[Federal Register Volume 68, Number 159 (Monday, August 18, 2003)]
[Notices]
[Pages 49488-49489]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-20950]


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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Draft Guidance for Reviewers: Instructions and Template for 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 The draft guidance document, when finalized, will provide 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 The draft guidance document, when finalized, will also 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DATES: Submit written or electronic comments on the draft guidance by 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 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 The draft guidance may also be 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electronic access to the draft guidance document.
    Submit written comments on the draft guidance to the Division of 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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