32792 Federal Register / Vol. 75, No. 110 / Wednesday, June 9, 2010 / Notices 

Protect Children and Adolescents,’’ at 21 

CFR part 1140. The final regulations 

apply to manufacturers, distributors, 

and retailers who make, distribute, or 

sell cigarettes or smokeless tobacco 

products. 

Beginning on June 22, 2010, these 

Federal regulations will prohibit 

retailers from selling cigarettes, cigarette 

tobacco, or smokeless tobacco to 

persons under the age of 18, and will 

require retailers to verify the age of all 

customers under the age of 27 by 

checking a photographic identification 

that includes the bearer’s date of birth. 

FDA is announcing the availability of 

a draft guidance document, which is 

intended to help small businesses 

comply with the requirements of the 

new regulations. FDA is soliciting 

comments on the draft guidance 

document and may amend the guidance 

document periodically as a result of 

comments received. 

II. Significance of Guidance 

FDA is issuing this draft guidance 

document consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The draft guidance, when 

finalized, will represent the agency’s 

current thinking on ‘‘Compliance with 

Regulations Restricting the Sale and 

Distribution of Cigarettes and Smokeless 

Tobacco To Protect Children and 

Adolescents.’’ 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 

requirements of the applicable statute 

and regulations. 

III. Comments 

The draft guidance is being 

distributed for comment purposes only 

and is not intended for implementation 

at this time. Interested persons may 

submit to the Division of Dockets 

Management (see ADDRESSES) either 

electronic or written comments 

regarding this document. It is only 

necessary to send one set of comments. 

It is no longer necessary to send two 

copies of mailed comments. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. Received comments may be 

seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

IV. Electronic Access 

An electronic version of the guidance 

document is available on the Internet at 

http://www.regulations.gov and http:// 

www.fda.gov/TobaccoProducts/ 

GuidanceComplianceRegulatory

Information/default.htm. 

Dated: June 7, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–13922 Filed 6–7–10; 11:15 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Office of Public Health Support; 

Division of Planning, Evaluation & 

Research Native American Research 

Centers for Health (NARCH) V 

Evidence-Based Interventions for 

Tribal Communities Against AIDS and 

STDs 

Announcement Type: Competitive 

Supplements. 

Funding Announcement Number: 

HHS–2010–IHS–NARCH–0001. 

Catalog of Federal Domestic 

Assistance Number: 93.933. 

Key Dates 

Application Deadline Date: June 30, 

2010. 

Review Date: July 15, 2010. 

Earliest Anticipated Start Date: 

September 1, 2010. 

I. Funding Opportunity Description 

Statutory Authority 

The Indian Health Service (IHS) is 

accepting competitive supplemental 

grant applications from existing Native 

American Research Centers for Health 

(NARCH) V grantees to establish and 

test Evidence-Based Interventions for 

Tribal Communities Against Acquired 

Immune Deficiency Syndrome (AIDS) 

and sexually transmitted diseases 

(STDs). This program is authorized 

under: the Snyder Act, 25 U.S.C. 13, the 

Public Health Service Act, 42 U.S.C. 241 

as amended, and the Indian Health Care 

Improvement Act, 25 U.S.C. 

1602(a)(b)(16). This program is 

described in the Catalog of Federal 

Domestic Assistance under 93.933. 

Background 

The NARCH V program supports 

partnerships between Federally 

recognized American Indian and Alaska 

Native (AI/AN) Tribes or Tribal 

organizations (including national and 

area Indian health boards, and Tribal 

colleges meeting the definition of a 

Tribal organization as defined by 25 

U.S.C. 1603(d) or (e)) and institutions 

that conduct intensive academic-level 

biomedical, behavioral and health 

services research. These partnerships 

are called Native American Research 

Centers for Health (NARCH). Due to the 

complexity of factors contributing to the 

health and disease of AI/ANs, and to 

their health disparities compared with 

other Americans, the collaborative 

efforts of the agencies of the Department 

of Health and Human Services (HHS) 

and the collaboration of academic 

researchers and AI/AN communities are 

needed to achieve significant 

improvements in the health status of AI/ 

AN people. To accomplish this goal, in 

addition to objectives set by the Tribes, 

Tribal organizations or Indian health 

boards, the IHS NARCH program 

pursues the following program 

objectives: 

To develop a cadre of AI/AN 

scientists and health professionals— 

Opportunities are needed to develop 

more AI/AN scientists and health 

professionals engaged in research, and 

to conduct biomedical, clinical, 

behavioral and health services research 

that is responsive to the needs of the AI/ 

AN community and the goals of this 

initiative. Faculty/researchers and 

students at each proposed NARCH 

develop investigator-initiated, 

scientifically meritorious research 

projects, including pilot research 

projects, and will be supported through 

science education projects designed to 

increase the numbers of, and to improve 

the research skills of, AI/AN 

investigators and investigators involved 

with AI/ANs. 

