[Federal Register Volume 64, Number 33 (Friday, February 19, 1999)]
[Notices]
[Pages 8380-8382]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-4093]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Program Announcement 99017]


Evaluating Potential Exposures To Blood and Risk of Hepatitis C 
Virus (HCV) Infection Among Persons Without Traditional Risk Factors; 
Notice of Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1999 funds for a cooperative agreement 
program for evaluating potential exposures to blood and risk of 
hepatitis C virus (HCV) infection among persons without traditional 
risk factors. This program addresses the ``Healthy People 2000'' 
priority area of Immunization and Infectious Diseases. The purpose of 
the program is to provide assistance for addressing the risk of HCV or 
hepatitis B virus (HBV) transmission through potential but unproven 
mucosal or percutaneous exposures to blood in the United States. 
Specifically, applications are solicited for projects aimed at 
determining if there is an increased risk of HCV or HBV infection 
associated with illegal intranasal drug use (e.g., cocaine or heroin), 
anabolic steroid abuse, tattooing, or body piercing in populations with 
a low prevalence of illegal injection drug use.

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, 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.

C. Availability of Funds

    Approximately $150,000 is available in FY 1999 to fund one award. 
It is expected that the award will begin on or about June 1999 and will 
be made for a 12-month budget period within a project period of one 
year. The funding estimate may change.

D. Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for the activities under (Recipient 
Activities), and CDC will be responsible for the activities listed 
under (CDC Activities).

Recipient Activities

    1. Conduct research to determine if there is a risk of HCV or HBV 
infection, independent of known risk factors for transmission, 
associated with percutaneous exposures, such as tattooing, body 
piercing, or illegal injection of anabolic steroids, or permucosal 
exposures, such as use of illegal intranasal drugs.
    2. Develop a study protocol to determine the prevalence of 
potential exposures for bloodborne pathogen transmission (i.e., illegal 
intranasal drug use, anabolic steroid abuse, tattooing, body piercing) 
in populations with a low prevalence of illegal injection drug use and 
their prevalence of HCV and HBV infection.
    3. Based on the protocol, conduct an epidemiologic study of the 
potential association between HCV or HBV infection and illegal 
intranasal drug use, anabolic steroid abuse, tattooing, and body 
piercing.
    4. Analyze, interpret, and publish results.

CDC Activities

    1. Upon request of recipient, provide technical assistance in the 
design, conduct, and analysis of the research,

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including development of the questionnaire and analytic plan.
    2. Upon request of recipient, perform serologic testing for HCV and 
HBV infection and report results back to study investigators.
    3. Upon request of recipient, participate in the analysis of the 
research data and the interpretation and presentation of research 
findings.
    4. If CDC is requested to provide technical assistance in the 
design of the study, CDC will participate in the development of a 
research protocol for Internal Review Board (IRB) review by all 
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.

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 in the application kit. On or before May 10, 1999, 
submit the application to: Andrea Wooddall, Grants Management 
Specialist, Grants Management Branch, Procurement and Grants Office, 
Announcement 99017, Centers for Disease Control and Prevention, 2920 
Brandywine Road, Mailstop E-18, Atlanta, Georgia 30341-4146.
    If your application does not arrive in time for submission to the 
independent review group, it will not be considered in the current 
competition unless you can provide proof that you mailed it on or 
before the deadline (i.e., receipt from U.S. Postal Service or a 
commercial carrier; private metered postmarks are not acceptable).

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): Extent to which applicant 
demonstrates a clear understanding of the subject area and of the 
purpose and objectives of this cooperative agreement program.
    2. Capacity (45 points): Extent to which applicant describes 
adequate resources and facilities (both technical and administrative) 
for conducting the project. Extent to which applicant documents that 
professional personnel involved in the project are qualified and have 
past experience and achievements in research related to that proposed, 
as evidenced by curriculum vitae, publications, etc. If applicable, 
extent to which applicant includes letters of support from non-
applicant organizations, individuals, etc., and the extent to which 
such letters clearly indicate the author's commitment to participate as 
described in the operational plan.
    3. Objectives and Technical Approach (45 points total):
    a. Extent to which applicant describes objectives of the proposed 
project which are consistent with the purpose and goals of this 
cooperative agreement program and which are measurable and time-phased. 
(10 points)
    b. 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 specific 
project area being addressed in the application. Extent to which 
applicant clearly identifies specific assigned responsibilities of all 
key professional personnel. Extent to which the plan clearly describes 
applicant's technical approach/methods for conducting the proposed 
studies and extent to which the approach/methods are appropriate and 
adequate to accomplish the objectives. Extent to which applicant 
describes specific study protocols or plans for the development of 
study protocols that are appropriate for achieving project objectives. 
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 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, 
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. 
(30 points)
    c. Extent to which applicant provides a detailed and adequate plan 
for evaluating progress toward achieving project process and outcome 
objectives. If the proposed project involves notifiable conditions, the 
degree to which applicant describes an adequate process for providing 
necessary information to appropriate State and or local health 
departments. (5 points)
    4. Budget: (not scored) Extent to which the proposed budget is 
reasonable, clearly justifiable, and consistent with the intended use 
of cooperative agreement funds.
    5. Human Subjects: Does the application adequately address the 
requirements of 45 CFR 46 for the protection of human subjects?
____Yes ____No Comments:________________

H. Other Requirements

Technical Reporting Requirements

    Provide CDC with original plus two copies of
    1. progress reports (semiannual)
    2. Financial and final Performance reports, no more than 90 days 
after the end of the project period.
    Send all reports to: Andrea Wooddall, Grants Management Specialist, 
Grants Management Branch, Procurement and Grants Office, Centers for 
Disease Control and Prevention, 2920 Brandywine Road, Mailstop E-18, 
Atlanta, GA 30341-4146.
    The following additional requirements are applicable to this 
program. For a complete description of each, see Attachment 1 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 2000
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 the Public Health Service Act 
Sections 301(a) [42 U.S.C. 241 (a)], 317(k)(2), [42 U.S.C. 247b(k)(1)] 
and [247b(k)(2)], as amended. The Catalog of Federal Domestic 
Assistance number is 93.283.

J. Where to Obtain Additional Information

    To obtain additional information, contact: Andrea Wooddall, Grants 
Management Specialist, Grants Management Branch, Procurement and Grants 
Office, Announcement 99017, Centers for Disease Control and Prevention, 
2920 Brandywine Road,

[[Page 8382]]

Mailstop E-18, Atlanta, GA 30341-4146, telephone (770) 488-2751, Fax 
(770) 488-2777, Email address: [email protected].
    See also the CDC Home Page on the Internet for applicable forms: 
http://www.cdc.gov.
    For program technical assistance, contact Rob Lyerla, Ph.D., 
Centers for Disease Control and Prevention, National Center for 
Infectious Diseases, Division of Viral and Rickettsial Diseases, 
Hepatitis Branch, 1600 Clifton Rd N.E., Mailstop G37, Atlanta, GA 
30333, Phone: 404-639-3048, E-mail address: [email protected]
    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 
Announcement number of interest.

    Dated: February 12, 1999.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 99-4093 Filed 2-18-99; 8:45 am]
BILLING CODE 4163-18-P