Grants and cooperative agreements; availability, etc.: based approach to case ascertainment, typology, surveillance, and research,

[Federal Register: June 13, 2000 (Volume 65, Number 114)]

[Notices]

[Page 37142-37146]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr13jn00-78]

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

1. 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.

2. 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.

3. 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.

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   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).

4. 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

      1. 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.

      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 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.

      3. 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.

      4. 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.

      5. 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

      1. 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.

      2. Assist in facilitating communication among recipients development of common multi-center protocol(s), quality control, interim data monitoring, data analysis, interpretation, reporting, and coordination.

      3. Assist in the development of a research protocol for IRB review by all cooperating institutions participating in the research project, including CDC IRB.

      4. Serve as a consultant to the Steering Committee.

5. 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.

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   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:

   1. Description and rationale of (a) the population source (including size, age, ethnicity, medical insurance status, socio- economic status, geographic), and

   2. 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.

   3. 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.

   4. 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.

   5. 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.

   6. 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.

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      (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.

   7. 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.

6. 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.

7. 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):

      1. 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.

      2. 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.

      3. 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.

      4. 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.

      5. 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):

      1. 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.

      2. The extent to which various strategies are described, and are sound, realistic, and feasible for case ascertainment.

      3. 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.

      4. The extent to which various strategies are described, and are sound, realistic, and feasible for assessment of potential misclassifications, and other biases.

      5. 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).

      1. 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.

      2. The extent to which various strategies are described and are realistic, feasible, and sustainable over 5 years for ascertainment of incident cases.

      3. 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.

      4. The extent to which various strategies are described and are realistic, feasible, and sustainable over 5 years for follow-up of incident cases for

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         characterization, typology and maintenance of a ``pool'' of incident cases.

      5. 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):

      1. 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.

      2. 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.

      3. 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):

      1. 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.

      2. 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.

      3. 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.

8. 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

   1. 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.

10. 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 bjc8@cdc.gov.

    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 adf8@cdc.gov.

    Dated: June 6, 2000. Henry S. Cassel, III, Deputy Director, Procurement and Grants Office, Center for Disease Control and Prevention (CDC).

    [FR Doc. 00-14829Filed6-12-00; 8:45 am]

    BILLING CODE 4163-18-P