Grant to Forty-Nine Community Services State Associations; Office of Community Services, 37234-37235 [E7-13151]
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37234
Federal Register / Vol. 72, No. 130 / Monday, July 9, 2007 / Notices
DATE: July 2, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer Centers for
Disease Control and Prevention.
[FR Doc. E7–13197 Filed 7–6–07; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–07–05CH]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–6974. Written
comments should be received within 30
days of this notice.
Proposed Project
An assessment of the determinants of
HIV risk factors for African-American
and Hispanic women in the
southeastern United States—New—the
National Center for HIV/AIDS, STD and
TB Prevention (NCHSTP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
In the United States, an estimated 1
million people are living with HIV.
About 40,000 new HIV infections occur
each year. Women account for about
27% of all new HIV/AIDS diagnoses,
with women of color in the South being
most affected. Women of color represent
80% of all women estimated to be living
with HIV/AIDS. In 2004, the rate HIV/
AIDS cases per 100,000 for nonHispanic African-American adult and
adolescent females (67.0) was 21 times
higher than that for non-Hispanic white
females (3.2). Similarly, the rate of HIV/
AIDS cases reported in 2004 for
Hispanic women (16.3) was 5 times
higher than the rate for non-Hispanic
white women.
Limited research data suggest that the
character and dynamics of women’s
sexual relationships, gender
relationships, sex roles, and experiences
related to race and ethnicity may be
important determinants of risk, both for
engaging in risk behaviors and for doing
so with high-risk partners. In addition,
women’s vulnerability is connected to a
variety of socioeconomic factors,
including delayed access to care and
support for HIV/AIDS. Accordingly, the
specific aims of the study are to:
• Enroll 850 African-American and
500 Hispanic women at risk for HIV
infection in a one-time survey.
• Conduct rapid oral HIV testing of
all women and facilitate linkage to
medical care among those identified as
HIV-positive.
• Characterize African-American and
Hispanic women on demographic,
psychological, behavioral, sociocultural,
and environmental/contextual
dimensions.
• Assess and compare the prevalence
of sexual and drug behaviors of African
American and Hispanic women.
• Identify characteristics of AfricanAmerican and Hispanic women
associated with sexual behaviors that
place them at risk for contracting HIV.
Similarly, identify characteristics that
protect against becoming infected with
HIV.
• Recruit a sub-sample of survey
respondents to take in a qualitative
interview.
• Use our findings to provide
recommendations on the design of
behavioral interventions for African
American and Hispanic women.
Women will complete a 10-minute
eligibility screening interview. The
survey interview will take
approximately 45 minutes each to
complete for those who agree to
participate in the study and 10 minutes
to complete for those who refuse to
enroll. Women completing the survey
will take part in a 45 minute HIV
counseling and testing session, which
will be followed by a 10-minute training
for how to refer other women to the
project. The qualitative interview will
take approximately one hour to
complete. The total response burden for
the three-year period is estimated to be
2712.39 hours (904.13 annualized
burden hours). There is no cost to
respondents except for their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Activity with women volunteers
Venue intercept interview ............................................................................................................
Eligibility screening interview .......................................................................................................
Refusal questionnaire ..................................................................................................................
ACASI survey interview ...............................................................................................................
HIV Testing & Counseling ...........................................................................................................
RDS Training ...............................................................................................................................
Qualitative interview .....................................................................................................................
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Dated: June 29, 2007.
Maryam I. Daneshvar, PhD,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–13243 Filed 7–6–07; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4163–18–P
Grant to Forty-Nine Community
Services State Associations; Office of
Community Services
Administration for Children and
Families
Office of Community Services,
ACF, HHS.
AGENCY:
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675
90
450
450
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ACTION:
Number of
responses per
respondent
1
1
1
1
1
1
1
Average
burden per
response
(hours)
3/60
10/60
10/60
45/60
45/60
10/60
1
Notice to award grant awards.
CFDA Number: 93.570.
Notice is hereby given that
awards will be made to forty-nine
Community Services State Associations
(CAA), in the amount of $65,000 each
for ongoing capacity-building within the
Community Services Network of
Federal, State and local organizations to
continue their work of addressing CSBG
program needs. State CAA Associations
SUMMARY:
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Federal Register / Vol. 72, No. 130 / Monday, July 9, 2007 / Notices
have developed a shared vision for
addressing the causes and effects of
poverty; established a framework to
convene fragmented programs across
State and local governments; and
utilized technological advances to better
serve communities and track program
successes. The period of this funding
will extend from September 30, 2007
through September 29, 2008.
