[Federal Register Volume 63, Number 124 (Monday, June 29, 1998)]
[Notices]
[Pages 35231-35237]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-17202]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Announcement Number 98086]


Translational Research Centers for Diabetes Control Within 
Managed-Care Settings; Availability of Funds for Fiscal Year 1998

Introduction

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1998 funds, and invites cooperative 
agreement applications for a multi-center, collaborative, diabetes 
translational research initiative within managed-care settings to (1) 
evaluate the extent to which healthcare providers and healthcare 
delivery systems implement accepted standards of diabetes care (e.g., 
American Diabetes Association), which can reduce the burden of diabetes 
and its complications; (2) explore the factors that affect variations 
in implementing quality diabetes care; and (3) develop and test 
strategies aimed at closing the gap between existing practice and 
optimal standards of care.
    The collaborative studies will consist of two phases. Phase 1 (12 
months)--Planning, collaborative development of the protocol(s), and 
development of the manual of operations. Phase 2 (48 months)--Conduct 
of studies selected by the Steering Committee, analysis, and reporting 
of the results.
    Under a Request for Contract, FY 1998 funds will be made available 
to fund one Data Coordinating Center (DCC). The organization funded for 
the DCC will not be eligible to receive funds under this Program 
Announcement. The DCC will collaborate with the recipients under this 
announcement in the design and writing of the study protocol(s) and 
consent forms, creation of the data collection forms, and writing of 
the manual(s) of operations. In addition, it will assist with the 
development of the operational plans, develop a system to collect, 
manage, and store scientific data, management and analysis, and 
collaborate with the Translational Research Centers in reporting of 
results.
    CDC is committed to achieving the health promotion and disease 
prevention objectives of Healthy People 2000, a national activity to 
reduce morbidity and mortality and improve the quality of life. This 
announcement is related to the priority area of Diabetes and Chronic 
Disabling Conditions. (For ordering a copy of Healthy People 2000, see 
the section Where to Obtain Additional Information.)

Authority

    This program is authorized under sections 301(a) and 317(k)(2) of 
the Public Health Service Act, as amended (42 U.S.C. 241(a) and 247b 
(k)(2)). Applicable program regulations are found in 42 CFR Part 51b--
Project Grants for Preventive Health Services.

Smoke-Free Workplace

    CDC strongly encourages all grant recipients to provide a smoke-
free workplace and to promote the non-use of all tobacco products, and 
Pub. L. 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities that receive Federal funds in which education, 
library, child care, health care, and early childhood development 
services are provided to children.

Eligible Applicants

    Eligible applicants are public and private nonprofit domestic 
organizations operating within managed-care settings and providing 
services to a minimum of 5,000 people with diabetes. Thus, managed-care 
organizations, teaching hospitals, universities, colleges, and research 
institutions are eligible to apply. Applicants claiming nonprofit 
status must include evidence of nonprofit status with their 
application.
    Minority individuals and women are encouraged to apply as Principal 
Investigators. Institutions caring for large numbers of racial and 
ethnic minority groups with diabetes are especially encouraged to 
apply.
    Funding Preference: A funding preference will be given to 
applications under the following conditions: Women, racial, and ethnic 
minority populations to be accessed by the applicant--to ensure that 
the selected Diabetes

[[Page 35232]]

Translational Research Centers will together have a good balance of 
racial and ethnic minority groups.
    Applicants must have direct access to a population of at least 
5,000 people with diabetes or access through a partnership, operating 
within a managed-care setting.
    Institutions may apply as a single entity or in a collaborative 
partnership. In this regard, applicants are encouraged to form 
collaborative arrangements with investigators at minority institutions 
or minority investigators at other institutions. However, only one 
institution will be named as the recipient of grant funds in a 
partnership.
    The expertise appropriate for the Translational Research Center 
applications includes a knowledge of the clinical, epidemiological, and 
health services research aspects of diabetes. All eligible applicants 
must have diabetes-related research capacity within a managed-care 
setting, i.e., access to large numbers of patients with diabetes 
(minimum of 5,000); strong multi disciplinary research groups, access 
to good data systems, access to academic skills in health services 
research, epidemiology, survey design, behavioral sciences, and health 
economics.
    Eligibility characteristics must be clearly specified with 
appropriate documentation in the Application Requirements section of 
your application (see Application Content).

    Note: Effective January 1, 1996, Pub. L. 104-65 states that an 
organization described in section 501(c)(4) of the Internal Revenue 
Code of 1986 which engages in Lobbying activities shall not be 
eligible for the receipt of Federal funds constituting an award, 
grant (cooperative agreement), contract, loan, or any other form.

