Agency Information Collection Activities; Proposed Collection; Comment Request; OAA Title III-C Evaluation, 20637-20638 [2012-8241]
Download as PDF
<![CDATA[
Federal Register / Vol. 77, No. 66 / Thursday, April 5, 2012 / Notices
Dated: March 26, 2012.
Laura Auletta,
Acting Director, Office of Governmentwide
Acquisition Policy, Office of Acquisition
Policy, Office of Governmentwide Policy.
problem will need to involve both the
health-care community and patients.
This request for information is intended
to solicit comments on both barriers to
medication adherence and strategies for
overcoming those barriers to improve
public health.
[FR Doc. 2012–8143 Filed 4–4–12; 8:45 am]
BILLING CODE 6820–EP–P
Dated: March 29, 2012.
Boris Lushniak,
Deputy Surgeon General.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2012–8179 Filed 4–4–12; 8:45 am]
Request for Information on
Prescription Medication Adherence
BILLING CODE 4150–49–P
Department of Health and
Human Services, Office of the Secretary,
Office of the Assistant Secretary for
Health, Office of the Surgeon General of
the United States Public Health Service.
ACTION: Request for information.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
The Office of the Assistant
Secretary for Health is seeking
information about causes, impact and
potential solutions associated with the
public health problem of prescription
medication non-adherence in adults
with chronic conditions. The purpose of
this notice is to provide individuals and
organizations with the opportunity to
identify issues relevant to all levels of
government, as well as individuals,
health care providers, and industry and
private organizations in efforts to
improve medication adherence in adults
with chronic conditions. Comments that
provide input on and evidence from
interventions that improve adherence
are particularly encouraged.
Comments must be in writing and
should not exceed 500 words. All
comments will receive careful
consideration. However, persons and
organizations submitting comments will
not receive individual responses.
DATES: Individuals and organizations
interested in providing information
must submit their comments on or
before May 7, 2012. Comments received
after this date will not be considered.
ADDRESSES: Department of Health and
Human Services, Office of the Surgeon
General, Room 710–H, 200
Independence Ave., SW., Washington,
DC 20201. Comments may also be sent
via email to medadhere@hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Dawn Alley, Ph.D., Office of the
Surgeon General, by telephone (202–
205–9491) or email
(Dawn.Alley@hhs.gov).
Tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
Many
different factors can contribute to poor
medication adherence, including
copayments, difficulty remembering and
managing complex regimens, and poor
health literacy. Solutions to this
SUPPLEMENTARY INFORMATION:
VerDate Mar<15>2010
16:20 Apr 04, 2012
Jkt 226001
Administration on Aging
Agency Information Collection
Activities; Proposed Collection;
Comment Request; OAA Title III–C
Evaluation
Administration on Aging, HHS.
Notice
AGENCY:
ACTION:
The Administration on Aging
(AoA) 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 collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection requirements relating to
SUMMARY:
OAA Title III–C Evaluation
Submit written or electronic
comments on the collection of
information by June 4, 2012.
ADDRESSES: Submit electronic
comments on the collection of
information to: Jennifer.
klocinski@aoa.hhs.gov.
Submit written comments on the
collection of information to
Administration on Aging, Washington,
DC 20201.
FOR FURTHER INFORMATION CONTACT:
Jennifer Klocinski at 202–357–0146.
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 request
or requirements that members of the
public submit reports, keep records, or
DATES:
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
20637
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, AoA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following collection
of information, AoA invites comments
on: (1) Whether the proposed collection
of information is necessary for the
proper performance of AoA’s functions,
including whether the information will
have practical utility; (2) the accuracy of
AoA’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.
Describe Collection of Information
The mission of the Administration on
Aging (AoA), operating through the
Older Americans Act (OAA) programs,
is to develop a comprehensive,
coordinated and cost-effective system of
home and community based services
that helps elderly individuals to
maintain their health and independence
in their homes and communities and
support family caregivers of older adults
and grandparents caring for
grandchildren, who are essential to
making community living possible.
