Full Text AI-97-003 ADOLESCENTS AND STD COOPERATIVE RESEARCH CENTER NIH Guide, Volume 26, Number 29, August 29, 1997 RFA: AI-97-003 P.T. Keywords: National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: October 15, 1997 Application Receipt Date: January 8, 1998 PURPOSE The purpose of this Request for Applications (RFA) is to stimulate multi-disciplinary, collaborative research to further understanding of sexually transmitted diseases (STDs) in adolescent populations and to develop and evaluate effective approaches to their prevention and control. 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 an Adolescents and Sexually Transmitted Diseases Cooperative Research Center (STD CRC). The STD CRC will provide a multi- disciplinary approach to STD research by bridging biomedical, clinical, behavioral, and epidemiological research; will foster interaction among STD investigators; and will facilitate intervention-oriented research. 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 RFA, Adolescents and Sexually Transmitted Diseases Cooperative Research Center (STD CRC), is related to the priority areas of STDs and AIDS. 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 REQUIREMENTS Applications will be limited to domestic institutions but may include an international component. Applications may be submitted by domestic for-profit and non-profit research institutions; public and private organizations, such as universities, colleges, hospitals, laboratories, units of State or local governments; and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT The administrative and funding mechanism to be used to undertake this program will be the Cooperative Agreement (U19), an "assistance" mechanism, rather than an "acquisition" mechanism, in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships, and governance of the study funded under cooperative agreement(s) are discussed later in this document under the section Terms and Conditions of Award. The total requested project period for applications submitted in response to this RFA may not exceed 5 years. At this time, the NIAID has not determined whether and how this solicitation will be continued beyond the present RFA. The anticipated award date is August 1, 1998. FUNDS AVAILABLE The estimated total funds (direct and indirect costs) available for the first year of support for awards under this RFA will be $1.2 million. In Fiscal Year 1998, the NIAID plans to fund one Adolescents and STD CRC. The final number of awards to be made is dependent upon the availability of funds. The initial year's total costs, including direct and indirect costs, should not exceed $1.2 million for each award. The usual PHS policies governing grants administration and management will apply. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIAID, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years and availability of funds. RESEARCH OBJECTIVES Background In 1995, an estimated 14 million cases of STDs occurred in the United States. Approximately 65% occurred in people under 24 years of age; three million occurred in teenagers. Associated health care costs exceeded $ 8 billion. Because of infections acquired during adolescence, women and their infants bear a disproportionate share of disease burden and long term sequelae of STDs, including infertility, ectopic pregnancy, cervical cancer , fetal wastage, low birth weight, and congenital/perinatal infection. Additionally, STDs disproportionately impact the health of some minority populations. Both the incidence of STDs and their long-term and potentially fatal sequelae are consistently higher among African and Hispanic Americans than among white Americans. o Chlamydial infection is the most prevalent bacterial STD in the U.S. and a major cause of pelvic inflammatory disease (PID); over four million cases are diagnosed annually. In virtually all studies, adolescents appear to have greater risk for infection compared to older women. Cross-sectional studies and data collected from adolescent and family planning clinics have documented that adolescents 15-19 years have the highest rates of infection irrespective of socioeconomic status. Due to delays in diagnosis or inadequate therapy, 10 to 40 percent of these young women with chlamydial cervicitis develop PID. o Gonorrhea, the other major cause of PID, occurs at an annual rate of approximately 0.5 million new cases, 25 percent of which occur in teenagers. Although rates of infection have been steadily decreasing in the last decade, gonorrhea rates have declined slowly in adolescent populations compared to older age groups. o During the 1980s, the rate of syphilis increased in African- American adolescent males and females. Congenital syphilis rates were particularly high among pregnant adolescent women because perinatal care is less frequent in younger women. o Trichomoniasis affects over three million American women; in the US and throughout the world, it is not uncommon to find 25% of these infections in adolescents. o In the U.S., as many as 40 million people are believed to be infected with human papillomavirus (HPV). High-risk HPV types are causally associated with cervical cancer. Globally, cervical cancer is the most common cause of cancer-related death in women. In one study, the incidence rate for HPV infection in college-aged women during their first year of sexual activity with a single partner was 25%. Another study of female college students found a 50% prevalence of the young women had HPV infection. o Approximately 65 million Americans are afflicted with genital herpes, caused by herpes simplex viruses 1 & 2 (HSV). Genital herpes is a painful, recurrent, incurable disease with annual costs estimated to exceed $96 million. Serological evidence of genital herpes infection suggests that rates increase rapidly during adolescence. Estimated annual cases of genital herpes in teenagers and young adults in