Proposed Data Collections Submitted for Public Comment and Recommendations, 45226-45227 [E8-17775]
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Federal Register / Vol. 73, No. 150 / Monday, August 4, 2008 / Notices
well as their knowledge, attitudes, and
behaviors related to preventive cancer
screenings. Of particular interest are
adults of various races and ethnicities
who are at high risk for lung cancer (i.e.,
long-term heavy smokers).
The proposed project will use focus
groups to gather information about the
target audiences’ experiences and
practices related to lung cancer
screening and testing. If warranted from
focus group data with adult consumers,
follow-up personal interviews will be
conducted with selected focus group
participants, especially those reporting
experience with screening tests, such as
spiral computed tomography (CT).
Physician Masterfile list. Potential
physician respondents will be mailed a
screening packet to complete and
return. Each focus group of physicians
will include approximately six
participants and last 75 minutes. Two
alternates will be recruited for each
physician focus group in order to ensure
participation of the targeted number of
respondents.
Information will be collected over the
two-year project period. There are no
costs to respondents except their time.
The total estimated annualized burden
hours are 198.
A total of 16 focus groups will be
conducted at professional focus group
facilities with long-term heavy smokers
ages 40–70. The data will be collected
from a convenience sample of adults
who will be screened and recruited
using lists maintained by the focus
group facilities. Each focus group will
include approximately nine participants
and last two hours. If warranted,
additional in-depth interviews will be
conducted with up to 16 focus group
participants.
Eight telephone focus groups will be
conducted with a random sample of
primary care physicians recruited from
the American Medical Association
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses
per
respondent
Average
burden per
response
(in hours)
Health Care Consumer Screener Form ..
Moderator’s Guide for Health Care Consumer Focus Groups.
Guide for In-Depth Interviews with
Health Care Consumers.
Physician Response Form ......................
Moderator’s Guide for Physician Focus
Groups.
144
72
1
1
2/60
2
5
144
8
1
1
8
64
24
1
1
5/60
1.5
5
36
..................................................................
....................
....................
......................
198
Type of
respondents
Form name
Health Care Consumers ..........................
Physicians ................................................
Total ..................................................
Marilyn S. Radke,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. E8–17772 Filed 8–1–08; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day-80–08BL]
pwalker on PROD1PC71 with NOTICES
Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–5960 and
send comments to Maryam I. Daneshvar,
CDC Acting Reports Clearance Officer,
1600 Clifton Road, MS–D74, Atlanta,
VerDate Aug<31>2005
16:50 Aug 01, 2008
Jkt 214001
GA 30333 or send an e-mail to
omb@cdc.gov.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper 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)
ways to enhance 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. Written comments should
be received within 60 days of this
notice.
Proposed Project
Rapid HIV Testing in Community
Mental Health Settings Serving African
Americans—New—National Center for
HIV, Viral Hepatitis, STD and TB
Prevention (NCHHSTP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
People with chronic mental illness,
including those with substance use
disorders, are at increased risk of HIV
PO 00000
Frm 00022
Fmt 4703
Sfmt 4703
Total
burden
(in hours)
compared with the general population.
However, not enough is known about
the risk behaviors, willingness to be
tested for HIV and HIV prevalence
among persons with chronic mental
illness. In addition, the interrelations
among diagnosis of HIV infection,
compliance with medical care,
subsequent risk behaviors, and the
course of mental illness have not been
well-described. Mental health clinics
are an important setting for HIV rapid
testing and promoting prevention efforts
against the transmission of HIV
infection.
The objectives of this project are to (1)
demonstrate improved access to HIV
testing and linkage to care in
participating mental health care
settings; and (2) describe the
relationship between mental illness,
HIV risk behaviors, and access to testing
and services, in order to inform the
development of optimal prevention
interventions for persons with severe
mental illness. Staff at selected
implementation sites will offer testing
for HIV to clients and administer a brief
survey to assess risk behaviors, previous
access to similar testing services, and
mental health symptoms.
CDC is requesting approval for a 2year clearance for data collection. Data
E:\FR\FM\04AUN1.SGM
04AUN1
45227
Federal Register / Vol. 73, No. 150 / Monday, August 4, 2008 / Notices
will be collected in 6 community mental
health sites. This project will collect
data from clients using a brief survey
administered on a voluntary basis.
