[Federal Register Volume 69, Number 104 (Friday, May 28, 2004)]
[Notices]
[Pages 30673-30684]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-12083]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Indian Health Service


Special Diabetes Program for Indians Competitive Grant Program; 
New Request for Application of Funds

    CFDA Number: 93.442.
    Key Dates:
    Letter of Intent Deadline: June 1, 2004.
    Application Deadline: July 15, 2004.

Overview

    The Indian Health Service (IHS) announces a new initiative under 
the Special Diabetes Program for Indians

[[Page 30674]]

(SDPI). This funding mechanism is a competitive grant program that will 
provide funding to selected SDPI grantees for a demonstration project 
to implement and evaluate defined activities in one of two areas 
(primary prevention of diabetes or prevention of cardiovascular disease 
in people with diabetes). The total amount of funding available is 
$23.3 million annually and the number of anticipated awards will be 
approximately 60 grants (30 for each demonstration project). Eligible 
applicants include grantees that have received SDPI funding. Applicants 
may submit one application per demonstration project (i.e., primary 
prevention of diabetes or prevention of cardiovascular disease in 
people with diabetes). Therefore, while most programs will only submit 
one application for one demonstration project, some may choose to 
submit one application for each demonstration project, for a total of 
two applications. However, applicants will only be eligible to receive 
one award for funding for one demonstration project. Competing grant 
applications will be accepted with a receipt date of July 15, 2004. 
There will be only one funding cycle for the project period FY2005-
FY2009. The anticipated start date for the awards will be September 29, 
2004. Applications will be mailed to all current SDPI grantees on or 
before June 1, 2004, and will be available on request from the IHS 
Grants Management Branch and the IHS National Diabetes Program. The 
application will also be posted on the IHS National Diabetes Program 
website.
    Awards will be subject to the availability of funds and grants will 
be administered in accordance with applicable Office of Management and 
Budget (OMB) Circulars, Department of Health and Human Services grant 
regulations at 45 CFR parts 74 and 92, the Public Health Service Grants 
Policy Statement, and other applicable IHS policies and procedures such 
as the regulations governing protection of human subjects at 45 CFR 
part 46.
    This initiative is described in the Catalog of Federal Domestic 
Assistance Nos. 93.442. Sections 301(a) and 405 of the Public Health 
Service Act, as amended, authorize these awards, and these are 
administered under PHS grants policies and Federal Regulations 42 CFR 
parts 52c, 74, and 92.
    The PHS strongly encourages all grant and contract recipients to 
provide a smoke-free workplace and promote the non-use of all tobacco 
products. In addition, Public Law 103-227, the Pro-Children Act of 
1994, prohibits smoking in certain facilities (or in some cases, any 
portion of a facility) in which regular or routine education, library, 
day care, health care or early childhood development services are 
provided to children. This is consistent with the PHS mission to 
protect and advance the physical and mental health of the American 
people.

I. Funding Opportunity Description

    The Indian Health Service (IHS) has developed a new competitive 
grant program under the Special Diabetes Program for Indians (42 U.S.C. 
254c-3). In response to Congressional direction (letter to IHS Director 
dated February 10, 2003) from Rep. George R. Nethercutt, Chair of the 
Diabetes Caucus for Congress, and subsequent Conference Language the 
purpose of this initiative is to provide funding to selected SDPI 
grantees for a demonstration project to implement and evaluate defined 
activities in each of two intervention areas (primary prevention of 
diabetes or prevention of cardiovascular disease in people with 
diabetes).

1. Background

    Diabetes is a serious problem for American Indians and Alaska 
Natives (AI/AN), and the prevalence of diabetes is increasing over time 
in this population (Burrows, 2000). In 1997, Congress appropriated 
funding in the amount of $30 million per year for the Special Diabetes 
Program for Indians (SDPI) to the Indian Health Service for the 
prevention and treatment of diabetes in AI/ANs (Roubideaux, 2001). This 
program of grants to Indian Health Service (IHS), tribal and urban 
Indian health programs has resulted in over 300 diabetes prevention and 
treatment programs in Indian communities. In 2003, Congress increased 
the SDPI funding to $150 million per year and directed the IHS to use a 
portion of the increase in funding for a ``competitive grant program'' 
to fund grantees to implement activities in two areas: (1) Primary 
prevention of diabetes; and (2) cardiovascular disease risk reduction 
in people with diabetes. In 2003, the Director of the IHS held a tribal 
consultation meeting to gather input from tribes on the SDPI 
competitive grant program. The resulting program is described in this 
Request for Applications.

2. Primary Prevention of Diabetes

    Research studies have recently shown that the risk of developing 
diabetes can be reduced in at-risk individuals through lifestyle 
changes and medication. The Diabetes Prevention Program, a randomized 
clinical trial funded by NIH, recruited 3234 individuals with Impaired 
Glucose Tolerance (IGT) to receive a lifestyle modification program, 
metformin or usual care. The study announced results in 2002 that the 
lifestyle modification program was associated with a reduction in the 
risk of diabetes by 58 percent. Metformin reduced the risk of diabetes 
by 31 percent (Knowler, 2002). Forty-five percent of participants were 
from minority groups, and 171 individuals in this study were American 
Indian. Importantly, the beneficial effects of these interventions were 
equal in all groups enrolled in the study, including American Indians. 
Other smaller studies have also shown that lifestyle changes can reduce 
the risk of developing diabetes, such as the Finnish and Da Qing 
studies (Pan XR, 1997; Tuomilehto J, 2001).

3. Cardiovascular Disease Risk Reduction

    Individuals with diabetes are at risk for cardiovascular disease 
(CVD), and the incidence of CVD in AI/ANs now exceeds rates in the 
general population. The Strong Heart Study, a longitudinal cohort study 
of the risk factors for cardiovascular disease in American Indians, has 
demonstrated that diabetes is a major risk factor and accounts for the 
majority of risk for cardiovascular disease events in American Indians 
(Howard, 1999). The risk of cardiovascular disease in individuals with 
diabetes can be reduced through control of blood pressure, reduction in 
cholesterol levels, glycemic control, aspirin use, smoking cessation, 
physical activity and weight management (ADA, 2004).

4. Summary of Demonstration Projects

Eligible Applicants
    SDPI grant recipients are eligible to apply for the SDPI 
Competitive Grant Program if they are one of the following entities:

A. Indian Health Service hospital or clinic
B. Federally-Recognized Tribes
C. Title V Urban Indian Health Programs
D. Consortium of any of the above

    Non-profit Tribal organizations and Area Indian/tribal health 
boards are not eligible to apply for these grants, consistent with 
recent tribal consultation on this issue. These organizations may be 
funded by eligible entities to assist with the demonstration project.
    Eligible entities may apply for one or both demonstration projects, 
but will only be funded for one project (primary prevention of diabetes 
or cardiovascular

