TRANSITION TO INDEPENDENT POSITIONS (TIP) RELEASE DATE: February 24, 2003 RFA: ES-03-006 National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov/) CATALOGUE OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.113 and 93.115 LETTER OF INTENT RECEIPT DATE: June 13, 2003 APPLICATION RECEIPT DATE: July 14, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Supplemental Instructions o Allowable Costs o Peer Review Process o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA Human health and human disease result from three interactive elements: (1) environmental exposures, (2) individual susceptibility, and (3) time. The mission of the National Institute of Environmental Health Sciences (NIEHS) is to reduce the burden of human illness and dysfunction from environmental exposures by understanding each of these elements and how they interrelate. The NIEHS achieves its mission through multidisciplinary biomedical research programs, prevention and intervention efforts, and communication strategies that encompass training, education, technology transfer, and community outreach. An important element of the NIEHS mission is to develop the next generation of exceptionally talented young scientists who are committed to understanding the impact of environmental exposures on human health. The NIEHS TIP Program is a Research Scholar Development Award (K22) program targeted to talented postdoctoral scientists. It provides a unique mechanism for attracting and supporting the transition to independent faculty positions of exceptionally talented new investigators who can impact our understanding of the problems and mechanisms associated with exposure to environmental agents in order to better protect the public health. RESEARCH OBJECTIVES Background The Congress of the United States enacted the Ruth L. Kirschstein National Research Service Act (NRSA) Program in 1974 to help ensure that highly trained scientists would be available in adequate numbers and in appropriate research areas to carry out the Nation's biomedical and behavioral research agenda. Under this congressional authority, the NIEHS awards the NRSA individual postdoctoral fellowship (F32) and Intramural Research Training Award (IRTA) to the most promising applicants to support full-time research training related to the mission of the NIEHS. The goal of these and other postdoctoral training programs is to develop the next generation of exceptionally talented young scientists who are committed to understanding the impact of environmental exposures on human health. The NIEHS has determined that there is a need for a mechanism to assist exceptionally talented investigators in making the career transition from postdoctoral training to independent academic research positions. To meet this need, the NIEHS has initiated the TIP Program to facilitate the transition of the most talented postdoctoral investigators into career positions relevant to the research priorities of the NIEHS. Goals and Scope The NIEHS TIP Program is designed for exceptionally talented new environmental health scientists in basic, clinical or population-based (epidemiology) research who have demonstrated outstanding scientific abilities during their training. The objective of the program is to provide a commitment of support for the most promising new investigators early in their career while they establish their independent research program in a research-intensive environment relevant to environmental health sciences. The TIP investigators are expected to design and pursue their research projects independently in their areas of interest. It is anticipated that the successful applicant will use the award to establish an independent research program and obtain preliminary data that will be the basis for a future research application. Specifically, the TIP investigator is expected to use the preliminary data in the environmental health sciences as a basis for an investigator initiated research grant (R01) or equivalent to the National Institutes of Health (NIH) in an area of a science directly relevant to the mission of the NIEHS within the first 24 months after initiation of the award. The NIEHS has identified priority areas of research that can significantly contribute to our understanding of the impact of environmental exposure on human health. Research proposals that address one of these areas will receive a priority for funding. The current areas of special emphasis are: o Molecular Epidemiology o Basic Molecular Mechanisms of Environmental Insult o Genetic Susceptibility and Predispostion (Environmental Genome Project) o Human Health Effects of Complex Mixtures o Reproductive Health o Neurodegenerative/Neurobehavioral Diseases or Disorders o Translational Research o Impact of Environmental Exposures on Special Populations (Women, Children and Minorities) o Immune System Modulation Additional information about these research topics is available on the NIEHS website at: http://www.niehs.nih.gov/dert/programs/special/special.htm. This site is updated each year. MECHANISM OF SUPPORT This RFA will use the NIH Research Scholar Development Award (K22) mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. Awards will be made prior to September 2005. This RFA uses just-in-time concepts. A detailed budget will be required at the time of activation of the award. This program does not require cost sharing as defined by the current NIH Grants Policy Statement at: http://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm FUNDS AVAILABLE The NIEHS intends to commit approximately $500,000 in FY04 to fund five new awards in response to this RFA. An applicant may request a project period of up to three years and a budget for direct costs of up to $100,000 per year. Although the financial plans of the NIEHS provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. Scholar Development grants (K22) are not renewable but may be extended at no additional costs at the discretion of the sponsoring institution where the TIP award has been made. At this time, it is not known if this RFA will be reissued. ELIGIBLE INSTITUTIONS Awards will be made at the institution where the postdoctoral applicant accepts a suitable position. Institutions eligible to receive awards include public or private domestic institutions, such as universities, colleges, hospitals, and laboratories. Please see the Award Process and Initiation section below for details. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS To be eligible to apply for a TIP Award the following criteria will apply: 1. The applicant must be either: A. A current or former NIEHS Individual National Research Service Fellow (NRSA, F32); or B. A current or former NIH Individual NRSA (F32) Fellow who is training in an area specific to the mission of the NIEHS, but whose support is from another Institute, Center or Division (IC) of the NIH and whose proposed research project directly addresses the effect of an environmental exposure on human illness or dysfunction; or C. A current NIEHS Intramural Research Training Awardee (IRTA), equivalent staff fellow, or intramural clinical fellow who has competed successfully in the NIEHS Intramural eligibility process. NIEHS clinical fellows with the M.D., M.D.- Ph.D., D.O., D.D.S., Pharm.D - MS, Pharm.D - Ph.D., RN - Ph.D. or comparable clinical or combined clinical/research degrees are eligible to apply. In most cases, clinical fellow applicants will have finished their clinical training and may have had some research experience in either a laboratory or clinical setting prior to an appointment in the NIEHS Intramural Program. Clinical candidates should possess aptitudes for independent research in clinically relevant, patient-oriented or population- based research (e.g., epidemiology, behavior, or disease prevention) areas. The Intramural contact person for this program is Dr. William T. Schrader, 919-541-3433, schrader@niehs.nih.gov. Individuals with a research or health professional doctoral level degree or equivalent with at least 18 months but not more than six years (72 months) of postdoctoral research training at the time of application, and with demonstrated outstanding abilities in basic, clinical or population-based (e.g., epidemiologic) research, are eligible to apply. This includes individuals with postdoctoral research experience in any environment (e.g., academic, industry, and government). Individuals who have had more than six years (72 months) of postdoctoral research experience are NOT eligible to apply. However, years of clinical training will not count against the six years of relevant research experience. Individuals who have held research or other professorship or equivalent positions in academe or elsewhere or have been a Principal Investigator on either PHS research grants (e.g., R29, R01, P01, or its subprojects) or non-PHS peer-reviewed research grants are NOT eligible to apply for this award. The NIEHS will return applications not considered relevant either to the mission or to the research priorities of the NIEHS as part of the initial review described in the section, REVIEW CRITERIA of this Request for Applications. This decision is final. Fellows are STRONGLY ENCOURAGED to contact the program administrator listed under WHERE TO SEND INQUIRIES to determine the priority and relevance of his/her research topic to the NIEHS prior to submitting an application. Applicants should identify an NIEHS area of special emphasis that is relevant to his/her research interests. This information is available on the NIEHS web site at http://www.niehs.nih.gov/dert/programs/special/special.htm. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. 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-152) or some other verification of legal admission as a permanent U.S. resident, at the time of submission. 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, jurisdictions, or administration. Individuals on temporary or student visas are NOT eligible to apply. The TIP K22 is a domestic U.S. award and may not be awarded to non-U.S. grantee institutions. 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 scientific/research issues to: Carol Shreffler, Ph.D. Scientific Program Administrator Organs and Systems Toxicology Branch (EC-23) Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, 111 T.W. Alexander Drive Research Triangle Park, NC 27709 Telephone: (919) 541-1445 FAX: (919) 541-5064 Email: shreffl1@niehs.nih.gov o Direct your questions about peer review to: Janice B. Allen, Ph.D. Scientific Review Administrator Scientific Review Branch (EC-30) Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, 111 T.W. Alexander Drive Research Triangle Park, NC 27709 Telephone: (919) 541-7556 FAX: (919) 541-2503 Email: allen9@niehs.nih.gov o Direct your questions about financial or grants management matters to: Ms. Susan Ricci Grants Management Specialist Grants Management Branch (EC-22) Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, 111 T.W. Alexander Drive Research Triangle Park, NC 27709 Telephone: (919) 316-4666 FAX: (919) 541-2860 Email: ricci@niehs.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 project 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 NIEHS staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to by the date listed at the beginning of this document. The letter of intent should be sent to: Janice B. Allen, Ph.D. Scientific Review Administrator Scientific Review Branch (EC-30) Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, 111 T.W. Alexander Drive 79 T.W. Alexander Drive, 3rd Floor (for express/courier service) Research Triangle Park, NC 27709 Telephone: (919) 541-7556 FAX: (919) 541-2503 Email: allen9@niehs.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. SUPPLEMENTAL INSTRUCTIONS Only one grant application may be submitted by a Principal Investigator for the specified receipt date. The applicant institution information requested on the face page should be that for the institution from which the application is being submitted, i.e., the institution where the trainee is located at the time of submission. The Description, Performance Sites, and Key Personnel should appear as page two. The Detailed Budget for the Initial Budget Period (Form Page 4) and Budget for Entire Proposed Period of Support (Form Page 5) are NOT required for the initial application and should be omitted. A detailed budget is subsequently required only for the activation of the award at the academic institution of employment. See specific instructions below for allowable costs The maximum amount awarded to each grantee on this RFA will be $300,000 direct costs for a three-year project period. The amount awarded for any given year (budget period) will not exceed $100,000 direct costs. The maximum salary allowed from this award is $50,000 per year. A two section narrative presentation (two-page maximum) should be inserted in the application just prior to the research plan titled "Future Goals and Objectives" and "Biography", respectively. In the Future Goals and Objectives section (one-half page maximum), the applicant should briefly describe his/her career track vision and describe the types of positions to be