Collection of data will provide
information on client demographics;
current behaviors that may facilitate
HIV transmission, including sexual and
drug-use behaviors; current psychiatric
symptoms, determined using brief rating
scales; access and barriers to HIV
testing, prevention, and treatment
services; and adherence to psychiatric
and medical treatment regimens.
CDC estimates the response rate will
be approximately 90%. Of the 644
persons approached who agree to be
surveyed, it is estimated that 95% of
persons will meet the eligibility criteria
and 98% will be able to provide
informed consent. Therefore, the goal
will be to approach 716 persons
annually for participation in the study.
The structured interview will take
approximately 20 minutes to complete.
Participation is voluntary. Data
collection will provide important
insights into the relationship between
HIV/STI risk behaviors and psychiatric
illness.
There is no cost to the respondents
other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Approached Individual ..............................
Eligible participant .....................................
Consented participant ...............................
Average
burden per
response
(in hours)
644
612
600
1
1
1
1/60
10/60
20/60
11
102
200
....................
....................
....................
313
Eligibility Screener ....................................
Consent Questionnaire .............................
Core Questionnaire ..................................
Total ...................................................
...................................................................
Marilyn S. Radke,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E8–17775 Filed 8–1–08; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Notice of Public Comment on Tribal
Consultation Session To Be Held on
September 11, 2008, in Phoenix, AZ
AGENCY:
Office of Head Start (OHS).
Notice of Public Comment on
Tribal Consultation Session to be held
on September 11, 2008, in Phoenix,
Arizona.
ACTION:
pwalker on PROD1PC71 with NOTICES
No. of responses per
respondent
No. of respondents
Type of respondent
SUMMARY: Pursuant to the Improving
Head Start for School Readiness Act of
2007, Public Law 110–134, notice is
hereby given of a one-day Tribal
Consultation Session to be held between
the Department of Health and Human
Services, Administration for Children
and Families, Office of Head Start
leadership and the leadership of Tribal
governments operating Head Start
(including Early Head Start) programs.
The purpose of the Consultation Session
is to discuss ways to better meet the
needs of Indian, including Alaska
Native, children and their families,
taking into consideration funding
allocations, distribution formulas, and
other issues affecting the delivery of
Head Start services in their geographic
locations [42 U.S.C. 9835, Section
640(l)(4)].
VerDate Aug<31>2005
16:50 Aug 01, 2008
Jkt 214001
Date & Location: The Consultation
Session will be held on September 11,
2008, at the Hyatt Regency Phoenix in
Phoenix, Arizona.
FOR FURTHER INFORMATION CONTACT:
´
Renee Perthuis, Acting Regional
Program Manager, American Indian/
Alaska Native Program Branch, Office of
Head Start, e-mail
reneeaian@acf.hhs.gov or (202) 260–
1721. Register to attend the Consultation
Session online at www.hsnrc.org.
SUPPLEMENTARY INFORMATION: The
Department of Health and Human
Services would like to invite leaders of
Tribal governments operating Head Start
(including Early Head Start) programs to
participate in a formal Consultation
Session with OHS leadership. The
Consultation Session will take place on
Thursday, September 11, 2008, at the
Hyatt Regency Phoenix in Phoenix,
Arizona.
The purpose of the Consultation
Session is to solicit input on ways to
better meet the needs of Indian,
including Alaska Native, children and
their families, taking into consideration
funding allocations, distribution
formulas, and other issues affecting the
delivery of Head Start services in their
geographic locations. Specific topics
will include policy, research, Head
Start/Early Head Start conversion,
program quality, and monitoring.
Tribal leaders and designated
representatives interested in submitting
written testimony or topics for the
Consultation Session agenda should
´
contact Renee Perthuis at
reneeaian@acf.hhs.gov. The proposal
agenda topics should include a brief
description of the topic area along with
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
Total burden hours
the name and contact information of the
suggested presenter.
The Consultation Session will be
conducted with elected or appointed
leaders of Tribal governments and their
designated representatives [42 U.S.C.
9835, Section 640(l)(4)(A)].
