COORDINATING CENTER FOR CALERIE (COMPREHENSIVE ASSESSMENT OF LONG-TERM EFFECTS OF REDUCING INTAKE OF ENERGY) STUDIES RELEASE DATE: May 8, 2002 RFA: AG-02-007 National Institute on Aging (http://www.nih.gov/nia/) LETTER OF INTENT RECEIPT DATE: June 12, 2002 APPLICATION RECEIPT DATE: July 12, 2002 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to become Principal Investigators o Special Requirements o Where to send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE The National Institute on Aging (NIA) invites applications for a Cooperative Agreement (UO1) to establish a Coordinating Center (CC) for the CALERIE (Comprehensive Assessment of Long-Term Effects of Reducing Intake of Energy) studies. The three recently funded CALERIE sites (also UO1 studies) are exploratory controlled studies on the effects of sustained caloric restriction interventions on physiology, body composition, and risk factors for age-related pathologies in non-obese persons. Each of the three CALERIE sites will be conducting site-specific protocols, but standardized protocols will be followed for a Common Data Set of measures conducted at all the sites. The CALERIE CC will have responsibility for implementing and participating in processes for making and implementing CALERIE-wide decisions, participation in development of procedures related the Common Data Set, management and reporting of data, and participation in data analyses. The CC will interact with the CALERIE study sites, the CALERIE Steering Committee, the NIA Program Administrator, and the CALERIE Data and Safety Monitoring Board (DSMB). The period of support for the CALERIE CC will be seven years. Up to $700,000 in total (direct plus facilities and administrative (F&A) costs) costs) for the first year may be requested, with increments above this level of up to 4% per year for future years. RESEARCH OBJECTIVES Background The three funded CALERIE sites were selected from the responses to the RFA "Exploratory Studies of Sustained Caloric Restriction in Non-Obese Persons: Physiologic Effects and Comparisons/ Interactions with Physical Activity, that was issued by the National Institute on Aging (NIA) in October 13, 2000 (NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/rfa-files/RFA-AG-01-001.html). Detailed information on the background and rationale for these studies may be found at the above address. Briefly, the CALERIE projects are funded under the Cooperative Agreement mechanism (UO1) and involve exploratory controlled human intervention studies on the effects of caloric restriction (CR) interventions on physiology, body composition, and risk factors for age-related pathologies in non-obese persons. The primary goals of the CALERIE projects are: to gain knowledge about the effects in humans of sustained caloric restriction (CR) on physiology, metabolism, body composition, risk factors for age-related pathologies, progression of age-related changes, and potential adverse effects, and to gain knowledge of similarities, differences and interactions between the effects of CR and physical activity (PA) on the above outcomes when employed in interventions to prevent weight gain. The endpoints of the CALERIE studies include energy intake and expenditure, physical activity, body composition, endocrine responses, insulin sensitivity/glucose metabolism, cardiovascular function, bone density, immune function, quality of life and potential adverse effects of CR. Study populations in the CALERIE studies will be nonobese, with a likely age range of 25-60 years. The expected duration of the CALERIE projects is seven years. They will be conducted in three phases as follows: Phase 1: Protocol Refinement (up to 2 years). Phase I is primarily devoted to the development of recruitment strategies, determining feasibility and safety of the proposed CR interventions, as well as standardization of common measures and methodologies. Approximately 190 subjects are expected to be studied in Phase 1. Phase 2: Protocol Implementation (at least two years). Activities under this phase include the conduct of intervention activities, continued screening and recruitment of subjects (if necessary), and preliminary data analysis. Approximately 300 subjects (100 per site) are expected to be studied in Phase 2. Phase 3: Data analysis and reporting (approximately one year). Each of the three CALERIE sites will be conducting site-specific protocols, in addition to standardized protocols that will collect common measures across the sites (Common Data Set). It is expected that information in the Common Data Set will be used in studies involving comparisons among sites, and/or studies that require aggregation of data from multiple sites. The other organizational components of the CALERIE studies with which the CC will interact are: the study sites, the Steering Committee, which is the main decision-making body, subcommittees that report to the Steering Committee, the Data and Safety Monitoring Board (DSMB), which will oversee progress of the studies and monitor the safety of human subjects, and, the NIA Program Administrator for the CALERIE projects. The Principal Investigator (PI) of the CALERIE CC will participate as a voting member of the Steering Committee. This RFA is to establish a Coordinating Center (CC) for the CALERIE studies to provide coordination, and organizational and analytical support. Overall the activities requested for the CC consist of organizational, informational, and data management and analysis functions for activities of the CALERIE Steering Committee, subcommittees, and DSMB. Specifically, the CC will work in collaboration with the CALERIE study sites and NIA program staff to: 1. Coordinate with the CALERIE Steering Committee the selection of the common data collection protocols, and standardized forms, and the data entry system for the creation and maintenance the Common Data Set for measurements to be done in common by two or all three of the CALERIE sites. Prepare, disseminate, and update the CALERIE Common Data Set Manual of Procedures (MOP), data collection forms, databases, and results reporting summaries for the CALERIE sites, and maintain and verify for correctness the resulting Common Data Set. 2. Provide or arrange for training to all CALERIE site personnel as needed on data management and analysis, and quality control and quality assurance. 