To enhance partnerships and reduce 

distrust of research by AI/AN 

communities—Recent community-based 

participatory research suggests that AI/ 

AN communities can work 

collaboratively in partnership with 

health researchers to further the 

research needs of AI/ANs. Fully 

utilizing all cultural and scientific 

knowledge, strengths, and 

competencies, such partnerships can 

lead to better understanding of the 

biological, genetic, behavioral, 

psychological, cultural, social, and 

economic factors either promoting or 

hindering improved health status of AI/ 

ANs, and generate the development and 

evaluation of interventions to improve 

their health status. Community distrust 

of research and researchers will be 

reduced by offering the Tribe greater 

control over the research process. 

Purpose 

The purpose of this opportunity for 

supplementing the existing NARCH V 

program is to determine the feasibility 

of adapting and implementing HIV 

evidence based interventions (EBI)(s) 

supported by the CDC for effective use 

within AI/AN communities, and to 

contribute to, and document, a 

successful adaption and implementation 


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in this new population and setting. 

Baseline and ongoing data will be 

collected and analyzed to help 

determine future effectiveness of the 

adapted EBI(s). 

While new treatments continue to 

offer hope for individuals infected with 

HIV, behavioral interventions shown to 

reduce HIV risk behaviors remain one of 

the most powerful tools in curbing the 

AIDS epidemic. Health departments 

(HDs) and community-based 

organizations (CBOs) increasingly are 

required to implement EBI(s) or public 

health strategies (PHSs) that have been 

shown to be efficacious for HIV 

prevention in rigorous controlled trials. 

Unfortunately, the development of new 

EBI(s) is a resource-intensive process 

that has not progressed as quickly as the 

epidemiology of the disease. One 

method to accelerate this process is by 

adapting existing EBI(s) supported by 

CDC’s previous Prevention Research 

Synthesis (PRS), Replicating Effective 

Programs (REP), and Diffusion of 

Effective Behavioral Interventions 

(DEBI) projects for new populations or 

settings. This announcement responds 

to concerns from the field and many AI/ 

AN communities that existing EBI(s) do 

not address the focused HIV prevention 

needs of AI/ANs due, at least in part, to 

lack of cultural relevance and to the 

absence of effectiveness data for these 

interventions with respect to Tribal 

communities. 

These supplements will facilitate the 

creation and testing of culturally 

adapted and evidence based 

interventions against AIDS and STDs. 

The methodology of Tribal or 

community based participatory research 

(T/CBPR) is expected to be the most 

effective approach to selecting, adapting 

and testing an existing EBI for 

deployment and maximal effectiveness 

in a given Tribal community. Effective 

T/CBPR partnerships can take years to 

develop, but the need for culturally 

relevant EBI(s) is urgent. Fortunately, a 

number of such partnerships have 

already been created under the NARCH 

program. These partnerships are an 

already existing T/CBPR infrastructure 

whose core purposes include the ability 

to help the Tribes respond to urgent 

research needs and opportunities, such 

as the object of this announcement. 

Grantees will test the use of a T/CBPR 

adaptation model to assist agencies with 

the process of tailoring an existing 

prevention intervention, previously 

shown to be effective and catalogued by 

CDC, for use in different small or hardto-access AI/AN population at risk for 

HIV infection. When adapting the EBI, 

the core elements that contributed to the 

efficacy of the original intervention will 

be maintained, which will increase 

efficiency of adaptation. Each grantee’s 

ability to successfully adapt, tailor, and 

implement their chosen intervention 

will be monitored and evaluated, and all 

operational processes will be 

documented. 

The nature of these projects will 

require collaboration to: (1) Coordinate 

activities with the IHS Research 

Program and IHS National HIV Program 

and (2) acquire technical assistance 

from the IHS Research Program and the 

Capacity Building Branch (CBB) of the 

Division of HIV/AIDS Prevention 

(DHAP) at CDC. 

Proposed activities that cover large 

populations and/or geographical areas 

that do not necessarily correspond with 

current IHS administrative areas are 

allowed. In conducting activities to 

achieve the purpose of this program, the 

recipient will be responsible for the 

activities under: 1. Recipient Activities, 

and HHS will be responsible for 

conducting activities under 2. HHS 

Activities. 

