[Federal Register Volume 63, Number 131 (Thursday, July 9, 1998)]
[Notices]
[Pages 37124-37128]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-18201]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Announcement 98081]


Notice of Availability of Fiscal Year 1998 Funds National 
Diabetes Prevention Center

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1998 funds for a cooperative agreement 
program for a National Diabetes Prevention Center whose functions will 
be to provide guidance and technical support regarding diabetes 
mellitus (DM) in Native American communities throughout the United 
States. Initial activities will target the challenges of DM in the 
Navajo Nation and the Zuni Pueblo tribe in the southwestern United 
States. If, and as additional funds become available, it is CDC's 
intent to expand this program to other Native American populations 
through collaboration with other federal agencies, such as, Indian 
Health Service (IHS). This program addresses the ``Healthy People 
2000'' priority area(s) of Diabetes and Chronic Disabling Conditions. 
Native American populations have a high incidence and prevalence of 
diabetes and diabetes complications. The purpose of this initiative is 
to establish a National Diabetes Prevention Center in Gallup, New 
Mexico, that will serve as a focal point for developing and testing new 
prevention and control strategies to address the burden of diabetes in 
Native Americans. Components of the center will include, but are not 
limited to, systematic community needs assessment, design, and 
development of coherent, theory-based community programs, 
implementation of community interventions, and focused interventional 
research, surveillance, program evaluation, health professional and 
community training, and tribal capacity building activities for 
diabetes prevention and control. The goal is to develop, evaluate and 
disseminate culturally relevant community based public health 
prevention strategies for Native Americans. It is envisioned that 
documented experiences, qualitative, and quantitative research 
findings, strategies, and benefits from all center activities including 
initial targeted programs, will ultimately be applicable to other 
Indian tribes and similar populations. All these activities will 
require established experiences in qualitative and quantitative 
assessment, creative theory-based program development, systematic 
program evaluation, and management and supervisory activities. 
Cooperative partnerships will be important in center activities.

B. Eligible Applicants

    Applications may be submitted by public and private nonprofit 
organizations and governments and their agencies. Thus, universities, 
colleges, research institutions, hospitals, other public and private 
organizations, including State and local governments or their bona fide 
agents, federally recognized Indian tribal governments, Indian tribes 
or Indian tribal organizations may apply.
    Congress, through the Departments of Labor, Health and Human 
Services, Education, and Related Agencies Appropriations Act, H.R. 
2264, 1998 Conference Report, page S-12088 directed CDC to establish a 
National Diabetes Prevention Center in Gallup, New Mexico, with initial 
activities involving and targeting the Navajo Nation and Zuni Pueblo 
tribe in the southwest U.S.

    Note: Public Law 104-65 states that an organization described in 
section 501(c)(4) of the Internal Revenue Code of 1986 that engages 
in lobbying activities is not eligible to receive Federal funds 
constituting an award, grant, cooperative agreement, contract, loan, 
or any other form.

C. Availability of Funds

    Approximately $2.3 million is available in FY 1998 to fund this 
program. It is expected that this one award will begin on or about 
September 30, 1998, and will be made for a 12-month budget period 
within a project period of up to five years. Funding estimates may 
change.
    Continuation awards within an approved project period will be made 
on the basis of satisfactory progress as evidenced by required reports 
and the availability of funds.

Direct Assistance

    Applicants may request Federal personnel, equipment, or supplies as 
direct assistance, in lieu of a portion of financial assistance.

[[Page 37125]]

Use of Funds

Allowable Uses
    Funds are awarded for a specifically defined purpose and must be 
targeted for implementation and management of the program. Funds can 
support lease of space and facilities, personnel, services directly 
related to the program, and the purchase of hardware and software for 
data collection, analysis, and project management and evaluation 
purposes.
Prohibited Uses
    Cooperative agreement funds cannot be used for (1) construction, 
(2) renovation, (3) the purchase or lease of passenger vehicles or 
vans, (4) to supplant non-Federal funds that would otherwise be made 
available for this purpose, or (5) cost of regular clinical patient 
care.

