106514 Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices 

health status issues are among the topics 

that may be considered by the 

Committee. Members are knowledgeable 

in areas such as clinical research, 

primary care patient experience, 

healthcare needs of patient groups in 

the United States or are experienced in 

the work of patient and health 

professional organizations, 

methodologies for eliciting patient 

preferences, and strategies for 

communicating benefits, risks and 

clinical outcomes to patients and 

research subjects. The Commissioner of 

Food and Drugs (the Commissioner), or 

designee, shall have the authority to 

select from a group of individuals 

nominated by industry to serve 

temporarily as nonvoting members who 

are identified with industry interests. 

The number of temporary members 

selected for a particular meeting will 

depend on the meeting topic(s). 

II. Qualifications 

Persons nominated for the Patient 

Engagement Advisory Committee 

should be full-time employees of firms 

that manufacture medical device 

products, or consulting firms that 

represent manufacturers or have similar 

appropriate ties to industry. 

III. Selection Procedure 

Any industry organization interested 

in participating in the selection of an 

appropriate nonvoting member to 

represent industry interest must send a 

letter stating that interest to the FDA 

contact (see FOR FURTHER INFORMATION

CONTACT) within 30 days of publication 

of this document (see DATES). Within the 

subsequent 30 days, FDA will send a 

letter to each organization that has 

expressed an interest, attaching a 

complete list of all such organizations; 

and a list of all nominees along with 

their current re ́sume ́s or curriculum 

vitae. The letter will also state that it is 

the responsibility of the interested 

organizations to confer with one another 

and to select a candidate or candidates 

(to serve in a pool of individuals with 

varying areas of expertise) to represent 

industry interest for the Committee, 

within 60 days after the receipt of the 

FDA letter. The interested organizations 

are not bound by the list of nominees in 

selecting a candidate or candidates. 

However, if no individual is selected 

within 60 days, the Commissioner will 

select temporary nonvoting members (or 

pool of individuals) to represent 

industry interests. 

IV. Nomination Procedure 

Individuals may self-nominate and/or 

an organization may nominate one or 

more individuals to serve as a 

temporary nonvoting industry 

representative. Nominations must 

include a cover letter and a current, 

complete re ́sume ́ or curriculum vitae for 

each nominee, including current 

business and/or home address, 

telephone number, and email address if 

available, and a signed copy of the 

Acknowledgement and Consent form 

available at the FDA Advisory 

Committee Membership Nomination 

Portal (see ADDRESSES). Nominations 

should specify the advisory committee 

for which the nominee is recommended 

within 30 days of publication of this 

document (see DATES). In addition, 

nominations should acknowledge that 

the nominee is aware of the nomination, 

unless self-nominated. FDA will 

forward all nominations to the 

organizations expressing interest in 

participating in the selection process for 

the Committee. Only interested industry 

organizations participate in the 

selection process. Persons who 

nominate themselves as nonvoting 

industry representatives will not 

participate in the selection process. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. 1001 et seq.) and 21 CFR part 14, 

relating to advisory committees. 

Dated: December 20, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–31272 Filed 12–27–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–0846] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

National Agriculture and Food Defense 

Strategy Survey 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing that a collection of 

information entitled ‘‘National 

Agriculture and Food Defense Strategy 

Survey’’ has been approved by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA). 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On August 

15, 2024, the Agency submitted a 

proposed collection of information 

entitled ‘‘National Agriculture and Food 

Defense Strategy Survey’’ to OMB for 

review and clearance under 44 U.S.C. 

3507. An Agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a currently valid OMB 

control number. OMB has now 

approved the information collection and 

has assigned OMB control number 

0910–0855. The approval expires on 

November 30, 2027. A copy of the 

supporting statement for this 

information collection is available on 

the internet at https://www.reginfo.gov/ 

public/do/PRAMain. 

Dated: December 16, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–31298 Filed 12–27–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–4597] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Shortages Data Collection 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing that a collection of 

information entitled ‘‘Shortages Data 

Collection’’ has been approved by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA). 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10 a.m.–12 p.m., 

11601 Landsdown St., North Bethesda, 

MD 20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On May 

20, 2024, the Agency submitted a 

proposed collection of information 

entitled ‘‘Shortages Data Collection’’ to 

OMB for review and clearance under 44 

U.S.C. 3507. An Agency may not 

conduct or sponsor, and a person is not 

required to respond to, a collection of 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices 106515 

information unless it displays a 

currently valid OMB control number. 

OMB has now approved the information 

collection and has assigned OMB 

control number 0910–0491. The 

approval expires on October 31, 2027. A 

copy of the supporting statement for this 

information collection is available on 

the internet at https://www.reginfo.gov/ 

public/do/PRAMain. 

Dated: December 13, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–31025 Filed 12–27–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–1562] 

E11A Pediatric Extrapolation; 

International Council for 

Harmonisation; 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 of a final 

guidance for industry entitled ‘‘E11A 

Pediatric Extrapolation.’’ The guidance 

was prepared under the auspices of the 

International Council for Harmonisation 

of Technical Requirements for 

Pharmaceuticals for Human Use (ICH). 

The guidance provides a comprehensive 

and systematic approach to pediatric 

extrapolation during drug development. 

Notably, the guidance discusses 

approaches to safety extrapolation and 

defining extrapolation as a continuum. 

The guidance also includes approaches 

to study designs and statistical 

methodologies, including modeling and 

simulation, for developing and 

implementing pediatric extrapolation. 

The guidance is intended to provide 

approaches that can increase the 

efficiency of pediatric drug 

development and accelerate the 

availability of safe and effective drugs 

approved for use in children. The 

guidance replaces the draft guidance 

‘‘E11A Pediatric Exploration’’ issued on 

August 29, 2022. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on December 30, 2024. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances 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–1562 for ‘‘E11A Pediatric 

Exploration.’’ 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 

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, or the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 71, 

Rm. 3128, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. The guidance may also be 

obtained by mail by calling CBER at 1– 

800–835–4709 or 240–402–8010. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Regarding the guidance: Lynne Yao, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 5412, Silver Spring, 

MD 20993–0002, 301–796–2141, 


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