1. Recipient Activities 

• Conduct targeted research and 

literature review on the question of 

whether any of the existing EBI 

supported by CDC can be successfully 

adapted to an AI/AN population at risk. 

• Identify the unique risk behaviors 

and contextual factors that lead to an 

increased risk of HIV acquisition or 

transmission. 

• Conduct pre-implementation 

phases of assessment, adaptation, 

tailoring of intervention, and IRB 

submission. 

• Assess EBI(s) to determine their 

compatibility with the needs of the 

community and IHS capacity and 

resources. No EBI(s) are capable of 

addressing all of the identified risk 

behaviors and contextual factors in the 

selected population. NARCH partners 

will select those most suitable for 

adaptation and implementation (i.e., the 

EBI that can be adapted to be most 

responsive to identified risk behaviors, 

contextual factors, and circumstances). 

• Review adaptations to determine 

cultural proficiency. 

• Conduct process evaluation to 

document an evidence base for the 

adaptations. 

• Adapt and tailor selected 

interventions to meet the needs of the 

AI/AN population identified. 

• Implement the adapted and tailored 

interventions. 

• Evaluate the utility and 

effectiveness of the adaptation and 

tailoring of the intervention. 

• Evaluate the effectiveness of the 

adapted and tailored intervention. 

Compare the magnitude of behavioral/ 

biologic change in the original and 

adapted interventions using measures 

from the original intervention with as 

little modification as possible (i.e. 

unprotected sex, condom negotiation, 

numbers of sex partners, etc). 

• Collaborate with IHS national 

programs (IHS Research Program and 

IHS National HIV Program) per 

quarterly meetings (including use of 

telecommunications) and by providing 

data on a bi-annual basis, identifying 

and documenting best practices for 

developing and implementing 

interventions. 

• Document the operational processes 

used during adaptation, tailoring, 

implementation and evaluation. 

• Report to IHS Research Program. A 

three page mid-year progress report and 

no more than a ten-page summary 

annual assessment and evaluation at the 

end of each project year. The report 

should establish the impact and 

outcomes of various methods of 

adapting, tailoring and implementing 

the intervention. 

2. HHS Activities (IHS Research and 

HIV Programs and CDC) 

• Provide funded NARCH with 

ongoing consultation and technical 

assistance to plan, implement, and 

evaluate each component of the 

comprehensive program as described 

under Recipient Activities above. 

Consultation and technical assistance 

will include, but not be limited to, the 

following areas: 

(a) CDC will train grantee(s) to deliver 

the original intervention. Grantees 

trained in the original intervention will 

develop an adapted and tailored 

intervention training curriculum based 

on the original intervention training 

included in the REP intervention 

package. Grantees will train local staff. 

(b) Provide oversight and technical 

assistance throughout adaptation, 

tailoring, implementation and 

evaluation. Awardees will implement 

the adapted intervention tailored to 

address the AI/AN population and 

locale. 

(c) Analyze Data: Participate in 

analysis of data gathered from project 

activities; assist in reporting and 

disseminating results. 

(d) Provide overall operational 

planning and program management. 

• Conduct site visits to assess 

program progress and mutually resolve 

problems, as needed. 

• Coordinate these activities with all 

IHS HIV activities on a national basis. 

• Coordinate with the CBB of DHAP 

at CDC to provide technical assistance 

related to the selection of the 


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appropriate EBI or PHS, cultural and 

linguistic adaptation of the intervention 

and supporting materials, and training 

of facilitators. 

II. Award Information 

Type of Awards 

Competitive supplemental revisions 

to existing NARCH V awards. 

Estimated Funds Available 

The total amount of funding 

identified for the current fiscal year (FY) 

2010 is approximately $1,800,000. 

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 awards 

funded under this announcement. 

Anticipated Number of Awards 

Three supplements of $600,000 per 

grantee are anticipated in FY 2010 

under the existing NARCH V awards. 

Additional NARCH awards may be 

supplemented, if additional funds 

become available. 

Project Period 

Projects will be funded for one annual 

budget period. There will be yearly 

continuation applications required. The 

continuation years will be pending 

funding and based on the following: 

• Satisfactory progress. 

• Availability of funds and agency 

capacity to sustain program(s). 

• Continuing need for IHS to support 

the program (program priorities). 

Awardees will be required to submit 

semi-annual cumulative progress 

reports, as described within this 

announcement and existing NARCH V 

Notices of Grant Award (NoA), as well 

as the Standard Form (SF) 2590 and a 

Progress Report, annually and financial 

statements as required in the PHS 

Grants Policy Statement, revised 0107. 

