Multidisciplinary Career Development in Cancer Nanotechnology Research

RFA Number: RFA-CA-05-025

Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov/)

Components of Participating Organizations
National Cancer Institute (NCI), (http://www.nci.nih.gov/)

Announcement Type
New

Update: The following update relating to this announcement has been issued:

Catalog of Federal Domestic Assistance Number(s)
93.393, 93.399

Key Dates

Release Date: December 1, 2004
Letters Of Intent Receipt Date: Not Applicable
Application Receipt Date: March 25, 2005
Peer Review Date: June/July 2005
Council Review Date: September 2005
Earliest Anticipated Start Date: September 2005
Additional Information to Be Available Date (URL Activation Date): Not Applicable
Expiration Date: March 26, 2005

Due Dates for E.O. 12372
Not Applicable

Executive Summary

This RFA supports the career development of individuals from the basic, biomedical, clinical, and information sciences and engineering who are pursuing research that applies nanotechnology development and application for the prevention, detection, diagnosis, or treatment of cancer. This funding opportunity will use Ruth L. Kirschstein National Research Service Awards (Kirschstein-NRSA) to support individual postdoctoral fellowships (F32) and senior fellowships (F33). The NCI intends to commit approximately $15.5M dollars over three years to fund a total of 36 new grants in response to this RFA (approximately 18 for each mechanism). The total amount of funds committed for F32 awards for FY 2005 is approximately $0.75 M. The total for F33 awards and supplements for FY 2005 is approximately $4.42M. An applicant may request a project period of up to 3 years for F32 (stipend levels depend on full years of post-degree experience at the time of award, and include an Institutional allowance; both amounts are determined yearly by Congress) and 2 years for F33 awards (stipend not to exceed the level of NRSA stipend support for individuals with more than 7 years experience). An applicant may request a project period of up to 3 years for F32 and 2 years for F33 awards. The anticipated start date for awards is September 2005, and funding will terminate no later than September 2008.

Eligible supporting organizations include f or-profit or non-profit organizations, public or private institutions (such as universities, colleges, hospitals, and laboratories), units of State and local governments, eligible agencies of the Federal government, and domestic (or foreign) institutions/organizations. Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his or her institution and mentor to develop an application for support. By the time of award, candidates for the F32 or F33 fellowship award must be citizens or non-citizen nationals of the United States or must have been lawfully admitted to the United States for Permanent Residence (i.e., possess a currently valid Alien Registration Receipt Card I-551 or other legal verification of such status). Before a Kirschstein-NRSA F32 postdoctoral fellowship or F33 senior fellowship award can be activated, the individual must have received a Ph.D., M.D., D.O., D.C., D.D.S., D.V.M., O.D., D.P.M., Sc.D., Eng.D., Dr. P.H., D.N.S., N.D., Pharm.D., D.S.W., Psy.D., or equivalent doctoral degree from an accredited domestic or foreign institution. Certification by an authorized official of the degree-granting institution that all degree requirements have been met is also acceptable. In addition, applicants for an F33 NRSA senior fellowship must be at least 7 years beyond one of the above qualifying degrees, have had at least 7 years of post-degree relevant research or professional experience, and have established an independent research career.

An applicant may submit only one application for this one-time RFA.

Application materials are available at http://grants.nih.gov/grants/funding/416/phs416.htm. Telecommunications for the hearing impaired is available at: TTY 301-451-5936.

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
    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
      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
    3. Merit Review Criteria
      A. Additional Review Criteria
      B. Additional Review Considerations
      C. Sharing Research Data
      D. Sharing Research Resources

  Section VI. Award Administration Information
    1. Award Notices
    2. Administrative 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. Award Criteria
    4. 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

This RFA supports the career development of individuals from the basic, biomedical, clinical, and information sciences and engineering who are pursuing research that applies nanotechnology development and application for the prevention, detection, diagnosis, or treatment of cancer. Nanotechnology offers an unprecedented opportunity to study and interact with normal and cancer cells in real time, at the molecular and cellular scales, and during the earliest stages of the cancer process. As a result, nanotechnology will be a mission-critical tool to meet the NCI's Challenge Goal of eliminating death and suffering from cancer by 2015. To achieve this vision, the NCI will support the training of a cadre of researchers who can work as members of multidisciplinary teams to apply the tools of nanotechnology to critical problems in cancer research and clinical oncology.

