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SEXUALLY TRANSMITTED INFECTIONS AND TOPICAL MICROBICIDES COOPERATIVE RESEARCH CENTERS (STI TM CRCs) RELEASE DATE: August 25, 2003 RFA Number: RFA-AI-03-042 - (Reissued as RFA-AI-08-004) National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov) CATALOGUE OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: No. 93.855, Immunology, Allergy, and Transplantation Research No. 93.856, Microbiology and Infectious Diseases Research LETTER OF INTENT RECEIPT DATE: November 17, 2003 APPLICATION RECEIPT DATE: December 16, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research and Development Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Center Directors o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The Sexually Transmitted Diseases Branch, Division of Microbiology and infectious Diseases (DMID), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS) invites applications for the Sexually Transmitted Infections and Topical Microbicides Cooperative Research Centers (STI TM CRCs). The purpose of this program is to stimulate multidisciplinary, collaborative research that is focused on developing tools and strategies for prevention and control of STIs and diseases. The goal of this initiative is to emphasize research aiding in the development of vaccines, therapeutics, diagnostics and behavioral and social interventions. Identification and development of topical microbicide agents and formulations is a priority. CRCs will conduct multiple interrelated research projects organized around a central theme, will be supported by administrative and other core resources, and will participate in a central Executive Committee of all CRC Directors. Together, the CRCs will form a consortium that: 1) conducts multi-disciplinary, intervention-oriented research, 2) fosters interaction among established STI investigators, and 3) supports development of investigators new to the field of STIs. RESEARCH AND CAREER DEVELOPMENT OBJECTIVES Background STIs are critical global and national health priorities because of the devastating impact on women and infants, and the inter-relationships with HIV/AIDS. Each year an estimated 15 million Americans suffer the effects of STIs at a cost exceeding $16 billion. STIs and HIV are linked both by biological interactions and by infections occurring in the same populations. Certain STIs can increase the risk of HIV acquisition and transmission, as well as alter the course of disease progression. Recent studies indicate that the more prevalent STIs (Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and organisms associated with bacterial vaginosis) that cause non-ulcerative diseases, as well as the STIs that cause ulcerative diseases (herpes simplex virus type 2, Treponema pallidum and Haemophilus ducreyi) increase the risk of HIV transmission by at least two- to five-fold. While all sexually active persons are susceptible, women and their children bear a disproportionate burden of the harm caused by STIs. Biologically, STIs are more easily passed from men to women, than from women to men. Because some STIs can ascend to the upper female genital tract, the long-term consequences of infection are also more severe for women. In addition, many infections are less often symptomatic in women, resulting in a delay or lack of treatment. Up to 40% of women with untreated chlamydia will develop pelvic inflammatory disease (PID); 20% of these women will become infertile. A woman with a STI during pregnancy may experience ectopic pregnancy, spontaneous abortion, chorioamnionitis and premature birth; her baby may be of low birth weight, have severe neurologic disease, or die. Social and economic imbalances with men and a lack of female controlled protective devices may make it more difficult for women to avoid exposure to STIs. Adolescents and young adults are particularly vulnerable to STIs and have extremely high rates of infection and disease. Most people with herpes simplex virus type 2 (HSV-2) and HIV became infected during adolescence. This pattern is due, in part, to behavioral factors. Teens are more likely to have unprotected intercourse, and to use alcohol and drugs during sex than their older counterparts. They may also be more likely to choose partners who are infected. Greater numbers of sexual partners and closely spaced relationships of shorter duration facilitate spread of acute infections. In addition, as a result of hormone-dependent changes, young women are at greater risk of acquiring chlamydia and gonorrhea during adolescence than at any other time in their lives. STIs are an area of significant health disparity. African Americans are hardest hit with rates more than thirty times greater than white Americans for some STIs. Poverty, inadequate health care and partner mixing patterns contribute to the excess disease observed in this and other affected communities. In addition, STIs contribute to the spread of HIV, which is also increasingly concentrated among women and minorities in the US. STIs and other reproductive tract infections and syndromes are the focus of this RFA. Chlamydia trachomatis is a major cause of PID and is among the most prevalent of all STIs. Asymptomatic infection is common among both men and women. Neisseria gonorrhoeae is another major cause of PID. An estimated 600,000 new infections occur each year. Treponema pallidum is the cause of syphilis, a genital ulcerative disease that may be important in contributing to HIV transmission in those parts of the country where