NEI CAREER TRANSITION AWARD (K22) RELEASE DATE: August 6, 2004 PA NUMBER: PAR-04-136 January 30, 2009 - See Notice (NOT-OD-09-039) This notice announces the expiration of this PAR. May 16, 2008 - See Notice (NOT-OD-08-069) Due to the upcoming receipt dates for several FOAs using these mechanisms, their expiration dates are being extended. September 21, 2007 - Expiration Date adjusted to accommodate recent changes to standing submission deadlines, per NOT-OD-07-093. January 25, 2007 - See Notice (NOT-OD-07-043) Extension of Several NRSA Training (T), NRSA Fellowship (F), and Career Development (K) expiration dates. (See clarification, NOT-EY-05-006) EXPIRATION DATE: New Date January 30, 2009 (per issuance of NOT-OD-09-039) (Changed from January 8, 2010 per NOT-OD-08-069) (Changed to January 8, 2008 per NOT-OD-07-093) Original Expiration Date: January 3, 2008 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENTS OF PARTICIPATING ORGANIZATION: National Eye Institute (NEI) (http://www.nei.nih.gov) Office of Dietary Supplements (ODS) (http://ods.od.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.867 THIS PAR CONTAINS THE FOLLOWING INFORMATION o Purpose of the PAR o Research Objectives o Mechanism of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PAR The purpose of the National Eye Institute (NEI) Career Transition Award is to enable outstanding individuals to establish an independent research program in vision research and to secure an appointment in an academic institution in the United States. This is accomplished in a two-phase award program. The Scholar Development Phase provides up to three years of mentored career development training in an NEI Intramural Research Program (IRP) laboratory. The Faculty Transition Phase provides up to two years of research support at an extramural institution to which the Scholar has been recruited as an independent faculty member. The NIH Office of Dietary Supplements will collaborate with the NEI in supporting Scholars whose research involves dietary interventions or risk factors which affect visual system diseases, disorders, or development. RESEARCH OBJECTIVES Background The mission of the NEI is to conduct and support the highest quality research aimed at increasing our understanding of the eye and visual system in health and disease. This research will promote the visual health of the Nation through development of effective means for the prevention, treatment, and rehabilitation of visual impairment, and through the timely dissemination of research findings and information. Over the past thirty years the NEI IRP has provided an extraordinary research environment for the training of new scientists who have the potential to become leaders in the area of vision research. This Career Transition Award mechanism is uniquely designed to facilitate the transition of these newly- trained individuals to independent research careers in U.S. academic institutions. Applicants for this award may engage in both basic and clinical research investigations at the NEI to improve our understanding of vision and visual impairment. Basic research programs include immunology, developmental biology, sensorimotor research, molecular biology and genetics. The Age-Related Eye Disease Study (AREDS) is an example of a major clinical research funded by the NEI to improve our understanding of the predisposing factors and clinical course of AMD and cataract. The outcome of this study has spurred new treatments and research on vitamins and antioxidants as prognostic factors for eye disorders. Scope NEI-sponsored investigations broadly cover all aspects of vision research. These programs represent a significant fraction of the vision research conducted in hundreds of extramural laboratories and clinics throughout the world, as well as in the NEI’s own IRP facilities in Bethesda, Maryland. The NEI IRP is organized into eight scientific units: the Division of Epidemiology and Clinical Research; the Laboratories of Immunology, Molecular and Developmental Biology, Sensorimotor Research, Retinal Cell and Molecular Biology, Mechanisms of Ocular Diseases, and Ophthalmic Genetics and Visual Function; and the Section on Molecular Structure and Function. Detailed information regarding specific IRP research projects that are currently being pursued and scientists who can potentially serve as mentors is available at http://www.nei.nih.gov/intramural/. Continued advances in vision research will require a diverse, highly trained cadre of scientists in adequate numbers to carry out the NEI’s biomedical and behavioral research agenda. The NEI Career Transition Program is designed to help ensure that promising applicants fulfill their potential to become productive, independent investigators. MECHANISM OF SUPPORT This PAR will use the NIH Career Transition Award (K22) mechanism. The applicant and the mentor will be solely responsible for planning, directing, and executing the proposed project. This PAR uses just-in-time concepts. It also uses the non-modular budgeting format (see http://grants.nih.gov/grants/funding/modular/modular.htm). This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm The total period of support for the NEI Scholars Program is up to five years. The Scholar Development Phase may be up to three years, and the Faculty Transition Phase may be up to two years. Both phases of the award are neither transferable nor renewable. o Intramural Scholar Development Phase The Scholar Development Phase takes place within the NEI IRP for up to three years. During this phase of the award, scholars are expected to spend full time on mentored career development activities such as research and didactic course work. Scholars will be fully supported by the NEI intramural unit in which the Scholar conducts his/her research. The level of support will be negotiated with the NEI Scientific Director at the time of award. o Extramural Faculty Transition Phase The Faculty Transition Phase will take place at a U.S. extramural institution for up to two years. During this phase of the award the Scholar is expected to devote at least 75% effort to the establishment of an independent vision research program. The NEI will provide Scholars with salary support commensurate with the applicant institution’s salary structure for persons of equivalent qualifications, experience, and rank, up to the legislatively-mandated salary limit. The institution may supplement the Scholar’s salary. 