ALZHEIMER'S DISEASE CLINICAL RESEARCH AND TRAINING PROGRAM: MENTORED SCIENTIST DEVELOPMENT AWARDS (K08 and K01) RELEASE DATE: April 17, 2002 RFA: AG-02-006 National Institute on Aging (NIA) (http://www.nih.gov/nia/) LETTER OF INTENT RECEIPT DATE: June 17, 2002 APPLICATION RECEIPT DATE: July 16, 2002 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanisms of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators 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 OF THIS RFA The National Institute on Aging (NIA) will accept applications for the Mentored Clinical Scientist Development Award (K08) or Mentored Research Scientist Award (K01) in the area of Alzheimer"s disease and related dementias research. NIA will offer the K08 or K01 award to support the development of outstanding academic physician scientists to continue or to focus their research effort in Alzheimer"s disease related to clinical practice. These mechanisms provide support for a period of supervised research and study for either clinically trained professionals with little research experience but who have the commitment and the potential to develop into productive, independent Alzheimer"s disease investigators (K08) or for clinically trained professionals with substantial research experience who wish to redirect their career to concentrate on Alzheimer"s research (K01). The award period is three years and must include a plan to obtain didactic training and supervised training experience and integrate a fundamental and theoretical understanding of dementia with a period of intensive clinically oriented and/or laboratory research. The proposed research should have both intrinsic importance and be a suitable vehicle for learning the skills necessary to become an independent physician-scientist concentrating on dementia research and practice. The scope and nature of the proposed research should also be suitable for potential development into an independently funded research endeavor. Whenever possible the research program should be designed to elicit results that can be translated into clinical practice. These awards will support developmental experiences in either clinical or laboratory research. Because of the focus on progression to independence as a researcher, the prospective candidate for the K08 or K01 award should propose a period of training consistent with this goal and his or her previous research and clinical experience. For example, a candidate with limited experience in dementia research may need a designated period of didactic training and closely supervised research experience for a longer period as the most efficient means of attaining independence. A candidate with substantial previous research experience, such as an investigator in another field redirecting his/her career focus into dementia research, may require a shorter didactic training period appropriate for the transition to independence. In all cases, the candidate must provide evidence of either having attained a broad understanding of theoretical aspects of the relevant clinical or basic science related to Alzheimer"s disease and related dementias, or that s/he will attain the same during the course of this award. All applicants are strongly encouraged to contact NIA staff listed below to discuss issues of eligibility and the specific provisions of this award as it pertains to NIA programmatic interests. While NINDS is not a sponsor of this RFA, the Institute has strong interest in research in Alzheimer"s disease and related dementias (see: http://www.ninds.nih.gov/about_ninds/clusters/neurodegeneration.htm) RESEARCH OBJECTIVES A. Environment: The institution must have well-established research programs in Alzheimer"s disease research including clinical facilities and basic laboratories similar to those of an NIA-sponsored Alzheimer"s Disease Center. The institution must have experience with clinical career development programs and qualified faculty in clinical and basic research related to Alzheimer"s disease and other neurodegenerative diseases to serve as mentors. The institution must be able to demonstrate a commitment to the development of the candidate as a productive, independent investigator. The candidate, mentor and institution must be able to describe an in-depth, broadly based career development program that will maximize the use of relevant research and educational resources. B. Program: The goal of this program is to train junior and mid level physicians to focus their careers on Alzheimer"s disease research and to apply basic knowledge of the disease process to clinical care of patients. There is a critical need to build better bridges between Alzheimer"s laboratory research and cutting edge new methods of diagnosis, treatment and prevention of the disease. Well-trained physician scientists are needed to provide the next generation of leadership for research and treatment of Alzheimer"s disease and the related dementias. The award provides for three consecutive 12 month appointments. At least 75 percent of the recipient"s full-time professional effort must be devoted to the program. The remainder may be devoted to other clinical and teaching pursuits consonant with the objectives of the award. Both the didactic and basic science components must be designed to develop the necessary knowledge and research skills in scientific areas relevant to the career goals of the candidate. C. Mentor(s): The recipient must receive appropriate mentoring throughout the three-year program. The mentor(s) must have expertise in Alzheimer"s disease and related dementias, have a funded research program, and demonstrate his/her availability and commitment to a clearly delineated training program. Where feasible, women and minority mentors should be involved as role models. D. Allowable Costs: 1. Salary: NIA will provide salary for the K08 or K01 recipient at a maximum of $100,000 per year. The institution may supplement the NIA contribution up to a level that is consistent with the institution"s salary scale, however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of this award. Under Institution authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution"s salary scale. The total salary requested must be based on a 100%, 12-month staff appointment. It must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. 