[Federal Register Volume 65, Number 114 (Tuesday, June 13, 2000)]
[Notices]
[Pages 37142-37146]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-14829]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Program Announcement 00097]
Uniform Population-Based Approach to Case Ascertainment,
Typology, Surveillance, and Research on Childhood Diabetes; Notice of
Availability of Funds
A. Purpose
The Centers for Disease Control and Prevention (CDC) announces the
availability of fiscal year (FY) 2000 funds for a cooperative agreement
program to develop a multi-center and uniform population-based approach
to case ascertainment, typology, surveillance, and research on
childhood diabetes (diagnosis before the age of 20 years). This program
addresses the ``Healthy People 2010'' focus area of Diabetes. For the
conference copy of ``Healthy People 2010,'' visit the internet site:
http://www.healthypeople>. In view of the importance of racial and
ethnic health disparity issues, the purpose of the program is to use a
uniform multi-center approach in diverse populations for multiple
purposes:
1. Using existing data of known prevalent cases of childhood
diabetes, develop a uniform typology of the prevalent cases, obtain
type-specific prevalence estimates, and describe characteristics of the
different types of childhood diabetes;
2. Based on the extensive collection of new cases of childhood
diabetes, develop a uniform typology of the incident cases, obtain
accurate and precise population-based estimates of the type-specific
incidence and secular trends of new cases, and describe the
characteristics of the different types of childhood diabetes;
3. Develop a uniform approach to follow incident cases of childhood
diabetes to ascertain changes in typology, characteristics and
outcomes, and to maintain a ``pool'' of incident cases of childhood
diabetes.
Characterization of types of childhood diabetes should include a
description of potential risk factors (including family history,
maternal diabetes, race/ethnicity, sex, weight and height, birth-
weight, etc), other characteristics (including presence of acanthosis
nigricans, symptoms and circumstances at or preceding diagnosis,
treatment and response to treatment, HbA1c, lipids, and blood pressure
levels, etc), potential laboratory measurements (C-peptide and insulin
levels, immunological markers, etc), potential complications (including
microalbuminuria, hypertension, retinopathy, neuropathy, infections,
etc), and quality of medical care (including screening frequencies for
HbA1c, lipid profiles, microalbuminuria, retinal and foot examinations,
blood pressure checks, nutrition counseling, rates of hospitalization
for complications, etc).
This collaborative program will consist of two phases. Phase I (12
months)--Planning, developing networks of care providers and other
partnerships, and collaboration on the development of the protocol and
Institutional Review Board clearances. Phase II (48 months)--Data
collection, monitoring, analyzes, and collaborative reporting of the
results, on a yearly basis.
B. Eligible Applicants
Applications may be submitted by public and private nonprofit
organizations and by governments and their agencies; that is,
universities, colleges, research institutions, hospitals, other public
and private nonprofit organizations, State and local governments or
their bona fide agents, and federally recognized Indian tribal
governments, Indian tribes, or Indian tribal organizations.
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 $500,000 is available in FY 2000 to fund
approximately 2 to 3 awards. It is expected that the average award will
be $200,000 ranging from $150,000 to $250,000. It is anticipated that
additional funds may be available in FY 2001-2004 to increase the
average award to approximately $500,000 in Years 2-5, ranging from
$400,000 to $600,000. It is expected that the awards will begin on or
about September 30, 2000, and will be made for a 12-month budget period
within a project period of up to 5 years.
[[Page 37143]]
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.
Use of Funds
Funds are awarded for a specifically defined purpose and must be
targeted for implementation and management of the project. Funds can
support personnel, activities directly related to the project, and the
purchase of 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.
Funding Priority
In making awards, priority consideration will be given as follows.
Due to the high prevalence of type 2 diabetes in American Indian
children, funding priority will be given to at least one center which
will have access to American Indian populations. In addition, approved
applications may also be ranked and funded based on populations with
racial/ethnic and socio-economic diversity to achieve geographic,
socio-economic and racial/ethnic representation of the U.S. population,
and a minimum mix of the different types of childhood diabetes (at
least 20% type 2).
Minimum Requirement
Applications for the development of a multi-center and uniform
population-based approach to case ascertainment, typology,
surveillance, and research on childhood diabetes in diverse populations
require access to information on large numbers of children with
diabetes (minimum of 50 incident cases per year) and their referent
populations (minimum of 300,000 children under the age of 20) with
racial/ethnic and socio-economic diversity, including under-insured.