[[Page 30675]]

disease risk reduction). Eligible entities may only participate in a 
consortium once for each demonstration project area (primary prevention 
of diabetes or cardiovascular disease).
Setting
    Applicants must demonstrate the following:
     Minimum burden of diabetes in population served--
applicants must submit information to show that the burden of diabetes 
in their community is significant and justifies funding for this 
demonstration project, such as the user population of their health 
program, the number of individuals in their diabetes registry, and any 
other descriptive data quantifying the problem of diabetes in the 
population served. In general, successful applicants will have at least 
a user population of 2500 and/or a diabetes registry of at least 250 
individuals. Eligible entities that have a diabetes registry of less 
than 250 people are encouraged to form a consortium with other eligible 
entities. In general, the minimum size of a consortium should be a 
total combined user population of >= 2500 and /or a total combined 
diabetes registry >= 250.
     Prior success in diabetes prevention and treatment 
activities--applicants must demonstrate prior successful activities to 
prevent or treat diabetes, including a description of the activities, 
any evaluation or outcomes so far, and evidence of successful 
compliance with SDPI requirements.
     Basic health infrastructure to participate in project--the 
applicant must demonstrate that the following basic health 
infrastructure is in place or a plan for putting it into place with 
this funding mechanism:
     Clinical services--such as a health clinic or center
    [ctrcir] Laboratory--available for testing associated with the 
demonstration project.
    [ctrcir] Administrative and financial staff to manage and monitor 
the project.
    [ctrcir] Health professionals--on site health educator/diabetes 
educator, dietitian, physical activity specialist, full-time clerk/
recruiter for this project, and physician consultant.
    [ctrcir] Pharmacist--available for project.
    [ctrcir] Data Coordinator--at least one person on site to manage 
data collection for the project and to report data to Coordinating 
Center.
    [ctrcir] RPMS site manager to use DMS, Lab, and Pharmacy packages.
    [ctrcir] Additional staff are recommended for each demonstration 
project:
    [dec221] Primary Prevention of Diabetes--diabetes educator and/or 
nurse to teach curriculum.
    [dec221] Cardiovascular Disease Risk Reduction--nurse case 
manager(s).
Structure
    The overall structure of the SDPI Competitive Grant Program will 
include:
     IHS National Diabetes Program--general oversight, 
coordination and leadership of SDPI Competitive Grant Program.
     IHS Grants Management Branch--general oversight of grant 
administration, financial audits, monitoring and reporting.
     Grantees--approximately 30 grantees in each of the two 
demonstration projects, approximately 60 total grantees.
     Coordinating Center--responsible for day-to-day 
coordination of data collection, evaluation, and certain logistics 
related to the Competitive Grant Program activities.
     Resource Center--responsible for providing technical 
assistance to grantees, including availability of medical experts 
related to the activities of the project.
Organizational Chart for SDPI Competitive Grant Program
    See Section VIII--Other Information.

5. Description of Each Demonstration Project

    In the following section, the primary prevention of diabetes 
demonstration project will be described first in terms of the 
participants and planned activities. Then, the cardiovascular disease 
risk reduction demonstration project will be described in a similar 
manner.
Primary Prevention of Diabetes
    Participant Eligibility, Recruitment, and Retention (Participants 
in demonstration project activities). Applicants must provide a plan 
for identifying, recruiting, screening and retaining individuals at 
risk for diabetes to participate in activities to prevent diabetes. 
Individuals recruited to participate in the activities of the primary 
prevention of diabetes demonstration project must meet the following 
criteria:
     Age > 18.
     At Risk for Diabetes/Pre-Diabetes--grantees will screen 
individuals at high risk for developing diabetes and recruit them to 
participate in activities to prevent diabetes as follows:
    [cir] Screening for pre-diabetes--individuals with any of the 
following risk factors for diabetes or components of the Metabolic 
Syndrome will be identified and screened for pre-diabetes:
    [dec221] Family member with diabetes.
    [dec221] Prior diagnosis of gestational diabetes.
    [dec221] Any component of Metabolic Syndrome (Grundy, 2004):
    -- Overweight or Obesity, especially abdominal obesity (BMI > 30; 
waist circumference > 40 inches in men and 35 inches in women; or 
waist:hip ratio > 0.9 in men, 0.85 in women).
    -- Blood pressure >= 130/85 mm Hg or previous diagnosis of 
hypertension.
    -- Fasting glucose >= 100 mg/dl.
    -- Low HDL Cholesterol (< 40 mg/dl in men, < 50 mg/dl in women).
    [dec221] High Triglycerides (>= 150 mg/dl).
    [cir] While fasting blood glucose may be used for screening, the 
diagnosis of pre-diabetes will be by Oral Glucose Tolerance Test (2-
hour blood glucose: 100-125 mg/dl = IFG; 140-199 mg/dl = IGT). For 
further information on the definition of pre-diabetes, see Section 
VIII--Other information.
    [cir] Intensive activities--individuals who are screened and 
diagnosed with pre-diabetes [Impaired Glucose Tolerance (IGT) or 
Impaired Fasting Glucose (IFG)] will be recruited to participate in 
intensive diabetes prevention activities.
    [cir] Less-Intensive, community/group activities--All Individuals 
with risk factors for diabetes, but not diagnosed with pre-diabetes, 
will participate in other less intensive diabetes prevention activities 
in the demonstration project.
    [cir] Individuals with the diagnosis of diabetes are not eligible 
to participate in the diabetes prevention activities and should be 
referred to the local health facility for diabetes care services.
     Exclusion Criteria--individuals not eligible to 
participate in the activities of the demonstration project will 
include:
    [cir] Current diagnosis of pregnancy.
    [cir] Active alcohol or substance abuse by provider judgment.
    [cir] End Stage Renal Disease on Dialysis.
     Recruitment of participants--grantees will develop 
strategies to recruit eligible individuals to participate in 
activities. Some of these activities may include:
    [cir] Sending an invitation letter after identification of eligible 
individuals for possible participation using RPMS or other clinic 
records, consistent with HIPAA regulations.
    [cir] Advertisements in local media sources, including radio, 
newspaper.
    [cir] Recruitment during screening or health events in the 
community.
    [cir] Targeted home visits to eligible individuals, perhaps by 
Community Health Representatives.
    [cir] Recruitment activities will be further refined and clarified 
through a

[[Page 30676]]

