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 

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 

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. 

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) 

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. 

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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