Availability of Funds

    Approximately $800,000 is available in FY 1998 to fund up to four 
Translational Research Centers. It is expected that the average award 
during the planning phase (Year 1) of this project will be $200,000 
(including direct and indirect costs), ranging from $150,000 to 
$250,000. However, it is anticipated that additional funds may be 
available in FY 1999 to increase the average award for Year 01 to 
approximately $500,000, ranging from $300,000 to $700,000.
    Please plan your project in anticipation of these additional funds. 
It is expected that awards will begin on or before September 30, 1998, 
and will be made for a 12-month budget period within a project period 
of up to 5 years. Funding estimates may vary and are subject to change.
    Continuation awards within the project period will be made on the 
basis of satisfactory progress and the availability of funds. At this 
time, CDC anticipates that there will not be a renewed competition 
after five years.

Use of Funds

    Allowable Uses: Funds are awarded for a specifically defined 
purpose and must be targeted for implementation and management of the 
project. Funds can support personnel, services directly related to the 
project, and the purchase of hardware and software for data collection, 
analysis, and project management and evaluation purposes.
    Prohibited Uses: Cooperative agreement funds under this program 
announcement 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 patient care.
    Restrictions on Lobbying: Applicants should be aware of 
restrictions on the use of Health and Human Services (HHS) funds for 
lobbying of Federal or State legislative bodies. Under the provisions 
of 31 U.S.C. Section 1352 (which has been in effect since December 23, 
1989), recipients (and their subtier contractors) are prohibited from 
using appropriated Federal funds (other than profits from a Federal 
contract) for lobbying Congress or any Federal agency in connection 
with the award of a particular contract, grant, cooperative agreement, 
or loan. This includes grants and cooperative agreements that, in whole 
or in part, involve conferences for which Federal funds cannot be used 
directly or indirectly to encourage participants to lobby or to 
instruct participants on how to lobby.
    In addition, the FY 1998 Department of Labor, Health and Human 
Services, and Education, and Related Agencies Appropriations Act, (Pub. 
L. 105-78) states in section 503(a) and (b) that no part of any 
appropriation contained in this Act shall be used, other than for 
normal and recognized executive-legislative relations, for publicity or 
propaganda purposes, for the preparation, distribution, or use of any 
kit, pamphlet, booklet, publication, radio, television, or video 
presentation designed to support or defeat legislation pending before 
the Congress or any State legislature, except in presentation to the 
Congress or any State legislature itself. No part of any appropriation 
contained in this Act shall be used to pay the salary or expenses of 
any grant or contract recipient, or agency acting for such recipient, 
related to any activity designed to influence legislation or 
appropriations pending before Congress or any State legislature.

Background

    A considerable body of evidence exists for the efficacy of 
interventions (e.g., glycemic control, cardiovascular disease (CVD) 
risks reduction, screening for diabetes complications) to reduce the 
avoidable burden of diabetes. Nevertheless, the effectiveness, 
generalizability, feasibility, and sustainability of several of these 
interventions in real-life settings are less than clear. Furthermore, 
several reports suggest that considerable gaps exist between existing 
practice and recommended standards of diabetes care for people with 
diabetes. For example, the American Diabetes Association has 
recommended standards of care for several aspects of diabetes 
management (American Diabetes Association, Clinical Practice 
Recommendations 1998, Diabetes Care 1998;21 (Suppl.1). However, 
national estimates from the Behavioral Risk Factor Surveillance System 
indicate that the population of Americans receiving appropriate 
diabetes care practices such as foot and eye examinations, glycosylated 
hemoglobin, and other preventive care evaluations fall short of the 
recommended standards.
    Managed care represents a revolution in the way health care is 
funded, organized, and delivered in the United States, and has affected 
the way in which diabetes treatment and control are conducted in both 
the private and public sectors. In the public sector, many health 
departments are in some stage of transition from directly delivering 
clinical services to using other delivery models that involve managed 
care. Thus, managed-care providers play a key role in the way people 
with diabetes are diagnosed and managed for increasing numbers of 
Americans. With more diagnostic and treatment services for diabetes 
being conducted in managed care, new partnerships are needed between 
managed-care health plans and public health agencies to design and 
implement essential and innovative diabetes-related services. 
Furthermore, managed-care (by virtue of coordinating all care for 
persons with diabetes) is probably the closest approximation to 
population medicine currently available in the United States. Managed-
care, therefore, offers significant opportunities to understand and 
test intervention effectiveness and cost-effectiveness within a real-
life context,

[[Page 35233]]

as well as the public health impact of system wide interventions.

