RFA-RR-02-003: CENTERS OF BIOMEDICAL RESEARCH EXCELLENCE (COBRE)

Department of Health
and Human Services (HHS)

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CENTERS OF BIOMEDICAL RESEARCH EXCELLENCE (COBRE) Release Date: December 11, 2001 RFA: RFA-RR-02-003 National Center for Research Resources Letter of Intent Receipt Date: January 18, 2002 Application Receipt Date: February 25, 2002 PURPOSE The purpose of the Institutional Development Award (IDeA) Program is to foster health-related research and increase the competitiveness of investigators at institutions located in states with historically low aggregate success rates for grant awards from the National Institutes of Health (NIH). To provide flexible support to build research capacity, the National Center for Research Resources (NCRR) of the National Institutes of Health invites applications for Centers of Biomedical Research Excellence (COBRE) from investigators at independent biomedical research institutions or biomedical research institutions that award doctoral degrees in the health sciences or sciences related to health within IDeA eligible states. Collaboration with other non-doctoral degree granting and research performing institutes or institutions is encouraged. The purpose of this Request for Applications (RFA) is to augment and strengthen the institutional biomedical research capacity through flexible support to expand and develop biomedical faculty research capability and enhance research infrastructure through support of a multi-disciplinary center, led by a peer-reviewed, funded investigator with expertise central to the research theme of the proposal. The application must have a thematic science focus in one research area such as neuroscience, cancer, structural biology, immunology, or bioengineering and may use basic, clinical or both research approaches to attain the goals of the proposed center. The scientific leadership provided by one or more established biomedical research faculty is critical to the success of this initiative, especially for the mentoring of promising junior investigators. The center is intended to support investigators from several complementary disciplines. It will enable the institution to develop a critical mass of investigators and enhance their competitiveness in a specific research area that accelerates the rate at which those investigators compete for other complementary NIH research grant support. It is also anticipated that, in some instances, the support through this initiative will facilitate the development of new disease specific research centers or augment the capability of existing centers. ELIGIBILITY REQUIREMENTS In making its assessment for eligibility, NCRR included all states/commonwealths with a success rate for obtaining NIH grant awards (number of applications awarded vs. number of applications approved) of less than 20 percent over the period of 1996-2000. Also included are those states that had higher success rates, but received less than $70 million average NIH funding over the five-year period. Under these criteria, the following states/commonwealth are eligible: Alaska Kentucky Nevada Rhode Island Arkansas Louisiana New Hampshire South Carolina Delaware Maine New Mexico South Dakota Hawaii Mississippi North Dakota Vermont Idaho Montana Oklahoma West Virginia Kansas Nebraska Puerto Rico Wyoming A maximum of three applications may be submitted from IDeA-eligible states that have no COBRE awards. Two applications may be submitted from a state that has one currently active COBRE award and those states that currently have 2 active COBRE awards may submit only one application. The applicant organization must be a domestic, public or private, or non-profit research institution. Institutions in states that do not currently hold a COBRE award are encouraged to apply. States are encouraged to give priority to institutions within their state that are not participants in the COBRE or Biomedical Research Infrastructure Network (BRIN) programs. A coordinating committee must be established by the eligible institutions to determine the lead applicant. Those states with Experimental Program to Stimulate Competitive Research (EPSCoR) committees may use them. However, the membership of the EPSCoR committees must be representative of the eligible institutions and include the appropriate biomedical research expertise needed to review the applications. The committee should have the responsibility to screen and rank-order applications and make final and binding recommendations for submission of applications to NIH. If an EPSCoR Committee is not available in an IDeA-eligible state, a comparable Committee must determine priorities for selection of proposals to be submitted. Collaboration between the eligible institutions is encouraged. Applications are encouraged from veterinary and dental schools in the IDeA states. Applications received from veterinary and dental schools will not count against the maximum of three COBRE awards held by an eligible state. The Principal Investigator (PI) of the COBRE application must be an established biomedical or behavioral research scientist who will ensure high quality research and who has the experience to administer effectively and integrate all components of the program. The PI must have an active biomedical or behavioral research program receiving NIH, NSF or other peer-reviewed support in the scientific area of the center and have the requisite administrative