ADVANCED RESEARCH COOPERATION IN ENVIRONMENTAL HEALTH Release Date: June 10, 1998 RFA: ES-98-005 P.T. National Institute of Environmental Health Sciences Letter of Intent Receipt Date: July 17, 1998 Application Receipt Date: October 27, 1998 PURPOSE The mission of the National Institute of Environmental Health Sciences (NIEHS) is to reduce the burden of human illness and dysfunction from environmental exposures. The NIEHS achieves its mission through multi-disciplinary biomedical research programs, prevention and intervention efforts, and communication strategies that encompass training, education, technology transfer, and community outreach. An important element of the NIEHS mission is to develop the research capacity of minority-serving institutions that have research scientists who are committed to understanding the impact of environmental exposures on human health. To address this need, the NIEHS has developed a pilot Program Project Grant that focuses on establishing research partnerships between investigators at Research Intensive Universities (RIUs) with significant environmental health sciences research and at Historically Black Colleges and Universities (HBCUs). The purpose of this grant is to establish a research infrastructure and a hypothesis- driven research program at an HBCU. 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, Advanced Research Cooperation in Environmental Health (ARCH), is related to the priority area of environmental health. 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 There are specific eligibility criteria for the partner institutions that must be met in order to apply for this RFA. Potential applicants are strongly encouraged to contact the Program Administrator listed under INQUIRIES. Applicant Organization and Investigators For this RFA, the applicant organization must be an HBCU. The principal investigator must have his/her primary appointment at the applicant HBCU, and have a strong interest in environmental health sciences. The ARCH application must also include an RIU with significant research support in environmental health sciences, and an RIU leader (co-investigator) who has demonstrated interests in environmental health sciences. Applications that include RIU investigators who are current NIEHS grantees are encouraged. HBCU and RIU Collaboration The HBCU/RIU collaboration must be between an HBCU with a strong interest in environmental health sciences and RIU investigators with a significant research base in peer reviewed environmental health sciences-related research support such as R01, P20/30, P42 etc. In addition, the HBCU/RIU partners should be within a reasonable working distance. If there is a significant distance between the collaborating institutions, the principal investigator should provide information on how the collaboration will work and a description of past successful collaborations with the partner RIU, if applicable. In addition, because of the breadth of the research at an NIEHS Center, the NIEHS strongly encourages HBCUs to establish partnerships with RIUs that have an NIEHS Center. MECHANISM OF SUPPORT The NIEHS ARCH Program will use the NIH Thematic Research Program Project Award (S11). The maximum requested direct costs and project period will be $1,000,000 per year for a maximum of five years. FUNDS AVAILABLE It is anticipated that one to three ARCH grants will be awarded depending upon the availability of funds and the quality of the applications received. Awards are not renewable, and supplements, except as described under the section, other ARCH program requirements, budget limits and evaluation, are not allowed. The NIEHS will make a commitment for funding an institution for the full term of the award. However, the fourth and fifth years of funding will be restricted pending the results of an in-depth review of the grantee's progress toward meeting the goals of the grant. The criteria for this review are described in the Mid- Program Evaluation Criteria for ARCH Awardee section of this RFA. RESEARCH OBJECTIVES Background The National Institutes of Health (NIH) has initiated many programs over the past twenty years to assist minority-serving institutions develop the scientific resources necessary to participate in the NIH research mission. Although there have been successes, investigators at minority institutions have not generally been competitive for the mainstream NIH research programs. NIEHS believes there is a critical need for a focused program to increase the participation of minority schools and investigators in the health research mission of the Institute. To address the need for increased minority participation the NIEHS has developed this pilot program, which focuses on establishing research partnerships between investigators at RIUs with significant environmental health sciences research and investigators at HBCUs with a strong interest in such research. Goals and Scope The ARCH program project grant is a mechanism for the support of a broadly-based research program involving investigators at an HBCU and established investigators at an RIU sharing knowledge and common resources. The goal of the ARCH grant is to establish a group of investigators at an HBCU that can successfully compete for NIH/NIEHS Research Project Grant (RPG) support, typically R01 grants. To achieve this goal an ARCH grant will provide support