[Federal Register Volume 76, Number 32 (Wednesday, February 16, 2011)]
[Notices]
[Page 9028]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-3462]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Guidance for Industry: Potency Tests for Cellular and Gene 
Therapy Products; 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 Industry: Potency 
Tests for Cellular and Gene Therapy Products'' dated January 2011. The 
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 that could support an investigational new drug application 
(IND) or a biologics license application (BLA). The guidance announced 
in this notice finalizes the draft guidance of the same title dated 
October 2008.

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

ADDRESSES: Submit written requests for single copies of the guidance to 
the Office of Communication, Outreach and Development (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 electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

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 Industry: Potency Tests for Cellular and Gene Therapy 
Products'' dated January 2011. The guidance document provides 
manufacturers of cellular and gene therapy 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 acceptance criteria for product release.
    In the Federal Register of October 9, 2008 (73 FR 59635), FDA 
announced the availability of the draft guidance of the same title. FDA 
received several comments on the draft guidance and those comments were 
considered as the guidance was finalized. A summary of changes includes 
the addition of text related to adjuvant testing and modification of 
assay parameters for validation studies. In addition, editorial and 
formatting changes were made to improve clarity. The guidance announced 
in this notice finalizes the draft guidance dated October 2008.
    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 part 211 has been approved under 
0910-0139; the collections of information in 21 CFR part 312 has been 
approved under 0910-0014; the collections of information in 21 CFR part 
601 has been approved under 0910-0338.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: February 10, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-3462 Filed 2-15-11; 8:45 am]
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