2. Research Development Support: NIA will provide up to $50,000 per year for: (a) research expenses such as supplies, equipment and technical personnel, (b) statistical services including personnel and computer time,(c) travel to research meetings or training, (d) tuition, fees, and books related to career development. 3. Ancillary Personnel Support: Salary for mentors, secretarial and administrative assistance, etc., is not allowed. 4. Indirect costs: Indirect costs will be reimbursed at 8 percent of modified total direct costs, or at the actual indirect cost rate, whichever is less. E. Evaluation: In carrying out its stewardship of human resource related programs, the NIA may begin requesting information essential to an assessment of the effectiveness of this program. Accordingly, recipients are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program. F. Other Income: Fees resulting from clinical practice, professional consultation, or other comparable activities required by the research and research-related activities of this award may not be retained by the career award recipient. Such fees must be assigned to the grantee institution for disposition by any of the following methods: The funds may be expended by the grantee institution in accordance with the NIH policy on supplementation of career award salaries and to provide fringe benefits in proportion to such supplementation. Such salary supplementation and fringe benefit payments must be within the established policies of the grantee institution. The funds may be used for health-related research purposes. The funds may be paid to miscellaneous receipts of the U.S. Treasury. Checks should be made payable to the Department of Health and Human Services, NIH and forwarded to the Director, Division of Financial Management, NIH, Bethesda, Maryland 20892. Checks must identify the relevant award account and reason for the payment. Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, or honoraria from other institutions for lectures or seminars, provided these activities remain incidental and provided that the retention of such pay is consistent with the policies and practices of the grantee institution. Usually, funds budgeted in an NIH supported research or research training grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be rebudgeted. NIA will consider approval for the use of released funds only under unusual circumstances. Any proposed retention of funds released as a result of a career award must receive prior written approval of NIA. G. Special Leave: Leave to another institution, including a foreign laboratory, may be permitted if directly related to the purpose of the award. Only local, institutional approval is required if such leave does not exceed 3 months. For longer periods, prior written approval of NIA is required. To obtain prior approval, the award recipient must submit a letter to NIA describing the plan, countersigned by his or her department head and the appropriate institutional official. A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the career award will continue during such leave. Leave without award support may not exceed 12 months. Such leave requires the prior written approval of NIA and will be granted only in unusual situations. Support from other sources is permissible during the period of leave. Such leave does not reduce the total number of months of program support for which an individual is eligible. Parental leave will be granted consistent with the policies of the NIH and the grantee institution. H. Termination or Change of Institution: When a grantee institution plans to terminate an award, NIA must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. If the individual is moving to another eligible institution, career award support may be continued provided: The new institution submits an application to transfer the award, complete with the requisite information concerning all aspects of the career development plan, mentoring, and institutional support (as described elsewhere in this RFA), The period of support requested is no more than the time remaining within the existing project period, and The application to transfer an award is submitted at least 60 days prior to the requested start date at the new institution to allow time for review by NIA staff. The Director of the NIH may discontinue an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, the Director of the NIH shall notify the grantee institution and career award recipient in writing of this determination, the reasons therefore, the effective date, and the right to appeal the decision. A final progress report, invention statement, and Financial Status Report are required upon either termination of an award or relinquishment of an award in a change of institution situation. MECHANISMS OF SUPPORT This RFA will use the NIH K01 and K08 award mechanisms. Planning, direction, and execution of the program will be the responsibility of the candidate and his/her mentor on behalf of the applicant institution. The project period is limited to three years. Awards are not renewable. FUNDS AVAILABLE The NIA has set aside $1 million in order to fund at least five awards. Awards are contingent upon availability of funds and receipt of a sufficient number of applications of outstanding scientific and technical merit. 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 Domestic institutions only INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS You must have an M.D. degree or its equivalent, must have completed postgraduate clinical training in a clinical area pertinent to the goals of this RFA such as Geriatric Medicine, Neurology, Psychiatry or Neuropathology and must have secured a faculty appointment in an appropriate research-intensive environment with established facilities for Alzheimer"s disease research comparable to an NIA-sponsored Alzheimer"s Disease Center. You must identify a mentor with extensive Alzheimer"s disease research experience, and must be willing to spend a minimum of 75 percent of full-time professional effort conducting research and research career development related to Alzheimer"s disease and related dementias. