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 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 89, No. 18 / Friday, January 26, 2024 / Notices 5245 

1On December 29, 2022, the President signed into 

law FDORA, which was enacted as part of the 

Consolidated Appropriations Act, 2023, Public Law 

117–328 (2022). 

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 

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 the draft guidance to the 

Division of Operational Policy, Office of 

Regulatory Affairs, Food and Drug 

Administration, Element Building, 

12420 Parklawn Dr., Rockville, MD 

20852. Send one self-addressed 

adhesive label to assist the office in 

processing your requests. The draft 

guidance may also be obtained by mail 

by emailing ORA at orapolicystaffs@

fda.hhs.gov. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: Ben 

Firschein, Office of Regulatory Affairs, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 32, Silver 

Spring, MD 20993–0002, 

Ben.Firschein@fda.hhs.gov, 240–402– 

0613; or Patrick Clouser, Office of 

Regulatory Affairs, Food and Drug 

Administration, Element Building, 

12420 Parklawn Dr., Rockville, MD 

20857, Patrick.Clouser@fda.hhs.gov, 

240–402–5276. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a revised draft guidance for industry 

entitled ‘‘Conducting Remote Regulatory 

Assessments—Questions and Answers.’’ 

This draft revises the draft guidance 

entitled ‘‘Conducting Remote Regulatory 

Assessments—Questions and Answers; 

Draft Guidance for Industry,’’ which 

was announced in the Federal Register 

on July 25, 2022 (87 FR 44129) 

(hereafter, the ‘‘original draft 

guidance’’). FDA issued the original 

draft guidance to describe the Agency’s 

thinking regarding its use of RRAs, to 

help increase the industry’s 

understanding of voluntary and 

mandatory RRAs, and to facilitate FDA’s 

process for conducting remote 

assessments for all types of FDAregulated products outside of the 

COVID–19 public health emergency. 

The comment period for the original 

draft guidance ended on September 23, 

2022. 

One of the mandatory RRAs FDA 

discussed in the original draft guidance 

was the requirement that establishments 

engaged in manufacturing, preparing, 

propagating, compounding, or 

processing drugs produce, upon request 

from FDA, records or other information 

by in advance of or in lieu of an 

inspection, under section 704(a)(4) of 

the FD&C Act. 

In the revised draft guidance we have 

clarified our answers to questions 

regarding: (1) the benefits of an RRA, 

and any consequences for not 

participating; (2) how a facility will 

know an RRA is being requested, and 

whether it is mandatory or voluntary; 

(3) when and how FDA may initiate an 

RRA; (4) how FDA may conduct RRAs 

in relation to FDA inspections or to 

activities by state and foreign regulatory 

partners; (5) what an establishment 

should expect during an RRA, including 

overall process and technological 

expectations, and how consent may be 

established for a voluntary RRA; (6) how 

FDA will seek to provide for ongoing 

communication between FDA and an 

establishment; and (7) what may occur 

upon the completion of an RRA. 

The revised draft guidance also 

contains revisions to align with recent 

changes to section 704(a)(4) of the FD&C 

Act made by the Food and Drug 

Omnibus Reform Act of 2022 (FDORA).1

Specifically, FDORA amended section 

704(a)(4) of the FD&C Act in several 

ways: 

1. FDORA sections 3611(b)(1)(A) and 

3612(a) expanded those subject to 

mandatory requests for records or other 

information under section 704(a)(4) of 

the FD&C Act to include: (a) 

establishments that engage in the 

manufacture, preparation, propagation, 

compounding, or processing of a device, 

and (b) sites or facilities that are subject 

to inspection under section 704(a)(5)(C) 

(i.e., bioresearch monitoring 

inspections) (21 U.S.C. 374(a)(5)). 

2. FDORA section 3611(b)(1)(B) added 

a requirement that FDA provide a 

rationale for requesting records or other 

information under section 704(a)(4) of 

the FD&C Act. 

3. FDORA section 3613(b) inserted 

new section 704(a)(4)(C) of the FD&C 

Act providing that FDA may rely on any 

records or other information obtained 

under section 704(a)(4) to satisfy 

requirements that may pertain to a 

preapproval or risk-based inspection, or 

to resolve deficiencies identified during 

such inspections, if applicable and 

appropriate. 

4. FDORA required FDA to issue or 

update guidance describing the 

circumstances under which the Agency 

intends to use its authority to issue 

requests for records or other information 

under section 704(a)(4) of the FD&C Act 

(as amended by FDORA), the processes 

for firms to respond, and the factors for 

determining whether a facility has 

appropriately and timely responded 

(FDORA section 3611(b)(2)). 

FDA seeks public comment on the 

revised draft guidance. We are 

particularly interested in receiving 

comments that relate to revisions the 

Agency is proposing to address the 

above FDORA requirements. 

This revised 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 ‘‘Conducting 

Remote Regulatory Assessments.’’ 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. 

II. Paperwork Reduction Act of 1995 

FDA tentatively concludes that this 

revised draft guidance contains no 

collection of information. Therefore, 

clearance by the Office of Management 

and Budget under the Paperwork 

Reduction Act of 1995 is not required. 

III. Electronic Access 

Persons with access to the internet 

may obtain the revised draft guidance at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, https://www.fda.gov/drugs/ 

guidance-compliance-regulatoryinformation/guidances-drugs, or https:// 

www.regulations.gov. 


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5246 Federal Register / Vol. 89, No. 18 / Friday, January 26, 2024 / Notices 

Dated: January 23, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–01589 Filed 1–25–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meetings of the Presidential Advisory 

Council on Combating AntibioticResistant Bacteria 

AGENCY: Department of Health and 

Human Services, Office of the Secretary, 

Office of the Assistant Secretary for 

Health. 