the U.S. increased from 15,000 yearly visits in 1966 to about 100,000 by 1995. o Both ulcerative and non-ulcerative STDs increase the risk of human immunodeficiency virus (HIV) transmission approximately 3-5 fold, independent of the effect of sexual behavior; and HIV infection, which decreases immune function, may alter the natural history and increase the prevalence of some STDs. One in five cases of AIDS is diagnosed in young people 20-29 years of age; given the length of the incubation period between HIV infection and onset of AIDS, virtually all of these people became infected as teenagers. Objectives and Scope In spite of decades of STD prevention and control programs and STD research, rates of infection continue to grow. The alarming dimensions of STDs and related health problems described above point to the need for more effective research that will lead to essential tools for preventing and controlling STDs, especially in adolescent populations. The 1996 report of the Institute of Medicine, "The Hidden Epidemic - Confronting Sexually Transmitted Diseases" identified adolescents as an underserved population that requires special emphasis in both STD research and STD service delivery. The report encourages efforts in prevention that are dependent upon the development of new biomedical tools (vaccines, topical microbicides and diagnostic tests), interventions and paradigms that are likely to be more effective for prevention and control of STDs in adolescent populations. The STD CRCs have been developed as multi-disciplinary research efforts that integrate clinical observations into basic biomedical research; apply the findings of basic research to the development of improved diagnostics, therapeutics, vaccines and topical microbicides; and integrate behavioral and epidemiological research needed to ensure the optimal utilization of these tools. The purpose of this RFA is to stimulate multi-disciplinary, collaborative research to further understanding of STDs in adolescent populations and to develop and evaluate effective approaches to STD prevention and control. The scientific complexity of the STD problems is such that coordinated, multi-disciplinary research is required to solve these problems. This will be accomplished through collaborations among scientists from various disciplines working in the scientific areas of biomedical, clinical, behavioral, and epidemiological research. In this RFA, the term scientific area refers to the four broad categories of investigation: (1) biomedical, (2) clinical, (3) behavioral, and (4) epidemiological research. The term discipline refers to investigators' specialized areas of expertise or training. Some examples of disciplines associated with the four scientific areas include but are not limited to (1) reproductive endocrinology, immunology, virology, and molecular biology; (2) gynecology, infectious diseases, and adolescent medicine; (3) psychology, sociology, and anthropology; (4) epidemiology, biostatistics, and computer modeling. Research on HIV infection is supported by the Division of Acquired Immunodeficiency Syndrome (DAIDS) and is not included in the scope of this RFA except in studies where it is directly linked to research on STDs as risk factors for HIV transmission or in alteration of the natural history of STDs. Applications must include: o at least three research projects: one should be in behavioral or epidemiological research in adolescent populations (of particular interest is research on social networks; and two or more projects that link disciplines within a single scientific area and at least one project that links disciplines in two different areas (disciplines and scientific areas are defined above); o research on two or more STD pathogens or syndromes selected from Diseases, Syndromes, and Areas of Interest listed below; o a strong clinical capability in adolescent medicine (described below) with accessible adolescent populations to participate in the clinical and behavioral/epidemiological research projects; and o provisions for the Principal Investigator of each CRC (also known as the CRC Director) to attend meetings with NIAID staff twice each year and for all CRC Project Leaders to attend CRC workshops twice during the program period. Diseases, Syndromes, and Areas of Interest Applicants are encouraged, but not limited, to consider research projects in the following areas: o Pathogens: Chlamydia trachomatis, Neisseria gonorrhoeae, Haemophilus ducreyi, Treponema pallidum, Trichomonas vaginalis, herpes simplex viruses 1 and 2, and human papillomavirus. In designing specific projects, use of human material to address basic research questions is highly recommended. o Adverse Outcomes of Pregnancy: Research is needed to define the epidemiology, pathogenesis, and immunology of STD-related adverse outcomes of pregnancy in adolescent populations. o Human Papillomavirus Infection: The NIAID's priorities in HPV include research on the epidemiology, natural history, pathogenesis, and immunology of infection , diagnosis and treatment in adolescent populations. o Pelvic Inflammatory Disease (PID): Additional research is needed in a number of areas, including diagnosis, epidemiology, pathogenesis, treatment, and long term sequelae. Of particular interest are age-related host factors that influence disease progression including tubal scarring. o Inter-Relatedness of Sexually Transmitted Infections: Because of the HIV epidemic, it is now recognized that infection with one sexually transmitted infection can alter susceptibility to and natural history of other STDs. Understanding the molecular bases of these interactions is needed, especially those that are age-related. For example, research is needed to examine the role of classical STDs in the acquisition and progression of HIV infection and on the role of HIV in alterations of the natural history, diagnosis, or response to treatment of STDs. One