[Federal Register Volume 69, Number 216 (Tuesday, November 9, 2004)]
[Notices]
[Pages 64958-64959]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-24879]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0465]


Draft Guidance for Food and Drug Administration Review Staff and 
Sponsors: Content and Review of Chemistry, Manufacturing, and Control 
Information for Human Gene 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 FDA Review 
Staff and Sponsors: Content and Review of Chemistry, Manufacturing, and 
Control (CMC) Information for Human Gene Therapy Investigational New 
Drug Applications (INDs)'' dated November 2004. The draft guidance 
document, when finalized, is intended to provide guidance to FDA review 
staff and sponsors of human gene therapy products on IND submissions, 
and on the information FDA CMC reviewers record and assess as part of 
the review of an original IND.

DATES: Submit written or electronic comments on the draft guidance by 
February 7, 2005, 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 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, suite 200N, 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 The draft guidance may 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section for electronic access to the draft guidance document.
    Submit written comments on the draft guidance to the Division of 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: Nathaniel L. Geary, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, suite 200N, 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 FDA Review Staff and Sponsors: Content and Review of 
Chemistry, Manufacturing, and Control (CMC) Information for Human Gene 
Therapy Investigational New Drug Applications (INDs)'' dated November, 
2004. The document provides guidance to help sponsors and reviewers to 
assess, given the phase of the investigation, whether an IND provides 
sufficient information to allow the reviewer to evaluate the proper 
identification (identity testing), quality, purity, and strength 
(potency) of the investigational product (21 CFR 312.23(a)(7)(i)). The 
draft guidance document is intended to help ensure that all applicable 
regulatory requirements are reviewed for the appropriate stage of 
product development.
    The draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on this topic. 
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 document 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 individuals may submit one paper copy. Comments are to be 
identified with the docket number found in the 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 document at 
either http:/

[[Page 64959]]

/www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: November 1, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-24879 Filed 11-8-04; 8:45 am]
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