[Federal Register Volume 82, Number 189 (Monday, October 2, 2017)]
[Notices]
[Pages 45858-45859]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21081]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-2837]


Electronic Study Data Submission; Data Standards; Support for 
Analysis Data Model Implementation Guide Version 1.1

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) Center for Drug 
Evaluation and Research (CDER) is announcing support for version 1.1 of 
Clinical Data Interchange Standards Consortium (CDISC), Analysis Data 
Model Implementation Guide (ADaM IG V1.1), an update to the FDA Data 
Standards Catalog (Catalog). (See http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm). ADaM IG V1.1 has been 
available from CDISC (www.cdisc.org) since February 12, 2016. FDA is 
encouraging sponsors and applicants to use ADaM IG V1.1 in 
investigational study data provided in regulatory submissions to CDER.

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-2017-N-2837 for ``Electronic Study Data Submission; Data Standards; 
Support for Analysis Data Model Implementation Guide Version 1.1.'' 
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 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: 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

[[Page 45859]]

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: [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 (NDAs), abbreviated new drug 
applications (ANDAs), biologics license applications (BLAs), and 
investigational new drug applications (INDs) to the Center for 
Biologics Evaluation and Research (CBER) or CDER by specifying the 
format for electronic submissions. The implementation of electronic 
submission requirements for study data became effective on December 17, 
2016 (24 months after issuance of final guidance for NDAs, BLAs, ANDAs, 
and 36 months for INDs). The eStudy Data guidance states that a Federal 
Register notice will specify the transition date for all version 
updates (with the month and day for the transition date corresponding 
to March 15).
    The transition date for support of version 1.1 of ADaM 1G V 1.1 is 
March 15, 2018. ADaM IG V.1.1 is supported as of this Federal Register 
notice and sponsors or applicants are encouraged to begin using it, the 
new version will only be required in submissions for studies that start 
after March 15, 2019. The Catalog will list March 15, 2019, which will 
be reflected in the Catalog, as the ``date requirement begins.'' When 
multiple versions of an FDA-supported standard are listed in the 
Catalog, sponsors or applicants can select any of those version to use.
    The transition date for the end of FDA support for ADaM IG V 1.0, 
is March 15, 2018.

II. Electronic Access

    Persons with access to the Internet may obtain the referenced 
material at http://www.fda.gov/ectd.

    Dated: September 22, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-21081 Filed 9-29-17; 8:45 am]
 BILLING CODE 4164-01-P