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 Public Health Service (PHS) funds be used for salary supplementation. Institutional supplementation of salary may not require extra duties or responsibilities that would interfere with the purpose of this award. Annual direct costs up to $100,000 will be provided for personnel, equipment, supplies, tuition and fees, travel, patient care costs, statistical services, and other career development- and research-related activities. The extramural institution will be reimbursed indirect costs at eight percent of modified total direct costs. o Special Considerations Before submitting an application for the Scholar Development Phase, the candidate must identify an individual or individuals within the NEI IRP who will serve as the mentor and will be committed to supervise the career development research and training activities for the duration of this phase of the award. The mentor must be an active investigator in the area of the proposed research and have both the research training experience and the resources needed to support the NEI Scholar. The NEI Career Transition Program is specifically intended to help develop scientists who will pursue an independent extramural vision research program. Therefore, acceptance into the IRP Scholar Development Phase does not convey any intent or commitment of the NEI to consider the NEI scholar for a tenure track position within the IRP. Nevertheless, NEI Scholars are not precluded from applying for available intramural tenure track positions at the NIH. If an NEI scholar obtains an NEI tenure track or NIH position, the NEI Scholar’s award will be terminated. Progression to the Faculty Transition Phase is not automatic. The NEI Division of Extramural Research will conduct a formal progress review no later than the end of the second year of the Scholar Development Phase to determine whether or not the Scholar will be recommended for transition. Following the Faculty Transition Phase, it is anticipated that Scholars will obtain a research project grant (R01) to support the continuation of their research. The Scholar would not be eligible to apply for any NIH mentored career development award. ELIGIBLE INSTITUTIONS The Scholar Development Phase of this award must be performed in the NEI IRP. The Faculty Transition Phase may be pursued at an extramural institution with 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/organization o Foreign institutions are not eligible to apply INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Candidates must be US citizens, non-citizen nationals, or permanent residents. The candidate must have a research or health professional doctoral level degree or its equivalent and must have demonstrated the potential for a highly productive research career. Candidates should be within seven years of receipt of their degree at the time of application. Clinical training does not count against the seven years. Former Principal Investigators on NIH research project grants (R01, R03, R15, R21, R41, R42, R43, R44), subprojects of program project grants (P01) or center grants (P30, P50), career development awards (K01, K08, K12, K23, K24), or the equivalent are not eligible to apply. 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. Women, individuals from underrepresented racial and ethnic groups, and individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS During the Scholar Development Phase, Scholars must provide annual progress reports using form PHS 2590, available at http://grants.nih.gov/grants/forms.htm. The form is due two months prior to the end of the budget period. The reports should detail progress achieved on the specific aims of the research plan and on the pursuit of identified career goals. Future goals for the research project and for further career development should also be indicated. The mentor must provide a separate narrative of the research and career development of the Scholar. The Scholars’ progression to the Faculty Transition Phase of the award will be based upon the assessment of a Scholar Review Committee (SRC). The SRC will be composed of the extramural program director, NEI Training Officer, and other senior NEI extramural staff. The SRC will meet within 30 days of receipt of the second year’s annual progress report (Scholars who wish earlier consideration of progression should discuss the timing with their extramural program director). The SRC determination will be based upon the cumulative research progress and evidence of increasing scientific independence, as documented by both the Scholar and the mentor. The findings of the SRC will be communicated to the Scholar, mentor, and NEI Scientific Director. The successful Scholar will be provided with an “Intent to Fund” letter with which he/she may pursue a tenure track appointment. Activation of the Faculty Transition Phase of the award will be made through submission of form PHS 2590 from the appropriate extramural institution. Scholars who do not successfully enter the transition phase of the award will be provided with a terminal, third year of Scholar Development Phase support WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PAR 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: Chyren Hunter, Ph.D. Training Officer Division of Extramural Research