[Federal Register Volume 68, Number 17 (Monday, January 27, 2003)]
[Notices]
[Pages 3885-3886]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-1743]


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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, [email protected].

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