rates of both infections are high. Trichomonas vaginalis causes vaginitis in women and non-gonococcal urethritis in men. An estimated 5 million new cases of trichomoniasis occur each year in the US, the majority in women. Epidemiologic studies suggest that T. vaginalis is associated with a two- to fourfold increased risk of HIV transmission. T. vaginalis has also been associated with adverse outcomes of pregnancy. Bacterial vaginosis (BV) is common in women of reproductive age. In the US, as many as 16% of pregnant women have BV. BV is associated with adverse outcomes of pregnancy including prematurity and low birth weight. BV is also associated with an increased risk of STIs and HIV. Human papillomavirus (HPV) infections are extremely common. Cervical cancer, caused by a subset of HPVs, is the second most common cause of cancer death in women worldwide. Genital herpes (HSV-2) is one of the most common STIs in the US, with as many as one million people becoming infected each year. More than one in five Americans—45 million people— are infected with HSV-2. Genital herpes can make HIV-infected individuals more infectious and is believed to play a role in the heterosexual spread of HIV in the US. The Sexually Transmitted Diseases (STD) CRCs were developed as multi- disciplinary research programs. Following the original RFA, seven STD CRCs were awarded in 1994. An additional RFA was issued and an Adolescent CRC was awarded in 1997 to focus on this high risk population. The original CRCs were recompeted in 1998 with six awards made. The development of topical microbicides as a prevention strategy has emerged since the previous competition. This has been integrated into the program. In the current RFA, the STD CRCs have been renamed the STI TM CRCs to emphasize the need to develop strategies and tools, such as topical microbicides, for the prevention and control of STIs and other reproductive tract infections. Research objectives The objective of the STI TM CRC program is to stimulate research that is focused on developing strategies and tools for the prevention and control of STIs and other reproductive tract infections, in particular BV and Trichomonas vaginalis. This requires multidisciplinary, collaborative research using biomedical, clinical, epidemiological, and social and behavioral approaches. Research aiding in the development of vaccines, therapeutics and behavioral and social interventions is needed. Identification and development of topical microbicide agents and formulations is a priority. Targeted STIs and syndromes include, but are not limited to: Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Treponema pallidum, BV, HPV and HSV-2. Centers may focus on a single STI or syndrome, or multiple STIs. Projects that focus on interactions among STIs, or among STIs and normal vaginal flora or HIV are also of interest. Specific areas of interest include, but are not limited to: 1. Vaginal ecology and innate defense mechanisms; mechanisms by which the normal vaginal flora and epithelial tissues are impacted by STIs, and; the impact of hormonal influences on the vaginal ecosystem. 2. Mechanisms of pathogenesis of organisms that cause STIs and associated syndromes including BV, PID, infertility, and premature delivery; the role of inflammatory and immune defense mechanisms in persistence and pathogenesis. 3. Mucosal immunology in the male and female genital tract including mucosal immune responses in normal subjects, those with STIs, and after interventions including topical microbicides, therapeutics and vaccines; to include development of assays. 4. Interactions among STIs, and STIs with HIV; the impact of STIs in the acquisition and progression of HIV infection and the role of HIV in alterations of the natural history, diagnosis, or response to treatment of STIs. 5. Discovery and pre-clinical testing of topical microbicides effective against one or more STIs, including methods to measure and assess vaginal/cervical inflammation and to compare changes induced by microbicides. 6. Development of prevention and control strategies for STIs including identification of vaccine candidates, possible therapeutic agents, and other target molecules. 7. Development and evaluation of new tools for diagnosis of STIs or STI- related diseases. 8. Development and use of animal models and infection/acquisition models for pathogenesis studies as well as pre-clinical testing of vaccines, topical microbicides and therapeutics. 9. Development and assessment of behavioral or social interventions using biomarkers as endpoints; epidemiological, behavioral and social factors contributing to introduction, spread and maintenance of STIs in communities, especially those populations most affected by STIs. Applications proposing to develop products may collaborate with an industry partner. Applications may also include a foreign research component or collaborative site. This application will not fund clinical trials. Career Development Objectives A central Development Awards Program (DAP) will be established by the CRCs to support investigators new to the field of STIs by providing them with the opportunity to apply for small amounts of funding for individual research projects and training activities . The goal of the program is to encourage and train young researchers in the field of STI research. The DAP will be administered by one CRC. Applicants interested in serving as the administrator for the DAP must include a DAP Core with proposed administrative structure, review process and criteria for selecting