The elucidation of the human genome, combined with many remarkable advances in cancer biology, has offered great potential for researchers to address complex biological systems using innovative tools and strategies. The use of integrative biology (combining experimental and computational approaches towards the understanding of cancer biology to study cancer systems) is fostering novel nanoscale engineering and design applications to prevent, detect, diagnose, and treat various types of cancers. Although nanotechnology offers great potential to yield important information on the fundamental processes of cancer, there are few formal opportunities to train scientists and engineers who wish to develop and test nanomaterials and nanodevices for cancer-related applications. This RFA is a component of the NCI Alliance for Nanotechnology in Cancer (http://nano.cancer.gov), an integrated 5-year initiative to develop and apply nanotechnology to cancer prevention, detection, diagnosis, and treatment, thereby enabling nanotechnology to become a fundamental driver of advances in cancer research and clinical oncology.

This announcement specifically aims to encourage applications for F32 individual postdoctoral fellowships from promising candidates with the potential to become productive, independent investigators in cancer nanotechnology research. It also aims to encourage applications for F33 senior fellowships from experienced scientists who wish to change the direction of their research or broaden their scientific background by acquiring new capabilities in cancer nanotechnology research. This training opportunity supports career development in numerous research disciplines, and it is expected that trainees will gain expertise in the computational, physical, and biological aspects of technology development at the nanoscale for cancer treatment. As part of the NCI Alliance for Nanotechnology in Cancer, awardees will be required to attend the annual scientific meeting of the NCI Centers of Cancer Nanotechnology Excellence (CCNEs).

The goal of this Fellowship Program in cancer nanotechnology research is to train highly skilled research scientists to develop and test nanomaterials and nanodevices and to apply these advances to address cancer-related issues. Awardees are expected to work as productive members of multidisciplinary research teams, assembled to address critical nanotechnology platform needs in cancer. It is expected that these individuals will pursue research that includes, but is not limited to, one or more of the following areas:

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

Section II. Award Information

1. Mechanisms of Support

This funding opportunity will use the Kirschstein-NRSA F32 and F33 award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation.

2. Funds Available

The NCI intends to commit approximately $15.5M dollars over 3 years to fund a total of 36 new grants in response to this RFA (approximately 18 for each mechanism). The total amount of funds committed for F32 awards for FY 2005 is approximately $0.75 M. The total for F33 awards and supplements for FY 2005 is approximately $4.42M.. An applicant may request a project period of up to 3 years for F32 (stipend levels depend on full years of postdegree experience at the time of award, and include an Institutional allowance; both amounts are determined yearly by Congress) and 2 years for F33 awards (stipend not to exceed the level of NRSA stipend support for individuals with more than 7 years experience). This funding is commensurate with current guidelines specified for Kirschstein-NRSA Awards (http://grants.nih.gov/grants/funding/416/phs416.htm). The anticipated start date for awards is September 2005, and funding will terminate no later than September 2008. 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 NCI 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.