collaborative process with grantees during the first (planning) year of 
the demonstration project.
     Target Number(s) of Participants
    [cir] Primary Prevention of Diabetes--grantees will be required to 
recruit, screen and enroll individuals at risk for diabetes to reach 
minimum recruitment goals as follows: For the intensive activity, the 
16-week DPP-Like curriculum will be taught on average twice a year for 
12 people with pre-diabetes. The class can be taught twice in one week 
(same content) to help reduce attrition. For example, 12 people per 
class, times 2 classes per week, times 2 curricula per year, equals a 
minimum of 48 people participating in the intensive activity per year, 
144-192 people over 3-4 years.
    [cir] The exact target numbers of participants will be determined 
through a collaborative process with grantees in the first (planning) 
year of the demonstration project.
     Retention Plan
    Grantees will meet in the first year (planning year) to discuss 
plans for retention of participants in a collaborative process.
    Description of Primary Prevention Demonstration Project Activities. 
Grantees will be required to implement all components of the activities 
described below:
     Intensive Activities--individuals diagnosed with pre-
diabetes will undergo an intensive diabetes education intervention 
similar to the Diabetes Prevention Program. The key components of this 
educational intervention include the following:
    [cir] Initial physical exam and baseline weight, height, laboratory 
tests and other measures.
    [cir] Intensive education curriculum--modeled after the DPP 16-week 
curriculum but using a group approach, taught by a diabetes educator 
and/or nutritionist and/or physical activity specialist, weekly for 16 
weeks, then quarterly classes. Curriculum may be offered for an average 
of 12 individuals at a time, repeated once during week, so that the 
total number of participants averages 24 for the duration of the 
curriculum. The curriculum will be offered up to 3 times per year.
    [cir] Individual coaching sessions--participants will meet with 
coach monthly during curriculum and quarterly thereafter to review 
progress, encourage retention, use tool box strategies for motivation/
retention, and meet with family at least once.
     Less Intensive/Community/Group activities--individuals 
with pre-diabetes and those at risk for diabetes will participate in 
community based motivational activities such as monthly walks, health 
fairs, competitions, etc. Families can participate in these activities, 
and diabetes prevention awareness activities should be incorporated. 
This activity provides an opportunity for the grantees to tailor 
activities to community needs.
Cardiovascular Disease Risk Reduction
    Participant Eligibility, Recruitment, and Retention (Participants 
in demonstration project activities). Applicants must provide a plan 
for identifying, recruiting, and retaining individuals with diabetes to 
participate in activities to reduce the risk of cardiovascular disease. 
Individuals recruited to participate in the activities of the 
cardiovascular disease risk reduction demonstration project must meet 
the following criteria:
     Age > 18.
     Diabetes and At Risk for Cardiovascular Disease--grantees 
will recruit participants who meet the following criteria:
    [cir] Diagnosis of type 2 diabetes.
    [cir] Individuals with the diagnosis of type 2 diabetes and any 
components of the Metabolic Syndrome and/or a prior history of CVD may 
serve as a special group in this project.
    [cir] Intensive Activities--individuals with diabetes will be 
recruited to participate in an intensive clinical activity to reduce 
their risk for cardiovascular disease.
    [cir] Less Intensive/Community Activities--Individuals at risk for 
diabetes and/or cardiovascular disease will be recruited to participate 
in community-based activities to raise awareness of the risk of 
cardiovascular disease in those with diabetes.
     Exclusion Criteria--individuals not eligible to 
participate in the activities of the demonstration projects will 
include:
    [cir] Current diagnosis of pregnancy.
    [cir] Active alcohol or substance abuse by provider judgment.
    [cir] End Stage Renal Disease on Dialysis.
     Recruitment of participants--grantees will develop 
strategies to recruit eligible individuals to participate in 
activities. Some of these activities may include:
    [cir] Sending an invitation letter after identification of eligible 
individuals for possible treatment using RPMS or other clinic records, 
consistent with HIPAA regulations.
    [cir] Advertisements in local media sources, including radio, 
newspaper.
    [cir] Recruitment during screening or health events in the 
community.
    [cir] Targeted home visits to eligible individuals, perhaps by 
Community Health Representatives.
    [cir] Recruitment activities will be further refined and clarified 
through a collaborative process with grantees during the first 
(planning) year of the demonstration project.
     Target Number(s) of Participants
    [cir] Grantees will be required to recruit and enroll individuals 
with diabetes into this intensive activity to meet recruitment goals as 
follows: The minimum diabetes registry will be 250, therefore, the 
minimum number of people with diabetes to recruit is 150-200 over the 
duration of the project (50 people per year), after exclusions and 
attrition.
    [cir] The exact target numbers of participants will be determined 
through a collaborative process with grantees in the first (planning) 
year of the demonstration project.
     Retention Plan
    [cir] Grantees will meet in the first year (planning year) to 
discuss plans for retention of participants in a collaborative process.
    Description of Cardiovascular Disease Risk Reduction Demonstration 
Project Activities. Grantees will be required to implement all 
components of the activities described below:
    (1) Intensive Activities--individuals with type 2 diabetes will 
undergo an intensive, clinical and case management approach to reducing 
their risk factors for CVD. The key components of this activity include 
the following:
    (a) Initial physical exam and baseline weight, height, laboratory 
tests, ECG and other measures.
    (b) Intensive case management approach--this clinic/health center, 
team-based strategy to reducing risk factors for diabetes will include 
a case management approach in which key risk factors for CVD will be 
monitored and treated to recommended targets at monthly clinic visits. 
The strategies and targets will include:
    i. (i) Blood pressure control (< 130/80) through diet and/or 
medication as indicated.
    ii. (ii) Lipid reduction (LDL < 100; HDL > 40; Triglycerides < 150) 
through diet and/or medication as indicated.
    iii. (iii) Glycemic control (A1C < 7.0) through diet and/or 
medication as indicated.
    iv. (iv) Weight management/reduction including nutrition and 
physical activity (BMI < 30; Waist circumference < 40 inches in men, 35 
inches in women).
    v. (v) Smoking cessation in those who smoke.
    vi. (vi) Aspirin use daily as indicated.
    vii. (vii) Stress reduction/management as indicated.
    viii. (viii) Clinic visits for individual treatment monthly (risk 
reduction

[[Page 30677]]

phase), then quarterly if targets met (risk maintenance phase).
    ix. (ix) Flowsheets will be used to manage and monitor risk factors 
and treatment.
    x. (x) Education on diabetes and CVD risk reduction--can occur in 
individual or group visits.
    xi. (xi) Participants will follow a schedule of regular laboratory 
tests and other measures.
    (2) Less Intensive/Community awareness activities--individuals 
identified to be at risk for diabetes or cardiovascular disease and the 
participants and their families will participate in community-based 
awareness activities that help educate the community on ways to reduce 
their risk of diabetes and/or cardiovascular disease. This provides an 
opportunity for the grantees to tailor activities to community needs.

6. Evaluation of Demonstration Projects

    The Congressionally mandated evaluation of the SDPI Competitive 
Grant Program demonstration projects will include the following 
components:
    A. Process Evaluation--documentation of the implementation of, and 
participation in, all activities.
    B. Outcome Evaluation--the design of the outcome evaluation is 
dependent on the duration of the demonstration projects. Since the 
initiative is funded for only 5 years, with the first year being a 
planning year and the last year being partially a dissemination year, 
the duration of the actual demonstration project activities then will 
be approximately 3-4 years. Given this timeline, only short and 
intermediate outcome will be actively measured. Long term outcome 
(e.g., changes in incidence and/or event rates) will be identified, 
codes will be established, and a tracking system will be developed 
within RPMS for evaluation beyond the 5 years of the project. 
Measurement will include comparisons over time (time series design) and 
comparisons between participants and non-participants (case-control 
design). Data collection will include primary data collection of key 
measures for each initiative and analysis of existing data including 
RPMS data (DM, Lab, Pharmacy packages) and the IHS Diabetes Care and 
Outcomes Audit. Evaluation measures will be further defined through a 
collaborative process in the first (planning) year and collection of 
data for certain measures will be required of all grantees. Key 
measures for each initiative may include:
    (1) Primary Prevention of Diabetes--baseline and yearly OGTT, 
weight, height, BMI, waist circumference, waist-hip ratio, assessment 
of participation in physical activity, body fat measurement, blood 
pressure, lipid panel, knowledge of diabetes and its prevention, 
barriers and challenges to participation, food intake/exercise 
journals.
    (2) Cardiovascular Disease Risk Reduction--baseline and quarterly 
A1C, blood pressure, lipid levels, weight, height, BMI, waist 
circumference, waist-hip ratio, liver/kidney function testing, smoking 
status, assessment of participation in physical activity, body fat 
measurement, knowledge of cardiovascular disease and its prevention, 
barriers and challenges to participation, food intake/exercise 
journals.

7. Participant Protections and Institutional Review Board Approval

    Applicants must describe their procedures relating to 
Confidentiality, Participant Protection, the Protection of Human 
Subjects Regulations, and compliance with Health Insurance Portability 
and Accountability Act (HIPPA) regulations, using the guidelines 
provided below. Problems with confidentiality, participant protection 
and protection of human subjects identified during peer review of the 
application may result in the delay of funding. Further guidance on 
this topic is provided in the description of the content and format of 
the application--Section IV.

