Full Text AI-95-012

HEPATITIS C COOPERATIVE RESEARCH CENTERS

NIH GUIDE, Volume 24, Number 8, March 3, 1995

RFA:  AI-95-012

P.T. 34

Keywords: 
  Infectious Diseases/Agents 
  Viral Studies (Virology) 
  Pathogenesis 
  Biomedical Research, Multidiscipl 


National Institute of Allergy and Infectious Diseases

Letter of Intent Receipt Date:  April 7, 1995
Application Receipt Date:  July 18, 1995

PURPOSE

The Enteric Diseases Branch of the Division of Microbiology and
Infectious Diseases (DMID) of the National Institute of Allergy and
Infectious Diseases (NIAID) invites applications for the
establishment of high-quality Hepatitis C Cooperative Research
Centers (HC CRCs).  The purpose of this Request for Applications
(RFA) is to stimulate multidisciplinary, multi-project, collaborative
research on hepatitis C virus (HCV).  Such clinical and basic
research will further the understanding of early and mid, rather than
late (liver failure or liver cancer), stages and manifestations of
hepatitis C infection, disease, and recovery.  The HC CRCs will build
on new findings to develop vaccine and therapy strategies.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This RFA,
Hepatitis C Cooperative Research Centers (HC CRCs), is related to the
priority area of immunization and infectious diseases.  Potential
applicants may obtain a copy of "Healthy People 2000" (Full Report:
Stock No. 017-001-00474-0 or Summary Report:  Stock No.
017-001-00473-1) through the Superintendent of Documents, Government
Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238).

ELIGIBILITY REQUIREMENTS

Research grant applications may be submitted by domestic non-profit
and for-profit organizations, public and private institutions, such
as universities, colleges, hospitals, laboratories, units of State
and local governments, and eligible agencies of the Federal
government.  Foreign organizations are not eligible to apply but may
be part of a collaborative arrangement as described under STUDY
POPULATIONS.  Racial/ethnic minority individuals, women, and persons
with disabilities are encouraged to apply as Principal Investigators.

MECHANISM OF SUPPORT

The administrative and funding mechanism to be used to undertake this
program will be the Multi-component Cooperative Agreement (U19), an
"assistance" mechanism, rather than an "acquisition" mechanism.  The
U19 must have a minimum of three inter-related research projects
around a common theme as well as collaborative efforts and
interactions among component investigator-initiated projects and
their investigators to achieve a common goal.  Further information
can be found in NIAID's "Application Guidelines for Multiproject
Research Awards, November 1994," which are available from the
individuals listed under INQUIRIES.

The Multi-component Cooperative Agreement differs from the Program
Project in that the U19 anticipates substantial NIH scientific and/or
programmatic involvement with the awardee during performance of the
activity.  Under the cooperative agreement, the NIH's purpose is to
support and/or stimulate the recipient's activity by involvement in
and otherwise working jointly with the award recipient in a partner
role.  However, NIH is not to assume direction, prime responsibility,
or a dominant role in the activity.  Details of the responsibilities,
relationships, and governance of the study funded under  agreement(s)
are discussed later in this document under the section Terms and
Conditions of Award.

HC CRCs may involve collaboration among investigators at several
institutions.  These consortium arrangements should follow the NIH
"Guidelines for Establishing and Operating Consortium Grants, January
1989."   These are available from the individuals listed under
INQUIRIES.

The total requested period for applications submitted in response to
this RFA may not exceed five years.  At present, the NIAID is
administratively limiting the duration of U19 agreements to four
years; this administrative limitation may change in the future.  At
this time, the NIAID has not determined whether and how this
solicitation will be continued beyond the present RFA.  The earliest
anticipated award date is May 1, 1996.