Purpose

    The purpose of this diabetes translational research initiative is 
to initiate a multicenter, collaborative program of applied population-
based research related to diabetes, and to develop a knowledge base 
through published research in scientific literature and handbooks for 
professional associations that will improve the process, delivery, and 
outcome of diabetes services within managed-care settings. The 
knowledge base to be developed will address methods for and assessment 
of effectiveness, cost-effectiveness, generalizability, feasibility, 
and sustainability of interventions. Such a knowledge base may include 
a variety of activities covering the range of diabetes interventions, 
including diabetes screening and diagnosis; treatment approaches, 
glycemic control, CVD risk reduction, and screening for diabetes 
complications.
    This program will improve the availability, accessibility, quality 
of process, effectiveness, cost-effectiveness, and health outcomes of 
diabetes-related services provided by managed-care health plans. The 
benefit of this program will be the establishment of new partnerships 
and relationships among managed-care health plans and between managed-
care health plans and public health agencies. Thus, the challenges of 
improving diabetes control services may be collaboratively assessed in 
a manner to have a national public health impact. The other goals of 
this program will include provision of data for policy development, 
assessment, and capacity-building at the State and local levels with 
respect to managed care and the CDC Diabetes Control Program's ability 
to develop appropriate diabetes control policies and to conduct 
diabetes surveillance in a changing health environment.

Program Requirements

    Work performed under this cooperative agreement will be the result 
of collaborative efforts among the funded Translational Research 
Centers and the Data Coordinating Center. Recipients will be 
responsible for implementing research methods and study design, 
analysis, use of data, and dissemination of results via peer-reviewed 
scientific publications or other related material.
    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for the activities under A., below, 
and CDC will be responsible for carrying out the activities described 
under B., below.
A. Recipient Activities
    1. Participate in the protocol development, data collection, 
quality control, final data analysis and interpretation, the 
preparation of publications, and presentation of findings.
    2. Establish a Steering Committee that will be the primary 
governing body of the study and will be comprised of each of the 
Principal Investigators from the Translational Research Centers and the 
Data Coordinating Center. The Steering Committee will have primary 
responsibility for developing common study protocols, facilitating the 
conduct and monitoring of the studies, and reporting the study results.
    3. Work cooperatively with the other Translational Centers, the 
Data Coordinating Center, and agree to follow the common protocol(s) 
and manual(s) of operations developed in Phase 1 of the study by the 
Steering Committee.
    4. Transmit all relevant study data to a central Data Coordinating 
Center for data editing, formatting, combination, and primary analysis.
    5. Collaborate with other health organizations, community groups, 
etc., as necessary to accomplish program activities.
    6. Maintain an effective and adequate management and staffing plan. 
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. CDC Activities
    1. Support and stimulate the recipients' activities by 
collaborating and providing scientific and public health consultation 
and assistance in the development of activities related to the 
cooperative agreement. Consistent with this concept, the tasks and 
activities in carrying out the studies will be shared among the 
recipients and the CDC.
    2. Establish a Data Coordinating Center that will serve as a 
resource for standardized assessment, analysis, reporting, and that 
will assist in the design and writing of study protocol(s) in 
collaboration with the Research Centers.
    3. Assist in the coordination of activities between the Diabetes 
Translational Research Centers and the Data Coordinating Center.
    4. Facilitate communication among recipients and assist in quality 
control, interim data monitoring, final data analysis and 
interpretation, and coordination and performance monitoring.
    5. Serve as a consultant to the Steering Committee.

Technical Reporting Requirements

    An original and two copies of the following reports must be 
submitted to the Grants Management Branch, CDC.
    A. Semiannual progress reports are required of all cooperative 
agreement recipients. The first semiannual report is required with each 
year's noncompeting continuation application and should cover program 
activities from date of the previous report (or date of award for 
reporting in the first year of the project). The second semiannual 
report is due 30 days after the end of each budget period and should 
cover activities from the date of the previous report. Progress reports 
should address the status of all recipient activities above, including:
    1. A comparison of actual accomplishments to the objectives 
established for the period.
    2. The reasons for slippage if established goals were not met.
    3. Other pertinent information essential to evaluating progress.
    4. Data pertaining to various project activities.
    B. A financial status report (FSR) is required no later than 90 
days after the end of each budget period. The final financial status 
report is required no later than 90 days after the end of the project 
period. Please submit the original and two (2) copies of all reports to 
the Grants Management Branch, CDC.

