E6-7391. Product Stability Data; Notice of Pilot Project

AGENCY:

Food and Drug Administration, HHS

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is seeking volunteers to participate in a pilot project involving the testing of a Health Level 7 (HL7) data interchange standard for the submission of product stability data to FDA to facilitate the review of this data. Using the data interchange standards and the analytical tools will allow consistent data presentation to the agency and allow a reviewer to more efficiently and consistently display and evaluate product stability data submitted in electronic format.

DATES:

Submit written or electronic requests to participate in the pilot project by July 17, 2006. Comments on this pilot project can be submitted at any time.

ADDRESSES:

Submit written requests to participate to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic requests to http://www.fda.gov/​dockets/​ecomments.

FOR FURTHER INFORMATION CONTACT:

Norman Schmuff, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 22, rm. 2472,Silver Spring, MD 20993-0002, [e-mail] or Norman Gregory, Food and Drug Administration, Center for Veterinary Medicine (HFV-143), Rockville, MD 20857, [e-mail].

SUPPLEMENTARY INFORMATION:

I . Background

Applicants provide product stability information in marketing applications and other submissions to the various centers of FDA. This information is currently provided in paper documents or as a series of portable document format (PDF) files. In January 2001, a format for presenting product stability data in extensible markup language (XML) and a prototype of a review tool for evaluating stability information were demonstrated at an FDA public meeting.

Subsequently, work has been underway in the Regulated Clinical Research Information Management technical committee in HL7 to refine the data design presented at the meeting with the goal of developing an XML standard for the exchange of product stability data based on the HL7 version 3 reference information model. HL7 is an international, open, American National Standards Institute (ANSI) accredited standards development organization that focuses on standards for the exchange of information related to health care. The Stability Data Standard was adopted by HL7 by a vote of the full membership in May 2005 and was adopted as an ANSI standard in October 2005. FDA is currently considering the adoption of the standard as a voluntary standard for transmission of stability data in new drug applications, abbreviated new drug applications, investigational new drugs, new animal drug applications, abbreviated new animal drug applications, and investigational new animal drugs.

The purpose of this pilot project is to assist in the evaluation of the data interchange standard, provide data for testing the analytical tools designed to facilitate the review of product stability data and to obtain feedback from reviewers and pharmaceutical companies on the creation and use of standardized product stability data.

II. Pilot Project Description

This pilot project is part of an effort to improve the process for submitting and reviewing product stability data by increasing the consistency of the process (by establishing a uniform procedure). A consistent look and feel is expected to facilitate the review of this data. Eventually, there is the expectation that a detailed data interchange standard for the submission of product stability data will be defined based on the HL7 model. As the HL7 model was developed via a collaboration between industry and FDA, certain portions of the model may be useful for industry, but not needed in submissions to FDA. Consequently, the HL7 stability model may be adopted in whole or in part. Participants in this pilot project will have the opportunity not only to assist FDA in testing the stability data interchange standard, but will also be able to familiarize themselves with the process at an early stage of development. Only a few participants are needed for this pilot.

1. Initial Approach

Because a limited number of voluntary participants are needed, the agency will use its discretion in choosing volunteers, basing this selection on a firm's experience with the preparation of product stability documents and data submissions to the different centers at FDA. During the pilot project specific technical instructions for providing the product stability data for testing will be made available to participants. Participants in the pilot project will be asked to provide the product stability data as described in the technical instructions and to provide technical feedback.

2. Scope

Existing expectations for the submission of product stability data will not be waived, suspended, or modified for purposes of this pilot project. However, aside from metadata associated with the XML instance, there will be no additional data expectations beyond those data usually submitted in applications. The pilot project will test the preparation and use of the submitted product stability data.

3. How to Participate and Submit Comments

Written and electronic requests to volunteer should be submitted to the docket number found in the heading of this document. In addition to requests to participate, interested persons can submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this pilot project. Two paper copies of any comments are to be submitted, except that individuals can submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. We will consider all received comments in making a determination on adopting the data interchange standard as a voluntary standard for the electronic submission of product stability data.

Dated: May 8, 2006.

Jefrey Shuren,

Assistant Commissioner for Policy.