Award recipients. Developmental Awards may be used to support a specific research project or training activity to take place at one or more of the CRCs. MECHANISM OF SUPPORT This RFA will use the NIH multi-project cooperative agreement (U19), an "assistance" mechanism, rather than an "acquisition" mechanism. The applicant will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. Individual projects in applications that are not funded in the competition described in this RFA may be submitted as new individual RO1 investigator-initiated applications using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application. The NIH U19 is a cooperative agreement award mechanism in which the Center Director retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Center Director, as described under the section "Cooperative Agreement Terms and Conditions of Award" The total project period for applications submitted in response to this RFA may not exceed five years. Applicants for U19 grants must follow special application guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI- PROJECT AWARDS; this brochure is available via the WWW at: http://www.niaid.nih.gov/ncn/grants/multibron.htm. FUNDS AVAILABLE NIAID intends to commit approximately $12.5 million in FY 2004 to fund up to 8 new and/or competitive continuation grants in response to this RFA. An applicant may request a project period of up to 5 years and a budget for total costs of up to $1.5 million per year. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. Funds for the DAP Core are in addition to the total costs. Details are provided in the Special Requirements section, item three, Developmental Awards Program Core. ELIGIBLE INSTITUTIONS The applicant may submit (an) application(s) if the institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic Foreign institutions are not eligible to apply. INDIVIDUALS ELIGIBLE TO BECOME CENTER DIRECTORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS CRCs conduct interrelated research projects organized around a central theme, are supported by an administrative core and other appropriate core scientific resources, and participate in a central Executive Committee (EC) of CRC Directors and a program officer in the NIAID STD Branch (see NIAID Staff Responsibilities below). Required aspects of CRCs are described below. 1. CRC Structure Each CRC must include a minimum of three interrelated research projects organized around a central theme. A Project Leader must be named for each research project. In addition, CRCs include shared resources, called cores, which provide services or resources to at least two research projects. These include a required administrative core, headed by the Center Director; may include scientific cores, each headed by a Core Leader; and may include a DAP core, headed by the Center Director. a. Administrative Core The Center Director is the Leader of the Administrative Core. The institution and the Center Director are responsible for the application and for collaborative research activities. Responsibilities of the Administrative Core include, but are not limited to: 1) oversight of CRC Projects and Scientific Cores; 2) promoting collaboration and coordination among Project and Core Leaders; 3) participating in EC meetings, conference calls and other activities, and; 4) nominating candidates for the Developmental Awards Program. The Administrative Core budget should include funding for overall administration (e.g., secretarial and other administrative services), expenses for publications for collaborative efforts, and communication expenses. In addition, the Administrative Core budget must include funds for the Center Director to travel to annual EC meetings as described below. Administrative costs (e.g., travel) associated with an individual project may be included in the Administrative Core, or the corresponding project. b. Scientific Cores Scientific cores are shared resources that provide services or resources to at least two research projects. Some examples of services provided by scientific cores are monoclonal antibody production, peptide synthesis, microbiology laboratory services, and statistical support. Each scientific core must have a Core Leader. The application should give a clear picture of the facilities, techniques, and skills the core will provide and the role of the Core Leader and each key participant. A budget must be provided for each core. c. Advisory Groups The application may include funds to support activities of advisory groups. It is recommended that advisory groups include community representatives as well as scientific experts. The application must include plans that indicate how such groups will be included in and contribute to the success of Center activities. Funds may be requested for reimbursement of reasonable expenses including representation at Center meetings. Advisory groups should be constituted after the grant award has been made and individual members should not be named in the application. Funds to support Advisory Groups may be included in the Administrative Core. 2. CRC Executive Committee (EC) Center Directors and a program officer from the NIAID STD Branch (see NIAID Staff Responsibilities below) will form a central EC. The EC will meet at least annually and will hold quarterly conference calls to facilitate interaction and collaboration across CRCs and with NIAID program staff. The EC will select one member to serve as Chair of the Committee. Project and Core Leaders from each CRC may attend annual EC meetings to summarize CRC scientific activities. Meetings may also be used, for example, to address common training needs, develop cross- Center initiatives, or host invited speakers. The application must include funds for the Center Director (an EC member), Project Leaders and Core Leaders to travel to annual EC meetings. 