CENTERS OF EXCELLENCE FOR RESEARCH ON COMPLEMENTARY AND ALTERNATIVE MEDICINE (CERC) RELEASE DATE: December 4, 2002 (This PA has been reissued, see PAR-06-047) (Clarification of program requirements, see NOT-AT-05-002) (see NOT-AT-04-002) PA NUMBER: PAS-03-038 LETTER OF INTENT RECEIPT DATE: March 29, 2003 APPLICATION RECEIPT DATE: April 29, 2003 EXPIRATION DATE: April 30, 2003 National Center for Complementary and Alternative Medicine (NCCAM) (http://www.nccam.nih.gov/) THIS PROGRAM ANNOUNCEMENT WITH SET-ASIDE FUNDS (PAS) CONTAINS THE FOLLOWING INFORMATION o Purpose of This PAS o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible To Become Principal Investigators o Special Requirements, Including Cooperative Agreement Terms and Conditions of Award o Where To Send Inquiries o Letter of Intent o Submitting an Application o Supplemental Instructions o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS PAS The National Center for Complementary and Alternative Medicine (NCCAM) seeks applications for Centers of Excellence for Research on Complementary and Alternative Medicine (CERC), using the NIH Program Project (P01) mechanism, as one component of a multi-faceted Centers for Research on Complementary and Alternative Medicine Program. The purpose of the CERC is to provide a vehicle for accomplished researchers to apply their expertise to address complementary and alternative medicine (CAM) research questions, with an emphasis on applying cutting-edge scientific approaches to elucidating the mechanisms of action of CAM therapies and modalities. Applications must comprise three to four research projects structured around a central scientific theme that is clearly relevant to CAM. Applicants should consult the NCCAM website (http://nccam.nih.gov/training/centers/index.htm) for relevant information regarding current specific NCCAM research priorities. RESEARCH OBJECTIVES Background CAM use in the U.S. is high, with yearly use prevalence between 30 and 42% of U.S. adults, and expenditures associated with CAM therapies exceeding non-reimbursed expenses incurred for all hospitalizations. Despite this broad use, there is insufficient scientific data on the safety and efficacy of CAM therapies. NCCAM is dedicated to conducting rigorous scientific research on complementary and alternative healing practices; to training researchers; and to disseminating authoritative information, as outlined in its Strategic Plan, posted at http://nccam.nih.gov/about/plans/fiveyear/index.htm. To this end, NCCAM employs a range of funding mechanisms, including centers, to support research, training, and career development. Centers have been a key component of the NCCAM research portfolio because they offer an opportunity to develop a program of related research projects that result in "a whole greater than the sum of its parts" and can serve as a focal point for the development of additional research and training activity. The first generation of specialized research centers introduced in 1998 allowed the NCCAM (then newly created) to cultivate research, scientific resources, and new investigators simultaneously within 16 programs. To assess the status of current CAM research centers and recommend future directions, in June 2002, NCCAM convened an Expert Panel on NCCAM Research Centers. Given that 1) the areas of CAM research are broad, 2) the expertise of investigators available to pursue CAM research ranges from novice to highly skilled and accomplished, and 3) there is a need to facilitate the development of a sustained research culture within the CAM community, the Panel recommended a multi faceted approach to the next generation of NCCAM Centers. (The NCCAM Centers Expert Panel Report is available at http://nccam.nih.gov/about/plans/centers/index.htm.) In response to the Panel's recommendation, the NCCAM has established the Centers for Research on Complementary and Alternative Medicine (CRC) Program. Currently the Centers Program consists of three individual activities, each designed to meet a different need. Additional individual programs may be developed and will be posted on the NCCAM website. The Developmental Centers for Research on Complementary and Alternative Medicine (DCRC) is intended to promote development of CAM research expertise and infrastructure, support enhanced communication and partnership-building between CAM and conventional institutions/investigators and to support developmental research projects. The International Centers for Research on Complementary and Alternative Medicine (ICRC) are designed to establish partnerships and cross-cultural exchange through which foreign and U.S. institutions and investigators can collaborate to design and implement research on CAM/traditional indigenous medical systems or components thereof in the cultures and/or environments in which they originated. Objectives The Centers of Excellence for Research on CAM (CERC), described in this announcement, are designed to provide a vehicle for highly skilled and accomplished researchers to apply their expertise in addressing CAM research questions, with an emphasis on elucidating the mechanisms of action of CAM therapies and approaches. STRUCTURE AND ORGANIZATION OF THE CERC Leadership Each CERC will be directed by a Principal Investigator (P.I.), who is required to commit a minimum of 25% time to the CERC. The P.I. will identify and select key personnel and allocate and monitor funds. A CERC External Advisory Committee (EAC) will provide guidance to the P.I. Further detail on responsibilities of the P.I. and the EAC are described in the Special Requirements of this announcement. Research Projects/Eligible