D. Program Requirements

    Work performed under this cooperative agreement will be the result 
of collaborative efforts between CDC, IHS, Native American populations, 
and the recipient. The establishment of a National Diabetes Prevention 
Center, with initial focus on the Navajo Nation and Zuni Pueblo tribe, 
is the overall major program direction. CDC will be available to 
provide assistance in the design and implementation of research methods 
and study design. As additional funds become available, it is CDC's 
intent to expand the Center's activities to address this program to 
other Native American populations with their own special and distinct 
needs for the challenges of DM. CDC will work collaboratively with the 
recipient in areas mutually agreed upon by IHS, the recipient, and 
tribal leadership.
    In conducting activities to achieve the purpose of this program, 
the recipient shall be responsible for the activities described under 
1., below, and CDC shall be responsible for carrying out the activities 
described under 2., below.

1. Recipient Activities

    a. Establish and maintain an effective and adequate management and 
staffing plan. This plan should include a description of how the center 
will be established, organized and operated. Additionally, this plan 
should address expansion in future years to focus on unique needs 
related to DM among other tribes and target populations, including how 
decisions will be made regarding future tribes or populations. The 
success of the program will depend on recruiting and hiring staff in a 
timely manner. Staff should have the education, background, and 
experience to successfully conduct the activities proposed in this 
application.
    b. Select, establish and maintain a Tribal Advisory Board of tribal 
members initially including members of the Navajo Nation, Zuni Pueblo 
tribe, and other tribes. The board will provide consultation, 
coordination, and linkage between the Native American communities and 
the recipient and participate in program and policy decisions.
    c. Establish a Steering Committee which shall be the primary 
scientific governing body of the center and comprised of the Principal 
Investigator of the Center, Native American researchers, IHS, and CDC. 
The Steering Committee will provide advice and guidance concerning the 
continued evolution of the National Center, as well as the initial 
specific activities addressing the important needs of DM in Navajo 
Nation and Zuni Pueblo tribe, as well as development of research 
protocols, facilitating the conduct and monitoring of intervention 
studies, and reporting study results. The Steering Committee 
chairperson or designee will participate in Tribal Advisory Board 
meetings, and maintain on-going communication and updates with the 
Tribal Advisory Board.
    d. Recipient will be responsible, with consultation with CDC, IHS, 
the Tribal Advisory Board, and the Steering Committee for the overall 
directives, strategies, planning, and functions of the National Center, 
including implementing research methods and study design, analysis, use 
of data, and dissemination of results via peer-reviewed scientific 
publications or other related material.
    Recipient will provide lead initiative in protocol development, 
evaluation, data collection, quality control, data analysis and 
interpretation, the preparation of publications and presentation of 
findings. Assess how routinely available data can be used to establish 
an active surveillance system, and what new data will be needed. 
Undertake a pilot project to demonstrate how available data can be 
effectively used to identify priorities and to effect change. Establish 
an information clearinghouse that will assemble and disseminate 
information on health status, effectiveness and cost-effectiveness of 
interventions. Develop a formative evaluation plan for tribal and 
community relations, and the management and overall operations of the 
center.
    e. Develop a multi-year, staged plan for community interventions 
and focused intervention research, targeting the members of the Navajo 
Nation and Zuni Pueblo tribe. As an initial component of the National 
Center, the recipient should address tribal relations throughout the 
project period and propose strategies and interventions that enhance 
tribal capacity to conduct proposed public health interventions. This 
plan should minimally include diabetes prevention interventions 
research in the following areas: Diabetes Care Interventions, Outreach 
Interventions, and Health Promotion Interventions. The plan should also 
address ways to protect human subjects involved in research activities 
including coordination with local institutional review boards and 
tribal councils.