3. Developmental Awards Program (DAP) Core The goal of the DAP program is to encourage and train young researchers in the field of STI research. The developmental award will provide applicants with small amounts of funding to allow them to formulate projects and collect data to support an application for an independent grant or to receive relevant training in the field of STIs. A Center Director or their designee interested in serving as the administrator for the DAP must propose a DAP Core with administrative structure, review process and criteria for selecting award recipients. One CRC will be selected to serve as the coordinator of the DAP. The DAP Core budget may include administrative personnel and typical office costs (e.g., photocopying, supplies) in addition to the $300,000 maximum in award funds, as described below. The budget for the DAP may be in addition to the total costs for the CRC. The DAP Core will be evaluated by the IRG, but will not influence the overall score. Potential Elements of the DAP: a. Candidates for a developmental award must be nominated by a CRC Director and can be internal or external to the CRC. b. The EC will review applications for developmental awards and will select awardees without regard to institutional association. c. At any time, there may be none, one, or multiple awardees at one or more of the CRCs. d. Developmental awards may be requested for a specific research project to take place at one or more of the CRCs or for a training activity (e.g. a course or workshop). The annual amount available for all developmental awards is $300,000 in direct costs. Individual awards may not exceed $75,000 e. The duration of support for each developmental award can be for up to three years. The EC will review progress on a regular basis. f. Recipients of a developmental award may not receive subsequent awards from this pool. If the investigator achieves independent funding through a traditional research grant (for example: R01, R21, R03) prior to the end of the developmental award, the award must be terminated, and unexpended funds must be returned to the central DAP fund. g. A progress report on the DAP should be included in the annual report of the CRC. COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD The following terms and conditions will be incorporated into the award statement and provided to the Center Director 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 part 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument used for this program is the multiproject cooperative agreement (U19), which is an "assistance" 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. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the research will be shared among the awardees and the NIAID Scientific Coordinator. 2. Awardee Rights and Responsibilities Awardees will have primary responsibility for defining the research objectives, approaches and details of the projects within the guidelines of the RFA and for performing the scientific activity. Specifically, awardees have primary responsibility as described below. Awardees agree to accept close coordination, cooperation, and participation of NIAID staff in all aspects of scientific and technical management of the project as stated below under NIAID Staff Responsibilities. Awardees will retain custody of and have primary rights to the data developed under these awards, subject to Government rights to access consistent with current HHS, PHS and NIH policies. 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, Center Directors 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 STIs and diseases. The Center Director will have ultimate responsibility for the coordination of efforts within the CRC and ensuring that results obtained are analyzed and published in a timely manner. It will be the responsibility of the Project and Core Leaders to plan and conduct the activities stipulated in the project proposal. Timely publication of major findings is encouraged. Publications and oral presentations of work performed under this agreement will require appropriate acknowledgment of the STI TM CRCs and NIAID support. NIAID may periodically review and generate internal reports from data and progress reports developed under this cooperative agreement. The data obtained will, however, be the property of the awardee. The multi-disciplinary and collaborative nature of the STI TM CRCs creates an extraordinary opportunity for information exchange and scientific advancement in STI research. CRC 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. 