[Federal Register Volume 79, Number 25 (Thursday, February 6, 2014)]
[Notices]
[Pages 7204-7205]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-02554]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0092]


Study Data Technical Conformance Guide and Data Standards 
Catalog; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a Study Data Technical Conformance Guide and an update 
to the Data Standards Catalog (formerly the Study Data Standards 
Catalog). The Study Data Technical Conformance Guide supplements the 
revised draft guidance for industry ``Providing Regulatory Submissions 
in Electronic Format--Standardized Study Data'' and provides 
specifications, recommendations, and general considerations on 
submitting standardized study data using FDA supported data standards 
specified in the Data Standards Catalog.

DATES: Although you can comment on these documents at any time, to 
ensure that the Agency considers your comments, please submit either 
electronic or written comments by May 7, 2014.

ADDRESSES: Submit written requests for a copy of the Study Data 
Technical Conformance Guide and the Data Standards Catalog to the 
Division of Drug Information, Center for Drug Evaluation and Research 
(CDER), Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 
51, Rm. 2201, Silver Spring, MD 20993-0002; or Office of Communication, 
Outreach and Development (HFM-40), Center for Biologics Evaluation and 
Research, Food and Drug Administration, 1401 Rockville Pike, Suite 
200N, Rockville, MD 20852-1448. Send one self-addressed adhesive label 
to assist that office in processing your requests.
    Submit electronic comments on the Study Data Technical Conformance 
Guide and the Data Standards Catalog to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 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. 1160, Silver Spring, MD 20993-0002, 
CDERDataStandards@

[[Page 7205]]

fda.hhs.gov; or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 1401 Rockville Pike, Suite 
200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a Study Data Technical 
Conformance Guide (the Guide) and an update to the Study Data Standards 
Catalog, which will be revised and renamed the Data Standards Catalog 
(the Catalog). The Guide supplements the guidance for industry, 
``Providing Regulatory Submissions in Electronic Format--Standardized 
Study Data,'' (eStudy Data guidance) (available at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm), 
and provides technical recommendations to sponsors for the electronic 
submission of standardized animal and human study data and related 
information contained in certain submissions to new drug applications 
(NDAs), abbreviated new drug applications (ANDAs), biologic license 
applications (BLAs), and investigational new drug applications (INDs). 
The eStudy Data guidance, when finalized, will implement the electronic 
submission requirements of section 745A(a) of the Federal Food, Drug, 
and Cosmetic Act with respect to standardized study data contained in 
NDA, ANDA, BLA, and IND submissions.
    The Guide integrates and updates the Study Data Specifications and 
the CDER Common Data Standards Issues document and is available on 
FDA's Study Data Standards Resources Web page at http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm. The Guide is 
intended to complement and promote interactions between sponsors and 
FDA review divisions. It is not intended to replace the need for 
sponsors to communicate directly with review divisions regarding data 
standards implementation approaches or issues. The Guide, when 
finalized, will supersede the Study Data Specifications (Versions 1.0-
2.0) and the CDER Study Data Common Issues Document (Versions 1.0-1.1). 
The Guide is organized as follows:
    Section 1: Introduction--provides information on regulatory policy 
and guidance background, purpose, and document control.
    Section 2: Planning and Providing Standardized Study Data--
recommends and provides details on preparing an overall study data 
standardization plan and a study data reviewer's guide.
    Section 3: Exchange Format--Electronic Submissions--presents the 
specifications, considerations, and recommendations for the file 
formats currently supported by FDA.
    Section 4: Study Data Submission Format: Clinical and Non-
Clinical--presents general considerations and specifications for 
sponsors using, for example, the following standards for the submission 
of study data: Clinical Data Interchange Standards Consortium, Study 
Data Tabulation Model, Analysis Data Model, and Standard for Exchange 
of Nonclinical Data.
    Section 5: Therapeutic Area Standards--presents supplemental 
considerations and specific recommendations when sponsors submit study 
data using FDA supported TA standards.
    Section 6: Terminology--presents general considerations and 
specific recommendations when using controlled terminologies/
vocabularies for clinical trial data.
    Section 7: General Electronic Submission Format--provides 
specifications and recommendations on submitting study data using the 
electronic Common Technical Document format.
    Section 8: Data Fitness--provides general recommendations on 
standards compliance, data traceability expectations, legacy data 
conversion, versioning, and data validation rules.

II. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the Guide and the 
Catalog at either http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm or http://www.regulations.gov.

    Dated: January 31, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-02554 Filed 2-5-14; 8:45 am]
BILLING CODE 4160-01-P