[Federal Register Volume 67, Number 72 (Monday, April 15, 2002)]
[Notices]
[Pages 18207-18209]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-9010]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 02046]


Cooperative Agreement for a Research Program To Determine the 
Incidence of Emerging Human Transmissible Spongiform Encephalopathies 
in the United States; Notice of Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2002 funds for a cooperative agreement 
program to determine the incidence of emerging human transmissible 
spongiform encephalopathies (TSE)in the United States. This program 
addresses the ``Healthy People 2010'' focus area of Immunization and 
Infectious Diseases.
    The purpose of the program is to enhance national surveillance for 
TSE or prion diseases. The objectives are to (1) develop new diagnostic 
techniques; (2) facilitate laboratory investigation of new emerging TSE 
and (3) develop a research program to determine the incidence of 
potential TSE or prion diseases in the United States. Go to the website 
in Part J. of this announcement for more background information.

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, including the District of Columbia, the 
Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of 
the Northern Mariana Islands, American Samoa, Guam, the Federated 
States of Micronesia, the Republic of the Marshall Islands, and the 
Republic of Palau, federally recognized Indian Tribal Governments, 
Indian Tribes, or Indian Tribal Organizations. Faith-Based 
organizations are eligible for this award.
    Applicant staff must have certification to practice neuropathology 
(a medical field focusing on examination and study of brain tissues) in 
the United States or certification to practice pathology (or neurology) 
in the United States and show, in their curriculum vitae, the extent of 
their experiences in neuropathology.

    Note: Title II of the United States Code section 1611 states 
that an organization described in section 501(c)(4) of the Internal 
Revenue Code that engages in lobbying activities is not eligible to 
receive Federal funds constituting an award, grant or loan.

C. Availability of Funds

    Approximately $750,000 is available in FY 2002 to fund one award. 
It is expected that the award will begin on or about September 30, 
2002, and will be made for a 12-month budget period within a project 
period of up to five years. The funding estimate may change.
    A continuation award within an approved project period will be made 
on the basis of satisfactory progress as evidenced by required reports 
and the availability of funds.

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 collaborative network of medical professionals (i.e. 
pathologists, neuropathologists, etc.) to report suspected variant 
Creutzfeldt-Jakob Disease (CJD) cases and collect data on physician-
diagnosed TSE.
    b. Develop a plan to confirm the diagnosis of TSE and characterize 
infecting prions to monitor the emergence of novel types of TSE such as 
variant (CJD).
    c. Collaborate with state and local health departments and other 
centers to establish effective ways of increasing state-of-the art 
diagnoses, including autopsy rates among physician-diagnosed cases of 
TSE.
    d. Develop a system for the collection of critical epidemiologic 
information on the cases confirmed with TSE.
    e. Develop research methodologies to assess the relationship, if 
any, of chronic wasting disease of deer and elk to human TSE.
    f. Provide training on TSE, as needed, such as clinical and 
neuropathologic manifestations of variant CJD, to medical professionals 
(i.e. neurologists, pathologists, etc.).
    g. Disseminate the results of research findings.

2. CDC Activities

    a. Provide assistance in the dissemination of results and other 
technical assistance as required.
    b. Assist in the development of a research protocol for 
Institutional Review Board (IRB) review by all cooperating institutions 
participating in the research project. The CDC IRB will review and 
approve the protocol initially and on at least an annual basis until 
the research project is completed.

E. Application Content

Letter of Intent (LOI)

    An LOI is required for this program. The narrative should be no 
more than two single-spaced pages, printed on one side, with one inch 
margins, and unreduced font. Your letter of intent will be used to 
enable CDC to plan for the review, and should include the following 
information (1) the program announcement number 02046 (2) name and 
address of institution and (3) name, address and telephone number of 
contact person. Notification can be provided by facsimile, postal mail, 
or electronic mail (e-mail).

Application

    Use the information in the Program Requirements (particularly in 
the Recipient Activities), Other Requirements, and Evaluation Criteria 
sections 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 narrative should be no more than 10 
double-spaced pages, printed on one side, with one-inch margins, and 
unreduced fonts.

F. Submission and Deadline

Letter of Intent (LOI)

    On or before May 30, 2002, submit the LOI to the Grants Management 
Specialist identified in the ``Where to Obtain Additional Information'' 
section of this announcement.

