Full Text AI-92-09 RESEARCH ON MOLECULAR IMMUNOLOGY OF SEXUALLY TRANSMITTED DISEASES NIH GUIDE, Volume 21, Number 19, May 22, 1992 RFA: AI-92-09 P.T. 34 Keywords: Immunology Sexually Transmitted Diseases Biology, Molecular National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: August 7, 1992 Application Receipt Date: November 18, 1992 PURPOSE The Sexually Transmitted Diseases Branch of the Division of Microbiology and Infectious Diseases (DMID) of the National Institute of Allergy and Infectious Diseases (NIAID) invites grant applications for program project grants to conduct basic research on the molecular nature of the human immune response to sexually transmitted diseases (STDs). The NIAID wishes to expand research in this area to develop molecular strategies to prevent infection, transmission, disease, and disease progression by immunization. Of particular interest is the integration of the disciplines of immunology and microbiology leading to productive interdisciplinary approaches that elucidate the basis of protective immunity to sexually transmitted infections. 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 Request for Applications (RFA), Research on Molecular Immunology of Sexually Transmitted Diseases, is related to the priority area of sexually transmitted diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-10473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic non-profit and for-profit research institutions; public and private organizations such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT Successful applicants funded under this RFA will be supported through a National Institutes of Health (NIH) program project grant (P01). This type of funding mechanism is utilized to encourage interdisciplinary investigator-initiated research designed to elucidate various aspects or components of a central research objective, in areas of high priority to the NIAID. This RFA solicitation represents a single competition with a specified deadline for receipt of applications. Although there are no present plans to reissue this RFA at any future time, the NIAID may invite competitive renewal applications upon expiration of the initial funding period, contingent upon the availability of funds for this purpose. If the NIAID does not solicit competitive renewal of the program project, the participating project Principal Investigators should consider the submission of discrete but interactive R01s sharing a common theme. FUNDS AVAILABLE The NIAID anticipates making two program project grant awards as a result of this RFA. The final number of awards to be made is dependent upon the availability of funds. The budget request for the initial year's total costs (direct and indirect) may not exceed $1 million for each application. Applicants may request budgets of up to five years of support. Although the current NIAID policy is to limit the duration of program projects to four years, it is possible that the duration may be extended. The earliest possible award date is July 1993. Funding beyond the first and subsequent years of the award will be contingent upon satisfactory progress during the preceding years and upon availability of funds. RESEARCH OBJECTIVES Background Despite control efforts to prevent spread of STDs, including human immunodeficiency virus (HIV) infection, both bacterial and viral STDs remain epidemic in many areas of the United States. Current estimates predict that in 1992 there will be 10 to 13 million new cases of STDs. Related health care costs are likely to exceed $5 billion. Although curative therapy is available for some of these acute infections, many individuals go on to develop serious complications and chronic disease. Furthermore, sexually transmitted infections have also been implicated in increased risk of HIV transmission. Recent studies indicate that the more prevalent non-ulcerative STDs, as well as ulcerative diseases, increase the risk of HIV transmission at least three to five-fold. Three strategies are central to the prevention and control of STDs: diagnosis and treatment, behavioral intervention, and vaccination. Since each of these strategies has limitations both in efficacy and implementation, a comprehensive control program utilizing all three components is necessary. Vaccines are strategically important for preventing both viral diseases for which there is no curative treatment and bacterial diseases for which antibiotic resistance is common or for which symptoms are so indolent that the patient neither seeks nor receives effective therapy. Most desirable are vaccines that prevent infection; however, vaccines may play a critical role in reducing transmission, ameliorating disease, or interrupting disease progression. Unfortunately, except for Hepatitis B, there are no vaccines for STDs. STD vaccine development is extremely difficult and complex for reasons related primarily to (1) the nature of the host-pathogen relationship, and (2) the consequences of co-infection with more than one sexually transmitted pathogen. As obligate pathogens of humans, the etiologic agents of these diseases have