Forms are available at the following 

Web site http://grants.nih.gov/grants/

funding/2590/2590.htm. The progress 

report should provide information about 

changes in the program and a summary 

report of any evaluations. These biannual reports will be closely monitored 

by the IHS staff to ensure that the grant 

is achieving the goals of the Office of 

HIV/AIDS Policy (OHAP) and the 

NARCH program. 

III. Eligibility Information 

1. Eligibility 

Eligible applicants are limited to 

current NARCH grantees with at least 

two years remaining of their current 

NARCH project period. Proof of 

eligibility status will be confirmed by 

the IHS Research Program. No current 

grantees other than existing NARCH V 

grantees are expected to meet this 

remaining project period requirement. 

2. Cost Sharing or Matching 

The NARCH Program does not require 

matching funds or cost sharing. 

3. Other Requirements 

Letters of intent are not required 

under this announcement. 

IV. Application and Submission 

Information 

1. Obtaining Application Materials 

1. The application package and 

instructions can be requested from the 

NARCH Program Official, Reyes 

Building, 801 Thompson Avenue, 

Rockville, MD 20852 or by e-mail to 

narch@ihs.gov. The National Institutes 

of Health (NIH) PHS 398 application 

instructions are available in an 

interactive format at: http://grants.nih.

gov/grants/funding/phs398/phs398.

html. Applicants must use the currently 

approved version of the PHS 398. For 

further assistance contact Mr. Paul 

Gettys Telephone (301) 443–2114, Email: Paul.Gettys@ihs.gov. In any 

instance where the PHS 398 instructions 

are contradicted by this announcement, 

the instructions in this announcement 

must be followed. PHS 398 page limits 

should be followed as for NIH activity 

Code R21. 

2. Content and Form Application 

Submission 

Mandatory documents for all 

applicants include: 

• Application forms: 

• PHS–398 Package http://grants.nih.

gov/grants/funding/phs398/phs398.

html; 

• Documentation of current OMB A– 

133 required Financial Audit, if 

applicable. Acceptable forms of 

documentation include: 

Æ E-mail confirmation from Federal 

Audit Clearinghouse (FAC) that audits 

were submitted; or 

Æ Face sheets from audit reports. 

These can be found on the FAC Web 

site: http://harvester.census.gov/fac/

dissem/accessoptions.html?submit=

Retrieve+Records. 

• Disclosure of Lobbying Activities 

(SF–LLL) (if applicable). 

Public Policy Requirements 

All Federal-wide public policies 

apply to IHS grants with exception of 

the Discrimination policy. 

3. Submission Dates and Times 

Submit a typed and signed original 

application, including the Checklist, 

and five (5) single-sided photocopies of 

the entire application (including 

Appendices and supporting documents) 

in one package to: Division of Grants 

Operations, Indian Health Service, 

Reyes Building, 801 Thompson Avenue, 

TMP 360, Rockville, MD 20852–1627 

Attn: Mr. Roscoe Brunson, (zip code is 

unchanged for express/courier services), 

Telephone: (301) 443–5204 by no later 

than 5pm EDT on June 30, 2010. 

Letters of Intent: Letters of Intent will 

not be required under this funding 

opportunity announcement. 

4. Intergovernmental Review 

Executive Order 12372 requiring 

intergovernmental review is not 

applicable to this program. 

5. Funding Restrictions 

• Pre-award costs are not allowable 

under this announcement. 

• The available funds are inclusive of 

direct and appropriate indirect costs. 

• Only one grant/cooperative 

agreement will be awarded per 

applicant. 

• IHS will not acknowledge receipt of 

applications. 

6. Dun and Bradstreet (D&B) Data 

Universal Numbering System (DUNS) 

Applicants are required to have a 

DUNS number to apply for a grant or 

cooperative agreement from the Federal 

Government. The DUNS number is a 

unique nine-digit identification number 

provided by D&B, which uniquely 

identifies business entities. The DUNS 

number is site specific; therefore each 

distinct performance site may be 

assigned a DUNS number. Obtaining a 

DUNS number is easy and there is no 

charge. To obtain a DUNS number, 

access http://fedgov.dnb.com/webform 

or by phone (866) 705–5711. 

