[Federal Register Volume 81, Number 52 (Thursday, March 17, 2016)]
[Notices]
[Pages 14450-14451]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05958]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1840]


Electronic Study Data Submission; Data Standards; Support End 
Date for Case Report Tabulation Data Definition Specification Version 
1.0

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 end of support for Version 1.0 
of Clinical Data Interchange Standards Consortium Case Report 
Tabulation Data Definition Specification (Define.xml) and an update to 
the FDA Data Standards Catalog. Use of Define.xml Version 2.0, which 
has been available since March 2013, is the newer standard supported by 
FDA. FDA support for Define.xml Version 1.0 will end for studies that 
start 12 months after March 15, 2017.

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: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2014-N-1840 for ``Electronic Study Data Submission; Data Standards; 
Support End Date for Case Report Tabulation Data Definition 
Specification

[[Page 14451]]

Version 1.0.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at http://www.regulations.gov or at the Division of Dockets 
Management 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Fatima Frye, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1192, Silver Spring, MD 20993-0002, 301-
796-5333, [email protected]; or Jack Zhang, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 7318, Silver Spring, MD 20993-0002, 240-
402-8187, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    On December 17, 2014, FDA published final guidance for industry 
``Providing Regulatory Submissions in Electronic Format--Standardized 
Study Data'' (eStudy Data) posted on FDA's Study Data Standards 
Resources Web page at http://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 CBER by specifying the format for 
electronic submissions. The eStudy Data guidance states that a Federal 
Register notice will specify the transition date for updates to 
standards (with the month and day for the transition date corresponding 
to March 15).
    The transition date for the end of FDA support for Define.xml 
Version 1.0 is March 15, 2017. Therefore, FDA support for Define.xml 
Version 1.0 will end for studies that start after March 15, 2018. The 
FDA Data Standards Catalog (see http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm) will be updated to list 
March 15, 2018, as the ``date support ends.''

II. Electronic Access

    Persons with access to the Internet may obtain the referenced 
material at http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm.

     Dated: March 10, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05958 Filed 3-16-16; 8:45 am]
 BILLING CODE 4164-01-P