evolved to effectively avoid, subvert, or ignore the immunodominant host response through strategies including: o phase variation: the ability to turn on and off the synthesis of a surface component/antigen; o antigenic variation: the ability to synthesize a particular antigen from a large repertoire of antigenic types; o surface microheterogeneity: the ability to vary surface immuno- accessibility of antigens among organisms within a population, e.g., the sporadic distribution of the H.8 antigen on gonococci within a single bacterial colony or within microcolonies in urethral exudate; o elicitation of immunodominant responses that are not protective: the ability to present surface antigens that do not result in protective immunity. Instead, the immune response often results in avoidance or subversion of host defenses. For example, the generation of blocking antibodies during gonococcal infection, or the generation of detrimental humoral or cellular responses to heat shock protein during chlamydial infection. Furthermore, the presence of several infections in the reproductive tract is likely to complicate vaccine development as pre-existing STDs compromise epithelial barriers through tissue fragility, induction of inflammatory cytokines, and the recruitment of target cells, such as lymphocytes (in the case of HIV), thereby lowering the infectious dose and compromising vaccine efficacy. Programmatic Interests and Requirements for ROMIS Program Projects Research Objectives A fundamental objective of the Institute's STD research program is to develop vaccines effective in preventing and controlling STDs. This requires focused interdisciplinary research to create effective molecular level strategies for eliciting protective immunity. "Molecular" is used here in the broadest sense to mean the interaction between molecules of the pathogen and the host; this is not limited to molecular genetics. Research Scope A wide range of research questions must be answered in order to meet this programmatic objective. Research issues and areas of high priority to the NIAID and to this RFA include, but are not limited to, the following: 1. Molecular specificity and function of immune responses What is the function of the immune response to infection? Does protective immunity occur as the result of infection? Since the surface of any given pathogen is a mosaic of antigens, and any given antigen is a mosaic of epitopes, it is essential to separate and characterize the specificity of protective and non-protective humoral and cellular immune responses occurring in sexually transmitted infections. 2. Immunity of the reproductive tract How can protective immunity be induced in the reproductive tract? Given that protection against infection is absolutely dependent upon functional (i.e., protective), neutralizing antibodies at mucosal surfaces, the phenotype (including isotype), source, and specificity of these antibodies must be described. The role of CD4, CD8, and CD16 cells as well as other effector cells in protective immunity must be elucidated. Can humoral and/or cellular immunity be induced that offers partial protection, i.e., reduces transmission, ameliorates disease, or prevents disease progression? What are the kinetic parameters of protective immune responses and how can protective immunity be enhanced both in terms of efficacy and longevity? It is necessary to characterize and compare protective immunity stimulated by direct inoculation of regional mucosal surfaces, other mucosal surfaces (e.g., oral), and parenteral routes. The role of cellular immunity in this process must be delineated. What are the differences between the immune responses of the male and female reproductive tract? How do reproductive hormones influence infectivity and the host response to infection? What is the role of regional immunity in prevention or manifestation of sexually transmitted infections? Currently, little is known about the immunology of the female reproductive tract, and even less is known about the male reproductive tract. Does partial immunity play a role in asymptomatic disease, and if so, can this be correlated with the higher prevalence of silent infections in women compared to men? 3. Diseases of interest Applicants are strongly encouraged to submit research projects that address the following diseases of high scientific priority to the NIAID and to this RFA: Chlamydial infection and gonorrhea: As etiologic agents of PID, development of vaccines for chlamydial infection and gonorrhea are of the highest priority. This urgency is in recognition of the high rates of morbidity and the significant socio-economic costs associated with pelvic inflammatory disease (PID). Special emphasis is placed on chlamydial infections because they are often silent in women and chlamydial PID more often results in tubal scarring and related complications. Human papillomavirus infection: The development of vaccines for the relatively limited number of sexually transmitted HPV types associated with progression to serious disease, (e.g., types 16, 18, 31, and 33), is a priority because of the