V. Application Review Information 

Points will be assigned to each 

evaluation criteria adding up to a total 

of 100 points. A minimum score of 65 

points is required for funding. Points are 

assigned as follows: 

1. Evaluation Criteria 

The instructions for preparing the 

application narrative also constitute the 

evaluation criteria for reviewing and 

scoring the application. Weights 

assigned to each section are noted in 

parentheses. The narrative should 

include all prior years of activity; 

information for multi-year projects 

should be included as an appendix (see 

E. ‘‘Categorical Budget and Budget 

Justification’’) at the end of this section 

for more information. It should be well 

organized, succinct, and contain all 


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information necessary for reviewers to 

understand the project fully. You are 

required to provide measures of 

effectiveness that will demonstrate the 

accomplishment of the various 

identified research objectives of the 

grant. Measures of effectiveness must 

relate to the purpose and goal stated in 

the ‘‘Funding Description’’ section of 

this announcement. Measures should 

include process and outcome 

information and contain both 

quantitative and qualitative data that 

measure the intended outcome. These 

measures of effectiveness must be 

submitted with the application and will 

be an element of evaluation. The goals 

of this IHS-supported research are to 

advance the understanding of HIV/ 

AIDS-related behavior and biological 

systems, improve the control and 

prevention of HIV/AIDS, and enhance 

community health and wellness. In the 

written comments, reviewers will be 

asked to evaluate the application and 

the likelihood that the proposed 

research will have a substantial impact 

on the pursuit of these goals. 

A. Significance (10 Points) 

a. Is the proposed selection process of 

the specific EBI to be implemented 

justified in terms of AI/AN risk, AI/AN 

behavior, and HIV or STD 

epidemiology? Are the proposed 

interventions and populations 

realistically matched in terms of 

behavioral determinants and risk 

behaviors? Is the applicant’s selected 

AI/AN population either small with 

high HIV incidence or harder to gain 

access to (e.g. male-to-female 

transgender, men who have sex with 

other men, rural communities with high 

stigma, etc.)? Is the selected population 

HIV positive? If HIV has not yet been 

detected in the population, are there 

existing STD or blood-borne disease 

problems that suggest a fertile field for 

HIV dissemination if the virus were to 

enter the community? 

b. If the aims of the application are 

achieved, how will scientific knowledge 

in AI/AN be advanced? What will be the 

effect of these studies on AI/AN 

communities and what will be the 

benefits to service providers and/or 

communities? 

c. Define the project target population, 

identify their unique characteristics, 

and describe the impact of HIV and/or 

other STDs or blood-borne diseases on 

the population. 

B. Research Objectives and Approach 

(40 Points) 

Applicants should address the 

following research objectives in their 

application: 

a. Process of selection, adaptation, 

tailoring and implementation of the EBI. 

One potential EBI may be selected to 

use as a tentative example in the 

application, to illustrate the approach 

that is planned by the applicant. 

However, if used, the example EBI 

should be justified for the anticipated 

population, either in terms of relevant 

theory or based on preliminary, 

preparatory T/CBPR activity such as 

meetings with Tribal officials, groups, 

Community Advisory Boards of the 

existing NARCH, or focus groups. Use of 

a specific EBI as an example as 

described above is not required in the 

application and is only one of various 

different ways the applicant may choose 

to describe their approach. If an 

example EBI is chosen for use in the 

application, it will not necessarily be 

the EBI finally chosen by the grantee’s 

full eventual process if the grant is 

funded. 

b. Refinement of adaptation and 

tailoring guidance. 

c. Research plan should address 

activities to be conducted over the 

entire project period. Are the conceptual 

framework, design, methods, and 

analyses adequately developed, wellintegrated, and appropriate to the aims 

of the project? Does the applicant 

acknowledge potential problem areas 

and consider alternative tactics? 

d. How will grantee gain access to and 

rapidly assess the specific population(s) 

(i.e., via community planning groups, 

community advisory boards, focus 

groups)? Has the applicant used local 

data to inform the current RFA? Are 

there existing relationships between the 

applicant and local/Tribal public health 

authorities and/or Tribal or IHS medical 

providers? Is the plan to obtain 

appropriate Tribal and/or Board 

approval(s) to test the intervention 

adequately described? 

e. Has the applicant demonstrated 

how they will establish and maintain 

collaboration with universities, research 

partners, IHS national programs, etc.? 

f. Has the applicant chosen an 

adequate sample size and demonstrated 

access to at least that many members of 

the target population who are not 

currently receiving intervention, 

particularly if the population is small or 

hard-to-reach? 

g. Has the applicant included a 

relative timeline or action plan for each 

phase of activities (selection, 

assessment, adaptation, tailoring, 

implementation, and evaluation 

including milestones; costs; 

development of materials (i.e., adapted 

and tailored training curriculum, 

evaluation tools, checklists) and 

required reports? Absolute timelines 

and dates will not be required. 

