Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Notices 86337 

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: 

CDER: Helena Sviglin, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 1117, 

Silver Spring, MD 20993–0002, 240– 

402–6511, cderdatastandards@

fda.hhs.gov. 

CBER: Lisa Lin and Anne Taylor, 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 7301, Silver Spring, 

MD 20993–0002, 240–402–7911, CBEReDATA@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA’s 

CBER and CDER are issuing this Federal 

Register notice to announce the date 

that support begins for CDISC 

SDTMv2.0, SDTMIGv3.4, and SENDIGGenetoxv1.0 and requirement ends for 

version 3.2 of the CDISC SDTMIG. The 

guidance for industry entitled 

‘‘Providing Regulatory Submissions in 

Electronic Format—Standardized Study 

Data,’’ published June 2021 (eStudy 

Data guidance) (available at https://

www.fda.gov/media/82716/download), 

implements the electronic submission 

requirements of section 745A(a) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 379k–1(a)) for study data 

contained in NDAs, ANDAs, certain 

BLAs, and certain INDs submitted to 

CBER or CDER by specifying the format 

for electronic submissions. The eStudy 

Data guidance states that a Federal 

Register notice will specify any new 

standards and version updates to FDAsupported study data standards that will 

be added to the Catalog, when the 

support for such standards and version 

updates begins or ends, and when the 

requirement to use such standards and 

version updates in submissions begins 

or ends. 

Support for CDISC SDTMv2.0, 

SDTMIGv3.4, and SENDIG-Genetoxv1.0 

begins December 13, 2023. The 

transition date for these version updates 

is March 15, 2024. The requirement for 

electronic submissions to be submitted 

using CDISC SDTMv2.0, SDTMIGv3.4, 

and SENDIG-Genetoxv1.0 is March 15, 

2025, for NDAs, ANDAs, certain BLAs, 

and certain INDs. The requirement for 

electronic submissions to be submitted 

using version 3.2 of the CDISC SDTMIG 

ends December 13, 2023. 

Dated: December 8, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–27310 Filed 12–12–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–0008] 

Request for Nominations for Voting 

Members for the Genetic Metabolic 

Diseases Advisory Committee 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

requesting nominations for voting 

members excluding consumer and 

industry representatives, to serve on the 

Genetic Metabolic Diseases Advisory 

Committee (the Committee) in the 

Center for Drug Evaluation and 

Research. Nominations will be accepted 

for current vacancies effective with this 

notice. FDA seeks to include the views 

of members of all gender groups, 

members of all racial and ethnic groups, 

and individuals with and without 

disabilities on its advisory committees 

and, therefore encourages nominations 

of appropriately qualified candidates 

from these groups. 

DATES: Nominations received on or 

before February 12, 2024 will be given 

first consideration for membership on 

the Committee. Nominations received 

after February 12, 2024 will be 

considered for nomination to the 

committee as later vacancies occur. 

ADDRESSES: All nominations for 

membership should be sent 

electronically by logging into the FDA 

Advisory Committee Membership 

Nomination Portal: https://

www.accessdata.fda.gov/scripts/

FACTRSPortal/FACTRS/index.cfm and 

selecting Academician/Practitioner from 

the dropdown menu (regardless of 

whether Academician/Practitioner 

accurately describes the nominee), or by 

mail to Advisory Committee Oversight 

and Management Staff, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5103, Silver Spring, 

MD 20993–0002. Information about 

becoming a member on an FDA advisory 

committee can also be obtained by 

visiting FDA’s website at https://

www.fda.gov/AdvisoryCommittees/ 

default.htm. 

FOR FURTHER INFORMATION CONTACT: 

Moon Choi, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 31, Rm. 2417, Silver Spring, 

MD 20993–0002, 301–796–2894, email: 

GEMDAC@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

requesting nomination for voting 

members to fill current vacancies on the 

Genetic Metabolic Diseases Advisory 

Committee. This notice does not include 

consumer and industry representative 

nominations. The Agency will publish 

two separate notices announcing the 

vacancy of a representative of consumer 

interests and the vacancy of a 

representative of industry interests. 

I. General Description of the Committee 

Duties 

The Committee reviews and evaluates 

data on the safety and effectiveness of 

marketed and investigational human 

drug and biologic products for use in 

the treatment of genetic metabolic 

diseases and makes appropriate 

recommendations to the Commissioner 

of Food and Drugs. 

II. Criteria for Voting Members 

The Committee consists of a core of 

nine voting members, including the 

Chair. Members and the Chair are 

selected by the Commissioner or 

designee from among authorities 

knowledgeable in the fields of medical 

genetics, manifestations of inborn errors 

of metabolism, small population trial 

design, translational science, pediatrics, 

epidemiology, or statistics and related 

specialties. Members will be invited to 

serve for overlapping terms of up to 4 

years. Non-Federal members of this 

committee will serve either as Special 

Government Employees or non-voting 

representatives. Federal members will 

serve as Regular Government 

Employees. The core of voting members 

may include one technically qualified 

member, selected by the Commissioner 

or designee, who serves as an 

individual, but 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 non-voting representative 

member who is identified with industry 

interests. There may also be an alternate 

industry representative. 

