DEVELOPMENTAL GRANTS FOR AUTISM CENTERS OF EXCELLENCE Release Date: April 25, 2001 RFA NUMBER: RFA-MH-01-013 (also see Notice NOT-OD-01-039) National Institute of Mental Health ( National Institute of Child Health and Human Development ( National Institute of Neurological Disorders and Stroke ( National Institute on Deafness and Other Communication Disorders ( National Institute of Environmental Health Sciences ( Letter of Intent Receipt Date: June 12, 2001 Application Receipt Date: July 12, 2001 THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. THIS RFA INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS RFA. PURPOSE The National Institutes of Health Autism Coordinating Committee (NIH/ACC) is implementing the aspects of the Children"s Health Act of 2000 that relate to autism. An important component of the Act is the establishment of Centers of Excellence in Autism Research by NIH. As a first stage in implementing this centers program, the NIH/ACC institutes are releasing this Request for Applications (RFA) to support teams of investigators in planning and developmental activities aimed at maximizing the probability that they will become highly qualified applicants for future Centers of Excellence in Autism Research support. Support under this RFA is intended to facilitate planning and developmental processes so that highly competitive applications for center support can be developed quickly. However, participation in this RFA or the review outcome of this participation, will not itself be a factor in the review of a subsequent Center application. Accordingly, teams with current autism research support, for example, may decide to submit a Center application without first having participated in this developmental RFA. Investigators interested in applying for support of autism research using mechanisms other than this RFA should see NIH PA-01-051 ( for a description of NIH"s broad support of research dealing with this disorder. 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), Developmental Grants for Autism Centers of Excellence, is related to one or more of the focus areas. Potential applicants may obtain a copy of "Healthy People 2010" at ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private institutions, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) Exploratory/Developmental Grant R21 award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Funding under this developmental RFA will be for one year at a maximum of $100,000 direct costs. For those applications that include more than one institution, direct costs of up to $125,000 for the year may be requested to allow for F&A costs on consortium arrangements. Awards are not renewable and supplements are not allowed. This RFA is a one- time solicitation. The earliest anticipated award date is September 30, 2001. Specific application instructions have been provided under "Application Procedures" (below) to reflect the purpose and nature of this mechanism and this RFA, as well as to accommodate the "Modular Grant" and "Just-In-Time" streamlining efforts being implemented by the NIH. FUNDS AVAILABLE The estimated total funds (direct and Facilities and Administrative (F&A) costs) available for support for all awards made under this RFA will be $1.7 million. Thus, up to 10 awards may be made if meritorious grant applications are received and funds are available. Allowable Costs Funds provided under this RFA are intended to support activities such as travel for group meetings, partial support for administrative personnel to facilitate the logistics of intensive interaction among investigative teams, support for critical ongoing pilot projects that could demonstrate feasibility in a Centers of Excellence proposal, development of resource cores, and/or other expenses that are reasonably incurred in activities that are crucial to developing a quality proposal for Centers of Excellence support. The usual NIH policies governing grants administration and management will apply. Although this program is provided for in the financial plans of the participating institutes, awards pursuant to this RFA are contingent upon the availability of funds for this purpose and the receipt of a sufficient number of applications of high scientific merit. RESEARCH OBJECTIVES Background In the few years since the NIH/ACC was established, there has been considerable expansion and enhanced coordination of autism research efforts at NIH. The members of the NIH/ACC have been and are committed to the broad intensification of autism research efforts called for in the Children"s Health Act of 2000. This RFA represents one component of that commitment. Even given the promising growth of the clinical and basic research fields relevant to autism, and the interaction among investigators in the field cultivated by sustained NIH support of the Collaborative Programs of Excellence in Autism (CPEA) program, the Centers of Excellence in Autism Research program will represent a quantum increase in the organization and scope of the scientific enterprise related to autism. The present RFA is intended to increase the number and quality of teams and/or sites fully prepared to organize the scientific and infrastructure resources necessary to generate outstanding applications to become Centers of Excellence for Autism Research. Developmental grants are a proven method of facilitating collaborations among teams of researchers who need to interact intensively in order to formulate integrative strategies. Following such focused preparation, researchers are in a far better position to apply for comprehensive center support, and the resulting centers are better conceptualized and more effective. Therefore, the primary goal of the present initiative is to support early and mid-stage development of interdisciplinary teams of accomplished investigators focused on basic and clinical issues related to autism. This support will provide them the opportunity to define common goals and objectives, prove the feasibility of their working as a cohesive, interactive research team, and aid in the acquisition of resources, equipment, or administrative support needed to operate an interdisciplinary center. This type of multidisciplinary, multi-faceted research is of paramount importance in better understanding the etiology, pathophysiology, and insightful treatment of autism. Demonstrating