Federal Register/Vol. 85, No. 228/Wednesday, November 25

75720 Federal Register / Vol. 85, No. 228 / Wednesday, November 25, 2020 / Notices DEPARTMENT OF HEALTH AND Support Economic Recovery, 85 FR business information that is included in HUMAN SERVICES 31353 (May 19, 2020) calls on agencies a comment. We post all comments to address the economic emergency received before the close of the Regulatory Relief To Support caused by the COVID–19 pandemic by comment period on the following Economic Recovery; Request for rescinding, modifying, waiving, or website as soon as possible after they Information (RFI) providing exemptions from regulations have been received: https:// and other requirements that may inhibit www.regulations.gov. Follow the search AGENCY: Office of the Secretary, economic recovery, consistent with instructions on that website to view Department of Health and Human applicable law and with protection of public comments. Services. the public health and safety, with ACTION: Request for information. national and homeland security, and I. Background with budgetary priorities and In December 2019, a novel SUMMARY: Under an Executive Order operational feasibility. To implement coronavirus known as SARS–CoV–2 that directs federal agencies to address the directives of E.O. 13924, the U.S. (‘‘the virus’’) was first noted by the the economic emergency created by the Department of Health and Human People’s Republic of China as having COVID–19 pandemic by rescinding, Services (‘‘HHS’’ or ‘‘the Department’’) been detected in Wuhan, Hubei modifying, waiving, or providing identified in in response to this E.O. 382 Province, People’s Republic of China, exemptions from regulations and other regulatory actions that it is considering causing an outbreak of the disease requirements that may inhibit economic to make permanent or keep as COVID–19, which has now spread recovery, consistent with applicable law temporary made in response to the globally. The Secretary of Health and and with protection of the public health COVID–19 crisis to improve access to Human Services declared a public and safety, with national and homeland care and reduce costs that it is health emergency (PHE) effective security, and with budgetary priorities considering to make permanent or keep January 27, 2020, under section 319 of and operational feasibility. The Order as temporary. See Attachment A (this the Public Health Service Act (42 U.S.C. directs agencies to ‘‘identify regulatory list is not intended to be 247d), in response to COVID–19, and standards that may inhibit economic comprehensive: Additional actions have has extended the declaration several recovery’’ and to take appropriate action been made by the Department and will times, most recently on October 2, 2020 such as rescission or suspension of continue to occur in response to the effective October 23. In Proclamation regulations, including by use of good PHE and pandemic) HHS is issuing this 9994 of March 13, 2020 (Declaring a cause or emergency authorities where Request for Information (RFI) to collect National Emergency Concerning the appropriate. Agencies have likewise information for the purpose of Novel Coronavirus Disease (COVID–19) been called on to assess the various considering the costs and benefits, Outbreak), President Trump declared temporary deregulatory actions they consistent with applicable law and with that the COVID–19 outbreak in the have taken to fight COVID–19 and its protection of the public health and United States constituted a national impact on our economy to determine safety, of retaining these particular emergency, beginning March 1, 2020. which temporary regulatory actions regulatory changes beyond the COVID– The federal government has taken should be made permanent. The Order 19 public health emergency. In addition sweeping action to control the spread of directs agencies to assist businesses and to the costs and benefits of these the virus in the United States. HHS and other entities in complying with the law actions, the Department seeks input on its federal partners are working together through prompt issuance of pre- any barriers that may exist to making with state, local, tribal and territorial enforcement rulings and to formulate these deregulatory actions permanent governments, public health officials, policies of enforcement discretion that including any evidence or experience healthcare providers, researchers, recognize such entities’ efforts to that commenters have. private sector organizations and the comply with the law. Invitation to Comment: HHS invites public to execute a whole-of-America DATES: To be assured consideration, comments regarding the questions response to the COVID–19 pandemic to comments must be received at the included in this notice. To ensure that protect the health and safety of the address provided below, no later than your comments are clearly stated, please American people. 