Draft Guidance for Industry: Validation of Growth-Based Rapid Microbiological Methods for Sterility Testing of Cellular and Gene Therapy Products; Availability, 7746-7747 [E8-2398]
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Federal Register / Vol. 73, No. 28 / Monday, February 11, 2008 / Notices
issued photo identification (i.e., driver’s
license) and should arrive 45 minutes
prior to the start of the meeting to clear
through security. Security will provide
registered attendees badges that must be
worn at all times and returned to
security prior to exiting the Hubert
Humphrey Building.
Registration questions may be
directed to Experient at
PAguidelines@experient-inc.com (email), (703) 525–8333 x3346 (phone) or
(703) 525–8557 (fax).
Dated: February 5, 2008.
Penelope Slade Royall,
RADM, USPHS, Deputy Assistant Secretary
for Health, Office of Disease Prevention and
Health Promotion.
[FR Doc. E8–2453 Filed 2–8–08; 8:45 am]
BILLING CODE 4150–32–P
major goals of the project include
increasing the empirical knowledge
about the effectiveness of a variety of
programs for low-income families to
sustain employment and advance to
positions that enable self-sufficiency, as
well as producing useful findings for
both policymakers and program
administrators.
This proposed information collection
activity focuses on identifying
promising strategies to be tested as part
of the study. Through semi-structured
discussions, respondents will be asked
to comment on the most important
strategies and interventions for potential
evaluation.
Respondents: Semi-structured
discussions will be held with
administrators or staff of State agencies,
local agencies, and programs with
responsibility for employment-related
services or activities for welfare and
other low-income families; researchers
in the field of welfare policy, poverty,
economic self-sufficiency, and low-wage
labor markets; and policymakers at
various levels of government.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Title: Innovative Strategies for
Increasing Self-Sufficiency (ISIS)—
Intervention Strategy Assessment Guide.
OMB No.: New Collection.
Description: The Administration for
Children and Families (ACF), U.S.
Department of Health and Human
Services (HHS), is proposing a data
collection activity as part of the
Innovative Strategies for Increasing SelfSufficiency (ISIS) demonstration and
evaluation. The ISIS project will test a
range of promising strategies to promote
employment, self-sufficiency, and
reduce dependence on cash welfare.
The ISIS project will evaluate multiple
employment-focused strategies that
build on previous approaches and are
adapted to the current Federal, State,
and local policy environment. The
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average burden
hours per
response
Total annual
burden hours
Intervention Strategy Assessment Guide ........................................
rwilkins on PROD1PC63 with NOTICES
Instrument
400
1
.5
200
Estimated Total Annual Burden
Hours: 200.
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration for
Children and Families, Office of
Administration, Office of Information
Services, 370 L’Enfant Promenade, SW.,
Washington, DC 20447, Attn: ACF
Reports Clearance Officer. E-mail
address: infocollection@acf.hhs.gov. All
requests should be identified by the title
of the information collection.
The Department specifically requests
comments on (a) whether the proposed
collection of information is necessary
for the paper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
VerDate Aug<31>2005
16:44 Feb 08, 2008
Jkt 214001
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: February 6, 2008.
Brendan C. Kelly,
Reports Clearance Officer.
[FR Doc. 08–599 Filed 2–8–08; 8:45 am]
BILLING CODE 4184–01–M
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.
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
ACTION:
Notice.
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
E:\FR\FM\11FEN1.SGM
11FEN1
Federal Register / Vol. 73, No. 28 / Monday, February 11, 2008 / Notices
rwilkins on PROD1PC63 with NOTICES
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 https://
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 § 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. Growthbased RMMs, like traditional methods of
detecting viable microorganisms as
described in § 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
VerDate Aug<31>2005
16:44 Feb 08, 2008
Jkt 214001
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, viabilitybased, 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.
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
7747
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
https://www.fda.gov/cber/guidelines.htm
or https://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]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Hemoglobin Based Oxygen Carriers:
Current Status and Future Directions;
Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled: Hemoglobin Based Oxygen
Carriers: Current Status and Future
Directions. The purpose of the public
workshop is to discuss the safety of
hemoglobin-based oxygen carriers
(HBOCs) as related to a variety of
potential uses of these investigational
products. We are having this discussion
because clinical and nonclinical studies
of HBOCs, as either blood substitutes or
as resuscitation fluids, have raised
questions about the safety of these
products as a group. The public
workshop will feature presentations and
roundtable discussions led by experts
from academic institutions, government,
and industry.
Date and Time: The public workshop
will be held on April 29, 2008, from
8:30 a.m. to 5 p.m. and April 30, 2008,
from 8:30 a.m. to 5 p.m.
Location: The public workshop will
be held at the Lister Hill Center
Auditorium, Building 38A, National
Institutes of Health, 8800 Rockville
Pike, Bethesda, MD 20894.
Contact Person: Rhonda Dawson,
Center for Biologics Evaluation and
Research (HFM–302), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448,
301–827–6129, FAX: 301–827–2843, email: rhonda.dawson@fda.hhs.gov.
Registration: Mail or fax your
registration information (including
name, title, firm name, address, and
telephone and fax numbers) to the
contact person by April 11, 2008. There
E:\FR\FM\11FEN1.SGM
11FEN1
]]>Agencies
[Federal Register Volume 73, Number 28 (Monday, February 11, 2008)]
[Notices]
[Pages 7746-7747]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-2398]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 https://www.fda.gov/cber/guidelines.htm or https://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]
BILLING CODE 4160-01-S