Stipends. Kirschstein-NRSA awards provide stipends to postdoctoral fellows as a subsistence allowance to help defray living expenses during the research training experience. The awards are not provided as a condition of employment with either the Federal government or the sponsoring institution. The stipend level for the first year of Kirschstein-NRSA support is determined by the number of full years of relevant postdoctoral experience at the time the award is issued (not at the time of activation, see below). Fellows with less than one full year of postdoctoral experience at the time of award will receive initial support at the zero level. Relevant experience may include research (including research in industry), teaching, internship, residency, clinical duties, or other time spent in full-time studies in a health-related field beyond that of the qualifying doctoral degree. The stipend schedule is updated nearly every year, and applicants are advised to check for the posting of the current stipend schedule on the NIH web site at http://grants.nih.gov/training/nrsa.htm. The awarding NIH Institute or Center will adjust awards on the anniversary date of the fellowship award to ensure consistency with the stipend schedule in effect at that time. The stipend for each subsequent year of Kirschstein-NRSA support is the next level of experience using the stipend schedule in effect at that time. Stipends will be adjusted on the anniversary date of the award and will not be changed mid-year to accommodate an increase in the level of experience. No departure from the published Kirschstein-NRSA stipend schedule may be negotiated between the institution and the fellow. For fellows sponsored by domestic non-federal institutions, the stipend will be paid through the sponsoring institution. For fellows sponsored by Federal or foreign institutions, the monthly stipend payment will be deposited in the fellow's U.S. bank account or paid directly to the fellow by U.S. Department of Treasury check. Stipends for Kirschstein senior fellows are determined individually at the time of award. The amount of the stipend is based on the salary or remuneration from their home institution on the date of award. However, in no case shall the NIH contribution to the stipend during the fellowship exceed the NRSA stipend provided for individuals with more than 7 years of experience. For fellows on sabbatical, the level of the NRSA stipend award will take into account concurrent sabbatical salary support provided by the home institution and any other supplementation. The stipend is not provided as a condition of employment with either the Federal Government or the institution.

Tuition and Fees. The NIH will offset the combined cost of tuition and fees at the following rate: 100 percent of all costs up to $3,000 and 60 percent of costs above $3,000. Costs associated with tuition and fees are allowable only if they are required for specific courses in support of the research training experience supported by the fellowship. A full description of the tuition policy is contained within the NRSA section of the Grants Policy Statement at http://grants.nih.gov/grants/policy/policy.htm.

Institutional Allowance. At the time of publication, fellows receive an institutional allowance of $5,500 per 12-month period to nonfederal, nonprofit, or foreign sponsoring institutions to help defray such awardee expenses as research supplies, equipment, health insurance (either self-only or family as appropriate), and travel to scientific meetings. Support for health insurance is allowable only if it is applied consistently for all individuals in a similar research training status regardless of the source of support. This allowance is intended to cover training related expenses for the individual awardee. The allowance is not available until the fellow officially activates the award. If an individual fellow is enrolled or engaged in training for less than 6 months of the award year, only one-half of that year's allowance may be charged to the grant. The Notice of Research Fellowship Award will be revised and the balance must be refunded to NIH. NIH will provide an institutional allowance of up to $4,400 for fellows sponsored by Federal laboratories or for-profit institutions for expenses associated with travel to scientific meetings, health insurance, and books. For fellows at for-profit institutions, the $4,400 will be paid to the institution for disbursement to the fellow. Funds for fellows at Federal laboratories will be disbursed from the NIH awarding Institute. The Institutional Allowance is adjusted from time-to-time. Prospective applicants are advised to check for the current Institutional Allowance in the most recent documentation related to Kirschstein-NRSA stipends at http://grants.nih.gov/training/nrsa.htm.

Other Training Costs. Additional funds may be requested by the institution when the training of a fellow involves extraordinary costs for travel to field sites remote from the sponsoring institution or accommodations for fellows who are disabled, as defined by the Americans With Disabilities Act. The funds requested for costs of this nature must be reasonable in relationship to the total dollars awarded under the fellowship and must be directly related to the approved research training experience. Such additional funds shall be provided only in exceptional circumstances that are fully justified and explained by the sponsoring institution. Awards for training at a foreign site may include a single economy or coach round-trip travel fare. No allowance is provided for dependents. U.S. flag air carriers must be used to the maximum extent possible when commercial air transportation is available for travel between the United States and a foreign country or between foreign countries. Funds are not provided to cover the cost of travel between the fellow's place of residence and a domestic training institution. However, in cases of extreme need or hardship, a one-way travel allowance may be authorized by the sponsoring institution. Such travel must be paid from the institutional allowance. Institutions hosting senior fellowship (F33) awardees may be eligible for research support supplements. Details and restrictions will be available at the program website http://nano.cancer.gov.

Facilities and Administrative Costs. F&A (indirect) costs are not allowed on individual fellowship awards.

