# Applied Research in Emerging Infections Hepatitis C Virus Infection

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URL: https://www.frixlaw.com/law-library/documents/fr%3A97-17704

## Record

- **Collection:** Federal Register
- **Document type:** Notice
- **Published:** July 8, 1997
- **Citation:** 62 FR 36546

## Text

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Announcement Number 779]

Applied Research in Emerging Infections Hepatitis C Virus
Infection

Introduction

The Centers for Disease Control and Prevention (CDC) announces the
availability of fiscal year (FY) 1997 funds for competitive cooperative
agreements and/or grants to support applied research on emerging
infections--epidemiologic studies 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
Public Law 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
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 $150,000 is available in FY 1997 to fund one award.
It is expected the award will begin on or about September 30, 1997, and
will be made for a 12-month budget period within a project period of up
to three years. Funding estimate may vary and 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 Department
of Health and Human Services (HHS) funds for lobbying of Federal or
State legislative bodies. Under the provisions of 31 U.S.C. Section
1352 (which has been in effect since December 23, 1989), 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 1997 Departments of Labor, HHS, and Education,
and Related Agencies Appropriations Act, which became effective October
1, 1996, expressly prohibits the use of 1997 appropriated funds for
indirect or ``grass roots'' lobbying efforts that are designed to
support or defeat legislation pending before State legislatures.
Section 503 of this new law, as enacted by the Omnibus Consolidated
Appropriations Act, 1997, Division A, Title I, Section 101(e), Pub. L.
No. 104-208 (September 30, 1996), provides as follows:
Sec. 503(a) 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, * * * except
in presentation to the Congress or any State legislative body itself.
(b) No part of any appropriation contained in this Act 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

[[Page 36547]]

and elsewhere, infectious diseases increasingly threaten public health
and contribute significantly to the escalating costs of health care.
In 1992, the Institute of Medicine of the National Academy of
Sciences published a report entitled Emerging Infections, Microbial
Threats to Health in the United States highlighting the threat of
emerging infections and making specific recommendations to address the
threat. This report emphasized a critical leadership role for CDC in a
national effort to detect and control infectious disease threats.
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. One component of these efforts is to
implement an extramural program for research in emerging infectious
disease surveillance, epidemiology, and prevention which will fill the
gaps in existing support for such research. In FY 1996, CDC initiated
the Extramural Applied Research Program in Emerging Infections (EARP)
and made grant or cooperative agreement awards to seven institutions
for projects in the areas of antimicrobial resistance and tickborne
diseases. This grant/cooperative agreement announcement specifically
addresses the area of hepatitis C virus infection (HCV).
In the United States, HCV is an important cause of acute and
chronic liver disease, although the natural history of this infection
is not well understood. 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 the transmission of HCV and providing infected
persons with specific information about the risk and consequences of
infection are dependent on a better understanding of the natural
history and the risk of transmission in different settings.
In studies conducted to date, an average of 5 percent of infants of
anti-HCV positive mothers are infected perinatally; however, little is
known about the natural history of infection in these infants.
Understanding the outcome of perinatal HCV infection is essential for
developing recommendations and providing appropriate information to HCV
infected persons regarding any special precautions or restrictions
related to pregnancy, as well as determining the need for development
of therapeutic interventions in pediatric populations.
Case-control studies conducted prior to the discovery of HCV showed
that household contact with a person with hepatitis was a risk factor
for acquiring acute non-A, non-B hepatitis. Since the discovery of HCV,
cross sectional studies of household contacts of persons with chronic
HCV infection have demonstrated an average seroprevalence of 4 percent;
however, none of these studies was done in the United States, none
conclusively demonstrated that transmission occurred within the
household, and none had a sufficient sample size to estimate the risk
if such transmission occurred. To determine if specific recommendations
are needed for preventing transmission of HCV in the household setting,
the risk of, and risk factors for, household transmission of HCV need
to be addressed.
Follow-up studies among infants and other household contacts of
HCV-infected women identified through prenatal testing can address
questions regarding the natural history of perinatal HCV infection and
regarding household transmission of HCV.