    1. Interventions research focused on Diabetes Care: These public 
health interventions are directed at persons with diabetes, their 
health care providers, and the health care system providing services 
to members of the Zuni Pueblo tribe and Navajo Nation. The goal is 
to increase access to and the quality of care provided to persons 
with diabetes. Research projects could examine methods of improving 
self-care practices related to diabetes management, appropriate care 
for children with diabetes or at high risk for diabetes, office 
practices and systems to more effectively accommodate the health 
care needs of persons with diabetes while being sensitive to the 
demands on providers and office staff, etc. The center will not 
engage in the direct delivery of services, but will work with the 
existing health care system to conduct public health research and 
programs. Important outcomes of diabetes care interventions are 
enhanced provider practices and facilitation of appropriate diabetes 
practice behaviors, development of patient empowerment programs, 
identification of barriers to care among under served populations, 
and coordination of existing services to better serve persons with 
diabetes.
    2. Interventions research focused on Outreach: These 
interventions support targeted community diabetes screening directed 
at persons at high risk for diabetes who have not been previously 
diagnosed; and ensure that persons with previously diagnosed 
diabetes who may not be receiving regular care return to the health 
care system for monitoring and treatment and prevention services. 
Projects could examine screening children for type 2 diabetes, 
strategies for insuring that persons return for regular preventive 
services, etc. An important outcome of the Outreach Intervention(s) 
is improved, early access to diabetes care and the resulting 
reduction of preventable diabetic complications.
    3. Interventions research focused on Health Promotion: These 
interventions are directed to the general population and seek to 
reduce risk factors associated with the development of diabetes, 
specifically by increasing physical activity and decreasing dietary 
fat intake. Research projects should be focused and targeted, e.g., 
examine interventions focusing on promoting lifestyle for prevention 
of diabetes among persons and children with risk factors, 
environmental and

[[Page 37126]]

policy changes that will facilitate prevention of diabetes among 
persons with risk factors for the disease, etc. Health promotion 
interventions should be prioritized and target sub-populations for 
which the potential for impact is greatest.

    Interventions must reflect an approach that addresses units of 
practice beyond the individual and beyond clinical care and services, 
and links the social, policy, and ecological/environmental variables 
that must be changed if a reduction in the burden of diabetes is to be 
achieved in this population. This plan will reflect information 
contained in the following:
    a. Qualitative and quantitative assessment of community capacity to 
adopt, implement and sustain diabetes prevention and control 
interventions.
    b. Community resource analysis and identification of community 
institutions, services, and organizations that can assist in achieving 
the center research goals for members of the Navajo Nation and Zuni 
Pueblo tribes.
    c. Strategies and success markers to insure community and 
researcher consensus related to all activities of the Prevention 
Center.
    d. Design relevant training opportunities for tribal members and 
researchers and others with key developmental and research duties.
    e. A review of published and unpublished diabetes public health 
prevention interventions relevant to diabetes prevention and control in 
Native American populations.
    f. Development of a science based and theory driven menu of 
interventions appropriate for members of the Navajo Nation and Zuni 
Pueblo tribe on review of interventions above. Strategies involving 
health promotion interventions should focus on populations with the 
greatest potential for impact, i.e. children.
    g. Detailed focus group evaluations to review and respond to the 
menu of interventions above. This evaluation will consist of several 
focus groups, including all segments of society--formal and informal 
tribal leaders, industry leaders, tribal and Federal Government 
agencies, restaurants, schools, children, persons with diabetes and 
their families, local celebrities, churches, social clubs and 
organizations, health professionals, etc. Focus groups and expert 
panels should include tribal members, health service providers, experts 
in diabetes and community interventions research, and others.
    h. Expert panel revision and prioritization of interventions based 
on focus group evaluations, evidence of effectiveness, cost-
effectiveness, and sustainability.
    i. Appropriate strategies to protect persons who will participate 
in center projects.
    f. Establish mechanisms to insure active and meaningful 
participation of targeted communities in all phases of program 
assessment, development, implementation, and evaluation through 
appropriate Native American agencies and community institutions that 
have demonstrated the experience, capacity, and relationships needed 
with the target community which will enable them to successfully 
deliver intervention activities in the target community, for example, 
sub-contracts, grants, etc.

2. Centers for Disease Control and Prevention (CDC) Activities

    a. Support and/or stimulate the recipient activities by 
collaborating and providing scientific and public health consultation 
and assistance in the development of National Center activities related 
to the cooperative agreement.
    b. Assign CDC staff persons onsite to provide technical assistance 
to the center, including programs addressing the national challenges of 
DM in Native American communities as well as the initial targeted 
public health program with the Navajo Nation and Zuni Pueblo tribe.
    c. Collaborate in protocol development, review for human subjects 
protection, evaluation, data collection, quality control, data analysis 
and interpretation, the preparation of publications and presentation of 
findings.