project on HIV infection may be included. o Reproductive Endocrinology: The role of reproductive hormonal changes, both endogenous (puberty) and exogenous, on the biology of susceptibility and resistance to infection is a high priority. o Immunology: Basic immunological research related to vaccine development for any of the pathogens or syndromes listed above is of interest. In order to make critical advances in this area vis a vis adolescent populations, functional collaborations between immunologists and microbiologists focused on the immune response in adolescent populations will be extremely important. Work on non- specific defense mechanisms including the role of defensins, normal flora (lactobacilli), mucus and pH is encouraged, especially in the context of changes associated with puberty and the use of hormonal contraceptives . o Behavioral/Epidemiological Research: Behavioral research is needed to decrease risk-associated behaviors and to increase health behaviors, specifically those related to seeking early diagnosis, treatment, and immunization. Also of interest is research on social networks; special attention should be paid to methods and evaluation outcomes that would be useful in characterizing social networks and in designing interventions for social networks. STD CRCs, because of their multi-disciplinary approach, are in a unique position to assess behavioral measures and evaluate interventions. o Topical Microbicides: Basic biomedical and clinical research leading to topical microbicide development to prevent sexually transmitted infections is needed. Topical microbicides are products for intravaginal use that are microbicidal (virucidal and/or bactericidal) but not necessarily spermicidal; they are used by women to prevent sexually transmitted infections (HIV and other STDs). Examples of such research include, but are not limited to, identifying early events in the infectious process, characterizing vaginal physiology and normal flora in adolescent populations, developing methods to measure and assess clinical significance of vaginal/cervical inflammation and comparing changes induced by microbicides in adolescent versus adult women. Clinical Capability As stated earlier, applications must have a strong clinical capability in adolescent medicine and access to adolescent populations to serve the clinical and behavioral and/or epidemiological research projects. In describing the clinical and laboratory facilities, the application should include specific information on the institution's present patient load, projections for patient involvement in future clinical investigations, history of recruitment of subjects, and disease prevalence as well as on the availability of appropriate biohazard facilities and safety procedures. Optional Developmental Component Applications may include a Developmental Fund Core to provide support for new investigators or pilot projects. Eligible investigators are individuals in the early or mid stages of their career who have NOT held an NIH grant including an R29, RO1, PO1, UO1, any research career or training grant (K or T awards), or any other type of grant or contract with annual direct costs in excess of $37,500 for research in STDs. Potential awardees and specific research projects to be pursued need not be identified in the CRC application. However, the application should include a one page description of the kind of project that might be funded under this mechanism and how it interdigitates with CRC research projects. Approval of the developmental funds portion of the application does not in any way commit the investigators to the execution of the sample project. In addition, the application must provide a description of review process and selection criteria for proposed projects. Budget Issues Budget requests within each project may include research-related costs for supplies, patient involvement and medical care, funds for limited investigator travel, and costs of publication. Proposals for studies that do not receive the majority of funding through the CRC will not be counted as a project. There must be concordance between the science proposed and the budget requested. Furthermore, if additional sources of funding have been identified for a project, then letters documenting a funding commitment must be included in the application. STD CRC award funds may be utilized to support the following research-related activities: o PI Level of Effort: The applicant Principal Investigator (STD CRC Director) must allot 15% of time to the administration of the CRC. If less effort is indicated, justification must be provided, including a written plan explaining how they will be able to successfully and fully meet the responsibilities demanded by these endeavors. Effort on scientific projects would be additional. o Shared Research Resources (Cores): The STD CRC may include funds for equipment, supplies, and services to expand and/or maintain clinical, laboratory, biostatistical, or behavioral facilities shared by research staff from at least two research projects. o Advisory group activities: The STD CRC funds may be used to support activities related to acquiring scientific advise from experts in the field. These advisory groups should be constituted after the grant award has been made and should not be named in the application. o Developmental Funds Core for New Investigators: This optional core sets aside and restricts funds solely to cover salaries and research costs for new investigator or pilot projects. There is no ceiling on the total dollar amount of the developmental funds pool, but once identified as developmental funds these monies constitute a restricted portion of the total CRC budget and will not be available for other CRC activities. The annual total amount for each developmental award may not exceed $40,000 and may be used for salary, technical support, laboratory supplies, and equipment. Supplies