in 4 Americans over 50Postmaster General Louis DeJoy's full testimony (C-SPAN)The Package Coalition homepageThe Trump administration this week asked the U.S. Supreme Court to reverse a lower court ruling that allowed for mail-order and telemedicine abortion during the when will propecia go generic hair loss treatment crisis. U.S.

Food and Drug Administration regulations require mifepristone, which is used in medication abortion, to be dispensed at a when will propecia go generic clinic, hospital or medical office. In June, U.S. District Judge for the District of Maryland Theodore Chuang blocked the requirements when will propecia go generic during the propecia, finding them to be a "substantial obstacle." Mifepristone, in combination with misoprostol, is FDA-approved for abortions up to ten weeks' gestation. In 2017, a New England Journal of Medicine article argued against the FDA regulations for mifepristone given the drug's safety record.

WHY IT MATTERS when will propecia go generic Acting Solicitor General Jeffrey B. Wall applied for a stay of Chuang's injunction on Wednesday as the case makes its way through the lower courts, arguing that the regulations do not represent an undue burden. "The safety requirements here when will propecia go generic concern only medication abortions using Mifeprex, which is approved for use only during the first ten weeks of pregnancy. They have no effect on the availability of surgical abortions, a method that this Court has treated as safe for women," wrote Wall.

Reproductive rights groups spoke out against the move, noting that people of color are disproportionately affected both by abortion restrictions and by the when will propecia go generic hair loss treatment propecia. "Black, Brown, Indigenous people and people of color are already dying/getting sick at disproportionate rates from hair loss treatment," said All Above All* on Twitter. "The Trump-Pence admin is trying to make this worse by asking SCOTUS to require people face unnecessary risk just to get abortion care." "The FDA’s in-person requirements on mifepristone subject patients to unnecessary exposure to a when will propecia go generic deadly propecia, and two federal courts have already rejected the Trump administration’s argument. Forcing patients to travel to a health center to access the safe, effective medication they need especially hurts people of color and people with low-incomes, who already face more barriers to care," said Planned Parenthood Federation of America President and CEO Alexis McGill-Johnson in a statement.THE LARGER TREND The hair loss treatment propecia has exacerbated many existing barriers to care, including for reproductive health services.

"We’ve seen the undue burden and hardship these restrictions create during hair loss treatment, especially in communities hit hardest by the propecia," said Skye Perryman, chief legal officer at the American College of Obstetricians and Gynecologists, a co-plaintiff in the telemedicine case, to Healthcare when will propecia go generic IT News. In response to the July ruling, some abortion providers reportedly moved to delivering mifepristone by mail. Still, others faced state laws when will propecia go generic that restricted the provision of abortion via telemedicine.And as Dr. Jacquelyn Yeh from Physicians from Reproductive Health pointed out in July, telemedicine itself involves hurdles such as broadband access and privacy concerns.

It remains to be seen whether the Supreme Court will grant the Trump administration's request. ON THE RECORD "As hair loss treatment ravages Black, Latino, Indigenous, and other communities of color across the country, the Trump administration should be aiming to keep us healthy – not moving forward with an agenda to endanger people who seek abortion," said McGill-Johnson. Kat Jercich is senior editor of Healthcare IT News.Twitter. @kjercichHealthcare IT News is a HIMSS Media publication..

Artificial intelligence technologies are being increasingly relied upon in the healthcare domain, order propecia ukwhere can you get propecia particularly when it comes to decision support, precision medicine, and the improvement of the quality of care. Regarding primary care specifically, AI also represents an opportunity to assist with electronic order propecia ukwhere can you get propecia health record documentation. A new study published in the Journal of American Medical Informatics Association this week shows that, although AI documentation assistants (or digital scribes) offer great potential in the primary care setting, they will need to be supervised by a human until strong evidence is available for their autonomous potential. In workshops with primary care doctors, wrote researchers from the Australian Institute of Health Innovation, "There was consensus that consultations of the future would increasingly involve order propecia ukwhere can you get propecia more automated and AI-supported systems.

However, there were differing views on how this human-AI collaboration would work, what roles doctors and AI would take, and what tasks could be delegated to AI." HIMSS20 Digital Learn on-demand, earn credit, find products and solutions. Get Started order propecia ukwhere can you get propecia >>. WHY IT MATTERS Researchers worked with primary care doctors who use EHRs regularly for documentation purposes to understand their views on future AI documentation assistants. They identified three major themes that order propecia ukwhere can you get propecia emerged from the discussions.

Professional autonomy, human-AI collaboration and new models of care. First, the doctors emphasized the importance of their ability to care for patients in their own way with the abilities AI technology provided."If they [patients] think that we're just getting suggestions from a computer, then maybe they can just get suggestions from a order propecia ukwhere can you get propecia computer. I think it becomes more difficult to convince them that our recommendations are more valuable than what they can pick up on the internet," said one physician. They noted the need for a bottom-up approach to technology development, with a focus on delivering clear benefits to practice and workflow, and expressed fears around potential legal complications that could stem from working with an AI assistant.With regard to order propecia ukwhere can you get propecia human-AI collaboration, doctors expressed a variety of viewpoints about what tasks could be delegated to AI.

Many believed that an AI system could assist with tasks such as documentation, referrals and other paperwork. Most said order propecia ukwhere can you get propecia that AI systems would lack empathy. "GPs voiced several concerns, including some potential biases in patient data and system design, the time needed to fix the errors and train the system, challenges of dealing with complex cases, and the auditing of AI," wrote the researchers. However, doctors also discussed how AI could help with emerging models of primary order propecia ukwhere can you get propecia care, including preconsultation, mobile health and telehealth.

THE LARGER TREND The question of reducing EHR-related clinician burnout has loomed large, with vendors and researchers trying to pinpoint major causes – and, in turn, potential solutions. AI has been raised as one such solution, with several major EHR vendors order propecia ukwhere can you get propecia offering plans for incorporating the technology into their workflows. But human input remains vital, as the new JAMIA study and other research has noted. AI could "bring back meaning and purpose in the practice order propecia ukwhere can you get propecia of medicine while providing new levels of efficiency and accuracy," wrote Stanford researchers in a 2017 Journal of the American Medical Association study.

But, they continued, physicians must "proactively guide, oversee, and monitor the adoption of artificial intelligence as a partner in patient care."ON THE RECORD"AI documentation assistants will likely ... Be integral to the future primary care consultations order propecia ukwhere can you get propecia. However, these technologies will still need to be supervised by a human until strong evidence for reliable autonomous performance is available. Therefore, different human-AI collaboration models will need order propecia ukwhere can you get propecia to be designed and evaluated to ensure patient safety, quality of care, doctor safety, and doctor autonomy," wrote the Australian Institute for Health Innovation researchers.

Kat Jercich is senior editor of Healthcare IT News.Twitter. @kjercichHealthcare IT News is a HIMSS Media publication.Konica Minolta Healthcare Americas will pay $500,000 to settle a whistleblower case that alleged its order propecia ukwhere can you get propecia Viztek electronic health record subsidiary had falsified data for certification tests.WHY IT MATTERSIn the qui tam complaint, filed in 2017 in U.S. District Court in New Jersey – where Konica Minolta is based – was filed by whistleblower Leighsa Wilson, who worked for two years at Viztek, best known for its PACS and imaging technologies, as a project manager for its EXA EHR product.In mid-2015, the complaint alleges, Viztek, which was in negotiations to be acquired by Konica Minolta, worked together with InfoGard Laboratories (which was then an ONC-authorized certification and testing body) to make false representations that the EHR software complied with requirements for certification – and qualified for receipt of incentive payments under the federal meaningful use program."To ensure that their product was certified and that their customers received incentive payments, Viztek and Konica Minolta. (a) falsely attested to InfoGard order propecia ukwhere can you get propecia that their software met the certification criteria.

(b) hard-coded their software to pass certification testing requirements temporarily without ensuring that the software released to customers met certification criteria. And (c) caused their users to falsely attest order propecia ukwhere can you get propecia to using a certified EHR technology, when their software could not support the applicable certification criteria in the field," according to the complaint, which also alleges that InfoGard "facilitated and participated in" these false attestations, "knowingly or with reckless disregard," certifying the EHR software despite its inability to meet ONC's certification criteria.The flaws in Viztek's software "not only rendered the system unreliable and unable to meet meaningful use standards, but the flaws also created a risk to patient health and safety. Rather than spend the time and resources necessary to correct the flaws in its EHR software, the EHR defendants opted to do nothing."THE LARGER TRENDThis is only the most recent settlement of this type from health IT vendors accused of False Claims Act violations, of course.Most notable, was the case of eClinicalWorks, which was alleged by the Department of Justice to have falsely claimed meaningful use certification, to have neglected to have safety addressed issues in its software and to have paid kickbacks to clients. That case was settled in 2017 for order propecia ukwhere can you get propecia $155 million.More recently, similar complaints were lodged against companies such as Practice Fusion and Greenway Health.

They settled with DOJ for $145 million and $57 million, respectively."We will be unflagging in our efforts to preserve the accuracy and reliability of Americans’ health records and guard the public against corporate greed," said U.S. Attorney for the District of Vermont Christina Nolan after the order propecia ukwhere can you get propecia Greenway case this past year. "EHR companies should consider themselves on notice."ON THE RECORD"The lives of patients depend upon the information processed by electronic health records," said Wilson – who, as a qui tam whistleblower will receive 20% of the financial settlement – in a statement. "Functionality testing and subsequent order propecia ukwhere can you get propecia certification must be performed and obtained through a reliable, measurable process.""Filing a qui tam lawsuit is a powerful and effective way to report problems with EHR software purchased with federal funds and get the problems fixed when they are ignored," said Luke Diamond, an associate at Phillips &.

Cohen. "The False Claims Act protects whistleblowers from order propecia ukwhere can you get propecia job retaliation and offers rewards if the government recovers funds as a result of the qui tam case.""Our client was concerned about possible patient harm that can occur if EHR software isn't properly certified, so she stepped forward to inform the government about what she had witnessed," said Colette Matzzie, a partner and whistleblower attorney with Phillips &. Cohen, which brought the case. "Ensuring that EHR software meets all governmental requirements is important to safeguard both patient care and federal funds."The Arc Madison Cortland in Oneida, New York, knows that there is a lack of providers that specialize in the intellectual/developmental order propecia ukwhere can you get propecia disability field.

Making the problem worse, not so many that understand dual diagnosis.THE PROBLEMWith hair loss treatment minimizing the ability for individuals to receive face-to-face services with their providers, many patients are resorting to emergency department visits.Additionally, The Arc is in a rural area requiring travel to see a provider, and there is a lack order propecia ukwhere can you get propecia of providers in the field. The population itself is underserved, with a lack of transportation to get to appointments. Without the ability to institute telemedicine as a solution to these problems, the population supported by order propecia ukwhere can you get propecia The Arc would have seen a lengthy (permanent?. ) pause for needed medical services.PROPOSALThe Arc this year received funding from the FCC to help provide telehealth services.“With this funding we can further treat patients, reduce crisis and allow for social distancing, which is imperative to our vulnerable population,” said Jackie Fahey, director of clinic services at The Arc Madison Cortland.