Purpose

The purpose of this grant/cooperative agreement announcement is to
provide assistance for projects addressing HCV infection. Specifically,
applications are solicited for projects addressing the natural history
of perinatal HCV infection and household transmission of HCV:
a. Follow a cohort of infants with perinatal HCV infection through
the first five years of life.
b. Assess the incidence of and risk factors for HCV infection among
household contacts of HCV-infected women of childbearing age.

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 under B. (CDC Activities):

A. Recipient Activities

1. Natural history of perinatal HCV infection:
a. Identify an existing group of at least 10 perinatally-infected
infants with follow-up data, including serial results of appropriate
laboratory testing available from birth until at least 2 years of age.
Infants should be anti-HIV negative;
b. Perform additional follow-up clinical evaluations for all HCV-
infected infants in the group for a 3-year period (until children are
5 years of age), including history, physical examination,
laboratory testing, and liver biopsy, as appropriate according to
clinical practice standards.
2. Risk for household transmission of HCV infection:
a. Identify an existing cohort of at least 200 anti-HCV positive
women of childbearing age and their household contacts with the
following characteristics:
(1) Majority of women anti-HIV negative,
(2) Women who gave birth to at least one child since their anti-HCV
status was confirmed,
(3) Anti-HCV status (baseline) of all household contacts known,
(4) A complete history of risk factors for HCV infection for all
women and their household contacts.
b. Determine the incidence of HCV infection among anti-HCV negative
household contacts by conducting anti-HCV testing and obtaining history
of potential risk factors for transmission at least 3 years after
baseline testing. Employ methods to maintain participation of the
cohort during the interim period between baseline and follow-up
testing.
c. For incident HCV infections in households, identify virus-
specific factors that may be responsible for transmission and confirm
the identity of virus strains in household contact-pairs when both are
infected.
3. Publish results.

B. CDC Activities

1. Research Project Grants
A research project grant is one in which substantial programmatic
involvement by CDC is not anticipated by the recipient during the
project period. 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.

[[Page 36548]]

2. 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. In addition to the
financial support provided, CDC may collaborate by: (a) providing
technical assistance in the design and conduct of the research; (b)
performing selected laboratory tests as appropriate and necessary;(c)
participating in data management, the analysis of research data, and
the interpretation and presentation of research findings; and (d)
providing 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 779 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, 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(s) in accordance with
the PHS Form 398, information contained in this grant/cooperative
agreement announcement, and the instructions outlined below. In order
to ensure an objective, impartial, and prompt review, applications must
conform to these instructions.

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 two 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
grant/cooperative agreement 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. Include in an appendix curriculum vitae for all
professional personnel involved with 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

[[Page 36549]]

contractor selection (e.g., sole-source or competitive solicitation).

Note: If indirect costs are requested from CDC on a new or
continuation application, 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 in an appendix 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'' 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.
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. 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,
(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, Alaskan Native, Asian,
Pacific Islander, Black and Hispanic. 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

[[Page 36550]]

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 five copies of each application PHS Form 398
should be submitted to Sharron Orum, Grants Management Officer, 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 August 25, 1997.
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 779. 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 Oppie M. Byrd, 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) 842-6546, facsimile (404)
842-6513, E-mail [email protected].
Programmatic technical assistance may be obtained from Harold S.
Margolis, M.D., National Center for Infectious Diseases, Division of
Viral and Rickettsial Diseases, Centers for Disease Control and
Prevention (CDC), 1600 Clifton Road, NE., Mailstop A-33, Atlanta,
Georgia 30333, telephone (404) 639-2339, E-mail address [email protected].
Please refer to Announcement 779 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,
Washington, D.C. 20402-9325, telephone (202) 512-1800.

Dated: July 1, 1997.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for
Disease Control and Prevention (CDC).
[FR Doc. 97-17704 Filed 7-7-97; 8:45 am]
BILLING CODE 4163-18-P

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A97-17704. Public record. Not legal advice.