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

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,

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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