€œWe could provide ongoing services to the individuals we serve order propecia ukwhere can you get propecia to ensure there are no unnecessary emergency department visits. This places less of a strain on our local emergency departments and unneeded additional costs.”With the purchase of tablets and headsets and telehealth services from vendor Doxy.me, The Arc was able to still provide medical care to its population of people with an I/DD. Additionally, eliminating emergency department visits also eliminates their exposure to hair loss treatment and eases the burden of the ED providers who are overburdened right now.MARKETPLACEThere are many vendors of telemedicine technology order propecia ukwhere can you get propecia and services on the health IT market today. Healthcare IT News recently compiled a comprehensive list of these vendors with detailed descriptions.

To read this special report, click here.MEETING THE CHALLENGE“When all of our locations were closed abruptly in the middle of March due to the hair loss treatment propecia, we needed to determine a way to quickly and easily implement a telehealth solution so that we were able to still support the individuals that we serve during the crisis, especially when many were order propecia ukwhere can you get propecia under strict quarantine protocols for a variety of reasons,” Fahey explained.“We signed up immediately for the Doxy.me telehealth platform as it was a user-friendly platform that is HIPAA-compliant. The feature we liked about Doxy.me was that it is web-based, so nothing had to be downloaded and it could easily be used on a laptop, tablet or smartphone.”The Arc rolled out the technology initially with its mental health providers, who offer psychiatry/medication monitoring services, social work counseling and mental health counseling. More than half the organization’s enrollment is enrolled in one or all of these three services, so it was able to continue providing services to a large number of enrolled individuals.“We then began to roll the telehealth services out to order propecia ukwhere can you get propecia nutrition, speech therapy, physical therapy and occupational therapy caseloads if individuals were appropriate to receive the service through telehealth,” Fahey said.RESULTSThe first success metric The Arc has been able to achieve with the technology is maintaining its utilization for mental health services. When everything was running normal prior to hair loss treatment, The Arc’s mental health services made up about 25% of the services it provided on a monthly basis.

With the implementation of telehealth services during the hair loss treatment propecia, the organization was able to achieve 20% of the services provided on a monthly basis.This has shown to staff that they have been able to still serve and respond to the needs of their psychiatry, social work and mental health counseling patients with minimal issues by implementing the telehealth technology.“The second success metric we have been able to achieve with the technology is we have been able to continue to receive referrals for our services and enroll new individuals order propecia ukwhere can you get propecia into the services they need if the services are able to be completed via telehealth,” she said. €œBetween April, May and June, we have enrolled 16 new individuals into ongoing clinic services, which is right on par for our normal enrollment average per month.”USING FCC AWARD FUNDSThe Arc Madison Cortland was awarded $49,455 by the FCC earlier this year for laptop computers and headsets to provide remote consultations and treatment during the hair loss treatment propecia for psychological services, counseling, and occupational and physical therapy for people with developmental and other disabilities.“With the funds, we purchased headsets and tablets to allow the people we support to have access to medical appointments, along with physical therapy, occupational therapy and psychology appointments remotely,” Fahey explained. €œThe technology enables us to continue to provide these services at a time when the people we support are unable to leave for traditional in-person appointments.“Because these are such uncertain times, and a time frame for when order propecia ukwhere can you get propecia we may return to ‘normalcy’ is unknown, the technology allows us to continue delivering medical support without the concern of a pause in those services.”Twitter. @SiwickiHealthITEmail the writer.

Bill.siwicki@himss.orgHealthcare IT News is a HIMSS Media publication.HIMSSCast host Jonah Comstock convenes order propecia ukwhere can you get propecia a panel of HIMSS Media editors – HITN Senior Editor Kat Jercich, MobiHealthNews Associate Editor Dave Muoio and HFN Associate Editor Jeff Lagasse – to discuss recent delivery slowdowns at the Post Office and how they have and haven't affected healthcare stakeholders, including startups and patients. The team also looks into the broader trend of the politicization of traditionally apolitical government agencies and how that could affect public faith in hair loss treatments or treatments.More about this episode:USPS service delays are hitting some mail-order pharmacies and telehealth platforms harder than othersMail delays may affect medication supply for nearly 1 in 4 Americans over 50Postmaster General Louis DeJoy's full testimony (C-SPAN)The Package Coalition homepageThe Trump administration this week asked the U.S. Supreme Court to reverse a lower court ruling that allowed for mail-order and telemedicine abortion during the order propecia ukwhere can you get propecia hair loss treatment crisis. U.S.

Food and Drug Administration regulations require mifepristone, which is used in medication abortion, to be dispensed at a clinic, hospital or order propecia ukwhere can you get propecia medical office. In June, U.S. District Judge for the District of Maryland Theodore Chuang blocked the requirements during the propecia, finding them to be a "substantial obstacle." Mifepristone, in combination with misoprostol, is FDA-approved order propecia ukwhere can you get propecia for abortions up to ten weeks' gestation. In 2017, a New England Journal of Medicine article argued against the FDA regulations for mifepristone given the drug's safety record.

WHY IT MATTERS Acting Solicitor General order propecia ukwhere can you get propecia Jeffrey B. Wall applied for a stay of Chuang's injunction on Wednesday as the case makes its way through the lower courts, arguing that the regulations do not represent an undue burden. "The safety requirements here concern only medication abortions using Mifeprex, which is approved for use only during the order propecia ukwhere can you get propecia first ten weeks of pregnancy. They have no effect on the availability of surgical abortions, a method that this Court has treated as safe for women," wrote Wall.

Reproductive rights groups spoke out against the order propecia ukwhere can you get propecia move, noting that people of color are disproportionately affected both by abortion restrictions and by the hair loss treatment propecia. "Black, Brown, Indigenous people and people of color are already dying/getting sick at disproportionate rates from hair loss treatment," said All Above All* on Twitter. "The Trump-Pence admin is trying to make this worse by asking SCOTUS to require people face unnecessary risk just to get abortion care." "The FDA’s in-person requirements on mifepristone subject patients to unnecessary exposure order propecia ukwhere can you get propecia to a deadly propecia, and two federal courts have already rejected the Trump administration’s argument. Forcing patients to travel to a health center to access the safe, effective medication they need especially hurts people of color and people with low-incomes, who already face more barriers to care," said Planned Parenthood Federation of America President and CEO Alexis McGill-Johnson in a statement.THE LARGER TREND The hair loss treatment propecia has exacerbated many existing barriers to care, including for reproductive health services.

"We’ve seen the undue burden and hardship these restrictions create during hair loss treatment, especially in communities hit hardest by the propecia," said Skye Perryman, chief legal officer at the American College of Obstetricians and order propecia ukwhere can you get propecia Gynecologists, a co-plaintiff in the telemedicine case, to Healthcare IT News. In response to the July ruling, some abortion providers reportedly moved to delivering mifepristone by mail. Still, others faced state laws that restricted the provision of abortion via telemedicine.And as Dr. Jacquelyn Yeh from Physicians from Reproductive Health pointed out in July, telemedicine itself involves hurdles such as broadband access and privacy concerns.

It remains to be seen whether the Supreme Court will grant the Trump administration's request. ON THE RECORD "As hair loss treatment ravages Black, Latino, Indigenous, and other communities of color across the country, the Trump administration should be aiming to keep us healthy – not moving forward with an agenda to endanger people who seek abortion," said McGill-Johnson. Kat Jercich is senior editor of Healthcare IT News.Twitter. @kjercichHealthcare IT News is a HIMSS Media publication..

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Start Preamble propecia price usa http://www.cardozaartgallery.com/how-to-get-prescribed-seroquel/ Notice of Amendment and Republished Declaration. The Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to amend his March 10, 2020 Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against hair loss treatment. The amendments to the Declaration are applicable as of February 4, 2020, except as propecia price usa otherwise specified in Section XII.

Start Further Info Robert P. Kadlec, MD, MTM&H, MS, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue Start Printed Page 79191SW, Washington, DC 20201. Telephone.

202-205-2882. End Further Info End Preamble Start Supplemental Information The Public Readiness and Emergency Preparedness (PREP) Act, 42 U.S.C. 247d-6d et.

Seq., authorizes the Secretary of Health and Human Services (the Secretary) to issue a declaration to provide liability protections to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from, the manufacture, distribution, administration, or use of certain medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct,” as defined in the PREP Act. Such declarations are subject to amendment as circumstances warrant. The PREP Act was enacted on December 30, 2005, as Public Law 109-148, Division C, Section 2.

It amended the Public Health Service (PHS) Act, adding Section 319F-3, which addresses liability immunity, and Section 319F-4, which creates a compensation program. These sections are codified at 42 U.S.C. 247d-6d and 42 U.S.C.

247d-6e, respectively. Section 319F-3 of the PHS Act has been amended by the propecia and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, enacted on March 13, 2013, and the hair loss Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136, enacted on March 27, 2020, to expand Covered Countermeasures under the PREP Act. On January 31, 2020, the Secretary declared a public health emergency pursuant to section 319 of the PHS Act, 42 U.S.C.

247d, effective January 27, 2020, for the entire United States to aid in the response to the hair loss Disease 2019 (hair loss treatment) outbreak, which subsequently became a global propecia. Pursuant to section 319 of the PHS Act, the Secretary renewed that declaration on April 21, 2020, July 23, 2020, and October 2, 2020. On March 10, 2020, the Secretary issued a declaration under the PREP Act for medical countermeasures against hair loss treatment.[] On April 10, the Secretary amended the Declaration to extend liability protections to Covered Countermeasures authorized under the CARES Act.[] On June 4, the Secretary amended the Declaration to clarify that Covered Countermeasures under the Declaration include qualified propecia and epidemic products that limit the harm that hair loss treatment might otherwise cause.[] On August 19, the Secretary amended the Declaration to add additional categories of Qualified Persons and to amend the category of disease, health condition, or threat for which he recommends the administration or use of Covered Countermeasures.[] The Secretary now further amends the Declaration pursuant to section 319F-3 of the Public Health Service Act.

This Fourth Amendment to the Declaration. (a) Clarifies that the Declaration must be construed in accordance with the Department of Health and Human Services (HHS) Office of the General Counsel (OGC) Advisory Opinions on the Public Readiness and Emergency Preparedness Act and the Declaration (Advisory Opinions).[] The Declaration incorporates the Advisory Opinions for that purpose. (b) Incorporates authorizations that the HHS Office of the Assistant Secretary for Health (OASH) has issued as an Authority Having Jurisdiction.[] (c) Adds an additional category of Qualified Persons under Section V of the Declaration and 42 U.S.C.

247d-6d(i)(8)(B), i.e., healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are permitted to practice.[] (d) Modifies and clarifies the training requirements for certain licensed pharmacists and pharmacy interns to administer certain routine childhood or hair loss treatment vaccinations. (e) Makes explicit that Section VI covers all qualified propecia and epidemic products under the PREP Act. (f) Adds a third method of distribution under Section VII of the Declaration and 42 U.S.C.

247d-6d(a)(5) that would provide liability protections for, among other things, additional private-distribution channels. (g) Makes explicit in Section IX that there can be situations where not administering a covered countermeasure to a particular individual can fall within the PREP Act and this Declaration's liability protections. (h) Makes explicit in Section XI that there are substantial federal legal and policy issues, and substantial federal legal and policy interests, in having a unified, whole-of-nation response to the hair loss treatment propecia among federal, state, local, and private-sector entities.

