and Human Services (HHS)
EXPIRED
NINR CAREER TRANSITION AWARD (K22) RELEASE DATE: July 29, 2003 RFA Number: RFA-NR-04-004 National Institute of Nursing Research (NINR) (http://www.ninr.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.361 LETTER OF INTENT RECEIPT DATE: October 17, 2003 APPLICATION RECEIPT DATE: November 14, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism of Support o Allowable Costs 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 of Nursing Research (NINR) invites applications for the career transition program from recently graduated doctorally prepared nurse scientists or doctorally prepared nurse scientists venturing into novel areas of research. The overall goals of this program are to support outstanding individuals to obtain a research training experience at the NIH in the intramural research laboratories and to facilitate their successful transition to an extramural environment as independent researchers. RESEARCH OBJECTIVES Background Intramural scientists and facilities at the NIH provide an infrastructure for the research training and career development of promising new scientists who will subsequently enter the extramural biomedical and health care research community and have the potential to become leaders in their fields of investigation. The goal of the NINR Career Transition Award program is to provide highly qualified developing doctorally prepared registered nurses with an opportunity to receive postdoctoral research training in an NIH intramural research laboratory or clinical research department. Transition funding will be provided upon completion of the fellowship for the continuation of their program of research in an extramural institution. The NINR Career Transition Award consists of an Intramural Support Phase and an Extramural Support Phase. The total period of combined intramural and extramural support will be up to five years. Initially, up to three years of the research training program will be provided in the Intramural Support Phase in which the salary of the awardee will be commensurate with his/her level of experience. The final two years of the program, the Extramural Support Phase, will provide salary and funds for supplies, equipment and technical support thorough the NIH Career Transition Award. Transition from the intramural phase of support to the extramural phase will be based upon the success of the recipient's postdoctoral research training program as determined by a formal internal NINR scientific progress review. Intramural Research at the NIH The NINR intramural research program is located on the Bethesda campus. In addition, NIH intramural research opportunities are available with other NIH institutes, such as the National Institute on Aging, the National Cancer Institute, the National Institute of Environmental Health Sciences, and the National Human Genome Research Institute. For example, at the National Institute on Aging, research opportunities are possible in conjunction with the Baltimore Longitudinal Study of Aging or with other on-going studies. At the National Cancer Institute opportunities are available with the Division of Cancer Epidemiology and Genetics. At the National Human Genome Research Institute there are both laboratory and clinical opportunities. To assist the applicant in finding a sponsor for this research training and career development experience, a listing of NIH intramural research opportunities can be accessed through the following website http://www1.od.nih.gov/oir/sourcebook/sci-prgms/sci-prgms-toc.htm The website identifies individual Institutes and Centers, describes intramural laboratories and clinical research services, and the topic areas of interest within the institutes and centers. Names and phone numbers of scientists are listed on the websites, and prospective applicants are encouraged to contact the scientists directly and dialogue with them about the potential for a laboratory and/or clinical postdoctoral research training experience. It is strongly recommended that potential candidates receive guidance regarding research and mentoring opportunities with NINR and with other NIH institute intramural research programs by contacting staff identified in the Inquiries section below. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) Career Transition (K22) award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total period of combined support is up to five years (up to three years intramural, up to two years extramural). There is no grant award associated with the intramural phase. Awards are not renewable. Total cost of the intramural phase is based on the candidate's experience and research expenses, not to exceed $125,000 per year. The final two years of the scholar's research program will be supported by the extramural institution to which the scholar is recruited and will be funded through an extramural, non-competing, K22 award. Costs for the extramural phase cannot exceed $125,000 plus fringe benefits per year in direct costs. Acceptance into the NINR Career Transition Award program does not convey any commitment or intent of the NINR to consider the awardee for Federal employment within the NINR. The NINR Career Transition Award is specifically intended to give a postdoctoral research training experience to candidates who will pursue their career in the extramural scientific research community. However, the NINR Career Transition awardee is not explicitly precluded from applying for available tenure track positions at the NIH. If an awardee obtains a NIH position, the NINR Career Transition Award will be terminated. ALLOWABLE COSTS Intramural Support Phase: The budget for the Intramural Support Phase includes the candidate's salary and research expenses determined by the NINR Division of Intramural Research. There is no grant award associated with the intramural phase. Total costs for the intramural phase are based on the candidate's experience and research expenses and are not to exceed $125,000 per year. The salary must be commensurate with the level of training and experience specified in the Federal pay schedule and will be negotiated with NINR at the time of an award. Extramural Support Phase: 1. Salary: The NIH will provide up to $50,000 in salary plus fringe benefits to the NINR Career Transition Award recipient. The total salary requested must be based on a full-time, 12-month faculty or staff appointment. It must be consistent with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other faculty or staff members of equivalent qualifications, rank, and responsibilities in the department concerned. There should be no less than 75 percent effort devoted by the candidate specifically to the proposed program of research. The institution may supplement the NIH 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 the Career Transition Award. Under expanded authorities, institutions may re- budget funds within the total costs awarded, but may not re-budget funds involving the salary component of the budget. 