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###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. FDA-2023-N-5022]

# 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 SENDIG-Genetoxv1.0 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                           ( print page 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,                         *CBER-eDATA@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 SENDIG-Genetoxv1.0 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 FDA-supported 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