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Notice

Population-Based Models To Establish Surveillance for Asthma Incidence in Defined Geographic Areas; Notice of Availability of Funds

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Information about this document as published in the Federal Register.

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A. Purpose

The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2001 funds for a cooperative agreement program for “Surveillance for Asthma Incidence: Developing Population-based Models.” This program addresses the “Healthy People 2010” focus areas of Maternal, Infant, and Child Health, and Respiratory Diseases.

The purpose of the program is to assist in the definition of population-based models from which sites for the surveillance of incident cases of asthma can be established. It is anticipated that such models could form a reporting network in the future. Asthma Incidence Surveillance sites will be population-based centers designed to assess the public health impact of asthma, to determine the incidence of asthma and to identify population-based risk factors associated with the onset of asthma.Start Printed Page 31242

The objectives of this project are, for the population or in a defined population that is essentially representative of the general population of a geographic area, to:

1. Define the population-base from which new (incident) cases of asthma can be identified.

2. Define the network of providers that serves the population-base and determine health care utilization practices.

3. Define the prevalence of asthma.

4. Provide estimates of the incidence of asthma.

5. Estimate the costs for a surveillance system for incident cases.

B. Eligible Applicants

Applications may be submitted by public and private nonprofit organizations, such as managed care organizations, and by governments and their agencies; that is, universities, colleges, hospitals, State and local governments or their bona fide agents, and federally recognized Indian tribal governments, Indian tribes, or Indian tribal organizations.

To be an eligible applicant, you must provide the following:

1. Define a population base of between 400,000 to 1,000,000 persons in the county, city, metropolitan area, or tribal jurisdiction. You must provide evidence of the population size in the geographic area based on the most recent census estimates.

2. If there are competing health care provider networks serving the population who are not within your partnership, you must document that the estimated proportion of the population served by your network is within the required population range. You must also document the process used to derive this estimate.

3. If the applicant is other than a State, city, county or territorial health departments, you must include a letter from the State Health Department indicating the degree of support and collaboration of that State Health Department in this project.

This documentation should be placed after the face page of the application. An application that does not provide the above information will be determined non-responsive and returned without review.

C. Availability of Funds

Approximately $400,000 is available in FY 2001 to fund up to two awards. It is expected that the average award will be $200,000, ranging from $150,000 to $225,000. It is expected that the awards will begin on or about September 30, 2001, and will be made for a 12 month budget period within a project period of up to two years. Funding estimates may change. Continuation awards within an approved project period will be made on the basis of satisfactory progress as evidenced by required reports and the availability of funds.

Depending on the availability of funds, a new competitive announcement, limited to recipients of this award, will follow to implement the incidence surveillance activities. It is expected that the number of recipients awarded funds in the next phase will be based on the progress of the recipients during this award as evidenced by required reports and site visits, the estimated budget needs for the surveillance activities, and the availability of projected funds for these projects.

Funding Preference

Preference may be given to proposals that represent geographic distribution among the approved projects.

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. Develop a working case definition for asthma for the purposes of this project.

b. Develop and implement a protocol to test the reliability and reproducibility of the asthma case definition, including, as necessary, in the second year of the project, contact with persons who have newly diagnosed asthma to conduct field testing of questionnaires and specimen collection.

c. Prepare a plan that allows for the collection of numerator and denominator data to calculate the appropriate rates. Specifically they should:

1. Define and enumerate their population base.

2. Demonstrate the ability to identify cases of asthma, including incident (new) cases and deaths from asthma, in their defined geographic area.

3. Demonstrate the ability to obtain relevant demographic and risk factor information.

4. Demonstrate that duplicate entries can be identified and eliminated from the database.

5. Define the period prevalence of asthma in their population, and estimate the incidence of asthma for that period.

6. Use the estimates of incidence and prevalence for sample size projections and cost considerations for the asthma incidence surveillance system.

d. In conjunction with (c) above, the program should define its network of health care providers and patterns of health care utilization within its defined geographic area. Specifically the program should demonstrate:

1. That this network serves the defined population base.

2. That persons with asthma utilize primary and specialty medical care and hospitalization services within the network.

3. That the appropriate diagnostic facilities and expertise for the evaluation of persons with asthma exists within the network.

4. That a high proportion of persons with asthma who come to medical attention will be ascertained.

5. That new individual cases of asthma will be ascertained based on the case definition.

e. The program should demonstrate that the proposed surveillance system will incorporate both public and private health care providers.

2. CDC Activities

a. Provide technical assistance as appropriate in all project areas.

b. Participate, as appropriate, in the analysis and interpretation of data, participate in the comparison of data across sites and participate in the dissemination of information.

c. Assist in the development of a research protocol for Institutional Review Board review by all cooperating institutions participating in the research project.

The CDC IRB will review and approve the project protocols initially and on at least an annual basis until the research project is completed.

E. Application Content

Letter of Intent (LOI)

A one-page non-binding letter of intent (LOI) is requested to enable CDC to determine the level of interest in this announcement and to assist in determining the size and composition of the independent review panel. The LOI should provide a brief description of the proposed project and identify the principle investigator, the name and addresses of organizations actively involved in the proposed project, and the address and telephone number for key contacts.

Application

Use the information in the Program Requirements, Other Requirements, and Evaluation Criteria sections to develop the application content. Your Start Printed Page 31243application will be evaluated on the criteria listed, so it is important to follow them in laying out your program plan. The narrative should be no more than twenty double-spaced pages, printed on one side, with one-inch margins, and unreduced font and should consist of, at a minimum, a plan, objectives, methods, evaluation and budget. The application must be submitted unstapled and unbound.

