[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
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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 spo2@cdc.gov.
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, gob0@cdc.gov.
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
