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###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. FDA-2008-D-0520]

# 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 The draft guidance document provides manufacturers of cellular and gene therapy (CGT) products with recommendations for developing tests to measure potency.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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by January 7, 2009.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                         Submit written requests for single copies of the draft guidance to the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug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 The draft guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800.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the                         **SUPPLEMENTARY INFORMATION**                         section for electronic access to the draft guidance document.                    

                        Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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://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                           ( print 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://www.regulations.gov*.                

## IV. Electronic Access

                    Persons with access to the Internet may obtain the draft guidance at either                     *http://www.fda.gov/​cber/​guidelines.htm*                     or                     *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

BILLING CODE 4160-01-S