[Federal Register Volume 80, Number 7 (Monday, January 12, 2015)]
[Notices]
[Pages 1508-1509]
From the Federal Register Online via the Government Publishing 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, [email protected].
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