[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in this notice finalizes the draft guidance of the same title dated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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