FUNDS AVAILABLE

The estimated total funds (direct and indirect costs) available for
the first year of support for awards under this RFA will be $1.5
million.  In Fiscal Year 1996, the NIAID plans to fund two or three
HC CRCs.  The final number of awards to be made is dependent upon the
availability of funds.  The initial year's total costs, including
direct and indirect costs, should not exceed $750,000 for each award.
The usual PHS policies governing grants administration and management
will apply.  This level of support is dependent on the receipt of a
sufficient number of applications of high scientific merit.  Although
this program is provided for in the financial plans of the NIAID,
awards pursuant to this RFA are contingent upon the availability of
funds for this purpose.  Funding beyond the first and subsequent
years of the  agreement upon satisfactory progress during the
preceding years and availability of funds.

RESEARCH OBJECTIVES

Background

Hepatitis due to hepatitis C virus (HCV) is classified as an emerging
infectious disease (IOM Report, 1992).  Just six years ago,
investigators identified HCV as an important etiological agent of
non-A, non-B hepatitis and chronic liver disease through cloning and
sequencing efforts.  HCV infects close to 200,000 individuals each
year in the U.S., affecting Hispanics and Afro-Americans
disproportionately.  The modes of transmission remain unidentified
for an alarming 43 percent of cases.  Recovery from infection is rare
and at least 70 percent and quite possibly 90 percent of those
infected become chronic carriers.  Thus, 140,000 - 180,000 U.S.
citizens become new chronic carriers each year.  Even when the
initial infection is asymptomatic, as it is in a high percentage of
people, severe chronic liver disease with its concomitant high
morbidity and mortality occurs.  The CDC estimates that one to two
percent of the people in the U.S., i.e., 2.5-5.0 million individuals,
are chronically infected with HCV.  The same one to two percent
carrier rate is true around the world with the exception of a few
high endemicity areas such as some inner city areas in the U.S.,
Egypt, the Sudan, and isolated villages in Asia.  In the U.S. the
total cost for HCV infection and chronic sequelae is estimated at
$1.5 billion per year.

Since identification of HCV considerable progress has been made.
Molecular biological techniques have enabled investigators to:  (1)
clone and sequence many genotypes; (2) map the HCV genome and
identify some of its functions; and (3) analyze structural and
nonstructural proteins and the processes by which they are made. New
diagnostics have been instrumental in:  (1) verifying the agent
causing liver disease in symptomatic patients as well as identifying
asymptomatic patients; (2) preventing transmission in transfusion,
transplantation and hemodialysis patients; and (3) identifying
cofactors for infection and chronic disease.  There have been efforts
to define modes of transmission as well as affected and at risk
population groups.  Studies of (immuno)pathogenesis and viral
replication are beginning.

Despite these advances, infection and disease caused by HCV remain
enigmatic, and prevention and treatment problematic.  Mechanisms of
liver disease and the host's role in viral persistence are largely
unexplored.  Significant gaps exist in the knowledge base regarding
HCV's natural history and progression of disease.  An obstacle to
vaccine development stems from the inadequate immune response to
natural infection -- viral clearance is exceedingly rare even though
neutralizing antibodies have recently been detected.  The large
number of HCV genotypes and their high rate of mutation as well as
the existence of genetic variants, i.e., "quasispecies," pose
obstacles both to prevention and treatment.  Alpha interferon, the
only available therapy, is less than adequate and has associated
toxicity.  Additionally, sample sizes in human studies have often
been inadequate to draw statistically significant conclusions.  HCV
indeed poses tough challenges for scientists and clinicians.

Prevention of infection, e.g., through vaccination, and cure or
amelioration of disease have the greatest promise for those at risk
and affected respectively.  For diseases like hepatitis B they have
been shown to be highly cost-effective.  Thus in this RFA, the NIAID
is interested in research focused on acute and chronic disease rather
than on liver failure or cancer.

Objectives and Scope

This RFA seeks to support state-of-the-art, innovative research on
hepatitis C virus.  Using integrated approaches from multiple
disciplines, the HC CRCs will serve as foci for generating the
knowledge needed to further understanding of HCV infection, recovery,
and pathogenesis.  And building on this knowledge, to devise original
preventive and therapeutic interventions.  The NIAID expects clinical
issues and needs to be the driving forces for research performed by
the HC CRCs.

