86336 Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Notices 

CFR part 601 regarding applicable 

manufacturing information for BLAs are 

approved under OMB control number 

0910–0338. 

III. Electronic Access 

Persons with access to the internet 

may obtain an electronic version of the 

draft guidance at https://www.fda.gov/ 

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

www.fda.gov/vaccines-blood-biologics/ 

guidance-compliance-regulatoryinformation-biologics/biologicsguidances, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: December 8, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–27309 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–5022] 

Data Standards; Support and 

Requirement Begins for the Clinical 

Data Interchange Standards 

Consortium Version 2.0 of the Study 

Data Tabulation Model, Version 3.4 of 

the Study Data Tabulation Model 

Implementation Guide, and Version 1.0 

of the Standard for Exchange of 

Nonclinical Data Implementation 

Guide—Genetox; Requirement Ends 

for the Clinical Data Interchange 

Standards Version 3.2 of the Study 

Data Tabulation Model Implementation 

Guide 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA or Agency) 

Center for Biologics Evaluation and 

Research (CBER) and Center for Drug 

Evaluation and Research (CDER) are 

announcing that support begins for 

version 2.0 of the Clinical Data 

Interchange Standards Consortium 

(CDISC) Study Data Tabulation Model 

(SDTMv2.0), version 3.4 of the CDISC 

Study Data Tabulation Model 

Implementation Guide (SDTMIGv3.4), 

and version 1.0 of the Standard for 

Exchange of Nonclinical Data 

Implementation Guide—Genetox 

(SENDIG-Genetoxv1.0) and announcing 

the date that these version updates are 

required in certain submissions. CBER 

and CDER are also announcing the date 

that requirement ends for version 3.2 of 

the CDISC SDTMIG (SDTMIGv3.2). The 

Agency will update the FDA Data 

Standards Catalog (Catalog) to reflect 

these changes. The Agency will publish 

in the technical specifications document 

entitled ‘‘Study Data Technical 

Conformance Guide’’ additional details 

on how to implement new variables. 

DATES: Support for version CDISC 

SDTMv2.0, SDTMIGv3.4, and SENDIGGenetoxv1.0 begins December 13, 2023. 

The requirement for electronic 

submissions to be submitted using 

CDISC SDTMv2.0, SDTMIGv3.4, and 

SENDIG-Genetoxv1.0 begins March 15, 

2025, for new drug applications (NDAs), 

abbreviated new drug applications 

(ANDAs), certain biologics license 

applications (BLAs), and certain 

investigational new drug applications 

(INDs). The requirement for electronic 

submissions to be submitted using 

version CDISC SDTMIGv3.2 ends 

December 13, 2023. 

ADDRESSES: You may submit comments 

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– 

2023–N–5022 for ‘‘Data Standards; 

Requirement Begins for the Clinical 

Data Interchange Standards Consortium 

Version 2.0 of the Study Data 

Tabulation Model and Version 3.4 of the 

Study Data Tabulation Model 

Implementation Guide; Requirement 

Ends for the Clinical Data Interchange 

Standards Version 3.2 of the Study Data 

Tabulation Model Implementation 

Guide.’’ 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 


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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