Full Text PA-96-072
NIH GUIDE, Volume 25, Number 30, September 6, 1996
PA NUMBER:  PA-96-072
P.T. 34


National Institute of Allergy and Infectious Diseases
National Institute of Dental Research
This Program Announcement (PA) is intended to foster applications
focusing on an hypothesis for AIDS-related pathogenesis applying
state-of-the-art methods and approaches to in vivo research.  In vivo
research includes studies of human clinical or epidemiologic cohorts,
animal models, or appropriate specimens from humans or animals.
Where scientifically justified, applicants are encouraged to include
both human and animal studies.  While the research necessary to test
a proposed pathogenesis hypothesis may be possible within a single
laboratory, some applications may require separate components at the
same or different institutions specializing in different scientific
disciplines (e.g., molecular biology, biochemistry, cellular biology,
cellular immunology, pathology, genetics and biophysics).
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 PA,
Mechanisms of AIDS Pathogenesis, is related to the Priority area of
HIV infection.  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 202-512-1800).
Applications may be submitted by domestic and foreign for-profit and
non-profit organizations, public and private, such as universities,
colleges, hospitals, laboratories, units of State or local
government, and eligible agencies of the Federal government.  The
total requested project period for an application submitted in
response to this PA may not exceed five years; a foreign application
may not request more than three years of support and will receive no
support for indirect costs.  Domestic applications may include
international components but these components will receive no support
for indirect costs.  Foreign institutions are not eligible for the
First Independent Research Support and Transition (FIRST) (R29)
Award.  Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as principal investigators.
The mechanisms of support will be investigator-initiated research
project grants (R01), Interactive Research Project Grants (IRPG), the
First Independent Research Support and Transition (FIRST) (R29)
award, and the Small Research Grants (R03).  Research support may
also be obtained through applications for a competitive supplement to
ongoing NIH-funded grants.
Information on the IRPG mechanism is available in program
announcement PA-96-001, published in the NIH Guide for Grants and
Contracts, Vol. 24, No. 35, October 6, 1995.  Applicants for R03
grants may request up to $50,000 annual direct costs for a period not
to exceed two (NIDR) or three (NIAID) years.  Applicants for R03
grants must follow special application guidelines, which are
referenced below.  Publications containing IRPG and R03 application
guidelines are available from the program staff listed under
INQUIRIES.  Responsibility for the planning, direction, and execution
of the proposed project will be solely that of the applicant.
Applicants are encouraged to coordinate, through the use of
consortium arrangements or subcontracts, integrated approaches with
individuals or institutions having relevant reagents and expertise in
their use, demonstrated ability in a particular area of relevant
research, or access to relevant animal or patient populations.
Potential applicants are encouraged to contact the program staff
listed under INQUIRIES for guidance concerning the organization and
scope of the proposed work, the most appropriate support mechanism,
and the preparation of the application.
This PA encourages hypothesis-focused applications for HIV
pathogenesis research linking in vitro studies to in vivo disease on
the targeted areas of research identified in the 1995 NIAID HIV/AIDS
Research Agenda listed below.  Additionally, this PA encourages
investigators with current NIH-funded grants on in vivo AIDS
pathogenesis to submit competitive supplement applications to examine
the effect of vaccination on lentiviral mucosal transmission and/or
viral disease.
The targeted research areas below are not listed in priority order
and are intended to be illustrative rather than exhaustive examples.
o  Possible direct and indirect mechanisms of HIV-mediated
immunodeficiency; e.g., the effect of HIV infection on immune
regulation including signaling ligands, receptors, pathways, and
cellular maturation processes.
o  Events at the cell and organ system levels that characterize or
predict HIV entry or disease progression; e.g., virus and infected
cell trafficking, viral burden and characteristics in blood and
tissues (particularly in lymph nodes, oral and gut mucosa, spleen,
bone marrow, and brain), and sites and kinetics of CD4+ cell
destruction in vivo.
o  Host genes, alleles, corresponding proteins and their mechanisms
of action that control susceptibility to HIV infection, level of
infectivity for HIV transmission, and/or rate of disease progression,
e.g., adhesion proteins, receptors, cytokines/chemokines and
regulatory pathways.
o  Impact of vaccine-induced immune responses on mucosal transmission
and in vivo pathogenesis.