However, each necessary step should be 

described, in logical order, to complete 

the project within the total budget 

amount allowed ($600,000). 

h. Has the applicant demonstrated 

sufficient understanding of EBI(s) as set 

forth by the CDC? 

i. Describe how the program will 

ensure that the intervention services 

and analyses will be culturally sensitive 

and relevant. 

C. Innovation (10 Points) 

a. Does the project employ concepts, 

approaches or methods novel to 

standard biomedical science? 

b. Does the project challenge existing 

paradigms or develop new 

methodologies or technologies? 

c. Is the target sub-population one that 

is not typically targeted for behavioral 

intervention research (e.g. AI/AN 

transgender, AI/AN men who have sex 

with other men, AI/AN communities, 

etc)? 

D. Project Evaluation and Reporting (20 

Points) 

a. Does the grantee provide a clear 

and organized plan for monitoring and 

evaluating each phase of the project 

through implementation, and to identify 

best practices? 

b. Has the applicant provided a 

quality assurance plan that addresses all 

phases of adaptation, tailoring, 

implementation and evaluation and 

included personnel responsible for 

ensuring quality? Has the applicant 

provided a plan for documenting 

process measures including who is 

responsible, processes to be measured, 

and sample tools that might be used? 

c. Do the outcomes and performance 

measures described in the evaluation 

include both quantitative and 

qualitative approaches? 

d. Reporting Requirements. Does 

application provide a clear and 

organized plan to strictly adhere to 

reporting requirements set forth in 

section VI.4.? 

e. Based on the plans for monitoring, 

evaluation through each phase, and 

reporting, does the grantee demonstrate 

obvious understanding of the evaluation 

and reporting processes and 

requirements? 

E. Organizational Capacity (10 Points) 

This section outlines the broader 

capacity of the organization to complete 

the project outlined in the work plan. It 

includes the identification of principal 

investigator and personnel responsible 

for completing tasks for successful 

completion of the project. 

a. Describe the ability of the 

organization to manage the proposed 


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research project and the quality of the 

established NARCH partnership(s). 

b. Include information regarding any 

similarly sized projects in scope and 

financial assistance as well as any other 

similar projects successfully completed 

and/or under way. 

c. Note who will be writing the 

required reports. 

F. Categorical Budget and Budget 

Justification (10 Points) 

Is the proposed budget reasonable in 

relation to the proposed work and 

research? Applicants must provide an 

itemized budget to complete the project 

in one year and budget justification for 

direct and indirect costs. 

a. Narrative justification for all costs, 

explaining why each line item is 

necessary or relevant to the proposed 

project. 

b. Budget justification should include 

a brief program narrative for the second 

and third years, in the event that the 

project is not completed in the first year. 

2. Review and Selection 

Each application will be prescreened 

by the DGO staff for eligibility and 

completeness as outlined in the funding 

announcement. Incomplete applications 

and applications that are nonresponsive to the eligibility criteria will 

not be referred to the Objective Review 

Committee. Applicants will be notified 

by DGO, via letter, to outline the 

missing components of the application. 

To obtain a minimum score for 

funding, applicants must address all 

program requirements and provide all 

required documentation. Applicants 

that receive less than a minimum score 

will be informed via e-mail of their 

application’s deficiencies. A summary 

statement outlining the strengths and 

weaknesses of the application will be 

provided to these applicants. The 

summary statement will be sent to the 

Authorized Organizational 

Representative that is identified on the 

face page of the application. 

VI. Award Administration Information 

1. Award Notices 

The Notice of Award (NoA) will be 

initiated by the DGO and will be mailed 

via postal mail to each entity that is 

approved for funding under this 

announcement. The NoA will be signed 

by the Grants Management Officer and 

this is the authorizing document for 

which funds are dispersed to the 

approved entities. The NoA will serve 

as the official notification of the grant 

award and will reflect the amount of 

Federal funds awarded, the purpose of 

the grant, the terms and conditions of 

the award, the effective date of the 

award, and the budget/project period. 

The NoA is the legally binding 

document and is signed by an 

authorized grants official within the 

IHS. 

2. Administrative Requirements 

Grants are administered in accordance 

with the following regulations, policies, 

and OMB cost principles: 

A. The criteria as outlined in this 

Program Announcement. 

B. Administrative Regulations for 

Grants: 

• 45 CFR, Part 92, Uniform 

Administrative Requirements for Grants 

and Cooperative Agreements to State, 

Local and Tribal Governments. 