and equipment expenditures for each award may not exceed $20,000 annually. Projects and investigators funded under the developmental core may not receive subsequent awards from this pool. The duration of support is limited to three years. If the investigator achieves independent funding through a traditional research grant (R01) or a FIRST (R29) award prior to the end of the developmental award, the award must be terminated, and unexpended funds must be returned to the developmental funds pool. In general, the CRC should try to advance learning experiences in STD research and to make medical students, house staff and postdoctoral candidates more aware of STD research opportunities in the clinical, biomedical, and behavioral sciences. It is permissible for projects to include post-residency personnel who spend a maximum of one third of their time in clinical activities related to the research focus of the project. Formal training programs in clinical or basic sciences that include stipends for these students are supported by other funding mechanisms at the NIH, such as the National Research Service Awards (T-32s) and do not, therefore, fall within the purview of this request. 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. If so, a letter of agreement from either the GCRC program director or principal investigator should be included with the application. SPECIAL REQUIREMENTS Collaborative Organization The application should include a plan to maintain close collaboration and communication among members this STD CRC (and potentially among of the seven other STD CRCs) and 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. The application must also include a signed letter of agreement from each collaborator and/or consultant to the program indicating willingness to participate in the program and a description of the exact nature of the participation. Terms and Condition of Award The following terms and conditions will be incorporated into the award statement and provided to the Principal Investigator as well as the institutional official at the time of award. These special Terms of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument used for this program is the cooperative agreement (U19), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Awards will be made to an institution on behalf of a Principal Investigator who will be responsible for the coordination of STD CRC scientific and administrative activities. Support of all CRC activities will be coordinated through a Central Operations Office located within the applicant organization. 1. Awardee Rights and Responsibilities Awardees will have primary responsibility for defining the details for the project within the guidelines of the RFA and for performing the scientific activity, and agree to accept close coordination, cooperation, and participation of NIAID staff in those aspects of scientific and technical management of the project described in 2. below. Specifically, awardees have primary responsibilities as described below. Under the Cooperative Agreement, a partnership relationship exists between the recipient of the award and NIAID in which successful applicants are responsive to the guidelines and conditions set forth in the RFA. At the same time, investigators are expected to define research objectives and approaches in accord with their own interests and perceptions of novel and exploitable approaches to the research which ultimately is likely to result in improved prevention and control of STDs. It is the primary responsibility of the Principal Investigator to clearly state the objectives and approaches of the research, to plan and conduct the research stipulated in the proposal, and to ensure that the results obtained are analyzed and published in a timely manner. NIAID may periodically review and generate internal reports from data and progress reports developed under this cooperative agreement. Awardees will retain custody of and have primary rights to the data developed under this award, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. The multi-disciplinary and collaborative nature of the STD CRCs creates an extraordinary opportunity for information exchange and scientific advancement in STD research. Principal Investigators are expected to take advantage of this opportunity by participation in both formal events established expressly for this purpose and informal investigator-initiated dialogues. 2. NIAID Staff Responsibilities The NIAID will have substantial scientific/programmatic involvement during the conduct of this activity, through technical assistance, advice and coordination above and beyond normal program stewardship for grants, as described below. The NIAID will work closely with the Principal Investigators and shall be represented by a Scientific Coordinator (Program Officer). The Scientific Coordinator will be a program officer in the STD Branch of NIAID. During the award period, the NIAID Scientific Coordinator may provide appropriate assistance, advice, and guidance in: design of research activities; coordination and facilitation of information, technology, and reagent exchange between STD CRCs; data collection and analysis; assistance in review and selection of developmental fund applicants; and technical and administrative activities of CRCs. However, it is again emphasized that the role of NIAID will be to facilitate and not to direct the activities of the STD CRC. It is anticipated that decisions in all activities outlined within this RFA will be reached by consensus of the investigators and that the NIAID Scientific Coordinator will be given the opportunity to offer input to this process. 