[Federal Register Volume 63, Number 32 (Wednesday, February 18, 1998)]
[Notices]
[Pages 8204-8208]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-3981]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Announcement Number 814]


Applied Research in Emerging Infections; Hepatitis C Virus 
Infection--Sexual Transmission

Introduction

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1998 funds for competitive cooperative 
agreements and/or grants to support applied research on emerging 
infections--epidemiologic studies of sexual transmission of hepatitis C 
virus (HCV) infection.
    CDC is committed to achieving the health promotion and disease 
prevention objectives of Healthy People 2000, a national activity to 
reduce morbidity and mortality and improve the quality of life. This 
announcement is related to the priority area of Immunization and 
Infectious Diseases. (For ordering a copy of Healthy People 2000, see 
the section Where to Obtain Additional Information.)

Authority

    This program is authorized under Sections 301 and 317 of the Public 
Health Service Act, as amended (42 U.S.C. 241 and 247b).

Smoke-Free Workplace

    CDC strongly encourages all grant recipients to provide a smoke-
free workplace and to promote the non-use of all tobacco products, and 
Pub. L. 103-227, the Pro-Children's Act of 1994, prohibits smoking in 
certain facilities that receive Federal funds in which education, 
library, day care, health care and early childhood development services 
are provided to children.

Eligible Applicants

    Applications may be submitted by public and private non-profit 
organizations and governments and their agencies. Thus, universities, 
colleges, research institutions, hospitals, other public and private 
non-profit organizations, State and local governments or their bona 
fide agents, federally recognized Indian tribal governments, Indian 
tribes or Indian tribal organizations, and small, minority-and/or 
women-owned non-profit businesses are eligible to apply.

Availability of Funds

    Approximately $500,000 is available in FY 1998 to fund one or two 
awards. It is expected the awards will begin on or about August 10, 
1998 and will be made for a 12-month budget period within a project 
period of up to three years. The funding estimate is subject to change.
    Continuation awards within the project period will be made on the 
basis of satisfactory progress and availability of funds.

Determination of Which Instrument To Use

    Applicants must specify the type of award for which they are 
applying, either grant or cooperative agreement. CDC will review the 
applications in accordance with the evaluation criteria. Before issuing 
awards, CDC will determine whether a grant or cooperative agreement is 
the appropriate instrument based upon the need for substantial CDC 
involvement in the project.

Use of Funds

Restrictions on Lobbying

    Applicants should be aware of restrictions on the use of HHS funds 
for lobbying of Federal or State legislative bodies. Under the 
provisions of 31 U.S.C. Section 1352, recipients (and their subtier 
contractors) are prohibited from using appropriated Federal funds 
(other than profits from a Federal contract) for lobbying Congress or 
any Federal agency in connection with the award of a particular 
contract, grant, cooperative agreement, or loan. This includes grants/
cooperative agreements that, in whole or in part, involve conferences 
for which Federal funds cannot be used directly or indirectly to 
encourage participants to lobby or to instruct participants on how to 
lobby.
    In addition, the FY 1998 Department of Labor, Health and Human 
Services, and Education, and Related Agencies Appropriations Act (Pub. 
L. 105-78) states in Section 503 (a) and (b) that no part of any 
appropriation contained in this Act shall be used, other than for 
normal and recognized executive-legislative relationships, for 
publicity or propaganda purposes, for the preparation, distribution, or 
use of any kit, pamphlet, booklet, publication, radio, television, or 
video presentation designed to support or defeat legislation pending 
before the Congress or any State legislature, except in presentation to 
the Congress or any State legislature itself.
    No part of any appropriation shall be used to pay the salary or 
expenses of any grant or contract recipient, or agent acting for such 
recipient, related to any activity designed to influence legislation or 
appropriations pending before the Congress or any State legislature.