Areas of Research Each CERC will comprise three to four synergistic research projects that must be structured around a central scientific theme focused on either a particular disease or class of diseases treated by CAM, a specific group of CAM therapies or treatment approaches, or a specific research theme such as wellness or the placebo effect. The emphasis of the research is to be on elucidating mechanisms of action. However, the program may include one Phase I clinical trial or one Phase II study of modest size, provided it is adequately powered to detect a meaningful difference between groups or validates surrogate markers of disease or clinical endpoints. Some examples of disciplinary approaches of potential interest include: o Molecular biology o Cellular biology o Psychoneuroimmunology o Pharmacology o Neurobiology This list should not be considered to be comprehensive, restrictive, or in priority order. Specific NCCAM research priorities are listed on the NCCAM website (http://nccam.nih.gov/training/centers/index.htm). Applicants proposing studies that include the use of botanicals or other complex natural products as a component should refer to the Policy of the NCCAM on Natural Products Research, posted on the NCCAM website at http://www.nccam.nih.gov/research/policies/naturalproducts.htm. Core(s) Each CERC is required to have an administrative core, which must serve all projects within the CERC. The administrative core is responsible for day-to-day administration, as well as program coordination and ongoing evaluation of the Center. Additional scientific cores may be included, as appropriate, bearing in mind that each core must be utilized by at least two proposed projects. Applications must clearly demonstrate how each core will serve the needs of the research program, and how each project will use core resources. Two related considerations that should be detailed if applicable are: (1) the degree to which investigators within the CERC will use and benefit from core resources and; (2) the degree to which the resources will promote new and/or expanded CAM research efforts. MECHANISM OF SUPPORT This initiative is a three-year Program Announcement with set-aside funds (PAS) that will use the NIH program project (P01) award mechanism. A P01 Center grant application (CERC) may request up to five years of support. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. The length of award will be determined through the peer review and Council advisory process. Applicants are solely responsible for planning, directing, and executing the proposed CERC. This type of award supports broadly based multidisciplinary research programs that have a well-defined central research focus or objective. An important feature is that the interrelationships among the individual scientifically meritorious projects will result in a greater contribution to the overall program goals than if each project were pursued individually. FUNDS AVAILABLE In FY 2003, NCCAM will commit up to $3.6 million to fund as many as three new CERC applications in response to this initiative. Applications exceeding 1.2 million total cost in any year will be considered unresponsive and returned without further consideration. The requested direct cost budget for the CERC will include direct and facilities and administrative costs for all subcontracts. Applications will be accepted in response to this initiative on April 29, 2003, on February 17, 2004, and on February 15, 2005. NCCAM's research priorities are posted at the NCCAM website (http://nccam.nih.gov/training/centers/index.htm) and will be updated on or before October 1 of each year beginning in 2003. Although NCCAM's financial plans provide support for this program, awards pursuant to this PAS are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. At this time, it is not known if this PAS will be reissued. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS Each CERC application must demonstrate that the following Special Requirements and Provisions are met. Further requirements are explained under the heading "Supplemental Instructions" in the SUBMITTING AN APPLICATION Section, below. Applicants must: o Attach letters of support from an appropriate, high-ranking official at the applicant institution and from each collaborating institution(s), documenting significant institutional commitment to the Center and to the collaboration; o Delineate how different components of the CERC, including key personnel, will interact, why they are essential to accomplishing the overall goal of the research, and how the combined resources create capabilities that are more than the sum of the parts; o Describe the collaborative process and methods of communication, and identify areas of potential collaboration and areas of focused collaboration; o Describe scientific and/or programmatic synergy between projects, and between projects and proposed cores (e.g., the degree of interaction between projects and with the cores must result in a program where "the whole is be greater than the sum of its parts"). o Show that research projects proposed for the CERC do not overlap in purpose or intent with existing NIH-funded grants, but will constitute new activities or a natural progression of current research; o Plan to participate, with collaborators, in an annual meeting with other NCCAM-funded center P.I.s. Travel costs for this purpose should be included in the proposed budget for the application; o Describe plans for an External Advisory Committee (EAC). Specific expertise required of EAC members should be specified but the names of individuals should not be provided. o Address how the effects of separation will be managed, if any component of a proposed Center is physically separated from the others (i.e., in a different department or institution) o Enter into a Clinical Trial Agreement, if applicable. Further information on NCCAM requirements for clinical trials are posted on the NCCAM website at http://nccam.nih.gov/research/policies/index.htm. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: Direct inquiries regarding scientific/programmatic issues to: Christine Goertz, D.C., Ph.D. Coordinator, Centers for Research on CAM Program National Center for Complementary and Alternative Medicine National Institutes of Health 6707 Democracy Blvd. Suite 401 Bethesda, MD 20892-5475 Office (301) 402-1030 Fax (301) 480-3621 Goertzc@mail.nih.gov Direct inquiries about peer review issues to: Martin Goldrosen, Ph.D. Director, Office of Scientific Review National Center for Complementary and Alternative Medicine National Institutes of Health 6707 Democracy Boulevard, Suite 401, MSC 5475 Bethesda, MD 20892-5475 Telephone: (301) 594-2014 FAX: (301) 480-2419 Email: goldrosm@mail.nih.gov Direct inquiries about fiscal or grants management matters to: Victoria Carper, MPA Grants Management Officer National Center for Complementary and Alternative Medicine National Institutes of Health 6707 Democracy Blvd., Suite 401, MSC 5475 Bethesda, MD 20892-5475 Phone: 301-594-9102 Fax: 301-480-1552 Email: vp8g@nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research, name, address, and telephone number of the Principal Investigator; o Names of other key personnel, participating institutions; o Number and title of this PAS. 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 NCCAM staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Christine Goertz, D.C., Ph.D. Coordinator, Centers for Research on CAM Program National Center for Complementary and Alternative Medicine National Institutes of Health 6707 Democracy Blvd. Suite 401, MSC 5475 Bethesda, MD 20892-5475 Office (301) 402-1030 Fax (301) 480-3621 Goertzc@mail.nih.gov SUBMITTING AN APPLICATION Applications are to be submitted using the Form PHS 398 (rev. 5/01) using the SUPPLEMENTAL INSTRUCTIONS provided below. The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, telephone (301) 435-0714; FAX: (301) 480-0525; email: grantsinfo@nih.gov. Submit the complete signed application with the checklist, and three photocopies without the checklist 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: Martin Goldrosen, Ph.D. Director, Office of Scientific Review National Center for Complementary and Alternative Medicine National Institutes of Health 6707 Democracy Blvd., Suite 401, MSC 5475 Bethesda, MD 20892-5475 Telephone: (301) 594-2014 FAX: (301) 480-2419 Email: goldrosm@mail.nih.gov SUPPLEMENTAL INSTRUCTIONS This section supplements the instructions found in Form PHS 398 (Rev. 5/01) for preparing a grant application. Additional instructions are required because the Form PHS 398 has no specific instructions for multi-project applications consisting of research projects and core(s) interrelated by a common theme such as the CERC. The following are specific instructions for sections of the PHS 398 (rev. 5/01) application form that are to be completed differently than usual. For all other items in the individual project application, follow the standard PHS 398 instructions. The instructions below are divided as follows: CERC application overview, which addresses the overall objectives and unifying theme(s) of this multi-project grant, the relationships among research projects and the cores (including the administrative and organizational structure) and how they will each contribute to the overall objectives and the overall budget. Specific instructions for individual projects, describing modifications to PHS Form 398 instructions to address the collaborative/interactive nature of the project. Specific instructions for the cores, each of which must provide services or resources to at least two research projects. Instructions describe modifications to PHS Form 398 instructions on selected items to address the collaborative or interactive role of the CERC. CERC application overview This multi-project grant application should be assembled and paginated as a single, complete document. Face page Items 1 - 15: complete these items as instructed. This should be the first page of the entire application and all succeeding pages should be numbered consecutively. Form page 2 Using page 2 of PHS 398, provide a succinct but accurate description (abstract) of the overall CERC application addressing the major, common theme of the program. Do not exceed the space provided. Under "key personnel", list the P.I., followed by all other key personnel (project leader, core leaders, consultants) in alphabetical order. Form page 3 - Table of contents Do not use Form page 3 of the PHS 398; a more comprehensive table of contents is needed for a multi-project application. Bearing in mind that the application will be scientifically reviewed project by project, including the cores, prepare a detailed table of contents that will enable reviewers to locate specific information pertinent to the overall application as well as to each component research project and core. Describe scientific and/or programmatic synergy between projects, and between projects and proposed cores (e.g., the degree of interaction between projects and with the cores must result in a program where "the whole is be greater than the sum of its parts"). Delineate how different components of the CERC, including key personnel, will interact, why they are essential to accomplishing the overall goal