Federal Register/Vol. 86, No. 11/Tuesday, January 19, 2021/Notices
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5200 Federal Register / Vol. 86, No. 11 / Tuesday, January 19, 2021 / Notices in the future. The activities and specified in the Foster Care leaders, partners and stakeholders, and products from this project will help Independence Act of 1999. front-line staff as well as young adults ACF to fulfill the ongoing legislative Respondents: Semi-structured being served by the programs. mandate for program evaluation interviews will be held with program ANNUAL BURDEN ESTIMATES Number of Number of responses per respondents respondent Avg. burden Total burden Annual burden Instrument (total over (total over per response (in hours) (in hours) request request (in hours) period) period) Outreach email for discussion with program administrators and staff ............................................................................... 38 1 8 304 152 Outreach email for Focus Group Recruiters ....................... 96 1 8 768 384 Discussion Guide for program leaders ................................ 23 1 1 23 12 Discussion Guide for program partners and stakeholders .. 14 1 1 14 7 Discussion Guide for program front-line staff ...................... 66 1 1 66 33 Focus Group Guide for program participants ...................... 240 1 2 480 240 Estimated Total Annual Burden Authorizations (EUAs) (the which the Authorizations may be sent. Hours: 828. Authorizations) under the Federal Food, See the SUPPLEMENTARY INFORMATION Comments: The Department Drug, and Cosmetic Act (FD&C Act) for section for electronic access to the specifically requests comments on (a) biological products for use during the Authorizations. whether the proposed collection of COVID–19 pandemic. FDA issued one FOR FURTHER INFORMATION CONTACT: information is necessary for the proper Authorization for a biological product as Michael Mair, Office of performance of the functions of the requested by Pfizer, Inc, and one Counterterrorism and Emerging Threats, agency, including whether the Authorization for a biological product as Food and Drug Administration, 10903 information shall have practical utility; requested by ModernaTX, Inc. The New Hampshire Ave., Bldg. 1, Rm. (b) the accuracy of the agency’s estimate Authorizations contain, among other 4340, Silver Spring, MD 20993–0002, of the burden of the proposed collection things, conditions on the emergency use 301–796–8510 (this is not a toll-free of information; (c) the quality, utility, of the authorized products. The number). and clarity of the information to be Authorizations follow the February 4, collected; and (d) ways to minimize the 2020, determination by the Secretary of SUPPLEMENTARY INFORMATION: burden of the collection of information Health and Human Services (HHS) that I. Background there is a public health emergency that on respondents, including through the Section 564 of the FD&C Act (21 has a significant potential to affect use of automated collection techniques U.S.C. 360bbb–3) allows FDA to national security or the health and or other forms of information strengthen the public health protections security of U.S. citizens living abroad technology. Consideration will be given against biological, chemical, nuclear, and that involves a novel (new) to comments and suggestions submitted and radiological agents. Among other coronavirus. The virus, now named within 60 days of this publication. things, section 564 of the FD&C Act SARS–CoV–2, causes the illness Authority: Title IV–E of the Social Security allows FDA to authorize the use of an Act, IV–E § 477(g) (1–2), as amended by the COVID–19. On the basis of such unapproved medical product or an Foster Care Independence Act of 1999. determination, the Secretary of HHS unapproved use of an approved medical declared on March 27, 2020, that product in certain situations. With this Mary B. Jones, circumstances exist justifying the ACF/OPRE Certifying Officer. EUA authority, FDA can help ensure authorization of emergency use of drugs that medical countermeasures may be [FR Doc. 2021–01086 Filed 1–15–21; 8:45 am] and biological products during the used in emergencies to diagnose, treat, BILLING CODE 4184–73–P COVID–19 pandemic, pursuant to the or prevent serious or life-threatening FD&C Act, subject to the terms of any diseases or conditions caused by authorization issued under that section. biological, chemical, nuclear, or DEPARTMENT OF HEALTH AND The Authorizations, which include an HUMAN SERVICES radiological agents when there are no explanation of the reasons for issuance, adequate, approved, and available are reprinted in this document. Food and Drug Administration alternatives. DATES: The Authorization for Pfizer, Inc. [Docket No. FDA–2020–N–2358] is effective as of December 11, 2020; the II. Criteria for EUA Authorization Authorization for ModernaTX, Inc. is Section 564(b)(1) of the FD&C Act Authorizations of Emergency Use of effective as of December 18, 2020. provides that, before an EUA may be Two Biological Products During the ADDRESSES: Submit written requests for issued, the Secretary of HHS must COVID–19 Pandemic; Availability single copies of the EUAs to the Office declare that circumstances exist AGENCY: Food and Drug Administration, of Counterterrorism and Emerging justifying the authorization based on HHS. Threats, Food and Drug Administration, one of the following grounds: (1) A ACTION: Notice. 