[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]
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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 gcg4@cdc.gov.
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:
mja2@cdc.gov.
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
