[Federal Register Volume 85, Number 130 (Tuesday, July 7, 2020)]
[Notices]
[Pages 40658-40659]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14512]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1206]


Electronic Study Data Submission; Data Standards; Support and 
Requirement Begin for Study Data Tabulation Model Version 1.7 
Implementation Guide 3.3 and for Define-Extensible Markup Language 
Version 2.1; Requirement Ends for Study Data Tabulation Model Version 
1.3 Implementation Guide 3.1.3

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 the dates that support and 
requirement will begin for version 1.7 of the Clinical Data Interchange 
Standards Consortium (CDISC) for Study Data Tabulation Model (SDTM) 
Implementation Guide (IG) 3.3, as well as for version 2.1 of the 
Define-Extensible Markup Language (Define-XML). CBER and CDER are also 
announcing the date that support and requirement will end for version 
1.3 of the CDISC SDTM IG 3.1.3. The Agency will update the FDA Data 
Standards Catalog (Catalog) to reflect these changes.

ADDRESSES: You may submit either electronic or written comments 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-2020-N-1206 for ``Electronic Study Data Submission; Data Standards; 
Support and Requirement Begin for Study Data Tabulation Model Version 
1.7 Implementation Guide 3.3 and for Define-Extensible Markup Language 
Version 2.1; Requirement Ends for Study Data Tabulation Model Version 
1.3 Implementation Guide 3.1.3.'' 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.

FOR FURTHER INFORMATION CONTACT: Chenoa Conley, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1117, Silver Spring, MD 20993-0002, 301-
796-0035, [email protected], or Stephen Ripley, Center for 
Biologics Evaluation and Research, Food and Drug Administration, Bldg. 
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: On December 17, 2014, FDA published a final 
guidance for industry entitled ``Providing Regulatory Submissions in 
Electronic Format--Standardized Study Data'' (eStudy Data guidance), 
posted on FDA's Study Data Standards Resources web page at https://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm. 
The eStudy Data guidance 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 new drug 
applications (NDAs), abbreviated new drug applications (ANDAs), 
biologics license applications (BLAs), and certain investigational new 
drug applications (INDs) submitted to

[[Page 40659]]

CDER or CBER 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, when the support begins or ends, 
and when the requirement begins or ends, that will be added to the 
Catalog. Support for version 1.7 of the CDISC SDTM IG 3.3 and version 
2.1 of the Define-XML will begin on March 15, 2021, and the date that 
the requirement begins will be on March 15, 2022, for NDAs, ANDAs, and 
certain BLAs. For noncommercial INDs, the date that requirement begins 
will be March 15, 2023. Support and requirement ended for version 1.3 
of the CDISC SDTM IG 3.1.3 will end on March 15, 2021.

    Dated: June 30, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14512 Filed 7-6-20; 8:45 am]
BILLING CODE 4164-01-P