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7746 Federal Register / Vol. 73, No.

28 / Monday, February 11, 2008 / Notices

issued photo identification (i.e., driver’s DEPARTMENT OF HEALTH AND major goals of the project include
license) and should arrive 45 minutes HUMAN SERVICES increasing the empirical knowledge
prior to the start of the meeting to clear about the effectiveness of a variety of
through security. Security will provide Administration for Children and programs for low-income families to
registered attendees badges that must be Families sustain employment and advance to
worn at all times and returned to positions that enable self-sufficiency, as
Proposed Information Collection well as producing useful findings for
security prior to exiting the Hubert Activity; Comment Request
Humphrey Building. both policymakers and program
Title: Innovative Strategies for administrators.
Registration questions may be This proposed information collection
Increasing Self-Sufficiency (ISIS)—
directed to Experient at activity focuses on identifying
Intervention Strategy Assessment Guide.
PAguidelines@experient-inc.com (e- OMB No.: New Collection. promising strategies to be tested as part
mail), (703) 525–8333 x3346 (phone) or Description: The Administration for of the study. Through semi-structured
(703) 525–8557 (fax). Children and Families (ACF), U.S. discussions, respondents will be asked
Dated: February 5, 2008. Department of Health and Human to comment on the most important
Penelope Slade Royall, Services (HHS), is proposing a data strategies and interventions for potential
collection activity as part of the evaluation.
RADM, USPHS, Deputy Assistant Secretary
for Health, Office of Disease Prevention and
Innovative Strategies for Increasing Self- Respondents: Semi-structured
Health Promotion. Sufficiency (ISIS) demonstration and discussions will be held with
evaluation. The ISIS project will test a administrators or staff of State agencies,
[FR Doc. E8–2453 Filed 2–8–08; 8:45 am]
range of promising strategies to promote local agencies, and programs with
BILLING CODE 4150–32–P
employment, self-sufficiency, and responsibility for employment-related
reduce dependence on cash welfare. services or activities for welfare and
The ISIS project will evaluate multiple other low-income families; researchers
employment-focused strategies that in the field of welfare policy, poverty,
build on previous approaches and are economic self-sufficiency, and low-wage
adapted to the current Federal, State, labor markets; and policymakers at
and local policy environment. The various levels of government.

ANNUAL BURDEN ESTIMATES


Number of Average burden
Number of Total annual
Instrument responses per hours per
respondents burden hours
respondent response

Intervention Strategy Assessment Guide ........................................ 400 1 .5 200

Estimated Total Annual Burden the quality, utility, and clarity of the ACTION: Notice.
Hours: 200. information to be collected; and (d)
In compliance with the requirements ways to minimize the burden of the SUMMARY: The Food and Drug
of Section 3506(c)(2)(A) of the collection of information on Administration (FDA) is announcing the
Paperwork Reduction Act of 1995, the respondents, including through the use availability of a draft document entitled
Administration for Children and of automated collection techniques or ‘‘Guidance for Industry: Validation of
Families is soliciting public comment other forms of information technology. Growth-Based Rapid Microbiological
on the specific aspects of the Consideration will be given to Methods for Sterility Testing of Cellular
information collection described above. comments and suggestions submitted and Gene Therapy Products,’’ dated
Copies of the proposed collection of within 60 days of this publication. February 2008. The draft guidance
information can be obtained and document provides manufacturers of
Dated: February 6, 2008.
comments may be forwarded by writing cellular and gene therapy products with
Brendan C. Kelly, recommendations on the validation of
to the Administration for Children and Reports Clearance Officer.
Families, Office of Administration for growth-based Rapid Microbiological
[FR Doc. 08–599 Filed 2–8–08; 8:45 am] Methods (RMMs) for sterility testing of
Children and Families, Office of
Administration, Office of Information BILLING CODE 4184–01–M their products. This draft guidance
Services, 370 L’Enfant Promenade, SW., addresses considerations for method
Washington, DC 20447, Attn: ACF validation and determining equivalence
DEPARTMENT OF HEALTH AND of an RMM to sterility assays. This draft
Reports Clearance Officer. E-mail HUMAN SERVICES
address: infocollection@acf.hhs.gov. All guidance applies to somatic cellular
requests should be identified by the title therapy and gene therapy products.
Food and Drug Administration
of the information collection. DATES: Although you can comment on
The Department specifically requests [Docket No. FDA–2008–D–0055] any guidance at any time (see 21 CFR
comments on (a) whether the proposed 10.115 (g)(5)), to ensure that the agency
Draft Guidance for Industry: Validation considers your comment on this draft
collection of information is necessary
of Growth-Based Rapid guidance before it begins work on the
for the paper performance of the
rwilkins on PROD1PC63 with NOTICES

Microbiological Methods for Sterility final version of the guidance, submit


functions of the agency, including
Testing of Cellular and Gene Therapy written or electronic comments on the
whether the information shall have
Products; Availability draft guidance by May 12, 2008.
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the AGENCY: Food and Drug Administration, ADDRESSES: Submit written requests for
proposed collection of information; (c) HHS. single copies of the draft guidance to the

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