RESPIRATORY PATHOGENS: SPECIFIC RESEARCH NEEDS

NIH Guide, Volume 26, Number 33, October 3, 1997

PA NUMBER:  PA-97-111

National Institute of Allergy and Infectious Diseases
National Heart, Lung, and Blood Institute
National Institute on Deafness and Other Communication Disorders

PURPOSE

The National Institute of Allergy and Infectious Diseases (NIAID), the National
Heart, Lung, and Blood Institute (NHLBI), and the National Institute on Deafness
and Other Communication Disorders (NIDCD), National Institutes of Health (NIH),
invite applications for research issues of importance, opportunity and need in
understanding selected respiratory pathogens and host responses to these
pathogens. The purpose of this omnibus solicitation is to alert the extramural
research community to areas of need and importance to the mission of the
Respiratory Diseases Branch, NIAID, the Division of Lung Diseases, NHLBI, and the
Division of Human Communication, NIDCD.  Projects aimed at stimulating basic and
applied research that may lead to more effective and accepted prophylactic and
therapeutic approaches for controlling severe respiratory infections will be
considered.  Applications on measles will not be considered responsive to this
PA since other NIAID initiatives have been issued recently to support research
in this area.

Applications submitted in response to Program Announcements are assigned
according to established PHS referral guidelines.  When the subject of an
application is of interest to more than one component of NIH, dual assignments
are made.

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 PA, RESPIRATORY PATHOGENS: SPECIFIC
RESEARCH NEEDS, 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 202-512-1800).

ELIGIBILITY

Applications may be submitted by 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. 
Domestic and foreign institutions are eligible to apply for R01 grants.  Foreign
institutions are not eligible for FIRST awards (R29).  Racial/ethnic minority
individuals, women, and persons with disabilities are encouraged to apply as
Principal Investigators.

MECHANISM OF SUPPORT

Traditional research project grant (R01) and FIRST award (R29) applications may
be submitted in response to this program announcement.  Applications for R01
grants may request up to five years of support; applications for R29 grants must
request five years of support.

Responsibility for the planning, direction, and execution of the proposed
research for all applicable mechanisms of support will be solely that of the
applicant.

RESEARCH OBJECTIVES

Background

Respiratory infections caused by viruses and bacteria are the major causes of
acute illnesses in the United States and among infectious diseases, a major cause
of morbidity and mortality worldwide.  Common examples of severe illnesses
associated with these infections include pneumonia, influenza, otitis media and
meningitis.  Pneumonia affects untold numbers of infants, elderly, chronically
ill and immunocompromised individuals annually.  In children under 5 years of
age, approximately one-half of pneumonia deaths are attributable to bacterial
infections whereas the remainder are associated with viral (such as
parainfluenza, coronavirus and rhinovirus) or mixed viral and bacterial
infections.  In elderly and immunocompromised individuals, there is increasing
evidence that viral pneumonia is under-diagnosed and responsible for significant
morbidity and mortality.  Influenza-related pneumonia remains the primary cause
of infectious disease-related deaths, in the United States, and represents the
fourth leading cause of death in the elderly.  Otitis media is caused by a
variety of bacterial and viral etiologic agents, which, in addition to
significantly impacting on health care costs, cause substantial morbidity and
long-term effects on speech and language development in children.  Infections
with bacterial respiratory pathogens also cause meningitis and other serious and
fatal invasive diseases.

Research Objectives and Scope

A major goal of the Respiratory Diseases Program, NIAID, is to stimulate and
support research that may lead to more effective and accepted prophylactic and
therapeutic approaches for controlling severe respiratory infections in infants
as well as adults.  Related research supported by the Division of Lung Diseases,
NHLBI, focuses on lung specific responses and interactions with pathogens, for
example the role of surfactant and lung defensins in the lung host defenses
against respiratory infections and delineating the interactions between lung
cells and pathogens including events leading to granuloma formation. These
programs contribute to the goal of controlling respiratory infections through a
better understanding of the mechanisms of the disease.  Although accomplishments
in this field are many, there still remains significant gaps.  The intent of this
Program Announcement is to define these gaps and solicit interest in the research
community to develop  research applications within these areas.  Specifically,
this PA is focused on research areas and on certain organisms which are presently
underrepresented in our research portfolios.  Specific areas of interest are:

I.   Evaluation of the unique immunogenic and pathogenic mechanisms associated
with virulence and determination of the role and molecular regulation of
virulence factors for Mycoplasma pneumoniae, Burkholderia(Pseudomonas) cepacia
and Chlamydia pneumoniae;

II.  Isolation and functional characterization of novel structural and secretory
proteins (e.g. adhesins, cytolysins, & microbial immunomodulators) of human
bacterial respiratory pathogens and novel host defense molecules (e.g. defensins)
released in response to bacterial respiratory infections;

III. Characterization of events (in cellular and molecular detail) that are
associated with carriage of meningococci and pneumococci and those events that
lead to invasion;

IV. Determination and characterization of factors (host and viral) involved in
the  progression to lower tract disease and/or complications due to infections
with respiratory viruses other than influenza;

V. Development of new and innovative vaccine approaches for: parainfluenza
viruses, Neisseria meningitidis group B, Pseudomonas aeruginosa(other than
polysaccharide antigens), Mycoplasma pneumoniae, Chlamydia pneumoniae, and
Moraxella catarrhalis. 

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 new 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 reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of
March 18, 1994, Volume 23, Number 11.

Investigators may obtain copies from these sources or from the program staff
listed under INQUIRIES.  Program staff may also provide additional relevant
information concerning the policy.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application for PHS 398 (rev. 5/95)
and will be accepted on the standard application deadlines as indicated on the
application kit.