experience to direct the program. A minimum time commitment of 25 percent is required for this individual, however, up to 50 percent effort will be supported for mentoring and administrative oversight of the COBRE. If the PI is not in place at the institution at the time of review or award, a plan to recruit such an individual must be included in the application. An award pursuant to this RFA will not be made until and unless the institution has appointed a permanent COBRE PI. MECHANISM OF SUPPORT This RFA will use the exploratory grant award mechanism (P20). Responsibility for planning, directing and executing the proposed project will be solely that of the applicant. All current policies and requirements that govern the research grant programs of the NIH will apply to grants awarded under this RFA. The anticipated award date is August 2002. FUNDS AVAILABLE The NCRR plans to make up to 15 awards in fiscal year 2002. An applicant must request a project period of five years and a budget for direct costs of up to $1,500,000 per year, excluding facilities and administrative (F&A) costs on consortium arrangements. The budget for year one may include additional direct costs of up to $500,000 as a one-time expenditure for alteration and renovation of laboratory or animal facilities. Funds may be used to develop Offices of Sponsored Programs and for faculty expansion (i.e. recruitment of additional faculty who complement the scope of the proposed program) up to $100 thousand per year for each position. These funds may be used for salary, supplies and equipment costs. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Although the NCRR financial plans provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of applications of outstanding scientific and technical merit. At this time, it is not known if competing renewal applications will be accepted and/or if this RFA will be reissued. Consortium Arrangements When a grant application includes research activities that involve institutions other than the grantee institution, it is considered a consortium effort. Such activities may be included in the COBRE grant application, but it is imperative that a consortium application be prepared so that the programmatic, fiscal, and administrative considerations are explained fully. In addition, the COBRE thematic science focus must be evident in the application, which includes consortia arrangements. Applicants for COBRE grants should exercise great diligence in preserving the interactions of the participants and the integration of the consortium project(s) with those of the parent institution, because synergism and cohesiveness can be diminished when projects are located outside of the group at the parent institution. For the purposes of this RFA, F&A costs for the consortium organization(s) are excluded from the limit on the amount of direct costs that can be requested for the entire application. Applicants are encouraged to review the NIH policy and procedures applicable to consortium agreements, which are published as part of the NIH Grants Policy Statement, Part III, available on the NIH homepage at http://grants.nih.gov/grants/policy/nihgps_2001/index.htm. Questions may be directed to the fiscal contact identified below under Inquiries. RESEARCH OBJECTIVES This program seeks to promote the initiation and development or expansion of unique, innovative state-of-the-art biomedical and behavioral research at institutions in IDeA-eligible states. The research focus of this program encompasses the full spectrum of the basic and clinical sciences and also includes cellular and molecular biology, biophysics and biotechnology, genetics and developmental biology, pharmacology and others. The NIH recognizes that the contributions from the institutions in IDeA-eligible states are important and essential in fulfilling the promise of the NIH research agenda. The intent of this RFA is to assist these institutions to implement and use the technologies and other resources needed to conduct state-of-the-art biomedical research. The goal of this RFA is to enhance the ability of investigators to compete independently for NIH research grants. The objectives of this program will be accomplished by providing support to a principal investigator to serve as mentor to the junior investigators and to enhance the ability of the institution to compete for complementary NIH individual research grant support. This program will support three to five research projects with a thematic science focus. This initiative is not intended to replace the support for ongoing investigator-initiated research programs of established investigators. Established investigators should serve as mentors to the junior investigators to advance their careers. This initiative is intended to provide support for research projects led by junior investigators. A junior investigator is a faculty member without external, peer-reviewed funding, who has the institutional support and position to facilitate their submitting independent investigator- initiated research grant applications. RESEARCH PLAN Describe an overall research plan to justify support of a multi- disciplinary COBRE program for five years. The research plan of an application must contain the description of at least three and up to five multidisciplinary, collaborative research projects. Describe the Specific Aims in the selected area of research and the goals for the first year and for the long term. Delineate the design