Full Text PAR-96-060 ACUTE INFECTION AND EARLY DISEASE RESEARCH NETWORK NIH GUIDE, Volume 25, Number 20, June 21, 1996 PA NUMBER: PAR-96-060 P.T. 34 Keywords: AIDS Pathogenesis INTERVENTION, TYPES OF National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: August 1, 1996 Application Receipt Dates: October 11, 1996; September 1, 1997; September 1, 1998 PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) gives special consideration for funding to scientifically meritorious applications in response to Program Announcements (PA). Program Announcements identify areas of ongoing research emphasis for the NIAID. In this PA, The Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), solicits applications to study the pathogenesis of acute/early HIV-1 infection in adult humans, and to develop and evaluate the impact of therapeutic interventions at this early stage of HIV-1 infection on HIV disease. The goal of this initiative is to build a network of three to five HIV-1 Acute Infection and Early Disease Research Units through cooperative agreements (U01) during the first year, with additional units funded over the next several years as this emerging area of science matures. Each awarded unit will perform innovative, integrated, investigator-initiated pathogenesis and clinical research on acute (i.e, within one month post initial infection) and early (i.e., up to 12 months post initial infection) HIV-1 infection and will be part of the Acute Infection and Early Disease Research Network (AIEDRN). The multi-unit format (Network) is required to enroll sufficient numbers of these hard-to-identify patients for study. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Acute Infection and Early Disease Research Network, is related to the priority area of HIV infection. 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 may be submitted by domestic non-profit and for-profit organizations, public and private organizations, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. While foreign organizations are not eligible to apply, domestic organizations may include foreign components. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT The administrative and funding mechanism to be used to undertake this program will be the cooperative agreement (U01), an "assistance" mechanism in which substantial NIH scientific and/or programmatic involvement is anticipated. 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. Cooperative agreements may include a combination of academic, non-profit research, and commercial organizations; applications that include collaborations with domestic or international organizations with access to larger numbers of people with acute infection and early HIV disease are strongly encouraged. RESEARCH OBJECTIVES Background Approximately 40,000 individuals are newly infected with HIV in the United States each year. Nonetheless, acute HIV infection is an under-diagnosed entity because it is often asymptomatic and because risk behavior associated with HIV infection is not identified. Acute infection is characterized by high levels of viral replication/dissemination to lymphoid tissues and immunologic activation. Observations from several small cohorts suggest that: (a) the concentration of HIV circulating in the blood (viral load) reaches a peak in the first two to four weeks of HIV infection and subsequently declines, and (b) the CD4+ T cell count of acutely infected individuals declines precipitously during the first days of HIV infection, however this rapid decline reverses itself, with a subsequent rebound in the CD4+ T cell count. Individuals with high levels of plasma HIV-1 RNA within six months from seroconversion experience more than tenfold increase in the risk for AIDS development, suggesting that inadequate suppression of viremia during the acute infection may be a critical factor in disease progression. The identification of both host and viral factors that influence the early establishment of a chronic HIV reservoir will facilitate the development, selection and administration of treatment and prevention modalities. Antiviral and/or immunological interventions during acute/early infection may have a great impact on the rate of disease progression and survival in HIV+ individuals. Preliminary results of a placebo controlled European- Australian study of ZDV are promising as CD4+ lymphocytes counts were higher in individuals receiving ZDV. Because of the difficulties associated with identifying individuals at this stage of infection, there have been few studies to analyze the associated viral and immunological changes as well as the effect of therapeutic interventions. Scope of Research This initiative will support innovative, integrated pathogenesis and clinical research for acute (up to one month post initial infection) and early (up to 12 months post initial infection) HIV-1 infection in adult humans. It will support single-unit and multi-unit clinical research and conduct in-depth studies of HIV pathogenesis and factors that influence response to interventions. The treatment strategies will be based on state-of-the-art concepts of early disease pathogenesis. The goal of this initiative is to build a network of three to five HIV-1 Acute Infection and Early Disease Research Units through cooperative agreements (U01) in the first year. Each unit will comprise basic and clinical scientists coordinated under the direction of a single Principal Investigator, and each unit will be part of the Acute Infection and Early Research Disease Network. Unlike many other major NIH cooperative research projects, the structure of the groups and funding are not linked to a specific experiment or clinical trial. Thus this mechanism has the potential for considerable flexibility in resource allocation which will facilitate the rapid testing of hypotheses about the pathogenesis of HIV-1 infection and early phase clinical trials of promising treatments of acute/early HIV infection. The