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. You must be a U.S. citizen or a non-citizen national, or must have been lawfully admitted for permanent residence and possess an Alien Registration Receipt Card (I-551) or have some other verification of legal admission as a permanent resident. Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible. Former principal investigators on NIH research project (R01), FIRST Awards (R29), sub-projects of program project (P01) or center grants (P50), or the equivalent, are not eligible for the K08 award but may apply for the K01 award. If you apply for these K awards, then you may not concurrently apply for any other PHS award that duplicates the provisions of this award nor have another application pending award. Both K08 and K01 recipients are encouraged to apply for independent research grant support during the period of this award. Recipients would be allowed to maintain the award if other PHS support is procured, as long as the new support does not interfere with the ability to meet the K08 or K01 requirements. WHERE TO SEND INQUIRIES We strongly encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Such contact should occur early in the planning phase of the application preparation and will help ensure that the applications are responsive to the career development goals and policies of NIA. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Elisabeth Koss, Ph.D. Neuroscience and Neuropsychology of Aging Program National Institute on Aging 7201 Wisconsin Ave., Suite 3C307 Bethesda, MD 20892-9205 Telephone: (301) 496-9350 FAX: (301) 496-1494 Email: kosse@nia.nih.gov o Direct your questions about peer review issues to: Mary Nekola, Ph.D. Chief, Scientific Review Scientific Review Office National Institute on Aging 7201 Wisconsin Avenue, Room 2C212 Bethesda, MD 20892-9205 Email: NekolaM@nia.nih.gov o Direct your questions about financial or grants management matters to: Deborah Stauffer Grants Management Specialist National Institute on Aging 7201 Wisconsin Ave., Suite 2N212 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 492-3672 Email: stauffed@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 NIA 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: Elisabeth Koss, Ph.D. Neuroscience and Neuropsychology of Aging Program National Institute on Aging 7201 Wisconsin Ave., Suite 3C307 Bethesda, MD 20892-9205 Telephone: (301) 496-9350 FAX: (301) 496-1494 Email: kosse@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. 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, three sealed letters of recommendation, 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. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. 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 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. The application must address the following issues: 1. Candidate Describe your commitment to a career in clinical or laboratory-based biomedical research related to Alzheimer"s disease and related dementias. Establish your potential to develop into an independent investigator. Describe your immediate and long-term career objectives, explaining how the award will contribute to their attainment. For K01 applicants, outline previous research experience and the rationale for redirecting research interests to Alzheimer"s disease. Career awards are full-time awards. At least 75% effort must be on research and career development activities. The remainder of the effort should be on clinical, teaching duties, or other duties that are consistent with the award goals. You may receive compensation from other than PHS sources for the time on the career award that is not allocated to research. Letters of recommendation. Three sealed letters of recommendation addressing your potential for a research career must be included as part of the application. 2. Career Development Plan Describe your career development plan incorporating consideration of your goals and prior experience. Where necessary, the application must describe a systematic plan to obtain both the necessary didactic training and research experience to launch an independent research career related to Alzheimer"s disease and other dementias of aging. If you are interested in clinical research you must describe the availability of courses such as research design, biostatistics, epidemiology, and ethical and regulatory issues at your institution and the integration of these studies into your career development plan. If you have limited research training you may require a phased developmental period including didactic training during the first year of the award while gradually phasing in a period of intense, supervised research experience. If you have more experience at the time of application you may need a shorter developmental period and may already have an adequate theoretical background. In any case, the career development plan must be tailored to your particular needs and your ultimate goal of achieving independence as a researcher. You must describe plans to receive instruction in the responsible conduct of research. These plans must detail the proposed subject matter, format, frequency, and duration of instruction. No award will be made if an application lacks this component. 3. Research Plan Describe the research plan and the use of a clinical science or laboratory approach to a research project that will likely lead to increased knowledge or better treatment of Alzheimer"s disease and/or related dementias. Describe the research plan as outlined in form PHS 398 including sections on the Specific Aims, Background and Significance, Progress Report/ Preliminary Studies, Research Design and Methods. You should consult with your mentor regarding the development of this section, but the proposed research should derive from your own background, research interests, and career goals. The proposed research should also be suitable for development into a project capable of generating independent funding. 