The OAA Title III–C Elderly Nutrition
Services Program (statutory authority is
contained in Title II section
205(a)(2)(A), and Title III sections 311,
331, 336 and 339 of the Older
Americans Act (OAA) (42U.S.C. 3032),
as amended by the Older Americans Act
Amendments of 2006, P.L. 109–365) is
part of these comprehensive home- and
community-based services. It is
intended to reduce hunger and food
insecurity, reduce social isolation and
improve the health and well-being of
the older adult who participate.
The Older Americans Act requires
AoA to conduct evaluations of OAA
programs. The requirements stipulated
under 206(a) of the OAA direct that
‘‘The Secretary shall measure and
evaluate the impact of all programs
authorized by this Act, their
effectiveness in achieving stated goals in
E:\FR\FM\05APN1.SGM
05APN1
Tkelley on DSK3SPTVN1PROD with NOTICES
20638
Federal Register / Vol. 77, No. 66 / Thursday, April 5, 2012 / Notices
general, and in relation to their cost,
their impact on related programs, their
effectiveness in targeting for services
under this Act unserved older
individuals with greatest economic need
(including low-income minority
individuals and older individuals
residing in rural areas) and unserved
older individuals with greatest social
need (including low-income minority
individuals and older individuals
residing in rural areas), and their
structure and mechanisms for delivery
of services, including, where
appropriate, comparisons with
appropriate control groups composed of
persons who have not participated in
such programs. Evaluations shall be
conducted by persons not immediately
involved in the administration of the
program or project evaluated’’.
The purpose of this data collection is
to fulfill this requirement and
understand how well this program is
meeting its goals and mission through
the conduct of a process and outcome
evaluation that is a rigorous and
independent assessment of the
Program’s progress, efficiency and
effectiveness. This information
collection will enable AoA to effectively
report its results to the President, to
Congress, to the Department of Health
and Human Services and to the public.
The information will also aid in
program refinement and continuous
improvement.
The evaluation design is comprised of
three primary components:
1. A process study, which examines
the strategies, activities, and resources
of the program at each level of the Aging
Network—State Unit on Aging (SUA),
Area Agency on Aging (AAA), and Local
Service Provider (LSP);
2. A cost study, which determines the
cost per meal by cost category and
program type at the local service
provider level; and
3. A client outcome study, which
examines the health and social effects of
the program on participants compared
to non-participants. Included is an
analysis of the nutrient quality of the
meals provided.
The process study will include all 56
SUAs, a sample of AAAs (N=300), a
sample of local service providers
(N=200), and a sample of program
participants and non-participants
(N=2400). The SUA process component
includes a short faxable data verification
survey which asks the SUA to verify
basic information on topics such as
organization structure, staff and
volunteers and population served and a
survey that covers a variety of topics.
The AAA process component includes a
short faxable survey that focuses on
VerDate Mar<15>2010
16:20 Apr 04, 2012
Jkt 226001
program funding, staffing, and client
characteristics and a web-based survey
that covers a range of topics. The local
service provider process component
includes a short faxable survey that is
comparable to the AAA faxable survey
and a web-based survey that covers a
range of topics. The cost study will be
conducted with a sample of local
service providers (including AAAs that
provide direct nutrition services) and
includes a data collection tool that asks
about the component costs associated
with meal production and delivery.
The client outcome study includes
subcomponents: (1) A survey of a
matched sample of program participants
and non-participants and consists of an
assessment of health and well-being
outcomes, individual level
characteristics, and program service use
and quality assessments; (2) an
assessment of diet quality using a 24–
Hour Recall of nutrient intake; (3) a
study of healthcare utilization using
linked Medicare files with client data
collected via the initial survey described
above and brief, follow-up interviews to
measure service use over the year
following the initial survey; and (4) an
analysis of the nutrient quality of the
meals provided to program participants
collected from the local service
providers. Data will be collected via
face-to-face interviews with the aid of
Computer Assisted Personal Interview
(CAPI) software. Respondents’ diet
quality and the nutrient content of the
meals provided through the program
will be measured using the USDA’s
Automated Multiple Pass Method
(AMPM) software. Respondents will be
re-contacted at 6 and 12 months via
telephone with a brief survey to
measure frequency of participation in
the Program since the previous
interview.