for a broadly based multi- disciplinary research program that has a well-defined central research focus or objective. The NIEHS envisions the support received from the ARCH grant as the foundation necessary for achieving the above stated goal, and it is anticipated that the HBCU scientists will compete for other types of NIH/NIEHS grants during the period of ARCH funding as part of the overall strategy for this effort. Thus, as the ARCH program develops at the HBCU institution, it is expected that the HBCU investigators will compete for other types of grants in areas relevant to the NIEHS mission (K01, R15, R01, P01, F31/32, T32 etc.) that will provide research support after the ARCH support ends. Information on the mission and program interests of NIEHS is available on the web site: http://www.niehs.nih.gov/dert/programs/special/special.htm. In addition, it is anticipated that as a result of the research collaboration between an HBCU and RIU, talented minority undergraduates will be attracted to the graduate training program(s) of the RIU. As the program project develops, the RIU and HBCU may wish to develop a collaborative training program that takes advantage of the unique strengths of each institution. ESSENTIAL CHARACTERISTICS of ARCH PROGRAM PROJECT GRANT Overall Characteristics The ARCH grant will support a broadly based multi-disciplinary research and development program that is a collaborative effort between an HBCU and an RIU. The program focus should be on establishing a group of investigators at the HBCU that can compete for NIH RPG support. Key factors for an ARCH program project are as follows: o There must be a unifying, well-defined goal or problem area of research to which each project relates and contributes. o There must be the participation of established investigators from the RIU and HBCU in several disciplines, and all investigators must contribute to, and share the responsibilities for, fulfilling the program objectives. The program should be large enough to make a collaborative effort successful, and yet not so diverse in scope as to make the program collaboration and communication ineffective. o The RIU investigators included in this project must have significant peer- reviewed research project grant support that is relevant to the NIEHS mission (see NIEHS web site: http://www.niehs.nih.gov/external/intro.htm). o There must be a demonstrated commitment of the HBCU and RIU institutions to the support and encouragement of the ARCH program. Such support usually involves release time of faculty, capital improvements that will facilitate the research and assistance in the acquisition of scientific equipment and supplies. o There must be a commitment of the HBCU to the recruitment of new faculty that have successfully competed for NIH R01 grants in areas of science relevant to the mission of the NIEHS. Administrative and Planning Core There must be strong leaders at both the HBCU and RIU who are substantially committed to the project, are capable of scientific leadership and are willing to accept responsibility for the administration and integration of the program. Assessment of the ability of the program principal investigator (ARCH program director) and RIU leader to develop a tightly integrated program of collaborative research will be a significant consideration in the evaluation of the application. The administrative/planning core must provide the support of the administrative and research development infrastructure for the entire program and should not be duplicated within any other components. The responsibilities and activities for the administrative and planning core include: o Appropriate and adequate organization and facilities for the conduct of the research and development activities such as seminars, workshops, reference collection, computer support, etc. o An Internal Advisory Committee formed of the individual project leaders (RIU and HBCU investigators) that will assist the principal investigator in making scientific and administrative decisions in the operation of the program. o An External Advisory Committee, comprised of at least three members who are recognized as leaders in environmental health sciences, that will provide overall guidance and advice to the principal investigator and program investigators on program direction. o A Senior Scientific Advisor who has been successful in attracting RPGs from the NIH. This individual will assist the principal investigator in the overall development of the HBCU research infrastructure and advise the HBCU investigators on the preparation of research grant applications. Research Program Development Core Two types of projects (Pilot and Research) will be supported as part of the ARCH program and both types must be present. It is of paramount importance that each project (Pilot and Research) be of sufficient scientific merit to warrant independent support and that each project is an integral part of the ARCH program. To be funded, an ARCH program must have at least two Pilot projects and one Research project that are judged to have significant and substantial scientific merit on their own. Research projects are R01-type projects that have as the project leader either RIU or HBCU faculty who have been principal investigators on R01 grants from the NIH in the past three years. A faculty member from the other collaborating institution