Full Text PA-96-048
 
EXPANDED RESEARCH ON EMERGING DISEASES
 
NIH GUIDE, Volume 25, Number 14, May 3, 1996
 
PA NUMBER:  PA-96-048
 
P.T. 34

Keywords: 
  Infectious Diseases/Agents 
  Microbiology 

 
National Institute of Allergy and Infectious Diseases
 
PURPOSE
 
The National Institute of Allergy and Infectious Diseases gives
special consideration for funding to scientifically meritorious
applications in response to Program Announcements.  Program
Announcements identify areas of ongoing research emphasis for the
NIAID.
 
The Division of Microbiology and Infectious Diseases of the National
Institute of Allergy and Infectious Diseases (NIAID) invites
applications for research on emerging and re-emerging human
pathogens.  The purpose of this PA is to encourage basic and applied
research projects yielding new data that will enhance prediction,
prevention, treatment, and control of emerging and re- emerging
infectious diseases threatening the U.S.  Projects dealing with those
bacterial, viral, fungal and parasitic pathogens of humans which have
been newly recognized, and whose prevalence has markedly increased
within the last two decades, are of interest.  Applications dealing
with additional new infectious disease problems that may emerge
during the course of this PA are also encouraged. Since other NIAID
initiatives have recently been available to support research on other
high priority areas such as HIV, opportunistic infections in AIDS
patients, Lyme disease, and tuberculosis, projects on these topics
will not be considered responsive to this PA.
 
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 program
announcement, Expanded Research on Emerging Diseases, 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 20402-0325 (telephone 202-512-1800).
 
ELIGIBILITY REQUIREMENTS
 
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 and local
governments, and eligible agencies of the Federal government.
Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as Principal Investigators.
Foreign institutions are not eligible for the First Independent
Research Support and Transition (FIRST) award (R29).
 
MECHANISM(S) OF SUPPORT
 
Investigator-initiated research project grant (R01) ,FIRST award
(R29), and small grant (R03) applications may be submitted in
response to this program announcement.
 
NIAID uses R03 grants to support small highly innovative or pilot
projects.  Applicants for R03 grants may request up to $50,000 annual
direct costs for a period not to exceed three years.  Funds and time
requested should be appropriate for the research proposed. Applicants
for R03 grants must follow the special application guidelines and
Terms and Conditions of Award for NIAID SMALL RESEARCH GRANTS, which
appeared in the NIH Guide for Grants and Contracts, Vol. 25, No. 9,
March 22, 1996.
 
RESEARCH OBJECTIVES
 
Background
 
The emergence of the AIDS epidemic, the appearance of hantavirus in
the Southwest, and the emergence of Lyme disease in the Northeast
have demonstrated the vulnerability of the U.S. to emerging diseases.
The NIAID recently co-funded two studies by the Institute of Medicine
dealing with emerging diseases (see:  Institute of Medicine:
Emerging Infections- -Microbial Threats to Health in the United
States, National Academy Press; and The U.S. Capacity to Address
Tropical Infectious Disease Problems, National Academy Press).  These
studies warned that the threat posed by disease-causing microbes may
be expected to continue and intensify in coming years.
 
Factors influencing the pattern of emergence and distribution of
infectious diseases in general include those associated with the
microbial agent itself, the agent's hosts and vectors, and the
environment in which agent and host interact. However, for many
infectious agents, the specific factors contributing to emergence are
poorly understood.  Nonetheless, knowledge of these principles is
essential in planning strategies to prevent, treat, and control such
diseases.
 
The natural life cycle of many infectious agents is multi-faceted and
in addition to the organism, may include one or several reservoir or
amplifying hosts, and often an arthropod vector.  A change affecting
the interaction of any of these fundamental elements might lead to
the emergence or re-emergence of a disease.
 
Natural or man-made changes to the environment typically impact on
vectors or hosts.  There are multiple recent examples of natural
environmental changes influencing disease emergence in the U.S.  The
heavy rainfall and seasonal winds following an extended period of
drought are believed to have contributed to the current epidemic of
the fungal disease coccidioidomycosis in the Western U.S. Another
recent example is the 1993 emergence of hantavirus in the
Southwestern U.S.  It is now thought that the virus in part emerged
as a result of climatic and environmental conditions favorable for an
increase in  infected rodent populations.
 
