
[Federal Register Volume 80, Number 7 (Monday, January 12, 2015)]
[Notices]
[Pages 1508-1509]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-00206]


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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, Version 2.0 
(Guide), and an update to the Data Standards Catalog (Catalog). The 
Guide supplements the final guidance for industry entitled ``Providing 
Regulatory Submissions in Electronic Format--Standardized Study Data'' 
(eStudy Data guidance) and provides specifications and recommendations 
for, as well as general considerations on, submitting standardized 
study data using FDA-supported data standards specified in the Catalog. 
The Guide is intended to complement and promote interactions between 
sponsors and FDA review divisions.

DATES: Submit either electronic or written comments on these documents 
at any time.

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, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 
2201, Silver Spring, MD 20993-0002. Send one self-addressed adhesive 
label to assist that office in processing your requests.
    Submit electronic comments on the guidance 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. 1192, Silver Spring, MD 20993-0002, 301-
796-5333, ronald.fitzmartin@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of Version 2.0 of the Guide and 
an update to the Catalog. The Guide supplements the final guidance for 
industry entitled ``Providing Regulatory Submissions in Electronic 
Format--Standardized Study Data'' (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 implements the electronic submission 
requirements of section 745A(a) of the Federal Food, Drug, and Cosmetic 
Act (which was added by section 1136 of the Food and Drug 
Administration Safety and Innovation Act (Pub. L. 112-144)) for 
standardized study data contained in NDA, ANDA, BLA, and IND 
submissions.
    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 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, a study data reviewer's guide, and an analysis 
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 
Nonclinical''--presents general considerations and specifications for 
sponsors using, for example, the following standards for the submission 
of study data: Study Data Tabulation Model (SDTM), Analysis Data Model 
(ADaM), and Standard for Exchange of Nonclinical Data (SEND).
    Section 5: ``Therapeutic Area Standards''--presents supplemental 
considerations and specific recommendations when sponsors submit study 
data using FDA-supported therapeutic area standards.
    Section 6: ``Terminology''--presents general considerations and 
specific recommendations when using controlled terminologies/
vocabularies for clinical trial data.
    Section 7: ``Electronic Submission Format''--provides 
specifications and recommendations on submitting study data using the 
electronic Common Technical Document format.
    Section 8: ``Data Validation and Traceability''--provides general 
recommendations on conformance to standards, data validation rules, 
data traceability expectations, and legacy data conversion.
    In the Federal Register of February 6, 2014 (79 FR 7201), FDA 
announced the availability of Version 1.0 of the Study Data Technical 
Conformance Guide. The comment period on the Guide ended on May 7, 
2014. We reviewed all comments received and revised it accordingly. 
Updates to Version 2.0 include, but are not limited to:
    Section 2: Added a subsection to include an Analysis Data 
Reviewer's Guide.
    Section 3: Clarified dataset sizes, column lengths, special 
characters for variables, and datasets.
    Section 4: Clarified general considerations and domain 
specifications for SDTM and ADaM.
    Section 6: Clarified a number of subsections, including controlled 
terminology, medications, pharmacologic class, and indication, and 
added a World Health Organization Drug Dictionary.

[[Page 1509]]

    Section 7: Clarified the electronic submission format and the 
folder structure for study datasets.
    Section 8: Renamed the section ``Data Validation and Traceability'' 
from ``Data Fitness'' and clarified several of the subsections, 
including Traceability Issues and Legacy Data Conversion.

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 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-00206 Filed 1-9-15; 8:45 am]
BILLING CODE 4164-01-P


