Medicare, Medicaid, and CHIP Programs: Research and Analysis on Impact of CMS Programs on the Indian Health Care System, 55479-55480 [2012-22189]
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55479
Federal Register / Vol. 77, No. 175 / Monday, September 10, 2012 / Notices
ESTIMATED ANNUALIZED BURDEN TABLE
Number of
respondents
Type of respondent
1. NHANES Respondents ...........................................................................................................
2. Special study/pretest participants ............................................................................................
Dated: August 30, 2012.
Ron A. Otten,
Director, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Directors, Centers for Disease Control
and Prevention.
[FR Doc. 2012–22188 Filed 9–7–12; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Care Act in 2010 (ACA). AI/AN people
have traditionally been medically
underserved and have health disparities
significantly above those of the
population as a whole. In order to
ensure that AI/AN people have full
knowledge of these new changes and
the fullest access to CMS programs, this
award will study the adoption and
impact of these new authorities on the
Indian health care system.
Amount of the Award
Centers for Medicare & Medicaid
Services
Medicare, Medicaid, and CHIP
Programs: Research and Analysis on
Impact of CMS Programs on the Indian
Health Care System
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice of Single Source Award.
AGENCY:
The total amount of funding available
over a five year period is $3,175,000.00.
The initial award will be awarded at
$635,000.00. The subsequent years will
be awarded on a non-competing
continuation basis at approximately
$635,000.00 per year for 5 total years,
and will be subject to the availability of
funds and satisfactory performance by
the recipient.
SUMMARY:
Justification for Single Source Award
Purpose of Award
The IHS and Tribal health programs
have had long standing authority to bill
Medicare and Medicaid for services
provided at their facilities. These
participating and billing authorities
were expanded by the American
Recovery and Reinvestment Act of 2009
(ARRA), the Children’s Health
Insurance Program Reauthorization Act
of 2009 (CHIPRA), and the Affordable
For the past five years through
Cooperative Agreements with IHS,
NIHB has provided analysis and
research of the potential and actual
impact of CMS programs on AI/AN
beneficiaries and the health care system
serving these beneficiaries. This work
has included extensive analysis and
research on Medicare and Medicaid data
enrollment of AI/AN beneficiaries to
understand utilization of the AI/AN
population in the context of CMS
programs. In addition, the NIHB has
been instrumental in tracking CMS
regulations and providing analysis and
research to better understand the
implications of CMS regulatory
guidance on the Indian health programs.
Based on this experience, NIHB is the
only entity capable of carrying out the
scope of activities because the scope of
work builds on past experience and
knowledge. Any other source would not
have all of the knowledge and
experience gained in the last five years.
The NIHB provides research on health
program issues impacting AI/ANs to
over 565 Federally-recognized Tribes
and has historically provided these
services for several decades in
conjunction with the HIS. The NIHB
program has a national focus relevant to
its AI/AN constituency who need to
mstockstill on DSK4VPTVN1PROD with NOTICES
This notice supports
expansion of research on the impact of
CMS programs on the Indian health care
system through a single source award.
The Indian Health Service (IHS), Tribes
and Tribal Organizations and Urban
programs, deliver health care services to
American Indian/Alaska Native (AI/AN)
people through a network of hospitals,
clinics and other providers. This award
expands research on the impact of CMS
programs and the delivery of health care
to AI/AN beneficiaries.
FOR FURTHER INFORMATION CONTACT:
Rodger Goodacre, Centers for Medicare
& Medicaid Services, Office of Public
Affairs/Tribal Affairs Group, 7500
Security Boulevard, M/S S1–05–13,
Baltimore, MD 21244–1850, (410) 786–
3209.
Intended Recipient: National Indian
Health Board (NIHB).
VerDate Mar<15>2010
16:57 Sep 07, 2012
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Number of
responses per
respondent
3,850
2,037
Average
burden per
response
(in hours)
1
1
2.4
2
know through substantive research
about the changes and updates in the
latest health care services and access
through CMS programs.
Project Period
The anticipated period of
performance is for this cooperative
agreement is August 31, 2012 through
August 30, 2017 with funding awarded
in 12-month budget increments subject
to the availability of funds and
satisfactory performance.