widespread prevalence and marked increase of HPV-related disease in the last decade. Syphilis: Of all the STDs, syphilis should be one of the easiest to control because the cases are clustered, and good diagnostic tests as well as effective treatments are available. However, the epidemic of the eighties underscores the need to develop effective vaccines and behavioral interventions. The epidemiology of syphilis suggests that protective immunity does occur, although the specific mechanisms are unknown. Furthermore, there is evidence to suggest that the immune system also plays a significant role in the pathogenesis of syphilis; additional research must be conducted to delineate the role of the immune response in this disease. Genital Herpes: Human studies involving three different herpes vaccines suggest that it may be possible to ameliorate disease frequency and severity through vaccination. Special emphasis should be placed on delineating the role of the immune system in preventing primary infection, preventing the establishment of latency, and preventing transmission to neonates. 4. Emphasis on populations at risk - women, minorities and adolescents Applicants are strongly encouraged to characterize the immune response in women both because of the gaps in our understandings of the female reproductive tract and because of the disproportionate burden of STD morbidity (e.g., infertility, ectopic pregnancy, cervical cancer, fetal wastage, low birth weight, and congenital/perinatal infection) that is borne by women and their perinatally infected children. Additionally, STDs greatly impact the health of minority populations and youth in the United States. Both the incidence of STDs and the incidence of the long-term and potentially fatal sequelae are consistently higher among African and Hispanic Americans than among white Americans. Moreover, numerous epidemiological studies have documented high prevalence of STDs and STD sequelae in youth -- of the projected 10 to 13 million cases of STDs occurring this year, 63 percent are expected to occur in people younger than 25 years old. For these reasons, applicants are strongly encouraged to study STDs in populations that are at greatest risk; these populations include women, inner city minorities, adolescents, and infants. SPECIAL REQUIREMENTS To facilitate effective research approaches to further the understanding of protective immunity leading to vaccine development, specific application requirements and constraints for structuring Research on Molecular Immunology of Sexually Transmitted Diseases (ROMIS) program projects are as follows: 1. Collaborative interdisciplinary approach Because one of the primary objectives of this RFA is to stimulate collaboration between microbiologists and immunologists, each proposed project must combine microbiological and immunological approaches. Microbiological disciplines to be drawn from include bacteriology, parasitology, and/or virology. 2. Central focus on human immune response Because virtually all STD pathogens are obligate pathogens of a single host (human beings), and because our understanding of the specific nature of the relationship of these microbes with their human host is incomplete, the central focus of all ROMIS program projects must be study of the human immune response to sexually transmitted infections. 3. Clinical Facility and Study Population The program project must have a strong clinical facility with an accessible patient population that is appropriate to answering STD research questions. This population must be characterized with respect to other sexually transmitted pathogens including, but not limited to, Chlamydia trachomatis, Neisseria gonorrhoeae, Treponema palladium, HPV, HSV, and HIV. Costs for establishing and/or maintaining the study population should be included as a separate clinical core within the proposed budget. 4. Required number of diseases or syndromes Research may be designed to focus on several STD pathogens, or may focus entirely on a single STD pathogen. Interdisciplinary study of several pathogens presents opportunities to design projects that reflect the high frequency of co-infection within patient populations as well as the potential to understand the interactive nature of co- infections in the context of immune response. It is also recognized, however, that interdisciplinary, in-depth study of a single pathogen may provide unique opportunities for accelerated advances in scientific understanding of immune function. Therefore, the number of pathogens proposed for study is less important than the quality of the science that is proposed within applications. 5. Study of HIV HIV is not a pathogen of interest under this RFA, although study of the natural history of STDs in an HIV-positive population is permissible if the emphasis is on the role of the altered immune system on the course of the STD(s) under investigation. 