multi year nature of a program announcement provides additional and necessary flexibility to allow the support for the scientific capability to expand and keep pace, as warranted, with this emerging, rapidly developing and high priority area of HIV-related research. In order to address these scientific needs, each unit should: o identify, accrue and retain acute/early HIV-1 positive individuals for pathogenesis studies and clinical trials. This requires strong linkages with and intense screening from unique referral sources such as Sexually Transmitted Diseases (STD) Clinics, emergency rooms, blood banks, and primary care centers, as well as close collaboration with centers and investigators studying existing natural history cohorts. The projected enrollment in the application should be at least 30 to 50 patients per year. Of the total number of subjects, a minimum of 10 to 15 subjects per year should be acutely infected, i.e., within one month post initial infection. Applicants may include studies on ways to improve detection and recruitment of new infected individuals. o conduct independent and collaborative (both through the Network and with outside investigators) studies of the in vivo pathogenesis of early HIV disease. o evaluate and optimize therapeutic interventions in small, focused clinical studies; perform extensive virologic and immunologic evaluation that will provide new insights into the pathogenesis of acute/early HIV infection and the efficacy of therapeutic approaches. The identification and use of existing resources (such as the Centers For AIDS Research, CFAR) should be maximized. The banking and storage of specimens for later analyses and for use in collaboration with investigators outside the network is encouraged. o have the potential capability of supporting, through participation in the Network activities, multi-unit evaluation (Phase I/II and Phase II clinical studies) of novel therapeutic interventions for acute infection and/or early HIV disease. The Network will include the awarded units' clinical sites and laboratories. In order to facilitate interpretation of data across the network, central quality assurance and data management of the laboratories can be provided by the Division of AIDS as needed. The Network activities will be coordinated by a Steering Committee formed by the Unit Principal Investigators. The Network serves to facilitate information exchange, foster collaboration and coordinate activities to minimize duplication. Additionally, the Network should have the capability and flexibility to conduct multi-unit clinical trials involving a larger number of patients (Phase II studies) as scientific opportunities become available. These studies may also require international collaboration. In summary, the primary objective of this PA is to conduct intense pathogenesis research and single- and multi-unit early phase clinical intervention studies into acute infection and early HIV disease. SPECIAL REQUIREMENTS Terms and Conditions of Award A. Applicability. 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 by the NIAID to award research projects involving (1) clinical trials, (2) prevention, education and control studies, and (3) epidemiological studies in excess of $500,000 direct cost per year at a single institution or in the aggregate for studies proposing multi-institution collaborative arrangements submitted either as subcontracts to a single application or as separate applications shall be a cooperative agreement (U01), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIAID scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. For single applications, the dollar limit excludes indirect costs of any subcontracts that are reported as a direct cost on the application budget page summary. Under the cooperative agreement, the NIAID 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 study will be shared among the awardees and the NIAID Program Officer or designee. Under the cooperative agreement, a relationship will exist between the award recipient(s) and the NIAID in which the performers of the activities (1) are responsible for the requirements and conditions described below and (2) agree to accept program assistance from a named NIAID Program Officer in achieving project objectives. Failure of an awardee to meet the performance requirements, including these special terms and conditions of award, or significant changes in the level of performance, may result in a reduction in budget, withholding of support, or suspension and/or termination of the award. B. Awardee Rights and Responsibilities The awardee is responsible for: 1. Research design and protocol development, including definition of objectives and approaches, planning, implementation, participant recruitment and follow-up, data collection, quality control, interim data and safety monitoring, final data analysis and interpretation, and publication of results. 2. Establishing with the other Principal Investigators a mandatory AIEDRN Steering Committee to facilitate information exchange, foster collaboration and coordinate activities to minimize duplication. The Steering Committee should designate a single Protocol Chairperson for each multi-unit clinical trial protocol within the research plan and define core data collection strategies, methods and cross-study analyses. 3. Functioning as the scientific coordinator for protocols (Protocol Chairpersons) and assuming responsibility for developing protocols and monitoring study performance for their protocols. All proposed protocols will be submitted by the Protocol Chair through the Principal Investigator to the NIAID Program Officer for review. Multi-unit clinical studies will be submitted to the NIAID Program Officer for review and approval, subject to negotiation with the awardees. 