Institutions may apply as a single entity or in collaborative
partnership or network(s). However, only one institution will be named
as the recipient of funds in a partnership/network.
Eligibility characteristics for review must be clearly specified
with appropriate documentation in the Application Requirements section
of your application (see Application Content).
D. Program Requirements
In conducting activities to achieve the purpose of this program,
the recipient will be responsible for the activities under 1.
(Recipient Activities), and CDC will be responsible for the activities
listed under 2. (CDC Activities).
1. Recipient Activities
a. Establish and sustain networks or partnerships with health care
providers and health care systems who have access to information on
cases of childhood diabetes. Collaborate with other health
organizations, community groups, State Health Department, Diabetes
Control Programs etc., as necessary to accomplish program activities.
b. 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 each center. The Steering Committee will
have primary responsibility for developing manual(s) of operations and
common study protocols, submitting the protocols for CDC and other
Institutional Review Boards, and coordinating resolution of
Institutional Review Board issues, facilitating the conduct of the
study and on-going data collection, analyses, and reporting of study
results.
c. Participate in the methodology and protocol development, on-
going data collection and follow-up, quality control, data analysis and
interpretation, the preparation of peer-reviewed publications, and
presentation of findings.
d. Work cooperatively with the other Centers, and agree to follow
the common protocol(s) and manual(s) of operations developed in Phase I
of the study by the Steering Committee.
e. Maintain an effective and adequate management and staffing plan.
Staff should have the education, background, and experience to
successfully conduct the activities proposed in this application. As a
part of the application, the existing staff and all proposed positions
should to be included.
2. CDC Activities
a. Support the recipients' activities by collaborating and
providing scientific and public health consultation and assistance in
the development of activities related to the cooperative agreement and
coordination sharing.
b. Assist in facilitating communication among recipients
development of common multi-center protocol(s), quality control,
interim data monitoring, data analysis, interpretation, reporting, and
coordination.
c. Assist in the development of a research protocol for IRB review
by all cooperating institutions participating in the research project,
including CDC IRB.
d. Serve as a consultant to the Steering Committee.
E. Application Content
Competing Applications
Use the information in the Program Requirements, Other
Requirements, and Evaluation Criteria sections of the announcement and
the Errata Sheet in the application to develop the application content.
Your application will be evaluated on the criteria listed, so it is
important to follow them in laying out your program plan.
The outcome of this program should provide reliable estimates of
the prevalence, incidence and secular trends of the different types of
childhood diabetes, and should enable the development of case
definition and characterization at diagnosis and follow-up of the
different types of childhood diabetes. More specifically, the following
questions should be answered:
1. Using existing data of known prevalent cases of childhood
diabetes, how could prevalent cases be classified, and what are the
type-specific prevalence estimates and the characteristics (including
medical care received) of the different types of childhood diabetes?
2. Based on the extensive collection of new data, how could
incident cases of childhood diabetes be classified, and what are the
accurate and precise population-based estimates of the type-specific
incidence and secular trends, and the characteristics (including
medical care received) of the different types of diabetes.
3. How could incident cases of childhood diabetes be followed in a
uniform approach, and what are their characteristics, outcomes and
quality of care at follow-up? How could a ``pool'' of incident cases be
maintained for studying secular trends in incidence and factors
associated with causation?
Emphasis should be on rigorous scientific approaches and
methodologies that should yield access to populations of diverse
ethnicity, socioeconomic status and insurance coverage, produce
reliable population-based estimates that should adequately address
ascertainment biases, and should assure sustainability to provide data
for secular trend assessment and follow-up for the different types of
childhood diabetes.
[[Page 37144]]
Each applicant must describe the proposed populations, the
methodology and study designs that best address the objectives of this
program, as well as the networks and partnerships that should help
achieve these objectives. Applications should propose a uniform and
multi-center approach, which considers the problem of racial/ethnic
health disparities.
Collaborative protocol(s) to study the above questions should be
developed by a Steering Committee composed of the recipients. The
collaborative study protocol(s) should 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 project because the
final protocol(s) should be collaboratively developed by the
investigators during the planning phase (Phase I).
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. Description and rationale of (a) the population source
(including size, age, ethnicity, medical insurance status, socio-
economic status, geographic), and
b. The partnership/network(s) which will provide access to
information on the cases within this population source (not to exceed 5
pages).
