Agency Information Collection Activities: Proposed Collection: Comment Request, 74065-74066 [2010-30170]
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Federal Register / Vol. 75, No. 229 / Tuesday, November 30, 2010 / Notices
of risk projected and different
approaches taken by manufacturers
seeking to meet those requirements.
FDA would like to convene sessions of
experts and hold focused meetings over
the next 3 years to discuss REMS
implementation to date, and explore
practical policy approaches relevant to
restricted distribution processes and
quality care counseling.
C. Eligibility Information
This supplement is available only to
the existing grant recipient, Brookings.
D. Requirements of the Supplemental
Application
1. The application clearly
demonstrates an understanding of the
purpose and objectives of the program
expansion as described in section B of
this document.
2. The application clearly describes
the steps involved in a proposed
schedule for planning, implementing,
and accomplishing the activities to be
carried out under the program
expansion.
3. The application establishes
Brookings ability to perform the
responsibilities under the program
expansion including the availability of
appropriate staff and sufficient funding.
4. The application describes
Brookings ability to act as a neutral,
independent third party to convene a
wide group of diverse stakeholders with
relevant expertise related to selected
topics.
5. The application specifies the
manner in which interaction with FDA
will be maintained throughout the
lifetime of the project.
6. The application specifies how
Brookings will monitor progress of the
work under the program expansion and
how progress will be reported to FDA.
7. The application shall include a
detailed budget that shows: (1)
Anticipated costs for personnel, travel,
communications and postage, and
supplies and (2) the sources of funds to
meet those needs, if other than FDA.
II. Award Information/Funds Available
jdjones on DSK8KYBLC1PROD with NOTICES
A. Award Amount
FDA anticipates supplementing this
program expansion by providing
approximate total cost of $501,534
(direct costs only) in each budget period
beginning in 2010, and the remaining
budget periods (years: 2011, 2012, and
2013).
B. Length of Support
The initial supplemental award will
be awarded to correspond with the 2010
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15:13 Nov 29, 2010
Jkt 223001
budget period, and the remaining
budget periods (2011, 2012, and 2013)
will be dependant on the grantee’s
successful performance, and financial
management.
III. Paper Application and Submission
Information
To submit a paper application in
response to this supplemental notice,
applicants should download the PHS–
398 form at https://grants.nih.gov/grants/
funding/phs398/phs398.html. (FDA has
verified the Web site address, but FDA
is not responsible for any subsequent
changes to the Web site after this
document publishes in the Federal
Register.)
For all paper application submissions,
the following steps are required:
Submit paper via Express mail to (see
the For Further Information and
Additional Requirements Contact
section of this document).
Dated: November 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–30054 Filed 11–29–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB), under the
Paperwork Reduction Act of 1995. To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer at (301) 443–
1129.
Comments are invited on: (a) The
proposed collection of information for
the proper performance of the functions
of the agency; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information;
(c) ways to enhance the quality, utility,
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
74065
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.
Proposed Project: Ryan White HIV/
AIDS Program Core Medical Services
Waiver Application Requirements
(OMB No. 0915–0307)—Extension
HRSA utilizes standards for granting
waivers of the core medical services
requirement for the Ryan White HIV/
AIDS Program. These standards meet
the intent of the Ryan White HIV/AIDS
Program to increase access to core
medical services, including
antiretroviral drugs, for persons with
HIV/AIDS and to ensure that grantees
receiving waivers demonstrate the
availability of such services for
individuals with HIV/AIDS who are
identified and eligible under Title XXVI
of the Public Health Service (PHS) Act.
The core medical services waiver
uniform standard and waiver request
process will apply to Ryan White HIV/
AIDS Program Grant awards under Parts
A, B, and C of Title XXVI of the PHS
Act. Core medical services waivers will
be effective for a 1-year period that is
consistent with the grant award period.