Relevant topics for research may include but are not limited to:

o  identify host responses to infection, e.g., correlates of immunity
associated with prevention of infection and disease as well as
recovery from acute and chronic infection;

o  explore host mechanisms involved in fostering and maintaining
viral persistence;

o  identify mechanisms of pathogenesis which lead to and exacerbate
liver disease;

o  develop small animal model and in vitro systems which are relevant
for HCV vaccine, antiviral, and pathogenesis research;

o  develop infectious cDNA clones and utilize them in ways directly
relevant to disease research; and

o  assess the impact of viral heterogeneity, e.g., genotypes and
"quasispecies", on disease initiation and progression, the
development of protective immunity, treatment outcome, etc.;

o  utilize findings to bridge the gaps between basic, applied, and
clinical research by developing and evaluating intervention
strategies, e.g., broaden or enhance protective immunity, subvert
avoidance mechanisms.

SPECIAL REQUIREMENTS

Relevant Disciplines

To foster multidisciplinary research, each HC CRC should include
approaches from at least four disciplines such as virology,
immunology, pathogenesis, the liver (cells, tissue, and organ) and
changes (biology, biochemistry, etc.) in response to infection,
clinical infection and disease, model system development, and applied
research.

HC CRC Collaborative Studies

During the award period collaborative studies among HC CRCs may
enhance research progress and increase the significance of HC CRC
contributions.  Examples include, but are not limited to, rapid
accrual of patients or augmented access to samples.  Hence,
applicants should be willing to share samples as well as to
participate in multicenter activities and common protocols.  These
will be encouraged and stimulated by the Scientific Coordinator
through discussions with the Program Directors and at meetings and
workshops scheduled as part of these awards.

Steering Committee Meetings and Workshops

To coordinate activities, facilitate interchanges, and develop
collaborative opportunities, HC CRC Program Directors and the NIAID
Scientific Coordinator will meet twice a year as a Steering
committee.  To enhance information exchange, Project Leaders will be
expected to attend workshops in Years 1 and 3 of the award period.

Clinical Capability

To move forward with basic and clinical approaches, HC CRCs must have
access to, and clinical experience with, well-characterized and
diverse patient samples and populations representing different
disease stages.  The value of research and studies performed will be
directly related to the care exercised in selection and
characterization of cases and controls.  Programs should include
participation of human subjects to address research questions.  NIAID
encourages:  (1) collaborative arrangements with ongoing studies or
clinical care capable of providing patient populations, specimens and
information; (2) applicants from institutions that have a General
Clinical Research Centers (GCRC) funded by the NIH National Center
for Research Resources to identify the GCRC as a resource for
conducting the proposed research.  In both cases letters of
collaboration or agreement from the study's principal investigator
and/or GCRC program director should be included in the application
material.

Access to and experience with patient populations also will be
helpful should progress warrant studies with promising new vaccine
and therapy candidates.

In describing the clinical and laboratory facilities, the applicant
should include specific information on present patient load,
projections for patient involvement in future clinical
investigations, history of recruitment and study of subjects, and
disease category and prevalence as well as the availability of
appropriate biohazard facilities and safety procedures.

Budget and Related Issues

Applications should budget appropriate funds to allow the Program
Director of each HC CRC (also known as the HC CRC Director) to attend
meetings in Bethesda, MD with the NIAID Scientific Coordinator twice
each year and for all HC CRC Project Leaders to attend HC CRC
workshops twice during the program period.  Applicants should be
aware that no additional travel monies will be awarded.  Funds for
travel to HC CRC meetings must be included in applicant's budget.
(See below:  SPECIAL REQUIREMENTS, Terms and Conditions of Award, 3.
Collaborative Responsibilities.).