National Eye Institute 5635 Fishers Lane, Suite 1300, MSC 9300 Bethesda, MD 20892-9300 Telephone: (301) 451-2020 FAX: (301) 402-0528 Email: firstname.lastname@example.org The Office of Dietary Supplements, Office of the Director, NIH will support meritorious Career Development (K22) applications to this initiative for clinical and basic research related to studies involving nutritional interventions. For further information, please contact: Mary Frances Picciano, Ph.D. (NIH/OD) Senior Nutrition Scientist Office of Dietary Supplements National Institutes of Health Suite 3B01 6100 Executive Boulevard Bethesda, MD 20892-7517 Phone: 301-435-2920 FAX: 301-480-1845 Email: PiccianiM@mail.nih.gov o Direct your questions about peer review issues to: Samuel C. Rawlings, Ph.D. Chief, Scientific Review Branch Division of Extramural Research National Eye Institute 5635 Fishers Lane, Suite 1300, MSC 9300 Bethesda, MD 20892-9300 Telephone: (301) 451-2020 FAX: (301) 402-0528 Email: email@example.com o Direct your questions about financial or grants management matters to: William W. Darby Grants Management Officer Division of Extramural Research National Eye Institute 5635 Fishers Lane, Suite 1300, MSC 9300 Bethesda, MD 20892-9300 Telephone: (301) 451-2020 FAX: (301) 496-9997 Email: firstname.lastname@example.org SUBMITTING AN APPLICATION Potential applicants are strongly encouraged to contact the program staff listed under INQUIRIES. Such contact should occur early in the planning phase of application preparation and will help ensure that applications are responsive to the goals and policies of this announcement. Early in the process, candidates must obtain commitments from the IRP investigator(s) who will serve as mentor during the Intramural Scholar Development Phase. The potential Scholar and mentor(s) must work collaboratively to design the proposed career development and research experiences. Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. PLEASE NOTE THAT THE D&B NUMBERS ARE NOT AVAILABLE FOR THE INTRAMURAL PHASE BUT ARE REQUIRED FOR THE EXTRAMURAL FACULTY TRANSITION PHASE. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The D&B number should be entered on line 11 of the face page of the PHS 398 form. 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. The title and number of this program announcement must be typed on line 2 of the face page of the application form and the YES box must be checked. Supplemental Application Guidelines Item 6, Enter the combined dates of support needed to complete both the Scholar Development and Faculty Transition Phases. Items 9, 10, 11, 12, 13, 14, 16: Leave these items blank. o Table of Contents: Do not use forms in the PHS 398 application. Prepare a page titled “Career Transition Award Table of Contents” which contains the following sections: Section I: Basic Administrative Data 1. Face Page 2. Description, Performance Site(s), and Key Personnel 3. Budget Scholar Development Phase: Do not provide any dollar figures in the application. The final budget will be negotiated with the Scientific Director at the time of award. Use continuation pages as needed to provide a detailed justification for the budgetary needs of the proposed research program. Faculty Transition Phase: Candidates who receive approval for transition to faculty support have two years from the approval date in which to activate this phase of their award. Upon activation, a budget will be submitted as part of the Form PHS 2590 Non-competing grant Progress Report. The application should provide an updated research plan and documentation of institutional commitment to necessary facilities and resources. 4. Biographical Sketches: Provide for both the candidate and the mentor(s), using the Biographical Sketch Format Page. Do not exceed four pages. 5. Resources (Resources Format Page) Section II: Specialized Information 1. Letters of Reference (Attach to Face Page) Provide three sealed letters of recommendation addressing the candidate’s potential for a laboratory or clinical research career. It is recommended that one letter be from the most recent mentor in either a postdoctoral research or clinical setting or from the applicant’s thesis advisor. 2. Candidate (not to exceed one page) Describe the candidate’s commitment to a career in vision research. Discuss the candidate’s potential to develop into a successful independent investigator. 3. Career Development Plan (not to exceed two pages) Propose a career development plan for the Scholar Development Phase of the award. The candidate’s education and prior experience should be documented. Present a systematic plan to obtain the scientific background and the new research training experience necessary to launch an independent research career. Include the need for any formal courses, mentoring format, plans for immersion into the laboratory, research techniques or methods, etc. Describe plans to receive training in the responsible conduct of research. Include the proposed subject matter, format, frequency, and during of instruction, as well as the amount and nature of senior staff participation. No award will be made if an application lacks this component. 4. Mentor(s)’s Statement (not to exceed one page) Describe the mentor(s)’s research qualifications and previous research training experience. Describe the nature and extent of the mentor(s)’s commitment and supervision. Document a strong, well-established research program related to the candidate’s area of interest. This should include an environment with staff capable of productive collaboration with the candidate. Letters of commitment of space and resources to be provided to the Scholar should be provided by the NEI Scientific Director. Indicate how the career development plan will be used to promote the candidate’s scientific independence and professional development. 