Background

    Once expected to be eliminated as a public health problem, 
infectious diseases remain the leading cause of death worldwide. In the 
United States and elsewhere, infectious diseases increasingly threaten 
public health and contribute significantly to the escalating costs of 
health care.
    In partnership with other Federal agencies, State and local health 
departments, academic institutions, and others, CDC has developed a 
plan for revitalizing the nation's ability to identify, contain, and 
prevent illness from emerging infectious diseases. The plan, Addressing 
Emerging Infectious Disease Threats; A Prevention Strategy for the 
United States, identifies objectives in four major areas: surveillance; 
applied research; prevention and control; and infrastructure.
    Under the objective for applied research, the plan proposes to 
integrate laboratory science and epidemiology to optimize public health 
practice in the United States. In FY 1996, CDC initiated the Extramural 
Applied Research Program in Emerging Infections (EARP).

[[Page 8205]]

This grant/cooperative agreement announcement specifically addresses 
the area of hepatitis c virus (HCV) infection.
    In the United States, an estimated 3.9 million persons are 
chronically infected with HCV and are a potential source of 
transmission to others. In the absence of pre- or post-exposure 
prophylaxis, preventing infection is dependent on providing infected 
persons with specific information about the risk of transmission in 
different settings. This announcement addresses the sexual transmission 
of HCV infection.
    Case-control studies have demonstrated an independent association 
between acquiring acute non-A, non-B hepatitis and a history of 
exposure to an infected sex partner or to multiple heterosexual 
partners. HCV seroprevalence studies of STD populations have generally 
demonstrated an increased risk associated with high-risk sexual 
behaviors, including multiple partners and failure to use a condom. In 
contrast, HCV seroprevalance studies of long-term partners of patients 
with chronic HCV infection have generally shown either very low or 
absent risk, but these studies had inadequate sample sizes to address 
the issue, most were not conducted in the United States, and in several 
of the studies in which transmission between long term sex partners was 
reported, a common parenteral exposure in the past could not be ruled 
out. Because of the limited and inconsistent data available, there are 
currently no specific recommendations for changes in sexual practices 
for infected persons and their steady partners. Definitive studies in 
this area are needed to determine if such recommendations need to be 
developed.

Purpose

    The purpose of this grant/cooperative agreement program is to 
provide assistance for projects addressing the sexual transmission of 
HCV infection between steady partners. Specifically, applications are 
solicited for projects aimed at determining if there is an increased 
risk of HCV infection among steady sexual partners of HCV infected 
persons and identifying potential risk factors responsible for 
transmission.

Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for the activities under A. 
(Recipient Activities), and CDC will be responsible for conducting 
activities for a cooperative agreement under B. (CDC Activities):

Research Project Grants

    A research project grant is one in which substantial programmatic 
involvement by CDC is not anticipated by the recipient. Applicants for 
grants must demonstrate an ability to conduct the proposed research 
with minimal assistance, other than financial support, from CDC. This 
would include possessing sufficient resources for clinical, laboratory, 
and data management services and a level of scientific expertise to 
achieve the objectives described in their research proposal without 
substantial technical assistance from CDC.

Cooperative Agreements

    A cooperative agreement implies that CDC will assist recipients in 
conducting the proposed research. The application should be presented 
in a manner that demonstrates the applicant's ability to address the 
research problem in a collaborative manner with CDC.

A. Recipient Activities

    Determine if there is an increased risk of HCV infection among 
steady sexual partners of HCV infected persons and identify potential 
risk factors responsible for transmission.
    1. Enroll a sufficient number of anti-HCV positive persons and 
their steady sexual partners (estimated at 1000 participants 
each) to evaluate low frequency events. A steady sexual partner is 
defined as one whose only partner was the index case during the 
previous 3 or more years.
    a. Index cases should represent a broad spectrum of infection 
(e.g., asymptomatic persons identified through routine screening, 
symptomatic persons with various stages of chronic liver disease, 
etc.), a broad range of duration of infection (when it can be 
determined), and as broad an age range as possible.
    2. Conduct an anti-HCV seroprevalence study of the sexual partners 
and a complete risk behavior history on cases and partners. All samples 
with anti-HCV repeatedly reactive results using enzyme immuno-assay 
should be tested using a supplemental anti-HCV assay.
    3. Use nucleic acid detection methods to identify virus-specific 
factors in either the index case or the partner that may be responsible 
for transmission and to confirm the identity of virus strains in 
partner-pairs when both are infected.
    4. Publish results.

