[Federal Register Volume 83, Number 15 (Tuesday, January 23, 2018)]
[Notices]
[Pages 3161-3163]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01119]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-6879]
Electronic Study Data Submission; Data Standards; Timetable for
Updates to the Food and Drug Administration Data Standards Catalog for
Study Data Submitted Electronically Under the Federal Food, Drug, and
Cosmetic Act
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the timetable for updates to the FDA Data Standards Catalog for study
data submitted electronically in new drug applications (NDAs),
abbreviated new drug applications (ANDAs), biologics license
applications (BLAs), and certain investigational new drug applications
(INDs) to the Center for Biologics Evaluation and Research (CBER) and
the Center for Drug Evaluation and Research (CDER). The initial
implementation timetable for submitting standardized study data in
electronic format was 24 months for NDAs, ANDAs, and applications, and
36 months for certain INDs after publication of the final guidance
``Providing Regulatory Submissions in Electronic Format--Standardized
Study'' in December 2014. When future updates to study data standards
listed in the FDA Data Standards Catalog (Catalog) occur, these updated
standards will be required in studies with a start date no earlier than
12 months after a Federal Register notice announcing such updates is
published. When future new study data standards are listed in the
Catalog, these new standards will be required in studies with a start
date no earlier than 24 months after a Federal Register notice
announcing such new standards is published.
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,
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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-2017-N-6879 for ``Electronic Study Data Submission; Data Standards;
Timetable for Updates to the FDA Data Standards Catalog for Electronic
Submissions of Study Data.'' 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.gpo.gov/fdsys/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: Ron Fitzmartin, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1115, Silver Spring, MD 20993-0002, 301-
796-5333, [email protected]; or Stephen Ripley, 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, [email protected].
SUPPLEMENTARY INFORMATION: On December 17, 2014, FDA published final
guidance for industry entitled ``Providing Regulatory Submissions in
Electronic Format--Standardized Study Data'' posted on FDA's Study Data
Standards Resources web page at https://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm. The guidance implemented
the electronic submission requirements of section 745A(a) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379k-1) for
study data contained in NDAs, ANDAs, applications under subsection (a)
or (k) of section 351 of the Public Health Service Act (PHS Act) (42
U.S.C. 262), and certain INDs. The initial implementation date for the
electronic submission requirement for standardized study data was 24
months after final guidance for NDAs, ANDAs, and applications under
subsection (a) or (k) of section 351 of the PHS Act (December 17, 2016)
and 36 months after final guidance for INDs (December 17, 2017). To
provide a consistent timetable for announcing FDA's support and
requirement for future version updates and new study data standards,
the guidance states that a Federal Register notice will specify a
transition date with a specific month and day for the transition date.
When a Federal Register notice is published after March 15 of the
current calendar year, the transition date will be March 15 of the next
calendar year.
When future version updates to supported study data standards and
new study data standards are announced in the Federal Register, they
will be required in studies that have a start date no earlier than 12
months after the transition date for version updates and no earlier
than 24 months after the transition date for new study data standards.
Table 1 presents an example of timetables for the requirement to use
future version updates and new study data standards after publication
of Federal Register notices. In the example, a new study data transport
format standard and a version update to the Study Data Tabulation Model
Implementation Guide (SDTMIG) each have a single date listed when the
standard will be required. The new study data transport format is
supported as of the date of the Federal Register notice, but will only
be required in studies that start 24 months after the transition date
of March 15, 2019. The SDTMIG version update is supported as of the
date of the Federal Register notice, but will only be required in
studies that start 12 months after the transition date of March 15,
2019.
Table 1--Example of Timetables for Required Study Data Standards
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Federal Register
notice of FDA Transition date Date requirement
FDA data standards catalog support (yyyy-mm- (yyyy-mm-dd) begins (yyyy-mm-
dd) dd)
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New Study Data Transport.................................. 2019-02-20 2019-03-15 2021-03-15
SDTMIG Version Update..................................... 2018-09-05 2019-03-15 2020-03-15
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[[Page 3163]]
Dated: January 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01119 Filed 1-22-18; 8:45 am]
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