[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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