• 45 CFR, Part 74, Uniform 

Administrative Requirements for Grants 

and Agreements with Institutions of 

Higher Education, Hospitals, and other 

Non-profit Organizations. 

C. Grants Policy: 

• HHS Grants Policy Statement, 

Revised 01/07. 

D. Cost Principles: 

• Title 2: Grant and Agreements, Part 

225—Cost Principles for State, Local, 

and Indian Tribal Governments (OMB 

A–87). 

• Title 2: Grant and Agreements, Part 

230—Cost Principles for Non-Profit 

Organizations (OMB Circular A–122). 

E. Audit Requirements: 

• OMB Circular A–133, Audits of 

States, Local Governments, and Nonprofit Organizations. 

3. Indirect Costs 

This section applies to all grant 

recipients that request reimbursement of 

indirect costs in their grant application. 

In accordance with HHS Grants Policy 

Statement, Part II–27, IHS requires 

applicants to obtain a current indirect 

cost rate agreement prior to award. The 

rate agreement must be prepared in 

accordance with the applicable cost 

principles and guidance as provided by 

the cognizant agency or office. A current 

rate covers the applicable grant 

activities under the current award’s 

budget period. If the current rate is not 

on file with the DGO at the time of 

award, the indirect cost portion of the 

budget will be restricted. The 

restrictions remain in place until the 

current rate is provided to the DGO. 

Generally, indirect costs rates for IHS 

grantees are negotiated with the 

Division of Cost Allocation (DCA) 

http://rates.psc.gov/and the Department 

of Interior (National Business Center) 

http://www.aqd.nbc.gov/indirect/ 

indirect.asp. If your organization has 

questions regarding the indirect cost 

policy, please call (301) 443–5204 to 

request assistance. 

4. Reporting Requirements 

The reporting requirements for this 

program are noted below. 

A. Progress Reports 

Program progress reports are required 

semi-annually. These reports will 

include a brief comparison of actual 

accomplishments to the goals 

established for the period, or, if 

applicable, provide sound justification 

for the lack of progress, and other 

pertinent information as required. A 

final report must be submitted within 90 

days of expiration of the budget/project 

period. 

B. Financial Reports 

Semi-annual Financial Status Reports 

(FSR) reports must be submitted within 

30 days after the budget period ends. 

Final FSRs are due within 90 days of 

expiration of the project period. 

Standard Form 269 (long form for those 

reporting on program income; short 

form for all others) will be used for 

financial reporting. 

Federal Cash Transaction Reports are 

due every calendar quarter to the 

Division of Payment Management, 

Payment Management Branch at: 

www.dpm.gov. Failure to submit timely 

reports may cause a disruption in timely 

payments to your organization. 

Grantees are responsible and 

accountable for accurate reporting of the 

Progress Reports and Financial Status 

Reports which are generally due semiannually. Financial Status Reports (SF– 

269) are due 90 days after each budget 

period and the final SF–269 must be 

verified from the grantee records on 

how the value was derived. 

Failure to submit required reports 

within the time allowed may result in 

suspension or termination of an active 

grant, withholding of additional awards 

for the project, or other enforcement 

actions such as withholding of 

payments or converting to the 

reimbursement method of payment. 

Continued failure to submit required 

reports may result in one or both of the 

following: (1) The imposition of special 

award provisions; and (2) the nonfunding or non-award of other eligible 

projects or activities. This requirement 

applies whether the delinquency is 

attributable to the failure of the grantee 

organization or the individual 

responsible for preparation of the 

reports. 

Telecommunication for the hearing 

impaired is available at: TTY (301) 443– 

6394. 


erowe on DSK5CLS3C1PROD with NOTICES
Federal Register / Vol. 75, No. 110 / Wednesday, June 9, 2010 / Notices 32797 

VII. Agency Contacts 

Grants (Business): For specific grantrelated and business management 

information: 

Roscoe Brunson, Grants Management 

Specialist, 801 Thompson Avenue, 

TMP, Suite 360, Rockville, MD 20852, 

(301) 443–5204 or 

roscoe.brunson@ihs.gov. 

Program (Programmatic/Technical): 

For program-related and general 

information regarding this 

announcement: 

Alan Trachtenberg, MD, MPH, IHS 

Research Program, 801 Thompson 

Ave, TMP Suite 450, Rockville, MD 

20852, (301) 443–0578 or 

narch@ihs.gov. 

Dated: June 2, 2010. 

Yvette Roubideaux, 

Director, Indian Health Service. 

[FR Doc. 2010–13852 Filed 6–8–10; 8:45 am] 

BILLING CODE 4165–16–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Health Center Program 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice of Noncompetitive 

Replacement Awards to Albany Area 

Primary Health Care, Inc. 