6. Epidemiological and Biostatistical Aspects of Study Design Detailed description of the epidemiological characteristics of the study population including demographics and relevant clinical profiles is necessary. Statistical power considerations and data analysis plans should be detailed. The use of multivariate techniques to look at independent variables such as race and gender, controlling for possible confounders and considering possible interaction with other factors, is encouraged. 7. Structure of Program Projects The required structure and format of P01 applications is found in the NIAID Program Projects and Center Grants Brochure that is available from Dr. Olivia Preble at the address listed under "LETTER OF INTENT". Number and Emphasis of Projects: ALL PROGRAM PROJECT APPLICATIONS MUST INCLUDE AT LEAST THREE RESEARCH PROJECTS (see AWARD CRITERIA for further clarification.) At a minimum, two of these projects, and preferably three, must involve the study of some aspect of the humoral or cellular immune response in humans. It is permissible for the third project (or additional projects) to involve study of relevant STD animal models; however, emphasis on comparison to the human immune response is encouraged. Role of Program Director and Organization of Projects: The Director of the Program Project will be responsible for the overall direction and administration of the total program project. It is the Program Project Director's responsibility to promote effective coordination and strong interaction among the research staff of individual projects. Each project should have clearly defined research objectives, a separately identifiable budget, and a research staff headed by a project leader. It is the primary responsibility of the project leader to clearly state the objectives and approaches of the project, 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. 8. Allowable Costs Award funds may be utilized to support the following research-related activities: Scientific and Professional Personnel Costs: The requested percentage of an individual's salary may not exceed the percentage of effort devoted specifically to activities associated with the ROMIS program project grant. Information substantiating this level of effort must be included in the application. Administrative Costs: This category includes the costs necessary for the central administration and fiscal management of the program project, such as salaries of the Chief Administrator and secretarial support. Those costs may not duplicate or replace costs included in the institution's indirect cost base. Shared Research Resources (Cores): Shared Research Resources or cores must serve at least two research projects. The ROMIS program project grant may include core funds for equipment, supplies, and services to expand and/or maintain clinical, laboratory, or biostatistical facilities. Study Population Costs: The costs necessary for establishing, characterizing and/or maintaining a study population appropriate for answering the proposed STD research questions should be requested as clinical core funding. This clinical core will include monies for clinic personnel, supplies/equipment, study-related patient care, patient reimbursement and ancillary costs, laboratory-related microbiological, and immunological diagnostic tests and analyses. As with other cores, this shared research resource should serve at least two research projects. Other Costs: In addition to the above categories, budget requests within each project may include research-related costs for supplies, funds for limited investigator travel, and costs of publication. Since the program project cannot provide funds for new construction, adequate physical facilities must be available to meet the primary needs of the project. General Clinical Research Center (GCRC): An applicant whose institution has an NIH-supported GCRC funded by the NIH National Center for Research Resources may wish to utilize the GCRC for conducting the proposed research. In such a case, a letter of agreement from either the GCRC program director or Principal Investigator must be included with the application. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues must be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 under Research Plan items 1-4 and item 5 - Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations [i.e., Native Americans (including American Indians or Alaskan Natives], Asian and Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups must be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. (For further specifics see "Research Scope" item 4 -- Populations at Risk) LETTER OF INTENT Prospective applicants are asked to submit, by August 7, 1992, a letter of intent that includes a descriptive title of the overall proposed research program and the name, address, and telephone number of the Principal Investigator, the names of the proposed project leaders and other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. The letter of intent is requested in order to provide an indication of the number and scope of applications to be reviewed. The letter of intent is not binding, does not commit the sender to submit an application, nor is it a requirement for submission of an application. The letter of intent is to be sent to: Dr. Olivia Preble Chief, Microbiology