11:59 p.m. on December 28, 2020. identify the specific question, or other In February 2020, Secretary Azar ADDRESSES: Because of staff and section of this notice, that your declared that circumstances justified the comments address. Please also refer to resource limitations, we cannot accept authorization of emergency use for tests any specific HHS policy or policies comments by facsimile (FAX) to detect and diagnose COVID–19. In listed in the Appendix to this notice transmission. March 2020, the Secretary declared that (see Attachment A), if applicable, by Comments, including mass comment circumstances justified the reference to the numbers associated in submissions, must be submitted 1 authorization of emergency use for electronically at http:// the Appendix with these policies. Inspection of Public Comments: All drugs and biological products during www.regulations.gov. Follow the comments received before the close of the COVID–19 pandemic. Emergency ‘‘Submit a comment’’ instructions. the comment period are available for Use Authorizations (EUAs) allow For information on viewing public viewing by the public, including any medical countermeasures to be comments, see the beginning of the personally identifiable or confidential authorized by the U.S. Food and Drug SUPPLEMENTARY INFORMATION section. Administration (FDA), pursuant to 2 FOR FURTHER INFORMATION CONTACT: 1 Commenters on FDA guidance may also wish to certain criteria, during emergencies. Allison Beattie, Department of Health refer to FDA’s website COVID–19-Related Guidance Operation Warp Speed is a partnership and Human Services, 200 Independence Documents for Industry, FDA Staff, and Other among components of HHS, the Stakeholders, available at https://www.fda.gov/ Avenue SW, Room 713F, Washington, emergency-preparedness-and-response/ Department of Defense, and industry DC 20201. Email: [email protected]. coronavirus-disease-2019-covid-19/covid-19- Telephone: (202) 690–7741. related-guidance-documents-industry-fda-staff-and- 2 Coronavirus (COVID–19) Testing, U.S. Dep’t of other-stakeholders and submit comments to the Health and Human Serv.’s, https://www.hhs.gov/ SUPPLEMENTARY INFORMATION: Executive relevant docket associated with each guidance coronavirus/testing/index.html (last updated Aug. Order 13924, Regulatory Relief To listed, in addition to responding to this RFI. 19, 2020). VerDate Sep<11>2014 20:19 Nov 24, 2020 Jkt 253001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4703 E:\FR\FM\25NON2.SGM 25NON2 jbell on DSKJLSW7X2PROD with NOTICES2 Federal Register / Vol. 85, No. 228 / Wednesday, November 25, 2020 / Notices 75721 and academic partners with a goal to Likewise, FDA established a process to and professional associations; patients produce and deliver 300 million doses more rapidly disseminate and and patient advocacy groups; long-term of safe and effective vaccines, with the implement agency recommendations care facilities, hospice providers, initial doses available by January 2021, and policies related to COVID–19.8 pharmacists, and pharmacy as part of a broader strategy to accelerate To continue the federal response to associations; nonprofit human services the development, manufacturing, and the COVID–19 pandemic, President providers; and other interested members distribution of COVID–19 vaccines, Trump signed Executive Order 13924 on of the public. The information gathered therapeutics, and diagnostics May 19, 2020, to direct agencies to in response to the RFI will be used to (collectively known as continue to remove regulatory barriers better inform HHS’ decisions regarding countermeasures).3 The CDC is that could be stymying American which regulatory flexibilities used in providing $10.25 billion to states, economic recovery.9 HHS is fulfilling the COVID–19 response should be kept territories, and local jurisdictions, and this obligation by reviewing certain temporary or made permanent. HHS and the Indian Health Service is providing regulatory practices that could aid in the entire U.S. government are $750 million to tribal health programs economic recovery in ways that improve committed to a healthy and resilient for COVID–19 testing.4 The CARES Act healthcare delivery. America. COVID–19 has had a sizable Provider Relief Fund supports American II. Request for Information impact on the healthcare industry, families, workers, and healthcare which was forced to adjust to, among providers in the battle against the To respond to the COVID–19 other things, remote and contactless COVID–19 pandemic. HHS is pandemic and its impact on the care of patients in addition to caring for distributing $175 billion to hospitals healthcare industry, HHS made

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