8. Report of Results and Dissemination of Effort

    Given the importance of the outcomes of this demonstration project 
to future funding of the SDPI, particular emphasis will be placed on 
the timely and comprehensive reporting of results through a variety of 
mechanisms. These mechanisms include, but are not limited to: Internal 
NDP/IHS reports, regular briefings of the TLDC, Congressional testimony 
and supporting documentation, presentations to appropriate advocacy 
groups, other potential funding agencies, other SDPI grantees, I/T/U 
diabetes programs and scientific presentations/publications. Consistent 
with the government-to-government relationship between the federal 
government and tribes, all reports, presentations, and manuscripts for 
publications will be provided to the appropriate tribal or local 
organizational authority for review and approval prior to 
dissemination. However, by virtue of application under this 
announcement, and as a condition of award, grantees must agree to 
conduct said review within 30 days of notice of intent to disseminate. 
Failure to respond will be treated as concurrence and dissemination 
will proceed as proposed.
    Given the diversity and need for culturally appropriate activities, 
some of the specifics of the project activities will be developed 
through a collaborative process in the first (planning) year. Grantees 
must agree to attend at least quarterly meetings in the first year, and 
at least one annual meeting thereafter. Applicants should include 
travel costs for these required meetings in their proposed budgets.
    Timeline

PGY-01 (FY2005, FY2004 funding): Planning Year
PGY-02--PGY-4 (FY2006-2008, FY2005-2007 funding): Demonstration Project 
Activities
PGY-05 (FY2009, FY2008 funding): Dissemination/Training

II. Award Information

    The SDPI Competitive Grant Program will provide funding for 
selected SDPI grantees to demonstrate the implementation of a set of 
defined activities in one of two areas:

A. Primary Prevention of Diabetes

B. Prevention of Cardiovascular Disease in People With Diabetes

    The total estimated amount of funding available for each year of 
this initiative is $23.3 million and the number of anticipated awards 
will be approximately 60 grants. The expected amount of individual 
awards will vary based on the size of the program, and will range from 
$250,000 to $400,000 per year in total costs (direct and indirect costs 
combined). Applicants may request up to but no more than $400,000 in 
total costs (direct and indirect costs combined) per year in any year 
of the grant project. The actual amount may vary, depending on 
availability of funding, projected target numbers of participants, 
unanticipated program requirements, the number and quality of 
applications received, and the final judgment of the IHS National 
Diabetes Program. A sample budget is included in Section VIII--Other 
Information. Competing grant applications will be accepted with a 
receipt date of July 1, 2004. There will be only one funding cycle for 
FY2004-FY2008. The anticipated start date for the awards will be 
September 29, 2004. This funding will be awarded as a grant, renewable 
annually for up to 5 years. The IHS NDP will determine if grants are 
renewable after 5 years depending on funding levels and congressional 
actions. Therefore, awards may be requested for up to 5 years of 
support. Applicants should request the first year

[[Page 30678]]

as a planning year, and the next 4 years as full implementation of 
demonstration project activities. A sample budget is included in 
Section VIII--Other Information.
    Awards under this initiative will be administered using the 
competing institutional grant mechanism of the IHS. The responsibility 
for planning, directing and executing the program, as well as data 
acquisition and analysis and evaluation of the proposed program, lies 
solely with the applicant organization. However the grantee must comply 
with IHS National Diabetes Program requirements for implementation of 
the intervention and the evaluation.
    Annual continuation of awards will depend on availability of funds, 
grantee progress meeting goals and objectives, and timely submission of 
requested data and reports.

III. Eligibility Information

1. Eligible Applicants

    Applicants eligible to receive an award under this announcement are 
SDPI grantees. The applicant must be one of the following:

A. Indian Health Service program (hospital or clinic)
B. Federally-Recognized Tribe
C. Title V Urban Indian Health Program
D. A Consortium of any of the above

    If one of the above entities is sanctioned to serve as an applicant 
for more than one SDPI grantee(s), then a letter of support must be 
included in the application from each SDPI grantee the applicant is 
representing. The letter must specifically state that the applicant is 
officially representing that SDPI grantee in this application. 
Applicants for consortia who do not submit these letters of support at 
the time of the application receipt date will not be reviewed and are 
ineligible for the award. If an SDPI grantee sanctions a consortium to 
apply, that SDPI grantee may not submit another application by itself. 
Smaller applicants are encouraged to apply as a consortium, especially 
if their diabetes registry is < 250.
    Applicants are strongly encouraged to establish eligibility of 
their proposed applications prior to submission. Inquiries about 
eligibility should be addressed to Mary Tso at the National Diabetes 
Program, (505) 248-4182.
    Applicants that are not SDPI grantees are not eligible. Non-profit 
tribal organizations or national/area health boards are not eligible, 
consistent with recent tribal consultation on this issue.
    Applications that do not meet these eligibility requirements will 
be returned to the applicant without further review.

2. Cost Sharing or Matching

    The proposed application may include additional affiliated 
organizations to implement the activities of the demonstration project, 
and these organizations may include colleges or universities, 
additional tribes, or other Indian organizations/health boards. 
Applicants must include letters from these affiliated organizations 
indicating their agreement to participate in this project. The 
applicant must include information on any cost sharing and/or funding 
for subcontracts to these organizations in the budget.
    Applicants must submit a letter indicating their agreement to work 
with the SDPI Competitive Grant Program Coordinating Center and comply 
with all requirements for implementation of the interventions and the 
collection of data for the evaluation. A sample letter is included in 
the application materials.

3. Other

Other Applicant Requirements
    The applicant must be an SDPI grantee that has demonstrated prior 
compliance with SDPI grant requirements.
    The Project Director, the individual responsible for the 
administration (including fiscal management) of the overall project, 
must have his/her primary appointment with the applicant organization. 
Special arrangements of employment, such as interorganizational 
personnel agreements, are permissible. The Project Director may be, but 
is not required to be, the Project Coordinator.
    The Project Coordinator is the individual responsible for the day-
to-day leadership and management of the activities within the project.
    The Project Coordinator for the application must meet the following 
requirements:
     A relevant health professional degree.
     Experience with project management, including skills in 
project coordination, budgeting, reporting and supervision of staff.
     Working knowledge of diabetes, or a plan to receive 
relevant training.
Tribal Approval of Application/Letters of Support
    It is the policy of the IHS that all projects involving AI/AN 
Tribes be approved by the Tribal governments with jurisdiction. 
Therefore, the following documentation is required as a part of this 
application:
     For a federally recognized Indian Tribe--a resolution of 
support from the Tribal government must be part of the application. 
Applications that involve more than one Indian Tribe must include 
resolutions of support from all participating Tribes.
     For an eligible consortium of Tribes--a resolution of 
support from each Tribe of the consortium must be included.
     For Title V Urban Indian health programs--a letter of 
support from the program's board must be included.
     For IHS hospitals or clinics--a letter of support from the 
Service Unit Director or Chief Executive Officer must be included.
     For all applicants--letters of support from all partners 
and collaborating entities.
Mechanism of Support
    Awards under this initiative will be administered using the 
competing institutional grant mechanism of the IHS. The responsibility 
for planning, directing, and executing the program, as well as data 
acquisition and analysis and evaluation of the proposed program, lies 
solely with the applicant organization. The maximum grant period may 
not exceed five years, with the opportunity for a competing renewal at 
the end of that period if Congressional funding continues.

IV. Application and Submission Information

1. Address To Request Application Package

    Applications will be sent to all SDPI grantees. Applications may be 
requested at the following addresses:
     Denise Clark, Grants Management Branch, Indian Health 
Service, Reyes Building, 801 Thompson Avenue, Suite 100, Rockville, MD 
20852-1627 (ZIP Code is unchanged for express/courier services), 
Telephone: (301) 443-5204.
     Area Diabetes Consultants within each IHS Area Office. 
Contact information for Area Diabetes Consultants is available on the 
IHS Web site at: http://www.ihs.gov/MedicalPrograms/Diabetes/index.asp.
     Applications will also be posted on the IHS National 
Diabetes Program Web site at: http://www.ihs.gov/MedicalPrograms/Diabetes/index.asp.

