TRANSITION TO INDEPENDENT POSITIONS (TIP) Release Date: March 23, 1999 RFA: ES-99-006 P.T. National Institute of Environmental Health Sciences Letter of Intent Receipt Date: June 15, 1999 Application Receipt Date: July 27, 1999 PURPOSE 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 multi-disciplinary 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 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. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Transition to Independent Positions (TIP), is related to the priority area of Environmental Health. Potential applicants may obtain a copy of "Healthy People 2000" at http://www.crisny.org/health/us/health7.html. ELIGIBILITY REQUIREMENTS There are specific eligibility criteria that must be met in order to apply for this program. If an applicant is uncertain of his/her eligibility, he/she is strongly encouraged to contact the program administrator listed at the end of this announcement. GENERAL REQUIREMENTS Individuals with a research or health professional doctoral level degree or equivalent with no more than five years 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, government). Individuals who have had more than five years of postdoctoral research experience or who have held research or other professorship or equivalent positions in academe or elsewhere are NOT eligible to apply. However, years of clinical training will not count against the five years of relevant research experience. Individuals who have been principal investigators 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. Minorities and women are encouraged to apply. 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. SPECIFIC REQUIREMENTS To be eligible to apply for a TIP Award the following additional 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 Fellow who is training in an area specific to the mission of the NIEHS, but whose support is from another Institute, Center or Division (ICD) of the NIH, or C. A current NIEHS Intramural Research Training Awardee (IRTA), staff fellow, or clinical fellow who has competed successfully in the NIEHS Intramural eligibility process. The Intramural contact person for this program is Dr. Steven Akiyama, 919-541-3467. 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 CONSIDERATIONS of this Request for Applications. This decision is final. Fellows are STRONGLY ENCOURAGED to contact the program administrator listed at end of this Request for Applications 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: http://www.niehs.nih.gov/dert/programs/special/special.htm. 2. The applicant must have COMPLETED at least 18 months of postdoctoral training at the time of submission of an application (July 27 Receipt Date). 3. The applicant must submit the application on a PHS Research Grant Application form (PHS 398, rev. 4/98). 4. The applicant must include three letters of recommendation which address the applicant’s potential to become an important contributor to basic, clinical or population-based (e.g., epidemiologic) research or behavioral science 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 predoctoral 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 included with the application) will not be allowed. Note: The letter from the current postdoctoral mentor should address the following points. 1. The applicant’s role and intellectual contribution to the laboratory research activities. 2. The current postdoctoral mentor’s role in the development of the proposed project. 3. The applicant’s potential for independent research. All applicants are encouraged to contact the NIEHS regarding their eligibility for this award (see INQUIRES section). FUNDS AVAILABLE The total estimated funds available for this Request for Applications is approximately $500,000 which will support 4 to 5 awards. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. MECHANISM OF SUPPORT The NIEHS TIP Program will use the NIH Research Scholar Development Award (K22). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The requested costs and project period will be $100,000 (direct cost) per year for a maximum of three years (a maximum of $300,000 direct costs). Scholar Development grants (K22s) 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. RESEARCH OBJECTIVES Background The Congress of the United States enacted the National Research Service Act 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 National Institute of Environmental Health Sciences (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 transition from postdoctoral trainee to academic researcher. To meet this need, the NIEHS has initiated the TIP Program to facilitate the transition of the most talented trainees 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 grantees are expected to design and pursue their research projects independently in their areas of interest. It is anticipated 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 Awardee is expected to use the preliminary data as a basis for an investigator initiated research grant (R01) to the NIH in an area of a science 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 which can significantly contribute to our understanding of the impact of environmental exposure on human health. Research proposals which address one of these areas will receive a priority for funding. The current areas of special emphasis are: Molecular Epidemiology (this is an emerging area of science of particular importance to NIEHS) Basic Molecular Mechanisms of Environmental Insult Development of Alternative Models for Environmental Health Research and Toxicology Testing Genetic Susceptibility Human Health Effects of Complex Mixtures Human Health Effects of Endocrine Disrupting Chemicals Role of the Environment in Neurodegenerative Diseases, including Parkinson s Disease Prevention Research-Molecular and Community-Based Approaches Impact of Environmental Exposures on Special Populations (Women, Children and Minorities) Additional information about these research topics is available on the NIEHS web site http://www.niehs.nih.gov/dert/programs/special/special.htm). This site is updated each year. ALLOWABLE COSTS The final 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. Indirect costs will be reimbursed at eight percent of modified total direct costs or at the actual 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 the awardee’s research and academic career. 1. 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. 2. 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. 3. Ancillary Personnel Support: Salary for secretarial or administrative assistance is not allowed. 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 which will be signed by the Grants Management Officer. This letter is a conditional intent of the NIEHS to make an award, and may be used by the potential awardee to identify a suitable academic institution and enter into negotiations for a position. 