and Immunology Review Section Scientific Review Branch Division of Extramural Activities National Institute of Allergy and Infectious Diseases 9000 Rockville Pike Solar Building, Room 4C-20 Bethesda, MD 20892 Telephone: (301) 496-8208 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these program project grant awards. These forms are available at most institutional business offices and the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301-496-7441. Before preparing the application, the brochure entitled "Information Brochure on NIAID Program Projects and Center Grants" should be carefully read. It contains instructions on formatting program project applications, review criteria, and other useful information. Requests for the brochure and questions concerning instructions are to be addressed to Dr. Olivia Preble at the address indicated above. The RFA label available in the PHS 398 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, "Research on the Molecular Immunology of Sexually Transmitted Diseases, RFA AI-92-09" 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 Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies must also be sent directly to: Dr. Olivia Preble Chief, Microbiology and Immunology Review Section Scientific Review Branch Division of Extramural Affairs National Institute of Allergy and Infectious Diseases 9000 Rockville Pike Solar Building, Room 4C-20 Bethesda, MD 20892 The address for use with OVERNIGHT MAIL, EXPRESS, OR COURIER SERVICE to Dr. Preble, is 6003 Executive Blvd., Room 4C-20, Rockville, MD 20852. Applications must be received by both the Division of Research Grants (DRG) and Dr. Preble by November 18, 1992. Applications received after November 18, 1992 will be returned to the applicant without review. The DRG will not accept any application in response to this announcement that is the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. Nor does it preclude the concurrent submission of component projects as independent R01s; however, should both the P01 and the R01 applications be recommended for funding, the R01 must be relinquished in favor of the P01, to preserve the latter's strength and integrity. THE COPIES OF THE APPLICATION WHICH ARE SENT TO DRG MUST BE RECEIVED AS A SINGLE PACKAGE FROM THE PRINCIPAL INVESTIGATOR AND CONFORM TO THE INSTRUCTIONS CONTAINED IN THE PHS 398 (rev. 9/91) APPLICATION KIT. OTHERWISE, THE APPLICATION WILL BE CONSIDERED INCOMPLETE AND WILL BE RETURNED TO THE APPLICANT. REVIEW CONSIDERATIONS Applications will be received and reviewed for completeness by DRG. Incomplete applications will be returned to the applicant without review. Applications will be reviewed by NIAID staff to determine administrative and programmatic responsiveness to this RFA; those judged to be non-responsive will be returned to the applicant without review. Those applications considered responsive to the RFA may be subjected to a triage review by an NIAID peer review group, before or during the initial review committee meeting, to determine the scientific merit relative to the other applications submitted in response to the RFA. The NIAID will withdraw from further competition those applications judged by the triage peer review group to be non-competitive for award, and will notify the Principal Investigator and institutional official. Those applications judged to be competitive will be reviewed for scientific and technical merit by a review committee convened by the NIAID in March 1993. The second level of review will be provided by the National Advisory Allergy and Infectious Diseases Council in May 1993. The earliest award date is July 1993. Summary of Application Requirements: General Review Considerations EACH PROGRAM PROJECT APPLICATION MUST CONTAIN AT LEAST THREE RESEARCH PROJECTS. It should be emphasized that for a program project application to be considered for funding, NIH requires a minimum of THREE research projects in that application to have been judged by the peer review group as having "significant and substantial merit." Each individual research project must be scientifically meritorious in its own right and must also demonstrate the essential elements of unity of theme, interdependence, and synergy. A project intended primarily to establish, characterize, and maintain the study population will not be considered a research project, and funds to support such activity should be requested in the "Core." Particular attention must be given to the following areas when preparing applications: 1. The detailed description of each research project should demonstrate how it contributes to the attainment of the program project objectives. Furthermore, in addressing the organization and administrative structure of the program project grant, the mutually reinforcing inter-relationships among the investigators must be clearly described. This section must include an organizational chart showing the name, the organization, and the scientific discipline of the Principal Investigator, the Project Leaders, and the key personnel for the projects and cores. 