and Human Services (HHS)
EXPIRED
NINDS MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARDS IN TRANSLATIONAL RESEARCH RELEASE DATE: July 26, 2002 PA NUMBER: PAR-02-140 (This PAR has been reissued, see PAR-05-160) EXPIRATION DATE: July 31, 2005 National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov) THIS PROGRAM ANNOUNCEMENT (PA) CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators (PIs) o Special Requirements o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA Recent discoveries across a broad range of research areas in the neurosciences offer promising opportunities for improved therapies for neurological disorders. As part of its mission to reduce the burden of neurological disease, NINDS is committed to encouraging the "translation" of these basic discoveries into new treatments. The goal of this PA is to announce a career development opportunity for new investigators to build a program of translational research in neurological disorders under the guidance of an experienced mentor. This PA is one of three coordinated programs being released by NINDS to promote translational research, including "NINDS Exploratory/Developmental Projects in Translational Research" (http://grants.nih.gov/grants/guide/pa-files/PAR-02-138.html), and "NINDS Cooperative Program in Translational Research" (http://grants.nih.gov/grants/guide/pa-files/PAR-02-139.html). RESEARCH OBJECTIVES The research project for this award must specifically be in the area of translational research. For the purposes of this program translational research is defined as the process of applying new ideas, insights, and discoveries generated through basic scientific inquiry to the treatment or prevention of human disease. Projects will typically include either a disease-relevant assay, or candidate therapeutics that have a significant effect in a disease model. The career development and training experience must focus on translational research. This should include the principles of therapeutics, candidate screening and evaluation, assay validation, the development and use of animal models of neurological disorders, toxicology and safety testing, biostatistics, the preparation of Investigational New Drug (IND) or Investigational Device Exemptions (IDE) applications, and interactions with private sector companies involved with the manufacture and marketing of therapeutic drugs or devices. Although all of these elements will not normally be included in the research project, experience and training in these areas should be built into the career development plan. The rapid translation of basic neuroscience research findings into improvements in clinical neurology and neurosurgery practice and outcomes remains an important part of improving the quality, efficiency, effectiveness, and cost- effectiveness of health care. Significant hurdles exist, however, to implementing this goal. There is broad agreement among researchers and health care providers about the urgent need to accelerate the application of evidence- based findings and tools in clinical practice. The overall objective of this program is to attract and encourage investigators at the postdoctoral or early faculty development stage to focus their efforts on translational research in neurological disorders. This program is intended to promote more extensive interaction among basic and clinical researchers, and to accelerate the development of interventions and effective treatments that will improve the quality of life of persons with neurological disorders. MECHANISM OF SUPPORT This PA will use the NIH Research Scientist Development Award Research & Training (K01) mechanism. Applicants will be solely responsible for planning, directing, and executing the proposed project. These awards are intended to support a period of intensive supervised career development experiences in the development of treatments for neurological disease. Candidates for the K01 award normally will have some postdoctoral research experience at the time of application. The candidate must be able to demonstrate the need for 3-5 years of additional supervised research, and the potential for a highly productive independent career. K01 Awards are not renewable. 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 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. Candidates for NINDS K01 awards must have a Ph.D. or equivalent research-intensive degree (e.g., Pharm.D.) and must have demonstrated the potential for highly productive independent research in the period after the doctorate. The candidate must identify a mentor(s) with extensive basic and/or clinical research experience. Candidates must be willing to spend a minimum of 75 percent of full-time professional effort conducting research and research career development during the entire award period. The candidate must clearly describe the need for intensive research supervision for a period lasting 3-5 years leading to research independence. Current or past principal investigators on NINDS/NIH research grants are not eligible for this award (the only exceptions are the R03 and R21 awards). Candidates must be U.S. citizens or non-citizen nationals, or must have been lawfully admitted for permanent residence by the time of award. Individuals admitted for permanent residence must be able to produce documentation of their immigration status such as an Alien Registration Receipt Card (I-551) or 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 for this award. SPECIAL REQUIREMENTS A. Environment: The institution must have well-established research and career development programs and qualified faculty in basic and/or clinical research to serve as mentors. It is particularly desirable that the institutional setting be conducive to translational research and therapy development. The institution must be able to demonstrate a commitment to research and to the continuing development of the candidate as an independent scientist. Institutions with outstanding basic and clinical neurology researchers who can serve as mentors are particularly encouraged to take advantage of these career awards to train the next generation of translational neurological sciences researchers. B. Program: The award provides up to 5 years of salary and research support. At least 75 percent of the recipient"s full-time professional effort must be devoted to the goals of this award. The remainder may be devoted to other scholarly activities and research pursuits consistent with the objectives of the award. In particular, candidates for the K01 award must be able to devote substantial time and effort to achieve the objectives of the career development award. C. Mentor(s): Candidates must name a primary mentor who together with the applicant is responsible for the planning, direction, and execution of the program. The mentor should be recognized as an accomplished investigator in the area of therapy development and have a track record of success in training independent investigators. The mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable research costs of this award. Because of the scope of this program, candidates may wish to nominate co-mentors that can provide particular expertise which will augment and balance the research strengths of the primary mentor. NINDS strongly encourages outstanding research scientists with significant basic-clinical (i.e., translational) neurological sciences research experience to serve as mentors or co-mentors. D. Allowable Costs: 1. Salary: The NINDS will provide salary of up to $85,000 plus fringe benefits for the career award recipient. The total salary requested is normally based on a full-time, 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. The institution may supplement the NIH salary 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. Because the salary amount provided by this award is based on the full-time institutional salary, no other NIH funds may be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the K01. Under NIH grants policy, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution"s salary scale up to the current legislated maximum salary. 