[Federal Register: January 27, 2003 (Volume 68, Number 17)]
[Notices]
[Page 3885-3886]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27ja03-79]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 02N-0532]
Nonclinical Datasets; Notice of Pilot Project
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA), Center for Drug
[[Page 3886]]
Evaluation and Research (CDER), is seeking volunteers to participate in
a pilot project involving the evaluation of various analysis tools to
facilitate the use of electronic datasets for analysis of animal data
submitted to FDA by applicants of new drug applications (NDAs). These
analysis tools will allow a reviewer to more efficiently display and
evaluate nonclinical datasets submitted in electronic format.
DATES: Submit written requests to participate in the pilot project by
March 28, 2003. Comments on this pilot project may be submitted at any
time.
ADDRESSES: Submit written requests to participate and comments
regarding the pilot project to the Dockets Management Branch (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments
.
FOR FURTHER INFORMATION CONTACT: Randy Levin, Center for Drug
Evaluation and Research (HFD-001), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-5411, levinr@cder.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Under current FDA regulations (21 CFR 314.50), applicants must
provide nonclinical data in NDAs. In January 1999, the agency published
guidance describing how applicants could provide nonclinical data in
the form of electronic datasets. In the guidance for industry entitled
``Providing Regulatory Submissions in Electronic Format--NDAs,'' FDA
provided recommendations on how to organize the datasets and how to
provide descriptive information on the datasets and the data variables
(metadata). The Center for Biologics Evaluation and Research (CBER) has
provided similar recommendations for biologics license applications
(BLAs) in their guidance entitled ``Providing Regulatory Submissions in
Electronic Format--BLAs.'' A joint CBER and CDER guidance for industry
entitled ``Providing Regulatory Submissions in Electronic Format--
General Considerations,'' which published in January 1999, provided
recommendations for the file formats for nonclinical datasets.
Recently, FDA received recommendations for a standard presentation
of certain clinical data from the Clinical Data Interchange Standards
Consortium, Inc. (CDISC), a nonprofit organization including members
from pharmaceutical companies, biotechnology companies, contract
research organizations, and software vendors. CDISC is currently
facilitating the work on similar standards for nonclinical datasets.
Where possible, the standards developed for clinical datasets and
metadata should be used in the development of standardized
presentations of the datasets for routine toxicology studies (e.g.,
chronic toxicology and carcinogenicity studies).
In addition, CDER has entered into a cooperative research and
development agreement with PharmQuest Corp. for the development of
analysis tools by which to evaluate the nonclinical datasets prepared
using defined standards. The use of these standardized datasets will
reduce the amount of effort required of the reviewer to evaluate
nonclinical data.
The purpose of the pilot project is to help in the development of
analysis tools designed to facilitate the review and evaluation of
electronic nonclinical datasets and to obtain feedback from reviewers
and pharmaceutical companies on the creation and use of standardized
nonclinical data and metadata.
II. Pilot Project Description
This pilot project is part of an effort to improve the process for
submitting nonclinical data. Eventually, FDA expects to recommend
detailed data standards for the submission of nonclinical data.
Participants in this pilot project will have the opportunity not only
to assist the agency in testing the use of various analysis tools and
standardized nonclinical data and metadata, but would also be able to
familiarize themselves with the process at an early stage of
development. Only a few participants are needed for this pilot.
A. Initial Approach
Because a limited group of voluntary participants are needed, the
agency will use its discretion in choosing volunteers, based on their
having previously submitted nonclinical datasets to FDA and having
demonstrated familiarity with our recommendations for creating
nonclinical datasets as presented in the guidance for industry entitled
``Providing Regulatory Submissions in Electronic Format--NDAs.'' During
the pilot project, specific technical instructions for providing the
nonclinical data for testing will be made available to pilot
participants. Participants in the pilot project will be asked to
provide nonclinical datasets as described in the technical instructions
and to provide technical feedback.
B. Scope
Existing requirements for the submission of nonclinical data will
not be waived, suspended, or modified for purposes of this pilot
project. The pilot project will test the preparation and use of the
submitted nonclinical electronic datasets.
C. How to Participate
Written requests to volunteer should be submitted to the Dockets
Management Branch (see ADDRESSES). Requests are to be identified with
the docket number found in brackets in the heading of this document.
III. Comments
Interested persons may submit to the Dockets Management Branch (see
ADDRESSES) written or electronic comments regarding this pilot project.
Submit a single copy of electronic comments to http://www.fda.gov/dockets/ecomments
or two hard copies of any written comments, except
that individuals may submit one hard 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 electronic filing and when drafting a guidance
document for submitting nonclinical study data as electronic datasets.
Received comments may be seen in the Dockets Management Branch between
9 a.m. and 4 p.m., Monday through Friday.
Dated: January 15, 2003.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 03-1743 Filed 1-24-03; 8:45 am]
BILLING CODE 4160-01-S