[Federal Register Volume 71, Number 94 (Tuesday, May 16, 2006)]
[Notices]
[Pages 28353-28354]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-7391]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0181]


Product Stability Data; Notice of Pilot Project

AGENCY: Food and Drug Administration, HHS

ACTION: Notice.

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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, 
[email protected] or Norman Gregory, Food and Drug 
Administration, Center for Veterinary Medicine (HFV-143), Rockville, MD 
20857, [email protected].

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

[[Page 28354]]

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.
[FR Doc. E6-7391 Filed 5-15-06; 8:45 am]
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