Notification of Intent To Apply (Preapplication Letter)

    To assist CDC in planning and executing the evaluation of 
applications submitted under this Program Announcement (98086), a 
nonbinding letter of intent-to-apply is requested from potential 
applicants. Although not a prerequisite of the application, the letter 
should be submitted to Bernice A. Moore, Epidemiology and Statistics 
Branch, Division of Diabetes Translation, National Center for Chronic 
Disease Prevention and Health Promotion, Centers for Disease Control 
and Prevention (CDC), Mailstop K-10, 4770 Buford Highway NE., Atlanta, 
GA 30341-3717, telephone (770) 488-5855; fax (770) 488-5966; or 
Internet or CDC WONDER E-mail at <a href="/cdn-cgi/l/email-protection#7012111d1f301314135e171f06"><span class="__cf_email__" data-cfemail="a0c2c1cdcfe0c3c4c38ec7cfd6">[email protected]</span></a>. It should be postmarked 
no later than one month before the planned submission deadline (due not 
later than July 15, 1998. The letter should identify the Program 
Announcement number, the

[[Page 35234]]

name and address of the applicant's institution, and telephone number 
of a contact person. The letter of intent does not influence review or 
funding decisions, but it will enable CDC to plan the review more 
efficiently.

Application Content

    It is anticipated that applications for Diabetes Translational 
Research Centers within this initiative will focus on important aspects 
of the process and outcome of care for people with diabetes. Process of 
care may include diabetes screening and diagnosis; treatment 
approaches; glycemic control; cardiovascular disease (CVD) risks 
reduction; screening for diabetes complications; and outcome of care 
may include quality of life and avoidable morbidity and death among 
people with diabetes. In addition, the extent and causes of variation 
in implementation of accepted standards of diabetes care may be 
explored at three levels--individuals, healthcare providers, and health 
care delivery systems. Emphasis should be on identifying important and 
potentially modifiable factors that contribute to the failure to use 
recommended standards of diabetes care, and on designing and testing 
(using rigorous scientific approaches) cost-effective strategies aimed 
at achieving optimal care. Furthermore, in keeping with the philosophy 
of Translational Research, designs should emphasize intervention 
effectiveness which span diverse populations and a variety of 
healthcare approaches (e.g., type of managed care), leading to findings 
with high generalizability. Thus, good translational research will 
require multicenter participation and represent populations of diverse 
age, ethnicity, socioeconomic status, and severity of diabetes. 
Furthermore, strategies aimed at achieving optimal diabetes care should 
aim for generalizability, sustainability and cost-effectiveness.
    Each applicant must propose the research questions and study 
designs that best address the objectives of this initiative and are 
most appropriate for their patient population. The outcome of this 
initiative should result in the following questions:
    1. What are the current levels of care provided to people with 
diabetes, and how does it compare with the recommended standards of 
diabetes care (e.g., American Diabetes Association)?
    2. What is the health-related quality of life for people with 
diabetes and what factors influence patient satisfaction and quality of 
life?
    3. What are the major factors that influence the process, delivery, 
effectiveness, costs, and sustainability of interventions aimed at 
glycemic control, and conventional CVD risk factor (elevated blood 
pressure, dyslipidemia, smoking, overweight, physical inactivity) 
reduction among people with diabetes?
    4. What are the major factors that influence the process, delivery, 
effectiveness, costs, and sustainability of interventions aimed at the 
early detection of microvascular complications of diabetes (e.g., 
retinopathy, nephropathy)?
    Collaborative protocols to study the above questions will be 
developed by a Steering Committee composed of the recipients and the 
Principal Investigator of a Data Coordinating Center selected under a 
separate Request for Contract. The collaborative study protocol(s) will 
move into the implementation stage with the concurrence of the Steering 
Committee.
    It is not the intent of this Program Announcement to solicit 
elaborately detailed research plans for the above proposed 
collaborative studies because the final protocols will be 
collaboratively developed by the investigators during the planning 
phase (Phase 1).