(1) When describing the population source, indicate the degree to
which racial and ethnic minority and socio-economically disadvantaged
populations are included, and how the population is sufficiently
typical of children with diabetes around the country or accurately
represents special groups of children with the disease.
(2) When describing the partnership/network(s), detail the various
types of providers which are included.
(3) Describe why and to what extent different types of childhood
diabetes will be captured, and detail all (hospital and non hospital)
data sources that will be used.
(4) Discuss how the population size (denominator) will be
ascertained for estimation of incidence and secular trends over the 5
years of study.
(5) Discuss how the population-based estimates will be tested.
(6) Discuss how the networks/partnerships will be sustained over a
long term to allow for trend estimates, follow-up, and maintenance of a
``pool'' of incident cases. Describe potential provider or patient
incentives that may be used to assure sustainability and follow-up.
(7) Include a discussion of the rationale, benefits and problems
that may be faced in relation to the selected population source and
partnership/network(s) developed, and describe the extent to which the
choice of the population source and the networks/partnerships is
scientifically sound, realistic, and likely to provide reliable
population-based estimates and secular trends for childhood diabetes.
c. Methodology: Case ascertainment, typology characterization, and
follow-up of (a) the prevalent cases, and (b) the incident cases (not
to exceed 5 pages).
(1) Describe why and how the previously collected data on prevalent
cases of childhood diabetes will be available, and include a
description of the case characteristics (including number, age, sex,
ethnicity, medical insurance status or socio-economic status,
geographic).
(2) Describe why and how information on a large number of incident
cases of childhood diabetes (50 a year) will be available
for each year of the study, and will approach complete ascertainment of
diagnosed childhood diabetes in the population source. Describe various
strategies to:
(3) Ascertain the prevalent and incident cases.
(4) Collect information to type and characterize the different
prevalent and incident types of childhood diabetes.
(5) Follow the incident cases for characterization and maintenance
of a ``pool'' of incident cases.
(6) Address potential for mis-classifications at baseline for
prevalent and incident cases, and changes at follow-up for the incident
cases, and other biases.
Note that characterization for (a) and (b) should include health
care received, potential outcomes, and risk factor levels, and should
use low-cost and realistic methods. Note that all proposed approaches
should discuss cost implications (cost per case identified and cost per
case maintained).
Also, note that emphasis should be on accurate estimation of
incidence (to approach complete ascertainment of newly diagnosed
childhood diabetes), as opposed to estimation of prevalence, which is
based on previously collected information. It is not anticipated in
this announcement that screening programs will be initiated to approach
complete ascertainment of incidence, but if such screening programs are
independently implemented, they may constitute a valuable addition to
the present study.
d. Standardization across sites (not to exceed 1 page):
(1) Discuss how methods for identification and classification of
childhood diabetes cases could be standardized across sites and over
the study period;
(2) Discuss how the design and the standardization will ensure that
maximum and wide use of the system will be made and sustained.
e. Background and experience of the principal investigator, co-
investigators, and the applying institution, organization, or agency
(not to exceed 3 pages).
(1) Describe the educational and professional background of the
principal investigator.
(2) Document the relevant experience of the principal investigator
and qualifications of the applying institution, organization, or agency
for carrying out epidemiological or surveillance research in chronic
disease (including access to computerized data systems and other
relevant resources) and collaborative, multi-center research projects.
(3) Describe existing partnership/network(s) with other agencies/
organizations/institutions or others (specifically, involvement in
existing or past registries of type 1 diabetes or other similar systems
designed for disease monitoring), and with supportive State Health
Departments, Diabetes Control Programs, or other relevant
organizations, for the purpose of relevant medical research.
(4) Attach evidence of collaborations and partnerships, specifying
the commitment of the parties involved in partnership/networking(s),
and provide details, including the terms of access to data and to
populations and any specified limits to collaboration.
(5) Provide a brief description of how the project will be
organized, and indicate the proposed staffing plan and expertise, and
the time line.
f. Human Subjects. Address the requirements of Title 45 CFR 46 for
the protection of human subjects, and detail the degree to which CDC
Policy requirements regarding the inclusion of women, ethnic, and
racial groups in the proposed research are met. 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.
[[Page 37145]]
(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.
g. 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
planned and developed to assure that the project protocol may be
written within the first nine months utilizing Steering Committee
meetings and teleconference calls by the Steering.