Supplementation of Stipends, Compensation, and Other Income The sponsoring institution is allowed to provide funds to the fellow in addition to the stipends paid by the NIH. Such additional amounts either may be in the form of augmented stipends (supplementation) or in the form of compensation, such as salary or tuition remission for services such as teaching or serving as a laboratory assistant, provided the conditions described below are met. Under no circumstances may the conditions of stipend supplementation or the services provided for compensation interfere with, detract from, or prolong the fellow's approved Kirschstein-NRSA training program.

Stipend Supplementation: Supplementation or additional support to offset the cost of living may be provided by the sponsoring institution. Supplementation does not require additional effort from the fellow. DHHS funds may not be used for supplementation under any circumstances. Additionally, no funds from other Federal agencies may be used for supplementation unless specifically authorized by the NIH and the other Federal Agency.

Compensation: The sponsoring institution may provide additional funds to a fellow in the form of compensation (as salary and/or tuition remission) for services such as teaching or serving as a research assistant. A fellow may receive compensation for services as a research assistant or in some other position on a Federal research grant, including a DHHS research grant. However, compensated services should occur on a limited, part-time basis apart from the normal research training activities, which require a minimum of 40 hours per week. In addition, compensation may not be paid from a research grant that supports the same research that is part of the fellow's research training experience as approved in the application.

Educational Loans or G.I. Bill: An individual may make use of Federal educational loan funds and assistance under the Veterans Readjustment Benefits Act (G.I. Bill). Such funds are not considered supplementation or compensation. Postdoctoral fellows may also be eligible to participate in the NIH Extramural Loan Repayment Program. Information on this program is available at http://www.lrp.nih.gov/.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Supporting Institutions

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

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. Fellowship awardees are required to pursue their research training on a full-time basis, devoting at least 40 hours per week to the training program. Women, minorities, and individuals with disabilities are encouraged to apply. Further details of the Kirschstein-NRSA F32 award mechanism can be found at http://grants.nih.gov/grants/guide/pa-files/RFA-03-067.html; details of the Kirschstein-NRSA F33 award mechanism can be found at http://grants.nih.gov/grants/guide/pa-files/RFA-00-131.html.

Citizenship. By the time of award, candidates for the F32 or F33 fellowship award must be citizens or non-citizen nationals of the United States or must have been lawfully admitted to the United States for Permanent Residence (i.e., possess a currently valid Alien Registration Receipt Card I-551 or other legal verification of such status). Non-citizen nationals are generally persons born in outlying possessions of the United States (i.e., American Samoa and Swains Island). Individuals on temporary or student visas are not eligible. Individuals may apply for the F32 in advance of admission to the United States as a Permanent Resident recognizing that no award will be made until legal verification of Permanent Resident status is provided.

Degree Requirements. Before a Kirschstein-NRSA F32 postdoctoral fellowship or F33 senior fellowship award can be activated, the individual must have received a Ph.D., M.D., D.O., D.C., D.D.S., D.V.M., O.D., D.P.M., Sc.D., Eng.D., Dr. P.H., D.N.S., N.D., Pharm.D., D.S.W., Psy.D., or equivalent doctoral degree from an accredited domestic or foreign institution. Certification by an authorized official of the degree-granting institution that all degree requirements have been met is also acceptable. In addition, applicants for an F33 NRSA senior fellowship must be at least 7 years beyond one of the above qualifying degrees, have had at least 7 years of post-degree relevant research or professional experience, and have established an independent research career.

Duration of Support. F32 awardees may receive up to 3 years of aggregate Kirschstein-NRSA support at the postdoctoral level, including any combination of support from institutional training grants (T32) and individual fellowship awards (F32). F33 senior fellowship awards may be requested for up to 2 years. Applicants must consider any prior Kirschstein-NRSA postdoctoral research training in determining the duration of fellowship support requested. Training beyond the 3-year aggregate limit may be possible under certain exceptional circumstances, but a waiver from the NIH awarding component is required. Individuals seeking additional Kirschstein-NRSA support beyond the 3rd year are strongly advised to consult with relevant NIH staff before preparing a justification. Any waiver will require a detailed justification of the need for additional research training.