The world is facing an unprecedented propecia. To effectively respond, there must be a more consistent pathway for Covered Persons to manufacture, distribute, administer or use Covered Countermeasures across the nation and the world.Start Printed Page 79192 (i) Revises the effective time period of the Declaration in light of the amendments to the Declaration.[] The Secretary republishes the Declaration, as amended, in full. Unless otherwise noted, all statutory citations are to the U.S.

Code. Description of This Amendment Declaration The Declaration has fifteen sections describing PREP Act coverage for medical countermeasures against hair loss treatment. OGC has issued Advisory Opinions interpreting the PREP Act and reflecting the Secretary's interpretation of the Declaration.[] The Secretary now amends the Declaration to clarify that the Declaration must be construed in accordance with the Advisory Opinions.

The Secretary expressly incorporates the Advisory Opinions for that purpose. Section V. Covered Persons Section V of the Declaration describes Covered Persons, including additional qualified persons identified by the Secretary, as required under the PREP Act.

The Secretary amends Section V to specify an additional category of qualified persons. Specifically, healthcare personnel who are permitted to order and administer a Covered Countermeasure through telehealth in a state may do so for patients in another state so long as the healthcare personnel comply with the legal requirements of the state in which the healthcare personnel are permitted to order and administer the Covered Countermeasure by means of telehealth. Telehealth is widely recognized as a valuable tool to promote public health during this propecia.

According to the Centers for Disease Control and Prevention (CDC), Telehealth services can facilitate public health mitigation strategies during this propecia by increasing social distancing. These services can be a safer option for [healthcare personnel (HCP)] and patients by reducing potential infectious exposures. They can reduce the strain on healthcare systems by minimizing the surge of patient demand on facilities and reduce the use of [personal protective equipment (PPE)] by healthcare providers.

Maintaining continuity of care to the extent possible can avoid additional negative consequences from delayed preventive, chronic, or routine care. Remote access to healthcare services may increase participation for those who are medically or socially vulnerable or who do not have ready access to providers. Remote access can also help preserve the patient-provider relationship at times when an in-person visit is not practical or feasible.

Telehealth services can be used to. Screen patients who may have symptoms of hair loss treatment and refer as appropriate Provide low-risk urgent care for non-hair loss treatment conditions, identify those persons who may need additional medical consultation or assessment, and refer as appropriate Access primary care providers and specialists, including mental and behavioral health, for chronic health conditions and medication management Provide coaching and support for patients managing chronic health conditions, including weight management and nutrition counseling Participate in physical therapy, occupational therapy, and other modalities as a hybrid approach to in-person care for optimal health Monitor clinical signs of certain chronic medical conditions (e.g., blood pressure, blood glucose, other remote assessments) Engage in case management for patients who have difficulty accessing care (e.g., those who live in very rural settings, older adults, those with limited mobility) Follow up with patients after hospitalization Deliver advance care planning and counseling to patients and caregivers to document preferences if a life-threatening event or medical crisis occurs Provide non-emergent care to residents in long-term care facilities Provide education and training for HCP through peer-to-peer professional medical consultations (inpatient or outpatient) that are not locally available, particularly in rural areas.[] Similarly, CMS has stressed the importance of telehealth during this propecia. Telehealth, telemedicine, and related terms generally refer to the exchange of medical information from one site to another through electronic communication to improve a patient's health.

Innovative uses of this kind of technology in the provision of healthcare is increasing. And with the emergence of the propecia causing the disease hair loss treatment, there is an urgency to expand the use of technology to help people who need routine care, and keep vulnerable beneficiaries and beneficiaries with mild symptoms in their homes while maintaining access to the care they need. Limiting community spread of the propecia, as well as limiting the exposure to other patients and staff members will slow viral spread.[] Accordingly, CMS and other HHS components has substantially expanded the scope of services paid under Medicare when furnished using telehealth technologies during this propecia.

Other HHS components have also taken steps to expand the use of telehealth during the propecia.[] Moreover, to expand the use of telehealth during this propecia, the Office for Civil Rights (OCR) at HHS is exercising enforcement discretion and will not impose penalties for noncompliance with the regulatory requirements under the Health Insurance Portability and Accountability Act (HIPAA) Rules against covered healthcare providers that serve patients through everyday communications technologies during the hair loss treatment nationwide public health emergency.[] This exercise of discretion Start Printed Page 79193applies to widely available communications apps, such as FaceTime or Skype, when used in good faith for any telehealth treatment or diagnostic purpose, regardless of whether the telehealth service is directly related to hair loss treatment.[] Many states have authorized out-of-state healthcare personnel to deliver telehealth services to in-state patients, either generally or in the context of hair loss treatment.[] To help maximize the utility of telehealth, the Secretary declares that the term “qualified person” under 42 U.S.C. 247d-6d(i)(8)(B) includes healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are permitted to practice. When ordering and administering Covered Countermeasures through telehealth to patients in a state where the healthcare personnel are not already permitted to do so, the healthcare personnel must comply with all requirements for ordering and administering Covered Countermeasures to patients through telehealth in the state where the healthcare personnel are licensed or otherwise permitted to practice.

Any state law that prohibits or effectively prohibits such a qualified person from ordering and administering Covered Countermeasures through telehealth is preempted.[] Nothing in this Declaration shall preempt state laws that permit additional persons to deliver telehealth services. The Secretary also amends Section V to include several examples of Covered Persons who are Qualified Persons, because they are authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures. Those examples include certain pharmacists, pharmacy interns, and pharmacy technicians who order or administer certain hair loss treatment tests and certain treatments.[] These examples are not an exclusive or exhaustive list of persons who are qualified persons identified by the Secretary in Section V.

The Secretary also amends Section V to make explicit that the requirement in that section for certain qualified persons to have a current certificate in basic cardiopulmonary resuscitation is satisfied by, among other things, a certification in basic cardiopulmonary resuscitation by an online program that has received accreditation from the American Nurses Credentialing Center, the Accreditation Council for Pharmacy Education (ACPE), or the Accreditation Council for Continuing Medical Education. The Secretary also amends Section V's training requirements for licensed pharmacists to order and administer certain childhood or hair loss treatments. To order and administer treatments, the licensed pharmacist must have completed the immunization training that the licensing State requires in order for pharmacists to administer treatments.

If the State does not specify training requirements for the licensed pharmacist to order and administer treatments, the licensed pharmacist must complete a vaccination training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE) to order and administer treatments. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments. Other than the basic cardiopulmonary resuscitation requirement and the practical training program requirement, this Amendment does not change the requirements for a pharmacist, pharmacy intern, or pharmacy technician to be a “qualified person” under 42 U.S.C.

247d-6d(i)(8)(B) who can order or administer childhood or hair loss treatments pursuant to the Declaration. Section VI. Covered Countermeasures The Secretary amends Section VI to make explicit that Section VI covers all qualified propecia and epidemic products under the PREP Act.Start Printed Page 79194 Section VII.

Limitations on Distribution The Secretary may specify that liability protections are in effect only for Covered Countermeasures obtained through a particular means of distribution. The Declaration previously stated that liability immunity is afforded to Covered Persons only for Recommended Activities related to (a) present or future federal contracts, cooperative agreements, grants, other transactions, interagency agreements, or memoranda of understanding or other federal agreements. Or (b) activities authorized in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasures following a declaration of an emergency.

hair loss treatment is an unprecedented global challenge that requires a whole-of-nation response that utilizes federal-, state-, and local- distribution channels as well as private-distribution channels. Given the broad scale of this propecia, the Secretary amends the Declaration to extend PREP Act coverage to additional private-distribution channels, as set forth below. The amended Section VII adds that PREP Act liability protections also extend to Covered Persons for Recommended Activities that are related to any Covered Countermeasure that is.

(a) Licensed, approved, cleared, or authorized by the Food and Drug Administration (FDA) (or that is permitted to be used under an Investigational New Drug Application or an Investigational Device Exemption) under the Federal Food, Drug, and Cosmetic (FD&C) Act or Public Health Service (PHS) Act to treat, diagnose, cure, prevent, mitigate or limit the harm from hair loss treatment, or the transmission of hair loss or a propecia mutating therefrom. Or (b) a respiratory protective device approved by the National Institute for Occupational Safety and Health (NIOSH) under 42 CFR part 84, or any successor regulations, that the Secretary determines to be a priority for use during a public health emergency declared under section 319 of the PHS Act to prevent, mitigate, or limit the harm from, hair loss treatment, or the transmission of hair loss or a propecia mutating therefrom. To qualify for this third distribution channel (but not necessarily to qualify for the other distribution channels), a Covered Person must manufacture, test, develop, distribute, administer, or use the Covered Countermeasure pursuant to the FDA licensure, approval, clearance, or authorization (or pursuant to an Investigational New Drug Application or Investigational Device Exemption), or the NIOSH approval.

This third distribution channel may extend PREP Act coverage when there is no federal agreement or authorization in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures following a declaration of an emergency. For example, a manufacturer, distributor, program planner, or qualified person engages in manufacturing, testing, development, distribution, administration, or use of a hair loss treatment test pursuant to an FDA Emergency Use Authorization for that hair loss treatment test. If the Covered Person satisfies all other requirements of the PREP Act and Declaration, there will be PREP Act coverage even if there is no federal agreement to cover those activities and those activities are not part of the authorized activity of an Authority Having Jurisdiction.

Section IX. Administration of Covered Countermeasures The Secretary amends Section IX to make explicit that there can be situations where not administering a covered countermeasure to a particular individual can fall within the PREP Act and this Declaration's liability protections. Section XI.

Geographic Area The Secretary makes explicit in Section XI that there are substantial federal legal and policy issues, and substantial federal legal and policy interests within the meaning of Grable &. Sons Metal Products, Inc. V.

308 (2005), in having a unified, whole-of-nation response to the hair loss treatment propecia among federal, state, local, and private-sector entities. The world is facing an unprecedented global propecia. To effectively respond, there must be a more consistent pathway for Covered Persons to manufacture, distribute, administer or use Covered Countermeasures across the nation and the world.

Thus, there are substantial federal legal and policy issues, and substantial federal legal and policy interests within the meaning of Grable &. Sons Metal Products, Inc. V.

308 (2005), in having a uniform interpretation of the PREP Act. Under the PREP Act, the sole exception to the immunity from suit and liability of covered persons is an exclusive Federal cause of action against a Covered Person for death or serious physical injury proximately caused by willful misconduct by such Covered Person. In all other cases, an injured party's exclusive remedy is an administrative remedy under section 319F-4 of the PHS Act.

Through the PREP Act, Congress delegated to me the authority to strike the appropriate Federal-state balance with respect to particular Covered Countermeasures through PREP Act declarations. Section XII. Effective Time Period The Secretary amends Section XII to provide that liability protections for all Covered Countermeasures administered and used in accordance with the public health and medical response of the Authority Having Jurisdiction, as identified in Section VII(b) of this Declaration, begins with a “Declaration of Emergency,” as defined in Section VII (except that, with respect to qualified persons who order or administer a routine childhood vaccination that ACIP recommends to persons ages three through 18 according to ACIP's standard immunization schedule, PREP Act coverage began on August 24, 2020), and lasts through (a) the final day the Declaration of Emergency is in effect, or (b) October 1, 2024, whichever occurs first.