Title XXVI, Section 2671 of the PHS
Act, as amended by the Ryan White
HIV/AIDS Treatment Extension Act of
2009, Public Law 111–87, (Ryan White
HIV/AIDS Program), requires that
grantees expend 75 percent of Parts A,
B, and C funds on core medical services,
including antiretroviral drugs, for
individuals with HIV/AIDS who are
identified and eligible under the
legislation. In order for grantees under
Parts A, B, and C to be exempt from the
75 percent core medical services
requirement, they must request and
receive a waiver from HRSA.
Grantees must submit the waiver
request with the annual grant
application that includes the
certifications and documentation which
will be utilized by HRSA in making
determinations regarding waiver
requests. Grantees must provide
evidence that all of the core medical
services listed in the statute, regardless
of whether such services are funded by
the Ryan White HIV/AIDS Program, are
available to all individuals with HIV/
AIDS who are identified and eligible
under Title XXVI of the PHS Act in the
service area within 30 days.
The annual estimate of burden is as
follows:
E:\FR\FM\30NON1.SGM
30NON1
74066
Federal Register / Vol. 75, No. 229 / Tuesday, November 30, 2010 / Notices
Number of
respondents
Application
Responses
per
respondent
Total
responses
Hours per
response
Total burden
hours
Waiver Request ...................................................................
10
1
10
6.5
65
Total ..............................................................................
10
1
10
6.5
65
E-mail comments to
paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10–33,
Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. Written comments
should be received within 30 days of
this notice.
Dated: November 23, 2010.
Robert Hendricks,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2010–30170 Filed 11–29–10; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and draft instruments, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer at (301) 443–
1129.
Comments are invited on: (a) The
proposed collection of information for
the proper performance of the functions
of the agency; (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.
Proposed Project: Healthy Weight
Collaborative (OMB No. 0915–NEW)—
[NEW].
Background: The mission of the
Healthy Weight Collaborative (HWC) is
to discover, identify, develop, and
disseminate both evidence-based and
promising clinical and communitybased interventions to prevent and treat
obesity. The HWC was funded by the
Health Resources and Services
Administration under Title V, Section
501(a)(2) of the Social Security Act (42
U.S.C. 701(a)(2)) and Section 4002 of the
Patient Protection and Affordable Care
Act (Pub. L. 111–148).
The goal of the HWC is to value and
leverage each community team’s
strengths, networks, grantees, and
expertise towards the common goal of
promoting healthy weight for all
populations, especially those at high
risk for overweight and obesity.
The HWC is modeled after the
Institute for Healthcare Improvement
Collaborative Model for achieving
breakthrough improvement. Also known
as the Breakthrough Series, this model
was developed in 1996 to help
healthcare organizations make
breakthrough improvements in quality
Number of
respondents
Instrument
Responses
per
respondent
while reducing costs. This model is
designed to close the gap between
science and practice by creating a
structure in which organizations can
easily learn from each other and from
recognized experts in topic areas in
which they want to make quality
improvements.
Approximately 50 community teams
will be recruited to participate in the
HWC. The intended beneficiaries of this
program are children and their families,
and teams in the HWC can include
health departments, community-based
organizations, HRSA and the
Department of Health and Human
Services (HHS) grantees; especially
safety net providers and other
stakeholders in the HRSA and HHS
program network. Teams will be asked
to report on non-personally identifiable
aggregate information from clinical and
public health or community
interventions related to four domains,
including clinical and public health:
• Body Mass Index (BMI), collected
from an electronic health record.
• Nutrition, which includes measures
related to change in knowledge,
attitudes, behavior, and consumption.
• Physical Activity, which includes
measures related to change in
knowledge, attitudes, behavior, and
levels of activity.
• Partnerships and Process
Improvement, which includes measures
related to linkages made between
clinical and community-based or public
health programs, increased efficiencies
related to these linkages, and the
number of people served by these
linkages.
The annual estimate of burden is as
follows:
Total
responses
Hours per
response
Total burden
hours
jdjones on DSK8KYBLC1PROD with NOTICES
BMI .......................................................................................