3. Collaborative Responsibilities The CRC Principal Investigator of the Adolescents and STDs CRC and the other seven STD CRCs and NIAID Scientific Coordinator will meet twice a year to review progress of the CRCs at the NIH in Bethesda, Maryland (or at a site designated by NIAID). The first such meeting will be a Post Award Meeting. In addition, two workshops for the Principal Investigators and CRC Project Leaders will be convened during the project period to share STD research advances, and to discuss STD research needs and opportunities, to develop collaborations. It is likely that workshops will be convened in Year 1 and Year 3 of the project period at the NIH in Bethesda, Maryland (or at a site designated by NIAID). Applicants should be aware that there are no additional travel monies available. Funds for travel to all meetings must be included in applicant's budget. A critical element of the STD CRCs' success is the degree of communication among its members. Therefore, additional informal meetings among participants from other STD CRCs as well as regular telephone and written communication will be encouraged. 4. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award) between award recipients and the NIAID may be brought to arbitration. An arbitration panel will be composed of three members -- one selected by the Principal Investigator, a second member selected by the NIAID, and the third member selected by the two prior members. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations at 42 CFR part 50, subpart D, and HHS regulation at 45 CFR part 16. In the event that research supported by the Cooperative Agreement results in development of a therapeutic or other medical intervention, NIAID will retain the option to cross-file or independently file an application for investigational clinical trial (i.e., an Investigational New Drug Application [IND]) to the United States Food and Drug Administration. Reports of data generated by the CRC or any of its members which are required for inclusion in INDs and Clinical Brochures and for cross-filing purposes will be submitted by the Principal Investigator to the Scientific Coordinator upon request. Such reports will be in final draft form and include background information, methods, results, and conclusion. They will be subject to approval and revision by NIAID and may be augmented with test results from other Government sponsored projects prior to submission to the appropriate regulatory agency. STUDY POPULATIONS A strong emphasis is placed on studying STDs in adolescent populations that are disproportionately affected. These populations include women and minorities. Subjects may be recruited or specimens obtained from domestic sites or through collaborations with foreign institutions in developing countries if the collaboration is beneficial to the foreign country and offers the potential for collection of STD data that are pertinent to U.S. populations and could not be generated as effectively in the United States. 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 subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects of the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). 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 the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. 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. LETTER OF INTENT Prospective applicants are asked to submit, by October 15, 1997, a letter of intent that includes a descriptive title of the overall proposed research; the name, address, and telephone number of the Principal Investigator; a list of the key investigators and their institution(s), and the number and title of the RFA in response to which the application may be submitted. Although the letter of intent is not required, is not binding, does not commit the sender to submit an application, and does not enter into the review of subsequent applications, the information that it contains allows NIAID staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Madelon Halula at the address listed under INQUIRIES. APPLICATION PROCEDURES Before preparing an application, the applicant should carefully read the new information brochure accompanying the RFA, "NIAID Program Project Grants and Multiproject Cooperative Agreements". Instructions for formatting the application as outlined in the brochure should be followed carefully. Failure to follow the instructions may result in unnecessary delays in the review process. Applications are to be submitted on the standard research grant application form PHS 398 (rev. 5/95). Application forms are available at most institutional offices of sponsored research and from the Division of Extramural Outreach Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, email: [email protected]. Applications from multi-component consortia must contain a single face page, an overall budget page, and separate budget pages for each institution involved. The RFA label available in the PHS 398 (rev. 5/95) 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, the RFA title and number must be typed on line 2 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 6701 ROCKLEDGE DRIVE - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional exact copies of the grant application and five sets of appendix material must also be sent to: Dr. Madelon Halula Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4C-16 Bethesda, MD 20892 Rockville, MD 20852 (for express/courier service) Applications must be received by the January 8, 1998. All components, subparts and sections of the application must be collated into the application, and the packages sent to the DRG and to the NIAID must each be complete in themselves. Applications that do not conform to the instructions contained in PHS 398 (rev. 5/95) application kit will be judged nonresponsive and will be returned to the applicant. Current NIH policy permits a component research project of a multiproject grant application to be concurrently submitted as a traditional individual research project (R01) application. If, following review, both the multiproject application and the R01 application are found to be in the fundable range, the investigator must relinquish the R0l and will not have the option to withdraw from the multiproject grant. This is an NIH policy intended to preserve the scientific integrity of a multiproject grant, which may be seriously compromised if a strong component project(s) is removed from the program. Investigators wishing to participate in a multiproject grant must be aware of this policy before making a commitment to the Principal Investigator and awarding institution. REVIEW CONSIDERATIONS Review Method Upon receipt, applications will be reviewed for completeness by the Division of Research Grants (DRG) and for responsiveness by NIAID staff. Incomplete and non-responsive applications will be returned to the applicant without further consideration or review. 