This change is to conform the text of the Declaration to the Third Amendment.[] The Secretary also amends Section XII to provide that liability protections for all Covered Countermeasures identified in Section VII(c) of this Declaration begins on the date of this amended Declaration and lasts through (a) the final day the Declaration of Emergency is in effect, or (b) October 1, 2024, whichever occurs first. Because the Secretary is adding Section VII(c) to the Declaration in this Amendment, Section XII provides that Section VII(c) is effective as of the date this amended Declaration is published. Additional Amendments The Secretary also makes other, non-substantive amendments.

Declaration, as Amended, for Public Readiness and Emergency Preparedness Act Coverage for Medical Countermeasures Against hair loss treatment To the extent any term previously in the Declaration, including its amendments, is inconsistent with any provision of this Republished Declaration, the terms of this Republished Declaration are controlling. This Declaration must be construed in accordance with the Advisory Opinions Start Printed Page 79195of the Office of the General Counsel (Advisory Opinions). I incorporate those Advisory Opinions as part of this Declaration.[] This Declaration is a “requirement” under the PREP Act.

I. Determination of Public Health Emergency 42 U.S.C. 247d-6d(b)(1) I have determined that the spread of hair loss or a propecia mutating therefrom and the resulting disease hair loss treatment constitutes a public health emergency.

I further determine that use of any respiratory protective device approved by NIOSH under 42 CFR part 84, or any successor regulations, is a priority for use during the public health emergency that I declared on January 31, 2020 under section 319 of the PHS Act for the entire United States to aid in the response of the nation's healthcare community to the hair loss treatment outbreak. II. Factors Considered 42 U.S.C.

247d-6d(b)(6) I have considered the desirability of encouraging the design, development, clinical testing, or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of the Covered Countermeasures. III. Recommended Activities 42 U.S.C.

247d-6d(b)(1) I recommend, under the conditions stated in this Declaration, the manufacture, testing, development, distribution, administration, and use of the Covered Countermeasures. IV. Liability Protections 42 U.S.C.

247d-6d(a), 247d-6d(b)(1) Liability protections as prescribed in the PREP Act and conditions stated in this Declaration are in effect for the Recommended Activities described in Section III. V. Covered Persons 42 U.S.C.

247d-6d(i)(2), (3), (4), (6), (8)(A) and (B) Covered Persons who are afforded liability protections under this Declaration are “manufacturers,” “distributors,” “program planners,” and “qualified persons,” as those terms are defined in the PREP Act. Their officials, agents, and employees. And the United States.

In addition, I have determined that the following additional persons are qualified persons. (a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of Emergency, as that term is defined in Section VII of this Declaration; [] (b) any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act. (c) any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act.

(d) a State-licensed pharmacist who orders and administers, and pharmacy interns who administer (if the pharmacy intern acts under the supervision of such pharmacist and the pharmacy intern is licensed or registered by his or her State board of pharmacy), [] (1) treatments that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule or (2) FDA-authorized or FDA-licensed hair loss treatments to persons ages three or older. Such State-licensed pharmacists and the State-licensed or registered interns under their supervision are qualified persons only if the following requirements are met. I.

The treatment must be authorized, approved, or licensed by the FDA. Ii. In the case of a hair loss treatment, the vaccination must be ordered and administered according to ACIP's hair loss treatment recommendation(s).

Iii. In the case of a childhood treatment, the vaccination must be ordered and administered according to ACIP's standard immunization schedule. Iv.

The licensed pharmacist must have completed the immunization training that the licensing State requires in order for pharmacists to order and administer treatments. If the State does not specify training requirements for the licensed pharmacist to order and administer treatments, the licensed pharmacist must complete a vaccination training program of at least 20 hours that is approved by the Accreditation Start Printed Page 79196Council for Pharmacy Education (ACPE) to order and administer treatments. Such a training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments.

V. The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments.

Vi. The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation; [] vii. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period.

Viii. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers treatments, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (treatment registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a treatment must review the treatment registry or other vaccination records prior to administering a treatment. And ix.

The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients as appropriate. X. The licensed pharmacist and the licensed or registered pharmacy intern must comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) hair loss treatment vaccination provider agreement and any other federal requirements that apply to the administration of hair loss treatment(s).

(e) Healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are licensed or otherwise permitted to practice. When ordering and administering Covered Countermeasures by means of telehealth to patients in a state where the healthcare personnel are not already permitted to practice, the healthcare personnel must comply with all requirements for ordering and administering Covered Countermeasures to patients by means of telehealth in the state where the healthcare personnel are permitted to practice. Any state law that prohibits or effectively prohibits such a qualified person from ordering and administering Covered Countermeasures by means of telehealth is preempted.[] Nothing in this Declaration shall preempt state laws that permit additional persons to deliver telehealth services.

Nothing in this Declaration shall be construed to affect the National treatment Injury Compensation Program, including an injured party's ability to obtain compensation under that program. Covered Countermeasures that are subject to the National treatment Injury Compensation Program authorized under 42 U.S.C. 300aa-10 et seq.

Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other terms and conditions of the Declaration apply to such Covered Countermeasures. VI.

Covered Countermeasures 42 U.S.C. 247d-6b(c)(1)(B), 42 U.S.C. 247d-6d(i)(1) and (7) Covered Countermeasures are.

(a) Any antiviral, any drug, any biologic, any diagnostic, any other device, any respiratory protective device, or any treatment manufactured, used, designed, developed, modified, licensed, or procured. I. To diagnose, mitigate, prevent, treat, or cure hair loss treatment, or the transmission of hair loss or a propecia mutating therefrom.

Or ii. To limit the harm that hair loss treatment, or the transmission of hair loss or a propecia mutating therefrom, might otherwise cause. (b) a product manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by a product described in paragraph (a) above.

(c) a product or technology intended to enhance the use or effect of a product described in paragraph (a) or (b) above. Or (d) any device used in the administration of any such product, and all components and constituent materials of any such product. To be a Covered Countermeasure under the Declaration, a product must also meet 42 U.S.C.

247d-6d(i)(1)'s definition of “Covered Countermeasure.” VII. Limitations on Distribution 42 U.S.C. 247d-6d(a)(5) and (b)(2)(E) I have determined that liability protections are afforded to Covered Persons only for Recommended Activities involving.

(a) Covered Countermeasures that are related to present or future federal contracts, cooperative agreements, grants, other transactions, interagency agreements, memoranda of understanding, or other federal agreements. (b) Covered Countermeasures that are related to activities authorized in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures following a Declaration of Emergency. Or (c) Covered Countermeasures that are.

I. Licensed, approved, cleared, or authorized by the FDA (or that are permitted to be used under an Investigational New Drug Application or an Investigational Device Exemption) under the FD&C Act or PHS Act to treat, diagnose, cure, prevent, mitigate, or limit the harm from hair loss treatment, or the transmission of hair loss or a propecia mutating therefrom. OrStart Printed Page 79197 ii.

A respiratory protective device approved by NIOSH under 42 CFR part 84, or any successor regulations, that the Secretary determines to be a priority for use during a public health emergency declared under section 319 of the PHS Act to prevent, mitigate, or limit the harm from hair loss treatment, or the transmission of hair loss or a propecia mutating therefrom. To qualify for this third distribution channel, a Covered Person must manufacture, test, develop, distribute, administer, or use the Covered Countermeasure pursuant to the FDA licensure, approval, clearance, or authorization (or pursuant to an Investigational New Drug Application or Investigational Device Exemption), or the NIOSH approval. As used in this Declaration, the terms “Authority Having Jurisdiction” and “Declaration of Emergency” have the following meanings.

(a) The Authority Having Jurisdiction means the public agency or its delegate that has legal responsibility and authority for responding to an incident, based on political or geographical (e.g., city, county, tribal, state, or federal boundary lines) or functional (e.g., law enforcement, public health) range or sphere of authority. (b) A Declaration of Emergency means any declaration by any authorized local, regional, state, or federal official of an emergency specific to events that indicate an immediate need to administer and use the Covered Countermeasures, with the exception of a federal declaration in support of an Emergency Use Authorization under Section 564 of the FD&C Act unless such declaration specifies otherwise. I have also determined that, for governmental program planners only, liability protections are afforded only to the extent such program planners obtain Covered Countermeasures through voluntary means, such as (a) donation.

(b) commercial sale. (c) deployment of Covered Countermeasures from federal stockpiles. Or (d) deployment of donated, purchased, or otherwise voluntarily obtained Covered Countermeasures from state, local, or private stockpiles.

VIII. Category of Disease, Health Condition, or Threat 42 U.S.C. 247d-6d(b)(2)(A) The category of disease, health condition, or threat for which I recommend the administration or use of the Covered Countermeasures is not only hair loss treatment caused by hair loss, or a propecia mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by hair loss treatment, hair loss, or a propecia mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases.

IX. Administration of Covered Countermeasures 42 U.S.C. 247d-6d(a)(2)(B) Administration of the Covered Countermeasure means physical provision of the countermeasures to recipients, or activities and decisions directly relating to public and private delivery, distribution and dispensing of the countermeasures to recipients, management and operation of countermeasure programs, or management and operation of locations for the purpose of distributing and dispensing countermeasures.

Where there are limited Covered Countermeasures, not administering a Covered Countermeasure to one individual in order to administer it to another individual can constitute “relating to. . .

An individual” under 42 U.S.C. 247d-6d. For example, consider a situation where there is only one dose [] of a hair loss treatment, and a person in a vulnerable population and a person in a less vulnerable population both request it from a healthcare professional.

In that situation, the healthcare professional administers the one dose to the person who is more vulnerable to hair loss treatment. In that circumstance, the failure to administer the hair loss treatment to the person in a less-vulnerable population “relat[es] to. .

. The administration to” the person in a vulnerable population. The person in the vulnerable population was able to receive the treatment only because it was not administered to the person in the less-vulnerable population.

Prioritization or purposeful allocation of a Covered Countermeasure, particularly if done in accordance with a public health authority's directive, can fall within the PREP Act and this Declaration's liability protections. X. Population 42 U.S.C.

247d-6d(a)(4), 247d-6d(b)(2)(C) The populations of individuals to whom the liability protections of this Declaration extend include any individual who uses or is administered the Covered Countermeasures in accordance with this Declaration. Liability protections are afforded to manufacturers and distributors without regard to whether the countermeasure is used by or administered to this population. Liability protections are afforded to program planners and qualified persons when the countermeasure is used by or administered to this population, or the program planner or qualified person reasonably could have believed the recipient was in this population.

XI. Geographic Area 42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(D) Liability protections are afforded for the administration or use of a Covered Countermeasure without geographic limitation.

Liability protections are afforded to manufacturers and distributors without regard to whether the Covered Countermeasure is used by or administered in any designated geographic area. Liability protections are afforded to program planners and qualified persons when the countermeasure is used by or administered in any designated geographic area, or the program planner or qualified person reasonably could have believed the recipient was in that geographic area. hair loss treatment is a global challenge that requires a whole-of-nation response.

There are substantial federal legal and policy issues, and substantial federal legal and policy interests within the meaning of Grable &. Sons Metal Products, Inc. V.

