Federal Register / Vol. 88, No. 206 / Thursday, October 26, 2023 / Notices 73603 

monitoring program; and (3) 

outsourcing facilities registered under 

section 503B (21 U.S.C. 356b) of the 

FD&C Act. FDA may consider the use of 

a remote interactive evaluation for any 

of the inspection program areas 

described in the draft guidance. 

During the Coronavirus Disease 2019 

(COVID–19) pandemic, FDA expanded 

our use of alternative tools for 

evaluating drug manufacturing facilities 

to support regulatory decision-making. 

When an inspection was not feasible or 

practical because of the public health 

emergency (PHE), FDA used other 

available tools and information to 

support regulatory decisions and 

oversight of facilities. FDA announced 

its policy for using these alternative 

tools in a guidance entitled ‘‘Remote 

Interactive Evaluations of Drug 

Manufacturing and Bioresearch 

Monitoring Facilities During the 

COVID–19 Public Health Emergency’’ 

posted in April 2021 and announced in 

the Federal Register on May 27, 2021 

(86 FR 28627) (‘‘2021 COVID–19 Remote 

Interactive Evaluations Guidance’’). 

FDA issued the guidance to 

communicate its policy for the duration 

of the COVID–19 PHE declared by the 

Secretary of Health and Human Services 

(HHS) on January 31, 2020, including 

any renewals made by the HHS 

Secretary in accordance with section 

319(a)(2) of the Public Health Service 

Act (42 U.S.C. 247d(a)(2)). Furthermore, 

in the Federal Register of March 13, 

2023 (88 FR 15417) FDA listed the: (1) 

guidances that will no longer be 

effective with the expiration of the PHE 

declaration, (2) guidances that FDA was 

revising to continue in effect for 180 

days after the expiration of the PHE 

declaration to provide a period for 

stakeholder transition and then would 

no longer be in effect, and (3) guidances 

that FDA was revising to continue in 

effect for 180 days after the expiration 

of the PHE declaration during which 

time FDA planned to further revise the 

guidances. The 2021 COVID–19 Remote 

Interactive Evaluations Guidance is 

included in the latter category and was 

revised to remain in effect for 180 days 

post expiration of the PHE declaration. 

Although the HHS Secretary of has 

announced that the COVID–19 public 

health emergency declaration has ended 

and FDA has largely resumed 

inspections, FDA has determined that 

continued use of alternative tools, 

including remote interactive 

evaluations, based on risk and program 

needs, will enhance our ability to assess 

facilities. 

This draft guidance describes the 

various remote interactive tools we may 

request to use to conduct an evaluation. 

In this draft guidance, we refer to our 

use of any combination of these 

interactive tools as a remote interactive 

evaluation. FDA may request to conduct 

a remote interactive evaluation prior to 

or following other types of regulatory 

oversight activities (e.g., an inspection 

or a request for records or other 

information). In preparing this draft 

guidance, FDA considered comments 

received on the 2021 COVID–19 Remote 

Interactive Evaluations Guidance. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘Remote Interactive Evaluations of 

Drug Manufacturing and Bioresearch 

Monitoring Facilities.’’ It does not 

establish any rights for any person and 

is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. 

FDA also is announcing that the 2021 

COVID–19 Remote Interactive 

Evaluations Guidance will be 

withdrawn upon publication of this 

draft guidance. FDA has determined 

that the 2021 COVID–19 Remote 

Interactive Evaluations Guidance is no 

longer needed because this new draft 

guidance is available and its 

recommendations, when finalized, will 

be applicable outside the context of the 

COVID–19 public health emergency. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA). The 

collections of information in 21 CFR 

part 312 have been approved under 

OMB control number 0910–0014. The 

collections of information in 21 CFR 

part 314 have been approved under 

OMB control number 0910–0001. The 

collections of information in 21 CFR 

part 58 pertaining to good laboratory 

practices have been approved under 

OMB control number 0910–0119. The 

collection of information pertaining to 

current good manufacturing practices 

have been approved under OMB control 

number 0910–0139. The collections of 

information relating to the registration 

of human drug compounding 

outsourcing facilities under section 

503B of the FD&C Act and associated 

fees under section 744K of the FD&C 

Act (21 U.S.C. 379j–62) have been 

approved under OMB control number 

0910–0776. The collections of 

information pertaining to human drug 

compounding under sections 503A (21 

U.S.C. 356a) and 503B of the FD&C Act 

have been approved under OMB control 

number 0910–0800. The collections of 

information in 21 CFR part 11 have been 

approved under OMB control number 

0910–0303. The collections of 

information in 21 CFR parts 50 and 56 

have been approved under OMB control 

number 0910–0130. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. 

Dated: October 23, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–23677 Filed 10–25–23; 8:45 am] 

BILLING CODE 4164–01–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 1009 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 

Allergy and Infectious Diseases Special 

Emphasis Panel; NIAID Investigator Initiated 

Program Project Applications (P01 Clinical 

Trial Not Allowed). 

Date: November 15, 2023. 

