Federal Register / Vol. 86, No. 146 / Tuesday, August 3, 2021 / Notices 41853 

these data for use in estimating future 

costs of the refugee resettlement 

program. ORR must implement the 

methodology at CFR 400.211 each year 

after receipt of its annual appropriation 

to ensure that appropriated funds will 

be adequate for reimbursement to States 

of the costs for assistance provided to 

entering refugees. The estimating 

methodology prescribed in the 

regulations requires the use of actual 

past costs by program component. If the 

methodology indicates that 

appropriated funds are inadequate, ORR 

must take steps to reduce federal 

expenses, such as by limiting the 

number of months of eligibility for 

Refugee Cash Assistance and Refugee 

Medical Assistance. This single-page 

financial report allows ORR to collect 

the necessary data to ensure that funds 

are adequate for the projected need and 

thereby meet the requirements of both 

the Refugee Act and ORR regulations. 

Respondents: State governments and 

Replacement Designees. 

ANNUAL BURDEN ESTIMATES

Instrument Total number 

of respondents 

Annual 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Annual burden 

hours 

ORR Financial Status Report Cash and Medical Assistance Program, Quarterly Report on Expenditures and Obligations ............................................. 63 4 1.50 378 

Estimated Total Annual Burden 

Hours: 378. 

Authority: 8 U.S.C. 1522 of the 

Immigration and Nationality Act (the 

Act) (Title IV, Sec. 412 of the Act) for 

each state agency requesting federal 

funding for refugee resettlement under 8 

U.S.C. 524 (Title IV, Sec. 414 of the 

Act). 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2021–16470 Filed 8–2–21; 8:45 am] 

BILLING CODE 4184–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–D–2024] 

Enhanced Drug Distribution Security at 

the Package Level Under the Drug 

Supply Chain Security Act; Draft 

Guidance for Industry; Availability; 

Extension of Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability; extension 

of comment period. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

extending the comment period for the 

notice of availability entitled ‘‘Enhanced 

Drug Distribution Security at the 

Package Level Under the Drug Supply 

Chain Security Act; Draft Guidance for 

Industry; Availability’’ that appeared in 

the Federal Register of June 4, 2021. 

The Agency is taking this action to 

allow interested persons additional time 

to submit comments. 

DATES: FDA is extending the comment 

period for the notice of availability 

published on June 4, 2021 (86 FR 

30053). Submit either electronic or 

written comments by September 2, 2021 

to ensure that the Agency considers 

your comment on this draft guidance 

before it begins work on the final 

version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2020–D–2024 for ‘‘Enhanced Drug 

Distribution Security at the Package 

Level Under the Drug Supply Chain 

Security Act; Draft Guidance for 

Industry.’’ Received comments will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 


jbell on DSKJLSW7X2PROD with NOTICES
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] 

BILLING CODE 4164–01–P 

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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