FOR FURTHER INFORMATION CONTACT:
Peter Thompson, Office of Community
Services, Administration for Children
and Families, 370 L’Enfant Promenade,
SW., Washington, DC 20447, Telephone:
202–401–4608, E-mail:
peter.thompson@acf.hhs.gov.
Dated: July 2, 2007.
Yolanda J. Butler,
Deputy Director, Office of Community
Services.
[FR Doc. E7–13151 Filed 7–6–07; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0229]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Devices:
Current Good Manufacturing Practice
Quality System Regulations
AGENCY:
Food and Drug Administration,
HHS.
rwilkins on PROD1PC63 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing information
collection, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
recordkeeping requirements related to
the medical devices current good
manufacturing practice (CGMP) quality
system (QS) regulation (CGMP/QS
regulation).
DATES: Submit written or electronic
comments on the collection of
information by September 7, 2007.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. Submit written
comments on the collection of
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16:59 Jul 06, 2007
Jkt 211001
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Medical Devices: Current Good
Manufacturing Practice Quality System
Regulations--21 CFR Part 820 (OMB
Control Number 0910–0073)—Extension
Under section 520(f) of the Federal
Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 360j(f)), the Secretary of the
Department of Health and Human
Services (the Secretary) has the
authority to prescribe regulations
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requiring that the methods used in, and
the facilities and controls used for, the
manufacture, pre-production design
validation (including a process to assess
the performance of a device but not
including an evaluation of the safety
and effectiveness of a device), packing,
storage, and installation of a device
conform to CGMP, as described in such
regulations, to assure that the device
will be safe and effective and otherwise
in compliance with the act.
The CGMP/QS regulation
implementing authority provided by
this statutory provision is found under
part 820 (21 CFR part 820) and sets forth
basic CGMP requirements governing the
design, manufacture, packing, labeling,
storage, installation, and servicing of all
finished medical devices intended for
human use. The authority for this
regulation is covered under sections
501, 502, 510, 513, 514, 515, 518, 519,
520, 522, 701, 704, 801, and 803 of the
act (21 U.S.C. 351, 352, 360, 360c, 360d,
360e, 360h, 360i, 360j, 360l, 371, 374,
381, and 383). The CGMP/QS regulation
includes requirements for purchasing
and service controls, clarifies
recordkeeping requirements for device
failure and complaint investigations,
clarifies requirements for verifying/
validating production processes and
process or product changes, and
clarifies requirements for product
acceptance activities quality data
evaluations and corrections of
nonconforming product/quality
problems.
Requirements are compatible with
specifications in the international
standards ‘‘ISO 9001: Quality Systems
Model for Quality Assurance in Design/
Development, Production, Installation,
and Servicing.’’ The CGMP/QS
information collections will assist FDA
inspections of manufacturers for
compliance with quality system
requirements encompassing design,
production, installation, and servicing
processes.
Section 820.20(a) through (e) requires
management with executive
responsibility to establish, maintain,
and/or review the following topics: (1)
The quality policy; (2) the
organizational structure; (3) the quality
plan; and (4) the quality system
procedures of the organization.
Section 820.22 requires the conduct
and documentation of quality system
audits and reaudits.
Section 820.25(b) requires the
establishment of procedures to identify
training needs and documentation of
such training.
Section 820.30(a)(1) and (b) through
(j), requires in respective order, the
establishment, maintenance, and/or
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Agencies
[Federal Register Volume 72, Number 130 (Monday, July 9, 2007)]
[Notices]
[Pages 37234-37235]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-13151]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Grant to Forty-Nine Community Services State Associations; Office
of Community Services
AGENCY: Office of Community Services, ACF, HHS.
ACTION: Notice to award grant awards.
-----------------------------------------------------------------------
CFDA Number: 93.570.
SUMMARY: Notice is hereby given that awards will be made to forty-nine
Community Services State Associations (CAA), in the amount of $65,000
each for ongoing capacity-building within the Community Services
Network of Federal, State and local organizations to continue their
work of addressing CSBG program needs. State CAA Associations
[[Page 37235]]
have developed a shared vision for addressing the causes and effects of
poverty; established a framework to convene fragmented programs across
State and local governments; and utilized technological advances to
better serve communities and track program successes. The period of
this funding will extend from September 30, 2007 through September 29,
2008.
FOR FURTHER INFORMATION CONTACT: Peter Thompson, Office of Community
Services, Administration for Children and Families, 370 L'Enfant
Promenade, SW., Washington, DC 20447, Telephone: 202-401-4608, E-mail:
peter.thompson@acf.hhs.gov.
Dated: July 2, 2007.
Yolanda J. Butler,
Deputy Director, Office of Community Services.
[FR Doc. E7-13151 Filed 7-6-07; 8:45 am]
BILLING CODE 4184-01-P