Specific Instructions

    All applicants must develop their applications in accordance with 
PHS Form 5161-1 (Revised 5/96), information contained in this Program 
Announcement, and the format and page limitations that follow. Provide 
a clear and succinct description and supportive references regarding 
how each of the statements apply in your application:
    1. Experience in one or more of the following areas: Health 
economics research, health services research, epidemiological research, 
or health information systems research.
    2. Employs or can engage investigators in the fields of economics, 
health services research, or information systems research who have 
direct experience at establishing, working with, and researching 
diabetes-related topics, and with a corresponding record of substantial 
publication in the peer-reviewed scientific literature.
    3. Ability and willingness to designate one experienced and 
published investigator as the project's principal investigator.
    4. The principal investigator for this project has access to a 
population of at least 5,000 people with diabetes who are cared for 
within a managed-care setting, and has access to research 
infrastructure and to basic data necessary to carry out this project.
    5. Describe the composition of the proposed study population (for 
example, addressing the inclusion of women and members of minority 
groups and their subpopulations in the section that will describe the 
research design). A copy of the CDC policy on Women, Racial and Ethnic 
Minorities is enclosed with the application kit for guidance.
    6. Nonprofit organizations must document their status on 
application PHS Form 5161-1 (Revised 5/96), Part D of the Checklist.
    Responses to the above may follow the Table of Contents in your 
application, but must appear as the first page(s) of the text of your 
application and be titled, Application Requirements. Eligibility 
characteristics must be clearly specified with appropriate 
documentation in the Application Requirements section of your 
application.
    The application narrative must include the following sections in 
the order presented below:
    A. Rationale for the research question(s) chosen to be addressed 
(not to exceed 1 page):
    Describe the research question(s) chosen to be addressed and the 
rationale for this selection. Include an explanation of why this 
question is a priority for the investigator(s) and what types of 
interest, experience, or expertise the investigator(s) brings to the 
particular problem inherent in the chosen research question(s).
    The extent to which the rationale for the chosen research question 
(1) is based on public health importance, (2) is based on the 
experience and expertise of the investigator(s), and (3) clearly 
communicates the anticipated value to the purpose of the Diabetes 
Translational Research Initiative.
    B. Objectives of the research (not to exceed 4 pages):
    Itemize the objectives and timelines of the research in relation to 
the chosen research question(s), and describe: (1) The extent to which 
the objectives of the chosen research question(s) are numerically 
measurable, specific, realistic, time-phased, and suitable for 
development into a collaborative, multicenter study protocol; the 
extent to which applicant presents a detailed operational plan for 
initiating and conducting the project that clearly and appropriately 
addresses all Recipient Activities; (2) the extent to which the 
applicant clearly identifies specific assigned responsibilities and 
time commitment of all key professional personnel; (3) the extent to 
which the plan clearly describes applicant's technical approach and 
methods for conducting the proposed studies and

[[Page 35235]]

extent to which the approach and methods are appropriate and adequate 
to accomplish the objectives; (4) the extent to which applicant 
describes collaboration with CDC and others during the various phases 
of the project and shows commitment to a multicenter, collaborative 
approach.
    C. Design of the research (not to exceed 3 pages):
    The extent to which the proposed methodology of the research is 
scientifically sound, realistic, appears likely to answer the chosen 
research question(s), and will produce generalizable findings; and, if 
appropriate, the degree to which the applicant has included women, 
racial and ethnic minority populations in the proposed research to 
include:
    1. The proposed plan for the inclusion of both sexes and racial and 
ethnic minority populations for appropriate representations.
    2. The proposed justification when representation is limited or 
absent.
    3. A statement whether the design of the study is adequate to 
measure differences when warranted.
    4. A statement whether the plans for recruitment and outreach for 
study participants include the process of establishing partnerships 
with community(ies) and recognition of mutual benefits.
    D. Background and experience of the principal investigator, 
coinvestigators, and the applying institution, organization, or agency 
(not to exceed 3 pages):
    Describe the educational and professional background of the 
principal investigator, and document the relevant experience of the 
principal investigator and qualifications of the applying institution, 
organization, or agency for carrying out health economics, health 
services, or information systems research. Specifically, emphasize the 
experience of the principal investigator in participating in 
collaborative, multicenter research projects, and describe the data 
sources that are available to the investigator. Describe the population 
and number of people with diabetes within the managed-care health plan, 
and provide details of the managed-care structure, organization, 
financing, and percentage of the Medicaid population under contract. 
Provide a brief description of how the project will be organized, and 
indicate the proposed staffing plan.
    E. Access to a large number of people with diabetes 
(<ls-thn-eq>5000) cared for within managed care (not to exceed 2 
pages):
    Describe the extent to which (1) the population used in carrying 
out this research project is sufficiently typical of people with 
diabetes around the country or accurately represents special groups of 
people with the disease--so that a solution to the collaborative 
research question(s) will have the broadest possible application; (2) 
the principal investigators have sufficient access to well developed 
data sources and ability to use it for the purposes of carrying out 
this research project; and (3) if applicable, attach evidence of 
collaboration specifying the commitment of the parties involved and 
provide details, including the terms of access to data and to 
populations and any specified limits to collaboration for the purposes 
of this project.
    F. Budget and budget justification (not to exceed 5 pages):
    Provide a detailed, line-item budget with justification that 
demonstrates the request is consistent with the purpose and objectives 
of this program. The budget for Phase I of the study should be clearly 
delineated. Budgets should allow for approximately three persons, 
including the Principal Investigator, to attend Steering Committee and 
Subcommittee meetings. The detailed budget for Phase I should be 
estimated on the basis of monthly meetings during Phase 1.
    G. Human Subjects:
    Whether or not exempt from DHHS regulations, if the proposed 
project involves human subjects, describe (in an appendix) adequate 
procedures for the protection of human subjects. Also, ensure that 
women, and racial and ethnic minority populations are appropriately 
represented in applications for research involving human subjects.

