Notice: Draft Guidance for Industry: Potency Tests for Cellular and Gene 
Therapy Products; Availability

Federal Register: October 9, 2008 (Volume 73, Number 197)         
                  Page 59635-59636

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 Industry: 
Potency Tests for Cellular and Gene Therapy Products'' dated October 
2008. The draft guidance document provides manufacturers of cellular 
and gene therapy (CGT) products with recommendations for developing 
tests to measure potency. The recommendations are intended to clarify 
the potency information needed to support an Investigational New Drug 
Application (IND) or a Biologics License Application (BLA).

DATES:  Although you can comment on any guidance at any time (see 21 
CFR 10.115(g)(5)), to ensure that the agency considers your comment on 
this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by January 7, 2009.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 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, suite 200N, 
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 The draft guidance may 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 CBER 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to the draft guidance document.
    Submit written comments on the draft guidance to the Division of 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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 draft document entitled 
``Guidance for Industry: Potency Tests for Cellular and Gene Therapy 
Products'' dated October 2008. The draft guidance document provides 
manufacturers of CGT products with recommendations for developing tests 
to measure potency. The recommendations are intended to clarify the 
potency information needed to support an IND or a BLA. Because potency 
measurements are designed specifically for a particular product, the 
guidance does not make recommendations regarding specific types of 
potency assays, nor does it propose criteria for product release.
    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 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 requirement of the applicable statutes 
and regulations.

II. Paperwork Reduction Act of 1995

    The draft 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 part 211 has been approved under 
0910-0139, expiration date September 20, 2008; the collections of 
information in 21 CFR part 312 has been approved under 0910-0014, 
expiration date May 31, 2009; the collections of information in 21 CFR 
part 601 has been approved under 0910-0338, expiration date June 30, 
2010.

III. Comments

    The draft guidance is being distributed for comment purposes only 
and is not intended for implementation

[[Page 59636]]

at this time. Interested persons may submit to the Division of Dockets 
Management (see ADDRESSES) written or electronic comments regarding the 
draft 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 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.
    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 only 
through FDMS at 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov. 

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/guidelines.htm 
or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov. 

    Dated: October 1, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-24052 Filed 10-8-08; 8:45 am]

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