2. Research Support: The NINR will provide up to $75,000 per year for (a) research expenses, such as supplies, equipment, consultants, patient care costs, and technical personnel; (b) travel to research meetings or training; and (c) statistical service, including personnel and computer time. 3. Ancillary Personnel Support: Salary for secretarial and administrative assistance, etc., is not allowed. 4. Facilities and Administrative (F&A) Costs: F&A costs will be reimbursed at eight percent of modified total direct costs. FUNDS AVAILABLE It is anticipated that applications for the NINR Career Transition Award will be solicited annually through the re-issuance of this RFA. NINR anticipates funding up to three awards in FY 2004 and has set aside up to $375,000 total costs annually for salary and research expenses. The funding level will be dependent upon the number of meritorious applications received, funds available, and the particular resource needs for the proposed project. ELIGIBLE INSTITUTIONS Intramural Support Phase: Intramural phase applications may be submitted for research within any intramural program at the NIH. Extramural Support Phase: Applications for transition to the extramural phase require that the extramural institution falls within one or more of the following categories: o For-profit or non-for-profit organizations o Public or private institutions, such as universities, colleges, and hospitals o Units of state and local governments o Eligible agencies of the Federal government o Domestic organizations Foreign institutions are not eligible to apply. INDIVIDUALS ELIGIBILE TO BECOME PRINCIPAL INVESTIGATORS Registered Nurses (RN) who are recent recipients of a doctoral degree or its equivalent and who have demonstrated the potential for a highly productive research career are eligible to apply. The doctoral degree must be awarded before the Career Transition Award can be activated. In general, individuals who have had more than five years of postdoctoral research training at the time of application are not eligible to apply; however, clinical training does not count against the five-year rule. During the NIH intramural phase of the award, the candidate is expected to devote 100 percent effort on research training for up to three years. During the extramural phase, the candidate must spend a minimum of 75 percent effort conducting research and engaging in research career development activities for the two years of the award. Candidates must be U.S. citizens or non-citizen nationals, or must have been lawfully admitted for permanent residence and possess an Alien Registration Card (I-151 or I-552) or some other verification of legal admission as a permanent U.S. resident by the time of the award. 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. Because the purpose of this initiative is to ease the transition of newly awarded doctoral candidates into postdoctoral education, current principal investigators on PHS research grants are not eligible. 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: o Direct your questions about the intramural support phase to: Melinda M. Tinkle, PhD, RN Intramural Program Director for Research and Training National Institute of Nursing Research Building 31, Room 5B-13 Bethesda, MD 20892-2078 TELEPHONE: (301) 402-7889 FAX: (301) 480-2479 Email: tinklem@mail.nih.gov o Direct your questions about the extramural support phase to: Martha L. Hare PhD, RN Program Director National Institute of Nursing Research 6701 Democracy Blvd, Room 710, MSC 4870 Bethesda, MD 20892-4870 TELEPHONE: (301) 451-3874 FAX: (301) 480-8260 Email: harem@mail.nih.gov o Direct your questions about peer review issues to: John E. Richters, PhD Chief, Office of Review Division of Extramural Activities National Institute of Nursing Research 6701 Democracy Blvd, Room 707, MSC 4870 Bethesda, MD 20892-4870 ATTN: NINR Career Development Award Telephone: (301) 594-5971 FAX: (301) 451-5645 Email: john.richters@nih.gov o Direct your questions about financial or grants management matters to: Cindy McDermott Chief, Office of Grants and Contracts Management Division of Extramural Activities National Institute of Nursing Research 6701 Democracy Blvd, Room 710, MSC 4870 Bethesda, MD 20892-4870 Telephone: (301) 594-6869 FAX: (301) 451-5648 Email: cindy_mcdermott@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 NINR 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: John E. Richters, PhD Chief, Office of Review Division of Extramural Activities National Institute of Nursing Research 6701 Democracy Blvd, Room 707, MSC 4870 Bethesda, MD 20892-4870 ATTN: NINR Career Development Award Telephone: (301) 594-5971 FAX: (301) 451-5645 Email: john.richters@nih.gov SUBMITTING AN APPLICATION The candidate must obtain a commitment from the intramural scientist before completing the K22 application. Potential applicants are encouraged to contact Dr. Melinda Tinkle, at the address listed under WHERE TO SEND INQUIRIES, prior to application submission. Questions regarding the extramural phase may be addressed to Dr. Martha Hare. 