2. In describing the clinical and laboratory facilities available to conduct each project, specific information should be included on the institution's present STD patient load and projections for patient involvement, diagnostic laboratory capabilities, and on the availability of appropriate biohazard facilities and safety procedures. 3. Included in information under the "Other Support" section must be an explicit written plan that explains how applicant Principal Investigators who also hold Principal Investigator status on other grants and contracts from any source (particularly on Center, Training, or other program project grants) will be able to successfully and fully meet the responsibilities demanded by all endeavors. 4. The application must include a signed letter of agreement from each collaborator and/or consultant to the program project indicating (1) willingness to participate in the program, and (2) the exact nature of the participation. In addition, a letter co-signed by the Principal Investigator, the Institution's Budget Official, and the Dean must detail a specific plan by which indirect costs and/or shared resources will be distributed to institutions collaborating with the awardee institution. 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 GCRC as a resource for conducting the proposed research. In such a case, a letter of agreement from either the GCRC program director or Principal Investigator must be included with the application. Summary of Application Requirements: Specific Review Considerations In addition to the minimum requirements for applications stated above, applications must satisfy the specific programmatic requirements that are summarized below. These requirements appear in greater detail in the "PROGRAMMATIC INTERESTS AND REQUIREMENTS FOR ROMIS PROGRAM PROJECTS" section, and applicants are urged to review this section. 1. Collaborative interdisciplinary approach: Each proposed project must combine microbiological and immunological approaches. 2. Central focus on human immune response: Minimally two, and preferably three, of the proposed projects must involve the study of some aspect of the human humoral or cellular immune response to sexually transmitted infections. 3. Clinical facility and study population: All ROMIS program project applications must have a strong clinical facility with an accessible patient population appropriate to answer STD research questions. Characterization of the patients must include a microbiological evaluation of sexually transmitted infections, including, but not limited to, Chlamydia trachomatis, Neisseria gonorrhoeae, Treponema palladium, HPV, HSV, and HIV. 4. Study design: Study design must reflect epidemiological/biostatistical expertise including statistical power considerations and data analysis. Applicants are strongly encouraged to consider the following within ROMIS program project applications: 1. Diseases of interest: Chlamydial infection, gonorrhea, HPV, syphilis, and HSV. HIV is not a pathogen of interest under this RFA unless the emphasis is on the role of the altered immune system on the course of the STD(s) under investigation. 2. Populations at risk: Special emphasis should be placed on studying STDs in populations that are disproportionately affected: women, inner city minorities, adolescents, and infants. AWARD CRITERIA Scientific merit and technical proficiency, based on the demonstrated and projected capabilities described in the application in response to the RFA, will be the predominant criteria for determining funding priorities. It should be emphasized that NIH policy limits consideration of funding of program projects to those with no less than three research projects that have been judged by a peer review group to have "significant and substantial" merit. After applications have been reviewed by the National Advisory Allergy and Infectious Diseases Council, NIAID staff reserves the right to give consideration to the following additional factors in the final selection of applications to be funded: pathogen(s) that are proposed for study; the potential impact on health of women, minorities, and adolescents; and geographic distribution of the awards. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcomed. Investigators seeking information about programmatic issues may contact: Dr. Penelope J. Hitchcock Acting Chief, Sexually Transmitted Diseases Branch Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases 9000 Rockville Pike Solar Building, Room 3A-21 Bethesda, MD 20892 Telephone: (301) 402-0443 Questions regarding fiscal matters may be addressed to: Mr. Todd Ball Grants Management Branch National Institute of Allergy and Infectious Diseases 9000 Rockville Pike Solar Building, Room 4B-22 Bethesda, MD 20892 Telephone: (301) 496-7075 Questions regarding review policies and procedures may be addressed to Dr. Olivia Preble at the address and telephone number given in the LETTER OF INTENT. 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. .
Return to NIH Guide Main Index
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
||||||||
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files. |