Typing and Mailing

    All pages must be clearly numbered and a complete index to the 
application and its appendixes must be included. Do not bind, staple, 
or paper clip any pages of any copy of the application, including 
appendixes. Do not include any bound documents (e.g., pamphlets or 
other publications) in the appendixes. Do not include cardboard, 
plastic, or other page separators between the sections. The entire 
application must be typewritten, single-spaced, and in unreduced type 
(12-point fonts) on 8\1/2\'' by 11'' white paper, with at least 1'' 
margins, including headers and footers, and printed on one side only.

Evaluation Criteria (Total 100 Points)

    Applications will be reviewed and evaluated according to the 
following criteria:
    A. Rationale for the Research Question(s) Chosen to be Addressed 
(15 points)
    Describe the research question(s) chosen to be addressed and the 
rationale for this selection. Included in this should be an explanation 
of why this question is a priority for the investigator(s) and what 
types of interest, experience, or expertise the investigator(s) brings 
to the particular problem inherent in the chosen research question(s).
    The extent to which the rationale for the chosen research question 
(1) is based on public health importance, (2) is based on the 
experience and expertise of the investigator(s), and (3) clearly 
communicates the anticipated value to the purpose of the Diabetes 
Translational Research Initiative.
    B. Objectives of the Research (20 points).
    (1) The extent to which the objectives of the chosen research 
question(s) are numerically measurable, specific, realistic, and time-
phased, and suitable for development into a collaborative, multicenter 
study protocol. The extent to which the applicant presents a detailed 
operational plan for initiating and conducting the project that clearly 
and appropriately addresses all Recipient Activities; (2) the extent to 
which the applicant clearly identifies specific assigned 
responsibilities and time commitment of all key professional personnel; 
(3) the extent to which the plan clearly describes applicant's 
technical approach and methods for conducting the proposed studies and 
the extent to which the approach and methods are appropriate and 
adequate to accomplish the objectives; and (4) the extent to which 
applicant describes collaboration with other translation centers during 
the various phases of the project, and shows commitment to a 
multicenter, collaborative approach.
    C. Design of the Research (20 points).
    The extent to which the proposed methodology of the research is 
scientifically sound, realistic, appears likely to answer the chosen 
research question(s), and will produce generalizable findings; and, if 
appropriate, the degree to which the applicant has included women, 
racial and ethnic minority populations in the proposed research to 
include:
    1. The proposed plan for the inclusion of both sexes and racial and 
ethnic minority populations for appropriate representations.
    2. The proposed justification when representation is limited or 
absent.
    3. A statement whether the design of the study is adequate to 
measure differences when warranted.
    4. A statement whether the plans for recruitment and outreach for 
study participants include the process of

[[Page 35236]]

establishing partnerships with community(ies) and recognition of mutual 
benefits.
    D. Background and Experience of the Principal Investigator and of 
the Applying Institution, Organization, or Agency (20 points).
    Describe the educational and professional background of the 
principal investigator, and document the relevant experience of the 
principal investigator and qualifications of the applying institution, 
organization, or agency for carrying out health economics, health 
services, or information systems research. Specifically, emphasize the 
experience of the principal investigator in participating in 
collaborative, multicenter research projects, and describe the data 
sources that are available to the investigator. Describe the population 
and number of people with diabetes within the managed-care health plan, 
and provide details of the managed-care structure, organization, 
financing, and percentage of Medicaid population under contract. 
Provide a brief description of how the project will be organized and 
indicate the proposed staffing plan.
    E. Access to a large Number of people with diabetes 
(<ls-thn-eq>5000) cared for within managed care (25 points).
    Describe the extent to which (1) the population used in carrying 
out this research project is sufficiently typical of people with 
diabetes around the country or accurately represents special groups of 
people with the disease--so that a solution to the collaborative 
research question(s) will have the broadest possible application; (2) 
the principal investigator has sufficient access to well developed data 
sources and ability to use it for the purposes of carrying out this 
research project; and (3) if applicable, attach evidence of 
collaboration specifying the commitment of the parties involved and 
provide, including the terms of access to data and to populations any 
specified limits to collaboration for the purposes of this project.
    F. Budget and Budget Justification (Not Weighted).
    The extent to which the budget is reasonable and consistent with 
the purpose and objectives of this program.
    G. Human Subjects (Not Weighted).
    If the proposed project involves human subjects, whether or not 
exempt from the Department of Health and Human Services (DHSS) 
regulations, the extent to which adequate procedures are described for 
the protection of human subjects. Note: Objective Review Panel 
recommendations on the adequacy of protections include: (1) Protections 
appear adequate and there are no comments to make or concerns to raise; 
(2) protections appear inadequate and the Review Panel has concerns 
related to human subjects; (3) disapproval of the application is 
recommended because the research risks are sufficiently serious and 
protection against the risks are inadequate as to make the entire 
application unacceptable, and (4) protections appear adequate that 
women, racial and ethnic minority populations are appropriately 
represented in applications involving human research.