III. Nomination Procedures 

Any interested person may nominate 

one or more qualified individuals for 

membership on the Committee with the 

exception of the following: individuals 

who are not U.S. citizens or nationals 

cannot be appointed as Advisory 

Committee Members (42 U.S.C. 217(a)) 


khammond on DSKJM1Z7X2PROD with NOTICES
86338 Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Notices 

in FDA. Self-nominations are also 

accepted. Nominations must include a 

cover letter; 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 

Nomination Portal (see ADDRESSES). 

Nominations must specify the advisory 

committee for which the nominee is 

recommended. Nominations must also 

acknowledge that the nominee is aware 

of the nomination, unless selfnominated. FDA will ask potential 

candidates to provide detailed 

information concerning such matters 

related to financial holdings, 

employment, and research grants and/or 

contracts to permit evaluation of 

possible sources of conflicts of interest. 

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 7, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–27301 Filed 12–12–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0008] 

Request for Nominations for 

Individuals and Consumer 

Organizations for Advisory 

Committees 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

requesting that any consumer 

organizations interested in participating 

in the selection of voting and/or 

nonvoting consumer representatives to 

serve on its advisory committees or 

panels notify FDA in writing. FDA is 

also requesting nominations for voting 

and/or nonvoting consumer 

representatives to serve on advisory 

committees and/or panels for which 

vacancies currently exist or are expected 

to occur in the near future. Nominees 

recommended to serve as a voting or 

nonvoting consumer representative may 

be self-nominated or may be nominated 

by a consumer organization. FDA seeks 

to include the views of individuals on 

its advisory committee regardless of 

their gender identification, religious 

affiliation, racial and ethnic 

identification, or disability status and, 

therefore, encourages nominations of 

appropriately qualified candidates from 

all groups. 

DATES: Any consumer organization 

interested in participating in the 

selection of an appropriate voting or 

nonvoting member to represent 

consumer interests on an FDA advisory 

committee or panel may send a letter or 

email stating that interest to FDA (see 

ADDRESSES) by January 29, 2024, for 

vacancies listed in this notice. 

Concurrently, nomination materials for 

prospective candidates should be sent to 

FDA (see ADDRESSES) by January 29, 

2024. Nominations will be accepted for 

current vacancies and for those that will 

or may occur through December 31, 

2023. 

ADDRESSES: All statements of interest 

from consumer organizations interested 

in participating in the selection process 

should be submitted electronically to 

ACOMSSubmissions@fda.hhs.gov or by 

mail to Advisory Committee Oversight 

and Management Staff, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5122, Silver Spring, 

MD 20993–0002. 

Consumer representative nominations 

should be submitted electronically by 

logging into the FDA Advisory 

Committee Membership Nomination 

Portal: https://www.accessdata.fda.gov/ 

scripts/FACTRSPortal/FACTRS/index.

cfm, or by mail to Advisory Committee 

Oversight and Management Staff, 10903 

New Hampshire Ave., Bldg. 32, Rm. 

5122, Silver Spring, MD 20993–0002. 

Additional information about becoming 

a member of an FDA advisory 

committee can also be obtained by 

visiting FDA’s website at https://

www.fda.gov/AdvisoryCommittees/ 

default.htm. 

FOR FURTHER INFORMATION CONTACT: For 

questions relating to participation in the 

selection process: Kimberly Hamilton, 

Advisory Committee Oversight and 

Management Staff, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5122, Silver Spring, 

MD 20993–0002, 301–796–8220, 

Kimberly.Hamilton@fda.hhs.gov. 

For questions relating to specific 

advisory committees or panels, contact 

the appropriate contact person listed in 

table 1. 

TABLE 1—ADVISORY COMMITTEE CONTACTS

Contact person Committee/panel 

Rakesh Raghuwanshi, Office of the Chief Scientist, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 1, Rm. 3309, Silver Spring, MD 20993–0002, 

301–796–4769, Rakesh.Raghuwanshi@fda.hhs.gov.

FDA Science Board Advisory Committee. 

Prabhakara Atreya, Center for Biologics Evaluation and Research, Food and Drug 

Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 1226, Silver Spring, MD 

20993–0002, 240–402–8006, Prabhakara.Altreya@fda.hhs.gov.

Allergenic Products Advisory Committee. 

Moon Hee Choi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2434, Silver Spring, MD 20993– 

0002, 301–796–2894, MoonHee.Choi@fda.hhs.gov.

Anesthetic and Analgesic Drug Products Advisory Committee, Non-Prescription Drugs Advisory Committee. 

She-Chia Jankowski, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6178, Silver Spring, MD 

20993–0002, 240–402–5343, She-Chia.Jankowski@fda.hhs.gov.

Antimicrobial Drugs Advisory Committee. 

Jessica Seo, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2412, Silver Spring, MD 20993– 

0002, 301–796–7699, Jessica.Seo@fda.hhs.gov.

Peripheral and Central Nervous System Drugs Advisory 

Committee. 

Yvette Waples, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2510, Silver Spring, MD 20993– 

0002, 301–796–9034, Yvette.Waples@fda.hhs.gov.

Cardiovascular and Renal Drugs Advisory Committee, 

Medical Imaging Drugs Advisory Committee. 


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