Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institute of Environmental Health Sciences (NIEHS), (http://www.niehs.nih.gov)

Components of Participating Organizations
National Institute of Environmental Health Sciences (NIEHS), (http://www.niehs.nih.gov)

Title: Transition to Independent Positions (TIP)

Announcement Type
New

Request For Applications (RFA) Number: RFA-ES-05-002

Catalog of Federal Domestic Assistance Number(s)
93.113, 93.115

Key Dates
Release Date: March 4, 2005
Letters of Intent Receipt Date(s): June 13, 2005
Application Receipt Dates(s): July 11, 2005
Peer Review Date(s): October –November 2005
Council Review Date(s): February 2006
Earliest Anticipated Start Date: June 2006
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: July 12, 2005

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

  Section I. Funding Opportunity Description
    1. Research Objectives

  Section II. Award Information
    1. Mechanism(s) of Support
    2. Funds Available

  Section III. Eligibility Information
    1. Eligible Applicants
      A. Eligible Institutions
      B. Eligible Individuals
    2.Cost Sharing or Matching
    3. Other - Special Eligibility Criteria

  Section IV. Application and Submission Information
    1. Address to Request Application Information
    2. Content and Form of Application Submission
    3. Submission Dates and Times
      A. Receipt and Review and Anticipated Start Dates
        1. Letter of Intent
      B. Sending an Application to the NIH
      C. Application Processing
    4. Intergovernmental Review
    5. Funding Restrictions
    6. Other Submission Requirements

  Section V. Application Review Information
    1. Criteria
    2. Review and Selection Process
      A. Additional Review Criteria
      B. Additional Review Considerations
      C. Sharing Research Data
      D. Sharing Research Resources
    3. Anticipated Announcement and Award Dates

  Section VI. Award Administration Information
    1. Award Notices
    2. Administrative and National Policy Requirements
      A. Cooperative Agreement Terms and Conditions of Award
        1. Principal Investigator Rights and Responsibilities
        2. NIH Responsibilities
        3. Collaborative Responsibilities
        4. Arbitration Process
    3. Reporting

  Section VII. Agency Contact(s)
    1. Scientific/Research Contact(s)
    2. Peer Review Contact(s)
    3. Financial/ Grants Management Contact(s)

  Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description

1. Research Objectives

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 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.

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 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:

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.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the NIH Research Scholar Development Award (K22) mechanism. This RFA is a one-time solicitation. Awards are not renewable. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses just-in-time concepts. See specific instructions in Section IV.6 and VI.1.

2. Funds Available

The NIEHS intends to commit approximately 500,000 dollars in FY 06 to fund 5 new grants in response to this RFA. An applicant may request a project period of up to 3 years and a budget for fiscal costs up to 100,000 dollars per year. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NIEHS provides support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Administrative costs: Administrative costs will be reimbursed at 8 percent of modified total fiscal costs, or at the actual administrative cost rate, whichever is less.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

Foreign Institutions are not eligible to apply.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

Individuals on postdoctoral appointments, or equivalent positions, 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. In exceptional circumstances, waivers to the six year limitation may be requested in writing, and these will be considered on a case by case basis. Individuals who have, or have held, research faculty 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 intended for faculty members are NOT eligible to apply for this award.

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.

2. Cost Sharing or Matching
Cost sharing is not required.

3. Other-Special Eligibility Criteria

To be eligible to apply for a TIP Award, 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 or former postdoctoral trainee appointed on an NIEHS Institutional Training Grant (T32) who has completed an eligibility process at trainee institution. The K22 application must include a letter signed by the program Director of the NIEHS funded T32 Institutional Training Grant, that the submitted application has been reviewed by the Program Director and an internal review committee, and has been determined to have scientific merit and completeness consistent with an individual postdoctoral fellowship application.