The most relevant studies are expected to examine molecular and
cellular biology, virology, and immunology within the context of
animal models and/or well-defined human cohorts or patient samples.
Investigators are encouraged to minimize the number of new animals
entered into research studies (and related support expenses) by
using, whenever possible, animals in ongoing supported non-human
primate research.
Descriptive research that is not structured around a specific
hypothesis(es) is not within the scope of this PA.  For example,
natural history epidemiologic studies in many DAIDS-supported cohorts
are critically important for collecting information on the cause and
course of disease.  Although the information provided by such studies
may provide a foundation for hypotheses that may be tested in
research, this PA is intended to encourage the next step in research,
the testing of these hypotheses.
Clinical trials and recruitment or retention of cohorts are not
encouraged under this PA.  However, identified costs for patient
visits, sample storage and handling specific to the applicant's
proposed research are appropriate.  Proposed analyses of samples
acquired from epidemiologic or clinical trials are also appropriate.
Investigators are encouraged to use existing supported epidemiologic
or clinical cohorts instead of requesting funds to support or
establish additional cohorts.  Applicants are responsible for
establishing components and/or collaborative arrangements.  Program
staff listed under INQUIRIES may be able to assist in forming
collaborations and suggesting relevant cohorts or reagent resources.
It is the policy of the NIH that women and members of minority groups
and their subpopulations 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 20, 1994 (FR 59 14508-14513) and reprinted
in the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 18, 1994.
Applications are to be submitted on the grant application form PHS
398 (rev. 5/95) and will be accepted at the standard application
deadlines as indicated in the application kit.  The receipt dates for
applications for AIDS-related research are also found in the PHS 398
instructions.  Application kits are available at most institutional
offices of sponsored research and may be obtained from the Office of
Extramural Outreach and Information Resources, National Institutes of
Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910,
telephone (301) 710-0267, email: ASKNIH@odrockm1.od.nih.gov.
The title and number of this program announcement must be typed in
Section 2 on the face page of the application (i.e., "Mechanisms of
AIDS Pathogenesis," PA-96-072).
The completed original application and five legible copies must be
sent or delivered to:
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)
Applicants for NIAID R03 grants must follow application guidelines
for SMALL RESEARCH GRANTS - NIAID, which appeared in the NIH Guide
for Grants and Contracts, Vol. 25, No. 9, March 22, 1996, and are
available from the NIAID program staff listed under INQUIRIES.  The
completed original and  three legible single-sided copies of the
application must be sent or delivered to the Division of Research
Grants at the above address.  In addition, mail two copies of the R03
application and all five sets of any appendices to the address below.
Also, direct inquiries regarding review issues and special
instructions for application preparation to the address below.
Stanley Oaks, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6003 Executive Boulevard, Room 4C06 - MSC 7042
Bethesda, MD  20892-7610
Telephone:  (301) 496-7042
FAX:  (301) 402-2638
Email:  os4g@nih.gov
Applicants for NIDR R03 grants must  follow the guidelines for the
Small Grants Program, which appeared in the NIH Guide for Grants and
Contracts, Vol. 20, No.12, March 22, 1991.  Applicants are also
required to follow the R03 page limitations described in the NIH
Guide Vol. 22, No. 1, January 8, 1993.  Copies of these guidelines
are available from the NIDR staff listed under INQUIRES.  The
completed original and three  legible single-sided copies of the
application must be sent or delivered to the Division of Research
Grants at the above address.  In addition, mail two copies of the R03
application to the address below.  Also, direct inquiries regarding
review issues and special instructions for application preparation to
the address below.
William Gartland, Ph.D.