2. Cost Sharing
Cost sharing is not required.

3. Other-Special Eligibility Criteria

Sponsor (Mentor). The applicant's sponsor should be an active investigator in the area of the proposed research who will directly supervise the candidate's research. The sponsor should either have expertise in the development and/or application of nanotechnology to cancer or have specific plans to obtain the requisite training, and must document the availability of research support and facilities for high-quality nanotechnology research training. In most cases, the F32 and F33 fellowship awards support research training experiences in new settings in order to maximize the acquisition of new skills and knowledge. However, in unusual circumstances, an applicant may propose postdoctoral training experiences at his/her doctoral institution or at the institution where he or she has been training for more than a year. In such cases, the applicant must carefully document the opportunities for new research training experiences specifically designed to broaden training involving nanotechnology research.

In most cases, the F33 senior fellowship award is used to support sabbatical experiences for established independent scientists who wish to take time from regular professional responsibilities to receive training to expand their research capabilities.

Foreign Sponsorship. Applicants requesting fellowship support for foreign research training must justify in the application that the foreign institution and sponsor offer unique opportunities and clear scientific advantages that are not currently available in the United States.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 416-1 is available at http://grants.nih.gov/grants/funding/416/phs416.htm in an interactive format. 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 PHS 416-1 research grant application instructions and forms (rev. 06/02). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. 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 12 of the face page of the PHS 416-1 form.

The title and number of this funding opportunity must be typed on line 3 of the face page of the application form.

APPLICATIONS MUST INCLUDE AT LEAST THREE SEALED LETTERS OF REFERENCE. APPLICATIONS WITHOUT AT LEAST THREE LETTERS OF REFERENCE WILL BE RETURNED OR DELAYED IN REVIEW. If the applicant has been lawfully admitted to the United States for permanent residence, the appropriate item should be checked on the Face Page of the application. Applicants who have applied for and have not yet been granted admission as a permanent resident should check the Permanent Resident block on the Face Page of the application, and also write in the word "pending." A notarized statement documenting legal admission for permanent residence must be submitted prior to the issuance of an award.

Concurrent Applications. An individual may not have more than one individual NRSA fellowship or comparable application pending review or award at the NIH or other DHHS agencies at the same time.

Instructions in the Responsible Conduct of Research:

Applications must include the candidate's plans for obtaining instruction in the responsible conduct of research, including the rationale, subject matter, appropriateness, format, frequency and duration of instruction. The amount and nature of faculty participation must be described. No award will be made if an application lacks this component.

3. Submission Dates

3.A. Receipt, Review and Anticipated Start Dates

Letters Of Intent Receipt Date: Not Applicable
Application Receipt Date: March 25, 2005
Peer Review Date: June/July 2005
Council Review Date: September 2005
Earliest Anticipated Start Date: September 2005

3.A.1 Letter of Intent
Not applicable.

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 416-1 research grant application instructions and forms as described above. Submit a signed, typewritten original of the application, including the checklist, and one signed photocopy 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, one additional copy of the application and all copies of the appendix material must be sent to:

Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: ncirefof@dea.nci.nih.gov

Appendices should be comprised of unbound materials with separators between documents.

Using the RFA Label: The RFA label available in the PHS 416-1 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 3 of the face page of the application. The RFA label is also available at http://grants.nih.gov/grants/funding/phs398/labels.pdf.

All applications submitted to the Center for Scientific Review must come via United States Postal Service or a recognized delivery/courier service. Individuals may not personally deliver packages to the building on Rockledge Drive. For further information please see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.

Certification Procedure: No application will be accepted without the applicant signing the certification block on the face page of the application. Individuals admitted to the United States as Permanent Residents must submit notarized evidence of legal admission prior to award.

Incomplete applications will not be reviewed.

3.C. Application Processing

Applications must be received on or before 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.

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

The NIH 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 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 8 weeks.

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

5. Funding Restrictions

All 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. Award Criteria).

Concurrent Awards: A Kirschstein-NRSA fellowship may not be held concurrently with another federally sponsored fellowship or similar Federal award that provides a stipend or otherwise duplicates provisions of this award.

