Agency Forms Undergoing Paperwork Reduction Act Review, 7066-7067 [E9-2973]
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7066
Federal Register / Vol. 74, No. 28 / Thursday, February 12, 2009 / Notices
circumstances the location of the
meeting has been changed.
FOR FURTHER INFORMATION CONTACT: Ms.
Monica A. Baltimore, Tower Building,
1101 Wootton Parkway, Suite 600,
Rockville, Maryland 20852. Phone: 240–
453–2882 Fax: 240–453–2883.
Correction
In the Federal Register of February 4,
2009, Vol. 74, No. 22, on page 6041, in
the 2nd column, correct the ADDRESSES
caption to read:
The meeting will be held at The
Gaylord National and Convention
Center, Annapolis Rooms 1 & 2, 201
Waterfront Street (National Harbor),
Oxon Hill, MD 20745.
Dated: February 9, 2009.
Mirtha R. Beadle,
Deputy Director, Office of Minority Health,
Office of Public Health and Science, Office
of the Secretary, U.S. Department of Health
and Human Services.
[FR Doc. E9–3014 Filed 2–11–09; 8:45 am]
BILLING CODE 4150–29–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Secretary’s Advisory
Committee on Human Research
Protections
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AGENCY: Department of Health and
Human Services, Office of the Secretary.
ACTION: Notice.
SUMMARY: Pursuant to Section 10(a) of
the Federal Advisory Committee Act,
U.S.C. Appendix 2, notice is hereby
given that the Secretary’s Advisory
Committee on Human Research
Protections (SACHRP) will hold its
nineteenth meeting. The meeting will be
open to the public.
DATES: The meeting will be held on
Tuesday, March 3, 2009 from 8:30 a.m.
until 5 p.m. and Wednesday, March 4,
2009 from 8:30 a.m. until 5 p.m.
ADDRESSES: The Sheraton National
Hotel, 900 South Orme Street,
Arlington, Virginia 22204. Phone: 703–
521–1900.
FOR FURTHER INFORMATION CONTACT: Jerry
Menikoff, J.D., M.D., Director, Office for
Human Research Protections (OHRP), or
Julia Gorey, J.D., Executive Director,
SACHRP; U.S. Department of Health
and Human Services, 1101 Wootton
Parkway, Suite 200, Rockville,
Maryland 20852; 240–453–8141; fax:
240–453–6909; e-mail address:
sachrp@osophs.dhhs.gov.
Under the
authority of 42 U.S.C. 217a, Section 222
of the Public Health Service Act, as
SUPPLEMENTARY INFORMATION:
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17:03 Feb 11, 2009
Jkt 217001
amended, SACHRP was established to
provide expert advice and
recommendations to the Secretary of
Health and Human Services and the
Assistant Secretary for Health on issues
and topics pertaining to or associated
with the protection of human research
subjects.
On March 3, 2009, SACHRP will
receive and discuss a report from an
internal task force charged with
prioritizing SACHRP’s existing
recommendations to OHRP. The
Committee will then hear a presentation
of the recent National Academy of
Sciences report entitled ‘‘Health
Research and the Privacy of Health
Information—The HIPAA Privacy
Rule,’’ followed by a presentation of the
Association of Academic Health
Centers’ recent survey on the impact of
the HIPAA Privacy Rule on research.
Lastly, SACHRP will hear a report from
the Subpart A Subcommittee, which is
charged with developing
recommendations for consideration by
SACHRP about the application of
Subpart A of 45 CFR part 46 in the
current research environment. This
subcommittee was established by
SACHRP at its October 4–5, 2004
meeting.
On March 4, 2009, the Committee will
receive and discuss a report from the
Subcommittee on Inclusion of
Individuals with Impaired DecisionMaking in Research. That subcommittee
is charged with developing
recommendations for consideration by
SACHRP about whether guidance or
additional regulations are needed for
research involving individuals with
impaired decision-making capacity. It
was formed as a result of discussions
during the July 31–August 1, 2006
SACHRP meeting. The day will
conclude with a panel discussion
addressing harmonization issues
associated with the Common Rule and
the FDA regulations.
