Federal Register / Vol. 89, No. 18 / Friday, January 26, 2024 / Notices 5243 

from cattle, as well as, with regard to 

§§ 189.5(e) and 700.27(e), foreign 

governments seeking designation under 

those regulations. 

In the Federal Register of August 11, 

2023 (88 FR 54617), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. We received one comment 

that was not related to the PRA and 

therefore will not be addressed in this 

document. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response Total hours 

189.5(c)(6) and 700.27(c)(6); affirmation of 

compliance.

54,825 1 54,825 0.033 (2 minutes) ............. 1,809 

189.5(e) and 700.27(e); request for designation.1 1 1 80 ...................................... 80 

189.5(e) and 700.27(e); response to request 

for review by FDA.

1 1 1 26 ...................................... 26 

Total ........................................................... ........................ ........................ ........................ ........................................... 1,915 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Type of respondent Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average burden per 

recordkeeper Total hours 

Domestic Facilities ............................................ 697 52 36,244 0.25 (15 minutes) ............. 9,061 

Foreign Facilities ............................................... 916 52 47,632 0.25 (15 minutes) ............. 11,908 

Total ........................................................... ........................ ........................ ........................ ........................................... 20,969 

1There are no capital or operating and maintenance costs associated with this collection of information. 

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. 

Dated: January 18, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–01586 Filed 1–25–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–6827] 

Advisory Committee; Vaccines and 

Related Biological Products Advisory 

Committee, Renewal 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; renewal of Federal 

advisory committee. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the renewal of the Vaccines 

and Related Biological Products 

Advisory Committee by the 

Commissioner of Food and Drugs (the 

Commissioner). The Commissioner has 

determined that it is in the public 

interest to renew the Vaccines and 

Related Biological Products Advisory 

Committee for an additional 2 years 

beyond the charter expiration date. The 

new charter will be in effect until the 

December 31, 2025, expiration date. 

DATES: Authority for the Vaccines and 

Related Biological Products Advisory 

Committee will expire on December 31, 

2025, unless the Commissioner formally 

determines that renewal is in the public 

interest. 

FOR FURTHER INFORMATION CONTACT: 

Sussan Paydar, Division of Scientific 

Advisors and Consultants, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Silver Spring, 

MD 20993–0002, 202–657–8533, 

Sussan.Paydar@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to 41 CFR 102–3.65 and approval by the 

Department of Health and Human 

Services and by the General Services 

Administration, FDA is announcing the 

renewal of the Vaccines and Related 

Biological Products Advisory 

Committee (the Committee). The 

Committee is a discretionary Federal 

advisory committee established to 

provide advice to the Commissioner. 

The Committee advises the 

Commissioner or designee in 

discharging responsibilities as they 

relate to helping to ensure safe and 

effective vaccines and related biological 

products for human use, and as 

required, any other product for which 

FDA has regulatory responsibility. 

The Committee reviews and evaluates 

data concerning the safety, 

effectiveness, and appropriate use of 

vaccines and related biological products 

which are intended for use in the 

prevention, treatment, or diagnosis of 

human diseases, and as required, any 

other products for which FDA has 

regulatory responsibility. The 

Committee also considers the quality 

and relevance of FDA’s research 

program, which provides scientific 

support for the regulation of these 

products and makes appropriate 

recommendations to the Commissioner. 

Pursuant to its charter, the Committee 

shall consist of a core of 15 voting 

members, including the Chairperson 

(the Chair). Members and the Chair are 

selected by the Commissioner or 

designee from among authorities 

knowledgeable in the fields of 

immunology, molecular biology, rDNA, 

virology, bacteriology, epidemiology or 

biostatistics, vaccine policy, vaccine 

safety science, federal immunization 

activities, vaccine development 

including translational and clinical 

evaluation programs, hypersensitivity 

reactions to the vaccines, preventive 

medicine, infectious diseases, 

pediatrics, microbiology, and 

biochemistry. Members will be invited 


lotter on DSK11XQN23PROD with NOTICES1
5244 Federal Register / Vol. 89, No. 18 / Friday, January 26, 2024 / Notices 

to serve for overlapping terms of up to 

4 years. Almost all non-Federal 

members of this committee serve as 

Special Government Employees. Ex 

Officio voting members, one each from 

the Department of Health and Human 

Services, the Centers for Disease Control 

and Prevention, and the National 

Institutes of Health, may be included. 

The core of voting members may 

include one technically qualified 

member, selected by the Commissioner 

or designee, who is identified with 

consumer interests and is recommended 

by either a consortium of consumeroriented organizations or other 

interested persons. In addition to the 

voting members, the Committee may 

include one nonvoting member who is 

identified with industry interests. There 

may also be an alternate industry 

representative. 

The Commissioner or designee shall 

have the authority to select members of 

other scientific and technical FDA 

advisory committees (normally not to 

exceed 10 members) to serve 

temporarily as voting members and to 

designate consultants to serve 

temporarily as voting members when: 

(1) expertise is required that is not 

available among current voting standing 

members of the Committee (when 

additional voting members are added to 

the Committee to provide needed 

expertise, a quorum will be based on the 

combined total of regular and added 

members) or (2) to comprise a quorum 

when, because of unforeseen 

circumstances, a quorum is or will be 

lacking. Because of the size of the 

Committee and the variety in the types 

of issues that it will consider, FDA may, 

in connection with a particular 

committee meeting, specify a quorum 

that is less than a majority of the current 

voting members. The Agency’s 

regulations (21 CFR 14.22(d)) authorize 

a committee charter to specify quorum 

requirements. 

If functioning as a medical device 

panel, an additional nonvoting 

representative of consumer interests and 

a nonvoting representative of industry 

interests will be included in addition to 

the voting members. 

Further information regarding the 

most recent charter and other 

information can be found at https://

www.fda.gov/advisory-committees/ 

vaccines-and-related-biologicalproducts-advisory-committee/chartervaccines-and-related-biologicalproducts-advisory-committee or by 

contacting the Designated Federal 

Officer (see FOR FURTHER INFORMATION

CONTACT). In light of the fact that no 

change has been made to the committee 

name or description of duties, no 

amendment will be made to 21 CFR 

14.100. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app.). For general information 

related to FDA advisory committees, 

please visit us at https://www.fda.gov/ 

AdvisoryCommittees/default.htm. 

Dated: January 23, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–01585 Filed 1–25–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–0810] 

Conducting Remote Regulatory 

Assessments—Questions and 

Answers; Revised Draft Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability for 

comment of a revised draft guidance for 

industry entitled ‘‘Conducting Remote 

Regulatory Assessments—Question and 

Answers.’’ FDA has revised and is 

reissuing the draft guidance in response 

to public comments and recent 

amendments to the Federal Food, Drug, 

and Cosmetic Act (FD&C Act). When 

finalized, this guidance will describe 

FDA’s current thinking regarding its use 

of remote regulatory assessments 

(RRAs). FDA has used RRAs to conduct 

oversight, mitigate risk, meet critical 

public health needs, and help maximize 

compliance of FDA-regulated products. 

This revised draft guidance provides 

answers to frequently asked questions 

regarding RRAs. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by March 26, 2024 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– 

2022–D–0810 for ‘‘Conducting Remote 

Regulatory Assessments; Questions and 

Answers; 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 


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