2. Content and Format of Application Submission

    The application for this initiative must follow a required format 
that includes:
     SF 424 Application Forms; and
     Application Narrative and Supporting Documentation.
    The order of the application must follow the format below:

[[Page 30679]]

     SF 424 Face page.

     Applicant contact and administrative information.
     DUNS Number--As of October 1, 2003, applications must have 
a DUNS and Bradstreet (D&B) Data Universal Numbering System (DUNS) 
number as the Universal Identifier when applying for Federal grants or 
cooperative agreements. The DUNS number may be obtained by calling 
(866) 705-5711 or through the Web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on the SF 
424 face page. Internet applications for a DUNS number can take up to 
30 days and this could cause organizations to lose opportunities to 
apply, or delay them. It is significantly faster to obtain one by 
phone. You will need the following information to request a DUNS 
number:
     Organization name.
     Organization address.
     Organization telephone number.
     Name of CEO, Executive Director, President, etc. (the 
person in charge).
     Legal structure of the organization.
     Year organization started.
     Primary business (activity) line.
     Total number of employees.
     SF 424A Budget pages--Summary budget by category (a more 
detailed, line-item budget is required below in Supporting 
Documentation listed below).
     Application Narrative: the applicant must include 
narrative (written) responses to the following questions/statements:
     Statement of Need (10 points). [squf] 
[t]
    [squf] State the demonstration project for which you are 
applying (primary prevention of diabetes or cardiovascular disease risk 
reduction--only one demonstration project per application).
    [squf] Clearly identify yourself or your consortium as 
the applicant and indicate the basis for its eligibility under this 
initiative as described above in Section III.
    [squf] Define the target populations that will receive 
and participate in the demonstration project and provide a rationale 
for selecting those target populations, as well as the geographic area 
to be served. (Note: Extensive demographic information is not 
required.) If you plan to focus on a specific segment of the at-risk 
community, explain why this is necessary or desirable. Include a 
description of Tribe(s) or communities served. If the applicant is a 
consortium, describe all partners and communities served.
    [squf] Describe the burden of diabetes, the nature of 
the problem and extent of the need for the demonstration project in the 
target population(s). Documentation of need may come from quantitative 
as well as qualitative sources. The quantitative data could come from 
community assessments you or others have conducted, or from local data 
or trend analyses, diabetes registry numbers and/or IHS Diabetes Care 
and Outcomes Audit data. Qualitative sources could include focus groups 
and key informant interviews you or others have conducted with the 
targeted community, as well as anecdotal reports. Based on your 
quantitative and qualitative findings, discuss your understanding why 
and how your community or population served is affected by diabetes and 
the issues facing the targeted individuals, family members/significant 
others, and community.
    [ctrcir] Organizational and Community Readiness and Feasibility (10 
points)
    [squf] Discuss previous efforts to address the problem 
of diabetes in the community, the capability and experience of the 
applicant organization and other participating organizations with 
similar projects and populations, including experience organizing and 
mobilizing the community, and providing relevant diabetes services, as 
well as culturally appropriate/competent services.
    [squf] Describe your previous efforts at organizing and 
mobilizing the targeted individuals, families, and community (by your 
organization and/or others), and explain why you think the community is 
ready to participate in this particular approach to preventing diabetes 
or cardiovascular disease.
    [squf] Describe the extent to which the community 
indicates support for your proposed project.
    [squf] Describe the extent to which other stakeholders 
indicate support for your proposed project. Identify categories of 
stakeholders--for example, treatment and other professional groups, 
civic groups, governmental organizations, faith-based groups, and 
others--and discuss the role you expect them to play in the project. 
(You should include letters of support showing stakeholder interest in 
the project with this application).
    [ctrcir] Project Approach (30 points)
    [squf] Clearly state the purpose, goals, and objectives 
of your proposed demonstration project activities. Describe how 
achievement of goals will produce meaningful and relevant results 
(e.g., decrease the incidence of diabetes or cardiovascular disease, 
increase individual and community involvement; help increase healthy 
behaviors; increase support for sustained community awareness and 
involvement, etc.).
    [squf] Discuss and explain the core values that will 
guide the implementation of project activities, and explain how each of 
these values will be operationalized. At a minimum, discuss each of the 
following as it relates to the proposed project: (a) Healthy 
lifestyles; (b) participatory process; (c) authentic community voice; 
(d) leadership development; and, (e) cultural context for engaging and 
involving individuals and community. You may identify and discuss other 
values important to your targeted individuals and community.
    [squf] Describe how the demonstration activities will be 
implemented for the area you selected (primary prevention of diabetes 
or cardiovascular disease prevention) for both the intensive and 
community level activities as described in Section I. Funding 
Opportunity Description. Clearly explain each activity you plan to 
provide, in terms of mobilizing and engaging the community, screening 
eligible participants, and actual delivery of the activities. 
Demonstrate how the proposed activities will meet your goals and 
objectives.
    [squf] Clearly state the unduplicated number of 
individuals you propose to serve (annually and over the entire project 
period) with grant funds. Applicants should propose to serve no fewer 
than 48 individuals with pre-diabetes per year for the primary 
prevention of diabetes project, or 50 individuals per year for the 
cardiovascular disease risk reduction project.
    [squf] Describe how the target population will be 
identified, recruited, screened and retained.
    [squf] Describe how the proposed project will address 
issues of age, race, culture, language, disability, literacy, and 
gender in the target population.
    [squf] Describe how community members helped prepare the 
application, and how they will help plan, implement, and evaluate the 
project.
    [squf] Discuss how you plan to develop effective 
partnerships with community organizations and other groups, so as to 
minimize duplication of services and perceived threats of encroachment 
on established ``territory.''
    [squf] Describe the potential barriers to successful 
conduct of the proposed demonstration project and how you will overcome 
them.
    [ctrcir] Staff, Management, and Relevant Experience (30 points)
    [squf] Provide a list of staff who will participate in 
the project, showing the role of each and their level of effort and 
qualifications. Include the Project

[[Page 30680]]

Director, Project Coordinator, and other key personnel as listed above 
(see Section 1, basic health infrastructure). Provide an organizational 
chart for the administration of the project. Describe any plans for 
recruitment of key personnel not already on staff in your health 
program.
    [squf] Show that the necessary groundwork (e.g., 
planning, consensus development, memoranda of agreement, identification 
of potential facilities) has been completed or is near completion so 
that the project can be implemented and the demonstration project can 
begin as soon as possible, and no later than 12 months after grant 
award. If applicable, identify any cash or in-kind contribution that 
you or your partnering organizations will make to the project.
    [squf] Describe the resources available for the proposed 
project (e.g., facilities, equipment), and provide evidence that 
services will be provided in a location that is adequate, accessible, 
compliant with the Americans with Disabilities Act (ADA), and amenable 
to the target population.
    [squf] Provide a proposed timeline for Years 1-5 of the 
project (table, chart or graph), which corresponds to Year 1 (Planning 
Year) and Years 2-5 (Implementation of activities) showing key 
activities, milestones, and responsible staff. (Note: The timeline 
should be part of the Project Narrative. It should not be placed in an 
appendix). Please note that some details in the timeline may be 
modified after the collaborative process in the planning year; 
therefore, for this application, please propose a timeline for your 
activities.
    [ctrcir] Capacity Building (10 points)
    [squf] Describe how the demonstration project activities 
supported by this grant will fit with other existing services or 
programs.
    [squf] Describe how the proposed demonstration project 
will build upon and complement existing private, Tribal, and/or IHS 
services in your community.
    [squf] Indicate the gaps that the demonstration project 
activities supported by this grant will fill or the manner in which 
they will extend/expand current efforts.
    [squf] Identify new knowledge and skills that staff and 
local programs will acquire by participating in this demonstration 
project.
    [squf] Describe strategies for sustaining the 
demonstration project activities beyond the project period if Congress 
does not continue funding for this initiative after 2008.
    [ctrcir] Evaluation and Data (10 points)
    [squf] Document your ability to collect, manage, and 
report on required evaluation measures as outlined above (use examples 
listed in Section I). The IHS/NDP will provide the necessary protocols 
and forms for collecting and reporting data, so you do not need to 
include data collection forms in your application. Describe current use 
of RPMS, and whether you are using the RPMS packages such as pharmacy, 
laboratory and DMS. If you are not using RPMS, please describe your 
current health data system and its compatibility or comparability to 
RPMS.
    [squf] In general terms, describe any experience in 
collecting similar data, in its quality control, and transfer to 
external programs such as the IHS/NDP.
    [squf] Describe the local process for reviewing and 
approving all reports and publications based on data such as these.
    Provide appropriate assurance/commitment as to compliance with the 
required review timelines.
    [ctrcir] Supporting Documentation:
    [squf] Detailed Budget, for Years 1-5, to include the 
following items:
    [squf] Staff/Personnel
    [squf] Travel
    [squf] Equipment
    [squf] Supplies
    [squf] Operational Costs
    [squf] Consultant
    [squf] Contractual
    [squf] Total Direct Costs
    [squf] Indirect Costs
    [squf] Total Budget Amount
    [squf] Budget Justification

