[Federal Register: November 9, 2004 (Volume 69, Number 216)]
[Notices]
[Page 64958-64959]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09no04-73]
-----------------------------------------------------------------------
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Draft Guidance for Food and Drug Administration Review Staff and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.
-----------------------------------------------------------------------
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 The draft guidance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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Training, and Manufacturers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 The draft guidance may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section for electronic access to the draft guidance document.
Submit written comments on the draft guidance to the Division of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
[[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]
BILLING CODE 4160-01-S