[Federal Register: May 16, 2006 (Volume 71, Number 94)]
[Notices]
[Page 28353-28354]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16my06-92]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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,
norman.schmuff@fda.hhs.gov or Norman Gregory, Food and Drug
Administration, Center for Veterinary Medicine (HFV-143), Rockville, MD
20857, norman.gregory@fda.hhs.gov.
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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