    [squf] Note:
    Although the budget for the proposed project is not a review 
criterion, the Review Group will be asked to comment on the 
appropriateness of the budget after the merits of the application 
have been considered. The final amount of the award will vary based 
on factors as detailed in Section II. A sample budget is included in 
Section VIII--Other Information.

    [ctrcir] Position descriptions of key personnel and CV/resumes of 
identified key personnel.
    [ctrcir] Required documentation, including:
    [squf] Letters of support from key stakeholders
    [squf] Tribal resolutions or equivalent (urban board, 
IHS SUD/CEO).
    [ctrcir] Assurances (SF424 Forms).
Participant Protection Plan
    Applicants must describe their procedures relating to 
Confidentiality, Participant Protection, and Health Insurance 
Portability and Accountability Act (HIPPA) regulations, using the 
guidelines provided below. Problems with confidentiality, participant 
protection, and compliance with HIPPA regulations identified during 
review of the application may result in the delay or denial of funding.
    All Applicants must address each of the following elements relating 
to confidentiality and participant protection. The application must 
briefly document how these requirements will be addressed or why they 
are not applicable.
    [ctrcir] Protect Clients and Staff from Potential Risks
     Identify and describe any foreseeable physical, medical, 
psychological, social, legal or other risks or adverse affects.
     Describe the procedures that will be followed to minimize 
or protect participants against potential risks, including risks to 
confidentiality.
     Identify plans to provide help if there are adverse 
effects to participants.
    [cir] Fair Selection of Participants
     Describe the target population(s) for the proposed 
project. Include age, gender, and racial/ethnic background and note if 
the population includes pregnant women or other vulnerable groups.
     Explain the reasons for including or excluding 
participants.
     Explain how participants will be recruited and selected. 
Identify who will select participants.
     Please remember that the grant must be used to serve only 
those eligible under applicable statutes and regulations. If a Tribe 
contracting for IHS programs under the Indian Self-Determination and 
Education Assistance Act attempts to add this grant to the Title V 
funding agreement after award, an appropriate eligibility determination 
must be made by the Tribe and IHS before ineligibles may be served 
under 25 U.S.C. 1680c(b)(1)(B).
    [cir] Absence of Coercion
    Explain if participation in the project is voluntary or required.
     If the project plans to pay participants, state how 
participants will be awarded money or gifts.
     State how participants will be told that they may receive 
services even if they do not participate in the project.
    [cir] Data Collection
     Identify from whom data will be collected. Describe the 
potential settings for data collection.
     Identify what type of specimens (e.g., blood) will be 
used, if any. Describe how the material will be monitored to ensure the 
safety of participants.
    [cir] Privacy and Confidentiality
     Explain how privacy and confidentiality will be ensured. 
Include who will collect the data.
     Describe:

[[Page 30681]]

    [squf] Where data will be stored.
    [squf] Who will or will not have access to information.
    [squf] How the identity of participants will be kept 
private, for example, through the use of a coding system on data 
records, limiting access to records, or storing identifiers separately 
from data.
    [cir] Adequate Consent Procedures
     List what information will be given to individuals who 
participate in the project. Notice given to participants must, at a 
minimum, include:
    [squf] The individual's right to a genuine, free, and 
independent choice among eligible providers, that includes the 
individual's right to an alternative provider to which the individual 
has no religious objection.
    [squf] A description of the data to be collected, how 
the data will be used, and how the data will be kept private.
    [squf] The participant's right to leave the project at 
any time.
    [squf] Possible risks from participation in the project.
    [squf] Plans to protect participants from these risks.
     Explain how consent will be elicited from people with 
limited reading skills, and people who do not use English as their 
first language.

    Note: If the project poses potential physical, medical, 
psychological, legal, social or other risks, written informed 
consent is necessary.

     Indicate if informed consent will be requested from 
participant. Describe how the consent will be documented. For example: 
Will consent forms be read? Will prospective participants be questioned 
to be sure they understand the forms? Will they be given copies of what 
they sign?

    Note: Never imply that the participant waives or appears to 
waive any legal rights, may not end involvement with the project, or 
releases the project or its agents from liability for negligence.

     Risk Benefit Discussion
    Discuss why the risks are reasonable compared to expected benefits 
and importance of the knowledge from the project.
     Protection of Human Subjects Regulations
    Applicants for the Competitive Grant Program are not required to 
address Protection of Human Subjects Regulations (45 CFR part 46). 
However, the IHS National Diabetes Program will conduct a cross-site 
evaluation of the Competitive Grant Program Grantee activities. The 
evaluation may require grantees to comply with the Protection of Human 
Subjects Regulations, consistent with an evaluation design to be 
developed. In that event, the IHS National Diabetes Program will assist 
grantees in obtaining Institutional Review Board (IRB) approval for 
their projects.
    Additional information about Protection of Human Subjects 
Regulations can be obtained on the Web at http://ohrp.osophs.dhhs.gov. 
Applicants may also contact OHRP by e-mail [email protected] or by 
phone (301) 496-7005.
     References--list any references cited in the application 
narrative
     Appendix items--include any additional required or 
supplementary materials not already included in the format for the 
application
    The total length of the Application Narrative should not exceed 15 
pages, typed, single spaced, in size 11-12 font in Arial or Times New 
Roman, with 1 inch margins, on 8 x 11.5 inch paper. The application 
should be assembled in the order as listed above.
    Applicants must send the original application by mail to IHS Grants 
Management Branch and 2 copies of the application by mail to the IHS 
National Diabetes Program.

3. Submission Dates and Times

A. Letter of Intent Deadline: June 1, 2004
    Prospective applicants are asked to submit a letter of intent that 
includes the selected demonstration project for the application 
(primary prevention of diabetes or prevention of CVD in people with 
diabetes), the name, address, and telephone number of the Project 
Director and its Project Coordinator, and the number and title of this 
RFA. The letter of intent must be received by the IHS National Diabetes 
Program, 5300 Homestead Rd, NE., Albuquerque, NM, 87110, telephone 
(505) 248-4182, FAX (505) 248-4188, e-mail: [email protected], 
before 6 m.d.t. on June 1, 2004. Letters may be submitted by mail, fax 
or e-mail.
    Although a letter of intent is not required, is not binding, and 
does not enter into the review of a subsequent application, the 
information that it contains allows the IHS staff to estimate the 
potential review workload and avoid conflict of interest in the review.
B. Application Due Date: July 15, 2004
    The applications must be received before 6 p.m. m.d.t. on July 15, 
2004. If an application is received after that date, it will be 
returned to the applicant without review. To be considered timely, an 
application must be received on or before the deadline date. No 
additional materials received after the deadline will be considered. 
Applications not meeting the deadline date specified in the 
announcement are considered late applications and will not be 
considered for funding under the announcement.
    Receipt of applications will be acknowledged by postcard.