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\" x 11" white paper, with at least 1"
margins, including headers and footers, and printed on one side only.
F. Submission and Deadline
Letter of Intent (LOI)
Your letter of intent should include the following information: The
name and address of the applying institution, telephone number of the
contact person, and the program announcement number.
The letter of intent must be submitted on or before, June 30,
2000,to the Grants Management Specialist, as identified in the ``Where
to Obtain Additional Information'' section of this announcement.
Application
Submit the original and five copies of form PHS 398. Forms are
available at the following Internet address: http://www.cdc.gov/od/pgo/forminfo.htm or in the application kit. Submit the application on or
before July 21,2000, to the Grants Management Specialist identified in
the section ``Where to Obtain Additional Information.''
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
orderly processing. (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.)
Late Applications: Applications which do not meet the criteria in
(a) or (b) above are considered late applications, will not be
considered, and will be returned to the applicant.
G. Evaluation Criteria (Total 100 Points)
Each application will be evaluated individually against the
following criteria by an independent review group appointed by CDC.
1. Description and rationale for the population and partnership/
network(s) (25 points):
a. The extent to which (1) the population is described, (2) the
rationale, benefits and problems that may be faced in relation to the
population are discussed, and (3) the approach selected is
scientifically sound, realistic, and likely to provide reliable
population-based estimates and characterization of the different types
of childhood diabetes. In particular, the extent to which data sources
other than hospitalization data will be available.
b. The extent to which (1) the partnership/network(s) is described,
(2) the rationale, benefits and problems that may be faced in relation
to the partnership/network(s) are discussed, and (3) the network/
partnership(s) selected are scientifically sound, realistic, and likely
to provide reliable population-based estimates and characterization of
the different types of childhood diabetes. In particular, the extent to
which different types and sources of providers are available.
c. The degree to which (1) racial/ethnic minority and socio-
economically disadvantaged populations and both sexes are included, (2)
the population is sufficiently typical of children with diabetes around
the country or accurately represents special groups of children with
the disease, and (3) different types of childhood diabetes will be
captured.
d. The extent to which the ascertainment of the population source
and testing of the population-based estimates are scientifically sound,
realistic, and likely to provide reliable and accurate population-based
estimates and secular trends for childhood diabetes.
e. The extent to which the population and partnership/network(s)
will be sustained over the study duration, and will allow for secular
trends assessment, follow-up of incident cases, and maintenance of a
``pool'' of incident cases.
2. Rational for case ascertainment, typology, and characterization
of prevalent cases (15 points):
a. The extent to which previously collected data on prevalent cases
of childhood diabetes are described, and the size, characteristics,
quality, and accessibility of this information.
b. The extent to which various strategies are described, and are
sound, realistic, and feasible for case ascertainment.
c. The extent to which various strategies are described, and are
sound, realistic, and feasible for collection of information to type
and characterize the different types of childhood diabetes, and the
extent to which characterization includes health care received,
potential outcomes, and risk factor levels.
d. The extent to which various strategies are described, and are
sound, realistic, and feasible for assessment of potential
misclassifications, and other biases.
e. The extent to which low-cost and realistic methods are used, and
cost implications are discussed (cost per case identified).
3. Rationale for the methodology, case ascertainment, typology,
characterization, and follow-up of incident cases (25 points).
a. The extent to which information on a large number of incident
cases of childhood diabetes (50 a year) is available and
described, and will approach complete ascertainment of diagnosed
childhood diabetes in the population source.
b. The extent to which various strategies are described and are
realistic, feasible, and sustainable over 5 years for ascertainment of
incident cases.
c. The extent to which (1) various strategies are described and are
realistic, feasible, and sustainable over 5 years for collection of
information to type and characterize the difference types of childhood
diabetes, (2) characterization includes health care received, potential
outcomes, and risk factor levels, and (3) potential mis-classifications
at baseline, and changes at follow-up, and other biases are assessed.
d. The extent to which various strategies are described and are
realistic, feasible, and sustainable over 5 years for follow-up of
incident cases for
[[Page 37146]]
characterization, typology and maintenance of a ``pool'' of incident
cases.
e. The extent to which low-cost and realistic methods are used, and
cost implications (cost per case identified and cost per maintained)
are discussed.