308 (2005), in having a unified, whole-of-nation response to the hair loss treatment propecia among federal, state, local, and private-sector entities. The world is facing an unprecedented propecia. To effectively respond, there must be a more consistent pathway for Covered Persons to manufacture, distribute, administer or use Covered Countermeasures across the nation and the world.

Thus, there are substantial federal legal and policy issues, and substantial federal legal and policy interests within the meaning of Grable &. Sons Metal Products, Inc. V.

308 (2005), in having a uniform interpretation of the PREP Act. Under the PREP Act, the sole exception to the immunity from suit and liability of covered persons under the PREP Act is an exclusive Federal cause of action against a covered person for death or serious physical injury proximately caused by willful misconduct by such covered person. In all other cases, an injured party's exclusive remedy is an administrative Start Printed Page 79198remedy under section 319F-4 of the PHS Act.

Through the PREP Act, Congress delegated to me the authority to strike the appropriate Federal-state balance with respect to particular Covered Countermeasures through PREP Act declarations.[] XII. Effective Time Period 42 U.S.C. 247d-6d(b)(2)(B) Liability protections for any respiratory protective device approved by NIOSH under 42 CFR part 84, or any successor regulations, through the means of distribution identified in Section VII(a) of this Declaration, begin on March 27, 2020 and extend through October 1, 2024.

Liability protections for all other Covered Countermeasures identified in Section VI of this Declaration, through means of distribution identified in Section VII(a) of this Declaration, begin on February 4, 2020 and extend through October 1, 2024. Liability protections for all Covered Countermeasures administered and used in accordance with the public health and medical response of the Authority Having Jurisdiction, as identified in Section VII(b) of this Declaration, begin with a Declaration of Emergency as that term is defined in Section VII (except that, with respect to qualified persons who order or administer a routine childhood vaccination that ACIP recommends to persons ages three through 18 according to ACIP's standard immunization schedule, liability protections began on August 24, 2020), and last through (a) the final day the Declaration of Emergency is in effect, or (b) October 1, 2024, whichever occurs first. Liability protections for all Covered Countermeasures identified in Section VII(c) of this Declaration begin on the date of this amended Declaration and last through (a) the final day the Declaration of Emergency is in effect, or (b) October 1, 2024, whichever occurs first.

XIII. Additional Time Period of Coverage 42 U.S.C. 247d-6d(b)(3)(B) and (C) I have determined that an additional 12 months of liability protection is reasonable to allow for the manufacturer(s) to arrange for disposition of the Covered Countermeasure, including return of the Covered Countermeasures to the manufacturer, and for Covered Persons to take such other actions as are appropriate to limit the administration or use of the Covered Countermeasures.

Covered Countermeasures obtained for the SNS during the effective period of this Declaration are covered through the date of administration or use pursuant to a distribution or release from the SNS. XIV. Countermeasures Injury Compensation Program 42 U.S.C 247d-6e The PREP Act authorizes the Countermeasures Injury Compensation Program (CICP) to provide benefits to certain individuals or estates of individuals who sustain a covered serious physical injury as the direct result of the administration or use of the Covered Countermeasures, and benefits to certain survivors of individuals who die as a direct result of the administration or use of the Covered Countermeasures.

The causal connection between the countermeasure and the serious physical injury must be supported by compelling, reliable, valid, medical and scientific evidence in order for the individual to be considered for compensation. The CICP is administered by the Health Resources and Services Administration, within the Department of Health and Human Services. Information about the CICP is available at the toll-free number 1-855-266-2427 or http://www.hrsa.gov/​cicp/​.

XV. Amendments 42 U.S.C. 247d-6d(b)(4) Amendments to this Declaration will be published in the Federal Register, as warranted.

Start Authority 42 U.S.C. 247d-6d. End Authority Start Signature Dated.

December 3, 2020. Alex M. Azar II, Secretary of Health and Human Services.

End Signature End Supplemental Information [FR Doc. 2020-26977 Filed 12-8-20. 8:45 am]BILLING CODE 4150-37-P.

Start Preamble order propecia ukwhere can you get propecia Notice of Amendment and How to get prescribed seroquel Republished Declaration. The Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to amend his March 10, 2020 Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against hair loss treatment. The amendments to the Declaration are applicable as of February 4, 2020, except as otherwise specified in order propecia ukwhere can you get propecia Section XII. Start Further Info Robert P. Kadlec, MD, MTM&H, MS, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue Start Printed Page 79191SW, Washington, DC 20201.

Telephone. 202-205-2882. End Further Info End Preamble Start Supplemental Information The Public Readiness and Emergency Preparedness (PREP) Act, 42 U.S.C. 247d-6d et. Seq., authorizes the Secretary of Health and Human Services (the Secretary) to issue a declaration to provide liability protections to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from, the manufacture, distribution, administration, or use of certain medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct,” as defined in the PREP Act.

Such declarations are subject to amendment as circumstances warrant. The PREP Act was enacted on December 30, 2005, as Public Law 109-148, Division C, Section 2. It amended the Public Health Service (PHS) Act, adding Section 319F-3, which addresses liability immunity, and Section 319F-4, which creates a compensation program. These sections are codified at 42 U.S.C. 247d-6d and 42 U.S.C.

247d-6e, respectively. Section 319F-3 of the PHS Act has been amended by the propecia and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, enacted on March 13, 2013, and the hair loss Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136, enacted on March 27, 2020, to expand Covered Countermeasures under the PREP Act. On January 31, 2020, the Secretary declared a public health emergency pursuant to section 319 of the PHS Act, 42 U.S.C. 247d, effective January 27, 2020, for the entire United States to aid in the response to the hair loss Disease 2019 (hair loss treatment) outbreak, which subsequently became a global propecia. Pursuant to section 319 of the PHS Act, the Secretary renewed that declaration on April 21, 2020, July 23, 2020, and October 2, 2020.

On March 10, 2020, the Secretary issued a declaration under the PREP Act for medical countermeasures against hair loss treatment.[] On April 10, the Secretary amended the Declaration to extend liability protections to Covered Countermeasures authorized under the CARES Act.[] On June 4, the Secretary amended the Declaration to clarify that Covered Countermeasures under the Declaration include qualified propecia and epidemic products that limit the harm that hair loss treatment might otherwise cause.[] On August 19, the Secretary amended the Declaration to add additional categories of Qualified Persons and to amend the category of disease, health condition, or threat for which he recommends the administration or use of Covered Countermeasures.[] The Secretary now further amends the Declaration pursuant to section 319F-3 of the Public Health Service Act. This Fourth Amendment to the Declaration. (a) Clarifies that the Declaration must be construed in accordance with the Department of Health and Human Services (HHS) Office of the General Counsel (OGC) Advisory Opinions on the Public Readiness and Emergency Preparedness Act and the Declaration (Advisory Opinions).[] The Declaration incorporates the Advisory Opinions for that purpose. (b) Incorporates authorizations that the HHS Office of the Assistant Secretary for Health (OASH) has issued as an Authority Having Jurisdiction.[] (c) Adds an additional category of Qualified Persons under Section V of the Declaration and 42 U.S.C. 247d-6d(i)(8)(B), i.e., healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are permitted to practice.[] (d) Modifies and clarifies the training requirements for certain licensed pharmacists and pharmacy interns to administer certain routine childhood or hair loss treatment vaccinations.

(e) Makes explicit that Section VI covers all qualified propecia and epidemic products under the PREP Act. (f) Adds a third method of distribution under Section VII of the Declaration and 42 U.S.C. 247d-6d(a)(5) that would provide liability protections for, among other things, additional private-distribution channels. (g) Makes explicit in Section IX that there can be situations where not administering a covered countermeasure to a particular individual can fall within the PREP Act and this Declaration's liability protections. (h) Makes explicit in Section XI that there are substantial federal legal and policy issues, and substantial federal legal and policy interests, in having a unified, whole-of-nation response to the hair loss treatment propecia among federal, state, local, and private-sector entities.

The world is facing an unprecedented propecia. To effectively respond, there must be a more consistent pathway for Covered Persons to manufacture, distribute, administer or use Covered Countermeasures across the nation and the world.Start Printed Page 79192 (i) Revises the effective time period of the Declaration in light of the amendments to the Declaration.[] The Secretary republishes the Declaration, as amended, in full. Unless otherwise noted, all statutory citations are to the U.S. Code. Description of This Amendment Declaration The Declaration has fifteen sections describing PREP Act coverage for medical countermeasures against hair loss treatment.

OGC has issued Advisory Opinions interpreting the PREP Act and reflecting the Secretary's interpretation of the Declaration.[] The Secretary now amends the Declaration to clarify that the Declaration must be construed in accordance with the Advisory Opinions. The Secretary expressly incorporates the Advisory Opinions for that purpose. Section V. Covered Persons Section V of the Declaration describes Covered Persons, including additional qualified persons identified by the Secretary, as required under the PREP Act. The Secretary amends Section V to specify an additional category of qualified persons.

Specifically, healthcare personnel who are permitted to order and administer a Covered Countermeasure through telehealth in a state may do so for patients in another state so long as the healthcare personnel comply with the legal requirements of the state in which the healthcare personnel are permitted to order and administer the Covered Countermeasure by means of telehealth. Telehealth is widely recognized as a valuable tool to promote public health during this propecia. According to the Centers for Disease Control and Prevention (CDC), Telehealth services can facilitate public health mitigation strategies during this propecia by increasing social distancing. These services can be a safer option for [healthcare personnel (HCP)] and patients by reducing potential infectious exposures. They can reduce the strain on healthcare systems by minimizing the surge of patient demand on facilities and reduce the use of [personal protective equipment (PPE)] by healthcare providers.

Maintaining continuity of care to the extent possible can avoid additional negative consequences from delayed preventive, chronic, or routine care. Remote access to healthcare services may increase participation for those who are medically or socially vulnerable or who do not have ready access to providers. Remote access can also help preserve the patient-provider relationship at times when an in-person visit is not practical or feasible. Telehealth services can be used to. Screen patients who may have symptoms of hair loss treatment and refer as appropriate Provide low-risk urgent care for non-hair loss treatment conditions, identify those persons who may need additional medical consultation or assessment, and refer as appropriate Access primary care providers and specialists, including mental and behavioral health, for chronic health conditions and medication management Provide coaching and support for patients managing chronic health conditions, including weight management and nutrition counseling Participate in physical therapy, occupational therapy, and other modalities as a hybrid approach to in-person care for optimal health Monitor clinical signs of certain chronic medical conditions (e.g., blood pressure, blood glucose, other remote assessments) Engage in case management for patients who have difficulty accessing care (e.g., those who live in very rural settings, older adults, those with limited mobility) Follow up with patients after hospitalization Deliver advance care planning and counseling to patients and caregivers to document preferences if a life-threatening event or medical crisis occurs Provide non-emergent care to residents in long-term care facilities Provide education and training for HCP through peer-to-peer professional medical consultations (inpatient or outpatient) that are not locally available, particularly in rural areas.[] Similarly, CMS has stressed the importance of telehealth during this propecia.

