Federal Register / Vol. 87, No. 55 / Tuesday, March 22, 2022 / Notices 16217 

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., Eastern Time 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.’’ FDA 

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 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 the information as 

‘‘confidential.’’ Any information marked 

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, September18, 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. 

FOR FURTHER INFORMATION CONTACT: 

Prabhakara Atreya or Christina Vert, 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Silver Spring, MD 

20993–0002, 240–506–4946, 

CBERVRBPAC@fda.hhs.gov; or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

FDA’s website at https://www.fda.gov/ 

AdvisoryCommittees/default.htm and 

scroll down to the appropriate advisory 

committee meeting link, or call the 

advisory committee information line to 

learn about possible modifications 

before coming to the meeting. 

SUPPLEMENTARY INFORMATION: Consistent 

with FDA’s regulations, this notice is 

being published with less than 15 days 

prior to the date of the meeting based on 

a determination that convening a 

meeting of the Vaccines and Related 

Biological Products Advisory 

Committee as soon as possible is 

warranted. This notice could not be 

published 15 days prior to the date of 

the meeting due to the need for prompt 

discussion regarding considerations for 

use of COVID–19 vaccine booster doses 

and the process for COVID–19 vaccine 

strain selection to address current and 

emerging variants given the COVID–19 

pandemic. 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing platform. On April 6, 

2022, the committee will meet in open 

session to discuss considerations for use 

of additional COVID–19 vaccine booster 

doses and the process for COVID–19 

vaccine strain selection to address 

current and emerging variants. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available at the time 

of the advisory committee meeting, and 

the background material will be posted 

on FDA’s website after the meeting. 

Background material is available at 

https://www.fda.gov/Advisory

Committees/Calendar/default.htm. 

Scroll down to the appropriate advisory 

committee meeting link. The meeting 

will include slide presentations with 

audio components to allow the 

presentation of materials in a manner 

that most closely resembles an in-person 

advisory committee meeting. 

Procedure: On April 6, 2022, from 

8:30 a.m. to 5 p.m. Eastern Time, the 

meeting is open to the public. Interested 

persons may present data, information, 

or views, orally or in writing, on issues 

pending before the committee. All 

electronic and written submissions 

submitted to the Docket (see ADDRESSES) 

on or before March 31, 2022, will be 

provided to the committee. Comments 

received after March 31, 2022, and by 

April 5, 2022, will be taken into 

consideration by FDA. Oral 

presentations from the public will be 

scheduled between approximately 1:30 

p.m. and 2:30 p.m. Eastern Time. Those 

individuals interested in making formal 

oral presentations should notify the 

contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and email addresses 

of proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before March 29, 2022. Time allotted 

for each presentation may be limited. If 

the number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by March 30, 2022. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Prabhakara 

Atreya or Christina Vert (see FOR

FURTHER INFORMATION CONTACT) at least 7 

days in advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/ 

AdvisoryCommittees/AboutAdvisory

Committees/ucm111462.htm for 

procedures on public conduct during 

advisory committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: March 15, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–06053 Filed 3–21–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–3462] 

Verification Systems Under the Drug 

Supply Chain Security Act for Certain 

Prescription Drugs; Draft Guidance for 

Industry; Correction 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 


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16218 Federal Register / Vol. 87, No. 55 / Tuesday, March 22, 2022 / Notices 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice entitled ‘‘Verification Systems 

Under the Drug Supply Chain Security 

Act for Certain Prescription Drugs; Draft 

Guidance for Industry’’ that appeared in 

the Federal Register of March 10, 2022. 

The document omitted the date by 

which comments on the draft guidance 

should be submitted to FDA. This error 

is corrected in this document for clarity. 

FOR FURTHER INFORMATION CONTACT: 

Sarah Venti, 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: In the 

Federal Register of March 10, 2022 (87 

FR 13738), appearing on page 13738, in 

FR Doc. 2022–05018, in the second 

column, the DATES section is corrected 

to read as follows: 

DATES: The announcement of the 

guidance is published in the Federal 

Register on March 10, 2022. Although 

you can comment on any guidance at 

any time (see 21 CFR 10.115(g)(5)), to 

ensure that the Agency considers your 

comment on this draft guidance before 

it begins work on the final version of the 

guidance, submit either electronic or 

written comments on the draft guidance 

by May 9, 2022. 

Dated: March 17, 2022. 

Andi Lipstein Fristedt, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs, U.S. Food and Drug 

Administration. 

[FR Doc. 2022–06006 Filed 3–21–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; 

Amended Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the National Institute of 

Diabetes and Digestive and Kidney 

Diseases Special Emphasis Panel, March 

23, 2022, 09:00 a.m. to March 24, 2022, 

04:00 p.m., National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD, 20892 which was 

published in the Federal Register on 

February 25, 2022, 308582. 

Dr. Kozel wants to change the date for 

his meeting. The meeting is closed to 

the public. 

Dated: March 16, 2022. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–05966 Filed 3–21–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; 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: Microbiology, 

Infectious Diseases and AIDS Initial Review 

Group; Acquired Immunodeficiency 

Syndrome Research Study Section; Acquired 

Immunodeficiency Syndrome Research 

Study Section (AIDS). 

Date: April 20, 2022. 

Time: 10:00 a.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3F40A, 

Rockville, MD 20892 (Virtual Meeting). 

Contact Person: Dimitrios Nikolaos 

Vatakis, Ph.D., Scientific Review Officer, 

Scientific Review Program, Division of 

Extramural Activities, National Institute of 

Allergy and Infectious Diseases, National 

Institutes of Health, 5601 Fishers Lane, MSC– 

9823, Bethesda, MD 20892, (301) 761–7176, 

dimitrios.vatakis@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: March 16, 2022. 

Tyeshia M. Roberson-Curtis, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–05968 Filed 3–21–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the Sleep Disorders 

Research Advisory Board, April 7, 2022, 

12:00 p.m. to 5:00 p.m., Virtual Meeting, 

which was published in the Federal 

Register on March 09, 2022, V 87 Vol. 

46, Page 13302, FR Doc No. 2022– 

04982. 

Meeting is being amended to change 

the telephone call in number to 1–669– 

254–5252 (Meeting ID: 161 532 8417 

Passcode: 330488). The meeting is open 

to the public. 

Dated: March 16, 2022. 

David W. Freeman, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–05969 Filed 3–21–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Neurological 

Disorders and Stroke; 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 of 

Neurological Disorders and Stroke Special 

Emphasis Panel; Clinical Trials and 

Comparative Effectiveness Studies in 

Neurology. 

Date: March 28–29, 2022. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 (Virtual 

Meeting). 

Contact Person: Shanta Rajaram, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, Division of Extramural Activities, 


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