is strongly encouraged to be included in the project. The maximum project period for a Research project is five years. However, regardless of the number recommended by the Special Emphasis Panel (SEP), the number of Research projects supported by the ARCH grant cannot exceed the number of Pilot projects. Pilot projects are intended to provide an HBCU investigator an opportunity to develop his/her research skills and/or to obtain the preliminary research data needed for the submission of a NIH Research Project Grant (R01) application. Pilot projects are established between an HBCU investigator and an RIU mentor/collaborator. The maximum project period for a Pilot project is 30 months. However, the project leader for a Pilot project may delay the start of the Pilot project for up to 6 months after the award of an ARCH grant to begin the project. This will provide the HBCU investigator a period of time to establish his/her research laboratory. In order to assess the success of the Pilot projects and to provide for new Pilot projects, the principal investigator must include a provision for: o the scientific merit review of new Pilot projects that may be submitted by the HBCU investigators who were not part of the initial application or whose projects were not recommended for inclusion at the time of the original submission. Copies of all proposals, with documentation of their reviews, relative ranking, and final action must be retained by the ARCH Program Project Principal Investigator. o the tracking of the results of each Pilot project (abstract, R01 application, etc.). These records must be available to reviewers at program review meetings. A Facilities Core may be proposed provided it meets the criteria listed below: o The Core must provide service, on a continuing basis to two or more Research or Pilot projects. This support may be directed to different projects as the scientific program advances. o The Facility Core should utilize state-of-the-art techniques and equipment in order to maximize the efficiency of the entire ARCH program. o Core support funded by this grant should provide service for only Research and Pilot projects. Service provided to other projects may be done on a fee-for- service-basis or there must be some reciprocal service provided to the program that is substantially of the same value. 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 is provided 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 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 in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: https://grants.nih.gov/grants/guide/notice-files/not98-024.html ALLOWABLE COSTS Allowable budget items for program project grant applications are consistent with those for individual research project grants (See OMB Circular A-21 in PHS Grants Policy Statement). The awardee and sponsoring HBCU institution will have considerable latitude in deciding how these funds will be expended, with the exception of administrative/planning core (described below). This is to allow sufficient budgetary flexibility for the principal investigator to achieve the program goal. Budget Components and Restrictions for ARCH Program The ARCH award will provide multiple components of support that in total, will provide funds for the establishment of a research and development collaboration between groups of investigators at an HBCU and an RIU. The general budget categories and dollar levels that can be supported by this award are listed below. However, the specifics for each budget category are the responsibility of the principal investigator. The total direct cost that may be requested for an ARCH program is limited to $1,000,000. However, the indirect costs for the subcontract to the RIU that are included as a part of the HBCU direct costs, are not included in the $1,000,000 per year budget limit. A. Administrative/Planning Core 1. The ARCH grant will provide up to $125,000 (direct cost) per year for administrative/planning support of ARCH investigators. These funds are intended to support the research infrastructure necessary to provide HBCU investigators an adequate opportunity to develop competitive research applications. Funds for the conduct of Pilot and Research projects including salary are to be included in the Research Program Development Core budget. The HBCU principal investigator and the RIU leader are responsible for development of the Administrative/Planning Core budget. A listing of some of the items that may be included in this core is provided below. Budget Item Maximum allowable support 1. Principal Investigator 25% effort 2. RIU leader 15% effort 3. HBCU Pilot project Investigator 10% effort 4. HBCU or RIU Senior Scientific Advisor 10% effort 5. RIU Research project Investigator 5% effort 6. Administrative assistant at HBCU 50% effort 7. Administrative assistant at RIU 25% effort 8. Computer network support/Office supplies as justified 9. Seminars/Program enhancement/Courses as justified 10. Travel for ARCH investigators as justified 2. A request of up to $100,000 for major equipment items for HBCU investigators may be included in the Administrative/Planning Core budget in the first year. This equipment may be in addition to equipment that is requested for the Research/Pilot projects or the Core facility. These equipment items must be well justified and be an integral part of the research program the HBCU investigator(s) plan to develop. These funds are in addition to the $125,000 for the administrative/planning core budget items identified above (1). B. Research Program Development Core The ARCH grant will provide up to $400,000 (direct cost) per year for research program development at the HBCU to include: 1) Pilot projects between ARCH (HBCU and RIU) investigators, 2) HBCU faculty recruitment of NIH R01-level scientists, and 3) Facility Core. In addition, the ARCH grant will provide the RIU up to $375,000 per year for Research projects (4). 