Telehealth, telemedicine, and related terms generally refer to the exchange of medical information from one site to another through electronic communication to improve a patient's health. Innovative uses of this kind of technology in the provision of healthcare is increasing. And with the emergence of the propecia causing the disease hair loss treatment, there is an urgency to expand the use of technology to help people who need routine care, and keep vulnerable beneficiaries and beneficiaries with mild symptoms in their homes while maintaining access to the care they need. Limiting community spread of the propecia, as well as limiting the exposure to other patients and staff members will slow viral spread.[] Accordingly, CMS and other HHS components has substantially expanded the scope of services paid under Medicare when furnished using telehealth technologies during this propecia. Other HHS components have also taken steps to expand the use of telehealth during the propecia.[] Moreover, to expand the use of telehealth during this propecia, the Office for Civil Rights (OCR) at HHS is exercising enforcement discretion and will not impose penalties for noncompliance with the regulatory requirements under the Health Insurance Portability and Accountability Act (HIPAA) Rules against covered healthcare providers that serve patients through everyday communications technologies during the hair loss treatment nationwide public health emergency.[] This exercise of discretion Start Printed Page 79193applies to widely available communications apps, such as FaceTime or Skype, when used in good faith for any telehealth treatment or diagnostic purpose, regardless of whether the telehealth service is directly related to hair loss treatment.[] Many states have authorized out-of-state healthcare personnel to deliver telehealth services to in-state patients, either generally or in the context of hair loss treatment.[] To help maximize the utility of telehealth, the Secretary declares that the term “qualified person” under 42 U.S.C.

247d-6d(i)(8)(B) includes healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are permitted to practice. When ordering and administering Covered Countermeasures through telehealth to patients in a state where the healthcare personnel are not already permitted to do so, the healthcare personnel must comply with all requirements for ordering and administering Covered Countermeasures to patients through telehealth in the state where the healthcare personnel are licensed or otherwise permitted to practice. Any state law that prohibits or effectively prohibits such a qualified person from ordering and administering Covered Countermeasures through telehealth is preempted.[] Nothing in this Declaration shall preempt state laws that permit additional persons to deliver telehealth services. The Secretary also amends Section V to include several examples of Covered Persons who are Qualified Persons, because they are authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures. Those examples include certain pharmacists, pharmacy interns, and pharmacy technicians who order or administer certain hair loss treatment tests and certain treatments.[] These examples are not an exclusive or exhaustive list of persons who are qualified persons identified by the Secretary in Section V.

The Secretary also amends Section V to make explicit that the requirement in that section for certain qualified persons to have a current certificate in basic cardiopulmonary resuscitation is satisfied by, among other things, a certification in basic cardiopulmonary resuscitation by an online program that has received accreditation from the American Nurses Credentialing Center, the Accreditation Council for Pharmacy Education (ACPE), or the Accreditation Council for Continuing Medical Education. The Secretary also amends Section V's training requirements for licensed pharmacists to order and administer certain childhood or hair loss treatments. To order and administer treatments, the licensed pharmacist must have completed the immunization training that the licensing State requires in order for pharmacists to administer treatments. If the State does not specify training requirements for the licensed pharmacist to order and administer treatments, the licensed pharmacist must complete a vaccination training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE) to order and administer treatments. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments.

Other than the basic cardiopulmonary resuscitation requirement and the practical training program requirement, this Amendment does not change the requirements for a pharmacist, pharmacy intern, or pharmacy technician to be a “qualified person” under 42 U.S.C. 247d-6d(i)(8)(B) who can order or administer childhood or hair loss treatments pursuant to the Declaration. Section VI. Covered Countermeasures The Secretary amends Section VI to make explicit that Section VI covers all qualified propecia and epidemic products under the PREP Act.Start Printed Page 79194 Section VII. Limitations on Distribution The Secretary may specify that liability protections are in effect only for Covered Countermeasures obtained through a particular means of distribution.

The Declaration previously stated that liability immunity is afforded to Covered Persons only for Recommended Activities related to (a) present or future federal contracts, cooperative agreements, grants, other transactions, interagency agreements, or memoranda of understanding or other federal agreements. Or (b) activities authorized in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasures following a declaration of an emergency. hair loss treatment is an unprecedented global challenge that requires a whole-of-nation response that utilizes federal-, state-, and local- distribution channels as well as private-distribution channels. Given the broad scale of this propecia, the Secretary amends the Declaration to extend PREP Act coverage to additional private-distribution channels, as set forth below. The amended Section VII adds that PREP Act liability protections also extend to Covered Persons for Recommended Activities that are related to any Covered Countermeasure that is.

(a) Licensed, approved, cleared, or authorized by the Food and Drug Administration (FDA) (or that is permitted to be used under an Investigational New Drug Application or an Investigational Device Exemption) under the Federal Food, Drug, and Cosmetic (FD&C) Act or Public Health Service (PHS) Act to treat, diagnose, cure, prevent, mitigate or limit the harm from hair loss treatment, or the transmission of hair loss or a propecia mutating therefrom. Or (b) a respiratory protective device approved by the National Institute for Occupational Safety and Health (NIOSH) under 42 CFR part 84, or any successor regulations, that the Secretary determines to be a priority for use during a public health emergency declared under section 319 of the PHS Act to prevent, mitigate, or limit the harm from, hair loss treatment, or the transmission of hair loss or a propecia mutating therefrom. To qualify for this third distribution channel (but not necessarily to qualify for the other distribution channels), a Covered Person must manufacture, test, develop, distribute, administer, or use the Covered Countermeasure pursuant to the FDA licensure, approval, clearance, or authorization (or pursuant to an Investigational New Drug Application or Investigational Device Exemption), or the NIOSH approval. This third distribution channel may extend PREP Act coverage when there is no federal agreement or authorization in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures following a declaration of an emergency. For example, a manufacturer, distributor, program planner, or qualified person engages in manufacturing, testing, development, distribution, administration, or use of a hair loss treatment test pursuant to an FDA Emergency Use Authorization for that hair loss treatment test.

If the Covered Person satisfies all other requirements of the PREP Act and Declaration, there will be PREP Act coverage even if there is no federal agreement to cover those activities and those activities are not part of the authorized activity of an Authority Having Jurisdiction. Section IX. Administration of Covered Countermeasures The Secretary amends Section IX to make explicit that there can be situations where not administering a covered countermeasure to a particular individual can fall within the PREP Act and this Declaration's liability protections. Section XI. Geographic Area The Secretary makes explicit in Section XI that there are substantial federal legal and policy issues, and substantial federal legal and policy interests within the meaning of Grable &.

Sons Metal Products, Inc. V. Darue Eng'g. &. Mf'g., 545 U.S.

308 (2005), in having a unified, whole-of-nation response to the hair loss treatment propecia among federal, state, local, and private-sector entities. The world is facing an unprecedented global propecia. To effectively respond, there must be a more consistent pathway for Covered Persons to manufacture, distribute, administer or use Covered Countermeasures across the nation and the world. Thus, there are substantial federal legal and policy issues, and substantial federal legal and policy interests within the meaning of Grable &. Sons Metal Products, Inc.

V. Darue Eng'g. &. Mf'g., 545 U.S. 308 (2005), in having a uniform interpretation of the PREP Act.

Under the PREP Act, the sole exception to the immunity from suit and liability of covered persons is an exclusive Federal cause of action against a Covered Person for death or serious physical injury proximately caused by willful misconduct by such Covered Person. In all other cases, an injured party's exclusive remedy is an administrative remedy under section 319F-4 of the PHS Act. Through the PREP Act, Congress delegated to me the authority to strike the appropriate Federal-state balance with respect to particular Covered Countermeasures through PREP Act declarations. Section XII. Effective Time Period The Secretary amends Section XII to provide that liability protections for all Covered Countermeasures administered and used in accordance with the public health and medical response of the Authority Having Jurisdiction, as identified in Section VII(b) of this Declaration, begins with a “Declaration of Emergency,” as defined in Section VII (except that, with respect to qualified persons who order or administer a routine childhood vaccination that ACIP recommends to persons ages three through 18 according to ACIP's standard immunization schedule, PREP Act coverage began on August 24, 2020), and lasts through (a) the final day the Declaration of Emergency is in effect, or (b) October 1, 2024, whichever occurs first.

This change is to conform the text of the Declaration to the Third Amendment.[] The Secretary also amends Section XII to provide that liability protections for all Covered Countermeasures identified in Section VII(c) of this Declaration begins on the date of this amended Declaration and lasts through (a) the final day the Declaration of Emergency is in effect, or (b) October 1, 2024, whichever occurs first. Because the Secretary is adding Section VII(c) to the Declaration in this Amendment, Section XII provides that Section VII(c) is effective as of the date this amended Declaration is published. Additional Amendments The Secretary also makes other, non-substantive amendments. Declaration, as Amended, for Public Readiness and Emergency Preparedness Act Coverage for Medical Countermeasures Against hair loss treatment To the extent any term previously in the Declaration, including its amendments, is inconsistent with any provision of this Republished Declaration, the terms of this Republished Declaration are controlling. This Declaration must be construed in accordance with the Advisory Opinions Start Printed Page 79195of the Office of the General Counsel (Advisory Opinions).

I incorporate those Advisory Opinions as part of this Declaration.[] This Declaration is a “requirement” under the PREP Act. I. Determination of Public Health Emergency 42 U.S.C. 247d-6d(b)(1) I have determined that the spread of hair loss or a propecia mutating therefrom and the resulting disease hair loss treatment constitutes a public health emergency. I further determine that use of any respiratory protective device approved by NIOSH under 42 CFR part 84, or any successor regulations, is a priority for use during the public health emergency that I declared on January 31, 2020 under section 319 of the PHS Act for the entire United States to aid in the response of the nation's healthcare community to the hair loss treatment outbreak.

II. Factors Considered 42 U.S.C. 247d-6d(b)(6) I have considered the desirability of encouraging the design, development, clinical testing, or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of the Covered Countermeasures. III. Recommended Activities 42 U.S.C.

247d-6d(b)(1) I recommend, under the conditions stated in this Declaration, the manufacture, testing, development, distribution, administration, and use of the Covered Countermeasures. IV. Liability Protections 42 U.S.C. 247d-6d(a), 247d-6d(b)(1) Liability protections as prescribed in the PREP Act and conditions stated in this Declaration are in effect for the Recommended Activities described in Section III. V.

Covered Persons 42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B) Covered Persons who are afforded liability protections under this Declaration are “manufacturers,” “distributors,” “program planners,” and “qualified persons,” as those terms are defined in the PREP Act. Their officials, agents, and employees. And the United States. In addition, I have determined that the following additional persons are qualified persons.

(a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of Emergency, as that term is defined in Section VII of this Declaration; [] (b) any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act. (c) any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act. (d) a State-licensed pharmacist who orders and administers, and pharmacy interns who administer (if the pharmacy intern acts under the supervision of such pharmacist and the pharmacy intern is licensed or registered by his or her State board of pharmacy), [] (1) treatments that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule or (2) FDA-authorized or FDA-licensed hair loss treatments to persons ages three or older. Such State-licensed pharmacists and the State-licensed or registered interns under their supervision are qualified persons only if the following requirements are met. I.

The treatment must be authorized, approved, or licensed by the FDA. Ii. In the case of a hair loss treatment, the vaccination must be ordered and administered according to ACIP's hair loss treatment recommendation(s). Iii. In the case of a childhood treatment, the vaccination must be ordered and administered according to ACIP's standard immunization schedule.