4. Intergovernmental Review

    This funding opportunity is not subject to Executive Order 12372, 
``Intergovernmental Review of Federal Programs.'' A State approval is 
not required.

5. Funding Restrictions

Allowable Administrative Costs
    Certain administrative costs for managing a comprehensive program 
are allowable and may vary, depending upon the size and complexity of 
the program's activities. The costs budgeted for this grant may not 
duplicate items already budgeted in other cost centers, such as 
Facilities and Administration (F&A) or ``Indirect'' cost pool. The 
grantee receiving the award must be prepared to provide documentation 
showing the direct relationship of proposed costs to the program, and 
that costs of this type are charged in a uniform manner.
    Allowable Costs:
     Project Director, up to 25% effort
     Project Coordinator, up to 50% effort
     Project Director, Project Coordinator, and key personnel 
travel to 4 grantee meetings in the first (planning year) and 1 meeting 
per year during Years 2-5 in Albuquerque or another location determined 
by the Coordinating Center. Applicants should not assume that they will 
be able to drive to these meetings if the location of these meetings is 
not in Albuquerque. To ensure enough funding is budgeted for travel to 
grantee meetings, applicants may project costs assuming Washington, DC, 
is the location for these meetings.
     Limited salary support for secretarial or clerical help is 
allowable only when in direct support of the proposed project. For 
guidance, applicants should refer to the OMB Circular appropriate for 
them, A-87 (Cost Principles for State, Local, and Indian Tribal 
Governments), at http://www.whitehouse.gov/omb/circulars or A-122 (Cost 
Principles for Non-Profit Organizations), http://www.whitehouse.gov/omb/circulars, should contact the grants management officer under 
INQUIRIES.
     Data manager, up to 50% effort
     Other remaining key personnel as described above at 
percent effort

[[Page 30682]]

appropriate for scope of work at each site.
     Consortium and Contract Arrangements--subcontracts may be 
used to work with other entities to implement the project activities.
Unallowable Costs
     No construction activity is allowed.
    Grantees will be allowed a reasonable period of time in which to 
submit required financial and performance reports.
    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 the 
imposition of special award provisions, or cause other eligible 
projects or activities involving the grantee organization, or the 
individual responsible for the delinquency to not be funded.
    Failure to obtain prior approval for change in Scope, Project 
Director, Project Coordinator, undertaking any activities disapproved 
or restricted as a condition of the award, may result in fund 
restrictions or termination.

6. Other Submission Requirements

    Submit a typed and signed original application, including 
appendices and supporting documents, in one package to:
    Grants Management Branch, Indian Health Service, Reyes Building, 
801 Thompson Avenue, Rockville MD 20852-1627 (ZIP Code is unchanged for 
express/courier services), Telephone: (301) 443-5204.
    Also, at the time of submission, send 222214 additional single-
sided photocopied and signed applications, including the appendices and 
supporting documentation to: IHS National Diabetes Program, Indian 
Health Service, 5300 Homestead Road, NE., Albuquerque, NM 87110, 
Telephone: (505) 248-4182, FAX: (505) 248-4188.

V. Application Review Information

    Upon receipt, IHS will administratively review applications for 
completeness and responsiveness. Applications that are incomplete, non-
responsive to this RFA, do not meet eligibility criteria or do not 
follow the guidelines of the SF 474 will be returned to the applicant 
without further consideration.
    Applications will be evaluated for technical merit by appropriate 
peer review groups convened by the IHS National Diabetes Program in 
accordance with the criteria stated below.

1. Criteria

    Priorities for funding will be based on the technical merit of the 
application, the assessed potential of the applicant and the likelihood 
of the applicant to successfully implement the defined interventions. 
Awards will be made only to applicants with financial management 
systems and management capabilities that are acceptable under PHS 
policy. Awards will be administered under the PHS Grants Policy 
Statement.
    Applications will be reviewed and scored according to the quality 
of their responses to the requirements listed below for developing the 
application narrative. The number of points after each heading is the 
maximum number of points a review committee may assign to that section 
of the application narrative:
     Statement of Need (10 points).
     Organizational and Community Readiness and Feasibility (10 
points).
     Project Approach (30 points).
     Staff, Management, and Relevant Experience (30 points).
     Capacity Building (10 points).
     Evaluation and Data (10 points).
    Suggested content for each of the above sections of the Project 
Narrative are detailed in the application format section.
    Reviewers will assess the application by considering the 
Application Narrative, Supporting Documentation, and Appendices.

2. Review and Selection Process

    The IHS NDP will convene 2 review groups, one for each 
demonstration project in this initiative, which will consist of the 
following types of individuals:
     IHS staff.
     Tribal/Community representatives.
     Scientific experts.
    The reviewers cannot be affiliated with any applicants.
    The IHS National Diabetes Program will develop the review selection 
process consistent with the review criteria and will ensure appropriate 
representation of relevant expertise.
    The Director of the IHS National Diabetes Program will make the 
final funding decisions in consideration of the following points, some 
of which were based on input from the Tribal consultation:
     The strengths and weaknesses of the application as 
identified by peer reviewers;
     The likelihood of success in implementation of the 
activities;
     Demonstrated capacity of the applicant for programmatic 
implementation;
     Availability of funds, and;
     Other factors based on Tribal consultation, including 
distribution of awards in terms of geography and balance among program 
size, program type (i.e., IHS, Tribal, urban vs. rural, hospital vs. 
clinic, etc.).

3. Anticipated Announcement and Award Dates

    Anticipated Selectee Date: August 30, 2004.
    Anticipated Notice of Grant Award Date: September 29, 2004.

VI. Award Administration Information

1. Award Notices

    Grants Management will not award a grant without an approved 
application in conformance with regulatory and policy requirements and 
which describes the purpose and scope of the project to be funded. When 
the application is approved for funding, the Grants Management Office 
will prepare a Notice of Grant Award with special terms and conditions 
binding upon the award and refer to all general terms applicable to the 
award.

2. Administrative and National Policy Requirements

    None.

3. Reporting

    The IHS NDP and the Grants Management Office have requirements for 
the progress reports and financial reports based on the terms and 
conditions of this grant. Grantees are responsible and accountable for 
accurate reporting of the Progress Reports and Financial Status 
Reports, which are generally due annually. Financial Status Report (SF 
269) is due 90 days after each budget period and the final SF 269 must 
have no unliquidated obligations and must indicate the exact balance of 
unobligated funds.
    Grantees will be allowed a reasonable period of time in which to 
submit required financial and performance reports.
    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 the 
imposition of special award provisions, or cause other

[[Page 30683]]

eligible projects or activities involving the grant recipient, or the 
individual responsible for the delinquency to not be funded.
    Progress reports will be required on an annual basis.

VII. Agency Contacts

    Questions on the SDPI Competitive Grant Program may be directed to: 
Mary Tso, National Diabetes Program, Indian Health Service, 5300 
Homestead Road, NE., Albuquerque, NM 87110, Telephone: (505) 248-4182, 
FAX: (505) 248-4188, E-mail: [email protected].
    Questions on grants management and fiscal matters may be directed 
to: Denise Clark, Grants Management Branch, Indian Health Service, 
Reyes Building, 801 Thompson Avenue, Rockville MD 20852-1627, 
Telephone: (301) 443-5204, FAX: (301) 443-9602, E-mail: 
[email protected].