SUMMARY: The Health Resources and 

Services Administration (HRSA) will be 

transferring Health Center Program 

(section 330 of the Public Health Service 

Act) Community Health Center (CHC), 

Increased Demand for Services (IDS), 

and Capital Improvement Program (CIP) 

funds originally awarded to Unadilla 

Health Care Center, Inc., to Albany Area 

Primary Health Care, Inc., to ensure the 

provision of critical primary health care 

services to underserved populations in 

Dooly County, Georgia. 

SUPPLEMENTARY INFORMATION: 

Former Grantee of Record: Unadilla 

Health Care Center, Inc. 

Original Period of Grant Support: 

December 1, 2008, to November 30, 

2010 (CHC); March 27, 2009, to March 

26, 2011 (IDS); and June 29, 2009, to 

June 28, 2011 (CIP). 

Replacement Awardee: Albany Area 

Primary Health Care, Inc. 

Amount of Replacement Awards: The 

current awards for Unadilla Health Care 

Center, Inc., were issued at $678,041 

(CHC); $126,411 (IDS); and $316,325 

(CIP). The amounts transferred will be 

the remaining funds from those most 

recent awards. 

Period of Replacement Awards: The 

period of support for the replacement 

awards is the remaining time in the 

Health Center project period ending on 

November 30, 2010 (CHC); March 26, 

2011 (IDS); and June 28, 2011 (CIP). 

Authority: Section 330 of the Public 

Health Service Act, 42 U.S.C. 254b. 

CFDA Numbers: 93.224 and 93.703 

Justification for the Exception to 

Competition 

The former grantee, Unadilla Health 

Care Center, Inc. (UnaHealth), notified 

HRSA that it was unable to carry out the 

administrative and programmatic 

requirements to appropriately manage 

the grant funds and indicated that it 

would be relinquishing the grant funds. 

UnaHealth is unable to provide the 

necessary primary health care services 

in Dooly County, Georgia, to the more 

than 3,000 low income, underserved 

and uninsured individuals in the 

service area. 

Albany Area Primary Health Care, Inc. 

(AAPHC) is an experienced provider of 

care and has a demonstrated record of 

compliance with the Health Center 

Program statutory and regulatory 

requirements and is located in the same 

geographical area. AAPHC will provide 

services to the residents of Dooly 

County at a site proximate to 

UnaHealth’s current location. 

Community support for this transfer is 

demonstrated by letters of support from 

three other existing section 330 grantees 

in the service area, as well as a letter of 

support from the local Primary Care 

Association. 

This underserved target population 

has an immediate need for vital primary 

health care services and would be 

negatively impacted by any delay or 

disruption of services caused by a 

competition. As a result, in order to 

ensure that critical primary health care 

services remain available to the original 

target population without disruption, 

this replacement award will not be 

competed. 

FOR FURTHER INFORMATION CONTACT: 

Lynn Spector via e-mail at 

lspector@hrsa.gov or 301–594–4300. 

Dated: June 3, 2010. 

Mary K. Wakefield, 

Administrator. 

[FR Doc. 2010–13865 Filed 6–8–10; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Environmental 

Health Sciences; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Environmental Health Sciences Special 

Emphasis Panel; Conferences and Scientific 

Meetings Support. 

Date: June 30, 2010. 

Time: 1 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: NIEHS/National Institutes of Health, 

Building 4401, East Campus, 79 T.W. 

Alexander Drive, Research Triangle Park, NC 

27709, (Telephone Conference Call) 

Contact Person: Leroy Worth, PhD, 

Scientific Review Officer, Scientific Review 

Branch, Division of Extramural Research and 

Training, Nat. Institute of Environmental 

Health Sciences, P.O. Box 12233, MD EC–30/ 

Room 3171, Research Triangle Park, NC 

27709, (919) 541–0670, worth@niehs.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.115, Biometry and Risk 

Estimation—Health Risks from 

Environmental Exposures; 93.142, NIEHS 

Hazardous Waste Worker Health and Safety 

Training; 93.143, NIEHS Superfund 

Hazardous Substances—Basic Research and 

Education; 93.894, Resources and Manpower 

Development in the Environmental Health 

Sciences; 93.113, Biological Response to 

Environmental Health Hazards; 93.114, 

Applied Toxicological Research and Testing, 

National Institutes of Health, HHS) 

Dated: June 2, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–13842 Filed 6–8–10; 8:45 am] 

BILLING CODE 4140–01–P 


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