[Federal Register Volume 86, Number 42 (Friday, March 5, 2021)]
[Notices]
[Pages 12951-12952]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04609]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-2354]


Data Standards; Requirement Begins for the Clinical Data 
Interchange Standards Consortium Version 1.1 of the Standard for 
Exchange of Nonclinical Data Developmental and Reproductive Toxicology 
Implementation Guide and Version 1.6 of the Study Data Tabulation 
Model; Clarification to Food and Drug Administration Data Standards

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for 
Drug Evaluation and Research (CDER) is announcing the date that support 
will begin for version 1.1 of the Clinical Data Interchange Standards 
Consortium (CDISC) Standard for Exchange of Nonclinical Data 
Developmental and Reproductive Toxicology Implementation Guide (SENDIG-
DART) and version 1.6 of the Clinical Data Interchange Standards 
Consortium (CDISC) Study Data Tabulation Model (SDTM) and the dates 
when such new standard and version update will be required in certain 
submissions. The Agency will update the FDA Data Standards Catalog 
(Catalog) to reflect these changes. An additional note is added to the 
Catalog clarifying the requirements for the submission of a simplified 
trial summary dataset to determine a study start date at the point of 
submission at the electronic gateway.

DATES: Support for version 1.1 of the CDISC SENDIG-DART and version 1.6 
of the CDISC SDTM will begin on March 15, 2021. The requirement for 
electronic submissions to be submitted using version 1.1 of the CDISC 
SENDIG-DART will begin March 15, 2023, for new drug applications 
(NDAs), abbreviated new drug applications (ANDAs), and certain 
biologics license applications (BLAs), and March 15, 2024, for certain 
investigational new drug applications (INDs). The requirement for 
electronic submissions to be submitted using version 1.6 of the CDISC 
SDTM will begin on March 15, 2022.

ADDRESSES: You may submit comments as follows.

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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-2020-N-235 for ``Data Standards; Requirements Begin for the 
Clinical Data Interchange Standards Consortium Version 1.1 of the 
Standard for Exchange of Nonclinical Data Developmental and 
Reproductive Toxicology Implementation Guide and Version 1.6 of the 
Study Data Tabulation Model. Clarification to the FDA Data Standards 
Catalog.'' 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.
    <bullet> 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

[[Page 12952]]

``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.

FOR FURTHER INFORMATION CONTACT: Bryan Spells, 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, email: <a href="/cdn-cgi/l/email-protection#67040302150306130614130609030615031427010306490f0f1449000811"><span class="__cf_email__" data-cfemail="0c6f68697e686d786d7f786d62686d7e687f4c6a686d2264647f226b637a">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: FDA's CDER is issuing this Federal Register 
notice to announce the date that support will begin for version 1.1 of 
the CDISC SENDIG-DART and version 1.6 of the CDISC SDTM and the dates 
when such new standard and version update will be required in certain 
submissions. The FDA guidance for industry ``Providing Regulatory 
Submissions in Electronic Format--Standardized Study Data'' (October 
2020) (eStudy Data guidance), posted on FDA's Study Data Standards 
Resources web page at https://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm, 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 CDER or the Center for 
Biologics Evaluation and Research 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 version 1.1 of the CDISC SENDIG-DART and version 1.6 of 
the CDISC SDTM will begin on March 15, 2021, the transition date. The 
requirement for electronic submissions to be submitted using version 
1.1 of the CDISC SENDIG-DART will begin March 15, 2023, for NDAs, ANDAs 
and certain BLAs, and March 15, 2024, for certain INDs. The requirement 
for electronic submissions to be submitted using version 1.6 of the 
CDISC SDTM will begin on March 15, 2022.

    Dated: February 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-04609 Filed 3-4-21; 8:45 am]
BILLING CODE 4164-01-P


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