5. Research Plan (not to exceed ten pages) Applicants are advised to address the research plan in two parts. First present the Scholar Development Phase, which should be prepared after consultation with the mentor(s). Include descriptions of the hypothesis and specific aims, background, significance and rationale, preliminary studies and any results, research design and methods, and literature cited. As appropriate, discuss the use of human and animal subjects. Relate the research plan to the candidate’s career goals and career development plan. Second, present the Faculty Transition Phase. This should provide general research directions for the independent extramural phase. Describe the broad research goals and potential avenues of research that would be stimulated by the specific research project. 6. Training in the Responsible Conduct of Research Candidates 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. 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 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. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight weeks. PEER REVIEW PROCESS Applications submitted for this PAR will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened by the NEI in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o 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 written critique o Receive a second level review by the National Advisory Eye Council. REVIEW CRITERIA Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025) In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the applicant will assume an independent extramural vision research career. o Candidate o Career Development Plan o Scholar Development Phase o Faculty Transition Phase o Mentor(s) o Environment The scientific review group will address and consider each of these criteria in assigning the application’s overall score, weighting them as appropriate for each application. The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. CANDIDATE: Does the candidate have the capacity and commitment to pursue an independent research career? Does the candidate have the potential to develop into an outstanding independent research scientist who will make significant contributions to the field? CAREER DEVELOPMENT PLAN: Does the career development propose new training appropriate to the candidate’s prior scientific training and experience? Is the plan likely to contribute substantially to the continued scientific development and productivity of the candidate? SCHOLAR DEVELOPMENT PHASE: Is the research proposed appropriate to the candidate’s prior scientific training and experience? Is the proposed new research innovative, significant, and likely to contribute to the scientific literature. FACULTY TRANSITION PHASE: Are the scholar’s overall goals for the Faculty Transition phase in concert with the goals to be achieved during the Scholar Development Phase? Is the scholar’s research program comprehensive, pursuing both current and potential avenues for research and research collaboration(s). Has the scholar considered how to best utilize this two- year phase to enhance his/her research program as a tenure-track investigator? MENTOR(S): Are the mentor(s)’ research qualifications, scientific stature, experience, and track record appropriate to the applicant’s career development needs. Is there evidence of previous experience in fostering the development of new investigators. Is the extent of ENVIRONMENT: For both the Scholar Development Phase and the Faculty Transition Phase has the scholar been made aware of and provided appropriate resources to carry out his/her research and training goals? Is there a plan for integration of the scholar into the research environment, e.g., through attendance at seminars, laboratory meetings, clinical grant rounds, committee responsibilities. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: Training in the Responsible Conduct of Research o Appropriateness and quality of the proposed training in the responsible conduct of research. PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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 will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW CONSIDERATIONS Sharing Research Data Applicants requesting $500,000 or more in direct costs in any year of the proposed research are expected to include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PAR 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 as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS ANIMAL WELFARE PROTECTION: Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as mandated by the Health research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable. 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 DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose- finding studies (phase I); efficacy studies (phase II), efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. 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). SHARING RESEARCH DATA: Investigators submitting an NIH application seeking more than $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible http://grants.nih.gov/grants/policy/data_sharing Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. 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 PAR 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 PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/. 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. The Office of Dietary Supplements (ODS) was mandated by Congress in 1994 and established within the Office of the Director, National Institutes of Health (NIH). The Dietary Supplement Health and Education Act (DSHEA) [Public Law 103-417, Section 3.a] amended the Federal Food, Drug, and Cosmetic Act "to establish standards with respect to dietary supplements." This law authorized the establishment of the ODS. 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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