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[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,

[[Page 3162]]

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]
 BILLING CODE 4164-01-P
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