Optional Developmental Fund for Pilot Studies

Applicants may include a request for a Developmental Fund of up to
$60,000 in direct costs to provide support for pilot projects.  Such
pilot projects might develop methods or resources capable of
enhancing basic and clinical research progress, follow-up on new
observations and hypotheses, or perform short term high risk - high
benefit research.  They should fit within the relevant disciplines
listed above.  It is envisioned that availability of funds for pilot
studies will increase flexibility and responsiveness to important new
scientific observations and medical reports and encourage the
development of research investigators interested in hepatitis C.

Pilot studies need not be restricted to the awardee institution. IT
IS EMPHASIZED THAT PILOT STUDIES AWARDED FROM THE DEVELOPMENTAL FUND
ARE DISTINCT FROM INDIVIDUAL HC CRC RESEARCH PROJECTS.

Direct costs may not exceed $20,000 for any single pilot study and
supplies and equipment expenditures may not exceed $7,000 annually
per study.  The duration of support for each study typically would be
one year, but may be up to two years.  In the event the study is
independently funded through a traditional research project grant
(R01) or a FIRST (R29) award prior to the end of the award period,
the support of the pilot study from the Developmental Fund must be
terminated, and unexpended funds must be returned to the
Developmental Fund.  Funds reserved for pilot projects may not be
rebudgeted into other budget categories except in unusual
circumstances and following approval from the Awarding Unit and the
Scientific Coordinator.  The HC CRC must maintain detailed records of
disbursements and expenditures of the Developmental Fund.

Potential awardees and specific research projects to be pursued need
not be identified in the application.  However, the application
should include a one page description of the kind of project that
might be funded under this mechanism and how it interdigitates with
other CRC projects.  Approval of the developmental funds portion of
the application does not in any way commit the program directors to
the execution of the sample project.  It is anticipated that prior to
the HC CRC Program Director proposing pilot studies to the NIAID
Scientific Coordinator, these studies and their budgets will be
reviewed and recommended by a local review committee.  The
application must provide a description of the review process and
selection criterion for proposed projects.  Examples of criteria are
scientific merit of the proposal, medical relevance and need for data
to advance the research objectives of the HC CRC.  It is recommended
that no one applying for a development pilot project be on the review
committee.  Studies involving Human Subjects will require prior
approval by the Institutional Review Board like all other NIH
supported projects.

The $30,000 annual direct costs should be entered in the OTHER
category in the Consolidated Budget (see pages 12 and 19 in the
accompanying brochure).

Terms and Conditions of Award

The following terms and conditions will be incorporated into the
award notice.

These special Terms of Award are in addition to, and not in lieu of,
otherwise applicable OMB administrative guidelines, HHS Grant
Administration Regulations at 45 CFR Parts 74 and 92, and other HHS,
PHS, and NIH Grant Administration policy statements.

The administrative and funding instrument used for this program is
the agreement (U19), an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial NIH scientific and/or
programmatic involvement with the awardee is anticipated during the
performance of the activity.  Under the agreement, the NIH's purpose
is to support and/or stimulate the recipient's activity by
involvement in and otherwise working jointly with the award recipient
in a partner role, but it is not to assume direction, prime
responsibility, or a dominant role in the activity.

Awards will be made to an institution on behalf of a Program Director
who will be responsible for the coordination of HC CRC scientific and
administrative activities.  Support of all HC CRC activities will be
coordinated through a Central Operations Office located within the
applicant organization.

1.  Awardee Rights and Responsibilities

Awardees will have primary responsibility for defining the details
for the project within the guidelines of the RFA and for performing
the scientific activity, and agree to accept close coordination,
cooperation, and participation of NIAID staff in those aspects of
scientific and technical management of the project as stated below
under NIAID Staff Responsibilities.  Specifically, awardees have
primary responsibilities as described below.

Under the Cooperative Agreement, a partnership relationship exists
between the recipient of the award and NIAID in which successful
applicants are responsive to the guidelines and conditions set forth
in the RFA.  At the same time, investigators are expected to define
research objectives and approaches in accord with their own interests
and perceptions of novel and exploitable approaches to the research
which ultimately is likely to result in improved prevention and
control of hepatitis C.

