Appendix C

Appendix C
60-Day Federal Register Notice

7746

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

rwilkins on PROD1PC63 with NOTICES

ANNUAL BURDEN ESTIMATES
Instrument

Number of
respondents

Number of
responses per
respondent

Average burden
hours per
response

Total annual
burden hours

Intervention Strategy Assessment Guide ........................................

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)

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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]
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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.

PO 00000

Frm 00052

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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

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