principles supporting the research or the hypotheses to be tested. Preliminary studies are not required for COBRE applications, but applicants with preliminary results should describe them. In the absence of preliminary results, applicants should describe the rationale and scientific basis for the proposed research. Describe the area of multi-disciplinary research that is the focus of the COBRE. Critically assess existing knowledge and approaches that have been or are being directed in the area, and specifically describe how the multi-disciplinary COBRE approach will advance the field. State concisely the importance and health relevance of the proposed research to the Specific Aims. Clearly indicate what unique research opportunities will be provided by the proposed COBRE. If the proposed COBRE research is closely related to ongoing research or an existing center, explain how the research activities of the COBRE will complement but not overlap with existing research. Describe the efforts of each member of the multi- disciplinary research team and how they will be integrated and organized to accomplish the specific aims of the project. Provide a tentative sequence or timetable for the project. Include how the data will be collected, analyzed, and interpreted. Describe how the data and technological advances will be disseminated to other investigators. Clearly describe the qualifications of the COBRE PI selected for this effort. If that individual is not a member of the faculty at the time of review of the application, include a detailed plan that will result in having that individual on the full-time faculty within one year from the date of peer-review of the institution"s application. Although no non-federal matching funds are required for these applications, clear evidence of institutional commitment should be included with the application. The level of institutional commitment will differ among applicant institutions because of the variability of resources available among institutions. At a minimum, a letter of support from a senior institutional official (e.g., President or Dean) should outline the commitment of resources and facilities to sustain and support the COBRE throughout the period of funding. The institutional environment and resources that are available to investigators must be briefly described. Available resources (e.g., laboratory facilities, patient populations, geographic distributions of space and personnel) and collaborative resources should be described. If core facilities are included for support, the relationship of each component project to the core should be described. A plan should be presented detailing the long-term goals as to how the institution intends to make the transition from the research support of the multi-disciplinary COBRE to competitive NIH grant support through applications submitted by its faculty members to relevant NIH institutes and centers. This must include both formative and summative evaluation strategies with specific milestones. ALTERATION AND RENOVATION Alteration and Renovation Costs to improve existing research laboratories or animal facilities are allowed. Alteration and renovation projects must be relevant to the scope of the proposed research and at the institution. Proposed renovations in successful applications will subsequently require the submission of design documents for review and approval before the renovation project may commence. As indicated earlier, this RFA will provide up to $500,000 in direct costs in year one of the award as a one-time cost expenditure. This RFA will not provide support for new construction, including the completion of shell space, or for equipment intended for teaching or other non-research related purposes. There is another NCRR program, entitled the Research Facilities Improvement Program, that accepts applications for construction and for extensive renovation. Refer to the NCRR Website: (http://www.ncrr.nih.gov). Research equipment/instrumentation for laboratories may be requested and must be justified by the proposed scientific projects. BIOGRAPHICAL SKETCHES For the Principal Investigator, co-investigator(s), and mentors, provide a brief biographical sketch or curriculum vitae, which includes a list of the five most recent or significant publications. This section must not exceed four pages per person. OTHER SUPPORT The application must provide a complete listing of current and pending support for the Principal Investigator, Co-Investigator(s), and non Co- Investigator Senior Personnel using only the format provided in the PHS 398 (revised 5/01). RESOURCES The application must describe the equipment and facilities available to the proposed COBRE. SPECIAL REQUIREMENTS The COBRE PI should budget for an annual two-day meeting in Bethesda, Maryland with NCRR staff. Each COBRE application must include an External Advisory Committee (EAC), comprised of at least three to five scientists, with national scientific reputations in their field, their expertise must be directly relevant to the scientific theme of the COBRE. The EAC critiques scientific progress of the COBRE and also offers advice on scientific matters to the COBRE PI. The EAC activities include concept development, program planning, encouraging faculty development and mentoring, identifying resources, and evaluating progress toward stated goals. The PI will share the advice and critiques provided by the EAC with other investigators at the center. The EAC will also review and approve candidates for replacement/substitute projects and investigators as required, before such requests are forwarded to NCRR. The EAC must meet at least twice per year on average. Minutes are to be recorded and made available for review by NCRR program staff responsible for the COBRE. 