F. Submission and Deadline

Letter of Intent (LOI)

Submit the LOI on or before July 10, 2001, to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

Application

Submit the original and two copies of PHS 5161-1 (OMB Number 0920-0428). Forms are available in the application kit and at the following Internet address: www.cdc.gov/​od/​pgo/​forminfo.htm.

On or before August 9, 2001, submit the application to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement. Deadline: Applications shall be considered as meeting the deadline if they are either:

1. Received on or before the deadline date; or

2. Sent on or before the deadline date and received in time for submission to the independent 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.

Late: Applications which do not meet the criteria in 1. or 2. above will be returned to the applicant.

G. Evaluation Criteria

Each application will be evaluated individually against the following criteria by an independent review group appointed by CDC.

1. Background and Need (10 points)

a. The extent to which applicant demonstrates a clear understanding of the subject area, particularly as it relates to the local situation.

b. The extent to which applicant's discussion of the background for the proposed project demonstrates a clear understanding of the purpose and objectives of this cooperative agreement program.

c. The extent to which applicant illustrates and justifies the need for the proposed project that is consistent with the purpose and objectives of this cooperative agreement program.

d. The extent to which applicant demonstrates past experience in conducting activities similar to those proposed and that the new activities will complement current ones.

2. Operational plan (40 points)

a. The extent to which applicant presents a detailed operational plan for initiating and conducting the project, which clearly and appropriately addresses all Recipient Activities for the project.

b. The extent to which applicant identifies key personnel with appropriate experience and adequate facilities for the project.

c. The extent to which applicant clearly identifies specific assigned responsibilities for all key professional personnel.

d. The extent to which the applicant enlists the participation of local health departments, academic institutions, and other public and private organizations with an interest in addressing public health issues relating to asthma. Specifically, the extent to which the applicant demonstrates active involvement by and collaboration with State, County, Local, City or Territorial Health departments.

e. The extent to which the applicant can provide evidence that this activity can be accomplished.

f. The extent to which applicant includes letters of support from proposed collaborators indicating essential collaborating organizations or individuals and their willingness to participate as proposed.

g. Since the proposed project may involve human subjects in research, describe the procedures for the protection of human subjects. Applications should meet the CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research. This includes:

1. The proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation.

2. The proposed justification when representation is limited or absent.

3. A statement as to whether the design of the study is adequate to measure differences when warranted.

4. A statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with community(ies) and recognition of mutual benefits.

3. Objectives (15 points)

The extent to which the plan is adequate to accomplish the stated objectives.

4. Methods (15 points)

a. The extent to which the plan clearly describes applicant's technical approach and methods for conducting the proposed studies.

b. The extent to which applicant describes specific study protocols or plans for the development of study protocols that are appropriate for achieving project objectives.

5. Evaluation (20 points)

a. The extent to which applicant provides an effective, comprehensive and appropriate evaluation plan to monitor and evaluate the scientific and operational accomplishments of the project.

b. The extent to which the applicant outlines measures to document progress in implementing the operational plan. The extent to which the applicant outlines a realistic time-line for the implementation of recipient activities.

6. Budget (Not scored)

The extent to which a 12-month budget is clearly detailed, justified, and appropriate for activities proposed.

7. Human Subjects (Not scored)

The extent to which the application adequately addresses the requirements of Title 45 CFR part 46 for the protection of human subjects. An application can be disapproved if the research risks are sufficiently serious and protection against risks is so inadequate as to make the entire application unacceptable.

H. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two copies of:

1. Semi-annual progress reports;

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 of the announcement.

AR-1 Human Subjects RequirementsStart Printed Page 31244

AR-2 Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research

AR-7 Executive Order 12372 Review

AR-8 Public Health System Reporting Requirements

AR-9 Paperwork Reduction Act Requirements

AR-11 Healthy People 2010

AR-12 Lobbying Restrictions

AR-15 Proof of Non-Profit Status

AR-22 Research Integrity

I. Authority and Catalog of Federal Domestic Assistance Number

This program is authorized under section 301 of the Public Health Service Act, [42 U.S.C. section 241], as amended. The Catalog of Federal Domestic Assistance number is 93.283.

J. Where To Obtain Additional Information

This and other CDC announcements can be found on the CDC home page Internet address http://www.cdc.gov. Click on “Funding” then “Grants and Cooperative Agreements.”

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 Program Announcement number of interest.

If you have questions after reviewing the contents of all the documents, business management technical assistance may be obtained from:Sonia Rowell, Grants Management Specialist,Grants Management Branch,Procurement and Grants Office,Centers for Disease Control and Prevention, 2920 Brandywine Road, Room 3000,Atlanta, GA 30341-4146,Telephone number: (770) 488-2724,Email address: svp1@cdc.gov

For program technical assistance, contact:Dr. Clive M. Brown,Medical Epidemiologist,National Center for Environmental Health, 1600 Clifton Road, MS-E17,Telephone number: (404) 498-1003,Email address: cmb8@cdc.gov

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Dated: June 4, 2001.

John L. Williams,

Director, Procurement and Grants Office, Centers for Disease Control and Prevention (CDC).

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[FR Doc. 01-14575 Filed 6-8-01; 8:45 am]

BILLING CODE 4163-18-P