Content of Noncompeting Continuation Applications

    Submitted within the project period need only include:
    A. A brief progress report that describes the accomplishments of 
the previous semi-annual period. This report will be in lieu of the 
semi-annual progress report.
    B. Any new or significantly revised items or information 
(objectives, scope of activities, operational methods, evaluation, key 
personnel, work plans, etc.) not included in year 01 or subsequent 
continuation applications.
    C. An annual budget and justification. Existing budget items that 
are unchanged from the previous budget period do not need 
rejustification. Simply list the items in the budget and indicate that 
they are continuation items.

Executive Order 12372 Review

    Applications are subject to Intergovernmental Review of Federal 
Programs as governed by Executive Order (E.O.) 12372, which sets up a 
system for State and local government review of proposed Federal 
assistance applications. Applicants should contact their State Single 
Point of Contact (SPOC) as early as possible to alert them to the 
prospective applications and receive any necessary instructions on the 
State process. For proposed projects serving more than one State, the 
applicant is advised to contact the SPOC for each affected State. The 
application kit includes a current list of SPOCs. If the SPOCs have any 
State process recommendations on applications submitted to CDC, they 
should send them to Sharron P. Orum, Grants Management Officer, Grants 
Management Branch, Procurement and Grants Office, Centers for Disease 
Control and Prevention (CDC), Mailstop E-18, Room 305, 255 East Paces 
Ferry Road, NE., Atlanta, GA 30305, no later than 30 days after the 
application due date (a waiver has been requested). Please include the 
Program Announcement Number and Program Title on the letter. The 
granting agency does not guarantee to ``accommodate or explain'' for 
State or tribal process recommendations it receives after that date.

Public Health System Reporting Requirement

    This program is subject to the Public Health System Reporting 
Requirements. Under these requirements, all community-based 
nongovernmental applicants must prepare and submit the items identified 
below to the head of the appropriate State or local health agency(s) in 
the program area(s) that may be impacted by the proposed project no 
later than the receipt date of the Federal application. The appropriate 
State or local health agency is determined by the applicant. The 
following information must be provided:
    A. A copy of the face page of the application (SF 424).
    B. A summary of the project that should be titled ``Public Health 
System Impact Statement'' (PHSIS), not to exceed one page, and should 
include the following:
    1. A description of the population to be served.
    2. A summary of the services to be provided.
    3. A description of the coordination plans with the appropriate 
State or local health agencies.
    If the State and/or local health official desires a copy of the 
entire application, it may be obtained from the State Single Point of 
Contact (SPOC) or directly from the applicant.

Catalog of Federal Domestic Assistance Number

    The Catalog of Federal Domestic Assistance number is 93.988.

Other Requirements

Paperwork Reduction Act

    Projects that involve the collection of information from 10 or more 
individuals and funded by this cooperative agreement will be subject to 
review by the Office of Management and Budget (OMB) under the Paperwork 
Reduction Act.

Human Subjects

    If the proposed project involves research on human subjects, the 
applicant must comply with the Department of Health and Human Services 
Regulations, 45 CFR part 46, regarding the protection of human 
subjects. Assurance must be provided to demonstrate that the project 
will be subject to initial and continuing review by an appropriate 
institutional review

[[Page 35237]]

committee. The applicant will be responsible for providing assurance in 
accordance with the appropriate guidelines and forms provided in the 
application kit. Should human subjects reviews be required, the 
proposed word play should incorporate timelines for such development 
and review activities.