ACTION: Notice. 

SUMMARY: As stipulated by the Federal 

Advisory Committee Act, the 

Department of Health and Human 

Services (HHS) is hereby giving notice 

that a meeting is scheduled to be held 

for the Presidential Advisory Council on 

Combating Antibiotic-Resistant Bacteria 

(PACCARB). The meeting will be 

streamed live on hhs.gov/live. A preregistered public comment session will 

be held during the virtual meeting. Preregistration is required for members of 

the public who wish to present their 

comments live during the meeting. 

Individuals who wish to send in their 

written public comment should send an 

email to CARB@hhs.gov. Registration 

information is available on the website 

http://www.hhs.gov/paccarb and must 

be completed by February 15, 2024, for 

the February 22, 2024, Public Meeting. 

Additional information about registering 

for the meeting and providing public 

comment can be obtained at http://

www.hhs.gov/paccarb on the Upcoming 

Meetings page. 

DATES: The meeting is scheduled to be 

held on February 22, 2024, from 9 a.m. 

to 4 p.m. ET (times are tentative and 

subject to change). The confirmed times 

and agenda items for the meeting will be 

posted on the website for the PACCARB 

at http://www.hhs.gov/paccarb when 

this information becomes available. Preregistration for attending the meeting is 

strongly suggested and should be 

completed no later than February 15, 

2024. 

ADDRESSES: The virtual meeting can be 

accessed through a live webcast on the 

day of the meeting. Additional 

instructions regarding attending this 

meeting virtually will be posted at least 

one week prior to the meeting at: http:// 

www.hhs.gov/paccarb. 

FOR FURTHER INFORMATION CONTACT: 

Jomana Musmar, M.S., Ph.D., 

Designated Federal Officer, Presidential 

Advisory Council on Combating 

Antibiotic-Resistant Bacteria, Office of 

the Assistant Secretary for Health, U.S. 

Department of Health and Human 

Services, 1101 Wootton Parkway, 

Rockville, MD 20852. Phone: 202–746– 

1512; Email: CARB@hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Presidential Advisory Council on 

Combating Antibiotic-Resistant Bacteria 

(PACCARB), established by Executive 

Order 13676, is continued by section 

505 of Public Law 116–22, the 

Pandemic and All-Hazards 

Preparedness and Advancing Innovation 

Act of 2019 (PAHPAIA). Activities and 

duties of the PACCARB are governed by 

the provisions of the Federal Advisory 

Committee Act (FACA), Public Law 92– 

463, as amended (5 U.S.C. app.), which 

sets forth standards for the formation 

and use of Federal advisory committees. 

The PACCARB shall advise and 

provide information and 

recommendations to the Secretary of 

Health and Human Services (Secretary) 

regarding programs and policies 

intended to reduce or combat antibioticresistant bacteria that may present a 

public health threat and improve 

capabilities to prevent, diagnose, 

mitigate, or treat such resistance. The 

PACCARB shall function solely for 

advisory purposes. 

Such advice, information, and 

recommendations may be related to 

improving: the effectiveness of 

antibiotics; research and advanced 

research on, and the development of, 

improved and innovative methods for 

combating or reducing antibiotic 

resistance, including new treatments, 

rapid point-of-care diagnostics, 

alternatives to antibiotics, including 

alternatives to animal antibiotics, and 

antimicrobial stewardship activities; 

surveillance of antibiotic-resistant 

bacterial infections, including publicly 

available and up-to-date information on 

resistance to antibiotics; education for 

health care providers and the public 

with respect to up-to-date information 

on antibiotic resistance and ways to 

reduce or combat such resistance to 

antibiotics related to humans and 

animals; methods to prevent or reduce 

the transmission of antibiotic-resistant 

bacterial infections; including 

stewardship programs; and coordination 

with respect to international efforts in 

order to inform and advance the United 

States capabilities to combat antibiotic 

resistance. 

The February 22, 2024, meeting will 

serve as a critical platform for key 

international stakeholders, and nongovernment organizations, to share their 

latest strategies and progress in tackling 

the global threat of antimicrobial 

resistance. The focus will be on both 

showcasing successful international and 

regional initiatives and identifying areas 

for enhanced collaboration and 

knowledge exchange. The meeting 

agenda will be posted on the PACCARB 

website at http://www.hhs.gov/paccarb 

when it has been finalized. All agenda 

items are tentative and subject to 

change. Instructions regarding attending 

the meeting virtually will be posted at 

least one week prior to the meeting at: 

http://www.hhs.gov/paccarb. 

Members of the public will have the 

opportunity to provide comments 

virtually during the February meeting 

by pre-registering online at http://

www.hhs.gov/paccarb; pre-registration 

is required for participation in this 

session with limited spots available. 

Written public comments can also be 

emailed to CARB@hhs.gov by midnight 

February 15, 2024, and should be 

limited to no more than one page. All 

public comments received prior to 

February 15, 2024, will be provided to 

the PACCARB members. 

Dated: January 10, 2024. 

Jomana F. Musmar, 

Designated Federal Officer, Presidential 

Advisory Council on Combating AntibioticResistant Bacteria, Office of the Assistant 

Secretary for Health. 

[FR Doc. 2024–01545 Filed 1–25–24; 8:45 am] 

BILLING CODE 4150–44–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings 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; Member 

Conflict: Biological Chemistry and 

Macromolecular Biophysics. 

Date: February 21, 2024. 

Time: 10:00 a.m. to 6:00 p.m. 


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