Nonetheless, man-made changes to the environment also lead to the
emergence of disease.  There have been several accounts of endemic
diseases emerging and spreading as the result of man-made changes
such as:  (a) development of dams and water projects resulting in
altered water distribution patterns, (b) deforestation and changing
land-use associated with the development of new communities, and (c)
the introduction of new hosts or the expansion of new vectors as the
result of changing commercial practices.  One example is the
emergence in Lyme disease in reforested suburban communities.  It is
now believed that changes in agricultural practices as well as
residential encroachments into previously unpopulated lands enhance
the risk of human contact with increasing populations of infected
ticks.
 
Historically, commerce has often brought new microbes, vectors, or
hosts into an area.  Impending expansion of worldwide commercial
trade may facilitate the emergence of new diseases, or increase the
spread of previously known diseases to a more receptive environment.
An example is the 1986 introduction of the Asian mosquito Aedes
albopictus into the U.S. in a shipment of tires.  This mosquito
adapts well to woodland or urban settings, and it has established
itself in over 18 states.  It is capable of transmitting a number of
diseases, and there is concern that this new vector might change the
historical distribution of disease.
 
Emerging and re-emerging disease problems may also relate to the
effectiveness of existing public health measures.  The recent
outbreaks of diarrheal disease caused by the protozoan parasite
cryptosporidium reflect increased demands on existing water treatment
facilities.  Furthermore, complacency with regard to implementation
of standard public health precautions may lead to re-emergence of
disease threats.  Recent examples are outbreaks of food-borne enteric
disease due to inadequate quality control in food handling and
preparation.
 
In some instances, infectious agents might emerge as the result of
selection of new genetic strains and variants with increased
infectiousness, virulence, or transmissibility  This is most often
seen as the cause of emergence of diseases that had previously been
controlled by antibiotics and other drugs (e.g., multiple
drug-resistant TB, antibiotic resistant bacteria, etc.).  This has
also been well-established as a cause for the emergence of new
influenza outbreaks, and, in an analogous fashion, probably
contributes to the emergence of other viruses particularly, the
bunyaviruses.
 
Major impediments in meeting these emerging disease threats are the
formidable research problems posed by the need for input from
multiple disciplines, and the relative scarcity of researchers
working in field-oriented disciplines.
 
Research Objectives and Experimental Approaches
 
The overall objective of this PA is to expand research on emerging
diseases, and help build a critical mass of investigators with
expertise in the varied laboratory, field-, and clinically-based
disciplines needed for the comprehensive study of emerging diseases.
Specifically, this PA is intended to stimulate basic and applied
research which will help formulate coordinated strategies for
predicting, detecting, controlling, and preventing emergence or re-
emergence of infectious diseases of humans.  Projects concerning
those bacterial, viral, fungal and parasitic pathogens of humans
which have been newly recognized, or whose incidence has markedly
increased, within the last two decades are of particular interest.
These include, but are not limited to, Hantaan and Sin nombre
viruses, hepatitis C and E, dengue virus, Group A Streptococcus,
Pneumococcus, Bartonella, Vibrio cholerae, Plasmodium,
Cryptosporidium, the microsporida, Coccidioides and Aspergillus.
Applications dealing with additional new infectious disease problems
that may emerge during the course of this PA are also encouraged.
Research responsive to this PA would include:
 
o  Basic and applied research on changes and adaptations of the
organism which might influence emergence or re-emergence. Studies
might address mechanisms leading to appearance in the natural
population of new or altered human pathogens with enhanced virulence
or drug resistance, or modified transmissibility or infectivity.
 
o  Basic and applied research on ecologic and environmental factors
influencing disease emergence and distribution.  Studies might
include evaluation of:  the influence of natural, man-made, or
climate-induced environmental change on emerging diseases; the
effects of alterations in host or vector population density and
distribution on diseases; and the influence of public health
practices or modern technological developments on disease
distribution. Field-oriented studies, to complement laboratory based
research, are particularly encouraged.
 
o  Research aimed at improved detection of emerging diseases.  The
primary aim should not be surveillance per se, but the related
research objectives, such as the development of improved diagnostic
reagents and assays, or of new predictive strategies that might aid
in the targeting of control efforts.  For example, recent advances in
satellite remote sensing technology and in computerized geographic
information systems (GIS) have been applied to the study of
infectious diseases and their distribution.  These tools have
provided predictive data for such purposes as identifying geographic
areas where there is an increased risk of vector-borne disease
transmission.
 