Application

    Submit the original and five copies of PHS-398 (OMB Number 0925-
0001) (adhere to the instructions on the Errata Instruction Sheet for 
PHS-398). Forms are available at the following Internet address: 
www.cdc.gov/od/pgo/forminfo.htm, or in the application kit.
    On or before June 15, 2002, 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:

[[Page 18208]]

    (a) Received on or before the deadline date; or
    (b) Sent on or before the deadline date and received in time for 
submission to the Objective Review Panel. (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

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

1. Plan (30 points)

    The extent to which the applicant presents a detailed operational 
plan for continuing and conducting the project and which clearly and 
appropriately addresses all recipient activities. Extent to which the 
applicant demonstrates existing collaborations with a network of 
neuropathologists and general pathologists in the United States and 
experience in testing brain tissues from a large number of confirmed 
CJD cases reported each year in the United States.

2. Objectives (10 points)

    The extent to which the applicant describes specific objectives for 
the continuation of the project which are consistent with the purpose 
of this program and which are measurable and time-phased.

3. Methods (15 points)

    The extent to which the applicant clearly identifies specific 
assigned responsibilities for all key professional personnel assigned 
to carry out each of the recipient activities. Extent to which the plan 
clearly describes the applicant's technical approach/methods for 
ensuring the completeness and reporting of epidemiologic information on 
the cases evaluated at the Pathology Center and extent to which the 
plan is adequate to accomplish the purpose. Extent to which the 
applicant describes specific plans for the continuation of activities 
that are appropriate for the purpose of the project. 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 (1) the proposed plan for the inclusion of both sexes and 
racial and ethnic minorities, (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, 
and (4) a statement as to whether the plans for recruitment and 
outreach for study participants include the process of establishing 
partnerships with community or communities and recognition of mutual 
benefits.

4. Capacity (25 points)

    The degree to which the applicant demonstrates existing laboratory 
capacity to perform state-of-the art diagnostic tests for human TSE and 
characterize infecting prions. Extent to which the applicant can 
document past experience and achievement in successfully completing the 
types of recipient activities necessary for achieving the purpose of 
this project. The degree to which the applicant demonstrates the 
ability to successfully collaborate with state and local health 
departments and professional associations whose members are involved in 
the care and diagnosis of CJD patients such as the American Academy of 
Neurology, the American Association of Neuropathologists, and the 
United States and Canadian Academy of Pathologists.

5. Evaluation (10 points)

    The extent to which the applicant provides a detailed and adequate 
plan for evaluating study results and for evaluating progress toward 
achieving the purpose of the project.

6. Measures of Effectiveness (10 points)

    The extent the applicant provides Measures of Effectiveness that 
will demonstrate the accomplishment of the various identified 
objectives of the cooperative agreement. Are the measures objective/
quantitative and do they measure the intended outcome?

7. Budget (not scored)

    The extent to which the line-item budget is detailed, clearly 
justified, consistent with the purpose and objectives of this program, 
and outlines how the budget relates to the Recipient Activities as 
listed under the ``Program Requirements'' section of this program 
announcement.

8. Human Subjects (not scored)

    Does the application adequately address the requirements of Title 
45 CFR part 46 for the protection of human subjects?

H. Other Requirements

Technical Reporting Requirement

    Provide CDC with an original plus two copies of the following:
    1. Progress report (annually)
    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-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
AR-22  Research Integrity

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under section 301(a) and 317(k)(2) of 
the Public Health Service Act, (42 U.S.C. Sections 241(a) and 
247b(k)(2)), 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 obtain additional information, contact: Merlin Williams, Grants 
Management Specialist, Grants Management Branch, Procurement and Grants 
Office, Centers for Disease Control and Prevention, Room 3000, 2920 
Brandywine Road, M/S K75, Atlanta, GA 30341-4146. Telephone number: 
(770)488-2765. Fax Number: (770)488-2670. E-mail address: [email protected].
    For program technical assistance, contact: Dr. Ermias Belay, 
Division of Viral and Rickettsial Diseases, National Center for 
Infectious Diseases, Centers for Disease Control and Prevention, 1600 
Clifton Road, NE, Mailstop A-39, Atlanta, GA 30333. Telephone number:

[[Page 18209]]

404-639-3091. Fax Number: 404-639-3838. E-mail address: [email protected].

    Dated: April 8, 2002.
Sandra R. Manning,
CFM, Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 02-9010 Filed 4-12-02; 8:45 am]
BILLING CODE 4163-18-P