4. Standardization across sites (15 points):
a. The extent to which the proposed approach to childhood diabetes
research is specific, realistic, time-phased, and suitable for
development into a collaborative, multi-center study protocol.
b. 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.
c. The extent to which applicant describes collaborations with
other sites during the various phases of the project, and shows
commitment to implement a standardized, multi-center, collaborative
approach.
5. Background and Experience of the Principal Investigator and of
the Applying Institution, Organization, or Agency (20 points):
a. The educational and professional background of the principal
investigator, and the relevant experience of the principal investigator
and qualifications of the applying institution, organization, or agency
for carrying on epidemiological or surveillance research in chronic
diseases (including access to computerized data systems and other
relevant resources) or multi-center research projects.
b. Existence of partnership/network(s) with other agencies/
organizations/institutions or others (specifically, involvement in
existing or past registries of type 1 diabetes or other similar systems
designed for disease monitoring), and with supportive State Health
Departments, Diabetes Control Programs, or other relevant
organizations, for the purpose of relevant medical research. Evidence
that commitment of the parties involved in partnership/networking for
this specific project is provided, including the terms of access to
data and to populations, and any specified limits to collaboration for
the purposes of this project.
c. The extent to which a brief description is provided on how the
project will be organized, what the time line and the proposed staffing
plan will be, and the extent to which the applicant clearly identifies
specific assigned responsibilities and time commitment of all key
professional personnel.
6. Human subjects (Not scored) Does the application adequately
address the requirements of Title 45 CFR Part 46 for the protection of
human subjects? 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: (a) the proposed
plan for the inclusion of both sexes and racial and ethnic minority
populations for appropriate representation, (b) the proposed
justification when representation is limited or absent, (c) a statement
as to whether the design of the study is adequate to measure
differences when warranted, (d) 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.
7. Budget and Budget Justification (Not scored): The extent to
which the budget is reasonable and consistent with the purpose and
objectives of this program; and specification and discussion of cost
per case identified, cost per case maintained, and cost per case type-
classified.
H. Other Requirements
Technical Reporting Requirements
Provide CDC with an original plus two copies of the following:
1. Progress reports (semiannual);
2. Financial status report, no more than 90 days after the end of
the budget period; and
3. Final financial and performance reports, no more than 90 days
after the end of the project period.
Send all reports to the Grants Management Specialist identified in
the ``Where to Obtain Additional Information'' section of this
announcement.
The following additional requirements are applicable to this
program. For a complete description of each, see Attachment I in the
application kit.
AR-1 Human Subjects Requirements
AR-2 Requirements for Inclusion of Women and Racial and Ethnic
Minorities in Research
AR-7 Executive Order 12372 Review
AR-9 Paperwork Reduction Act Requirements
AR-10 Smoke-Free Workplace Requirements
AR-11 Healthy People 2010
AR-12 Lobbying Restrictions
AR-15 Proof of Non-Profit Status
I. Authority and Catalog of Federal Domestic Assistance Number
This program is authorized under sections 301(a) and 317(k)(2) [42
U.S.C. 241(a) and 247b(k)(2)] of the Public Health Service Act, as
amended. The Catalog of Federal Domestic Assistance number is 93.988.
J. Where To Obtain Additional Information
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 you name and address and will be instructed to identify the
Announcement number of interest.
If you have questions after reviewing the contents of all the
documents, business management technical assistance may be obtained
from: Barry L. Copeland, Grants Management Specialist, Grants
Management Branch, Procurement and Grants Office, Announcement #00097,
Centers for Disease Control and Prevention, Room 3000, 2920 Brandywine
Road, Atlanta, GA 30341-4146, Telephone number (770) 488-2762, Email
address [email protected].
This and other CDC announcements can be found on the CDC homepage
internet address: http://www.cdc.gov See Attachment II for background
on the program. For program technical assistance, contact: Anne Fagot-
Campagna, Division of Diabetes Translation, Centers for Disease Control
and Prevention, 4770 Buford HWY, NE, Mailstop K-68, Atlanta GA, 30341,
telephone number (770) 488-1053 (or -1069), Email address [email protected].
Dated: June 6, 2000.
Henry S. Cassel, III,
Deputy Director, Procurement and Grants Office, Center for Disease
Control and Prevention (CDC).
[FR Doc. 00-14829 Filed 6-12-00; 8:45 am]
BILLING CODE 4163-18-P