Nutrition ................................................................................
Physical Activity ...................................................................
Partnerships and Process Improvement .............................
50
50
50
50
30
30
30
50
1,500
1,500
1,500
2,500
.10
.20
.20
.20
150
300
300
500
Total ..............................................................................
50
........................
7,000
........................
1,250
E-mail comments to
paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10–33,
VerDate Mar<15>2010
15:13 Nov 29, 2010
Jkt 223001
Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. Written comments
PO 00000
Frm 00068
Fmt 4703
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should be received within 60 days of
this notice.
E:\FR\FM\30NON1.SGM
30NON1
]]>Agencies
[Federal Register Volume 75, Number 229 (Tuesday, November 30, 2010)]
[Notices]
[Pages 74065-74066]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30170]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Comment Request
In compliance with the requirement for opportunity for public
comment on proposed data collection projects (section 3506(c)(2)(A) of
Title 44, United States Code, as amended by the Paperwork Reduction Act
of 1995, Pub. L. 104-13), the Health Resources and Services
Administration (HRSA) publishes periodic summaries of proposed projects
being developed for submission to the Office of Management and Budget
(OMB), under the Paperwork Reduction Act of 1995. To request more
information on the proposed project or to obtain a copy of the data
collection plans and draft instruments, e-mail paperwork@hrsa.gov or
call the HRSA Reports Clearance Officer at (301) 443-1129.
Comments are invited on: (a) The proposed collection of information
for the proper performance of the functions of the agency; (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.
Proposed Project: Ryan White HIV/AIDS Program Core Medical Services
Waiver Application Requirements (OMB No. 0915-0307)--Extension
HRSA utilizes standards for granting waivers of the core medical
services requirement for the Ryan White HIV/AIDS Program. These
standards meet the intent of the Ryan White HIV/AIDS Program to
increase access to core medical services, including antiretroviral
drugs, for persons with HIV/AIDS and to ensure that grantees receiving
waivers demonstrate the availability of such services for individuals
with HIV/AIDS who are identified and eligible under Title XXVI of the
Public Health Service (PHS) Act. The core medical services waiver
uniform standard and waiver request process will apply to Ryan White
HIV/AIDS Program Grant awards under Parts A, B, and C of Title XXVI of
the PHS Act. Core medical services waivers will be effective for a 1-
year period that is consistent with the grant award period.
Title XXVI, Section 2671 of the PHS Act, as amended by the Ryan
White HIV/AIDS Treatment Extension Act of 2009, Public Law 111-87,
(Ryan White HIV/AIDS Program), requires that grantees expend 75 percent
of Parts A, B, and C funds on core medical services, including
antiretroviral drugs, for individuals with HIV/AIDS who are identified
and eligible under the legislation. In order for grantees under Parts
A, B, and C to be exempt from the 75 percent core medical services
requirement, they must request and receive a waiver from HRSA.
Grantees must submit the waiver request with the annual grant
application that includes the certifications and documentation which
will be utilized by HRSA in making determinations regarding waiver
requests. Grantees must provide evidence that all of the core medical
services listed in the statute, regardless of whether such services are
funded by the Ryan White HIV/AIDS Program, are available to all
individuals with HIV/AIDS who are identified and eligible under Title
XXVI of the PHS Act in the service area within 30 days.
The annual estimate of burden is as follows:
[[Page 74066]]
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Application respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
Waiver Request.................. 10 1 10 6.5 65
-------------------------------------------------------------------------------
Total....................... 10 1 10 6.5 65
----------------------------------------------------------------------------------------------------------------
E-mail comments to paperwork@hrsa.gov or mail the HRSA Reports
Clearance Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. Written comments should be received within 30 days
of this notice.
Dated: November 23, 2010.
Robert Hendricks,
Director, Division of Policy and Information Coordination.
[FR Doc. 2010-30170 Filed 11-29-10; 8:45 am]
BILLING CODE 4165-15-P
