Federal Register - August 3, 2021
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Source: Federal Register
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Federal Register / Vol. 86, No. 146 / Tuesday, August 3, 2021 / Notices
as confidential will not be disclosed except in accordance with 21 CFR 10.20
and other applicable disclosure law. For more information about FDAs posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https
www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the Search box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 2404027500.
You may submit comments on any guidance at any time see 21 CFR
10.115g5.
Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993
0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Abha Kundi, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 209930002, 3017963130, drugtrackandtrace@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
jbell on DSKJLSW7X2PROD with NOTICES
In the Federal Register of June 4, 2021
86 FR 30053, FDA published a notice with a 60-day comment period to announce and request comments on a draft guidance for industry entitled Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act. FDA is extending the comment period until September 2, 2021. The Agency believes that an additional 30 days will allow adequate time for interested persons to submit comments without compromising the timely publication of the final version of the guidance.
II. Electronic Access Persons with access to the internet may obtain the draft guidance at either https www.fda.gov/Drugs/
GuidanceCompliance RegulatoryInformation/Guidances/
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default.htm, https www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https
www.regulations.gov.
Dated: July 29, 2021.
Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy.
Dated: July 28, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
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DEPARTMENT OF HEALTH AND
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National Institutes of Health DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Center for Scientific Review; Notice of Closed Meeting
National Institutes of Health
Pursuant to section 10d of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552bc4 and 552bc6, Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting Pursuant to section 10d of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552bc4 and 552bc6, Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Institute on Alcohol Abuse and Alcoholism Initial Review Group; Clinical, Treatment and Health Services Research Study Section.
Date: October 13, 2021.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, National Institute on Alcohol Abuse and Alcoholism, 6700B Rockledge Drive, Bethesda, MD 20892 Virtual Meeting.
Contact Person: Luis Espinoza, Ph.D., Scientific Review Officer, Extramural Project Review Branch, National Institute on Alcohol Abuse and Alcoholism, 6700B Rockledge Drive, Room 2109, Bethesda, MD 20817, 301 4438599, espinozala@mail.nih.gov.
Catalogue of Federal Domestic Assistance Program Nos. 93.271, Alcohol Research Career Development Awards for Scientists and Clinicians; 93.272, Alcohol National Research Service Awards for Research Training; 93.273, Alcohol Research Programs;
93.891, Alcohol Research Center Grants;
93.701, ARRA Related Biomedical Research and Research Support Awards, National Institutes of Health, HHS
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Name of Committee: Center for Scientific Review Special Emphasis Panel; AREA/
REAP: Cardiovascular and Respiratory Sciences.
Date: August 30, 2021.
Time: 1:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 Virtual Meeting.
Contact Person: Xiang-Ning Li, MD, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5112, MSC 7854, Bethesda, MD 20892, 301435
1744, lixiang@csr.nih.gov.
Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333, 93.337, 93.39393.396, 93.83793.844, 93.84693.878, 93.892, 93.893, National Institutes of Health, HHS
Dated: July 29, 2021.
Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy.
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