[Federal Register Volume 73, Number 28 (Monday, February 11, 2008)]
[Notices]
[Pages 7746-7747]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-2398]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0055]


Draft Guidance for Industry: Validation of Growth-Based Rapid 
Microbiological Methods for Sterility Testing of 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 draft document entitled ``Guidance for Industry: 
Validation of Growth-Based Rapid Microbiological Methods for Sterility 
Testing of Cellular and Gene Therapy Products,'' dated February 2008. 
The draft guidance document provides manufacturers of cellular and gene 
therapy products with recommendations on the validation of growth-based 
Rapid Microbiological Methods (RMMs) for sterility testing of their 
products. This draft guidance addresses considerations for method 
validation and determining equivalence of an RMM to sterility assays. 
This draft guidance applies to somatic cellular therapy and gene 
therapy products.

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this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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 May 12, 2008.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the

[[Page 7747]]

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 The draft guidance may also be obtained by 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SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.
    Submit written comments on the draft guidance to the Division of 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: Paul E. Levine, Jr. 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: Validation of Growth-Based Rapid 
Microbiological Methods for Sterility Testing of Cellular and Gene 
Therapy Products,'' dated February 2008. This draft guidance applies to 
somatic cellular therapy and gene therapy products. This draft guidance 
does not apply directly to human cells, tissues, and cellular and 
tissue products (HCT/Ps) which are regulated solely under section 361 
of the Public Health Service Act as described under 21 CFR 1271.10, or 
HCT/Ps which are regulated as medical devices under 21 CFR part 820. 
Such products are not subject to the sterility testing provision in 
Sec.  610.12 (21 CFR 610.12), or to the requirement in 21 CFR 610.9 to 
demonstrate that an alternative RMM is equivalent to the sterility 
method specified in the regulations. However, HCT/P and device 
establishments seeking to validate an RMM may find these 
recommendations useful.
    The principles of RMM validation described in this draft guidance 
apply only to growth-based RMMs. Growth-based RMMs, like traditional 
methods of detecting viable microorganisms as described in Sec.  
610.12, rely on the ability to recover and detect organisms from the 
product and demonstrate their viability by multiplication in liquid 
media. The specific recommendations in this document may not be 
applicable for non-growth-based RMMs which detect microbiological 
surrogates. This draft guidance focuses on RMMs with qualitative 
results (i.e., detection of microorganisms). If the RMM does not have 
the capability to speciate microorganisms, an additional method for 
speciation will be needed for investigation of detected contaminants. 
Early discussions with product review staff at CBER are encouraged for 
individuals intending to use or develop an RMM at any time in the 
product lifecycle using growth-based, viability-based, surrogate-based, 
or RMMs that provide quantitative results.
    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

    This 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 to which this draft guidance refers are 
covered by 21 CFR parts 601 (on BLAs) and 312 (on INDs), and were 
approved under OMB Control No. 0910-0338 and 0910-0014, respectively.

III. Comments

    The draft guidance is being distributed for comment purposes only 
and is not intended for implementation 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 Web site transitioned 
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will 
be accepted by FDA through FDMS only.

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.fda.gov/ohrms/dockets/default.htm.

    Dated: January 29, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-2398 Filed 2-8-08; 8:45 am]
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