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: GrantsInfo@nih.gov. The initial application for the NINR Career Transition Award program will NOT be processed through your current institution; therefore, follow the supplemental guidelines below for the face page. The applicant must provide her/his signature in item 14; signature is not required for item 15. Leave items 9-13 and 15 on the face page blank. Enter in item 6 (Dates of Proposed Period of Support) the combined 4 to 5 years of support needed to complete the intramural and the extramural support phases of the NINR Career Transition Award Program. Utilize the "Research Career Award" Table of Contents page, but re- label the page, "Career Transition Award." This page is included in the Form 398 packet and will facilitate organizing the research and career development components of the application. Add a "Career Development Plan" under "Section II: Specialized Information." Budget o Do NOT provide any dollar figures in the application. The final budget will be negotiated when a selected applicant accepts a position and will be within the allowable costs specified above. o For candidates who receive approval for transition to extramural support, a budget will be submitted as part of the form PHS 2590 Non- Competing Grant Progress Report as discussed below in Extramural Support Phase. The application must address the following issues: Candidate o Establish the candidate's commitment to a career in biomedical or behavioral research. o Establish the candidate's potential to develop and pursue a successful program of research as an independent investigator. o Establish the candidate's ability to work with other scientists in an interactive research environment. o Summarize the candidate's immediate and long-term career objectives, explaining how the award will contribute to their attainment. o Letters of recommendation. Three sealed letters of recommendation addressing the candidate's potential for a research career must be included as part of the application. One should be from a dissertation advisor or mentor, if the candidate is in a doctoral or postdoctoral research setting. These letters should address the candidate qualifications as already outlined. Career Development Plan o Applicant should describe the research training and career development plan, incorporating consideration of the candidate's goals and prior experience. The applicant should describe a systematic plan to obtain the necessary scientific background and research training experience to launch an independent research career (including the need for any courses, mentoring format, plans for immersion into the laboratory, research techniques or methods, etc.). Intramural Research Training Plan o The application must describe: 1) how the specific laboratory postdoctoral intramural experience will enhance the candidate's projected research career; and, 2) identify specific research training objectives. Research training objectives should include how the intramural research experience will assist the candidate in developing a unique program of research at an extramural institution. Sponsor's Statement (Intramural Phase) o The application must include a statement from the sponsor describing the elements of research training planned for the candidate, including any formal course-work, and specify how the candidate's scientific independence and professional development will be promoted. The sponsor should also include information on his/her research qualifications, previous experience as a research supervisor, research support related to the candidate's research plan, and nature of the supervision that will occur during the proposed award period. Extramural Research Plan o Describe the research plan, including the scientific objectives and specific aims, and the use of a basic or clinical approach to a scientific research problem sufficient to justify two years of support in the extramural phase, i.e., what are the research goals and potential avenues of research that will be undertaken based upon the intramural research training? The candidate must describe the research plan as outlined in form PHS 398 (rev. 5/01) including sections on the Specific Aims, Background and Significance, Progress Report/Preliminary Studies, Research Design and Methods. 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: John E. Richters, PhD Chief, Office of Review Division of Extramural Activities National Institute of Nursing Research 6701 Democracy Blvd, Room 707, MSC 4870 Bethesda, MD 20892-4870 ATTN: NINR Career Development Award Telephone: (301) 594-5971 FAX: (301) 451-5645 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. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. 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. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes. While the investigator may still benefit from the previous review, the RFA application is not to state explicitly how. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NINR. Incomplete applications and non- responsive applications will be returned to the applicant without review. 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 NINR in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o 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 Receive a second level review by the National Advisory Council for Nursing Research REVIEW CRITERIA The peer review criteria for applications submitted in response to this RFA are: Candidate o Capacity and commitment to pursue an independent research career; o Potential to develop into an outstanding independent research scientist who will make significant contributions to the field; o Quality and breadth of prior scientific training and experience including, where appropriate, the record of previous research support and publications; o Ability to plan, develop, and organize a program of research that will make full use of the support offered under this award. Career Development Plan o Appropriateness of the career development plan, considering the candidate's goals and prior experience; o The consistency of the career development plan with the candidate's research plan and potential for contributing to the scientific literature. Intramural Training Plan o Appropriateness of the intramural training plan, considering the candidate's goals and prior experience; o The logical sequence and scientific rigor of the intramural