Tax Liability Section 117 of the Internal Revenue Code applies to the tax treatment of all scholarships and fellowships. Under that section, non-degree candidates are required to report as gross income any monies paid on their behalf for stipends, or any course tuition and fees required for attendance. Degree candidates may exclude from gross income (for tax purposes) any amount used for tuition and related expenses such as fees, books, supplies, and equipment required for courses of instruction at a qualified educational organization. The taxability of stipends, however, in no way alters the relationship between Kirschstein-NRSA trainees or fellows and their institutions. Kirschstein-NRSA stipends are not considered salaries. In addition, any trainee supported under the Kirschstein-NRSA is not considered to be in an employee-employer relationship with the NIH or the awardee institution. It is therefore inappropriate and unallowable for institutions to charge costs associated with employment (such as FICA, workman's compensation, or unemployment insurance) to the fellowship award. It must be emphasized that the interpretation and implementation of the tax laws are the domain of the Internal Revenue Service (IRS) and the courts. The NIH takes no position on the status of a particular taxpayer, and it does not have the authority to dispense tax advice. Individuals should consult their local IRS office about the applicability of the law to their situation and for information on their tax obligations.

Section V. Application Review Information

1. Criteria

This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm.

2. Review and Selection Process

Upon receipt, applications will be reviewed for completeness by the CSR and for responsiveness by the NCI. 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 the Division of Extramural Activities at the NCI in accordance with the review criteria stated below.

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

3. Merit Review Criteria

Applications submitted in response to a funding opportunity will compete for available funds with all other recommended applications.

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 the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application.

The review criteria focus on four main components:

3.A. Additional Review Criteria:

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

Nanotechnology Expertise: The sponsor's laboratory should either have expertise in the use of nanotechnology or describe plans for the sponsor and the fellow to obtain such expertise.

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 also Section VIII - Other Information.

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 also Section VIII-Other Information.

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described in section 30b of subsection 6 of the instructions for the PHS 416-1(rev.06/02) will be assessed.

3.B. Additional Review Considerations

Budget: The reasonableness of the requested budget in relation to the proposed training period of support. An F33 applicant must provide detailed budget information when requesting additional research support funds.

Responsible Conduct of Research: Every NRSA fellow must receive instruction in the responsible conduct of research (http://grants.nih.gov/grants/guide//notice-files/not92-236.html.) Applications must include the applicant's plans for obtaining instruction in the responsible conduct of research, including the rationale, subject matter, appropriateness, format, frequency and duration of instruction. The amount and nature of faculty participation must be described. No award will be made if an application lacks this component.

3.C. Sharing Research Data
Not applicable.

3.D. Sharing Research Resources
Not applicable.

Section VI. Award Administration Information

1. Award Notices

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

If the application is under consideration for 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/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant by email or postal 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.

2. Administrative 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/grants/policy/nihgps_2003/NIHGPS_Part4.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/grants/policy/nihgps_2003/NIHGPS_part9.htm).

Service Payback

As required by the NIH Revitalization Act of 1993, postdoctoral fellows incur a service obligation of 1 month for each month of support during the first 12 months of the Kirschstein-NRSA postdoctoral support. The 13th and subsequent months of Kirschstein-NRSA support are acceptable postdoctoral payback service. Thus, individuals who continue under the award for 2 years will have paid off their first year obligation by the end of the 2nd year.

Applicants accepting an award for the first 12 months of Kirschstein-NRSA postdoctoral support must sign a payback agreement (PHS Form 6031) in which they agree to engage in health-related research training, research, and/or teaching for 12 months.

Those who do not pay back their obligation through continued Kirschstein-NRSA supported training may satisfy their obligation by serving in a position in which health-related research, research training, or teaching are the primary activities. Such individuals must engage in research, research training, or teaching at a rate of 20 or more hours per week averaged over a full work-year. Payback service may be conducted in an academic, governmental, commercial, or nonacademic environment, in the United States or in a foreign country. Examples of acceptable payback service include research associateships/assistantships, postdoctoral research fellowships, and college or high school science teaching positions. Examples of unacceptable payback service include clinical practice and administrative responsibilities not directly related to scientific research.