E. Application Content

    Applicant should use the information in the Program Requirements, 
Other Requirements, and Evaluation Criteria sections to develop the 
application content. The application will be evaluated on the criteria 
listed, so it is important to follow them in laying out the program 
plan. The narrative should be no more than 50 double-spaced pages, 
printed on one side, with one inch margins, and unreduced font. The 
application should contain:

1. Statement of Competence

    a. Document evidence of existing experience, capabilities, 
expertise, etc., in areas of effective community needs assessment, 
theory-based public health programs, and effective strategy 
development; cooperative program implementation; and core public health 
program evaluation. Indicate evidence of formal presentation, 
publication and dissemination of important results and observations. 
Evidence of experience and formal training in community needs 
assessment; development of theory-based public health prevention 
programs; implementation of program activities; and qualitative and 
quantitative evaluations must be included. Documentation of experience 
and inclusion in the application of effective partnership development 
and utilization throughout all phases of the project must be explicit.
    b. Clearly describe plans for establishing a National Center for 
public health prevention strategies targeting DM in Native American 
communities. Indicate sequential steps and strategies to establish a 
National Center; processes to insure broad collaboration and 
coordination among many potential partners, including, but not limited 
to, tribal nations, CDC and IHS; plans to systematically expand Center 
components to other Native American target-communities; strategies to 
evaluate effectiveness of a National Center, both as a leader in, and 
respondent to, the challenges of DM in Native American communities 
throughout the U.S.
    c. As an initial activity of the center, describe proposed public 
health intervention methods targeting the Navajo Nation and Zuni Pueblo 
tribe. Provide a list or examples of publications, papers, and 
journals, and describe research or intervention activities previously 
conducted with the Navajo Nation and Zuni Pueblo tribe. Provide a 
narrative which demonstrates an understanding of the purpose of the 
cooperative agreement and the applicant's competence in working with 
these initial target populations within the context of the National 
Center; description of applicant's linkages, and relationships with 
Native American nations in general and specifically in the southwestern 
U.S.; experience in diabetes, applied prevention and community-based 
strategies; plans to engage investigators who have direct experience in 
establishing, working with, and/or researching diabetes related topics 
and community based interventions, and with a corresponding record of 
substantial publication in peer-reviewed scientific literature; and 
type of academic entity. Describe the education, professional 
background, and relevant experience of the principal investigator; as 
well as other essential investigators and consultants.

2. Objectives

    Establish and submit long- and short-term objectives that are 
specific, measurable, time phased, realistic, and related to the 
purpose of this program--

[[Page 37127]]

a National Center and an initial public health community prevention 
strategy with the Navajo Nation and Zuni Pueblo tribe.

3. Operational Plan

    Submit a plan that addresses the stated needs and purpose of the 
cooperative agreement. The plan should identify the major components of 
the program to include:
    a. strategies/plans for protecting human subjects, and the 
inclusion of women, racial, and racial groups in the proposed research,
    b. time table which displays the accomplishment of proposed 
activities, how activities will be accomplished, and who will be 
responsible for accomplishments,
    c. methodology for selecting members of the Tribal Advisory Board 
and the nature and extent of the Board's activities,
    d. names of individuals and/or organizations that will be proposed 
to serve on the Tribal Advisory Board, curriculum vitae/community 
service profiles, and letters of support, cooperation and partnership, 
including evidence of a plan to insure rotating participation on the 
Advisory Board,
    e. methodology for assessing and building community capacity,
    f. methodology for recruiting and remunerating focus group 
participants,
    g. methodology for determining menu of theory-based public health 
strategies to reduce the burden of DM,
    h. methodology for developing multi-year, staged plan for a 
National Center that would provide guidance and technical assistance to 
Native American communities throughout the U.S.,
    i. methodology for the implementation of intervention strategies by 
appropriate organizations, agencies, individuals, and others who will 
assist in the delivery of intervention activity including competitive 
solicitation, for example, sub-contracts, grants, etc.,
    j. methodology for developing the training component for the 
center,
    k. methodology for establishing a surveillance system, and
    l. methodology for establishing an information clearinghouse,
    m. methodology for developing the multi-year, staged plan for 
community interventions and focused intervention research targeting 
members of the Navajo Nation and Zuni Pueblo tribe.