Provisions of the Notice
CMS has solicited a proposal from the
NIHB to undertake analysis, research
and studies to address the impact of
CMS programs and AI/AN beneficiaries
and the health care system serving those
beneficiaries. The project consists of
four principal research objectives:
• Study the ongoing impact of CMS
programs on the Indian health system
through analysis of, response to, and
implementation of CMS regulations by
Indian health providers.
• Study AI/AN demographic,
enrollment, and utilization data and
propose strategies to increase CMS data
system capabilities to create more
Indian specific reporting capacity.
• Provide ongoing study of CMS
efforts to increase AI/AN knowledge of
CMS programs and CMS responsiveness
to Indian health system.
• Provide research support on the use
and effectiveness of the CMS Tribal
Consultation Policy. CMS requested that
the NIHB submit an application which
includes:
1. Cover Letter.
2. SF–424 Application for Federal
Assistance.
3. SF–424A Budget Information—
Non-Construction Programs.
4. A budget narrative (not to exceed
three single spaced pages).
5. Abstract of Project.
6. A research project narrative that
describes each of the four separate
objectives (the entire narrative not to
exceed 12 single space pages).
7. SF–424B Assurances.
8. Health Board Resolution.
9. 501(c)(3) Non-Profit certification.
10. Resumes of all key personnel.
11. Position descriptions.
E:\FR\FM\10SEN1.SGM
10SEN1
55480
Federal Register / Vol. 77, No. 175 / Monday, September 10, 2012 / Notices
12. Disclosure of Lobbying Activities,
if applicable.
13. Copy of approved indirect cost
rate agreement, if applicable.
14. Documentation of current OMB
A–133 required financial audit, if
applicable.
Evaluation criteria for review of the
application will be comprised of three
principal areas:
a. Program information which
includes current organizational
capabilities and operations.
b. Program planning and evaluation
which includes identification of
measurable goals, products, personnel
and workplanning.
c. Program reporting which includes
organizational capabilities and
qualifications and categorical budget
and justification.
Authority: Section 1110 of the Social
Security Act, codified at 42 U.S.C. 1310.
Dated: August 16, 2012.
Daniel F. Kane,
Chief Grants Management Officer, Office of
Acquisition and Grants Management, Centers
for Medicare & Medicaid Services.
[FR Doc. 2012–22189 Filed 9–7–12; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0755]
Draft Compliance Policy Guide Sec.
690.150 on Labeling and Marketing of
Nutritional Products Intended for Use
To Diagnose, Cure, Mitigate, Treat, or
Prevent Disease in Dogs and Cats;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft compliance policy
guide (CPG) entitled ‘‘Compliance
Policy Guide Sec. 690.150 Labeling and
Marketing of Nutritional Products
Intended for Use to Diagnose, Cure,
Mitigate, Treat, or Prevent Disease in
Dogs and Cats.’’ This draft CPG is
intended to provide guidance to FDA
staff and industry on how FDA intends
to use its enforcement discretion with
regard to the labeling and marketing of
dog and cat food products that are
labeled and/or marketed as intending to
diagnose, cure, mitigate, treat, or
prevent diseases and to provide
nutrients in support of meeting the
animal’s total daily nutrient
requirements.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:57 Sep 07, 2012
Jkt 226001
Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
CPG before it begins work on the final
version of the CPG, submit either
electronic or written comments on the
draft CPG by November 9, 2012.
ADDRESSES: Submit written requests for
single copies of the draft CPG to the
Director, Division of Compliance Policy,
Office of Enforcement, Food and Drug
Administration, 12420 Parklawn Dr.,
Element Bldg., rm. 4044, Rockville, MD
20857. Send one self-addressed
adhesive label to assist that office in
processing your request, or fax your
request to 301–827–0482. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft CPG.
Submit electronic comments to https://
www.regulations.gov.
Submit written comments on the draft
CPG to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
William J. Burkholder, Center for
Veterinary Medicine (HFV–228), Food
and Drug Administration, 7519 Standish
Pl., Rockville, MD 20855, 240–453–
6865, William.Burkholder@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
DATES:
I. Background
FDA is announcing the availability of
a draft CPG entitled ‘‘Labeling and
Marketing of Nutritional Products
Intended for Use to Diagnose, Cure,
Mitigate, Treat, or Prevent Disease in
Dogs and Cats.’’ The purpose of this
CPG is to communicate FDA’s strategy
for enforcing the new animal drug
provisions of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) with
respect to dog and cat food products
that make labeling or marketing claims
to diagnose, cure, mitigate, treat, or
prevent disease. Since 1988, the Center
for Veterinary Medicine (CVM) has
observed an increase in the number of
dog and cat food products making such
claims that are sold with, or without,
the direction of a licensed veterinarian.