3. Collaborate with the CALERIE study sites (conditional on approval by the Steering Committee and NIA Program Administrator) in the analysis of common data both for internal use by the study sites and for publications. 4. Provide the NIA Program Administrator, the DSMB, and the Steering Committee with reports based on statistical and other analyses of issues related to the Common Data Set, or other needs arising during the course of studies. 5. Coordinate the logistics for the establishment and operation of a common laboratory for doubly labeled water analyses, and participate with the study sites in the development of data quality control procedures, and information databases regarding these samples and analyses over the course of the CALERIE studies. 6. Coordinate logistics for the establishment, operation, and quality control of laboratory assays for the Common Data Set, and a repository for biological specimens from the CALERIE study sites, including development of procedures for monitoring samples to be sent, assuring assay quality, data quality control, procedures for transfer of specimens to the repository, and related databases. 7. Prepare detailed reports in standardized formats on progress of study- specific recruitment, protocol completion, compliance, and adverse events, for use by the Steering Committee, DSMB, and NIA Program Administrator. 8. Prepare a list of all CALERIE site-specific data items including the equipment, test batteries, and assessment techniques that are used. 9. Monitor adherence of CALERIE components to NIH and NIA policies on transmission of information on adverse events, and maintain a database on adverse events and responses to them. 10. Support the activities of the CALERIE sites, the CALERIE Steering Committee, and the CALERIE DSMB through provision of materials, documentation support, meeting planning and logistics, and conference call coordination. This includes attendance at Steering Committee, subcommittee, and DSMB meetings to perform the functions listed above. 11. Participate in all CALERIE Steering Committee and DSMB meetings and conference calls, and CALERIE Subcommittee conference calls as needed. 12. Prepare and distribute the minutes and action items from the CALERIE Steering Committee (SC) and DSMB meetings and conference calls, CALERIE Site visits, and CALERIE Subcommittee meetings, and provide timelines for the completion of actions items and updates on the status of action items as required. 13. Assist the NIA Program Administrator in written, telephone, and electronic communications with the study sites and with various committees as requested. 14. Establish databases that catalogue and disseminate information about all CALERIE publications. 15. Develop and maintain a public and private (secured, password- protected) CALERIE Web page. The three funded CALERIE sites and the NIA Program Administrator are preparing Manuals of Procedures and developing the Common Data Set. By the anticipated September 30, 2002 start date for the CC, some decisions regarding the Common Data Set and other CALERIE activities will have been made, and some protocols begun. However, it is anticipated that many issues and procedures regarding the Common Data Set and other aspects of CALERIE Phase 1 studies will still need to be addressed at that time, and will benefit from CC participation. The decision process for finalizing CALERIE Phase 2 study protocols will not begin until 2003 at the earliest. MECHANISM OF SUPPORT This RFA will use the NIH cooperative agreement (U01) award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is September 30, 2002. The NIH U01 is a cooperative agreement award mechanism in which the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the section "Cooperative Agreement Terms and Conditions of Award." The total project period for an application submitted in response to the present RFA may not exceed seven years. FUNDS AVAILABLE For the initial year of funding the amount of funds requested for the CALERIE CC should not exceed $700,000 total cost (direct cost + F&A costs). Requested funding for increments above this level not to exceed 4% per year for future years is permissible. The size of the proposed budget for each year should be appropriate for the Phase being conducted by the trials in that year. No more than one award will be made as a result of this RFA and funding of this award is contingent upon availability of funds. ELIGIBLE INSTITUTIONS You may submit an application 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 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 1. Minimal requirements for potential applicants for the CALERIE Coordinating Center are as follows: o The applicant must have demonstrated prior experience as a coordinating center in multicenter studies. Previous experience with dietary or physical activity interventions, obesity and/or metabolic studies is mandatory. o The Principal Investigator, with other staff, must have appropriate biostatistical, data management and coordination expertise. o The applicant must have the ability to assist in designing protocols and the data collection system, including transmission via the Internet. o The applicant must demonstrate the willingness and ability to cooperate with the CALERIE sites and NIA staff in all design, data