FR Doc 04-28579 Nonclinical and Clinical Datasets; Notice of Pilot Project; FDA

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[Federal Register: December 30, 2004 (Volume 69, Number 250)]
[Notices]
[Page 78468-78469]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30de04-85]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0545]

Nonclinical and Clinical 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 Biologics
Evaluation and Research (CBER), 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 and
human data submitted to FDA by applicants of biologics license
applications (BLAs). These analysis tools will allow a reviewer to more
efficiently capture and evaluate nonclinical and clinical datasets
submitted in electronic format.

DATES: Submit written requests to participate in the pilot project by
February 28, 2005. 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 Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic comments 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: Richard Diamond, Center for Biologics
Evaluation and Research (HFM-6), Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-0372.

SUPPLEMENTARY INFORMATION:

I. Background

Under current FDA regulations (21 CFR 601.2), applicants must
provide nonclinical and clinical data in BLAs. CBER provided
recommendations for the electronic submission of BLAs, as well as new
drug applications (NDAs), in the ``Guidance for Industry: Providing
Regulatory Submissions to the Center for Biologics Evaluation and
Research (CBER) in Electronic Format--Biologics Marketing
Applications'' dated November 1999. A joint CBER and Center for Drug
Evaluation and Research (CDER) document entitled ``Guidance for
Industry: Providing Regulatory Submissions in Electronic Format--
General Considerations'' dated January 1999 provided recommendations
for the file formats for nonclinical and clinical datasets.
FDA announced on July 21, 2004, a standard format, called the Study
Data Tabulation Model (SDTM) developed by the Clinical Data Interchange
Standards Consortium (CDISC), that sponsors of human drug clinical
trials can use to submit data to the agency. It is expected that this
step will lead to greater efficiencies in clinical research and FDA
reviews of NDAs and BLAs. CDISC is an open, multidisciplinary,
nonprofit organization including members from pharmaceutical companies,
biotechnology companies, contract research organizations, and software
vendors. CDISC committed to the development of industry standards to
support the electronic acquisition, exchange, submission and archiving
of clinical trials data and metadata for medical and biopharmaceutical
product development. CDISC is currently facilitating the work on
similar standards for nonclinical and clinical datasets. Where
possible, the standards developed for clinical datasets and metadata
should be used in the development of standardized

[[Page 78469]]

presentations of the datasets for routine toxicology studies (e.g.,
chronic toxicology and carcinogenicity studies). Version 3.1 (V3.1) of
the CDISC Submission Data Domain Standards was officially released on
June 25, 2004. These standards and the accompanying Implementation
Guide can be viewed on the CDISC Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cdisc.org.\1\

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\1\FDA has verified the Web site address, but is not responsible
for subsequent changes to the Web site after this document publishes
in the Federal Register.
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FDA has performed some initial pilot testing of nonclinical and
clinical data applicable to drugs. The purpose of this pilot project is
to evaluate the Version 3.1 of the CDISC SDTM and the Implementation
Guide to determine applicability to clinical and nonclinical data
required for submission of CBER regulated BLAs, to help in the
refinement of analysis tools designed to facilitate the review and
evaluation of electronic nonclinical and clinical datasets, and to
obtain feedback from reviewers and pharmaceutical companies on the
creation and use of standardized nonclinical and clinical data and
metadata in a format that is applicable to BLA submissions.

II. Pilot Project Description

This pilot project is part of an effort to improve the process for
submitting nonclinical and clinical data. Eventually, FDA expects to
recommend detailed data standards for the submission of nonclinical and
clinical 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 and clinical 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 and clinical datasets to FDA
and having demonstrated familiarity with our recommendations for
creating nonclinical and clinical datasets as presented in the
``Guidance for Industry: Providing Regulatory Submissions to the Center
for Biologics Evaluation and Research (CBER) in Electronic Format--
Biologics Marketing Applications.'' During the pilot project, specific
technical instructions for providing the nonclinical and clinical data
for testing will be made available to pilot participants. Participants
in the pilot project will be asked to provide nonclinical and clinical
datasets as described in the technical instructions and to provide
technical feedback.

B. Scope

Existing requirements for the submission of CBER nonclinical and
clinical 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 and clinical electronic datasets.

C. How to Participate

Written requests to volunteer should be submitted to the Division
of Dockets Management (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 Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this pilot
project. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may 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 electronic filing and
when drafting a guidance document for submitting CBER nonclinical and
clinical study data as electronic datasets. Received comments may be
seen in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.

Dated: December 16, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-28579 Filed 12-29-04; 8:45 am]

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