Because of this increase, and to help
ensure animal safety, CVM is issuing
this draft CPG to set out its current
thinking with respect to factors it will
consider before determining whether to
take regulatory action against dog and
cat food products intended for use in
the diagnosis, cure, mitigation,
treatment, or prevention of disease.
FDA does not generally intend to
recommend or initiate regulatory
actions against dog and cat food
products that are labeled and/or
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Frm 00030
Fmt 4703
Sfmt 4703
marketed as intended for use to
diagnose, cure, mitigate, treat, or
prevent diseases and to provide
nutrients in support of meeting the
animal’s total daily nutrient
requirements when all the following
factors are present. Specifically: (1)
Manufacturers make the products
available to the public only through
licensed veterinarians or through retail
or Internet sales to individuals
purchasing the product under the
direction of a veterinarian; (2)
manufacturers do not market such
products as alternatives to approved
new animal drugs; (3) the manufacturer
is registered under section 415 of the
FD&C Act (21 U.S.C. 350(d)); (4)
manufacturers comply with all food
labeling requirements for such products
(see 21 CFR part 501); (5) manufacturers
do not include indications for a disease
claim (e.g., obesity, renal failure) on the
label of such products; (6)
manufacturers limit distribution of
material with any disease claims for
such products only to veterinary
professionals; (7) manufacturers secure
electronic resources for the
dissemination of labeling information
and promotional materials such that
they are available only to veterinary
professionals; (8) manufacturers include
only ingredients that are general
regarded as safe (GRAS) ingredients,
approved food additives, or feed
ingredients defined in the 2012 Official
Publication of the Association of
American Feed Control Officials
(AAFCO) for the intended uses in such
products; 1 and (9) the label and labeling
for such products are not false and
misleading in other respects.2
II. Significance of Guidance
This level 1 draft CPG is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft CPG, when finalized, will
represent the Agency’s current thinking
on this topic. It does not create or confer
any rights for or on any person and does
not operate to bind FDA or the public.
An alternative approach may be used if
such approach satisfies the
1 Although food containing these unapproved
food additives is adulterated within the meaning of
section 402(a)(2)(c)(i), FDA is unlikely to initiate
enforcement action solely on this basis if the food
additive in question is included in the 2012 edition
of the Official Publication of AAFCO. As part of its
efforts to work with State partners, FDA has
reviewed safety information related to many of
these listed products, and those listed in the 2012
Official Publication generally do not fall within our
current enforcement priorities.
2 A therapeutic claim that is not scientifically
substantiated would be considered false or
misleading, thus making the product misbranded.
E:\FR\FM\10SEN1.SGM
10SEN1
]]>Agencies
[Federal Register Volume 77, Number 175 (Monday, September 10, 2012)]
[Notices]
[Pages 55479-55480]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-22189]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Medicare, Medicaid, and CHIP Programs: Research and Analysis on
Impact of CMS Programs on the Indian Health Care System
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice of Single Source Award.
-----------------------------------------------------------------------
SUMMARY: This notice supports expansion of research on the impact of
CMS programs on the Indian health care system through a single source
award. The Indian Health Service (IHS), Tribes and Tribal Organizations
and Urban programs, deliver health care services to American Indian/
Alaska Native (AI/AN) people through a network of hospitals, clinics
and other providers. This award expands research on the impact of CMS
programs and the delivery of health care to AI/AN beneficiaries.
FOR FURTHER INFORMATION CONTACT: Rodger Goodacre, Centers for Medicare
& Medicaid Services, Office of Public Affairs/Tribal Affairs Group,
7500 Security Boulevard, M/S S1-05-13, Baltimore, MD 21244-1850, (410)
786-3209.
Intended Recipient: National Indian Health Board (NIHB).
