[Federal Register Volume 85, Number 48 (Wednesday, March 11, 2020)]
[Notices]
[Pages 14205-14206]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04898]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0315]


Electronic Study Data Submission; Data Standards; Support and 
Requirement Begin for Study Data Tabulation Model Version 1.8 With 
Standard for Exchange of Nonclinical Data Implementation Guide--Animal 
Rule Version 1.0

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) Center for 
Drug Evaluation and Research (CDER) is announcing that FDA will begin 
supporting the Clinical Data Interchange Standards Consortium (CDISC) 
for Study Data Tabulation Model version 1.8 (SDTM v1.8), and CDISC 
Standard for Exchange of Nonclinical Data Implementation Guide--Animal 
Rule version 1.0 (SENDIG-AR v1.0) on March 15, 2020, and that these new 
standards will be required in submissions to FDA effective March 15, 
2022. An update will be made to the FDA Data Standards Catalog 
(Catalog) to reflect these changes.

DATES: Submit either electronic or written comments at any time.

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-2020-N-0315 for ``Support and Requirement Begin for Study Data 
Tabulation Model Version 1.8 with Standard for Exchange of Nonclinical 
Data Implementation Guide--Animal Rule Version 1.0.'' 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.
     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.

FOR FURTHER INFORMATION CONTACT: Chenoa Conley, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New

[[Page 14206]]

Hampshire Ave., Bldg. 51, Rm. 1117, Silver Spring, MD 20993-0002, 301-
796-0035, email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On December 17, 2014, FDA published 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, abbreviated new drug 
applications, biologics license applications, and investigational new 
drug applications 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 standard version updates that will be added 
to the Catalog and will specify when support for the new standard 
begins or ends, and when the requirement to submit data using the new 
standard begins or ends. FDA will begin supporting SDTM v1.8 and 
SENDIG-AR v1.0 on March 15, 2020, and such Animal Rule \1\ submissions 
will be required to use the new standard effective March 15, 2022.
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    \1\ The Animal Rule refers to FDA's regulations for the approval 
of new drugs and biological products when human efficacy studies are 
not ethical or feasible (see 21 CFR 314.600-650 for drugs and 21 CFR 
601.90-95 for biologics).

    Dated: March 5, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-04898 Filed 3-10-20; 8:45 am]
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