Division of Extramural Research
National Institute of Dental Research
Building 45, Room 4AN-32
Bethesda, MD  20892-6402
Telephone:  (301) 594-2372
FAX:  (301) 480-8303
Email:  GartlandW@de45.nidr.nih.gov
FIRST (R29) applications must include at least three sealed letters
of reference attached to the face page of the original application.
FIRST applications submitted without the required number of reference
letters will be considered incomplete and will be returned without
Applications will be assigned on the basis of established PHS
referral guidelines.  Applications that are complete will be
evaluated for scientific and technical merit by study sections of the
Division of Research Grants, NIH (or by the review group of the
relevant Institute, Center, or Division), in accordance with the
standard NIH peer review procedures.  As part of the initial merit
review, all applications will receive a written critique and undergo
a process in which only those applications deemed to have the highest
scientific merit, generally the top half of applications under
review, will be discussed, assigned a priority score, and receive a
second level review by the appropriate national advisory council or
Review Criteria
o  Scientific, technical, or medical significance and originality of
proposed research;
o  Appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research;
o  Qualifications and research experience of the Principal
Investigator and staff, particularly, but not exclusively, in the
area of the proposed research;
o  Availability of the resources necessary to perform the research;
o  Appropriateness of the proposed budget and duration in relation to
the proposed research;
o  For studies involving human subjects, adequacy of plans to include
both genders and minorities and their subgroups as appropriate for
the scientific goals of the research.  Plans for the recruitment and
retention of subjects will also be evaluated.
The initial review group will also examine the provisions for the
protection of human and animal subjects, the safety of the research
environment, and conformance with the NIH Guidelines for the
Inclusion of Women and Minorities as Subjects in Clinical Research.
Applications will compete for available funds with all other approved
applications.  The following will be considered in making funding
o  Quality of the proposed project as determined by peer review
o  Availability of funds
o  Institute priority for area of proposed research
Inquiries are encouraged.  The opportunity to clarify any issues or
questions from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
Opendra K. Sharma, Ph.D.
Division of AIDS
National Institute of Allergy and Infectious Diseases
Solar Building, Room 2C06 - MSC 7620
Bethesda, MD  20892-7620
Telephone:  (301) 496-8378
FAX:  (301) 402-3211
Email:  os4g@nih.gov)
Eleni Kousvelari, D.D.S., D.Sc
Division of Extramural Research
National Institute of Dental Research
Natcher Building, Room 4AN-24
Bethesda, MD  20892-6402
Telephone: (301) 594-2427
FAX:  (301) 480-8318
Email:  Kousvelari@de45.nidr.nih.gov
Direct inquiries regarding fiscal matters to:
Ms. Jackie Johnson
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4C16 - MSC 7610
Bethesda, MD  20892-7610
Telephone:  (301) 496-7075
FAX:  (301) 480-3780
Email:  jj19e@nih.gov
Mr. Martin Rubinstein
Division of Extramural Research
National Institute of Dental Research
Natcher Building, Room 4AN-44A
Bethesda, MD  20892-6402
Telephone:  (301) 594-4800
FAX:  (301) 480-8301
Email:  Martin.Rubinstein@nih.gov
This program is described in the Catalog of Federal Domestic
Assistance, 93.856 - Microbiology and Infectious Diseases Research
and 93.855 - Immunology, Allergy and Transplantation Research.
Awards are made under authorization of the Public Health Service Act,
Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158,
42 USC 241 and 285) and administered under PHS grant policies and
Federal Regulations 42 CFR Part 52 and 45 CFR Part 74.  This program
is not subject to the intergovernmental review requirements of
Executive Order 12372 or Health Systems Agency review.
The PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products.  In addition, Public Law 103-227, the Pro-Children Act of
1994, prohibits smoking in certain facilities (or in some cases, any
portion of a facility) in which regular or routine education,
library, day care, health care or early childhood development
services are provided to children.  This is consistent with the PHS
mission to protect and advance the physical and mental health of the
American people.

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