of the research, and how the combined resources create capabilities that are more than the sum of the parts. Describe the collaborative process and methods of communication, including areas of potential collaboration and areas of focused collaboration. Also show that the research projects proposed for the CERC do not overlap in purpose or intent with existing NIH-funded grants, but will constitute new activities or a natural progression of current research. A page reference should be included for the budget for each project and each core. Further, each research project should be identified by number (e.g. project 1), title, and responsible Project Co-Leaders, and each core should be identified by number, title, and responsible Core Leader. Form page 4 - Detailed budget for initial budget period Use Form page 4 of PHS Form 398 as a composite budget for the entire CERC application. Indicate the page location of the composite budget in the "Table of Contents." Note: An additional Form page 4 must be used for each individual project and core within the CERC application. Narrative justification for individual budget categories should be presented for each of the projects and cores. Form page 5 - Budget for entire proposed CERC period Complete the total direct cost line entries for all requested budget periods (years) and the total direct cost for entire period of support for each project and core. Biographical sketch form page Biographical sketches of all professional personnel for all components should be placed at the end of the application with the P.I.'s first, followed by those of other key personnel in alphabetical order. Resources form page Do not complete for the overall application. Essential information is to be presented in the individual research project and core sections of the application. Checklist Complete for the entire application and place at the end of the application package. If the facilities and administrative costs (F&A) rate agreement has been established, indicate the type of agreement and the date. Identify all exclusions used in the calculation of the F&A costs for the initial budget period and all future budget years. Other support page Do not complete. Any required information will be requested from successful applicants prior to grant award. Program overview (research plan) Foreword: Include a one-page foreword that describes relevant previous collaborative arrangement(s), if any. Items a-d (see PHS 398 instructions) are limited to 25 pages. This narrative section summarizes the overall research plan for the multi- project application. The CERC application should be viewed as a confederation of synergistic research projects, each capable of standing on its own scientific merit, but complementary to one another. This important section provides the group of investigators an opportunity to give conceptual wholeness to the overall program by giving a statement of the general problem area and by laying out a broad strategy for attacking the problems. Indicate the contribution of each project and core to the overall scheme. Include a chart showing the percentage of core activities required for support of each project throughout the requested funding period. Summarize the special features in the environment and/or resources that make this application strong or unique. Appendix Follow the standard PHS 398 instructions, but provide six copies of a single appendix for the entire document. Order of materials in the appendix should follow that of the application, i.e., starting with materials relevant to the overall Program, continuing with materials relevant to the individual projects, and concluding with any materials relevant to the core(s). Every appendix item pertaining to a specific project or core must be clearly labeled as such. Include letters (on institutional letter head) from each proposed project Co-Leader and Core Leader confirming his/her role in the proposed Center, as well as from institutional officials confirming their commitment to the project. Specific instructions for individual projects A cover page is required for each research project and should include the number and title of the project. ) Use numbers (1,2,3, etc.) to designate individual research projects and give each a title; and provide the names and titles of the project leader and of participating investigators. Form page 2 For each proposed project, provide a description (abstract) of the proposed research according to the instructions for form page 2 of the PHS 398. In addition, the abstract should contain a brief description of how the research project will contribute to attainment of the CERC program objectives. Under "key personnel", follow the PHS 398 instructions, listing all key personnel participating in the project, beginning with the project leader. Distinguish co-investigators from other key personnel. Form page 3 Prepare a table of contents for each research project using form page 3 of the PHS 398. Since the biographical sketches of all participating investigators will be located at the end of the overall application and therefore should be referenced in the overall table of contents, it is not necessary to repeat these pages. Research plan (a-d) Do not exceed a total of 25 pages for Items a-d in the Research Plan for each individual project. Tables, charts, graphs, diagrams and figures must be included within the 25-page limit. Applications that exceed the 25-page limit or NIH requirements for type size and margins (refer to PHS 398 instructions for details) will be returned to the applicant without further consideration. The 25-page limit does not include Items e-i (Human