Purpose of Award
The IHS and Tribal health programs have had long standing authority
to bill Medicare and Medicaid for services provided at their
facilities. These participating and billing authorities were expanded
by the American Recovery and Reinvestment Act of 2009 (ARRA), the
Children's Health Insurance Program Reauthorization Act of 2009
(CHIPRA), and the Affordable Care Act in 2010 (ACA). AI/AN people have
traditionally been medically underserved and have health disparities
significantly above those of the population as a whole. In order to
ensure that AI/AN people have full knowledge of these new changes and
the fullest access to CMS programs, this award will study the adoption
and impact of these new authorities on the Indian health care system.
Amount of the Award
The total amount of funding available over a five year period is
$3,175,000.00. The initial award will be awarded at $635,000.00. The
subsequent years will be awarded on a non-competing continuation basis
at approximately $635,000.00 per year for 5 total years, and will be
subject to the availability of funds and satisfactory performance by
the recipient.
Justification for Single Source Award
For the past five years through Cooperative Agreements with IHS,
NIHB has provided analysis and research of the potential and actual
impact of CMS programs on AI/AN beneficiaries and the health care
system serving these beneficiaries. This work has included extensive
analysis and research on Medicare and Medicaid data enrollment of AI/AN
beneficiaries to understand utilization of the AI/AN population in the
context of CMS programs. In addition, the NIHB has been instrumental in
tracking CMS regulations and providing analysis and research to better
understand the implications of CMS regulatory guidance on the Indian
health programs. Based on this experience, NIHB is the only entity
capable of carrying out the scope of activities because the scope of
work builds on past experience and knowledge. Any other source would
not have all of the knowledge and experience gained in the last five
years. The NIHB provides research on health program issues impacting
AI/ANs to over 565 Federally-recognized Tribes and has historically
provided these services for several decades in conjunction with the
HIS. The NIHB program has a national focus relevant to its AI/AN
constituency who need to know through substantive research about the
changes and updates in the latest health care services and access
through CMS programs.
Project Period
The anticipated period of performance is for this cooperative
agreement is August 31, 2012 through August 30, 2017 with funding
awarded in 12-month budget increments subject to the availability of
funds and satisfactory performance.
Provisions of the Notice
CMS has solicited a proposal from the NIHB to undertake analysis,
research and studies to address the impact of CMS programs and AI/AN
beneficiaries and the health care system serving those beneficiaries.
The project consists of four principal research objectives:
Study the ongoing impact of CMS programs on the Indian
health system through analysis of, response to, and implementation of
CMS regulations by Indian health providers.
Study AI/AN demographic, enrollment, and utilization data
and propose strategies to increase CMS data system capabilities to
create more Indian specific reporting capacity.
Provide ongoing study of CMS efforts to increase AI/AN
knowledge of CMS programs and CMS responsiveness to Indian health
system.
Provide research support on the use and effectiveness of
the CMS Tribal Consultation Policy. CMS requested that the NIHB submit
an application which includes:
1. Cover Letter.
2. SF-424 Application for Federal Assistance.
3. SF-424A Budget Information--Non-Construction Programs.
4. A budget narrative (not to exceed three single spaced pages).
5. Abstract of Project.
6. A research project narrative that describes each of the four
separate objectives (the entire narrative not to exceed 12 single space
pages).
7. SF-424B Assurances.
8. Health Board Resolution.
9. 501(c)(3) Non-Profit certification.
10. Resumes of all key personnel.
11. Position descriptions.
[[Page 55480]]
12. Disclosure of Lobbying Activities, if applicable.
13. Copy of approved indirect cost rate agreement, if applicable.
14. Documentation of current OMB A-133 required financial audit, if
applicable.
Evaluation criteria for review of the application will be comprised
of three principal areas:
a. Program information which includes current organizational
capabilities and operations.
b. Program planning and evaluation which includes identification of
measurable goals, products, personnel and workplanning.
c. Program reporting which includes organizational capabilities and
qualifications and categorical budget and justification.
Authority: Section 1110 of the Social Security Act, codified at
42 U.S.C. 1310.
Dated: August 16, 2012.
Daniel F. Kane,
Chief Grants Management Officer, Office of Acquisition and Grants
Management, Centers for Medicare & Medicaid Services.
[FR Doc. 2012-22189 Filed 9-7-12; 8:45 am]
BILLING CODE 4120-01-P