Iv. The licensed pharmacist must have completed the immunization training that the licensing State requires in order for pharmacists to order and administer treatments. If the State does not specify training requirements for the licensed pharmacist to order and administer treatments, the licensed pharmacist must complete a vaccination training program of at least 20 hours that is approved by the Accreditation Start Printed Page 79196Council for Pharmacy Education (ACPE) to order and administer treatments. Such a training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments. V.

The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments. Vi. The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation; [] vii. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period.

Viii. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers treatments, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (treatment registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a treatment must review the treatment registry or other vaccination records prior to administering a treatment. And ix. The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients as appropriate. X.

The licensed pharmacist and the licensed or registered pharmacy intern must comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) hair loss treatment vaccination provider agreement and any other federal requirements that apply to the administration of hair loss treatment(s). (e) Healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are licensed or otherwise permitted to practice. When ordering and administering Covered Countermeasures by means of telehealth to patients in a state where the healthcare personnel are not already permitted to practice, the healthcare personnel must comply with all requirements for ordering and administering Covered Countermeasures to patients by means of telehealth in the state where the healthcare personnel are permitted to practice. Any state law that prohibits or effectively prohibits such a qualified person from ordering and administering Covered Countermeasures by means of telehealth is preempted.[] Nothing in this Declaration shall preempt state laws that permit additional persons to deliver telehealth services. Nothing in this Declaration shall be construed to affect the National treatment Injury Compensation Program, including an injured party's ability to obtain compensation under that program.

Covered Countermeasures that are subject to the National treatment Injury Compensation Program authorized under 42 U.S.C. 300aa-10 et seq. Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other terms and conditions of the Declaration apply to such Covered Countermeasures. VI.

Covered Countermeasures 42 U.S.C. 247d-6b(c)(1)(B), 42 U.S.C. 247d-6d(i)(1) and (7) Covered Countermeasures are. (a) Any antiviral, any drug, any biologic, any diagnostic, any other device, any respiratory protective device, or any treatment manufactured, used, designed, developed, modified, licensed, or procured. I.

To diagnose, mitigate, prevent, treat, or cure hair loss treatment, or the transmission of hair loss or a propecia mutating therefrom. Or ii. To limit the harm that hair loss treatment, or the transmission of hair loss or a propecia mutating therefrom, might otherwise cause. (b) a product manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by a product described in paragraph (a) above. (c) a product or technology intended to enhance the use or effect of a product described in paragraph (a) or (b) above.

Or (d) any device used in the administration of any such product, and all components and constituent materials of any such product. To be a Covered Countermeasure under the Declaration, a product must also meet 42 U.S.C. 247d-6d(i)(1)'s definition of “Covered Countermeasure.” VII. Limitations on Distribution 42 U.S.C. 247d-6d(a)(5) and (b)(2)(E) I have determined that liability protections are afforded to Covered Persons only for Recommended Activities involving.

(a) Covered Countermeasures that are related to present or future federal contracts, cooperative agreements, grants, other transactions, interagency agreements, memoranda of understanding, or other federal agreements. (b) Covered Countermeasures that are related to activities authorized in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures following a Declaration of Emergency. Or (c) Covered Countermeasures that are. I. Licensed, approved, cleared, or authorized by the FDA (or that are permitted to be used under an Investigational New Drug Application or an Investigational Device Exemption) under the FD&C Act or PHS Act to treat, diagnose, cure, prevent, mitigate, or limit the harm from hair loss treatment, or the transmission of hair loss or a propecia mutating therefrom.

OrStart Printed Page 79197 ii. A respiratory protective device approved by NIOSH under 42 CFR part 84, or any successor regulations, that the Secretary determines to be a priority for use during a public health emergency declared under section 319 of the PHS Act to prevent, mitigate, or limit the harm from hair loss treatment, or the transmission of hair loss or a propecia mutating therefrom. To qualify for this third distribution channel, a Covered Person must manufacture, test, develop, distribute, administer, or use the Covered Countermeasure pursuant to the FDA licensure, approval, clearance, or authorization (or pursuant to an Investigational New Drug Application or Investigational Device Exemption), or the NIOSH approval. As used in this Declaration, the terms “Authority Having Jurisdiction” and “Declaration of Emergency” have the following meanings. (a) The Authority Having Jurisdiction means the public agency or its delegate that has legal responsibility and authority for responding to an incident, based on political or geographical (e.g., city, county, tribal, state, or federal boundary lines) or functional (e.g., law enforcement, public health) range or sphere of authority.

(b) A Declaration of Emergency means any declaration by any authorized local, regional, state, or federal official of an emergency specific to events that indicate an immediate need to administer and use the Covered Countermeasures, with the exception of a federal declaration in support of an Emergency Use Authorization under Section 564 of the FD&C Act unless such declaration specifies otherwise. I have also determined that, for governmental program planners only, liability protections are afforded only to the extent such program planners obtain Covered Countermeasures through voluntary means, such as (a) donation. (b) commercial sale. (c) deployment of Covered Countermeasures from federal stockpiles. Or (d) deployment of donated, purchased, or otherwise voluntarily obtained Covered Countermeasures from state, local, or private stockpiles.

VIII. Category of Disease, Health Condition, or Threat 42 U.S.C. 247d-6d(b)(2)(A) The category of disease, health condition, or threat for which I recommend the administration or use of the Covered Countermeasures is not only hair loss treatment caused by hair loss, or a propecia mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by hair loss treatment, hair loss, or a propecia mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. IX. Administration of Covered Countermeasures 42 U.S.C.

247d-6d(a)(2)(B) Administration of the Covered Countermeasure means physical provision of the countermeasures to recipients, or activities and decisions directly relating to public and private delivery, distribution and dispensing of the countermeasures to recipients, management and operation of countermeasure programs, or management and operation of locations for the purpose of distributing and dispensing countermeasures. Where there are limited Covered Countermeasures, not administering a Covered Countermeasure to one individual in order to administer it to another individual can constitute “relating to. . . The administration to.

. . An individual” under 42 U.S.C. 247d-6d. For example, consider a situation where there is only one dose [] of a hair loss treatment, and a person in a vulnerable population and a person in a less vulnerable population both request it from a healthcare professional.

In that situation, the healthcare professional administers the one dose to the person who is more vulnerable to hair loss treatment. In that circumstance, the failure to administer the hair loss treatment to the person in a less-vulnerable population “relat[es] to. . . The administration to” the person in a vulnerable population.

The person in the vulnerable population was able to receive the treatment only because it was not administered to the person in the less-vulnerable population. Prioritization or purposeful allocation of a Covered Countermeasure, particularly if done in accordance with a public health authority's directive, can fall within the PREP Act and this Declaration's liability protections. X. Population 42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(C) The populations of individuals to whom the liability protections of this Declaration extend include any individual who uses or is administered the Covered Countermeasures in accordance with this Declaration.

Liability protections are afforded to manufacturers and distributors without regard to whether the countermeasure is used by or administered to this population. Liability protections are afforded to program planners and qualified persons when the countermeasure is used by or administered to this population, or the program planner or qualified person reasonably could have believed the recipient was in this population. XI. Geographic Area 42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(D) Liability protections are afforded for the administration or use of a Covered Countermeasure without geographic limitation.

Liability protections are afforded to manufacturers and distributors without regard to whether the Covered Countermeasure is used by or administered in any designated geographic area. Liability protections are afforded to program planners and qualified persons when the countermeasure is used by or administered in any designated geographic area, or the program planner or qualified person reasonably could have believed the recipient was in that geographic area. hair loss treatment is a global challenge that requires a whole-of-nation response. There are substantial federal legal and policy issues, and substantial federal legal and policy interests within the meaning of Grable &. Sons Metal Products, Inc.

V. Darue Eng'g. &. Mf'g., 545 U.S. 308 (2005), in having a unified, whole-of-nation response to the hair loss treatment propecia among federal, state, local, and private-sector entities.

The world is facing an unprecedented propecia. To effectively respond, there must be a more consistent pathway for Covered Persons to manufacture, distribute, administer or use Covered Countermeasures across the nation and the world. Thus, there are substantial federal legal and policy issues, and substantial federal legal and policy interests within the meaning of Grable &. Sons Metal Products, Inc. V.

Darue Eng'g. &. Mf'g., 545 U.S. 308 (2005), in having a uniform interpretation of the PREP Act. Under the PREP Act, the sole exception to the immunity from suit and liability of covered persons under the PREP Act is an exclusive Federal cause of action against a covered person for death or serious physical injury proximately caused by willful misconduct by such covered person.

In all other cases, an injured party's exclusive remedy is an administrative Start Printed Page 79198remedy under section 319F-4 of the PHS Act. Through the PREP Act, Congress delegated to me the authority to strike the appropriate Federal-state balance with respect to particular Covered Countermeasures through PREP Act declarations.[] XII. Effective Time Period 42 U.S.C. 247d-6d(b)(2)(B) Liability protections for any respiratory protective device approved by NIOSH under 42 CFR part 84, or any successor regulations, through the means of distribution identified in Section VII(a) of this Declaration, begin on March 27, 2020 and extend through October 1, 2024. Liability protections for all other Covered Countermeasures identified in Section VI of this Declaration, through means of distribution identified in Section VII(a) of this Declaration, begin on February 4, 2020 and extend through October 1, 2024.

Liability protections for all Covered Countermeasures administered and used in accordance with the public health and medical response of the Authority Having Jurisdiction, as identified in Section VII(b) of this Declaration, begin with a Declaration of Emergency as that term is defined in Section VII (except that, with respect to qualified persons who order or administer a routine childhood vaccination that ACIP recommends to persons ages three through 18 according to ACIP's standard immunization schedule, liability protections began on August 24, 2020), and last through (a) the final day the Declaration of Emergency is in effect, or (b) October 1, 2024, whichever occurs first. Liability protections for all Covered Countermeasures identified in Section VII(c) of this Declaration begin on the date of this amended Declaration and last through (a) the final day the Declaration of Emergency is in effect, or (b) October 1, 2024, whichever occurs first. XIII. Additional Time Period of Coverage 42 U.S.C. 247d-6d(b)(3)(B) and (C) I have determined that an additional 12 months of liability protection is reasonable to allow for the manufacturer(s) to arrange for disposition of the Covered Countermeasure, including return of the Covered Countermeasures to the manufacturer, and for Covered Persons to take such other actions as are appropriate to limit the administration or use of the Covered Countermeasures.

Covered Countermeasures obtained for the SNS during the effective period of this Declaration are covered through the date of administration or use pursuant to a distribution or release from the SNS. XIV. Countermeasures Injury Compensation Program 42 U.S.C 247d-6e The PREP Act authorizes the Countermeasures Injury Compensation Program (CICP) to provide benefits to certain individuals or estates of individuals who sustain a covered serious physical injury as the direct result of the administration or use of the Covered Countermeasures, and benefits to certain survivors of individuals who die as a direct result of the administration or use of the Covered Countermeasures. The causal connection between the countermeasure and the serious physical injury must be supported by compelling, reliable, valid, medical and scientific evidence in order for the individual to be considered for compensation. The CICP is administered by the Health Resources and Services Administration, within the Department of Health and Human Services.

Information about the CICP is available at the toll-free number 1-855-266-2427 or http://www.hrsa.gov/​cicp/​. XV. Amendments 42 U.S.C. 247d-6d(b)(4) Amendments to this Declaration will be published in the Federal Register, as warranted. Start Authority 42 U.S.C.