B. CDC Activities (Cooperative Agreement)

    1. Provide technical assistance in the design and conduct of the 
research.
    2. Perform selected laboratory tests as appropriate and necessary.
    3. Participate in data management, the analysis of research data, 
and the interpretation and presentation of research findings.
    4. Provide biological materials as necessary for studies, etc.

Technical Reporting Requirements

    An original and two copies of a narrative progress report are 
required semiannually. The first semiannual report is required with 
each year's non-competing continuation application and should cover 
program activities from date of the previous report (or date of award 
for reporting in the first year of the project).
    The second semiannual report and Financial Status Report (FSR) are 
due 90 days after the end of each budget period and should cover 
activities from the date of previous report. Progress reports should 
address the status of progress toward specific project objectives and 
should include copies of any publications resulting from the project. 
The final performance report and FSR are required no later than 90 days 
after the end of the project period.
    All reports should be directed to the CDC Grants Management Officer 
at the address referenced in the following section.

Application Process

Notification of Intent To Apply

    In order to assist CDC in planning and executing the evaluation of 
applications submitted under this Program Announcement, all parties 
intending to submit an application are requested to inform CDC of their 
intention to do so as soon as possible prior to the application due 
date but not later than 10 business days prior to the application due 
date. Notification should cite this Announcement number 814 and 
include: (1) Name and address of institution and (2) name, address, and 
phone number of contact person. Notification can be provided by 
facsimile, postal mail, or electronic mail (E-mail) to Sharron P. Orum, 
Grants Management Officer, Attn: Gladys T. Gissentanna, Grants 
Management Branch, Procurement and Grants Office, Centers for Disease 
Control and Prevention (CDC), 255 East Paces Ferry Road, NE., Room 300, 
Mailstop E-18, Atlanta, Georgia 30305, facsimile (404) 842-6513 or E-
mail [email protected].

Application Content

    All applicants must develop their application in accordance with 
the PHS Form 398, information contained in this

[[Page 8206]]

grant/cooperative agreement announcement, and the instructions outlined 
below.

General Instructions

    Due to the need to reproduce copies of the applications for the 
reviewers, ALL pages of the application must be in the following 
format:
    1. The original and five (5) copies must be unstapled and unbound.
    2. All pages must be clearly numbered, and a complete index to the 
application and its appendices must be included.
    3. All materials must be typewritten, single-spaced, using a font 
no smaller than size 12, and on 8\1/2\'' by 11'' white paper.
    4. Any reprints, brochures, or other enclosures must be copied onto 
8\1/2\'' by 11'' white paper by the applicant. No bound materials will 
be accepted.
    5. All pages must be printed on one side only, with at least 1'' 
margins, headers, and footers.

Special Instruction

    The application narrative must not exceed 10 pages (excluding 
budget and appendices). Unless indicated otherwise, all information 
requested below must appear in the narrative. Materials or information 
that should be part of the narrative will not be accepted if placed in 
the appendices. The application narrative must contain the following 
sections in the order presented below.

1. Abstract

    Provide a brief (two pages maximum) abstract of the project. 
Clearly identify the type of award that is being applied for: grant or 
cooperative agreement.

2. Background and Need

    Discuss the background and need for the proposed project. 
Demonstrate a clear understanding of the purpose and objectives of this 
program.

3. Capacity and Personnel

    Describe applicant's past experience in conducting projects/studies 
similar to that being proposed. Describe applicant's resources, 
facilities, and professional personnel that will be involved in 
conducting the project. Describe plans for administration of the 
project and identify administrative resources/personnel that will be 
assigned to the project. Provide in an appendix letters of support from 
all key participating non-applicant organizations, individuals, etc., 
which clearly indicate their commitment to participate as described in 
the operational plan. Do not include letters of support from CDC 
personnel. Letters of support from CDC will not be accepted. Award of a 
cooperative agreement implies CDC participation as outlined in the 
Program Requirements section of this announcement.