collection and analysis functions. The applicant should provide a plan for developing a cooperative relationship among the CALERIE sites and between the various CALERIE organizational components. o The applicant must have an established data system for collection and statistical analysis of common data. 2. Collaboration of Coordinating Center with CALERIE Organizational Components o The CC will be involved in collaborations with the NIA and the CALERIE study sites during all phases of the studies. Thus, the applicant is expected to demonstrate experience in working cooperatively with clinical sites and sponsoring organizations in a multi-site trial and in overseeing the implementation of and adherence to a common protocol, as well as assuring quality control of the data collected. In addition to organizing and attending regular meetings, the CC will be expected to maintain close communications with the NIA Program Administrator and the Principal Investigators of the CALERIE study sites. o Steering Committee. The primary governing body of the study will be the Steering Committee, which will have responsibility for overall study design and policy decisions (described in more detail under Terms and Conditions). The Principal Investigator of the CC will be a voting member of the Steering Committee. o Data and Safety Monitoring Committee (DSMB). An independent committee will be established by NIA staff and approved by the Director, NIA, to review the progress of the study on a regular basis (described in more detail under Terms and Conditions). o NIA Program Administrator. The NIA Program administrator function will be to assist the components as appropriate in all aspects of the CALERIE studies (described in more detail under Terms and Conditions). 3. Cooperative Agreement Terms and Conditions of Award The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92 and other HHS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument used for this program is a cooperative agreement (UO1), an assistance mechanism (rather than an acquisition mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardees is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient"s activity by working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the collaborative aspects will be shared among the awardees and the designated NIA Program administrator. 1. Awardee Responsibilities The Coordinating Center awardee agrees to work cooperatively with the CALERIE study sites and will have the primary responsibility for developing and implementing systems necessary for communications between the various CALERIE organizational components. The Coordinating Center will facilitate the design and refinement of all protocols, manuals of operation, and forms. Awardees at the study sites shall retain custody of, and primary rights to, the site- specific data developed under their award, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. The Steering Committee will define the rules regarding access to and publication of findings from analysis of common data. 2. Staff Responsibilities The designated NIA Program Administrator will have substantial scientific/programmatic involvement during conduct of this activity, through technical assistance, advice and coordination above and beyond normal program stewardship of grants. The awardee agrees to accept assistance from the designated NIA Program Administrator, as described below: o Participate in the monitoring of issues relating to recruitment, treatment, follow-up, quality control, and adherence to protocols. o Assist in the development and/or adjustment of study protocols. o In conjunction with the Steering Committee, approve the transition of study sites from Phase 2 to Phase 3. After approval from the Monitoring Board, the NIA must accept (approval by the Director, NIA) the protocol before it can be implemented. The NIA reserves the right to terminate or curtail the study (or an individual award) in the event of substantial shortfall in participant recruitment, follow-up, data reporting, quality control, or other major breech of the protocol, if human subject safety or ethical issues dictate a premature termination, or if there is failure to develop or implement mutually agreeable collaborative protocols. o Assistance in data analyses 3. Collaborative Responsibilities The Steering Committee (SC), comprised of each of the Principal Investigators of the CALERIE study sites, the Principal Investigator of the Coordinating Center, and the NIA Program Administrator, will have primary responsibility for developing and finalizing standard definitions/laboratory measures common to the protocols of the study sites. Each member of the Steering Committee will have one vote, and all major scientific decisions will be determined by majority vote of the Steering Committee. A Chairperson for the SC has been chosen from among the Principal Investigators of the CALERIE study sites. Subcommittees appointed by the Steering Committee and comprised of the Principal Investigators and appropriate staff from the study sites, the Coordinating Center will be involved in design of the protocol and the manual of operations, and in ongoing functions of the CALERIE studies such as consideration of potential ancillary studies and preparation of publications. The SC will meet every three to six months, or as dictated by the needs of the CALERIE studies. The DSMB will advise the study sites by periodically reviewing their research progress and the safety of the study subjects, as well as resolve any serious conflicts over how the overall study should proceed. The DSMB will be comprised of experts in relevant medical, statistical and bioethical fields. The DSMB"s approval will be required before initiation of Phase 1 study protocols, and before transition to Phase 2. The Chairperson of the Steering Committee and the NIA Program Administrator will participate as non-voting members of this Board. 4. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the U01 award), between U01 awardees and the NIA may be brought to arbitration. An arbitration panel will be composed of three members: one selected by the Steering Committee (without NIH representatives voting) or by the individual U01 awardee in the event of an individual disagreement, a second member selected by the NIA, and, the third member selected by the two prior selected members. For U01 awardees, this special arbitration procedure will in no way affect the awardee"s right to appeal an adverse action in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA 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 programmatic issues to: Charles Hollingsworth, Dr. P.H. Branch Chief, Clinical Trials Branch Geriatrics and Clinical Gerontology Program National Institute on Aging 7201 Wisconsin Avenue, Suite 3E-327 MSC 9205 Bethesda, MD 20892-9205 Express Mail Zip Code: 20814 Telephone: 301/435-3047, FAX: 301/402-1784 E-mail: hollinc@nia.nih.gov Direct inquiries regarding peer review issues to: Mary Nekola, Ph.D. Chief, Scientific Review Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2C-212 Bethesda, Maryland 20892-9205 Express Mail Zip Code: 20814 Telephone: 301/496-9666, FAX: 301/402-0066 E-mail: nekolam@nia.nih.gov Direct inquiries regarding financial or grants management matters to: Cynthia Riddick Grants Management Specialist National Institute on Aging 7201 Wisconsin Avenue, Suite 2N-212 Bethesda, Maryland 20892-9205 Express Mail Zip Code: 20814 Telephone: 301/496-1472, FAX: 301/402-3672 E-mail: riddickc@nia.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 o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA 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 IC 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: Chief of Review Chief, Scientific Review Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2C-212 Bethesda, Maryland 20892-9205 Telephone: 301/496-9666 FAX: 301/402-0066 E-mail: nekolam@nia.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). 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, Email: GrantsInfo@nih.gov. Supplemental Instructions: Applicants for the Coordinating Center should address the potential requirements of the CALERIE studies by providing a description of projected tasks likely to be performed by the CC and the centralized facilities, consistent with resources projected to be available for the CALERIE studies. Plans for collection and handling of data and samples consistent with the projected needs of the study sites should be discussed. Plans for ensuring data integrity and quality control should be discussed. Personnel: The application for CC must describe the expertise of key scientific, technical and administrative personnel and include a mechanism for replacing key professional or technical personnel should the need arise. The Principal Investigator of the Coordinating Center should be a biostatistician or other professional with experience in directing a coordinating center for large-scale collaborative multi-site clinical studies or other large-scale epidemiological research project involving multiple institutions. Staff needs may be modified as the CALERIE studies progress, however, adequate support staff should be designated to manage routine tasks: o PI of the Coordinating Center should provide overall scientific and biostatistical guidance. o Project Manager to attend to day-to-day details and communicate necessary information to study sites and/or to the other CALERIE organizational components. Staff training is also a responsibility of the Project Manager. o Statisticians to help in data analysis. o System analysts to help with developing and managing the database programs. o Computer programmers to develop computer database. o Clerks and administrative assistants to help in administrative work and data entry. Budget: The budgets for the Coordinating Center application should be based on the applicant"s best judgment of activities likely to be involved during the different Phases of the CALERIE studies. The Coordinating Center also will be responsible for organizing meetings of the Data and Safety Monitoring Board (DSMB) at least twice a year and for supporting the travel of these individuals to meeting sites and their lodging. These costs should be included in the budget. The Phase 1 budget (Year 1) should include costs of establishing the Coordinating Center staff, as required to carry out the Coordinating Center"s functions (including costs of training personnel of CALERIE sites for management and analyses, and quality control and quality assurance of common data). Phase 1 also will involve development of the protocols and manuals of operations by the study sites, in conjunction with the Steering Committee for the CALERIE studies and creation of a database for the common measures between the study sites. Budgets should include costs of organizing at least three "in person" Steering Committee meetings and for attendance of necessary Coordinating Center staff to these meetings. During Phase 2, the budgets should include projected data handling costs, reporting functions, meetings and other communications costs, and the projected expense of performing any interim analyses that may be requested by the DSMB. The applicant also should address the potential requirements of the CALERIE studies by budgeting for tasks to be performed for the development of a repository to store patient samples. It should, however, be understood that the specific centralized facilities required and their final budgets will be determined following the design of the final study protocols and the writing of the manual of operations by the study sites and the Steering Committee. Budgets should also include costs of organizing three Steering Committee meetings per year and providing for attendance of necessary Data Coordinating Center staff. The Phase 3 budget should be concerned with study closeout, analysis of study data, and reporting of results in collaboration with the study sites. Budgets should include the costs of organizing three meetings of the Steering Committee and providing for attendance of necessary Coordinating Center staff. USING THE RFA LABEL: 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. SENDING AN APPLICATION TO THE NIH: 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 must be sent to: Chief of Review Scientific Review Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2C212, MSC 9205 Bethesda, MD 20892-9205 APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the (NIA). Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications should be complete at the time of submission. The Scientific Review Office (SRO), NIA, will determine whether late materials will be accepted. If late materials are accepted, they will be limited to three typed pages and the Scientific Review Administrator (SRA) in charge of the review must authorize submission. 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 the NIA in accordance with the review criteria stated below. As part of the initial merit review, all applications: o Will receive a written critique o May undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Will receive a second level review by the National Advisory Council on Aging REVIEW CRITERIA. The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application"s overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you 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 your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? The final design of the protocols (site-specific and common) will be developed collaboratively by the CALERIE study sites and the Steering Committee. In assessing applications for the Coordinating Center, the scientific review group will focus on whether the applicant recognizes the significance of the issues involved and has the knowledge necessary to contribute meaningfully to the final design, including understanding of the scientific, ethical, and practical issues underlying the CALERIE studies. (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? Does the proposed approach in managing the logistical and data coordination have scientific and technical merit? Are the proposed plans and experience relating to data collection, management, editing, processing, analysis, and reporting adequate? Are the plans for coordination with the study site investigators adequate? Is the approach to developing a cooperative relationship among the study sites and between the various CALERIE organizational components adequate? Are the plans for exercising appropriate leadership in matters of study design, data acquisition, data management, and data analysis demonstrated? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? Does the applicant for the Coordinating Center offer innovative ideas on how to achieve the goals of the CALERIE studies with regard to its design and administration? Does the proposal address problems that may arise during the study and provide innovative solutions to such problems? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? Does the application provide evidence of specific competence and relevant experience of professional, technical, and administrative staff pertinent to the operation of a Coordinating Center for multi-site studies? Prior experience collecting data and patient specimens from multiple clinical sites, monitoring the data quality, and developing and utilizing statistical methods for analysis of data should be demonstrated. Is there evidence of experience in and willingness to participate appropriately in a collaborative study as described in this RFA? Are there adequate assurances that the Coordinating Center personnel have experience in utilizing procedures that insure the safety and confidentiality of medical records? (5) ENVIRONMENT: Does the scientific environment in which your 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? Has the application documented the adequacy of the proposed facility, technical hardware, and space for the Coordinating Center? Is there an appropriate organizational and administrative structure to the proposed Coordinating Center? Evidence of institutional support and commitment for the proposed program should be provided. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The CALERIE Coordinating Center will be setting up a repository of samples from human subjects. Therefore, the Center must comply with current human subjects protection policies regarding potential patient identifier information that are associated with these stored samples. o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: June 12, 2002 Application Receipt Date: July 12, 2002 Peer Review Date: September 2002 Council Review: September 2002 Earliest Anticipated Start Date: September 30, 2002 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 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. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at 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 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. 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. Furthermore, we caution reviewers 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 RFA is related to one or more of the priority areas. 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. 93.866, 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 under 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 to 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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