[Federal Register Volume 73, Number 70 (Thursday, April 10, 2008)]
[Notices]
[Pages 19511-19512]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-7585]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0205] (formerly Docket No. 2004D-0465)


Guidance for Food and Drug Administration Reviewers 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 document entitled ``Guidance for FDA Reviewers and 
Sponsors: Content and Review of Chemistry, Manufacturing, and Control 
(CMC) Information for Human Gene Therapy Investigational New Drug 
Applications (INDs),'' dated April 2008. The guidance document provides 
to sponsors recommendations on the CMC information to include in an 
original IND for human gene therapy. In addition, the guidance provides 
instructions to FDA reviewers about the information to record and 
assess as part of the IND review. The guidance document announced in 
this notice finalizes the draft guidance of the same title dated 
November 2004.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of the 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, suite 200N, Rockville, MD 
20852-1448. Send one self-addressed adhesive label to assist the office 
in processing your requests. The guidance may also be obtained by mail 
by calling CBER at 1-800-835-4709 or 301-827-1800. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the guidance 
document.
    Submit written comments on the 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.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Tami Belouin, Center for Biologics 
Evaluation and Research (HFM-17), Food and Drug Administration, 1401 
Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled 
``Guidance for FDA Reviewers and Sponsors: Content and Review of 
Chemistry, Manufacturing, and Control (CMC) Information for Human Gene 
Therapy Investigational New Drug Applications (INDs),'' dated April 
2008. The guidance document provides to sponsors of a human gene 
therapy IND recommendations on the CMC information to include in an 
original IND. In addition, the guidance provides instructions to FDA 
reviewers about the information to record and assess as part of the IND 
review. This guidance will help sponsors and FDA reviewers to assess, 
given the phase of the investigation, whether sufficient information is 
provided to assure the proper identification, quality, purity, and 
potency of the investigational product.
    In the Federal Register of November 9, 2004 (69 FR 64958), FDA 
announced

[[Page 19512]]

the availability of the draft guidance of the same title. FDA received 
several comments on the draft guidance and FDA considered those 
comments when finalizing the guidance. In addition, we revised the 
guidance to clarify its applicability for sponsors. The guidance 
announced in this notice finalizes the draft guidance dated November 
2004.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents FDA'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 
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR 211.100, 211.160, and 211.165(e) 
have been approved under OMB Control No. 0910-0139; 21 CFR 312.23(a) 
and (b), 312.32(c), and Form FDA 1571 have been approved under OMB 
Control No. 0910-0014; and 21 CFR part 1271 has been approved under OMB 
Control No. 0910-0559.

III. Comments

    Interested persons may, at any time, submit to the Division of 
Dockets Management (see ADDRESSES) written or electronic comments 
regarding the 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 
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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA 
through FDMS only.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/cber/guidelines.htm or http://www.regulations.gov.

    Dated: April 2, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-7585 Filed 4-9-08; 8:45 am]
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