4. Mentor"s Statement The application must include information on your mentor(s) including information on research qualifications and previous experience as (a) research supervisor(s) for training scientists in Alzheimer"s disease, related dementias, or other neurodegenerative diseases. The application must also include information describing the nature and extent of supervision that will occur during the proposed award period. There must be a clear statement of commitment from your mentor(s) describing the extent of his/her/their availability and effort to your training. 5. Environment and Institutional Commitment The sponsoring institution must document a strong, well-established research and training program related to Alzheimer"s disease and other neurodegenerative disease including a high quality research environment comparable to a NIA-sponsored Alzheimer"s Disease Center with staff capable of productive collaboration with you. Your sponsoring institution also must provide a statement of commitment to your development into a productive, independent investigator. The statement should indicate that the institution sponsoring you must treat you as a faculty member. 6. Budget Budget requests must be provided according to the instructions in form PHS 398. The request for tuition and fees, books, travel, research development support, etc., must be justified and specified by category. 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 Candidate o Career Development Plan o Research Plan o Mentor o Environment and Institutional Commitment o Budget 1. Candidate Quality of your academic and clinical record, Potential to develop as an independent clinical or laboratory based researcher in the field of Alzheimer"s disease, and Commitment to a career in Alzheimer"s research and clinical practice. 2. Career Development Plan Likelihood that the career development plan will contribute substantially to your scientific development, Probability of development of a competitive independent research program, Documentation of local expertise in Alzheimer"s disease and other neurodegenerative diseases and appropriateness of the content and duration of the proposed didactic and research phases of the award, Consistency of the career development plan with your career goals and prior research experience, and, Quality of the proposed training in responsible conduct of research. 3. Research Plan Reviewers recognize that applicants will have variable amounts of previous research experience and that an individual with limited research experience is less likely to be able to prepare a research plan with the breadth and depth of that submitted by a more experienced investigator. Although it is understood that K08 and K01 applications do not require the level of detail necessary in regular research grant proposals, a fundamentally sound research plan must be provided. In general the plan for the first year should be spelled out in detail while less detail is expected with regard to research planned for the later years of the award. The application should outline the general goals for years two and three. The following details should be provided: The significance of the area of dementia research in which you propose to establish independence, Appropriateness of the research plan to the stage of research development and as a vehicle for developing the research skills as described in the career development plan, Scientific and technical merit of the research question, design and methodology and its likelihood to advance dementia research, Relevance of the proposed research to your career objectives, and Adequacy of the plan"s attention to gender and minority issues associated with projects involving human subjects. 4. Mentor Appropriateness of mentor"s statement of support and research qualifications in Alzheimer"s disease and related dementias, Quality and extent of commitment of your mentor"s proposed role in providing you with guidance and advice, Previous experience in fostering the development of Alzheimer"s researchers, and History of research productivity and support, and Adequacy of support for the proposed research. 5. Environment and Institutional Commitment Your institution"s commitment to your scientific development and assurances that your institution intends you to be an integral part of its research program, Adequacy of research facilities (comparable to those of an NIA- sponsored Alzheimer"s Disease Center) and availability of appropriate educational opportunities, Quality and relevance of the environment for your scientific and professional development, and Your institution"s commitment to an appropriate balance of research and clinical responsibilities including the level of 75 percent effort proposed by you. 6. Budget Justification of the requested budget in relation to career development goals and research aims. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: June 17, 2002 Application Receipt Date: July 16, 2002 Peer Review Date: Fall, 2002 Council Review: January 2003 Earliest Anticipated Start Date: April 1, 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 o Research environment of the applicant institution. REQUIRED FEDERAL CITATIONS INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research, updated racial and ethnic categories in compliance with the new OMB standards, clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398, and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH- defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. 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 is available at http://grants.nih.gov/grants/funding/children/children.htm. 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. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. 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 Request for Applications (RFA), Alzheimer"s Disease Clinical Research and Training Program, 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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