4. Implementing the core data collection strategy and methods for multi-unit studies and cross-study analyses collectively decided upon by the Steering Committee. For each study involving multiple institutions, it is the responsibility of each awardee/site to ensure that data will be collected and submitted in a timely way following such procedures as agreed to by the Steering Committee. Additionally, individual investigators/sites must demonstrate the ability to implement the strategy specifically designed for their individual study population. 5. Establishing mechanisms for internal quality control and monitoring. Awardees are responsible for ensuring the accurate and timely assessment of the progress of studies, including development of procedures to ensure that data collection and management are: (a) adequate for quality control and analysis; (b) for clinical trials, as simple as appropriate in order to encourage maximum participation of clinicians and other providers and study subjects and to avoid unnecessary expense; and (c) sufficiently staffed across the participating institutions. 6. Preparing and submitting interim progress reports, when requested, to the NIAID Program Officer including, as a minimum, summary data on performance of multi-unit studies. The Steering Committee may require additional information on multi-unit studies from the individual awardees/sites. Such reports are in addition to the annual awardee noncompeting continuation progress reports. 7. Establishing procedures, where applicable, for all participating institutions in coordinated awards to comply with FDA regulations for studies involving investigational agents or devices and to comply with the requirements of 45 CFR Part 46 for the protection of human subjects. 8. Cooperating in the reporting of the study findings. The NIAID will have access to and may periodically review all data generated under an award. Where warranted by appropriate participation, plans for joint publication with NIAID of pooled data and conclusions, are to be developed by the Principal Investigator or Steering Committee, as applicable. NIH policies governing possible co-authorship of publications with NIAID staff will apply in all cases. C. NIAID Staff Responsibilities It is expected that the dominant role and prime responsibility for the activity will reside with the awardee(s) for the project as a whole. However, specific tasks and activities will be shared among the awardee(s) and the NIAID Program Officer and/or Scientific Coordinator(s). The Scientific Coordinator(s) will be the contact for all facets of the scientific interaction with the awardee(s), while the Program Officer will be the contact for issues such as administration and budget. As required for the coordination of activities and to expedite progress, the NIAID Program Officer may designate additional scientific coordinator(s) to provide advice or assistance to the awardee on specific scientific, technical or management issues. The NIAID Program Officer shall retain overall programmatic responsibility for the award(s) and will clearly specify to the awardee(s) the name(s) and role(s) of any such additional individuals and the lines of reporting authority. NIAID Extramural Program staff responsibilities will include: 1. Interacting with the Principal Investigator(s) on a regular basis to monitor study progress. Monitoring may include: (a) regular communications with the Principal Investigator and staff, (b) periodic site visits for discussions with awardee research teams, (c) observation of field data collection and management techniques, quality control, fiscal review, and other relevant matters, as well as (d) attendance at and participation in Steering Committee and other meetings. The NIAID retains, as an option, periodic external review of progress. 2. For multi-unit protocols, convening the first meeting of and subsequent participation in the Steering Committee that oversees study conduct. The NIAID Program Officer will be a full participant and voting member of the Steering Committee and, if applicable, subcommittees. 3. Serving as a resource with respect to ongoing NIAID activities that may be relevant to the research to facilitate compatibility and avoid unnecessary duplication. 4. Substantial assistance in the design and coordination of research activities for awardees including: a. Assisting by providing advice on the management and technical performance of the investigations. b. Providing access to and use of, when appropriate, reagents and assays, and other resources available through NIAID contractors and awardees. c. Technical advice and assistance with meeting FDA requirements for investigational drugs. d. For multi-unit protocols, through participation on the Steering Committee and with the agreements of the Principal Investigator(s), the NIAID Program Officer may coordinate activities among awardees by assisting in the design, development, and coordination of a common research or clinical protocol and statistical evaluations of data; in the preparation of questionnaires and other data recording forms; and in the publication of results. e. Reviewing and approving multi-unit clinical trial protocols to insure that they are within the scope of peer review and for adequacy of safety, human subjects, and representation of women and minorities, as required by Federal regulations. The NIAID Program Officer will monitor protocol progress, and may request that a protocol be closed to accrual for reasons including: (1) accrual rate insufficient to complete study in a timely fashion; (2) accrual goals met early; (3) poor protocol performance; (4) patient safety, human subjects, and women/minority recruitment concerns; (5) study results that are already conclusive; and (6) emergence of new information that diminishes the scientific importance of the study. The NIAID will not permit further expenditure of NIAID funds for a study after requesting closure (except for patients/subjects on-study and final data analysis and reporting). f. Reviewing and providing advice regarding the establishment of mechanisms for quality control and study monitoring for multi-center clinical trials. 