Federal Register / Vol. 77, No. 175 / Monday, September 10, 2012 / Notices 55479 

ESTIMATED ANNUALIZED BURDEN TABLE

Type of respondent Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

1. NHANES Respondents ........................................................................................................... 3,850 1 2.4 

2. Special study/pretest participants ............................................................................................ 2,037 1 2 

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 

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. 

mstockstill on DSK4VPTVN1PROD with NOTICES

55480 Federal Register / Vol. 77, No. 175 / Monday, September 10, 2012 / Notices 

1Although 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. 

2A therapeutic claim that is not scientifically 

substantiated would be considered false or 

misleading, thus making the product misbranded. 

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. 

SUMMARY: 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. 

DATES: 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 http:// 

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: 

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 

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 

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