[Federal Register Volume 66, Number 69 (Tuesday, April 10, 2001)]
[Notices]
[Pages 18643-18644]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-8745]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 01032]


Cooperative Agreement Program with the National Blood Data 
Resource Center; 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 with the National Blood Data Resource Center (NBDRC). This 
program addresses the ``Healthy People 2010'' focus area of 
Immunization and Infectious Diseases. For additional information on 
``Healthy People 2010'' visit the internet site: http://www.health.gov/healthypeople.
    The purpose of the program is to continue an active, nationwide 
study begun in 1997 of recipients of blood products from identified 
classic or variant Creutzfeldt-Jakob Disease (CJD) donors to assess the 
risk of blood-borne transmission of these diseases.
    The emergence of human immunodeficiency virus (HIV)/acquired 
immunodeficiency syndrome (AIDS) and its transmission to patients 
through blood products has led to continued heightened concerns in the 
United States about blood safety. These concerns increasingly focused 
on classic and variant CJD when the latter illness emerged in Europe in 
the mid 1990s, representing spread of the outbreak of bovine spongiform 
encephalopathy (BSE, commonly called mad cow disease) to humans.
    In the late 1990s, these concerns and several characteristics of 
classic and variant CJD, such as their severity, their 
transmissibility, the resistence of the agents to disinfection, and the 
absence of a practical screening test for infection, has led to an 
evolving blood safety policy concerning these illnesses. In 2000, this 
policy has included, for example, newly instituted screening criteria 
that excludes as blood or plasma donors, anyone with a history of being 
in the United Kingdom for 6 months or longer between 1980 and 1996, the 
period of greatest risk for human exposure to the agent of BSE. The 
policy has also provided for withdrawals of blood components derived 
from donors who subsequently develop either classic or variant CJD.
    The blood safety policy in the United States and the Emerging 
Infectious Disease Plan elucidated the need for surveillance projects 
to detect and improve the understanding of newly recognized potential 
threats to public health, and to enable meaningful evaluations of the 
associated public health prevention efforts.

B. Eligible Applicants

    Assistance will be provided only to NBDRC. No other applications 
are solicited.
    NBDRC is the only presently existing national, nonprofit 
organization whose primary functions include collecting and 
disseminating national data about blood and blood products and 
coordinating information from multiple blood collection sites. Further, 
the NBDRC is the only organization that has the professional 
affiliations already in place that will allow it to generalize data to 
the entire nation and to ensure that no duplication of data occurs.
    NBDRC, because of its earlier participation in the CJD 
Investigational Lookback Study, has unique possession of the personal 
identifiers of over 100 living recipients of blood components from 
reported donors who subsequently developed CJD. Further, NBDRC has the 
personal identifiers on many donor cases of CJD for which recipient 
reports have been collected. It is this existing data that is critical 
to the strength of the statistical power and success of this project.


    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 $50,000 is available in FY 2001 to fund one award. It 
is expected that the award 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 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. Maintain collaborative relationships with U.S. blood banks to 
identify classic and variant CJD blood donors and gather available, 
relevant, medical, and demographic information on such donors.
    b. Trace classic and variant CJD donor blood components to final 
disposition.
    c. Maintain collaborative relations with final disposition sites 
and collect vital statistics information from pre-existing records 
about recipients of the classic or variant CJD blood components.
    d. Maintain study information about the recipients of the blood 
components from classic CJD donors who were previously identified in 
this study and continue to monitor these recipients' vital status, 
including the causes of death should they die.
    e. Develop a plan that will:
    (1) Search national, state, and local organizational databases to 
match vital statistics and causes of death for the component 
recipients, including utilizing non-National Death Index databases to 
confirm the vital status of the component recipients.
    (2) Assess the risk of blood-borne transmission of CJD.
    f. Publish and disseminate results of the study.

2. CDC Activities

    a. Collaborate on investigation, evaluation, and assessment of the 
reported classic or variant CJD illness in donors and recipients in 
this project, as appropriate.
    b. Provide assistance in development of methodologies and analysis, 
as needed.
    c. Provide technical assistance in data pooling, management, 
analysis, and interpretation.
    d. 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

    Use the information in the Program Requirements, 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 font.

[[Page 18644]]

F. Submission and Deadline

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: http://www.cdc.gov/...Forms, or in the application kit.
    On or before May 30, 2001, submit the application to the Grants 
Management Specialist identified in the ``Where to Obtain Additional 
Information'' section of this announcement.

G. Evaluation Criteria

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

1. Plan  (10 points)

    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.

2. Objectives  (15 points)

    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  (30 points)

    Extent to which the applicant clearly identifies specific assigned 
responsibilities for all key professional personnel. Extent to which 
the plan clearly describes the applicant's technical approach/methods 
for conducting the proposed study and extent to which the plan is 
adequate to accomplish the purpose. Extent to which the applicant 
describes specific study protocols, or plans for the continuation of 
study protocols 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(ies) and recognition of 
mutual benefits.

4. Capacity  (30 points)

    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, and the 
extent to which the applicant demonstrates the ability to successfully 
collaborate with many blood banks in the United States on blood safety 
issues, such as those related to CJD.

5. Evaluation  (15 points)

    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. Budget  (not scored)

    Extent to which the line-item budget is detailed, clearly 
justified, and consistent with the purpose and objectives of this 
program.

7. Human Subjects  (not scored)

    Does the application adequately address the requirements of Title 
45 CFS Part 46 for the protection of human subjects?

H. Other Requirements

Technical Reporting Requirements

    Provide CDC with an original plus two copies of the following:
    1. Progress reports (annual);
    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

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: Andrea Wooddall, Grants 
Management Specialist, Grants Management Branch, Procurement and Grants 
Office, Centers for Disease Control and Prevention, Room 3000, 2920 
Brandywine Road, Atlanta, GA 30341-4146, Telephone number (770) 488-
2749, Email address [email protected].
    For program technical assistance, contact: Dr. Larry Schonberger, 
Division of Viral and Rickettsial Diseases, National Center for 
Infectious Diseases, Centers for Disease Control and Prevention, 1600 
Clifton Road, NE., Atlanta, GA 30333, Telephone number 404-639-3091, 
Email address [email protected].

    Dated: April 4, 2001.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 01-8745 Filed 4-9-01; 8:45 am]
BILLING CODE 4163-18-P