[Federal Register Volume 73, Number 70 (Thursday, April 10, 2008)]
[Notices]
[Pages 19512-19513]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-7588]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0206] (formerly Docket No. 2003D-0349)


Guidance for Food and Drug Administration Reviewers and Sponsors: 
Content and Review of Chemistry, Manufacturing, and Control Information 
for 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 document entitled ``Guidance for FDA Reviewers and 
Sponsors: Content and Review of Chemistry, Manufacturing, and Control 
(CMC) Information for Human Somatic Cell 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 somatic cell therapy. In addition, the 
guidance provides instructions to FDA reviewers about information to 
record and assess as part of the IND review. The guidance announced in 
this notice finalizes the draft guidance entitled ``Guidance for 
Reviewers: Instructions and Template for Chemistry, Manufacturing, and 
Control Reviewers of Human Somatic Cell Therapy Investigational New 
Drug Applications'' dated August 2003.

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 
Somatic Cell Therapy Investigational New Drug Applications (INDs),'' 
dated April 2008. The guidance document provides to sponsors of a human 
somatic cell therapy IND recommendations on the CMC information to 
include in an original IND. In addition, the guidance provides 
instructions to FDA reviewers about 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 August 18, 2003 (68 FR 49488), FDA 
announced the availability of the draft guidance entitled ``Draft 
Guidance for Reviewers: Instructions and Template for Chemistry, 
Manufacturing, and Control Reviewers of Human Somatic Cell Therapy 
Investigational New Drug Applications'' dated August 2003. 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 August 
2003.
    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

[[Page 19513]]

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. E8-7588 Filed 4-9-08; 8:45 am]
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