VIII. Other Information

1. Primary Prevention of Diabetes

    Applicants are encouraged to learn more about the Diabetes 
Prevention Program through the following resources:
     Original journal article: Knowler WC, Barrett-Conner E, 
Fowler SE et al. Reduction in the incidence of type 2 diabetes with 
lifestyle intervention or metformin. New England Journal of Medicine 
2002; 346:393-403.
     Diabetes Prevention Program Results Press Release: http://www.niddk.nih.gov/welcome/releases/8_8_01.htm.
     Diabetes Prevention Program website with study documents, 
including lifestyle manuals: http://www.bsc.gwu.edu/dpp/index.htmlvdoc.

2. Cardiovascular Disease Risk Reduction

     Applicants are encouraged to familiarize themselves with 
the American Diabetes Association Clinical Practice Recommendations: 
http://www.diabetes.org/for-health-professionals-and-scientists/cpr.jsp.

3. The Indian Health Service National Diabetes Program

     Mission Statement--The mission of the IHS National 
Diabetes Program is to develop, document, and sustain a public health 
effort to prevent and control diabetes in American Indian and Alaska 
Native peoples.
     Applicants are encouraged to refer to the IHS National 
Diabetes Program website for further information, such as the standards 
of diabetes care or best practices documents: http://www.ihs.gov/
MedicalPrograms/diabetes/index.asp.

4. Definition of Pre-Diabetes

    The term ``Pre-diabetes'' is a lay term that was coined as a simple 
way to describe a group of people who are at very high risk for 
diabetes. Translated to slightly more precise clinical terms, pre-
diabetes is used to classify people with blood glucose levels that are 
higher than normal but not yet in the diabetic range have ``pre-
diabetes.'' Pre-diabetes may be impaired fasting glucose (IFG) or 
impaired glucose tolerance (IGT), depending on the test used to 
diagnose it and the particular abnormality suffered by the patient. Not 
everyone with IGT has IFG, nor do all patients with IFG have IGT.
    A fasting plasma glucose test measures plasma glucose after an 
overnight fast of at least 8 hours. This test is most reliable when 
done in the morning. Fasting glucose levels of 100 to 125 mg/dl are 
above normal but not high enough to be called diabetes. This condition 
is a form of pre-diabetes called impaired fasting glucose (IFG). IFG is 
considered a pre-diabetic state, meaning that the individual is more 
likely to develop diabetes but does not have it yet.
    The oral glucose tolerance test (OGTT) consists of measures of 
plasma glucose levels after an overnight fast and after a glucose 
challenge. After a fast of 8 to 12 hours, blood glucose is measured 
before and 2 hours after drinking a glucose-containing solution, a 
glucola load of 75 grams or its equivalent. If the 2-hour blood glucose 
is within the range between 140 and 199 mg/dl, glucose tolerance is 
above normal but not high enough for diabetes. This condition, also a 
form of pre-diabetes, is called impaired glucose tolerance (IGT and, 
like IFG, it points toward a history of insulin resistance and a risk 
for developing diabetes.

5. Sample Budget

    Applicants should submit a proposed budget for each year of this 5-
year initiative. Year 1 will be a planning year, in which grantees 
prepare to implement activities. Years 2-5 will be for implementation 
of the proposed activities.
    Applicants should include the following items in their budgets each 
year as appropriate for their selected area (primary prevention of 
diabetes or cardiovascular risk reduction) and activities.
    [ctrcir] Personnel (may include funding for some or all of the 
following new staff and percent FTE for current staff to work on the 
demonstration project).

[mshbox] Project Director (up to 25%)
[mshbox] Project Coordinator (up to 50%)
[mshbox] Administrative Clerk/Recruiter (consider full time person)
[mshbox] RPMS Site Manager (only if not already funded by health 
program)
[mshbox] Health Educator/Diabetes Educator
[mshbox] Dietitian
[mshbox] Physical Activity Specialist
[mshbox] Pharmacist (CVD risk reduction)
[mshbox] Data Coordinator
[mshbox] Nurse Case Manager (CVD risk reduction)
[mshbox] Other

    Funding for some of these positions may also be put in the 
consultant or contractual budget categories. Do not include funding for 
these positions if already paid through another source i.e. dietitian 
already on staff.
    Include base salary, fringe benefits rate and amount, and total 
salary for each position.
    [ctrcir] Travel (4 grantee meetings in Year 1, 1 grantee meeting 
each year in Years 2-5--assume Albuquerque and/or Washington DC for 
travel cost calculations).
    [ctrcir] Equipment--as needed for project.
    [ctrcir] Supplies (general office supplies, supplies needed for 
activities in project).
    [ctrcir] Operational Expenses (consider incentives for activities, 
promotional items for both intensive and community based activities; 
consider buying computer equipment for this project, including internet 
access, for communication with Coordinating Center; other costs may 
include telephone, voice mail, computer support, shipping, copying, 
printing materials, etc).
    [ctrcir] Consultants (for project staff if not already included in 
Personnel).
    [ctrcir] Contractual (partners, collaborators).
    [ctrcir] Total Direct (Sum of a-g).
    [ctrcir] Indirect Costs (negotiated rate with BIA).
    [ctrcir] Total Budget (Total Direct plus Indirect Costs).

6. Sample Participant Protection Plan

    See Supplemental Instructions.

7. Organizational Chart for SDPI Competitive Grant Program

    See Supplemental Instructions

8. Sample Letter of Support

    See Supplemental Instructions.

9. References

    American Diabetes Association. Standards of Medical Care in 
Diabetes. Diabetes Care 2004; 27, Suppl 1: S15-S35.
    Burrows NR, Geiss LS, Engelgau MM, Acton KJ. Prevalence of 
diabetes among

[[Page 30684]]

Native Americans and Alaska Natives, 1990-1997: an increasing 
burden. Diabetes Care 2000 Dec; 23(12):1786-90.
    Grundy SM, Brewer HB, Cleeman JI, et al. Definition of Metabolic 
Syndrome. Report of the National Heart, Lung and Blood Institute/
American Heart Association Conference on Scientific Issues Related 
to Definition. Circulation 2004;109:433-438.
    Howard BV, Lee ET, Cowan LD et al. Rising tide of cardiovascular 
disease in American Indians. The Strong Heart Study. Circulation 
1999;99:2389-95.
    Knowler WC, Barrett-Connner E, Fowler SE et al. Reduction in the 
incidence of type 2 diabetes with lifestyle intervention or 
metformin. New England Journal of Medicine 2002; 346:393-403.
    Pan XR, Li GW, Hu YH, et al. Effects of diet and exercise in 
preventing NIDDM in people with impaired glucose tolerance: the Da 
Qing IGT and Diabetes study. Diabetes Care 1997;20:537-544.
    Roubideaux Y, Acton K. Diabetes in American Indians. In: Dixon 
M, Roubideaux Y. Promises to Keep: Public Health Policy for American 
Indians and Alaska Natives in the 21st Century. American Public 
Health Association, 2001.
    Tuomilehto J, Lindstrom J, Eriksson JG, et al. Prevention of 
type 2 diabetes mellitus by changes in lifestyle among subjects with 
impaired glucose tolerance New England Journal of Medicine 2001; 
344:1343-1350.


    Dated: May 21, 2004.
Robert G. McSwain,
Acting Director, Indian Health Service.
[FR Doc. 04-12083 Filed 5-27-04; 8:45 am]
BILLING CODE 4160-16-P