Subjects, Vertebrate Animals, Literature Cited, Consortia and Consultants/Collaborators). Item A - Specific aims (typically one page): List in priority order the broad, long range objectives of the proposed project and describe concisely and realistically the more immediate goals. In addition, state the project's relationship to the CERC program goals and how it relates to other research projects within the CERC and to the cores. Item B - Background and significance: Use this section to describe how the proposed research will contribute to meeting the goals and objectives and explain the rationale for the selection of the general methods and approaches proposed to accomplish the specific aims. In addition to the overall biological significance of the proposed research, this section should indicate the relevance of the project to the theme of the CERC. Item C Preliminary studies: Relevant preliminary studies and pilot data should be cited for each project. Item D - Research design and methods: The conceptualization and planning of the project must be sufficient to allow for an assessment of the project's potential. The proposed research must be presented in sufficient detail to allow evaluation of the proposed methods. Appropriate expertise to conduct the proposed research must be included among the key personnel, e.g., for research involving human subjects, statistical and/or clinical trial design expertise (as appropriate) is essential during the design and conduct of research. . Appendix. No appendix need be provided for individual projects, as a single appendix is to be provided for the entire CERC application. Checklist. Not required for individual projects. Submit a single checklist for the entire application. Specific instructions for cores The CERC application must include an administrative core and may include other scientific cores. Administrative core. The applicant (awardee) institution and the Principal Investigator will be responsible for the application and for collaborative research activities in the CERC program. The awardee institution will be legally and financially responsible and be accountable for the use and disposition of funds awarded to the application, and will attest to the availability of personnel and facilities capable of performing and supporting the administrative functions of the CERC program. Funding for the overall administrative efforts including secretarial, and other administrative services, travel to the annual NCCAM Center Director's meeting, expenses for publications demonstrating collaborative efforts, communication expenses, etc., should be requested here. Scientific core(s). A scientific core is a resource to the CERC grant as a whole. The application must indicate the specific projects it will serve. This section should present a clear picture of the facilities, techniques, and skills that the core will provide. The role of the core leader and each of the key participants should be described. The apportionment of dollars, or percentage of dollars, that will be required to support each component research project, which will utilize each scientific core should be presented. A cover page is required for each core and should include the title of the core and provide the names and titles of the core leader and of participating investigators. Form page 2 Provide a description (abstract) of the core activities and services according to the instructions on form page 2 of the PHS 398. In addition, the abstract should contain a brief description of how the core services will contribute towards attainment of the CERC program objectives. Form page 3 Prepare a table of contents for each core using page 3 of the PHS 398. Since the biographical sketches of all participating investigators will be located at the end of the overall application (and therefore should be referenced in the overall Table of Contents), it is not necessary to repeat these pages. Core plan The research (core) plan (items a-d) for each core section is limited to 25 pages. Item A - Specific aims: State the core's relationship to the CERC goals and how it relates to the research projects in the application. Item B - Background and significance: Use this section to describe how the proposed core activities will contribute to meeting the goals and objectives and explain the rationale for the selection of the general methods and approaches proposed to accomplish the specific aims. These resources should not duplicate resources already available to study investigators. In addition, this section should indicate the relevance of the core activities to the primary theme of the CERC. Appendix. No appendix is to be presented in the section for the administrative core; a single appendix for the entire CERC application is to follow all projects and the core. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by NCCAM. Incomplete and non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the PAS will be evaluated for scientific and technical merit by an appropriate peer review group convened by NCCAM in accordance with the review criteria stated below. As part of the initial merit review, all applications will: Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a second level review by the National Advisory Council on Complementary and Alternative Medicine. REVIEW CRITERIA The following aspects of the CERC will be evaluated: A) Individual Research Projects B) Cores C) Principal Investigator D) Resources and Environment E) Program Synergy F) Overall Program A) INDIVIDUAL RESEARCH PROJECTS 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 be asked to comment on the following aspects of each