It is the primary responsibility of the HC CRC Program Director to
clearly state the objectives and approaches of the research, to plan
and conduct the research stipulated in the application, and to ensure
that the results obtained are analyzed and published in a timely
manner.  The HC CRC Program Director also will propose pilot studies
to the NIAID Scientific Coordinator after review of these studies and
their budgets by a local review committee.  NIAID may periodically
review and generate internal reports from data and progress reports
developed under this  agreement.  The data obtained will, however, be
the property of the awardee.

2.  NIAID Staff Responsibilities

The NIAID will have substantial scientific/programmatic involvement
during the conduct of this activity, through technical assistance,
advice and coordination above and beyond normal program stewardship
for grants, as described below.

The NIAID will work closely with the Program Directors and shall be
represented by the Scientific Coordinator (Program Officer).  The
Scientific Coordinator will be the Hepatitis Program Officer in the
Enteric Diseases Branch of NIAID.  During the award period, the NIAID
Scientific Coordinator may provide appropriate assistance, advice,
and guidance in:

o  overall design of studies, e.g., prospective or intervention,
especially those undertaken jointly by the HC CRCs;
o  linkage to special populations and vaccine production facilities
funded through NIAID contracts, NIAID's data collection and analysis
contracts, and DMID staff capabilities with respect to IND filing;
o  coordination and facilitation of information, technology, reagent
and pedigree specimen exchange between HC CRCs themselves and with
other grantees;
o  assistance in review and selection of developmental fund awardees;
and
o  technical and administrative activities of HC CRCs.

However, it is again emphasized that the role of NIAID will be TO
FACILITATE AND NOT TO DIRECT THE ACTIVITIES of the HC CRCs.  It is
anticipated that decisions in all activities outlined within this RFA
will be reached by consensus of the investigators and that the NIAID
Scientific Coordinator will be given the opportunity to offer input
to this process.

In the event that research supported by the Cooperative Agreement
results in development of a therapeutic or other medical
intervention, NIAID will retain the option to cross-file or
independently file an application for investigational clinical trial
(i.e., an Investigational New Drug Application [INDA]) to the United
States Food and Drug Administration.  To facilitate this, reports of
data generated by the HC CRC or any of its members which are required
for inclusion in INDs and Clinical Brochures and for cross-filing
purposes will be submitted by the Program Director to the Scientific
Coordinator upon request.  Such reports will be in final draft form
and include background information, methods, results, and conclusion.
They will be subject to approval and revision by NIAID and may be
augmented with test results from other Government sponsored projects
prior to submission to the appropriate regulatory agency.

3.  Collaborative Responsibilities

The HC CRC Program Directors and NIAID Scientific Coordinator will
form a Joint Steering Committee which will meet at the NIH in
Bethesda, Maryland (or at a site designated by NIAID) twice a year.
Its functions include, but are not limited to: tracking and reviewing
activities/progress over the six months between meetings, planning
for the next six months and beyond, maintaining focus, and developing
collaborative efforts among HC CRCs.  The Program Directors and
Scientific Coordinator will have voting rights.  Issues for
discussion and agendas will be a collaborative responsibility.  The
first steering committee meeting will occur shortly Post Award.

Twice during the project period and in conjunction with the
semi-annual Steering Committee meeting, workshops for the Program
Directors and Project Leaders will be convened to share hepatitis C
research advances, to discuss research needs and opportunities, and
to develop collaborations.  It is likely that these workshops will be
convened in Year 1 and Year 3 of the project period at the NIH in
Bethesda, Maryland (or at a site designated by NIAID).

4.  Arbitration

Any disagreement that may arise on scientific/programmatic matters
(within the scope of the award) between award recipients and the
NIAID may be brought to arbitration.  An arbitration panel will be
composed of three members -- one selected by the Program Director, a
second member selected by the NIAID, and the third member selected by
the two prior members.  This special arbitration procedure in no way
affects the awardee's right to appeal an adverse action that is
otherwise appealable in accordance with PHS regulations at 42 CFR
part 50, subpart D, and HHS regulation at 45 CFR part 16.