the planning and development interaction of such teams to produce innovative, potentially high-impact approaches to important research problems would position these teams well to apply for support as Centers of Excellence in Autism Research. The present RFA is also intended to support activities that will attract into this effort outstanding investigators who have not have been part of the autism field. Such investigators may need initial support to establish appropriate collaborations with investigators with autism expertise and to demonstrate and document the feasibility of their new collaborations. Characteristics of Responsive Applications Critical elements of any application submitted in response to this RFA will include (1) an overview of the proposed team, (2) an explanation of how it could eventually constitute the backbone of a center, (3) a description of the potential center’s central theme and goals. The applicants should describe how the team can achieve its major development objectives during the 1-year period of support provided under this RFA, and the team’s vision of how a center created by them could develop over a period of several years. This would involve explaining the proposed contribution of each team member and how that investigator is synergistic with other members and their probable research programs. Only applications that include both basic and clinical research components will be considered responsive to this RFA. The Act stipulates that each Center of Excellence should include investigations into the cause, diagnosis, early detection, prevention, control, and treatment of autism. However, applications for the present RFA will be expected to propose developmental activities only in some substantial subset of these topics. It is also stipulated in the Act that the centers, as a group, shall conduct research including the fields of developmental neurobiology, genetics, and psychopharmacology. Thus, strengths in these areas will be desirable for the present RFA. It is expected that most of the teams that compete for support under this RFA will submit applications for the Centers of Excellence Program. However, some teams may be successful in the present competition and decide that their research programs are more suitable for support by R01 or other NIH mechanisms and proceed accordingly. Other teams may decide that they are prepared to apply for full center support without responding to this RFA. These developmental grants will provide institutions with the resources to set in place detailed plans for all of the components that would potentially make them competitive for Center of Excellence support. An appropriate developmental PI with expertise in basic or clinical research relevant to autism must be selected, as well as a Co-Director with expertise in a complementary field. The PI should have a demonstrated capability to organize, administer and direct the team. It is expected that the PI will have a substantial investment in this developmental effort, with the goal of assembling and organizing an outstanding center application. Investigators with the qualifications to be members of the research team, and to contribute to such a unique enterprise, may be located in different geographic locations. Therefore, collaborations among different institutions are encouraged, if scientifically appropriate. The proposed team will be responsible for the definition of the research goals and objectives of the developmental enterprise, as well as ongoing activities. The lead investigators should represent major scientific components that will be involved in the relevant proposed Center of Excellence, and each must have demonstrated scientific accomplishment, but they do not need to demonstrate prior interactive research amongst themselves. Since the organization and submission of applications in response to this RFA is time-limited, it is expected that modifications to the membership of the team may occur during the developmental funding period. For example, to provide the most effective combination of scientific skills, the team may well recruit new members during the funding period. Since the duration and total amount of support provided under the present mechanism are limited, it is not anticipated that totally new or substantial research projects will be entirely funded from this support. However, support for new pilot projects of limited scope, or pivotal funding of partially completed projects critical to a future Centers of Excellence application would be appropriate. Thus, the application for this RFA may contain descriptions of the Developmental Projects selected or examples of possible Developmental Projects. These projects will not be reviewed as traditional research projects. Rather, the proposed Developmental Projects will serve as an indication of the priorities to be focused on by the group, a reflection of the decision-making abilities of the scientific leadership, the ability to stimulate mutually beneficial collaborations between members of the team, and the initial ability of the group to interact productively and scientifically. Applications in response to this RFA should provide a description of the clinical populations, tissue resources, genetics resources, and other resources that will be involved as part of the team"s clinical research component. Activities During Funding Period During the course of the developmental award, the leadership team will be responsible for the design and implementation of planning activities that will lead to a well-developed, conceptually sound application for a Center of Excellence in Autism. This will include a proposed plan through which scientific synergy can occur on a stable and continuing basis that will incorporate: 1) an organizational structure specifically designed to facilitate intellectual cross-fertilization among team members, 2) a detailed description of core facilities that would support research activities, 3) a plan for the distribution and management of developmental funds for feasibility testing of new projects, 4) a strategy for providing career development opportunities for new and established investigators, and 5) a broad range of educational activities, from formal undergraduate and graduate programs to courses and seminars for students and researchers, visiting scientists program or other