1) Pilot Projects Items that may be included are HBCU and RIU investigator salaries, technical support, supplies, small equipment items, travel and other items which are necessary for the conduct of the pilot project. The maximum direct cost for the Pilot project is $75,000 per 12 month period, and the maximum length of a Pilot project is 30 months. At least two Pilot projects must be recommended by the Special Emphasis Panel (SEP) in order to be eligible for the ARCH Award. 2) HBCU Faculty Recruitment. Funds may be requested to help recruit up to two talented investigators to the HBCU who have been successful in obtaining NIH RPG support, typically R01 grants. The ARCH award will provide up to $125,000 per year (direct cost) for three years for the establishment of a research laboratory at the HBCU. These funds may be used to provide partial salary support (up to 75%) and laboratory set-up costs for investigators newly recruited to the HBCU. The University must provide a commitment of 25% salary support for the recruited investigator that is derived from non-Federal funds. Because it is unlikely that a specific individual to be recruited can be identified, a well-described plan for recruiting these individuals should be included in the application. 3) Facility Core. The Facility Core unit is a resource for the Research/Pilot projects that provides centralized services or equipment to several projects. At a minimum, a Facility Core must provide service or equipment for at least one Pilot and one Research project. The Facility Core may be located at either the RIU or HBCU, and the support may be directed to different component research projects as the scientific program advances. The principal investigator may request up to $100,000 per year (direct cost) for the Facility Core. 4) Research Projects. The maximum direct cost for a Research project is $125,000 per year, and funding maybe requested for up to five years. At least one Research project must be recommended by the SEP in order to be eligible for the ARCH award. OTHER ARCH PROGRAM REQUIREMENTS, BUDGET LIMITS AND EVALUATION A. Submission of Research Project Grants (RPG) to the NIH. Administrative and Research Program Development support is intended to provide the HBCU investigators the time, information and skills required to prepare NIH RPG applications, typically R01s. Since the ARCH grant is not intended to provide long term research support, HBCU investigators are required to apply for other NIH/NIEHS grants that will provide the long- term support required for environmental health sciences research projects. B. Graduate Student Support. The ARCH program is not intended to provide support for graduate students. Such support should be obtained through competitive training programs of the NIH/NIEHS such as the Individual (F31), Institutional (T32) National Research Service Awards or through supplements to ongoing RPGs. C. Supplemental Funds for Additional HBCU Investigators or Postdoctoral Trainees As the program develops, supplemental funds may be requested with the approval of the NIEHS staff, for the support of additional HBCU faculty and postdoctoral trainees on RIU Research projects and for the support of Research projects that were recommended by the SEP, but were not funded because there was not a sufficient number of meritorious Pilot projects. D. Mid-Program Evaluation Criteria for ARCH Awardee In addition to the usual review of the noncompeting application each year, there will be an in- depth review of the progress of the ARCH program toward meeting the program goal at the midpoint of the grant period. The criteria to be used for the evaluation are the following: o Number of peer-reviewed publications with an HBCU author/co-author. o Number and type of NIH RPGs submitted by and awarded to HBCU investigators (R01, R03, R15, P01, K01). o Success in attracting faculty who have successfully competed for NIH RPGs. o Status of the research infrastructure, and plans for sustaining and nurturing it after the ARCH funding ends. The in-depth mid-program evaluation will be used as a basis for awarding the fourth and fifth year of funds. Pre-application Phase. Communications between a potential principal investigator and program staff of the NIEHS at the pre-application planning phase will serve to (1) advise the applicant concerning the areas of program interests of the NIEHS; (2) facilitate the receipt of a well-organized, tightly-focused application; and (3) ensure that the application conforms to established guidelines and criteria for an S11 application. The initial contact with NIEHS program staff is the responsibility of the potential applicants and should be made as early as possible. This interaction may take the form of correspondence, such as a letter of intent, telephone