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 awardee has identified a permanent position, preferably tenure-track or equivalent, at a research intensive institution (sponsoring institution), the sponsoring institution will request that an award be issued by submitting a form PHS 398 (competing grant application) that includes a detailed budget. The application also must include letters from the institutional official signing the application describing the position and confirming that the awardee 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 Awardee. Finally, if the research involves animals/human subjects, the certification that the protocols were approved by the appropriate institutional committee 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 this 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 awardee. It is the intent of the NIEHS that the applicant relocate to a new 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 discouraged, and if proposed by the awardee, there must be an especially strong case for such a position. Please note that an award can ONLY be made after the principal investigator has accepted a position at a sponsoring institution, and this has been confirmed by the institutional official. In addition, the principal investigator must be appointed to a permanent position in a research intensive environment relevant to environmental health sciences. Finally, no funds can be used until the award has been made to a sponsoring institution. NIEHS recognizes that each awardee will have unique circumstances that will affect the timing for the initiation of the award. Thus, the NIEHS will allow the awardee up to eighteen months between the Letter to Commit Funds notice for funding an application and the start of a permanent position at a research intensive institution. LETTER OF INTENT Prospective applicants are asked to submit, by June 15, 1999, a letter of intent that includes a descriptive title of the proposed project, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and tile of this RFA. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NIEHS staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: Linda Bass, Ph.D. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, EC-24 111 T.W. Alexander Drive, EC-24 (for express/courier service) Research Triangle Park, NC 27709 Telephone: (919) 541-1307 FAX: (919) 541-2503 Email: bass@niehs.nih.gov INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided 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 research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994 available on the web at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not94-100.html INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: Grantsinfo@nih.gov. SUPPLEMENTAL INSTRUCTIONS The following supplemental instructions are provided: Only one grant application may be submitted by a principal investigator for a receipt date. The Detailed Budget for the Initial Budget Period (Form Page 4-DD) and Budget for Entire Proposed Period of Support (Form Page 5-EE) are not required for the initial application. A detailed budget is required for the activation of the award at the academic institution. The project period for these awards is a maximum of three years. The maximum amount awarded to each grantee on this Request for Applications 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. Equipment will be limited to $100,000 direct costs for the three-year project period. The maximum salary allowed from this award is $50,000 per year. Annual meetings, to be held either in conjunction with a national scientific meeting, such as the Society of Toxicology or in the Research Triangle Park, NC, are planned for the exchange of information among investigators. Applicants must budget travel costs associated with these meetings (one per year) in their applications. One page (maximum) sections in the application inserted just prior to the research plan titled "Future Goals and Objectives" and "Biography". In the Future Goals and Objectives section, the applicant should describe their career track vision and describe the types of positions to be pursued. In the Biography section the applicant should describe their scientific development from graduate school through postdoctoral experience(s). For each training experience, the applicant should describe their role in the laboratory/project and cite relevant publications that resulted from the experience. The applicant should include in this section a short narrative on how the proposed research project will lead to a successful R01 application. The Research Plan (Specific Aims, Background and Significance, Preliminary Studies, Research Design and Methods sections) is not to exceed 15 pages. Tables and figures but not the references are included in the 15 page limitation. Applications that exceed page limitations or 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, 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. It is expected that a TIP award would provide an investigator the opportunity to obtain the scientific data needed for an investigator-initiated research grant (R01) to the NIH in an area of a science relevant to the mission of the NIEHS. 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 1-3 publications from the Ph.D. work and one publication from the postdoctoral work. A biographical sketch of the postdoctoral mentor should be included in the application. The Request for Applications title and number must be typed on Line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the checklist, and three signed, clear, and single-sided 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: Linda Bass, Ph.D. Division of Extramural Research and Training National Institute of Environmental Health Sciences P. O. Box 12233, EC-24 111 T.W. Alexander Drive, EC-24 (for express/courier service) Research Triangle Park, NC 27709 Applications must be received by July 27, 1999. If an application is received after that date, it will be returned to the applicant without review. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the Center for Scientific Review (CSR) and responsiveness to the RFA by senior scientific staff of the Division of Extramural Research and Training, NIEHS. Only those applications considered to be responsive to the RFA will be forwarded for peer review. Applications that are incomplete and/or considered non-responsive to the Request for Applications will be inactivated and 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 a peer review group convened by the NIEHS in accordance with the standard NIH peer review procedures. As part of the initial review process, 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. Applications judged to be in the lower half of applications under review may or may not be discussed or assigned a priority score. Review Criteria Candidate o the applicant’s potential to become an important contributor to basic, clinical or population-based (e.g., epidemiologic) research or behavioral science relevant to 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 o 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. AWARD CRITERIA The anticipated date of notification of a Letter to Commit Funds is April of the following year. The following will be considered in making funding decisions: o potential of the applicant to make a significant contribution to the NIEHS mission, o quality of the proposed project’s scientific merit as determined by peer review, o availability of funds, and o program balance among research areas of the announcement. INQUIRIES Written and telephone inquiries concerning this Request for Applications are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Michael J. Galvin, Ph.D. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, EC-23 111 T.W. Alexander Drive, EC-23 (for express/courier service) Research Triangle Park, NC 27709 Telephone: (919) 541-7825 FAX: (919) 541-5064 Email: Galvin@niehs.nih.gov Direct inquiries regarding fiscal matters to: Mr. David L. Mineo Division of Extramural Research and Training National Institute of Environmental Health Sciences P. O. Box 12233, EC-22 111 T.W. Alexander Drive, EC-22 (for express/courier service) Research Triangle Park, NC 27709 Telephone: (919) 541-1373 FAX: (919) 541-5064 Email: mineo@niehs.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.113 and 93.115. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 43 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service (PHS) strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-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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