This information will be used by AoA
to measure how well and under what
circumstances does the OAA Title III–C
Elderly Nutrition Services Program meet
its legislative intent and goals. The
proposed data collection tools may be
found on the AoA Web site at
https://www.aoa.gov/AoARoot/
Program_Results/
Program_Evaluation.aspx.
AoA estimates the burden of this
collection of information as follows:
1,432.08 hours for organizations and
3,336.00 hours for individuals for a total
of 4,768.08 hours.
Dated: April 2, 2012.
Kathy Greenlee,
Assistant Secretary for Aging.
[FR Doc. 2012–8241 Filed 4–4–12; 8:45 am]
BILLING CODE 4154–01–P
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0330]
Ashish Macwan: Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) debarring
Ashish Macwan for 5 years from
providing services in any capacity to a
person that has an approved or pending
drug product application. FDA bases
this order on a finding that Mr. Macwan
was convicted of one count of
conspiracy to commit an offense against
the United States for conduct relating to
the development and approval,
including the process for development
and approval, of a drug product and to
the regulation of drug products under
the FD&C Act. In addition, the type of
conduct underlying the conviction
undermined the process for the
regulation of drugs. Mr. Macwan was
given notice of the proposed debarment
and an opportunity to request a hearing
within the time frame prescribed by
regulation. Mr. Macwan failed to request
a hearing, which constitutes a waiver of
his right to a hearing concerning this
action.
DATES: This order is effective April 5,
2012.
ADDRESSES: Submit applications for
termination of debarment to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Kenny Shade, Office of Regulatory
Affairs (HFC–230), Food and Drug
Administration, 12420 Parklawn Dr.,
Element Bldg, Rm. 4144, Rockville, MD
20857, 301–796–4640.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
Section 306(b)(2)(B)(i)(II) of the FD&C
Act (21 U.S.C. 335a(b)(2)(B)(i)(II))
permits FDA to debar an individual if it
finds that the individual has been
convicted of a conspiracy to commit a
felony under Federal law for conduct
relating to the development or approval,
including the process for development
or approval, of any drug product or
relating to the regulation of any drug
product under the FD&C Act and if FDA
finds that the type of conduct that
E:\FR\FM\05APN1.SGM
05APN1
]]>Agencies
[Federal Register Volume 77, Number 66 (Thursday, April 5, 2012)]
[Notices]
[Pages 20637-20638]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-8241]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration on Aging
Agency Information Collection Activities; Proposed Collection;
Comment Request; OAA Title III-C Evaluation
AGENCY: Administration on Aging, HHS.
ACTION: Notice
-----------------------------------------------------------------------
SUMMARY: The Administration on Aging (AoA) 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 collection of information, and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on the information collection requirements relating
to
OAA Title III-C Evaluation
DATES: Submit written or electronic comments on the collection of
information by June 4, 2012.
ADDRESSES: Submit electronic comments on the collection of information
to: Jennifer.klocinski@aoa.hhs.gov.
Submit written comments on the collection of information to
Administration on Aging, Washington, DC 20201.
FOR FURTHER INFORMATION CONTACT: Jennifer Klocinski at 202-357-0146.
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 request 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, AoA is publishing notice of the proposed collection
of information set forth in this document. With respect to the
following collection of information, AoA invites comments on: (1)
Whether the proposed collection of information is necessary for the
proper performance of AoA's functions, including whether the
information will have practical utility; (2) the accuracy of AoA'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.
Describe Collection of Information
The mission of the Administration on Aging (AoA), operating through
the Older Americans Act (OAA) programs, is to develop a comprehensive,
coordinated and cost-effective system of home and community based
services that helps elderly individuals to maintain their health and
independence in their homes and communities and support family
caregivers of older adults and grandparents caring for grandchildren,
who are essential to making community living possible.
The OAA Title III-C Elderly Nutrition Services Program (statutory
authority is contained in Title II section 205(a)(2)(A), and Title III
sections 311, 331, 336 and 339 of the Older Americans Act (OAA)
(42U.S.C. 3032), as amended by the Older Americans Act Amendments of
2006, P.L. 109-365) is part of these comprehensive home- and community-
based services. It is intended to reduce hunger and food insecurity,
reduce social isolation and improve the health and well-being of the
older adult who participate.