4. Objectives and Technical Approach

    Present specific objectives for the proposed project which are 
measurable and time-phased and are consistent with the Purpose and 
Recipient Activities of this Program Announcement. Present a detailed 
operational plan for initiating and conducting the project which 
clearly and appropriately addresses these objectives (if proposing a 
multi-year project, provide a detailed description of first-year 
activities and a brief overview of subsequent-year activities). Clearly 
identify specific assigned responsibilities for all key professional 
personnel. Include a clear description of applicant's technical 
approach/methods which are directly relevant to the above objectives. 
Describe specific study protocols or plans for the development of study 
protocols. Describe the nature and extent of collaboration with CDC (if 
applying for a cooperative agreement) and/or others during various 
phases of the project. Describe in detail a plan for evaluating study 
results and for evaluating progress toward achieving project 
objectives.

5. Budget

    Provide a line-item budget and accompanying detailed, line-by-line 
justification that demonstrates the request is consistent with the 
purpose and objectives of this program. If requesting funds for 
contracts, provide the following information for each proposed 
contract: (a) Name of proposed contractor, (b) breakdown and 
justification for estimated costs, (c) description and scope of 
activities to be performed by contractor, (d) period of performance, 
and (e) method of contractor selection (e.g., sole-source or 
competitive solicitation).

    Note: If indirect costs are requested from CDC, a copy of the 
organization's current negotiated Federal indirect cost rate 
agreement or cost allocation plan must be provided.

6. Human Subjects

    Whether or not exempt from DHHS regulations, if the proposed 
project involves human subjects, describe adequate procedures for the 
protection of human subjects. Also, ensure that women, racial and 
ethnic minority populations are appropriately represented in 
applications for research involving human subjects.

Evaluation Criteria

    The applications will be reviewed and evaluated according to the 
following criteria:

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 grant/
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 grant/
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.'' 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. 
Extent to which applicant describes adequate and appropriate 
collaboration with CDC (if applying for a cooperative agreement). 
Extent to which women, racial and ethnic minority populations are 
appropriately represented in applications involving human research. (30 
points)
    c. Extent to which applicant provides a detailed and adequate plan 
for evaluating progress toward achieving project process and outcome 
objectives.

[[Page 8207]]

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 grant/cooperative 
agreement funds.

5. Human Subjects (Not Scored)

    If the proposed project involves human subjects, whether or not 
exempt from the Department of Health and Human Services (DHHS) 
regulations, the extent to which adequate procedures are described for 
the protection of human subjects. Note: Objective Review Group (ORG) 
recommendations on the adequacy of protections include: (1) Protections 
appear adequate and there are no comments to make or concerns to raise, 
or (2) protections appear adequate, but there are comments regarding 
the protocol, (3) protections appear inadequate and the ORG has 
concerns related to human subjects, or (4) disapproval of the 
application is recommended because the research risks are sufficiently 
serious and protection against the risks are inadequate as to make the 
entire application unacceptable.

Executive Order 12372 Review

    This program is not subject to Executive Order 12372 Review.

Public Health System Reporting Requirements

    This program is not subject to the Public Health System Reporting 
Requirements.

Catalog of Federal Domestic Assistance Number

    The Catalog of Federal Domestic Assistance Number is 93.283.

Other Requirements

Paperwork Reduction Act

    Projects that involve the collection of information from ten or 
more individuals and funded by the grant/cooperative agreement will be 
subject to review and approval by the Office of Management and Budget 
(OMB) under the Paperwork Reduction Act.

Human Subjects

    If the proposed project involves research on human subjects, the 
applicant must comply with the Department of Health and Human Services 
Regulations (45 CFR part 46) regarding the protection of human 
subjects. Assurance must be provided to demonstrate that the project 
will be subject to initial and continuing review by an appropriate 
institutional review committee. The applicant will be responsible for 
providing evidence of this assurance in accordance with the appropriate 
guidelines and form provided in the application kit.
    In addition to other applicable committees, Indian Health Service 
(IHS) institutional review committees also must review the project if 
any component of IHS will be involved or will support the research. If 
an American Indian community is involved, its tribal government must 
also approve that portion of the project applicable to it.