types of training or educational approaches. The planning activities should emphasize the interface between clinical and basic research and should be structured to meet the needs and level of maturity of the ongoing efforts. Planning activities should address the following elements: o Establishment of an Organizational Structure - Organizational activities must occur, during which the group will be expected to define: - The organization and operational structure of the team. This will include planning for leadership by senior investigators, who will be responsible for the overall scientific direction of the Program. This will also involve delineating mechanisms for involving a dynamic group of investigators at all levels of experience. - A plan for interactive activities that will occur regularly over the entire course of the developmental award. These interactions will be determined by the applicants, and emphasis will be placed on establishing creative, productive interactions. In addition the interactive activities should be geared towards promoting the cross-fertilization between subdisciplines of research relevant to autism. - A description of the core facilities necessary to support the scientific goals of the program. Access to equipment and resources is often a problem, especially for multi-disciplinary programs. The establishment of core resources dedicated to team-related Developmental Projects will provide this access. Initially, core resources may simply be extensions of existing laboratories or facilities, and the definition of a core resource would vary considerably depending on the Developmental projects to be selected, existing facilities, and the scientific focus of the team. - A model of the process for the selection, monitoring, funding and, if necessary, termination of Developmental Projects to be implemented. - A plan for developing a full range of educational activities, from formal undergraduate and graduate programs to courses and seminars for student and researchers, visiting scientists program or other types of training, cross- training, or educational approaches. o Initiation or Expansion of Developmental Projects Applicants may select two to three highly interactive Developmental Projects for research support. These projects can be geared toward determining project feasibility, proof of principle, and/or acquisition of preliminary data. Developmental Projects may demonstrate newly established collaborative efforts between two or more groups of investigators or may be significant extensions of ongoing collaborations. When funded teams submit their Centers of Excellence application, it is not expected that the Developmental Projects will necessarily have generated sufficient data for meaningful interpretation, since the term of the developmental grants is quite limited. The progress made during this phase, however, will be an important indication of how successfully the developmental team functioned to implement innovative research. Centers of Excellence in Autism Research Because of the explosive growth of basic and clinical research into the biological and behavioral aspects of complex disorders, there exist rapidly expanding opportunities to speed the progress of biomedical research into disorders such as autism. The Autism Centers of Excellence specified in the Children"s" Health Act of 2000 are intended to support outstanding scientific projects, and also to create an infrastructure of excellence in basic and clinical science relevant to autism that will support and promote multidisciplinary research and provide an environment in which to train a new generation of autism researchers. The Act contains other provisions that will apply to Centers of Excellence. Some of these will primarily be relevant to the review of the Centers applications themselves, but are relevant to the present RFA mostly because applicants should be aware that they will need to address these issues in any future application they submit for Centers support. The text of the Act pertaining to Centers of Excellence is as follows: (1) IN GENERAL. The Director [of NIH] shall under subsection (a)(1) make awards of grants and contracts to public or nonprofit private entities to pay all or part of the cost of planning, establishing, improving, and providing basic operating support for centers of excellence regarding research on autism. (2) RESEARCH. Each center under paragraph (1) shall conduct basic and clinical research into autism. Such research should include investigations into the cause, diagnosis, early detection, prevention, control, and treatment of autism. The centers, as a group, shall conduct research including the fields of developmental neurobiology, genetics, and psychopharmacology. (3) SERVICES FOR PATIENTS.- (A) IN GENERAL. A center under paragraph (1) may expend amounts provided under such paragraph to carry out a program to make individuals aware of opportunities to participate as subjects in research conducted by the centers. (B) REFERRALS AND COSTS. A program under subparagraph (A) may, in accordance with such criteria as the Director may establish, provide to the subjects described in such subparagraph, referrals for health and other services, and such patient care costs as are required for research. (C) AVAILABILITY AND ACCESS. The extent to which a center can demonstrate availability and access to clinical services shall be considered by the Director in decisions about awarding grants to applicants which meet the scientific criteria for funding under this section. (4) COORDINATION OF CENTERS, REPORTS.- The Director shall, as appropriate, provide for the coordination of information among centers under paragraph (1) and ensure regular communication between such centers, and may require the periodic preparation of reports on the activities of the centers and the submission of the reports to the Director. (5) ORGANIZATION OF CENTERS.- Each center under paragraph (1) shall use the facilities of a single institution, or be formed from a consortium of cooperating institutions, meeting such requirements as may be prescribed by the Director. (6) NUMBER OF CENTERS, DURATION OF SUPPORT.- (A) IN GENERAL.- The Director shall provide for the establishment of not less than 5 centers under paragraph (1). (B) DURATION.