The Older Americans Act requires AoA to conduct evaluations of OAA
programs. The requirements stipulated under 206(a) of the OAA direct
that ``The Secretary shall measure and evaluate the impact of all
programs authorized by this Act, their effectiveness in achieving
stated goals in
[[Page 20638]]
general, and in relation to their cost, their impact on related
programs, their effectiveness in targeting for services under this Act
unserved older individuals with greatest economic need (including low-
income minority individuals and older individuals residing in rural
areas) and unserved older individuals with greatest social need
(including low-income minority individuals and older individuals
residing in rural areas), and their structure and mechanisms for
delivery of services, including, where appropriate, comparisons with
appropriate control groups composed of persons who have not
participated in such programs. Evaluations shall be conducted by
persons not immediately involved in the administration of the program
or project evaluated''.
The purpose of this data collection is to fulfill this requirement
and understand how well this program is meeting its goals and mission
through the conduct of a process and outcome evaluation that is a
rigorous and independent assessment of the Program's progress,
efficiency and effectiveness. This information collection will enable
AoA to effectively report its results to the President, to Congress, to
the Department of Health and Human Services and to the public. The
information will also aid in program refinement and continuous
improvement.
The evaluation design is comprised of three primary components:
1. A process study, which examines the strategies, activities, and
resources of the program at each level of the Aging Network--State Unit
on Aging (SUA), Area Agency on Aging (AAA), and Local Service Provider
(LSP);
2. A cost study, which determines the cost per meal by cost
category and program type at the local service provider level; and
3. A client outcome study, which examines the health and social
effects of the program on participants compared to non-participants.
Included is an analysis of the nutrient quality of the meals provided.
The process study will include all 56 SUAs, a sample of AAAs
(N=300), a sample of local service providers (N=200), and a sample of
program participants and non-participants (N=2400). The SUA process
component includes a short faxable data verification survey which asks
the SUA to verify basic information on topics such as organization
structure, staff and volunteers and population served and a survey that
covers a variety of topics. The AAA process component includes a short
faxable survey that focuses on program funding, staffing, and client
characteristics and a web-based survey that covers a range of topics.
The local service provider process component includes a short faxable
survey that is comparable to the AAA faxable survey and a web-based
survey that covers a range of topics. The cost study will be conducted
with a sample of local service providers (including AAAs that provide
direct nutrition services) and includes a data collection tool that
asks about the component costs associated with meal production and
delivery.
The client outcome study includes subcomponents: (1) A survey of a
matched sample of program participants and non-participants and
consists of an assessment of health and well-being outcomes, individual
level characteristics, and program service use and quality assessments;
(2) an assessment of diet quality using a 24-Hour Recall of nutrient
intake; (3) a study of healthcare utilization using linked Medicare
files with client data collected via the initial survey described above
and brief, follow-up interviews to measure service use over the year
following the initial survey; and (4) an analysis of the nutrient
quality of the meals provided to program participants collected from
the local service providers. Data will be collected via face-to-face
interviews with the aid of Computer Assisted Personal Interview (CAPI)
software. Respondents' diet quality and the nutrient content of the
meals provided through the program will be measured using the USDA's
Automated Multiple Pass Method (AMPM) software. Respondents will be re-
contacted at 6 and 12 months via telephone with a brief survey to
measure frequency of participation in the Program since the previous
interview.
This information will be used by AoA to measure how well and under
what circumstances does the OAA Title III-C Elderly Nutrition Services
Program meet its legislative intent and goals. The proposed data
collection tools may be found on the AoA Web site at https://www.aoa.gov/AoARoot/Program_Results/Program_Evaluation.aspx.
AoA estimates the burden of this collection of information as
follows: 1,432.08 hours for organizations and 3,336.00 hours for
individuals for a total of 4,768.08 hours.
Dated: April 2, 2012.
Kathy Greenlee,
Assistant Secretary for Aging.
[FR Doc. 2012-8241 Filed 4-4-12; 8:45 am]
BILLING CODE 4154-01-P