4. Partnership Development

    Written indicators of cooperation and partnerships with individuals 
and/or organizations should be provided. Provide plans for consensus 
building, role clarification between partners, communications, 
collaboration and conflict resolution.

5. Center Management

    Provide position descriptions and curricula vitae for center staff, 
including required knowledge, skills, and abilities and other desired 
qualifications and experience. Include an organization chart outlining 
line and staff authority. Provide problem-solving methods and program 
negotiation strategies intended to insure effective collaboration with 
tribes, CDC, IHS, Tribal Advisory Board, and Steering Committee. 
Provide plans for communication and coordination among all partners.

6. Evaluation Plan

    Provide a plan to monitor progress and make intermediate 
corrections in the establishment and overall operations of the Diabetes 
Prevention Center. The plan should also address how the evaluation plan 
for intervention activities will be developed. Describe the 
qualifications of professionals (staff, contractors, etc.) responsible 
for evaluation. Qualitative and quantitative general assessment plans 
for the National Center should be included, as well as more specific 
evaluation plans for initial activities with the Navajo Nation and Zuni 
Pueblo tribe.

7. Budget

    Submit a detailed budget and line item justification that is 
consistent with the purpose of the program.
Direct Assistance
    To request new direct-assistance assignees, include:

1. Number of assignees requested
2. Description of the position and proposed duties

F. Submission and Deadline

Application

    Submit the original and five copies of PHS-398 (OMB Number 0925-
0001) (adhere to the instructions on the Errata Instruction Sheet for 
PHS 398). Forms are in the application kit. On or before August 7, 
1998, submit the application to: Sharron P. Orum, Grants Management 
Officer, Grants Management Branch, Procurement and Grants Office, 
Announcement 98081, Centers for Disease Control and Prevention, Room 
300, 255 East Paces Ferry Road, NE., Mail stop E-18, Atlanta, Georgia 
30305-2209.
    If application does not arrive in time for submission to the 
independent review group, it will not be considered in the current 
competition unless the applicant can provide proof that application was 
mailed on or before the deadline (i.e., receipt from U.S. Postal 
Service or a commercial carrier; private metered postmarks are not 
acceptable).

G. Evaluation Criteria (100 Points)

    Each application will be evaluated individually against the 
following criteria by an independent review group appointed by CDC.
    Competence (35 points): The degree to which the applicant 
demonstrates:

    1. Demonstrated existing ability to carry out high quality 
research which addresses diabetes care, outreach and health 
promotion; as well as the necessary linkage among these three public 
health components. Specifically, the extent in which proposed 
research is focused on preventing or delaying development of 
disease, as well as public health approaches to secondary and 
tertiary prevention of complications of an already established 
disease will be carefully reviewed. In addition, strength of the 
applicant's experience and competence in diabetes and community-
based intervention research for Native Americans. Also, clear 
evidence of an organizational commitment to scientific research as 
evidenced by: organizational statement that explicitly includes a 
research agenda, evidence of scientific productivity by the 
organization's researchers via published papers in peer reviewed 
journals, examples of recent scientific research projects conducted 
by the applicant, and the proportion of the organization's overall 
operating budget that is devoted to research.
    2. Qualifications of the center director, and essential senior 
investigators.
    3. Understanding of the purpose of the proposed program and its 
demonstrated ability to feasibly establish a National Center which 
will address strategies for reducing the burden of DM throughout 
Native American communities, as well as the specific, initial focus 
on the Navajo Nation and Zuni Pueblo tribe.
    Objectives (10 points): The degree to which the proposed objectives 
are specific, time phased, and measurable and are consistent with the 
purpose of the announcement.
    Operational Plan (20 points): The extent to which the operational 
plan appears adequate and appropriate to carry out both the development 
and management of the National Center, as well as the proposed 
community interventions, focused intervention research, and 
surveillance activities with the Navajo Nation and Zuni Pueblo tribe, 
to include a time line which identifies activities accomplished, how, 
and who is assigned responsibility.
    Partnership Development (10 points): The degree to which the plan 
addresses consensus building, role clarification, communications and 
conflict resolution.
    Center Management (10 points): The degree to which the 
organizational