Time: 10:30 a.m. to 5:00 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 3F58, 

Rockville, MD 20892 (Virtual Meeting). 


ddrumheller on DSK120RN23PROD with NOTICES1
73604 Federal Register / Vol. 88, No. 206 / Thursday, October 26, 2023 / Notices 

Contact Person: Mario Cerritelli, 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, Room 3F58, Rockville, MD 

20852, 240–669–5199, cerritem@

mail.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: October 20, 2023. 

David W. Freeman, 

Supervisory Program Analyst, Office of 

Federal Advisory Committee Policy. 

[FR Doc. 2023–23626 Filed 10–25–23; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Drug Abuse; 

Notice of Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the National Advisory 

Council on Drug Abuse. 

The meeting will be held as a virtual 

meeting and is open to the public, as 

indicated below. Individuals who plan 

to view the virtual meeting and need 

special assistance such as sign language 

interpretation or other reasonable 

accommodations to view the meeting, 

should notify Dr. Jeanette Marketon via 

email at jeanette.marketon@nih.gov five 

days in advance of the meeting. The 

open session will be videocast and can 

be accessed from the NIH Videocasting 

and Podcasting website (http://

videocast.nih.gov/). 

A portion of 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 intramural programs 

and projects as well as the grant 

applications and/or contract proposals 

and the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with intramural 

programs and projects as well as the 

grant applications and/or contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Advisory 

Council on Drug Abuse. 

Date: February 6, 2024. 

Closed: 10:30 a.m. to 11:45 a.m. Agenda: 

To review and evaluate grant applications. 

Closed: 11:45 a.m. to 12:15 p.m. Agenda: 

Report to Council from the NIDA Board of 

Scientific Counselors (BSC). 

Open: 12:45 p.m. to 5:00 p.m. Agenda: 

Presentations and other business of the 

Council. 

Place: National Institutes of Health, 

National Institute on Drug Abuse, 301 North 

Stonestreet Avenue, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Susan R.B. Weiss, Ph.D., 

Director, Division of Extramural Research, 

Office of the Director, National Institute on 

Drug Abuse, NIH, Three White Flint North, 

RM 09D08, 11601 Landsdown Street, 

Bethesda, MD 20852 301–443–6480 sweiss@

nida.nih.gov. 

Contact Person: Jeanette Marketon, Ph.D., 

Director, Office of Extramural Policy, 

Division of Extramural Research Office of 

Extramural Policy, National Institute on Drug 

Abuse, NIH, Three White Flint North, RM 

09C68, 11601 Landsdown Street, Bethesda, 

MD 20852, 301–443–5239 

jeanette.marketon@nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to Dr. Jeanette Marketon at 

jeanette.marketon@nih.gov. The statement 

should include the name, address, telephone 

number and when applicable, the business or 

professional affiliation of the interested 

person. 

Information is also available on the 

Institute’s/Center’s home page: 

www.drugabuse.gov/NACDA/ 

NACDAHome.html, where an agenda and 

any additional information for the meeting 

will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.277, Drug Abuse Scientist 

Development Award for Clinicians, Scientist 

Development Awards, and Research Scientist 

Awards; 93.278, Drug Abuse National 

Research Service Awards for Research 

Training; 93.279, Drug Abuse and Addiction 

Research Programs, National Institutes of 

Health, HHS) 

Dated: October 20, 2023. 

David W. Freeman, 

Supervisory Program Analyst, Office of 

Federal Advisory Committee Policy. 

[FR Doc. 2023–23628 Filed 10–25–23; 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 1009 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 

Allergy and Infectious Diseases, Special 

Emphasis Panel; NIAID Investigator Initiated 

Program Project Applications (P01 Clinical 

Trial Not Allowed). 

Date: November 20, 2023. 

Time: 9:00 a.m. to 12:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 903 South 4th Street, Room RML 31/ 

3118, Hamilton, MT 59840 (Virtual Meeting). 

Contact Person: Kristin L. McNally, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

National Institute of Allergy and Infectious 

Diseases, National Institutes of Health, 903 

South 4th Street, Room RML 31/3118, 

Hamilton, MT 59840, mcnallyk@

niaid.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: October 20, 2023. 

David W. Freeman, 

Supervisory Program Analyst, Office of 

Federal Advisory Committee Policy. 

[FR Doc. 2023–23627 Filed 10–25–23; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[Docket ID: FEMA—2023–0029; OMB No. 

1660–0016] 

Agency Information Collection 

Activities: Proposed Collection, 

Comment Request; Revision to 

National Flood Insurance Program 

Maps: Application Forms and 

Instructions for LOMRs and CLOMRs 

AGENCY: Federal Emergency 

Management Agency, Department of 

Homeland Security. 

ACTION: 60-Day notice of renewal and 

request for comments. 

SUMMARY: The Federal Emergency 

Management Agency (FEMA), as part of 

its continuing effort to reduce 

paperwork and respondent burden, 

invites the general public to take this 

opportunity to comment on a renewal of 


ddrumheller on DSK120RN23PROD with NOTICES1