Women, Racial, and Ethnic Minorities Policy

    It is the policy of the CDC to ensure that women and racial and 
ethnic groups will be included in CDC-supported research projects 
involving human subjects, whenever feasible and appropriate. Racial and 
ethnic groups are those defined in OMB Directive No. 15 and include 
American Indian or Alaskan Native, Asian, Black or African American, 
Native Hawaiian or Other Pacific Islander, and Hispanic or Latino. 
Applicants shall ensure that women and racial and ethnic minority 
populations are appropriately represented in applications for research 
involving human subjects. Where clear and compelling rationale exist 
that inclusion is not feasible, this situation must be explained as 
part of the application. In conducting the review of applications for 
scientific merit, review groups will evaluate proposed plans for 
inclusion of minorities and both sexes as part of the scientific 
assessment and assigned score. This policy does not apply to research 
studies when the investigator cannot control the race, ethnicity and/or 
sex of subjects. Further guidance to this policy is contained in the 
Federal Register, Vol. 60, No. 179, Friday, September 15, 1995, pages 
47947-47951.

Confidentiality

    Any personal identifying information obtained in connection with 
the delivery of services provided to any individual under any program 
that is being carried out with a cooperative agreement made under this 
Program Announcement shall not be disclosed unless required by a law of 
a State or political subdivision or unless such an individual provides 
written, voluntary informed consent.

Application Submission and Deadline

    The application must be carefully completed, following the 
directions provided in this Program Announcement. An original and two 
copies of the application PHS Form 5161-1 (Revised 5/96) must be 
submitted to Sharron P. Orum, Grants Management Officer, Procurement 
and Grants Office, Centers for Disease Control and Prevention, (CDC), 
255 East Paces Ferry Road, NE., Mailstop E-18, Atlanta, GA 30305-2209, 
on or before August 14, 1998.
    1. Deadline: Applications shall be considered as meeting the 
deadline if they are either:
    a. Received on or before the deadline date; or
    b. Sent on or before the deadline date and received in time for 
submission to the objective review group. (Applicants must request a 
legibly dated U.S. Postal Service postmark or obtain a legibly dated 
receipt from a commercial carrier or U.S. Postal Service. Private 
metered postmarks shall not be acceptable as proof of timely mailing.)
    2. Late Applications: Applications that do not meet the criteria in 
1.a. and 1.b. above are considered late applications. Late applications 
will not be considered in the current competition and will be returned 
to the applicant.

Where To Obtain Additional Information

    A complete program description and information on application 
procedures are contained in the application package. Business 
management technical assistance may be obtained from Locke Thompson, 
Grants Management Specialist, Grants Management Branch, Procurement and 
Grants Office, Centers for Disease Control and Prevention (CDC), 255 
East Paces Ferry Road, NE., Room 300, Mailstop E-18, Atlanta, GA 30305-
2209, telephone (404) 842-6595; fax (404) 842-6513; or Internet or CDC 
WONDER E-mail at <lxt1@.cdc.gov>. Programmatic technical assistance may 
be obtained from Bernice A. Moore, Epidemiology and Statistics Branch, 
Division of Diabetes Translation, National Center for Chronic Disease 
Prevention and Health Promotion, Centers for Disease Control and 
Prevention (CDC), Mailstop K-10, 4770 Buford Highway NE., Atlanta, GA 
30341-3701, telephone (770) 488-5855; fax (770) 488-5966; or Internet 
or CDC WONDER E-mail at <<a href="/cdn-cgi/l/email-protection#b9dbd8d4d6f9daddda97ded6cf"><span class="__cf_email__" data-cfemail="bcdeddd1d3fcdfd8df92dbd3ca">[email protected]</span></a>>.
    To receive additional written information and to request an 
application kit, call 1-888-GRANTS4 (1-888-472-6874). You will be asked 
to leave your name and address and will be instructed to identify the 
Announcement number of interest.
    Please refer to Announcement Number 98086 when requesting 
information and submitting an application.
    You may obtain this and other CDC Announcements from one of two 
Internet sites on the actual publication date: CDC's homepage at http:/
/www.cdc.gov or at the Government Printing Office homepage (including 
free on-line access to the Federal Register at <a href="http://
www.access.gpo.gov">http://
www.access.gpo.gov</a>.
    Potential applicants may obtain a copy of Healthy People 2000 (Full 
Report, Stock No. 017-001-00474-0) or Healthy People 2000 (Summary 
Report, Stock No. 017-001-00473-1) referenced in the Introduction 
through the Superintendent of Documents, Government Printing Office, 
Washington, DC 20402-9325; telephone 202-512-1800.

    Dated: June 22, 1998.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 98-17202 Filed 6-26-98; 8:45 am]
BILLING CODE 4163-18-U


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