41854 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 FDA’s 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-2015- 

09-18/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, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

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 20993–0002, 

301–796–3130, drugtrackandtrace@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

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draft guidance for industry entitled 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may obtain the draft guidance at either 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/ 

default.htm, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: July 28, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16522 Filed 8–2–21; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Alcohol Abuse 

and Alcoholism; Notice of Closed 

Meeting 

Pursuant to section 10(d) 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 

552b(c)(4) and 552b(c)(6), 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) 443–8599, 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) 

Dated: July 29, 2021. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–16508 Filed 8–2–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meeting 

Pursuant to section 10(d) 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 

552b(c)(4) and 552b(c)(6), 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: 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, 301–435– 

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, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: July 29, 2021. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–16509 Filed 8–2–21; 8:45 am] 

BILLING CODE 4140–01–P 


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