STUDY POPULATIONS

A strong emphasis is placed on studying hepatitis C in racial/ethnic
populations that are disproportionately affected.  These populations
include African-Americans and Hispanics.  Subjects may be recruited
or specimens obtained from domestic sites or through collaborations
with foreign institutions if the collaboration is beneficial to the
foreign country and offers the potential for collection of hepatitis
C data that are pertinent to U.S. populations and could not be
generated as effectively in the United States.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS

It is the policy of the NIH that women and members of minority groups
and their sub-populations must be included in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations), which
have been in effect since 1990. The new policy contains some
provisions that are substantially different from the 1990 policies.

All investigators proposing research involving human subjects should
read the "NIH Guidelines For Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 28, 1994 (FR 59 14508-14513) and printed in
the NIH Guide for Grants and Contracts, Volume 23, Number 11, March
18, 1994.

Investigators also may obtain copies of the policy from Dr. Johnson
at the address listed under INQUIRIES.  Dr. Johnson may also provide
additional relevant information concerning the policy.

LETTER OF INTENT

Prospective applicants are asked to submit, by March 1, 1995, a
letter of intent that includes a descriptive title of the overall
proposed research, the name, address, and telephone number of the
Program Director, a list of the key investigators and their
institution(s), and the number and title of this RFA.  Although the
letter of intent is not required, is not binding, does not commit the
sender to submit an application, and does not enter into the review
of subsequent applications, the information that it contains allows
NIAID staff to estimate the potential review workload and to avoid
conflict of interest in the review.

The letter of intent is to be sent to Dr. Olivia Preble at the
address listed under INQUIRIES.

APPLICATION PROCEDURES

It is highly recommended that potential applicants contract Dr.
Leslye Johnson in the early stages of application preparation. Before
preparing an application, the applicant should carefully read the
information brochure, "NIAID APPLICATION GUIDELINES FOR MULTIPROJECT
RESEARCH AWARDS," available from the contacts listed under INQUIRIES.
Instructions for formatting the application as outlined in the
brochure should be followed carefully.  Failure to follow the
instructions may result in unnecessary delays in the review process.

Applications are to be submitted on the standard research grant
application form PHS 398 (rev. 9/91).  These application forms may be
obtained from the institution's office of sponsored research or its
equivalent and from the Office of Grants Information, Division of
Research Grants, National Institutes of Health, 5333 Westbard Avenue,
Room 449, Bethesda, MD 20892, telephone (301) 710-0267.

The RFA label available in the PHS 398 (rev. 9/91) application form
must be affixed to the bottom of the face page of the application.
Failure to use this label could result in delayed processing of the
application such that it may not reach the review committee in time
for review.  In addition, the RFA title and number must be typed on
line 2a of the face page of the application form and the YES box must
be marked.

Submit a signed, typewritten original of the application, including
the checklist, and three signed, exact, single-sided photocopies, in
one package, to:

Division of Research Grants
National Institutes of Health
6701 Rockledge Drive - MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (express mail)

At the time of submission, two additional exact copies of the grant
application and all five sets of appendix material must also be sent
to:

Dr. Olivia Preble
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4C-20  MSC 7610
6003 Executive Boulevard
Bethesda, MD  20892-7610
Rockville, MD  20852 (express mail)

Applications must be received by July 18, 1995.  All components,
subparts and sections of the application must be collated into the
application, and the packages sent to the DRG and to the NIAID must
each be complete in themselves.  Applications that do not conform to
the instructions contained in PHS 398 (rev. 9/91) application kit
will be judged nonresponsive and will be returned to the applicant.