3. NIAID Staff Responsibilities NIAID staff assistance will be provided by a program officer in the STD Branch who will serve as NIAID's Scientific Coordinator. The NIAID Scientific Coordinator 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. During performance of the award, the NIAID Scientific Coordinator, with assistance from other scientific program staff who are designated based on the research topic and their relevant expertise, may provide appropriate assistance, advice, and guidance by: participating in the design of the activities; advising in the selection of sources or resources (e.g., determining where a particular reagent can be found and facilitating reagent exchange among CRCs); coordinating or participating in the collection and/or analysis of data; advising in management and technical performance; or participating in the preparation of publications. The NIAID Scientific Coordinator will serve as a liaison/facilitator between the awardee, pharmaceutical and biotech industries, and other government agencies (e.g., FDA, USDA, CDC) and will serve as a resource of scientific and policy information related to the goals of the awardee's research. However, the role of NIAID will be to facilitate and not to direct the activities. It is anticipated that decisions in all activities will be reached by consensus and the NIAID staff will be given the opportunity to offer input into this process. The manner of reaching this consensus and the final decision-making authority will rest with the Center Director. The NIAID Scientific Coordinator will be a voting member of the CRC EC, will provide support for EC meetings and conference calls, and will respond to requests for EC meeting content. An NIAID Program Official will be assigned to perform normal program stewardship responsibilities for this award. The Program Official may serve as the Scientific Coordinator. 4. Collaborative Responsibilities Center Directors and the NIAID Scientific Coordinator will participate in a central Executive Committee (EC). The EC will meet at least annually and will hold quarterly conference calls to facilitate interaction and collaboration across CRCs and with NIAID program staff. Project and Core Leaders from each CRC may attend annual EC meetings to summarize CRC scientific activities. Meetings may also be used, for example, to address common training needs, develop cross-Center initiatives, or host invited speakers. A major activity of the EC will be administration of the EC Development Awards Program for investigators new to the field of STIs. Only applicants interested in serving as the DAP administrator should include a plan for this activity. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct questions about scientific/research issues to: Dr. Heidi Friedman Sexually Transmitted Diseases Branch Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Room 5022, MSC-6604 6610 Rockledge Drive MSC 6604 Bethesda, MD 20892-6604 Telephone: (301) 402-0443 FAX: (301) 480-3617 Email: hfriedman@niaid.nih.gov o Direct questions about peer review issues to: Dr. Madelon Halula Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 2180, MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 Telephone: (301) 402-2636 FAX: (301) 402-2638 Email: mhalula@niaid.nih.gov o Direct questions about financial or grants management matters to: Sharie Bernard Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 3219, MSC-7614 6700-B Rockledge Drive Bethesda, MD 20892-7614 Telephone: (301) 402-5540 FAX: (301) 480-3780 Email: sbernard@niaid.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed CRC o Name, address, and telephone number of the Center Director o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Dr. Madelon Halula Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 2180, MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 Telephone: (301) 402-2636 FAX: (301) 402-2638 Email: mhalula@niaid.nih.gov SUBMITTING AN APPLICATION Applicants for U19 grants must follow the forms and standard guidelines in the NIH public Health Service grant application (PHS 398, rev. 5/2001, Sections I-III) available at http://grants.nih.gov/grants/funding/phs398/phs398.html and the special application guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS; this brochure is available via the Internet at: http://www.niaid.nih.gov/ncn/grants/multibron.htm. Applications must have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. SUPPLEMENTARY INSTRUCTIONS: USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. 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. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) The Center for Scientific Review now accepts delivery of applications only by mail or courier service. Personal deliveries of applications will not be accepted (http://grants.nih.gov/grants/funding/phs398/instructions2/p1_mailing_address.htm). At the time of submission, two additional exact copies of the grant application and all five sets of any appendix material must be sent to: Dr. Madelon Halula Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 2180, MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 Telephone: (301) 402-2636 FAX: (301) 402-2638 Email: mhalula@niaid.nih.gov Applications that are not received as a single package on the receipt date or that do not conform to the instructions contained in PHS 398 (rev. 5/01) Application Kit (including areas modified and superseded by the NIAID BROCHURE ENTITLED "INSTRUCTIONS FOR APPLICATIONS FOR MULTI- PROJECT AWARDS"), will be judged non-responsive and will be returned to the applicant. SPECIAL INSTRUCTIONS FOR COMPLETION OF APPLICATIONS IN RESPONSE TO THIS RFA: Applicants for U19 cooperative agreements must follow special application guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS; this brochure is available from NIAID listed under INQUIRIES via the WWW at: http://www.niaid.nih.gov/ncn/grants/multibron.htm. This brochure presents specific instructions for sections of the PHS 398 (rev. 5/01) application form that should be completed differently than usual. For all other items in the application, follow the usual instructions in the PHS 398, Sections I-III. APPLICATION PROCESSING: All