Representatives from Tribal
organizations and Native non-profit
organizations are welcome to attend as
observers. Those wishing to participate
in the discussions must have a copy of
a letter signed by an elected or
appointed official or their designee,
which authorizes them to serve as a
representative of the Tribe. This should
be submitted not less than three days in
advance of the Consultation Session to
´
Renee Perthuis at 202–205–9721 (fax).
A detailed report of the Consultation
Session will be prepared and made
available within 90 days of the
consultation to all Tribal governments
receiving funds for Head Start
(including Early Head Start) programs.
Dated: July 29, 2008.
Patricia Brown,
Acting Director, Office of Head Start.
[FR Doc. E8–17774 Filed 8–1–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
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Food and Drug Administration
[Docket No. FDA–2008–D–0387]
Draft Guidance for Industry on
Labeling OTC Skin Protectant Drug
Products; Availability
AGENCY:
Food and Drug Administration,
HHS.
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[Federal Register Volume 73, Number 150 (Monday, August 4, 2008)]
[Notices]
[Pages 45226-45227]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-17775]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-80-08BL]
Proposed Data Collections Submitted for Public Comment and
Recommendations
In compliance with the requirement of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for opportunity for public comment on
proposed data collection projects, the Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
copy of the data collection plans and instruments, call 404-639-5960
and send comments to Maryam I. Daneshvar, CDC Acting Reports Clearance
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail
to omb@cdc.gov.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper 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) ways to enhance 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. Written comments should be received
within 60 days of this notice.
Proposed Project
Rapid HIV Testing in Community Mental Health Settings Serving
African Americans--New--National Center for HIV, Viral Hepatitis, STD
and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention
(CDC).
Background and Brief Description
People with chronic mental illness, including those with substance
use disorders, are at increased risk of HIV compared with the general
population. However, not enough is known about the risk behaviors,
willingness to be tested for HIV and HIV prevalence among persons with
chronic mental illness. In addition, the interrelations among diagnosis
of HIV infection, compliance with medical care, subsequent risk
behaviors, and the course of mental illness have not been well-
described. Mental health clinics are an important setting for HIV rapid
testing and promoting prevention efforts against the transmission of
HIV infection.
The objectives of this project are to (1) demonstrate improved
access to HIV testing and linkage to care in participating mental
health care settings; and (2) describe the relationship between mental
illness, HIV risk behaviors, and access to testing and services, in
order to inform the development of optimal prevention interventions for
persons with severe mental illness. Staff at selected implementation
sites will offer testing for HIV to clients and administer a brief
survey to assess risk behaviors, previous access to similar testing
services, and mental health symptoms.
CDC is requesting approval for a 2-year clearance for data
collection. Data
[[Page 45227]]
will be collected in 6 community mental health sites. This project will
collect data from clients using a brief survey administered on a
voluntary basis. Collection of data will provide information on client
demographics; current behaviors that may facilitate HIV transmission,
including sexual and drug-use behaviors; current psychiatric symptoms,
determined using brief rating scales; access and barriers to HIV
testing, prevention, and treatment services; and adherence to
psychiatric and medical treatment regimens.
CDC estimates the response rate will be approximately 90%. Of the
644 persons approached who agree to be surveyed, it is estimated that
95% of persons will meet the eligibility criteria and 98% will be able
to provide informed consent. Therefore, the goal will be to approach
716 persons annually for participation in the study. The structured
interview will take approximately 20 minutes to complete. Participation
is voluntary. Data collection will provide important insights into the
relationship between HIV/STI risk behaviors and psychiatric illness.
There is no cost to the respondents other than their time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
No. of Average
No. of responses burden per Total
Type of respondent Form name respondents per response burden
respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
Approached Individual............... Eligibility Screener.. 644 1 1/60 11
Eligible participant................ Consent Questionnaire. 612 1 10/60 102
Consented participant............... Core Questionnaire.... 600 1 20/60 200
---------------------------------------------------------------------------
Total........................... ...................... ........... ........... ........... 313
----------------------------------------------------------------------------------------------------------------
Marilyn S. Radke,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. E8-17775 Filed 8-1-08; 8:45 am]
BILLING CODE 4163-18-P