training plan with the candidates research plan; o Potential of the scholar to contribute to the scientific literature. Sponsor o Appropriateness of the sponsor's research interests and qualifications to the career development needs of the candidate; o Adequacy of the nature and extent of supervision that will occur during the proposed award period; o Adequacy of the proposed mentoring plan. Extramural Research Plan o A sound research plan that is consistent with the candidate's level of research development must be provided; o Usefulness of the intramural research plan as a vehicle for enhancing or expanding existing research skills as described in the career development plan; o Scientific and technical merit of the research question, design and methodology, judged in the context of the candidate's previous training and experience; o Adequacy of plans to include both genders, children, and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated, where appropriate. SELECTION PROCEDURES Following peer review, the written evaluations and priority score assigned to the application by the initial review group will be sent to the candidate. Intramural Support Phase Successful candidates will be selected based on priority score ranking, programmatic needs, and available resources. Each awardee will be evaluated for progress on an annual basis by the mentor and the appropriate member of the NINR Division of Intramural Research. Extramural Support Phase Transition to the extramural support phase is not automatic. The NINR will conduct a formal scientific progress review no later than the end of the second year of the Intramural Support Phase to determine whether or not the awardee will be recommended for the extramural phase of support. In order to proceed to the scientific progress review, the candidate must have a formal tenure-track (or equivalent) offer of a faculty position from an extramural institution. Other specific requirements for the scientific progress review include: o annual progress report from the awardee o revised research plan for extramural support phase o letter of commitment to the candidate from the Dean of the extramural institution agreeing to provide: protected research time, infrastructure, space needed to perform the proposed research and funds from the institution for equipment and supplies (and if necessary, salary). This review will be conducted by an NINR Progress Review Committee composed of members of the NINR Selection Committee, and other intramural and extramural staff and other reviewers as needed. The results of the review will constitute a final evaluation of the Intramural Support Phase and be presented in writing to the awardee. Approval will result in eligibility for the extramural phase of funding of the Career Transition Award, and up to a third additional year of intramural support to facilitate the transition to an extramural laboratory. Upon approval, the extramural institution will submit an application on behalf of the candidate for the extramural phase of support, using the form PHS 2590, the Non-Competing Grant Progress Report. The PHS 2590 should be submitted no later than two months prior to the start of the extramural phase and should specifically include: o Face page o Abstract and personnel page o Budget (12 month and multi-year) o Budget justification o Current investigator-initiated research grant support (in Other Support format) o All applications submitted for investigator-initiated support o Updated career progress o Publications in press or submitted o Revised research plan for extramural phase o Checklist At the end of the first year of extramural support, the awardee will submit a PHS 2590 for the final year of support. Upon completion of the final year, the awardee will submit a final progress report. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: October 17, 2003 Application Receipt Date: November 14, 2003 Peer Review Date: February 2004 Council Review: May 2004 Earliest Anticipated Start Date: July 1, 2004 AWARD CRITERIA Applications will compete for available positions/funds with all other scored applications submitted in response to this RFA. The following will be considered in making award decision: qualifications and potential of the applicant and quality of the proposed research project as determined by peer review; quality and appropriateness of the training environment to the applicant's career goals; availability of intramural NIH resources; programmatic priorities; and availability of funds. Evaluation of Scientific Progress Intramural Support Phase Each awardee's research progress will be evaluated on an annual basis. For this purpose, the awardee will prepare an annual progress report that will be evaluated by the mentor and the NINR Division of Intramural Research. Additionally, the NINR will conduct a formal scientific progress review no later than the end of the second year (See section on Selection Procedures, Extramural Support Phase). Extramural Support Phase The awardee will be required to submit a form PHS 2590 Non-Competing Grant Progress Report for the final year of extramural support. After the completion of this award, the awardee will be required to submit a final progress report. Additionally, periodic updates on various aspects of 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 may be solicited from the awardee. REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm MONITORING PLAN AND DATA AND SAFETY 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 and Safety 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 "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://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://stemcells.nih.gov/index.asp 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, in the project description and elsewhere in the application as appropriate, 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. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. 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 at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm 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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