Advisory Committees; Filing of Closed Meeting Reports, 38993 [2019-16992]

Download as PDF 38993 Federal Register / Vol. 84, No. 153 / Thursday, August 8, 2019 / Notices underestimation given that these actions should not be a burdensome process for the recordkeeper. (Comment 3) The commenter opposed changing the default from ‘‘opt-in’’ to ‘‘opt-out’’ for patients to consent to their tissue being used for research. Although simple malformations, such as warts and tumors, may be useful to labs to fine-tune their tests, and although many (even most) patients might be willing to share this tissue, a significant minority of Americans hold beliefs about the human body that would prevent them from consenting, and all Americans likely assume that their tissue is destroyed (burned as medical waste) after procedures have been performed. The commenter believes that changing what happens without changing the public understanding of what happens is fundamentally dishonest. The commenter recognizes that obtaining consent is time-consuming, particularly when the patient does not speak English as a first language, or has other comprehension issues; however, the commenter believes no lab has a right to the tissue of an American citizen for its private, profit-making use. (Response) The subject of the comment deals with sample acquisition, a step that happens in advance of the information communicated in this guidance. Therefore, patient ‘‘opt-in’’ versus ‘‘opt-out’’ is out of scope. This guidance describes the enforcement discretion policy FDA uses when sponsors choose to use de-identified samples for IVD medical device clinical trials. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Activity Number of recordkeepers Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours Recordkeeping regarding leftover human specimens that are not individually identifiable that are used in certain IVD studies ....................................................................... 700 1 700 4 2,800 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate. Dated: August 5, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–17026 Filed 8–7–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES FOR FURTHER INFORMATION CONTACT: Food and Drug Administration [Docket No. FDA–2019–N–0006] Advisory Committees; Filing of Closed Meeting Reports AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing that, as required by the Federal Advisory Committee Act, the Agency has filed with the Library of Congress the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2018. ADDRESSES: Copies are available at the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. You also may access the docket at https:// www.regulations.gov for the annual reports of those FDA advisory committees that held closed meetings jbell on DSK3GLQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:51 Aug 07, 2019 Jkt 247001 during fiscal year 2018. Insert the docket number found in brackets in the heading of this document at https:// www.regulations.gov into the ‘‘Search’’ box, clear filter under Document Type (left side of screen), and check ‘‘Supporting and Related Material,’’ then Sort By Best Match (from the dropdown menu; top right side of screen), ‘‘ID Number (Z–A)’’ or Sort By Best Match (from the drop-down menu) ‘‘Title (A–Z),’’ also found in the heading of this document. Russell Fortney, Director, Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–1068. Under section 10(d) of the Federal Advisory Committee Act (5 U.S.C. app.) and 21 CFR 14.60(d), FDA has filed with the Library of Congress the annual reports for the following FDA advisory committees that held closed meetings during the period October 1, 2017, through September 30, 2018: SUPPLEMENTARY INFORMATION: Center for Biologics Evaluation and Research: Blood Products Advisory Committee Vaccine and Related Biological Products Advisory Committee Center for Drug Evaluation and Research: Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Office of Commissioner Joint Meeting of the Pediatric Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee Annual Reports are available for public inspections between 9 a.m. and 4 p.m., Monday through Friday, at: (1) The Library of Congress, Madison Building, Newspaper and Current Periodical Reading Room, 101 Independence Ave. SE, Rm. 133, Washington, DC; 20540; and (2) Dockets Management Staff (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: August 5, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–16992 Filed 8–7–19; 8:45 am] BILLING CODE 4164–01–P National Center for Toxicological Research: Science Board to the National Center for Toxicological Research PO 00000 Frm 00067 Fmt 4703 Sfmt 9990 E:\FR\FM\08AUN1.SGM 08AUN1

Agencies

[Federal Register Volume 84, Number 153 (Thursday, August 8, 2019)]
[Notices]
[Page 38993]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16992]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0006]


Advisory Committees; Filing of Closed Meeting Reports

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
that, as required by the Federal Advisory Committee Act, the Agency has 
filed with the Library of Congress the annual reports of those FDA 
advisory committees that held closed meetings during fiscal year 2018.

ADDRESSES: Copies are available at the Dockets Management Staff (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852, 240-402-7500. You also may access the docket at 
https://www.regulations.gov for the annual reports of those FDA advisory 
committees that held closed meetings during fiscal year 2018. Insert 
the docket number found in brackets in the heading of this document at 
https://www.regulations.gov into the ``Search'' box, clear filter under 
Document Type (left side of screen), and check ``Supporting and Related 
Material,'' then Sort By Best Match (from the drop-down menu; top right 
side of screen), ``ID Number (Z-A)'' or Sort By Best Match (from the 
drop-down menu) ``Title (A-Z),'' also found in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Russell Fortney, Director, Advisory 
Committee Oversight and Management Staff, Food and Drug Administration, 
10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1068.

SUPPLEMENTARY INFORMATION: Under section 10(d) of the Federal Advisory 
Committee Act (5 U.S.C. app.) and 21 CFR 14.60(d), FDA has filed with 
the Library of Congress the annual reports for the following FDA 
advisory committees that held closed meetings during the period October 
1, 2017, through September 30, 2018:

Center for Biologics Evaluation and Research:

Blood Products Advisory Committee
Vaccine and Related Biological Products Advisory Committee

National Center for Toxicological Research:

Science Board to the National Center for Toxicological Research

Center for Drug Evaluation and Research:

Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory 
Committee and the Drug Safety and Risk Management Advisory Committee

Office of Commissioner

Joint Meeting of the Pediatric Advisory Committee and the 
Endocrinologic and Metabolic Drugs Advisory Committee

Annual Reports are available for public inspections between 9 a.m. and 
4 p.m., Monday through Friday, at:

    (1) The Library of Congress, Madison Building, Newspaper and 
Current Periodical Reading Room, 101 Independence Ave. SE, Rm. 133, 
Washington, DC; 20540; and
    (2) Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: August 5, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16992 Filed 8-7-19; 8:45 am]
 BILLING CODE 4164-01-P

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