Women, Racial and Ethnic Minorities

    It is the policy of the CDC and the Agency for Toxic Substances and 
Disease Registry (ATSDR) to ensure that individuals of both sexes and 
the various racial and ethnic groups will be included in CDC/ATSDR-
supported research projects involving human subjects, whenever feasible 
and appropriate. Racial and ethnic groups are those defined in OMB 
Directive No. 15 and include American Indian or Alaska Native, Asian, 
Black or African American, Native Hawaiian or Other Pacific Islander, 
Hispanic or Latino and White. Applicants shall ensure that women, 
racial and ethnic minority populations are appropriately represented in 
applications for research involving human subjects. Where clear and 
compelling rationale exist that inclusion is inappropriate or not 
feasible, this situation must be explained as part of the application. 
This policy does not apply to research studies when the investigator 
cannot control the race, ethnicity and/or sex of subjects. Further 
guidance to this policy is contained in the Federal Register, Vol. 60, 
No. 179, pages 47947-47951, dated Friday, September 15, 1995.

Application Submission and Deadline

    The original and two copies of each application PHS Form 398 should 
be submitted to Sharron Orum, Grants Management Officer, Attn: Gladys 
T. Gissentanna, Grants Management Branch, Procurement and Grants 
Office, Centers for Disease Control and Prevention (CDC), 255 East 
Paces Ferry Road, NE., Room 300, Mailstop E-18, Atlanta, Georgia 30305, 
on or before May 15, 1998.
    1. Deadline: Applications shall be considered as meeting the 
deadline if they are either:
    (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 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.)
    2. Late Applications: Applications which do not meet the criteria 
in 1.(a) or 1.(b) above are considered late applications. Late 
applications will not be considered and will be returned to the 
applicant.

Where To Obtain Additional Information

    To receive additional written information call (404) 332-4561. You 
will be asked to leave your name, address, and telephone number and 
will need to refer to Announcement 814. You will receive a complete 
program description, information on application procedures, and 
application forms.
    If you have questions after reviewing the contents of all the 
documents, business management technical assistance may be obtained 
from Gladys T. Gissentanna, Grants Management Specialist, Grants 
Management Branch, Procurement and Grants Office, Centers for Disease 
Control and Prevention (CDC), 255 East Paces Ferry Road, NE., Room 314, 
Mailstop E-18, Atlanta, Georgia 30305, telephone (404) 842-6801, 
facsimile (404) 842-6513, E-mail gcg4cdc.gov.
    Programmatic technical assistance may be obtained from Miriam J. 
Alter, Ph.D., National Center for Infectious Diseases, Division of 
Viral and Rickettsial Diseases, Hepatitis Branch, Centers for Disease 
Control and Prevention (CDC), 1600 Clifton Road, NE., Mailstop G-37, 
Atlanta, Georgia 30333, telephone (404) 639-2709, E-mail address: 
[email protected].
    Please refer to Announcement 814 when requesting information 
regarding this program.
    You may also obtain this and other CDC announcements from one of 
two Internet sites on the actual publication date: CDC's homepage at 
http://www.cdc.gov, or at the Government Printing Office homepage 
(including free on-line access to the Federal Register at http://
www.access.gpo.gov).
    Potential applicants may obtain a copy of Healthy People 2000 (Full 
Report, Stock No. 017-001-00474-0) or Healthy People 2000 (Summary 
Report, Stock No. 017-001-00473-1) referenced in the Introduction 
through the Superintendent of Documents, Government Printing Office,

[[Page 8208]]

Washington, D.C. 20402-9325, telephone (202) 512-1800.

    Dated: February 11, 1998.
Joseph R. Carter
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC)
[FR Doc. 98-3981 Filed 2-17-98; 8:45 am]
BILLING CODE 4163-18-P