Public attendance at the meeting is
limited to space available. Individuals
who plan to attend the meeting and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the designated contact persons.
Members of the public will have the
opportunity to provide comments on
both days of the meeting. Public
comment will be limited to five minutes
per speaker. Any members of the public
who wish to have printed materials
distributed to SACHRP members for this
scheduled meeting should submit
materials to the Executive Director,
SACHRP, prior to the close of business
Friday, February 27, 2009. Information
about SACHRP and the draft meeting
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agenda will be posted on the SACHRP
Web site at: https://www.hhs.gov/ohrp/
sachrp/.
Dated: February 6, 2009.
Jerry Menikoff,
Director, Office for Human Research
Protections, Executive Secretary, Secretary’s
Advisory Committee on Human Research
Protections.
[FR Doc. E9–3015 Filed 2–11–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–09–08BF]
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
Evaluation Models to Assess Patient
Perspectives on Opt-out HIV Testing in
Clinical Settings—New—National
Center for HIV, Viral Hepatitis, STD and
TB Prevention (NCHHSTP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
In 2006, CDC published the Revised
Recommendations for HIV Testing of
Adults, Adolescents and Pregnant
Women in Health Care Settings which
recommends routine, opt-out HIV
testing to persons 13–64 years of age in
health care settings. The goal of this
project is to develop evaluation models
for health care providers in a variety of
settings to independently assess the
effect that expanded HIV screening
activities have on patient attitudes
toward and acceptance of HIV testing.
The evaluation models will be
packaged into a toolkit containing
educational materials, administrative
tools and a model questionnaire to
measure patients’ perceptions of their
ability to decline testing, the sufficiency
and effectiveness of methods used to
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Federal Register / Vol. 74, No. 28 / Thursday, February 12, 2009 / Notices
impart information prior to testing, and
satisfaction with the testing process.
As part of the development of a model
questionnaire for inclusion in the
toolkit, three health care settings (a
hospital emergency department, a
private primary care practice and a
public primary care practice) will be
selected to pilot test the questionnaire.
In each health care site, 150 patients
will be asked to voluntarily complete a
brief computer assisted self interview
regarding their experience with the HIV
testing process during their health care
visit.
Collection of data will include
information on patient demographics
and current behaviors that may facilitate
HIV transmission; perceptions regarding
pressure to take the test; confidentiality
and privacy during testing; and patient
satisfaction and acceptance of opt-out
HIV testing. For persons who refused
HIV testing during their visit,
information about refusal will be
collected.
Results from the pilot will be assessed
to understand issues of feasibility of the
model questionnaire and validity of the
included items and scales. The findings
will be used to improve the
7067
questionnaire and protocols included in
the evaluation models toolkit.
CDC is requesting approval for a 1year clearance for data collection. CDC
estimates that 188 patients will be asked
to participate at each site and that 80%
will accept, resulting in approximately
450 new survey respondents across all
sites. The estimated average duration of
the survey is 20 minutes. Participation
is voluntary.
There is no cost to the respondents
other than their time.
The total estimated annual burden
hours are 150.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of form
Average
number of
respondents
per annum
Average
number of
responses per
respondent
Average
burden per
response
(hours)
Clinic Patient Survey ...................................................................................................................
450
1
20/60
Dated: February 4, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E9–2973 Filed 2–11–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–09–09AS]
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 or send
comments to Maryam I. Daneshvar, CDC
Acting Reports Clearance Officer, 1600
Clifton Road, MS D–74, 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
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17:03 Feb 11, 2009
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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
Management Information System for
Comprehensive Cancer Control
Programs—New—National Center for
Chronic Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
In 1994, the CDC, the American
Cancer Society, the National Cancer
Institute, the American College of
Surgeons, the North American
Association of Central Cancer Registries,
and other public health leaders at the
state and national levels began
promoting a comprehensive approach to
cancer control that would coordinate
and integrate cancer prevention and
control programs across specific cancer
funding boundaries. In 1998, the CDC
provided funding to Colorado,
Massachusetts, Michigan, North
Carolina, Texas, and the Northwest
Portland Area Indian Health Board as a
pilot to assist with implementation of
their existing comprehensive cancer
control plans. This pilot provided the
foundation for the National
Comprehensive Cancer Control Program
(NCCCP), which has since grown from
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six programs to 65. Currently, all 50
states, the District of Columbia, seven
tribes/tribal organizations, and seven
territories/U.S. Pacific Island
jurisdictions receive funding to
implement cancer control plans.
