Submission for OMB Review; Comment Request, 13549-13550 [2010-6141]
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Federal Register / Vol. 75, No. 54 / Monday, March 22, 2010 / Notices
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
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.
Focus Groups About Drug Products, as
Used by the Food and Drug
Administration
Focus groups provide an important
role in gathering information because
they allow for a more in-depth
understanding of individuals’ attitudes,
beliefs, motivations, and feelings than
do quantitative studies. Focus groups
serve the narrowly defined need for
direct and informal opinion on a
specific topic and as a qualitative
research tool have three major purposes:
• To obtain information that is useful
for developing variables and measures
for quantitative studies,
• To better understand people’s
attitudes and emotions in response to
topics and concepts, and
• To further explore findings
obtained from quantitative studies.
13549
FDA will use focus group findings to
test and refine its ideas and to help
develop messages and other
communications, but will generally
conduct further research before making
important decisions such as adopting
new policies and allocating or
redirecting significant resources to
support these policies.
FDA’s Center for Drug Evaluation and
Research, Office of the Commissioner,
and any other centers or offices
conducting focus groups about regulated
drug products may need to conduct
focus groups on a variety of subjects
related to consumer, patient, or
healthcare professional perceptions and
use of drug products and related
materials, including but not limited to,
DTC prescription drug promotion,
physician labeling of prescription drugs,
Medication Guides, OTC drug labeling,
emerging risk communications, patient
labeling, online sales of medical
products, and consumer and
professional education.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
No. of Responses
per Respondent
1,440
1 There
1
Hours per
Response
1,440
Total Hours
1.75
2,520
are no capital costs or operating and maintenance costs associated with this collection of information.
Annually, FDA projects about 20
focus group studies using 160 focus
groups with an average of 9 persons per
group, and lasting an average of 1.75
hours each. FDA is requesting this
burden for unplanned focus groups so
as not to restrict the agency’s ability to
gather information on public sentiment
for its proposals in its regulatory and
communications programs.
Dated: March 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–6172 Filed 3–19–10; 8:45 am]
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Total Annual
Responses (Hours)
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16:41 Mar 19, 2010
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: ANA Project Impact Assessment
Survey.
OMB No.: New Collection.
Description: The information
collected by the Project Impact
Assessment Survey is needed for two
main reasons: (1) To collect crucial
information required to report on the
Administration for Native Americans’
(ANA) established Government
Performance and Results Act (GPRA)
measures, and (2) to properly abide by
ANA’s congressionally-mandated
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statute (42 United States Code 2991 et
seq.) found within the Native American
Programs Act of 1974, as amended,
which states that ANA will evaluate
projects assisted through ANA grant
dollars ‘‘including evaluations that
describe and measure the impact of
such projects, their effectiveness in
achieving stated goals, their impact on
related programs, and their structure
and mechanisms for delivery of
services.’’ The information collected
with this survey will fulfill ANA’s
statutory requirement and will also
serve as an important planning and
performance tool for ANA.
Respondents: Tribal Governments,
Native American nonprofit
organizations, and Tribal Colleges and
Universities.
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13550
Federal Register / Vol. 75, No. 54 / Monday, March 22, 2010 / Notices
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
ANA Project Impact Assessment Survey ........................................................
Estimated Total Annual Burden Hours ............................................................
85
........................
1
........................
6
........................
510
510
Additional Information: Copies of the
proposed collection may be obtained by
writing to the 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. All requests
should be identified by the title of the
information collection. E-mail address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following:
Office of Management and Budget,
Paperwork Reduction Project,
Fax: 202–395–7285,
E-mail:
OIRA_SUBMISSION@OMB.EOP.GOV,
Attn: Desk Officer for the
Administration for Children and
Families.
Dated: March 16, 2010.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2010–6141 Filed 3–19–10; 8:45 am]
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I. Funding Opportunity Description
Statutory Authority
The Indian Health Service (IHS)
announces that competitive cooperative
agreement applications are now being
accepted by the IHS Office of Clinical
and Preventive Services (OCPS) for the
National Human Immunodeficiency
Virus/Acquired Immunodeficiency
Syndrome (HIV/AIDS) Program. This
program is authorized under the Snyder
Act, 25 U.S.C. 13, and the Indian Health
Care Improvement Act, 25 U.S.C.
1602(a)(b)(42)(43). This program is
described under 93.933 in the Catalog of
Federal Domestic Assistance (CFDA).
There will be only one funding cycle
during Fiscal Year (FY) 2010.
Background
Enhancement of HIV/AIDS testing
activities in American Indian/Alaska
Native (AI/AN) people is necessary to
reduce the incidence of HIV/AIDS in
those communities by increasing access
to HIV related services, reducing stigma,
and making testing routine. This open
competition seeks to expand fiscal
resources to increase the number of
AI/AN with awareness of his/her HIV
status. The cooperative agreements will
provide routine HIV screening for adults
as per 2006 Centers for Disease Control
and Prevention (CDC) guidelines, and
pre- and post-test counseling (when
appropriate).
