[Federal Register Volume 62, Number 130 (Tuesday, July 8, 1997)]
[Notices]
[Pages 36546-36550]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-17704]


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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