applications, whether new or recompeting, must be received by the application receipt date listed in the heading of this RFA (not merely postmarked on that date). If an application is received after that date, it will be returned to the applicant without review. Concurrent submission of an R01 and a Component Project of a Multi- project Application: Current NIH policy permits a component research project of a multi-project grant application (P01 or U19) to be concurrently submitted as a traditional individual research project (R01) or SBIR application. If, following review, both the multi-project application and the R01 or SBIR application are found to be in the fundable range, the investigator (Project Leader) must relinquish the R01 or SBIR and will not have the option to withdraw from the multi- project grant. This is an NIH policy intended to preserve the scientific integrity of a multi-project grant, which may be seriously compromised if a strong component project(s) is removed from the program. Investigators wishing to participate in a multi-project grant must be aware of this policy before making a commitment to the Center Director and awarding institution. Applicants to this RFA may not submit a U01 proposal containing a project identical to a project in a U19 proposal. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NIAID. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAID in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by the National Institute of Allergy and Infectious Diseases Council REVIEW CRITERIA The general review criteria for U19 multi-project cooperative agreement applications are presented in the NIAID brochure entitled "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS" at http://www.niaid.nih.gov/ncn/grants/multibron.htm. The 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 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 the RFA 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 transition toward applications development. The following review criteria will be used to evaluate the overall application. o Cohesiveness of Effort: Are the component research projects clearly focused on achieving a common goal? Projects with no direct relevance to the common goal will be designated as non-responsive and not contributing to requirements for multi-project grants. o Intra- and Inter-Center Collaborative Activities: Is there an effective network of collaborative activities within each Center (component projects and cores)? Applications must describe how they will establish successful collaborative efforts within their Center and with investigators from the other STI TM CRCs. Competitive renewals from existing STD CRCs must include a comprehensive progress report which must include evidence of successful collaborative activities supported through their CRC. The five criteria described below will be used to evaluate each component project. (1) Significance: Is this project likely to significantly advance the research area that is the specific focus of the application and facilitate applications development. (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? Is the likelihood of successful project completion high given the current state of research and development and the technical approach? Are the proposed timeline and interim milestones appropriate, feasible and technically sound? (3) Innovation: Does the proposed project leverage multi-disciplinary involvement to accelerate applications development. Does the approach represent the best use of current or emerging technologies and appropriate collaborations to achieve the research objectives. (4) Center Director and Project Leaders: Is the research and development team appropriately trained and experienced and well suited to carry out this work? Is the work proposed appropriate to the experience level of the Center Director and Project Leaders? (5) Environment: Does the 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 environments including partnerships with industry or employ useful collaborative arrangements? Is there adequate evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, applications will also be reviewed with respect to the following: o The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) o The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: November 17, 2003 Application Receipt Date: December 16, 2003 Scientific Peer Review Date: March, 2004 Advisory Council Review: June, 2004 Earliest Anticipated Start Date: August, 2004 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: 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 clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or 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 clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH- defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance in the following citations: No. 93.855, Immunology, Allergy, and Transplantation Research and No. 93.856, Microbiology and Infectious Diseases Research. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The NIH Grants Policy Statement is available at http://grants.nih.gov/grants/policy/policy.htm. This document includes general information about the grant application and review process; information on the terms and conditions that apply to NIH Grants and cooperative agreements; and a listing of pertinent offices and officials at the NIH. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the 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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