2. Research Development Support: In addition to salary, NINDS will provide up to $50,000 in research development support. These funds may be used for the following expenses: (a) tuition, fees, and books related to career development, (b) research expenses, such as supplies, equipment and technical personnel, (c) travel to research meetings or training, (d) statistical and computational services including personnel and computer time. All expenses must be directly related to the proposed research career development program. 3. Ancillary Personnel Support: Salary for mentors, secretarial and administrative assistance, etc., is not allowed. 4. Facilities and Administrative Costs: These costs will be reimbursed at 8 percent of modified total direct costs. E. Evaluation: In carrying out its stewardship of human resource related programs, the NIH 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 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: o 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. o The funds may be used for health-related research purposes. o 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, Office of Financial Management, NIH, Bethesda, Maryland 20892. Checks must identify the relevant award account and reason for the payment. o 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 NINDS/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. NINDS will give consideration to 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 NINDS. G. Special Leave: Leave to another institution, including a foreign laboratory, may be permitted if the proposed experience is 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 NINDS is required. To obtain prior approval, the award recipient must submit a letter to NINDS describing the plan, countersigned by the 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 NINDS 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. Under unusual and pressing circumstances, an awardee may submit a written request to the awarding component requesting a reduction in professional effort below 75 percent. Such requests will be considered on a case-by-case basis during the award period. In no case, will it be permissible to work at a rate of less than 50 percent effort. The nature of the circumstances requiring reduced effort might include medical conditions, disability, or pressing personal or family situations such as child or elder care. Permission to reduce the level of effort will not be approved to accommodate other sources of funding, job opportunities, clinical practice, or clinical training. In each situation, the grantee institution must submit documentation supporting the need for reduced effort along with assurance of a continuing commitment to the scientific development of the awardee. Further, the awardee must submit assurance of an intention to return to full-time professional effort (at least 75 percent) as soon as possible. During the period of reduced effort, the salary and other costs supported by the award will be reduced accordingly. H. Termination or Change of Institution: When a grantee institution plans to terminate an award, NINDS must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. Awardees planning a change of institution, must submit to NINDS, in advance of the change, a written request for transfer, countersigned by the appropriate institutional business official, describing the reasons for the change and including the new sponsor"s name and biosketch. The awardee must establish in this request that the specific aims of the research program to be conducted at the new institution are within the scope of the original peer reviewed research program. Additionally, the new mentor must have the appropriate research expertise to supervise the program and sufficient research support to ensure continuation of the research program to the end of the award. NINDS program staff will review this request and determine if it will require peer review and/or review by the NINDS Advisory Council. A new career award application must be submitted by the new institution far enough in advance of the requested effective date to permit review. The period of support requested in the new application must be no more than the time remaining within the existing award period. When a mentor at the grantee institution is to be replaced, the institution must submit a letter from the proposed mentor documenting the need for substitution, the new mentor"s qualifications for supervising the program, and the level of support for the candidate"s career development. The letter must also document that the specific aims of the research program will remain within the scope of the original peer reviewed research program. NINDS staff will evaluate the request, and will notify the grantee institution of the results of the evaluation. A final progress report, invention statement, and Financial Status Report are required upon either conclusion of an award or relinquishment of an award in a change of institution situation. 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: o Direct your questions about scientific/research issues to: NINDS Training and Career Development Officer National Institute of Neurological Disorders and Stroke 6001 Executive Boulevard, Room 2154 Bethesda, MD 20892 Telephone: 301-496-4188 Fax: 301-594-5929 Email: [email protected] o Direct your questions about peer review issues to: Raul A. Saavedra, Ph.D. Scientific Review Branch National Institute of Neurological Disorders and Stroke 6001 Executive Boulevard, Room 3208 Bethesda, MD 20892 Telephone: 301-496-7355 or 301-496-9223 Fax: 301-402-0182 Email: [email protected] o Direct your questions about financial or grants management matters to: King P. Bond, Jr. Grants Management Branch National Institute of Neurological Disorders and Stroke 6001 Executive Boulevard, Room 3290 Bethesda, MD 20892 Telephone: 301-496-9231 Fax: 301-402-0219 Email: [email protected] 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) 710-0267, Email: [email protected]. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five 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) APPLICATION PROCESSING: Applications must be received by or mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PA 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 a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. The application must address the following issues: Candidate o Describe the candidate"s commitment to a career in translational research for neurological disorders, and his/her potential to make future contributions to the neurological sciences. o Establish the candidate"s potential to develop into an independent investigator, describe the long-term career objectives, and explain how this award will contribute to these goals. o Affirm a commitment of at least 75 percent effort to research career development activities. o Include as part of the application three sealed letters of recommendation addressing the candidate"s potential for a research career. Career Development Plan o The career development and training experience must focus on translational research. Describe the career development plan incorporating consideration of the candidate"s goals and prior experience. A systematic plan should be presented for obtaining the necessary basic/clinical background and research experience to launch an independent research career. The career development plan must be specifically tailored to the needs of the candidate and the ultimate goal of achieving independence as a researcher. Research Plan o The research project for his award must specifically be in the area of translational research. The research plan must be described as outlined in form PHS 398 including sections on the Specific Aims, Background and Significance, Preliminary Studies, Research Design and Methods. The K01 candidate should consult with the proposed mentor(s) regarding the development of this section. Training in the Responsible Conduct of Research o Candidates for K01 awards 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. Mentor"s Statement o The application must include a statement from the mentor including information on the mentor"s experience in translational research for neurological disorders, and previous experience as a research supervisor. The application must also include information to describe the mentor"s research support related to the candidate"s research plan and the nature of the supervision that will occur during the proposed award period. Because this program is intended to provide a means to promote more extensive interaction among basic and clinical researchers, in some cases more than one mentor will be appropriate. The co- mentor(s) must provide similar information. If more than one mentor is proposed, the respective areas of expertise and responsibility should be described. Environment and Institutional Commitment o The sponsoring institution must document a strong, well-established basic and clinical research program in neurological sciences including a high-quality research environment with faculty that have had productive collaborations in translational research. The sponsoring institution also must provide a statement to document the level of commitment to the candidate"s development into a productive, independent investigator during the period of the award. This must include an indication of support for the candidate"s proposed level of effort (at least 75 percent), commitment to the necessary release time, as well as the availability of support and supervision during the award period. Budget Budget requests must be provided according to the instructions in form PHS 398, and the limitations referenced above. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. Applications in response to the NINDS K01 program will be evaluated for scientific and technical merit by a peer review group convened by the NINDS Scientific Review Branch in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm). 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 NINDS Advisory Council REVIEW CRITERIA Candidate o Quality of the K01 candidate"s research in basic and/or clinical neurological sciences. o Potential to develop as an outstanding, independent research scientist developing a program of translational research for neurological disorders, and making significant contributions to the neurological sciences. o Commitment to a career in translational research. Career Development Plan o Appropriateness of the content, the phasing, and the proposed duration of the career development plan for achieving scientific independence. o Consistency of the career development plan with the candidate"s career goals focused on translational research. o Likelihood that the plan will contribute substantially to the achievement of scientific independence, and the extent to which the award will enable a candidate to devote full time (at least 75 percent effort) to research and related activities. Research Plan o Importance of the translational research objective to the neurological disorder under study. o Scientific and technical merit of the research question, design and methodology, and potential for advancing the field of study. o Relevance of the proposed translational research project to the candidate"s career objectives. o Appropriateness of the research plan to the stage of research development and as a vehicle for developing the research skills described in the career development plan. o Adequacy of the plan"s attention to children, gender, and minority issues, when human subjects are involved. Training in the Responsible Conduct of Research o Quality of the proposed training in responsible conduct of research. Mentor/Co-Mentor o Appropriateness of mentor(s) research qualifications in translational research. o Quality and extent of mentor(s) proposed role in providing guidance and advice to the candidate, especially with regard to translational research. o Previous experience in fostering the development of basic and/or clinical researchers. o History of research productivity. o Adequacy of support for the proposed research project. Environment and Institutional Commitment o Adequacy of research facilities and training opportunities. o Quality and relevance of the environment for scientific and professional development of the candidate, and the extent to which it provides a means to promote more extensive interaction among basic and clinical researchers. o Applicant institution"s commitment to the scientific development of the candidate and assurances that the institution intends the candidate to be an integral part of its research program. o Applicant institution"s commitment to an appropriate balance of research and clinical responsibilities including the level of 75 percent effort proposed by the candidate. Budget o Justification of the requested budget in relation to career development goals and research aims. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: 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. INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) RESOURCE SHARING: A sharing plan for the distribution of unique research resources developed through NINDS Mentored Research Scientist Development Awards in Translational Research activities should be included in the application. The sharing plan should preserve research freedom and publication rights, while ensuring appropriate implementation of the Bayh-Dole Act (35 U.S.C. 200 et seq.) and dissemination of research resources. A Federal Register Notice published on December 23, 1999, titled "Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources: Final Notice," provides further information, and is available at http://www.ott.nih.gov/policy/rt_guide_final.html. The application should include a request for the funds necessary to implement the sharing plan, as part of the $50,000 maximum for research development support. DATA SHARING: The adequacy of the proposed plan to share data. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research and career development. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project and Career Development potential of the applicant, as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). 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. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants1.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 PA 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 PA 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. 93.853, 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 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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