- Support for a center established under paragraph (1) may be provided under this section for a period of not to exceed 5 years. Such period may be extended for 1 or more additional periods not exceeding 5 years if the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Director and if such group has recommended to the Director that such period should be extended. Future Plans This initial RFA will be followed by another in FY2002 that will solicit proposals for Centers of Excellence, with anticipated funding of the first round of successful applications in FY2003. The Act calls for NIH to fund no fewer than 5 Centers, which may require subsequent rounds of competition. The participating institutes intend to create a funding pool for the Centers that would be approximately $8 million per year to fund the total costs of a complement of 5 centers. The participating institutes will fund the Centers in a collaborative way so that they will become an interactive network of high-quality research enterprises covering a spectrum of interests in this disorder. The scope of NIH support was specified to include planning (as in this RFA), establishing, improving, and providing basic operating support for such Centers. Each Center will conduct basic and clinical research into autism, and such research should include investigations into the cause, diagnosis, early detection, prevention, control, and treatment of autism. Furthermore, the Centers, as a group, will conduct research including the fields of developmental neurobiology, genetics, and psychopharmacology. While the Centers of Excellence program will encompass this broad spectrum of research endeavors, individual initial applications under this RFA will not be required to include all these elements. 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 are 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 research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (, a complete copy of the updated Guidelines are available at The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. 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: 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. DATA AND SAFETY MONITORING It is the policy of NIH that provision be made for the oversight and monitoring of all intervention studies to ensure the safety of participants and the validity and integrity of the data. The NIH policy was published in the NIH Guide to Grants and Contracts, June 10, 1998 and is available at: NIMH guidance on data safety and monitoring is available at: REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS All investigators proposing research involving human subjects should read the policy that was published in the NIH Guide for Grants and Contracts, June 5, 2000 (Revised August 25, 2000), available at the following URL address NIH GRANTS POLICY STATEMENT The NIH Grants Policy Statement (NIHGPS) has been revised and reissued. The provisions of the revised NIHGPS are effective for all funded NIH grants and cooperative agreements with budget periods beginning on or after March 1, 2001. The revised NIHGPS is available at: LETTER OF INTENT Prospective applicants are asked to submit, by June 12, 2001, 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 RFA. Although this letter is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NIMH staff to estimate the potential review workload to plan the review. The letter of intent is to be sent to Dr. Steve Foote at the address listed under INQUIRIES. APPLICATION PROCEDURES Applicants are strongly encouraged to call one of the NIH program staff listed at the end of this document with any questions regarding the responsiveness of their proposed project to the goals of this RFA. Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted at the deadline indicated at the beginning of this document. 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: In addition, the application kits can be found on the following URL: There are special application instructions for this RFA: The Research Plan is limited to 10 pages. Appendix material is limited to 5 items. 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. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS BUDGET INSTRUCTIONS All applications submitted in response to this RFA must provide a modular budget, that is, they will request direct costs in $25,000 modules. The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $100,000, or up to $125,000 for applications with more than one institution, to allow for F&A costs for consortium arrangements) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page. [See sample pages at:] At the top of the page, enter the total direct costs requested for each year. This is not a Form page. o Under Personnel, list all project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language, salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of all personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent (LOI) to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: - Complete the educational block at the top of the form page, - List position(s) and any honors, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years, - List selected peer-reviewed publications, with full citations. o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. For purposes of identification and processing, item 2a on the face page of the application must be marked "YES" and the RFA number "MH-01-13" and the words "DEVELOPMENTAL GRANTS FOR AUTISM CENTERS OF EXCELLENCE" must be entered on the face page. Applications must be received by July 12, 2001. Applications not received as a single package on the receipt date or not conforming to the instructions contained in PHS 398 (rev. 4/98) Application Kit (as modified in, and superseded by, the special instructions below, for the purposes of this RFA), will be judged non-responsive and will be returned to the applicant. The RFA label and line 2 of the application should both indicate the RFA number. The RFA label must be affixed to the bottom of the face page. 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. The sample RFA label, available at the following URL [] has been modified to allow for this change. Please note this is in Portable Document Format (PDF). If the application submitted in response to this RFA is substantially similar to a grant application already submitted to the NIH for review, but that has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application that is essentially identical to one that has already been reviewed cannot be submitted in response to this RFA. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. Submit a signed, typewritten original of the application, including the checklist, and 3 signed, exact, 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 mail or courier service) At the time of submission, 2 additional copies of the application, including all appendix material, must be sent to: Jean G. Noronha, Ph.D. Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6154, MSC 9609 Bethesda, MD 20892-9663 Bethesda, MD 20817 (for courier/express service) Applications must be received by July 12, 2001. If an application is received after this date, it will be returned to the applicant without review. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC Program Director or Principal Investigator should be included with the application. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by program staff. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIMH in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and will be discussed, assigned a priority score, and receive a second level review by the respective Institute’s National Advisory Council. Review Criteria The criteria to be used in the evaluation of grant applications are listed below. To put those criteria in context, the following information is contained in instructions to the peer reviewers. The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. The reviewers will comment on the following aspects of the application in their written critiques in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. 1. Significance. Does this study address an important problem? 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 project? Does the applicant acknowledge potential problem areas and consider alternative tactics? What is the likelihood that support of the proposed developmental activities will improve the quality of a subsequent Center of Excellence in Autism Research application, and increase the likelihood of success. 3. Innovation. Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? Special emphasis will be placed on integration of basic and clinical research components relevant to autism into promising synergistic proposals. The review will not emphasize detailed protocols or methods. 4. Investigator. Are the investigators appropriately trained and well suited to carry out this work? The quality of the research team will be given special emphasis in this review. The inclusion of outstanding investigators who have not previously engaged in or have been associated with NIH-supported research directly relevant to autism, is encouraged, especially when there is autism expertise among some other members of the research team. 5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? Are there strong potential resources available at the performance site(s)? The initial review group will also examine: The appropriateness of proposed project budget and duration, the adequacy of plans to include children and both genders and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects, the provisions for the protection of human and animal subjects, and the safety of the research environment. Schedule Letter of Intent Receipt Date: June 12, 2001 Application Receipt Date: July 12, 2001 Scientific Review Date: August, 2001 Advisory Council Date: September, 2001 Earliest Date of Award: September 30, 2001 AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program balance, and the availability of funds. The earliest anticipated date of award is September 30, 2001. 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 (research scope and eligibility) issues to: Stephen L. Foote, Ph.D. Division of Neuroscience and Basic Behavioral Science National Institute of Mental Health Neuroscience Center, Room 7204, MSC-9645 6001 Executive Boulevard Bethesda MD 20892-9645 For express/overnight services: Rockville, MD 20852 Telephone: (301) 443-3563 Fax: (301) 443-1731 Email: Deborah Hirtz M.D. Clinical Trials, Division of Extramural Research National Institute of Neurological Disorders and Stroke 6001 Executive Boulevard, Room 2212, MSC 9523 Bethesda, MD 20892-9523 Telephone: (301) 496-5821 Fax: (301) 480-1080 Email: Marie Bristol-Power, Ph.D. National Institute of Child Health and Human Development 6100 Executive Blvd, Room 4B09, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6862 Fax: (301) 480-7773 Email: Judith A. Cooper, Ph.D. Scientific Programs Branch Division of Extramural Research National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400C, MSC-7180 Bethesda, MD 20892-7180 Telephone: (301) 496-5061 Fax: (301) 402-6251 Email: Cindy P. Lawler, Ph.D. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD EC-23 Research Triangle Park, NC 27709 Telephone: (919) 316-4671 FAX: (919) 541-5064 Email: Direct inquiries regarding fiscal matters to one of the following: Diana S. Trunnell Grants Management Branch Division of Extramural Activities National Institute of Mental Health, NIH 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-2805 Fax: (301) 443-6885 Email: Gladys Melendez-Bohler, M.S. Grants Management Branch National Institute of Neurological Disorders and Stroke 6001 Executive Boulevard, Room 3290, MSC 9537 Bethesda, Maryland 20892-9537 Telephone: (301) 496-3929 Fax: (301) 402-0219 Email: Mary E. Daley Lead Grants Management Specialist, Grants Management Branch National Institute of Child Health and Human Development Buidling 6100, Room 8A17, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1305 Fax: (301) 402-0915 Email: Sara Stone Chief, Grants Management Branch National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400B, MSC-7180 Bethesda, MD 20892-7180 Telephone: (301) 402-0909 Fax: (301) 402-1758 Email: Laura Williams-Boyd Grants Management Branch National Institute of Environmental Health Sciences P.O. Box 12233, MD EC-23 Research Triangle Park, NC 27709 Telephone: (919) 541-7629 FAX: (919) 541-2860 Email: AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance Nos: 93.242 (NIMH), 93.865 (NICHD), 93.853 (NINDS), 93.173 (NIDCD), and 93.113 (NIEHS). Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service 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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