pursued. In the Biography section (one and one-half page maximum), the applicant should describe their scientific development from graduate school through postdoctoral experience(s). For each training experience, the applicant should describe his/her role in the laboratory/project and cite relevant publications that resulted from the experience. The applicant should also include in this section a short narrative on how the proposed research project will lead to a successful R01 application. The Research Plan itself (Specific Aims, Background and Significance, Preliminary Studies, Research Design and Methods sections) is not to exceed 15 pages. Tables and figures but not the reference bibliography are included in the 15-page limitation. Applications that exceed the page limitations stated in this RFA announcement or the PHS 398 requirements for font size (height or letters), type density (characters per inch), and margins (see PHS 398 directions) will be returned to the investigator. The Research Plan is expected to follow the typical NIH grant application organization and structure, and should include, but is not limited to the following: o a one-page description (or less) of the long term research goals and how his/her research program would impact on an environmental health problem, and o a specific testable hypothesis, and o a set of specific aims to address the hypothesis, and o methods to obtain data to satisfy the specific aims. Although the research proposal is expected to be independently designed and carried out by the candidate, sponsor and other senior faculty input into the review and editing of the research proposal is encouraged as a part of the career development experience. If the application is a revision of a previously considered application, there should be a clear indication of changes marked as indicated in the instructions for the PHS 398 application. It is expected that a TIP award would provide an investigator the opportunity to obtain the scientific data needed for a subsequent investigator-initiated research grant (R01) or equivalent to the NIH within the mission of the NIEHS. The applicant MUST include three letters of recommendation that address the applicant=s potential to become an important contributor to basic or clinical biomedical or behavioral research or population-based (e.g., epidemiological) research relevant to the mission of NIEHS. One of the letters of recommendation MUST be from the current postdoctoral mentor and one MUST be from the applicant=s pre-doctoral program, preferably the mentor. Applications without letters of recommendation will be considered incomplete and will not be accepted. Late receipt of letters of recommendation (e.g. letters not submitted concomitantly with the application) will not be allowed. Letters should be mailed directly to Dr. Janice Allen at the address given in the WHERE TO SEND INQUIRIES section of this RFA. Note: The letter from the current postdoctoral mentor should address the following points. 1. The applicant=s role and intellectual contribution to the research activities of the laboratory. 2. The current postdoctoral mentor=s role in the development of the proposed project. 3. The applicant=s potential for independent research. Color/glossy photos may be submitted as an appendix, however, the appendix may not be used to circumvent the page limitation. Letters of recommendation are not considered appendices, and do not count towards the 15-page limit. The applicant must provide one to three publications from his/her Ph.D. work and one publication from his/her postdoctoral work. A PHS 398 form biographical sketch of the postdoctoral mentor should be included in the application. SPECIFIC INSTRUCTIONS FOR ALLOWABLE COSTS The detailed budget for the TIP award will be $100,000 direct cost per year for three years. The total direct costs for this award are $300,000 over a period of three years. Facilities and Administration (F&A) costs will be reimbursed at eight percent of modified total direct costs or at the actual facilities and administration (indirect) cost rate, whichever is less. The awardee and sponsoring institution will have considerable latitude in deciding how these funds will be expended, with the exception of salary (described below). This is to allow sufficient flexibility and benefit to the awardee=s research and academic career. Salary: The awardee may request up to $50,000 per year (plus fringe benefits) from this award for salary. The award does not require that salary support be derived from the award; use of the entire direct costs for research related expenses is allowed. The total salary requested must be 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 to other staff members of equivalent qualifications, rank, and responsibilities in the department. Research-Related Expenses: The entire direct costs of this award, or the balance remaining after subtracting the amount devoted to salary, may be used for supplies, equipment, technical personnel, travel and other research related expenses. Applicants must budget travel costs associated with a professional meeting (one per year) in their applications. Equipment is limited to $100,000 direct costs for the three-year project period. Ancillary Personnel Support: Salary for secretarial or administrative assistance is not allowed. 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 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: Janice B. Allen, Ph.D. Scientific Review Administrator Scientific Review Branch (EC-30) Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233 111 T.W. Alexander Drive 79 T. W. Alexander Drive, 3rd Floor (for express/courier service) Research Triangle Park, NC 27709 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 eight 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 NIEHS. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIEHS 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 Environmental Health Sciences Council. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of your application. Candidate o the applicant=s potential to become an important contributor to basic, clinical or population-based (e.g., epidemiological) research or behavioral science within the mission of NIEHS; o the qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research. Research Plan o the originality, innovation and scientific or medical significance of the project as to new concepts and ideas; o the appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; the appropriateness of the work proposed to the experience level of the principal investigator; the acknowledgment of potential problem areas and consideration of alternative tactics; o the adequacy of plans to include both genders, minorities, and their subgroups as appropriate for the scientific goals of any clinical research activities. Plans for the recruitment and retention of subjects will also be evaluated. o the adequacy of the proposed protection for humans, animals, or the environment to the extent they may be adversely affected by the activities proposed in the application. Budget Although a budget is not required, the appropriateness of the scope of work for the funds that are available through this grant will be considered. The applicant should assume that general laboratory equipment items such as spectrophotometer, centrifuges, etc., will be available at the institution. However, highly sophisticated or limited use equipment required for the studies should be identified and funds for the use of such equipment should be considered by the applicant in developing the research plan. For example, magnetic resonance imaging equipment and fluorescence cell sorters are available for a fee at many institutions, and the cost for their use should be considered by the applicant. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: June 14, 2003 Application Receipt Date: July 14, 2003 Peer-Review Date: October-November, 2003 Council Date: February 2004 Earliest Award Date: July 2004 AWARD CRITERIA The anticipated date of notification of a Letter to Commit Funds is March- April, 2004. The following will be considered in making funding decisions: (a) potential of the applicant to make a significant contribution to the NIEHS mission; (b) quality of the proposed projects scientific merit as determined by peer review; (c) availability of funds; and (d) program balance among research areas of the announcement. AWARD PROCESS AND INITIATION At the time a decision is made to make an award, the applicant will be provided a Letter to Commit Funds that states intent to commit funds, which will be signed by the NIEHS Grants Management Officer. This letter states the conditional intent of the NIEHS to make a grant award and may be used by the candidate when entering into negotiations for a position with a suitable institution to document potential grant support for the candidate=s research project. The date of this letter will determine the expiration date of the NIEHS offer to commit funds to a grant award. Please note that this is different from the usual NIH process since this commitment is not made initially to a specific institution. After a TIP investigator has identified a permanent position, preferably tenure-track or equivalent, at a research intensive domestic institution (sponsoring grantee institution), the sponsoring institution will request that an award be issued by submitting the appropriately prepared form PHS 398 (competing grant application) that includes a detailed budget. The application must also include letters from the institutional official signing the application describing the position and confirming that the TIP investigator has been offered and has accepted a permanent, preferably tenure- track or equivalent, position. In addition, a statement from the Department Chair or equivalent official must be included which describes the resources that will be available for the TIP investigator. Finally, if the research involves animals/human subjects, the certification that the protocols were approved by the appropriate institutional committee of the designated grantee institution must be provided. These and other relevant materials are to be submitted to the NIEHS Grants Management Office at the address listed on the Letter of Commitment. These materials will be used by NIEHS staff to carefully assess the appropriateness and soundness of the proposed arrangement. The institution will be examined for its ability to make a significant commitment of resources, time and other factors conducive to the research project and career establishment of the TIP investigator. In addition, the TIP investigator must be appointed to a permanent position in a research-intensive environment relevant to environmental health sciences. It is the intent of the NIEHS that the applicant relocate to another, different research intensive institution, and not remain at the current postdoctoral institution. Arrangements in which a candidate moves from a postdoctoral position to that of an assistant professor at the same institution are specifically discouraged, and if proposed by the TIP investigator, must document an especially strong, compelling case for such a position=s eligibility for consideration. Please note that an award can ONLY be made after the TIP investigator has accepted a position at a sponsoring institution; this acceptance of a position must be confirmed by the institutional official. Finally, it is important to note that no funds can be obligated or used until the award has been made to a grantee sponsoring institution. NIEHS recognizes that each TIP investigator will have unique circumstances that will affect the timing for the initiation of the award. Thus, the NIEHS will allow the TIP investigator up to 18 months between the date of the Letter to Commit Funds notifying the applicant of funding availability for an application and the start of a permanent position at a research-intensive institution. The grantee institution application submitted on behalf of the TIP applicant to activate the award must be received no later than 5:00 p.m. (EST) of the last business day of the first week in August of the year in which the 18-month period concludes. Please note that this timing is determined by the Federal fiscal year, not subject to change, and funds identified in the NIEHS Letter to Commit Funds will not be available after the close of the final NIEHS fiscal year for the 18-month period specified therein. REQUIRED FEDERAL CITATIONS INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects involving human subjects 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 read the AMENDMENT "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research B 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://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 applications to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when the 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" 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 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 Part 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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