5. Making recommendations for continued funding based on: (a) overall study progress, including study subject and/or data accrual; (b) cooperation in carrying out the research (e.g., attendance at Steering Committee meetings, implementation of group decisions, compliance with terms of award and reporting requirements); and/or (c) maintenance of a high quality of research which will allow pooling of data and comparisons across multiple cooperative agreement awards for common data elements. D. Collaborative Responsibilities In addition to the interactions defined above, awardees and NIAID staff shall share responsibility for the following activities: 1. Steering Committee. A Steering Committee will have primary responsibility to facilitate information exchange, foster collaboration and coordinate activities to minimize duplication. For multi-unit clinical trials the committee will establish scientific priorities, develop (through appropriate designees) common protocols and manuals, questionnaires and other data recording forms, establish and maintain quality control among awardees, review progress, monitor patient/subject accrual, coordinate and standardize data management and cooperate on the publication of results. Major scientific decisions regarding the core data of multi-unit clinical trials will be determined by the Steering Committee. The Steering Committee will document progress in written reports to the NIAID Program Officer and will provide periodic supplementary reports upon NIAID request. The Steering Committee will be composed of all Principal Investigators and, as deemed necessary, co-investigators and the NIAID Program Officer (or designee). An initial meeting of the Steering Committee will be convened early after award by the NIAID Program Officer. The final structure of the Steering Committee will be established at the first meeting. The NIAID Program Officer or designee will have voting membership on the Steering Committee and, as appropriate, its subcommittees. The Steering Committee usually will meet at least twice yearly. A Chairperson, other than the NIAID staff, will be selected by vote of the members. The Chairperson is responsible for coordinating the Committee activities, for preparing meeting agendas, and for scheduling and chairing meetings. E. IND Responsibilities For pilot studies, either the Principal Investigator or a pharmaceutical company may file an Investigational New Drug (IND) application to the United States Food and Drug Administration. The sponsor of the IND has responsibility for the conduct of trials under that IND, which includes adhering to applicable Federal regulations. For larger scale, multi center (Phase II) studies, NIAID will retain the option to cross-file or independently file an IND. Reports of data generated by the Network or any of its members required for inclusion in INDs and Clinical Brochures and for cross-filing purposes will be submitted by the Principal Investigator to the NIAID Program Officer upon request. Such reports will be in final draft form and include background information, methods, results, and conclusions. 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. If NIAID holds the IND for a trial, a DAIDS Program Officer will monitor the safety of the treatment(s) being evaluated. Regulatory responsibilities will be the responsibility of NIAID. Standard procedures (e.g., registration of sites participating in clinical trials) will apply. Interim and final reports on toxicity for all sponsored clinical trials will be routinely provided to the DAIDS Scientific Coordinator. F. 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 Steering Committee (with the NIAID member not voting) or by the individual awardee in the event of an individual disagreement, 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 rights to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR part 50, subpart D and HHS regulation at 45 CFR part 16. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and printed in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy 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 August 1, 1996, a letter of intent that includes a descriptive title of the overall proposed research, the name, address and telephone number of the Principal Investigator, and the number and title of this PA. 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. Tingley at the address listed under INQUIRIES. APPLICATION PROCEDURES Applicants are strongly encouraged to contact NIAID program staff with any questions regarding the responsiveness of their proposed project to the goals of this PA. Applications are to be submitted on the grant application form PHS 398 (rev. 9/95). Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, e-mail: asknih@odrockm1.od.nih.gov. The NIH policy ypdate on acceptance for review of unsolicited applications that requires more than $500,000 direct cost for any one year applies to applications to become part of the Acute Infection and Early Disease Research Network. The policy update was published in the NIH Guide, Vol. 25, No. 14, May 3, 1996, and is effective June 1, 1996. The policy requires the applicant to contact, in writing or by telephone, NIAID program staff (see INQUIRIES) when the application development process begins. If the NIAID is willing to accept assignment of the application for consideration of funding, the staff will notify the Division of Research Grants before the application is submitted. The applicant Principal Investigator must identify, in a cover letter sent with the application, the NIAID program staff member who agreed to accept assignment of the application. An application received without indication of prior staff concurrence and identification of that contact will be returned to the applicant without review. For purposes of identification and processing, mark "YES" in item 2 on the face page of the application and type in the PA number PA-96-060 and the title "Acute Infection And Early Disease Research Network". Applications that are not received as a single package on a receipt date or that do not conform to the instructions contained in PHS 398 (rev 9/95) Application Kit (as modified in, and superseded by, the NIAID BROCHURE ENTITLED "INSTRUCTIONS FOR ABBREVIATED APPLICATIONS FOR MULTI-PROJECT AWARDS"), will be judged not responsive and will be returned to the applicant. 