10903 New Hampshire Ave., Bldg. 1, determination by the Secretary of Rm. 4338, Silver Spring, MD 20993– Homeland Security that there is a SUMMARY: The Food and Drug 0002. Send one self-addressed adhesive domestic emergency, or a significant Administration (FDA) is announcing the label to assist that office in processing potential for a domestic emergency, issuance of two Emergency Use your request or include a Fax number to involving a heightened risk of attack VerDate Sep<11>2014 21:56 Jan 17, 2021 Jkt 253001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 E:\FR\FM\19JAN1.SGM 19JAN1 khammond on DSKJM1Z7X2PROD with NOTICES Federal Register / Vol. 86, No. 11 / Tuesday, January 19, 2021 / Notices 5201 with a biological, chemical, radiological, or licensed under sections 505, 510(k), Secretary of HHS that there is a public or nuclear agent or agents; (2) a 512, or 515 of the FD&C Act (21 U.S.C. health emergency that has a significant determination by the Secretary of 355, 360(k), 360b, and 360e) or section potential to affect national security or Defense that there is a military 351 of the PHS Act (42 U.S.C. 262), or the health and security of U.S. citizens emergency, or a significant potential for conditionally approved under section living abroad and that involves a novel a military emergency, involving a 571 of the FD&C Act (21 U.S.C. 360ccc). (new) coronavirus. The virus, now heightened risk to U.S. military forces, FDA may issue an EUA only if, after named SARS–CoV–2, causes the illness including personnel operating under the consultation with the HHS Assistant COVID–19. Notice of the Secretary of authority of title 10 or title 50, United Secretary for Preparedness and HHS’s determination was provided in States Code, of attack with (i) a Response, the Director of the National the Federal Register on February 7, biological, chemical, radiological, or Institutes of Health, and the Director of 2020 (85 FR 7316). On the basis of such nuclear agent or agents; or (ii) an agent the Centers for Disease Control and determination, the Secretary of HHS or agents that may cause, or are Prevention (to the extent feasible and declared on March 27, 2020, that otherwise associated with, an appropriate given the applicable circumstances exist justifying the imminently life-threatening and specific circumstances), FDA 2 concludes: (1) authorization of emergency use of drugs risk to U.S. military forces; 1 (3) a That an agent referred to in a and biological products during the determination by the Secretary of HHS declaration of emergency or threat can COVID–19 pandemic, pursuant to that there is a public health emergency, cause a serious or life-threatening section 564 of the FD&C Act, subject to or a significant potential for a public disease or condition; (2) that, based on the terms of any authorization issued health emergency, that affects, or has a the totality of scientific evidence under that section. Notice of the significant potential to affect, national available to FDA, including data from Secretary of HHS’s declaration was security or the health and security of adequate and well-controlled clinical provided in the Federal Register on U.S. citizens living abroad, and that trials, if available, it is reasonable to April 1, 2020 (85 FR 18250). Having involves a biological, chemical, believe that: (A) The product may be concluded that the criteria for issuance effective in diagnosing, treating, or radiological, or nuclear agent or agents, of the Authorizations under section preventing (i) such disease or condition; or a disease or condition that may be 564(c) of the FD&C Act are met, FDA or (ii) a serious or life-threatening attributable to such agent or agents; or issued two authorizations for the disease or condition caused by a (4) the identification of a material threat emergency use of biological products product authorized under section 564, by the Secretary of Homeland Security during the COVID–19 pandemic. On approved or cleared under the FD&C pursuant to section 319F–2 of the Public December 11, 2020, FDA issued an EUA Health Service (PHS) Act (42 U.S.C. Act, or licensed under section 351 of the to Pfizer, Inc. for the Pfizer-BioNTech 247d–6b) sufficient to affect national PHS Act, for diagnosing, treating, or COVID–19 Vaccine, subject to the terms security or the health and security of preventing such a disease or condition of the Authorization. On December 18, U.S. citizens living abroad. caused by such an agent; and (B) the 2020, FDA issued an EUA to Once the Secretary of HHS has known and potential benefits of the ModernaTX, Inc.