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 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. 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. This policy announcement is found in the NIH Guide for Grants and Contracts Announcement (updated September 5, 2001), at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-061.html. 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 or ethical reasons not to include them. This 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: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. 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 RFA 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. 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 Request for Applications (RFA), entitled CENTERS OF BIOMEDICAL RESEARCH EXCELLENCE (COBRE), is related to many priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. 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 NCRR staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to: Dr. Sheryl K. Brining Office of Review National Center for Research Resources National Institutes of Health 6705 Rockledge Drive, Room 6018 Bethesda, MD 20892-7965 Telephone: (301) 435-0809 FAX: (301) 480-3660 E-mail: Sb44K@nih.gov APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) available at http://grants.nih.gov/grants/funding/phs398/phs398.html must be used in applying for these grants. This version of the PHS 398 is available in an interactive, searchable format. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. An application for a COBRE award must include the following: o A clear definition of the nature and extent of research collaboration, including a full explanation of the necessary administrative, fiscal, and scientific aspects of the proposed COBRE. o A research plan for five years that includes the proposed organization and component functions of the COBRE. The plan should demonstrate the applicant"s knowledge, ingenuity, practicality, and commitment to developing a significant, productive, research program. o A description of and justification for the proposed individual research projects (a ten-page limitation for the Research Plan Section for each project) and core service facilities that collectively will contribute to the center. Applicants are required to propose at least three and up to five meritorious research projects and must describe the nature and scope of any scientific research collaborations. o A description of the research and research training or career development goals and capabilities of the proposed COBRE. The PI must establish a time line for supported applicant investigators to prepare and submit proposals for traditional research grant review during the performance period of the COBRE award. o A description of the infrastructure for conducting studies aimed at developing a nationally-competitive biomedical research program. o Line drawings (8.5 by 11 inches) of any proposed alteration and renovation and an itemized budget. Justification of this alteration and renovation relative to the impact on the COBRE activities must be provided. 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. 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) At the time of submission, two additional copies of the application and five copies of any appendices must be sent to: Dr. Sheryl K. Brining Director, Office of Review National Center for Research Resources 6705 Rockledge Drive, Room 6018 Bethesda, MD 20892 Telephone: (301) 435-0809 FAX: (301) 480-3660 E-mail: Sb44L@nih.gov Schedule Letter of Intent Receipt Date: January 18, 2002 Application Receipt Date: February 25, 2002 Council Review: May 2002 Earliest Award Date: August 2002 Applications must be received by February 25, 2002. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept an application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS o Extent to which the objectives of the program are likely to be met: 1. to augment and strengthen the institutional biomedical research capability. 2. to provide support for the development of a multidisciplinary center. 3. to encourage basic or clinical research. 4. to focus on a scientific theme such as (but not limited to) neuroscience, structural biology, immunology, cancer or bioengineering. o Qualifications of the Principal Investigator: 1. as an established biomedical research scientist. 2. as the head of an active research laboratory. 3. as the recipient of relevant, peer-reviewed, funded research (NIH, NSF or other peer-reviewed research). o Quality of the individual research projects: 1. in terms of their individual scientific merit. 2. in terms of their contribution to the goals of the center program. 3. in terms of the planned collaborations among the projects within the center or with outside institutions. 4. in terms of the mentorship available to the junior investigators of these projects. o Quality of the research training, career development and mentoring plan for junior investigators of the center. o Suitability of the plan for recruiting new faculty. o Appropriateness of available infrastructure that supports the center. o Suitability of the plan to establish core laboratory(s). o Evidence of institutional commitment. o Suitability of the External Advisory Committee. Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by NCRR staff. Applications that are incomplete and/or non-responsive to this RFA, or exceed the maximum allowable first year direct cost limit of $2,000,000, excluding F&A costs for consortium budgets, 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 a Special Emphasis Panel convened by NCRR in accordance with the review criteria. As part of the initial review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit, generally the top one half of applications under review, will be discussed, assigned a priority score, and receive a second level of review by the National Advisory Research Resources Council. Applications determined to be of low scientific merit will be withdrawn from further competition and the principal investigator and the official signing for the applicant organization will be notified. The review of the COBRE application is based not only on the traditional review criteria for research projects, but also considers the qualification and stature of the Principal Investigator to provide leadership, both scientific and administrative, and the feasibility and potential for investigators to become competitive for independent funding. The following criteria will be used to evaluate the 1) administration and the overall potential for enriching the intellectual milieu for doing research, 2) scientific merit of the individual biomedical research projects, and 3) effectiveness in training and promoting junior investigators. Senior, funded investigators must not be proposed as project leaders. Administration of the center o The qualifications of the Principal Investigator to provide scientific and administrative leadership in developing and directing the COBRE, and establishing thematic collaborative research efforts, o The significance, approach, and innovation of the proposed research projects and of the COBRE as a whole, o The nature, scope, and effectiveness of the plans for coordination and cooperation among research project investigators, o The strengths of the applicant investigators and the collaborating researchers, if involved, particularly the academic qualifications, biomedical expertise and research productivity, o The level of institutional commitment with regard to commitment of resources and facilities to sustain the COBRE program, including, but not restricted to existing relevant equipment, animal, and/or computer resources, and departmental or interdepartmental cooperation, o The need for the proposed core facilities and the effectiveness of these facilities to enhance the research effort. Scientific Merit of the individual proposals will be evaluated using the following review criteria: (1) Significance: Does this project address an important biomedical research question? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the research project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the research 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) Investigator: Is the investigator appropriately trained and well suited to carry out this research project? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the research project will be performed contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? Overall Evaluation: A research project 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 move a field forward. An assessment of the merit of the COBRE"s evaluation plans, including formative and summary evaluation strategies, will be taken into account in the overall evaluation of the proposal. In addition to the above criteria: o For research projects involving human subjects, the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The age- appropriate inclusion or exclusion of children in the research project and evaluate the plans for conducting the research in accord with the NIH guidelines on the inclusion of children as participants in research involving human subjects will be evaluated, o For research projects that use animals, the adequacy of the proposed plan for animal welfare and biohazard safety in the research environment, and o The appropriateness of the proposed budget and duration, including the justification for requested items in terms of the aims and methods of the proposed research studies will be evaluated. AWARD CRITERIA Funding decisions will be based on scientific and technical merit as determined by the Initial Review Group, the National Advisory Research Resources Council, geographic distribution, program balance, the enhancement of the research competitiveness of the institution, and the availability of funds. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. W. Fred Taylor, Ph.D. Division of Research Infrastructure National Center for Research Resources National Institutes of Health 6705 Rockledge Drive Bethesda, MD 20892-7965 Telephone: (301) 435-0760 FAX: (301) 480-3770 E-mail: taylorf@ncrr.nih.gov For information on budget and fiscal matters, contact: Ms. Irene Grissom Office of Grants Management National Center for Research Resources National Institutes of Health Bethesda, MD 20892 Telephone: (301) 435-0844 FAX: (301) 480-3777 E-mail: grissomi@ncrr.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.389. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74 and 92. 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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