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 could be included with the application. Applicants from an institution receiving government funds under Center for AIDS Research (CFAR), Strategic Program For Innovative Research On AIDS Treatment (SPIRAT), AIDS Clinical Trial Unit (ACTU), AIDS Vaccine Evaluation Unit (AVEU), DATRI, and CPCRA programs, should describe how these programs are integrated with the proposed studies, if applicable, and ensure that no scientific and budget overlap exists with the proposed project. 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, ROOM 1040 - 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 all five sets of any appendix material must be sent to Dr. Tingley at the address listed under INQUIRIES. REVIEW CONSIDERATIONS Review Procedures Upon receipt, applications will be reviewed for completeness by the NIH Division of Research Grants (DRG) and for responsiveness by NIAID staff. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the PA 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, a process (triage) 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 PA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. The second level of review will be provided by the National Advisory Allergy and Infectious Diseases Council. Review Criteria The review criteria for this PA are essentially the same as those for unsolicited research project grant applications, with specific areas of emphasis as noted below: A. Scientific, technical, or clinical significance and originality of the proposed research. B. Appropriateness and adequacy of the experimental approach and the methodology proposed to carry out the research, specifically including the adequacy and feasibility of the applicant's plans, methods, approaches and problem solving strategies to: (1) identify, screen and recruit into research projects individuals with acute or early HIV-1 infection; (2) follow subjects for the long term and retain them in research studies; and (3) perform and quality assure laboratory assays in support of these studies. The applicant should demonstrate the ability to enroll and retain an adequate number of subjects given the size of the unit and the proposed scientific agenda. The Network will be encouraged to develop mechanisms, when appropriate, to assure comparability and standardization of laboratory testing across Units. C. Qualifications and research experience of the Group Leader and key staff in the area of the proposed research, specifically: (1) the scientific ability and track record of the applicants in conducting research on the pathogenesis of HIV; (2) the experience, leadership scientific ability and administrative competence of the applicant for the development, implementation and management of pilot Phase I/II clinical trials; and (3) experience of the applicants in performing virologic, immunologic and pharmacologic assays in support of state-of-the-art pathogenesis research and AIDS clinical trials. D. Availability of necessary resources to conduct the research. E. Adequacy of the proposed means for protecting against adverse effects of the research upon humans, animals or the environment, where such are involved. F. In clinical studies, if there is inadequate representation of women and/or minorities in a study design AND this affects the potential to answer the scientific question(s) addressed, such inadequacy will be considered to be a weakness or deficiency in the study design. This weakness will be reflected in the priority score assigned to the project, unless a convincing justification is provided by the investigator to explain the inadequate representation. AWARD CRITERIA Funding decisions will be based on scientific and technical merit as determined by peer review, the availability of funds and program priority. However, the predominant criteria for funding priorities will be the scientific and technical merit of the applications. Schedule Application Receipt Date: September 1, 1996 Scientific Review Date: November 1996 Earliest Date of Award: February 1997 INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues: Michael Hedderman, R.N., M.P.H Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2B30 Bethesda, MD 20892 Telephone: (301) 496-8214 FAX: (301) 480-4582 Email: mh33a@nih.gov Direct inquiries regarding scientific issues to: Carla B. Pettinelli, M.D. Ph.D. Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2C14 Bethesda, MD 20892 Telephone: (301) 496-0700 FAX: (301) 402-3171 Email: cp22n@nih.gov Direct Inquiries regarding review issues: Dianne Tingley, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C07 Bethesda, MD 20892 Telephone: (301) 496-2550 FAX: (301) 402-2638 Email: dt15g@nih.gov Direct inquiries regarding fiscal matters and the special instructions for preparation of the grant application to: Linda Shaw Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B31 Bethesda, MD 20892-7610 Telephone: (301) 402-6611 FAX: (301) 480-3780 Email: ls15k@nih.gov AUTHORITY AND REGULATIONS This program is supported under authorization of the Public Health Service Act, Sec. 301 (c), Public Law 78-410, as amended. The Catalogue of Federal Domestic Assistance Citation is (Sec. 93.856, Microbiology and Infectious Diseases Research, or No. 93.855 - Immunology, Allergy, and Transplantation Research, or both, as appropriate). Awards will be administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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