[Federal Register: August 18, 2003 (Volume 68, Number 159)]
[Notices]
[Page 49488-49489]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18au03-118]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D-0349]
Draft Guidance for Reviewers: Instructions and Template for
Chemistry, Manufacturing, and Control Reviewers of Human Somatic Cell
Therapy Investigational New Drug Applications; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft document entitled ``Guidance for Reviewers:
Instructions and Template for Chemistry,
[[Page 49489]]
Manufacturing, and Control (CMC) Reviewers of Human Somatic Cell
Therapy Investigational New Drug Applications (INDs)'' dated August
2003. The draft guidance document, when finalized, will provide
instructions to CMC reviewers of human somatic cell therapies on what
information should be recorded and assessed as part of their review of
an original IND. The draft guidance document, when finalized, will also
provide CMC reviewers the format in the corresponding human somatic
cellular therapy CMC template to prepare their reviews.
DATES: Submit written or electronic comments on the draft guidance by
November 17, 2003, to ensure their adequate consideration in
preparation of the final document. General comments on agency guidance
documents are welcome at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Training, and Manufacturers
Assistance (HFM-40), Center for Biologics Evaluation and Research
(CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville,
MD 20852-1448. Send one self-addressed adhesive label to assist the
office in processing your requests. The draft guidance may also be
obtained by mail by calling the CBER Voice Information System at 1-800-
835-4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.
Submit written comments on the draft guidance to the Division of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://www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Astrid L. Szeto, Center for Biologics
Evaluation and Research (HFM-17), Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852-1448, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft document entitled
``Guidance for Reviewers: Instructions and Template for Chemistry,
Manufacturing, and Control (CMC) Reviewers of Human Somatic Cell
Therapy Investigational New Drug Applications (INDs)'' dated August
2003. The draft guidance document provides instructions and a template
that are intended to be tools to assist CMC reviewers of human somatic
cell therapy INDs. The draft guidance document is intended to help
ensure that all applicable regulatory requirements are reviewed for the
appropriate stage of product development.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will provide instructions to CMC reviewers of human somatic
cell therapies on what information should be recorded and assessed as
part of their review of an original IND. It does not create or confer
any rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirement of the applicable statutes and regulations.
II. Comments
The draft guidance is being distributed for comment purposes only
and is not intended for implementation at this time. Interested persons
may submit to the Division of Dockets Management (see ADDRESSES)
written or electronic comments regarding the draft guidance. Submit
written or electronic comments to ensure adequate consideration in
preparation of the final guidance. 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. A copy of the draft guidance and received comments are
available for public examination in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm
Dated: August 7, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-20950 Filed 8-15-03; 8:45 am]
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