Purpose
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
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Office of Clinical and Preventive
Services: National HIV Program
Announcement Type: Cooperative
Agreement.
Funding Opportunity Number: HHS–
2010–IHS–OCPS–HIV–0001.
Catalog of Federal Domestic
Assistance Number: 93.933.
Key Dates
Application Deadline Date: April 30,
2010.
Review Date: May 12, 2010.
Anticipated Start Date: June 1, 2010.
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These cooperative agreements will be
used to identify best practices to
enhance HIV testing, including rapid
testing and/or conventional HIV
antibody testing, and to provide a more
focused effort to address HIV/AIDS
prevention in AI/AN populations in the
United States.
The nature of these projects will
require collaboration to: (1) Coordinate
activities with the IHS National HIV
Program; and (2) submit and share nonpersonally identifiable (NPI) data
surrounding HIV/AIDS testing,
treatment and education.
These agreements are intended to
encourage development of sustainable,
routine HIV screening programs in
Tribal health facilities that are aligned
with 2006 CDC HIV screening
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guidelines (https://www.cdc.gov/mmwr/
preview/mmwrhtml/rr5514a1.htm). Key
features include streamlined consent
and counseling procedures (verbal
consent, opt-out), a clear HIV screening
policy, identifying and implementing
any necessary staff training, community
awareness, and a clear follow-up
protocol for HIV positive results
including linkages to care. Grantees may
choose to bundle HIV tests with
sexually transmitted diseases (STD)
screening.
II. Award Information
Type of Awards
Cooperative Agreement.
Estimated Funds Available
The total amount of funding
identified for the current Fiscal Year
(FY) 2010 is approximately $540,000.
Competing and continuation awards
issued under this announcement are
subject to the availability of funds. In
the absence of funding, the agency is
under no obligation to make additional
awards under this announcement.
Anticipated Number of Awards
Approximately six cooperative
agreement (CA) awards will be issued
under this program announcement.
Projects will be funded for annual
budget periods in the amount of
approximately $90,000.
Project Period
This is a 2 year project.
Programmatic Involvement
Limitations—Only one CA project
will be awarded per Tribe, Tribal
organization, or intertribal consortium.
Proposed activities that cover large
populations and/or geographical areas
that do not necessarily correspond with
current IHS administrative areas are
encouraged. In conducting activities to
achieve the purpose of this program, the
recipient will be responsible for the
activities under: (1) Recipient Activities,
and IHS will be responsible for
conducting activities under (2) IHS
Activities.
1. Recipient Activities
• Assist AI/AN communities and
Tribal organizations in increasing the
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]]>Agencies
[Federal Register Volume 75, Number 54 (Monday, March 22, 2010)]
[Notices]
[Pages 13549-13550]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-6141]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: ANA Project Impact Assessment Survey.
OMB No.: New Collection.
Description: The information collected by the Project Impact
Assessment Survey is needed for two main reasons: (1) To collect
crucial information required to report on the Administration for Native
Americans' (ANA) established Government Performance and Results Act
(GPRA) measures, and (2) to properly abide by ANA's congressionally-
mandated statute (42 United States Code 2991 et seq.) found within the
Native American Programs Act of 1974, as amended, which states that ANA
will evaluate projects assisted through ANA grant dollars ``including
evaluations that describe and measure the impact of such projects,
their effectiveness in achieving stated goals, their impact on related
programs, and their structure and mechanisms for delivery of
services.'' The information collected with this survey will fulfill
ANA's statutory requirement and will also serve as an important
planning and performance tool for ANA.
Respondents: Tribal Governments, Native American nonprofit
organizations, and Tribal Colleges and Universities.
[[Page 13550]]
ANNUAL BURDEN ESTIMATES
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
ANA Project Impact Assessment Survey........ 85 1 6 510
Estimated Total Annual Burden Hours......... ............... ............... ............... 510
----------------------------------------------------------------------------------------------------------------
Additional Information: Copies of the proposed collection may be
obtained by writing to the 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. All requests should be identified by the title of the
information collection. E-mail address: infocollection@acf.hhs.gov.
OMB Comment: OMB is required to make a decision concerning the
collection of information between 30 and 60 days after publication of
this document in the Federal Register. Therefore, a comment is best
assured of having its full effect if OMB receives it within 30 days of
publication. Written comments and recommendations for the proposed
information collection should be sent directly to the following:
Office of Management and Budget, Paperwork Reduction Project,
Fax: 202-395-7285,
E-mail: OIRA_SUBMISSION@OMB.EOP.GOV,
Attn: Desk Officer for the Administration for Children and Families.
Dated: March 16, 2010.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2010-6141 Filed 3-19-10; 8:45 am]
BILLING CODE 4184-01-P
