2014-02554. Study Data Technical Conformance Guide and Data Standards Catalog; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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 The Study Data Technical Conformance Guide supplements the revised draft guidance for industry “Providing Regulatory Submissions in Electronic Format—Standardized Study Data” and provides specifications, recommendations, and general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, [e-mail]; 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.