proposed developmental research project 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 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 forward in a field. (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? (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. Are the investigators appropriately trained and well-suited to carry out this work? Is the work proposed appropriate to the experience level of the Project Leader(s) and other researchers (if any)? (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? Additional review criteria: In addition to the above criteria, in accordance with NIH policy, all research components will also be reviewed with respect to the following: Inclusion: The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (Please see Inclusion Criteria included in the section on Federal Citations, below). Protections: The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. Data Sharing: The adequacy of the proposed plan to share data. Budget: The reasonableness of the proposed budget and duration in relation to the proposed research. Based on the evaluation described above, each project will receive a numerical score from 1.0 to 5.0. B) CORES Each core will receive a merit descriptor (outstanding, acceptable, unacceptable) that reflects: o Technical merit and justification of the proposed core; o Qualifications, experience, and commitment of the personnel involved in the core; o Adequacy of plans for use of the core by the research projects and the benefit to the projects from core resources; and o Adequacy of day-to-day administration, as well as program coordination and ongoing evaluation of the center (administrative core) C) PRINCIPAL INVESTIGATOR The P.I will be evaluated with respect to: o Leadership and scientific ability to develop a program of integrated research projects with a well-defined central research focus; and o Time commitment of a minimum of 25% effort. D) RESOURCES AND ENVIRONMENT Each application will receive a merit descriptor for Resources and Environment (outstanding, acceptable, unacceptable) that reflects the following: o Institutional commitment to the program; o The extent to which CAM investigators and clinicians are involved in the research, if appropriate; o The intellectual and physical resources available to the program project participants; and o Adequacy of facilities to support the proposed research, including clinical facilities, laboratory facilities and data management systems, when needed. E) PROGRAM SYNERGY Each application will receive a merit descriptor (highly integrated, integrated, not integrated) that reflects the degree of synergy of the proposed CERC. In particular, program synergy will be evaluated on: o The potential for scientific impact of the proposed CERC, which should be greater than that the sum of its component research projects and cores, i.e., the proposed components should interact synergistically to add value to the CERC as a whole. o Demonstration of an effective relationship among collaborating departments and institutions, including documentation of current relationships, as well as the functions, commitments and contributions that each collaborating member will bring to the proposed project. o The nature, scope, and effectiveness of the plans for communication, coordination, and collaboration among research project investigators. F) OVERALL PROGRAM A single numerical priority score will be assigned to the CERC application as a whole. In assigning the priority score for the application as a whole, although primary emphasis will be placed on scientific merit of the research projects, and past productivity (where applicable), significant consideration will also be given to the strength of core(s), leadership ability of the P.I., institutional commitment, resources and environment, and program synergy. An application in which the reviewers consider no more than two component research projects to be of substantial and significant scientific merit will not satisfy the requirements for this P01 award, and therefore will be recommended for "no further consideration." RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: March 29, 2003 Application Receipt Date: April 29, 2003 Peer Review: July 2003 Review by NCCAM Council: September 2003 Earliest Anticipated Award Date: September 15, 2003 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review); o Availability of funds; o Programmatic priorities. REQUIRED FEDERAL CITATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub- populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy is based on 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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a complete copy of the updated Guidelines is available at ttp://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: 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 and supported by the NIH, unless there are clear and compelling scientific and ethical reasons not to include them. This policy applies to all initial (Type I) 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. 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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.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 PAS in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PAS is related to the priority area of CAM Research. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.213 and 93.242, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 described at http://grants.nih.gov/grants/policy/policy.htm and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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