247d-6d. End Authority Start Signature Dated. December 3, 2020. Alex M. Azar II, Secretary of Health and Human Services.

End Signature End Supplemental Information [FR Doc. 2020-26977 Filed 12-8-20. 8:45 am]BILLING CODE 4150-37-P.

Propecia amazon

Start Preamble Office of additional reading the Assistant Secretary for Health, Office propecia amazon of the Secretary, Department of Health and Human Services. Notice. As stipulated by the propecia amazon Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that two meetings are scheduled to be held for the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB). The meetings will be open to the public via WebEx and teleconference. A pre-registered propecia amazon public comment session will be held during both meetings.

Pre-registration is required for members of the public who wish to attend the meetings via WebEx/teleconference. Individuals who wish to send in their written public comment should send an email to CARB@hhs.gov. Registration information is available on the website http://www.hhs.gov/​paccarb and must be completed by October 1, 2021 for the October 6, 2021 virtual propecia amazon Public Meeting. And, by November 29, 2021 for the November 30-December 1, 2021 virtual Public Meeting. Additional information about registering for the meeting and providing public comment can be obtained at http://www.hhs.gov/​paccarb on the Upcoming propecia amazon Meetings page.

The October meeting is scheduled to be held on October 6, 2021, from 10:00 a.m. To 11:00 propecia amazon a.m. ET (times are tentative and subject to change). The November/December meeting is scheduled to be held on November 30, 2021 from 10:00 a.m. To 3:00 p.m propecia amazon.

And December 1, 2021, from 10:00 a.m. To 3:00 propecia amazon p.m. ET (times are tentative and subject to change). The confirmed times and agenda items for both meetings will be posted on the website for the PACCARB at http://www.hhs.gov/​paccarb when this information becomes available. Pre-registration for attending the meeting is strongly suggested and should be completed no later than October 1, 2021 for the propecia amazon October meeting and November 29, 2021 for the November/December meeting.

Instructions regarding attending this meeting virtually will be posted at least one week prior to the meeting at. Http://www.hhs.gov/​paccarb. Start Further Info Jomana Musmar, M.S., Ph.D., Designated Federal Officer, Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services, Room L616, Switzer Building, 330 C St. SW, Washington, DC 20024.

Phone. 202-746-1512. Email. CARB@hhs.gov. End Further Info End Preamble Start Supplemental Information The Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB), established by Executive Order 13676, is continued by Section 505 of Public Law 116-22, the propecia and All-Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPAIA).

Activities and duties of the Advisory Council are governed by the provisions of the Federal Advisory Committee Act (FACA), Public Law 92-463, as amended (5 U.S.C. App.), which sets forth standards for the formation and use of federal advisory committees. The PACCARB shall advise and provide information and recommendations to the Secretary regarding programs and policies intended to reduce or combat antibiotic-resistant bacteria that may present a public health threat and improve capabilities to prevent, diagnose, mitigate, or treat such resistance. The PACCARB shall function solely for advisory purposes. Such advice, information, and recommendations may propecia for sale be related to improving.

The effectiveness of antibiotics. Research and advanced research on, and the development of, improved and innovative methods for combating or reducing antibiotic resistance, including new treatments, rapid point-of-care diagnostics, alternatives to antibiotics, including alternatives to animal antibiotics, and antimicrobial stewardship activities. Surveillance of antibiotic-resistant bacterial s, including publicly available and up-to-date information on resistance to antibiotics. Education for health care providers and the public with respect to up-to-date information on antibiotic resistance and ways to reduce or combat such resistance to antibiotics related to humans and animals. Methods to prevent or reduce the transmission of antibiotic-resistant bacterial s.

Including stewardship programs. And coordination with respect to international efforts in order to inform and advance the United States capabilities to combat antibiotic resistance. The October 6, 2021 public meeting will be held virtually and is dedicated to deliberation and vote of the letter with recommendations from the Immediate Action Subcommittee of the Advisory Council. The meeting agenda will be posted on the PACCARB website at http://www.hhs.gov/​paccarb when it has been finalized. All agenda items are tentative and subject to change.

The November 31, 2021 and December 1, 2021 public meeting will be held virtually and will be dedicated to addressing the current situation regarding antimicrobial resistance as well as to a presentation from the National Academies of Sciences, Engineering, and Medicine on their report, Examining the Long-term Health and Economic Effects of Antimicrobial Resistance in the United States. The meeting agenda will be posted on the PACCARB website at http://www.hhs.gov/​paccarb when it has been finalized. All agenda items are tentative and subject to change. Instructions regarding attending both meetings virtually will be posted one Start Printed Page 49552week prior to each meeting at. Http://www.hhs.gov/​paccarb.

Members of the public will have the opportunity to provide comments live during the October meeting via conference line by pre-registering online at http://www.hhs.gov/​paccarb. Pre-registration is required for participation in this session with limited spots available. Written public comments can also be emailed to CARB@hhs.gov by midnight October 1, 2021 and should be limited to no more than one page. All public comments received prior to October 1, 2021, will be provided to Advisory Council members. Members of the public will have the opportunity to provide comments live during the November 30, 2021 and December 1, 2021 public meeting via conference line by pre-registering online at http://www.hhs.gov/​paccarb.

There will be two separate sessions available for public comment. An Innovation Spotlight will be held on November 30, 2021 where companies and/or organizations involved in combating antibiotic resistance have an opportunity to present their work to members of the Advisory Council. And on December 1, 2021, where all members of the general public are welcome to provide oral comment during this separate session. Pre-registration is required for participation in these sessions with limited spots available. Further information about these two sessions can be found online at http://www.hhs.gov/​paccarb.

Written public comments can also be emailed to CARB@hhs.gov by midnight November 29, 2021 and should be limited to no more than one page. All public comments received prior to November 29, 2021, will be provided to Advisory Council members. Start Signature Dated. August 26, 2021. Jomana F.

Musmar, Designated Federal Officer, Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, Office of the Assistant Secretary for Health. End Signature End Supplemental Information [FR Doc. 2021-19027 Filed 9-2-21. 8:45 am]BILLING CODE 4150-44-P.

Start Preamble Office of the try this Assistant Secretary for Health, Office of the Secretary, Department of Health and Human order propecia ukwhere can you get propecia Services. Notice. As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that two meetings are scheduled to be held for the Presidential Advisory order propecia ukwhere can you get propecia Council on Combating Antibiotic-Resistant Bacteria (PACCARB). The meetings will be open to the public via WebEx and teleconference.

A pre-registered public order propecia ukwhere can you get propecia comment session will be held during both meetings. Pre-registration is required for members of the public who wish to attend the meetings via WebEx/teleconference. Individuals who wish to send in their written public comment should send an email to CARB@hhs.gov. Registration information is available on the website http://www.hhs.gov/​paccarb and must be completed by October 1, 2021 for the October order propecia ukwhere can you get propecia 6, 2021 virtual Public Meeting.

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ET (times are tentative and subject to change). The November/December meeting is scheduled to be held on November 30, 2021 from 10:00 a.m. To 3:00 order propecia ukwhere can you get propecia p.m. And December 1, 2021, from 10:00 a.m.

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Instructions regarding attending this meeting virtually will be posted at least one week prior to the meeting at. Http://www.hhs.gov/​paccarb. Start Further Info Jomana Musmar, M.S., Ph.D., Designated Federal Officer, Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services, Room L616, Switzer Building, 330 C St.

SW, Washington, DC 20024. Phone. 202-746-1512. Email.

CARB@hhs.gov. End Further Info End Preamble Start Supplemental Information The Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB), established by Executive Order 13676, is continued by Section 505 of Public Law 116-22, the propecia and All-Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPAIA). Activities and duties of the Advisory Council are governed by the provisions of the Federal Advisory Committee Act (FACA), Public Law 92-463, as amended (5 U.S.C. App.), which sets forth standards for the formation and use of federal advisory committees.

The PACCARB shall advise and provide information and recommendations to the Secretary regarding programs and policies intended to reduce or combat antibiotic-resistant bacteria that may present a public health threat and improve capabilities to prevent, diagnose, mitigate, or treat such resistance. The PACCARB shall function solely for advisory purposes. Such advice, information, and recommendations may be related to improving. The effectiveness of antibiotics.

Research and advanced research on, and the development of, improved and innovative methods for combating or reducing antibiotic resistance, including new treatments, rapid point-of-care diagnostics, alternatives to antibiotics, including alternatives to animal antibiotics, and antimicrobial stewardship activities. Surveillance of antibiotic-resistant bacterial s, including publicly available and up-to-date information on resistance to antibiotics. Education for health care providers and the public with respect to up-to-date information on antibiotic resistance and ways to reduce or combat such resistance to antibiotics related to humans and animals. Methods to prevent or reduce the transmission of antibiotic-resistant bacterial s.

Including stewardship programs. And coordination with respect to international efforts in order to inform and advance the United States capabilities to combat antibiotic resistance. The October 6, 2021 public meeting will be held virtually and is dedicated to deliberation and vote of the letter with recommendations from the Immediate Action Subcommittee of the Advisory Council. The meeting agenda will be posted on the PACCARB website at http://www.hhs.gov/​paccarb when it has been finalized.

All agenda items are tentative and subject to change. The November 31, 2021 and December 1, 2021 public meeting will be held virtually and will be dedicated to addressing the current situation regarding antimicrobial resistance as well as to a presentation from the National Academies of Sciences, Engineering, and Medicine on their report, Examining the Long-term Health and Economic Effects of Antimicrobial Resistance in the United States. The meeting agenda will be posted on the PACCARB website at http://www.hhs.gov/​paccarb when it has been finalized. All agenda items are tentative and subject to change.

Instructions regarding attending both meetings virtually will be posted one Start Printed Page 49552week prior to each meeting at. Http://www.hhs.gov/​paccarb. Members of the public will have the opportunity to provide comments live during the October meeting via conference line by pre-registering online at http://www.hhs.gov/​paccarb. Pre-registration is required for participation in this session with limited spots available.

Written public comments can also be emailed to CARB@hhs.gov by midnight October 1, 2021 and should be limited to no more than one page. All public comments received prior to October 1, 2021, will be provided to Advisory Council members. Members of the public will have the opportunity to provide comments live during the November 30, 2021 and December 1, 2021 public meeting via conference line by pre-registering online at http://www.hhs.gov/​paccarb. There will be two separate sessions available for public comment.

An Innovation Spotlight will be held on November 30, 2021 where companies and/or organizations involved in combating antibiotic resistance have an opportunity to present their work to members of the Advisory Council. And on December 1, 2021, where all members of the general public are welcome to provide oral comment during this separate session. Pre-registration is required for participation in these sessions with limited spots available. Further information about these two sessions can be found online at http://www.hhs.gov/​paccarb.

Written public comments can also be emailed to CARB@hhs.gov by midnight November 29, 2021 and should be limited to no more than one page. All public comments received prior to November 29, 2021, will be provided to Advisory Council members. Start Signature Dated. August 26, 2021.

Jomana F. Musmar, Designated Federal Officer, Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, Office of the Assistant Secretary for Health. End Signature End Supplemental Information [FR Doc. 2021-19027 Filed 9-2-21.