Awards to individual applicants are
made for a five-year budget period. All
funded programs are required to submit
continuation applications and semiannual progress reports consistent with
federal requirements that all agencies, in
response to the Government
Performance and Results Act of 1993,
prepare performance plans and collect
program-specific performance measures.
These data items are listed in the
Funding Opportunity Announcement.
The data are collected on templates
which serve as a guide, but do not
standardize the information to be
collected. This non-standardized
approach to progress reporting results in
comprehensive cancer control program
reports that vary in content and detail.
Because the data are stored as
attachments rather than in a database,
information cannot be sorted or
aggregated electronically to produce
summary reports.
CDC’s Comprehensive Cancer Control
Branch (CCCB), which manages the
NCCCP, proposes to develop a databasedriven Management Information System
(MIS), which will achieve two
objectives. First, the MIS will provide
an organized source of information
about the activities and
accomplishments of all funded NCCCP
programs. Secondly, the MIS will
provide an efficient mechanism for
generating state, regional, and national
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]]>Agencies
[Federal Register Volume 74, Number 28 (Thursday, February 12, 2009)]
[Notices]
[Pages 7066-7067]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-2973]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-09-08BF]
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 e-mail
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
Evaluation Models to Assess Patient Perspectives on Opt-out HIV
Testing in Clinical Settings--New--National Center for HIV, Viral
Hepatitis, STD and TB Prevention (NCHHSTP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
In 2006, CDC published the Revised Recommendations for HIV Testing
of Adults, Adolescents and Pregnant Women in Health Care Settings which
recommends routine, opt-out HIV testing to persons 13-64 years of age
in health care settings. The goal of this project is to develop
evaluation models for health care providers in a variety of settings to
independently assess the effect that expanded HIV screening activities
have on patient attitudes toward and acceptance of HIV testing.
The evaluation models will be packaged into a toolkit containing
educational materials, administrative tools and a model questionnaire
to measure patients' perceptions of their ability to decline testing,
the sufficiency and effectiveness of methods used to
[[Page 7067]]
impart information prior to testing, and satisfaction with the testing
process.
As part of the development of a model questionnaire for inclusion
in the toolkit, three health care settings (a hospital emergency
department, a private primary care practice and a public primary care
practice) will be selected to pilot test the questionnaire. In each
health care site, 150 patients will be asked to voluntarily complete a
brief computer assisted self interview regarding their experience with
the HIV testing process during their health care visit.
Collection of data will include information on patient demographics
and current behaviors that may facilitate HIV transmission; perceptions
regarding pressure to take the test; confidentiality and privacy during
testing; and patient satisfaction and acceptance of opt-out HIV
testing. For persons who refused HIV testing during their visit,
information about refusal will be collected.
Results from the pilot will be assessed to understand issues of
feasibility of the model questionnaire and validity of the included
items and scales. The findings will be used to improve the
questionnaire and protocols included in the evaluation models toolkit.
CDC is requesting approval for a 1-year clearance for data
collection. CDC estimates that 188 patients will be asked to
participate at each site and that 80% will accept, resulting in
approximately 450 new survey respondents across all sites. The
estimated average duration of the survey is 20 minutes. Participation
is voluntary.
There is no cost to the respondents other than their time.
The total estimated annual burden hours are 150.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average number Average number Average burden
Type of form of respondents of responses per response
per annum per respondent (hours)
----------------------------------------------------------------------------------------------------------------
Clinic Patient Survey........................................ 450 1 20/60
----------------------------------------------------------------------------------------------------------------
Dated: February 4, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. E9-2973 Filed 2-11-09; 8:45 am]
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