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 the program
staff listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.
 
APPLICATION PROCEDURES
 
Applicants for Small Research (R03) grants are to follow the
application guidelines, NIAID SMALL RESEARCH GRANTS, which are
available from program staff listed under INQUIRIES.
 
Applicants are strongly encouraged to contact NIAID program staff
with any questions regarding the responsiveness of their proposed
project to the goals of this PA.  Applications are to be submitted on
the grant application form PHS 398 (rev. 5/95) and will be accepted
on the standard application deadlines as indicated in the application
kit.  Applications kits are available at most institutional offices
of sponsored research and may be obtained from the Grants Information
Office, Office of Extramural Outreach and Information Resources,
National Institutes of Health, 6701 Rockledge Drive, MSC 7910,
Bethesda, MD 20892-7910, telephone 301/435-0714, email:
ASKNIH@odrockm1.od.nih.gov.
 
Each application must be identified by checking "YES" on line 2 of
the PHS face page, and the number and title of this program
announcement must be typed in section 2a.
 
The completed original and five legible, single-sided copies of the
application must be sent or delivered to:
 
DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817-7710 (for express/courier service)
 
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
review.
 
Applicants from institutions that have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research
Resources may wish to identify the Center as a resource for
conducting the proposed research.  If so, a letter of agreement from
the GCRC Program Director must be included in the application
material.
 
REVIEW CONSIDERATIONS
 
Applications will be assigned on the basis of established PHS
referral guidelines.  Applications will be reviewed for scientific
and technical merit in accordance with the standard NIH peer review
procedures.  Following scientific/technical review, the applications
will receive secondary review by the appropriate national advisory
council.
 
As part of the initial merit review, a process may be used by the
initial review group in which applications will be determined to be
competitive or non-competitive based on their scientific merit
relative to other applications.  Applications judged to be
competitive will be discussed and be assigned a priority score.
Applications determined to be non-competitive will be withdrawn from
further consideration and the Principal Investigator and the official
signing for the applicant organization will be notified.
 
Review Criteria
 
o  scientific, technical, or medical significance and originality of
the 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  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 and the safety of the
research environment.
 
AWARD CRITERIA
 
Applications will compete for available funds with all other
favorably recommended applications.  The following will be considered
when making funding decisions:  quality of the proposed project as
determined by peer review, program balance among research areas of
the program announcement, availability of funds.
 
INQUIRIES
 
Written and telephone inquiries are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is welcome.
 
Direct inquiries regarding programmatic (eligibility and
responsiveness) issues to:
 
Stephanie L. James, Ph.D.
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Solar Building, Room 3A-10
6003 Executive Boulevard MSC 7630
Bethesda, MD  20892-7630
Telephone:  (301) 496-2544
FAX:  (301) 402-0659
Email:  sj13y@nih.gov
 
Direct inquiries regarding fiscal matters to:
 
Todd Ball
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4B-35
6003 Executive Boulevard MSC 7610
Bethesda, MD  20892-7610
Telephone:  (301) 496-7075
FAX:  (301) 480-3780
Email:  tb22j@nih.gov
 
RO3 APPLICANTS ONLY:  Inquiries regarding review issues, requests for
the special instructions for application preparation, two copies of
the application and all five sets of any appendices may be directed
to:
 
Olivia Preble, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4C-19
6003 Executive Boulevard MSC 7610
Bethesda, MD  20892
Telephone:  (301) 496-8208
FAX:  (301) 402-2638
Email:  op2t@nih.gov
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance No. 93.856, Microbiology and Infectious Disease 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 grants policies and
Federal Regulations 42 CFR 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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