[[Page 37128]]

structure and staffing of the center appears sound and the feasibility 
of expansion plans to address other unique needs within Native American 
communities and special target populations. The degree to which expert 
consultants are engaged in achieving the objectives of the center.
    Evaluation Plan (10 points): The quality of the proposed methods 
for evaluating all activities related to the program, including 
formative, process and impact evaluation.
    Human Subjects (Not Weighted): Consistent with the requirements of 
the federal regulations on protection of human subjects in research (45 
CFR Part 46), does the proposal provide an explanation of how research 
activities will be reviewed so that human subjects will be protected? 
Do any proposed research activities seem contrary to ethical research 
practice?

______ Yes
______ No
Comments____________________

    Women, Racial, and Ethnic Minorities (5 points): The degree to 
which the applicant has met the CDC Policy requirements regarding the 
inclusion of women, ethnic, and racial groups in the proposed research. 
This includes:
    1. The proposed plan for the inclusion of both sexes and racial and 
ethnic minority populations for appropriate representation.
    2. The proposed justification when representation is limited or 
absent.
    3. A statement as to whether the design of the study is adequate to 
measure differences when warranted.
    4. A statement as to whether the plans for recruitment and outreach 
for study participants include the process of establishing partnerships 
with community(ies) and recognition of mutual benefits.
    Budget (Not Weighted): The extent to which the budget is reasonable 
and consistent with the purpose and objective of the program 
announcement.

H. Other Requirements

Technical Reporting Requirements

    Provide CDC with an original plus two copies of:
    1. quarterly progress reports
    2. financial status report, no more than 90 days after the end of 
the budget period.
    3. final financial and performance reports, no more than 90 days 
after the end of the project period.
    Send all reports to: Sharron P. Orum, Grants Management Officer, 
Grants Management Branch, Procurement and Grants Office, Centers for 
Disease Control and Prevention, Room 300, 255 East Paces Ferry Road, 
NE., MS E18, Atlanta, GA 30305-2209.
    The following additional requirements are applicable to this 
program and are incorporated herein by reference. For a complete 
description of each, see Attachment 1 in the application kit.
AR98-1  Human Subjects Requirements
AR98-2  Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research
AR98-7  Executive Order 12372 Review
AR98-8  Public Health System Reporting Requirements
AR98-9  Paperwork Reduction Act Requirements
AR98-10  Smoke-Free Workplace Requirements
AR98-11  Healthy People 2000
AR98-12  Lobbying Restrictions
AR98-15  Proof of Non-Profit Status

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under the Public Health Service Act, 
Sections 317(k)(2) [42 U.S.C. 247b(k)(2)] and 301(a) [42 U.S.C. 
241(a)], as amended. The Catalog of Federal Domestic Assistance number 
is 93.135.

J. Where to Obtain Additional Information

    Please refer to Program Announcement 98081 when you request 
information. For a complete program description, information on 
application procedures, an application package, and business management 
technical assistance, contact: Sharron P. Orum, Grants Management 
Officer, Grants Management Branch, Procurement and Grants Office, 
Announcement 98081, Centers for Disease Control and Prevention, Room 
300, 255 East Paces Ferry Road, NE., Mailstop E-18, Atlanta, GA 30305-
2209, telephone (404) 842-6805, Email address [email protected].
    See also the CDC home page on the Internet: http://www.cdc.gov.
    For program technical assistance, contact: Mr. Bud Bowen, Program 
Director, Division of Diabetes Translation, Centers for Disease Control 
and Prevention, 4770 Buford Hwy, NE., Mailstop K-10, Atlanta, GA 30341-
3724, telephone (770) 488-5013, Email address, [email protected].

    Dated: July 2, 1998.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 98-18201 Filed 7-8-98; 8:45 am]
BILLING CODE 4163-18-P