conversations, etc. Program staff are particularly cognizant of the scope of their programs and of the S11 guidelines and are especially qualified to advise applicants concerning the preparation of a complete and well-developed application. This communication will enable the staff to discuss issues such as the need for integration of all projects into the theme of the overall program, the established review guidelines, the proper format of the applications, and the necessary relevancy of the proposal to the programs supported by the NIEHS. LETTER OF INTENT Prospective applicants are asked to submit, by July 17, 1998, a letter of intent that includes a descriptive title of the proposed project, the name, address, and telephone number of the Principal Investigator at the HBCU and the Leader at the RIU. In addition, the names of the other investigators from the HBCU and RIU should be provided. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows the NIEHS 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: David Brown, M.P.H. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, EC-24 111 T.W. Alexander Drive, EC-24 (for express/courier service) Research Triangle Park, NC 27709 Telephone: (919) 541-4964 FAX: (919) 541-2503 Email: [email protected] APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, Email: [email protected]. The application can also be downloaded from the web. Investigators preparing an ARCH program project grant application should follow the program project guidelines of the NIEHS. The web site address for these instructions is http://www.niehs.nih.gov/dert/programs/p01.htm. In addition, applicants should be aware that the ARCH grant has additional requirements, described below, that differ from a typical program project. These requirements must be appropriately considered in the preparation of the application. SUPPLEMENTAL INSTRUCTIONS The following supplemental instructions are provided: Annual meetings, to be held either in conjunction with a national scientific meeting, such as the Society of Toxicology or in the Research Triangle Park, NC, are planned for the exchange of information among investigators and to review the progress of the ARCH program in attaining the stated goals. Applicants must budget travel costs associated with these meetings (one per year) for the principal investigator and RIU leader in their applications. If IRB or IACUC review is unavoidably delayed beyond submission of the application, a follow-up IRB certification from an official signing for the applicant organization must be sent to and received by the Scientific Review Administrator of the Special Emphasis Panel by December 2, 1998. If IRB certification and/or IACUC verification is not received by December 2, 1998, the application will be considered incomplete and returned to the applicant. 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, type written original of the application, including the checklist, and three signed, clear, and single-sided 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) At the time of submission, two additional copies of the application must be sent to: David Brown, M.P.H. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, EC-24 111 T.W. Alexander Drive, EC-24 (for express/courier service) Research Triangle Park, NC 27709 Telephone: (919) 541-4964 FAX: (919) 541-2503 Email: [email protected] Applications must be received by October 27, 1998. However, an application received after the deadline may be acceptable if it carries a legible proof-of- mailing date assigned by the carrier and the proof-of-mailing is not later than one week prior to the deadline date. Proof of mailing is a U.S. Postmark or dated receipt from a commercial carrier. Private meter marks are not acceptable. Late applications with a postmark after October 27, 1998, will be returned to the applicant without review. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the Center for Scientific Review (CSR) and responsiveness to the RFA by the NIEHS. Applications that are incomplete and/or considered non-responsive to the RFA will be inactivated and returned to the applicant without further consideration. As part of this review, program staff will determine if the RIU investigators meet the criteria for peer-reviewed investigator-initiated research support relevant to the NIEHS mission. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by a peer review group convened by the NIEHS in accordance with the standard NIH peer review procedures. As part of the initial review process, 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. Applications judged to be in the lower half of applications under review may or may not be discussed or assigned a priority score. The final review and recommendations of all applications assigned to the NIEHS is made by the National Advisory Environmental Health Sciences Council (NAEHS). The Council is the primary body for determining the significance of the application to the program goals and mission of the NIEHS. Review Criteria The following is a listing of some of the items considered by the review committee. A. Overall program 1. A program cohesiveness that clearly indicates that the presence of the ARCH program will make a difference in the research infrastructure and capacity of the HBCU. 2. The likelihood that the collaboration between the RIU and HBCU will be successful. B. Administrative and Planning Core: 1. Scientific and administrative leadership ability and experience of the HBCU principal investigator and the RIU leader, and their commitment and ability to devote adequate time to the effective management of the ARCH program. 