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 received in response to the RFA. Applications judged to be competitive will be discussed and assigned a priority score. The NIAID will remove from competition those applications judged to be non-competitive for award and will notify the Principal Investigators and institutional business officials. For applications found non-competitive, summary reports will be very brief and will only highlight the major reason(s) for the non- competitive rating. Those applications judged by the reviewers to be competitive for award will be further reviewed for scientific and technical merit by a review committee convened by the Division of Extramural Activities, NIAID. The second level of review will be provided by the National Advisory Allergy and Infectious Diseases Council. Review Criteria The review criteria are stated in the NIAID Program Project Grants and Multiproject Cooperative Agreements brochure which accompanies the RFA. In addition, applicants are expected to address research priorities, objectives, and other requirements stated in this RFA as well as the following: o the scientific and technical significance, merit, and originality of the research projects and anticipated contributions to the prevention and control of STDs; o the scientific expertise and experience of the Principal Investigator, the Project Leaders and key project and core personnel; o documentation of a strong capability in adolescent medicine, adequate and appropriate patient populations, disease prevalence, and historical success of recruitment and retention of subjects; o inclusion of populations that are not currently represented in existing STD CRCs; o documentation of the sponsoring institution's commitment to the cooperative program and willingness to accept the participation and assistance of NIAID staff; o adequacy of proposed plan for coordination and communication within the applicant STD CRC and with NIAID and other STD CRCs; and o adequacy of review plan and selection criteria for new investigators making application to the optional Developmental Funds. In addition, applications from existing STD CRCs must include a comprehensive progress report (as stated above under Objectives and Scope) and demonstrate successful collaborative activities supported through their CRC. Applicants who have not had an STD CRC should explain how they will establish successful collaborative efforts. AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program priorities and balance, and availability of funds. Program balance takes into account pathogen(s) proposed for study, the potential impact on health of women, minorities and adolescents, as well as geographic distribution of the existing CRCs (of particular interest is access to populations that are currently not being studied in other STD CRCs). INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Penelope J. Hitchcock Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 3A-24 Bethesda, MD 20892 Bethesda, MD 20852 (for express/courier service Telephone: (301) 402-0443 Email: [email protected] Direct inquiries regarding review issues, address the letter of intent to, and mail two copies of the application and all five sets of appendices to: Dr. Madelon Halula Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4C-16 Bethesda, MD 20892 Bethesda, MD 20852 (for express/courier service Telephone: (301) 402-2636 FAX: (301) 402-2638 Email: [email protected] Direct inquiries regarding fiscal matters to: Ms. Sharie Bernard Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4B-33 Bethesda, MD 20892 Telephone: (301) 496-7075 Schedule Letter of Intent Receipt Date: October 15, 1997 Application Receipt date: January 8, 1998 Scientific Review Date: April 1998 Advisory Council Date: June 1998 Earliest Award Date: August 1998 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.855 Immunology, Allergic and Immunological Diseases Research and 93.856 Microbiology and Infectious Diseases Research. Grants are awarded under the authority of the Public Health Service Act, Section 301 (42 USC 241) and administered under PHS grants policies and Federal Regulations, most specifically at 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of the Executive Order 12372 or Health Systems Agency review. The PHS and EPA strongly encourage all grant 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 EPA and PHS missions to protect and advance the physical and mental health of the American people. ADDENDUM STD CRCs can serve as important resources to increase awareness of the prevention, diagnosis, and treatment of STDs in the public health, the lay and the local medical communities. The NIAID has been involved with the Centers for Disease Control's (CDC) Accelerated Research Program in STDs. Several proposed projects for this CDC program involve collaborations between the existing STD CRCs and state and local health departments. Applicants with interest in this area should contact the Division of STDs/HIV, National Center for Prevention Services, CDC for information on support of outreach projects. .
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