Q3C(R8) Recommendations for the Permitted Daily Exposures for Three Solvents-2-Methyltetrahydrofuran, Cyclopentyl Methyl Ether, and Tert-Butyl Alcohol-According to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents; International Council for Harmonisation; Draft Guidance for Industry; Availability, 34638 [C1-2020-11280]

Download as PDF 34638 Federal Register / Vol. 85, No. 109 / Friday, June 5, 2020 / Notices Estimated Total Annual Burden Hours: 9,900. Comments: The Department specifically requests comments on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. (Authority: 5 U.S.C. 301; 42 U.S.C. 470, 620 et seq., 622(b), 629b(a), 652(b), 654A, 670 et seq., 671(a), 1302, and 1396a(a)) Mary B. Jones, ACF/OPRE Certifying Officer. [FR Doc. 2020–12125 Filed 6–4–20; 8:45 am] BILLING CODE 4184–25–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–D–1301] Q3C(R8) Recommendations for the Permitted Daily Exposures for Three Solvents—2-Methyltetrahydrofuran, Cyclopentyl Methyl Ether, and TertButyl Alcohol—According to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents; International Council for Harmonisation; Draft Guidance for Industry; Availability Correction In notice document 2020–11280, appearing on pages 31785 through 31786 in the issue of Wednesday, May 27, 2020 make the following correction. On page 31785, in the first column, on the last line, ‘‘July 26, 2024’’ should read ‘‘July 27, 2020’’. lotter on DSK9F5VC42PROD with NOTICES [FR Doc. C1–2020–11280 Filed 6–4–20; 8:45 am] BILLING CODE 1300–01–D VerDate Sep<11>2014 18:21 Jun 04, 2020 Jkt 250001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–1335] Authorization of Emergency Use of Certain Medical Devices During COVID–19; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the issuance and reissuance of Emergency Use Authorizations (EUAs) (the Authorizations) for certain medical devices related to the coronavirus disease 2019 (COVID–19) public health emergency. FDA has issued, and in some cases reissued, the Authorizations listed in this document under the Federal Food, Drug, and Cosmetic Act (FD&C Act). These Authorizations contain, among other things, conditions on the emergency use of the authorized products. The Authorizations follow the February 4, 2020, determination by Secretary of Health and Human Services (HHS) that there is a public health emergency that has significant potential to affect national security or the health and security of U.S. citizens living abroad, which involves the virus that causes COVID–19, and the subsequent declarations on February 4, 2020, March 2, 2020, and March 24, 2020, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID–19, personal respiratory protective devices, and medical devices, including alternative products used as medical devices, respectively, subject to the terms of any authorization issued under the FD&C Act. These Authorizations, which include an explanation of the reasons for issuance and reissuance, are listed in this document and are available on FDA’s website at the links indicated in this document. SUMMARY: These Authorizations are effective on their date of issuance. ADDRESSES: Submit written requests for single copies of the EUAs to the Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your request or include a Fax number to which the Authorization may be sent. See the SUPPLEMENTARY INFORMATION DATES: PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 section for electronic access to the Authorizations. FOR FURTHER INFORMATION CONTACT: Jennifer J. Ross, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993–0002, 301–796–8510 (this is not a toll-free number). SUPPLEMENTARY INFORMATION: I. Background Section 564 of the FD&C Act (21 U.S.C. 360bbb–3) allows FDA to strengthen the public health protections against biological, chemical, radiological, or nuclear agent or agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product in certain situations. With this EUA authority, FDA can help ensure that medical countermeasures may be used in emergencies to diagnose, treat, or prevent serious or lifethreatening diseases or conditions caused by a biological, chemical, radiological, or nuclear agent or agents when there are no adequate, approved, and available alternatives. Section 564(b)(1) of the FD&C Act provides that, before an EUA may be issued, the Secretary of HHS must declare that circumstances exist justifying the authorization based on one of the following grounds: (1) A determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a biological, chemical, radiological, or nuclear agent or agents; (2) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to U.S. military forces, including personnel operating under the authority of title 10 or title 50, U.S. Code, of attack with (i) a biological, chemical, radiological, or nuclear agent or agents; or (ii) an agent or agents that may cause, or are otherwise associated with, an imminently life-threatening and specific risk to U.S. military forces; 1 (3) a determination by the Secretary of HHS that there is a public health emergency, or a significant potential for a public health emergency, 1 In the case of a determination by the Secretary of Defense, the Secretary of HHS shall determine within 45 calendar days of such determination, whether to make a declaration under section 564(b)(1) of the FD&C Act, and, if appropriate, shall promptly make such a declaration. E:\FR\FM\05JNN1.SGM 05JNN1

Agencies

[Federal Register Volume 85, Number 109 (Friday, June 5, 2020)]
[Notices]
[Page 34638]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: C1-2020-11280]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1301]


Q3C(R8) Recommendations for the Permitted Daily Exposures for 
Three Solvents--2-Methyltetrahydrofuran, Cyclopentyl Methyl Ether, and 
Tert-Butyl Alcohol--According to the Maintenance Procedures for the 
Guidance Q3C Impurities: Residual Solvents; International Council for 
Harmonisation; Draft Guidance for Industry; Availability

Correction

    In notice document 2020-11280, appearing on pages 31785 through 
31786 in the issue of Wednesday, May 27, 2020 make the following 
correction.
    On page 31785, in the first column, on the last line, ``July 26, 
2024'' should read ``July 27, 2020''.
[FR Doc. C1-2020-11280 Filed 6-4-20; 8:45 am]
 BILLING CODE 1300-01-D

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