2. Appropriateness and adequacy of multi-disciplinary teams constituting the program's members. 3. Academic environment and resources in which the research will be conducted, including availability of space, equipment, human subjects, animals, or other resources as required, and the potential for interaction with scientists from other departments. 4. Administrative organization to foster the scientific development at the investigators and institution. 5. Institutional commitments to the program including fiscal responsibility and management capability of the institutions to assist the HBCU principal investigator and the RIU leader in following DHHS, PHS, and NIH policies. 6. Appropriateness of the budget in relation to the proposed program. 7. Human subjects protection, animal welfare, and biohazard issues. 8. Appropriateness of first year equipment requested, if any, for the program. C. Research Program Development Core: Facility Core 1. Utility/benefit of the Facility Core to the program, 2. Qualifications, experience, commitment of the personnel involved in the core. 3. Appropriateness of the budget. D. Research Program Development Core: Scientific Projects The review of the individual research projects is similar to the review of individual project grant applications (R01) for the Research and Pilot projects. These projects must have substantial scientific merit and, in essence, be of sufficient quality to be supported if they were submitted as individual projects. The review criteria are intended to focus more on the global picture of each project and the program overall rather than concentrating on the details of each experiment in their critiques. The review criteria are as follows: 1. Significance: Does the study address an important environmental health sciences problem? If the aims of the application are achieved, then how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive the field. 2. Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? 3. Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 4. Investigators: Unless already evaluated elsewhere in this report, assess whether the project leader is appropriately trained and well suited to carry out the proposed work. Also address the adequacy of their time commitment. 5. Environment: Does the environment in which the work will be performed contribute to the probability of success? Do the proposed experiments take advantage of the unique features of the scientific environment or employ useful collaborative arrangements. 6. When human subjects are involved, the adequacy of plans to include women and minorities in the study design and the potential of that design to address the scientific question(s) proposed must be addressed. Additionally, each project will be evaluated on the basis of its contribution to the overall goal of the ARCH program. E. Research Program Development Core: Faculty Recruitment 1. Plans to recruit new faculty that have successfully competed for NIH RPG grants. 2. The commitment of the HBCU to recruit investigators with respect to money, laboratory and office space, and other support. As part of the scientific and technical merit evaluation of the research plan, reviewers will be instructed to address: Adequacy of plans for including children as appropriate for the scientific goals of the research, or justification for exclusion. AWARD CRITERIA The anticipated date of award is July l, 1999. The following will be considered in making funding decisions: o commitment of the university to establish a research infrastructure that is sustainable after ARCH support ends. o potential of the HBCU investigators to obtain NIH research project grants (R01s) relevant to the mission of the NIEHS. o potential of the ARCH program to make a significant contribution to the NIEHS mission; o quality of the Research and Pilot projects scientific merit as determined by peer review; and o availability of funds. Schedule Letter of Intent Receipt Date: July 17, 1998 Application Receipt Date: October 27, 1998 Initial Scientific Review: January 1999 Second Level Review by NAEHS Council: May 1999 Earliest date for award: July 1999 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: Michael J. Galvin, Ph.D. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, EC-23 111 T.W. Alexander Drive, EC-23 (for express/courier service) Research Triangle Park, NC 27709 Telephone: (919) 541-7825 FAX: (919) 541-5064 Email: [email protected] Direct inquiries regarding fiscal matters to: Mr. David L. Mineo Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, EC-22 111 T.W. Alexander DRIVE, EC-22 (for express/courier service) Research Triangle Park, NC 27709 Telephone: (919) 541-1373 FAX: (919) 541-5064 Email: [email protected] AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.113 and 93.115. Awards are made under authorization of the Public Health Service Act, Title IV, Part a (Public Law 78-410, as amended by Public Law 99-158, 43 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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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