D. 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. Joel Abramowitz, 919-541-4892, or abramow1@niehs.nih.gov.

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 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.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times
Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: June 13, 2005
Application Receipt Date(s): July 11, 2005
Peer Review Date: October-November 2005
Council Review Date: February 2006
Earliest Anticipated Start Date: June 1, 2006

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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 IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Janice Allen, Ph.D.
Division of Extramural Research and Training (EC-30)
National Institute of Environmental Health Sciences
79 TW Alexander Drive
Building 4401, Room 3170B
Research Triangle Park, NC 27709
Phone: (919) 541-7556
FAX: (919) 541-2503
Email: allen9@niehs.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. 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 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Janice Allen, Ph.D.
Division of Extramural Research and Training (EC-30)
National Institute of Environmental Health Sciences
79 TW Alexander Drive
Building 4401, Room 3170B
Research Triangle Park, NC 27709
Phone: (919) 541-7556
FAX: (919) 541-2503
Email: allen9@niehs.nih.gov

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf. Personal deliveries of applications are no longer permitted.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NIEHS. Incomplete and non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity 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 a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm (see also Section VI.3. Reporting).

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

6. Other Submission Requirements

In addition to the Supplementary Instructions in the PHS 398 for Research Career Awards http://grants.nih.gov/grants/funding/phs398/phs398.pdf (Instructions, Part III, starting on page 44), the following information must be included in the application:

Future Goals and Objectives and Biography

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.

Research Plan

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:

Although the research proposal is expected to be independently designed and carried out by the candidate, input by the sponsor and other senior faculty into the review and editing of the research proposal is encouraged as a part of the career development experience.

Letters of Recommendation

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.

Additional Information:

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.

Revised Applications:

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.

Budget:

Specific Instructions for Allowable Costs

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. The specific instructions below for allowable costs are as follows:

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.

Plan for Sharing Research Data
A plan for sharing research data is not required.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria
Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIEHS. Incomplete and/or non-responsive applications will not be reviewed.

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 NIEHS in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

The following will be considered in making funding decisions:

Review Criteria

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. 

Relevance of program priorities

Candidate:

1. The candidate's potential for a productive career in basic, clinical, or population-based (e.g., epidemiologic) research or behavioral science relevant to the mission of the NIEHS.

2. The qualifications and research experience of the candidate in the area of the research proposed.

3. The demonstration of original and independent thinking.

4. The ability of the candidate to function as an independent investigator.

In this case, the term “independent investigator” is defined as one who would be competitive for an NIH RO1 grant.

Research Plan:

1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

2. Approach. Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

3. Innovation. Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

4. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

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 the Research Plan, Section E on Human Subjects in the PHS Form 398).

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 the Research Plan, Section E on Human Subjects in the PHS Form 398).

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 Form 398 research grant application instructions will be assessed.

2.B. Additional Review Considerations

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.

2.C. Sharing Research Data
A data sharing plan is not required and reviewers will not factor in such a plan into the determination of scientific merit or the priority score.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates
The anticipated date of notification of a Letter to Commit Funds is March-April, 2006.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

At the time a decision is made to make an award, the applicant will be mailed 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 research intensive faculty position, preferably tenure-track or equivalent, at a 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 faculty, 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 faculty 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.

Prior to funding funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization by e-mail. The NGA signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

2.A. Cooperative Agreement Terms and Conditions of Award
Not applicable

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity 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:

1. Scientific/Research Contacts:

Carol Shreffler, Ph.D.
Division of Extramural Research and Training (EC-23)
National Institute of Environmental Health Sciences
79 TW Alexander Drive
Building 4401, Room 3411
Research Triangle Park, NC 27709
Phone: (919) 541-1445
FAX: (919) 541-5064
Email: shreffl1@niehs.nih.gov

2. Peer Review Contacts:

Janice Allen, Ph.D.
Division of Extramural Research and Training (EC-30)
National Institute of Environmental Health Sciences
79 TW Alexander Drive
Building 4401, Room 3170B
Research Triangle Park, NC 27709
Phone: (919) 541-7556
FAX: (919) 541-2503
Email: allen9@niehs.nih.gov

3. Financial or Grants Management Contacts:

Susan Ricci
Division of Extramural Research and Training (EC-22)
National Institute of Environmental Health Sciences
79 TW Alexander Drive
Building 4401, Room 3408
Research Triangle Park, NC 27709
Phone: (919) 316-4666
FAX: (919) 541-2860
Email: ricci@niehs.nih.gov

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
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). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $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 and 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.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is 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 Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

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 (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 applications for research involving human subjects and individuals designated as key personnel. The policy is available 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 (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.

Public Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

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.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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