[Federal Register Volume 66, Number 112 (Monday, June 11, 2001)]
[Notices]
[Pages 31241-31244]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-14575]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 01127]


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

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.

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    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

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application 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, seeAttachment I of the 
announcement.
AR-1  Human Subjects Requirements

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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 
ProgramAnnouncement 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: [email protected]
    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: [email protected]

    Dated: June 4, 2001.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 01-14575 Filed 6-8-01; 8:45 am]
BILLING CODE 4163-18-P