Current NIH policy permits a component research project of a
multiproject grant application to be concurrently submitted as a
traditional individual research project (R01) application.  If,
following review, both the multiproject application and the R01
application are found to be in the fundable range, the investigator
must relinquish the R01 and will not have the option to withdraw from
the multiproject grant.  This is an NIH policy intended to preserve
the scientific integrity of a multiproject grant, which may be
seriously compromised if a strong component project(s) is removed
from the program.  Investigators wishing to participate in a
multiproject grant must be aware of this policy before making a
commitment to the Program Director and awarding institution.

REVIEW CONSIDERATIONS

Review Method

Upon receipt, applications will be reviewed for completeness by the
Division of Research Grants (DRG) for completeness and for
responsiveness by NIAID staff.  Incomplete and non-responsive
applications will be returned to the applicant without further
consideration or review.

Those applications that are complete and responsive may be subjected
to a triage by a peer review group to determine their scientific
merit relative to other applications received in response to this
RFA.  The NIAID will remove from competition those applications
judged to be non-competitive for award and will notify the Program
Directors and institutional business officials.

Those applications judged by the reviewers to be competitive for
award will be further reviewed for scientific and technical merit by
a review committee convened by the Division of Extramural Activities,
NIAID.  The second level of review will be provided by the National
Advisory Allergy and Infectious Diseases Council.

Review Criteria

The standard review criteria are stated in the NIAID GUIDELINES FOR
MULTIPROJECT RESEARCH AWARDS, which is available from the program
staff listed under INQUIRIES.  In addition, the following criteria
will apply:

o  the scientific and technical significance, merit, and originality
of the research projects and anticipated contributions to the
understanding of HCV's immunology and disease;

o  the scientific expertise and experience of the Program Director,
the Project Leaders and key project and core personnel;

o  documentation of a strong clinical capability, adequate and
appropriate patient populations, disease prevalence, and historical
success of recruitment and retention of subjects;

o  documentation of the sponsoring institution's commitment to the
program and willingness to accept the participation and assistance of
NIAID staff;

o  adequacy of proposed plan for coordination and communication
within the applicant HC CRC and with NIAID and other HC CRCs; and

o  adequacy of proposed plan for selection of pilot studies.

AWARD CRITERIA

Funding decisions will be made on the basis of scientific and
technical merit as determined by peer review, program balance, and
availability of funds.

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcome.  Direct inquiries regarding programmatic
issues to:

Dr. Leslye Johnson
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Solar Building, Room 3A-22  MSC 7630
6003 Executive Boulevard
Bethesda, MD  20892-7630
Telephone:  (301) 496-7051
Email:  lj7m@nih.gov

Direct inquiries regarding review issues, address the letter of
intent to, and mail two copies of the application and all five sets
of appendices to:

Dr. Olivia Preble
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4C-20  MSC 7610
6003 Executive Boulevard
Bethesda, MD  20892-7610
Rockville, MD  20852
Telephone:  (301) 496-8208
Email:  op2t@nih.gov

Direct inquiries regarding fiscal matters to:

Linda M. Shaw
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4B-33  MSC 7610
6003 Executive Boulevard
Bethesda, MD  20892-7610
Rockville, MD  20852
Telephone:  (301) 496-7075
Email:  lsl5k@nih.gov

Schedule

Letter of Intent Receipt Date:  April 7, 1995
Application Receipt Date:       July 18, 1995
Scientific Review Date:         November 1995
Advisory Council Date:          January 1996
Earliest Award Date:            May 1, 1996

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.855 Immunology, Allergic and Immunological Diseases
Research and 93.856 Microbiology and Infectious Diseases Research.
Grants are awarded under the authority of the Public Health Service
Act, Section 301 (42 USC 241) and administered under PHS grants
policies and Federal Regulations, most specifically at 42 CFR Part 52
and 45 CFR Part 74.  This program is not subject to the
intergovernmental review requirements of the Executive Order 12372 or
Health Systems Agency review.

The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and promote the non-use of all tobacco products.  This
is consistent with the PHS mission to protect and advance the
physical and mental health of the American people.

.

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	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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