Application kits are available at most institutional offices of sponsored
research and may be obtained from the Division of Extramural Outreach and
Information, National Institutes of Health, 6701 Rockledge Drive, MSC 7910,
Bethesda, MD 20892-7910, telephone (301) 710-0267, email: asknih@od.nih.gov.

For purposes of identification and processing, item 2 on the face page of the
application must be marked "YES".  The PA number and the PA title must also be
typed in section 2.

The completed, signed original and five legible, single-sided copies of the
application must be sent or delivered to:

CENTER FOR SCIENTIFIC REVIEW
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) award 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 REQUESTING $500,000 OR MORE IN ANNUAL DIRECT COSTS.  The NIH Policy
Update on Acceptance for Review of Unsolicited Applications that Request More
Than $500,000 Direct Cost for Any One Year applies to applications in response
to this PA.  The Policy Update was published in the NIH Guide for Grants and
Contracts, Volume 25, No. 14, May 3, 1996, and became effective June 1, 1996.

Applicants from institutions that have a General Clinical Research Centers (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

Review Procedures

Applications will be assigned on the basis of established PHS referral
guidelines.  Upon receipt, applications will be reviewed for completeness by the
NIH Division of Research Grants.  Incomplete applications will be returned to the
applicant without further consideration.

Applications will be reviewed for scientific and technical merit by study
sections of the Division of Research Grants, NIH, 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 the applications under review, will be discussed, assigned a priority
score, and receive a second level review by the appropriate national advisory
council.

Review Criteria

The five criteria to be used in the evaluation of grant applications are listed
below.  To put those criteria in context, the following information is contained
in instructions to the peer reviewers.

The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.  The
reviewers will comment on the following aspects of the application in their
written critiques in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals.  Each of these
criteria will be addressed and considered by the reviewers in assigning the
overall score weighting them as appropriate for each application.  Note that the
application does not need to be strong in all categories to be judged likely to
have a major scientific impact and thus deserve a high priority score.  For
example, an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.

1.  Significance.  Does this study address an important problem? If the aims of
the application are achieved, how will scientific knowledge be advanced?  What
will be the effect of these studies on the concepts or methods that drive this
field?

2.  Approach.  Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of the
project?  Does the applicant acknowledge potential problem areas and consider
alternative tactics? 

3.  Innovation.  Does the project employ novel concepts, approaches or method? 
Are the aims original and innovative? Does the project challenge existing
paradigms or develop new methodologies or technologies? 

4.  Investigator.  Is the investigator appropriately trained and well suited to
carry out this work?  Is the work proposed appropriate to the experience level
of the principal investigator and other researchers (if any)?

5.  Environment.  Does the scientific environment in which the work will be done
contribute to the probability of success?  Do the proposed experiments take
advantage of unique features of the scientific environment or employ useful
collaborative arrangements?  Is there evidence of institutional support?

The initial review group will also examine: the appropriateness of proposed
project budget and duration; the adequacy of plans to include both genders and
minorities and their subgroups as appropriate for the scientific goals of the
research and plans for the recruitment and retention of subjects; 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 announcement, and availability of funds.

INQUIRIES

Written and telephone inquiries are encouraged.  The opportunity to clarify any
issues or questions from potential applicants including the availability of other
mechanisms of support is welcome.

Inquiries regarding programmatic (research scope and eligibility) issues may be
directed to:

Christopher E. Taylor, Sc.D.
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Solar Building, Room 3B01
6003 Executive Blvd., MSC 7630
Bethesda, MD 20892-7630
Telephone: (301)-496-5305
FAX:       (301)-496-8030
Email:      ct18m@nih.gov

Hannah H. Peavy, M.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Suite 10018, MSC 7952
Bethesda, MD 20892-7952
Telephone: (301)-435-0222
FAX:       (301)-480-3557
Email:      hannah_peavy@nih.gov

Kenneth A. Gruber, Ph.D.
Division of Human Communication
National Institute on Deafness and Other Communication Disorders
Executive Plaza South Bldg., Room 400C
6120 Executive Boulevard MSC 7180
Bethesda, MD 20892-7180
Telephone: (301)402-3458
FAX:       (301)402-6251
Email:     Kenneth_gruber@nih.gov

Direct inquiries regarding fiscal matters to:

Todd Ball
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4B35
6003 Executive Blvd.
Bethesda, MD 20892-7610
Telephone: (301) 492-5512
Fax:       (301) 480-3780
Email:      tb22j@nih.gov

Raymond L. Zimmerman
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7150, MSC 7926
Bethesda, MD 20892-7926
Telephone: (301)-435-0171
FAX:       (301)-480-3310
Email:      raymond_zimmerman@nih.gov

Sharon Hunt
Grants Management Officer
National Institute on Deafness and Other Communication Disorders
Executive Plaza South Bldg., Room 400B
6120 Executive Boulevard MSC 7180
Bethesda, MD 20892-7180
Telephone: (301)402-6251
FAX:       (301)402-1758
Email      Hunts@nih.gov

AUTHORITY AND REGULATIONS

This program is supported under authorization of the Public Health Service Act,
Sec. 301(c), Public Law 78-410, as amended for NIAID, and Title IV, Part A
(Public Law 78-410) amended by Public Law 99-158, USC 241 and 285 for NIDCD, and
NHLBI. The Catalogue of Federal Domestic Assistance Citation is (No. 93.855 -
Immunology, Allergy, and Transplantation Research [or] No. 93.856 - Microbiology
and Infectious Disease Research, 93.173 - Research Related to Deafness and
Communications Disorders or 93.838 - Lung Diseases Research).

Awards will be administered under PHS grants policies and Federal Regulations 24
CFR Part 52 and 45 CFR Part 74, for NIAID, 42 CFR Part 52 and 45 CFR Part 74 for
NIDCD and NHLBI. This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems 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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