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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