Payback service positions are arranged by the individual, not by the NIH. The NIH will review and approve the activity at the end of the year in which it occurs. Service to satisfy any outstanding obligation must be initiated within 2 years after termination of Kirschstein-NRSA support and must be performed on a continuous basis. For individuals who fail to fulfill their service obligations, the United States is entitled to recover the total amount of Kirschstein-NRSA funds paid to the individual for the obligated period plus interest at a rate determined by the Secretary of the U.S. Department of Treasury. Financial payback must be completed within 3 years, beginning on the date the United States becomes entitled to recover such amount.

Under certain conditions, the Secretary, DHHS, may extend the period for starting service, permit breaks in service, extend the period of repayment, or otherwise waive the payback obligation when compliance would constitute a substantial hardship against equity and good conscience. Policies regarding the Kirschstein-NRSA payback obligation are explained in the Kirschstein-NRSA Section of the NIH Grants Policy Statement available at http://grants.nih.gov/grants/policy/policy.htm. Specific questions may appear in a list of Frequently Asked Questions that appears on the Web at http://grants.nih.gov/training/faq_fellowships.htm. Other questions on payback should be directed to the appropriate NIH Institute contact.

Leave Policies

In general, fellows may receive stipends during the normal periods of vacation and holidays observed by individuals in comparable training positions at the sponsoring institution. For the purpose of these awards, however, the period between the Spring and Fall semesters is considered to be an active time of research and research training and is not considered to be a vacation or holiday. Fellows may receive stipends for up to 15 calendar days of sick leave per year. Sick leave may be used for the medical conditions related to pregnancy and childbirth. Fellows may also receive stipends for up to 30 calendar days of parental leave per year for the adoption or the birth of a child when those in comparable training positions at the grantee institution have access to paid leave for this purpose and the use of parental leave is approved by the program director.

A period of terminal leave is not permitted and payment may not be made from fellowship funds for leave not taken. Fellows requiring periods of time away from their research training experience longer than specified here must seek approval from the NIH awarding component for an unpaid leave of absence.

Part-Time Training

While NRSA awardees are required to pursue research training full time, devoting at least 40 hours per week to the training program, under… unusual and pressing personal circumstances, a fellow may submit a written request to the awarding component to permit less than full-time training. Such requests will be considered on a case-by-case basis. They must be approved by the awarding NIH Institute or Center in advance for each budget period. The nature of the circumstances requiring the part-time training might include medical conditions, disability, or pressing personal or family situations such as child or elder care. Permission for part-time training will not be approved to accommodate other sources of funding, job opportunities, clinical practice, clinical training, or for other responsibilities associated with the fellow's position at the institution. In each case, the fellow must submit a written request countersigned by the sponsor and an appropriate institutional business official that includes documentation supporting the need for part-time training. The written request also must include an estimate of the expected duration of the period of part-time training, an assurance that the fellow intends to return to full-time training when that becomes possible, and an assurance that the trainee intends to complete the proposed research training program. In no case will it be permissible for the fellow to be engaged in Kirschstein-NRSA supported research training for less than 50 percent effort. Individuals who must reduce their commitment to less than 50 percent effort must take a leave-of-absence from Kirschstein-NRSA fellowship support. The fellowship notice of award will be reissued and the stipend will be pro-rated during the period of any approved part-time training. Part-time training may affect the rate of accrual or repayment of the service obligation for postdoctoral fellows.

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

3. Award Criteria

NIH staff use the following criteria in making awards: (1) eligibility of the applicant; (2) the SRG recommendation of the overall merit of the application; (3) the relevance of the application to the Institute's research training priorities and program balance; and (4) the availability of funds.

4. Reporting

Fellowships must be administered in accordance with the current NRSA section of the Grants Policy Statement at http://grants.nih.gov/grants/policy/policy.htm and any terms and conditions specified on the award notice.

Reporting Procedures. Fellowship Activation. No funds may be disbursed until the fellow has started training under the award and an Activation Notice (PHS 416-5) and (when appropriate) a Payback Agreement (PHS 6031) has been submitted to the NIH. An awardee has up to 6 months from the issue date on the

award notice to activate the award. Under unusual circumstances, an NIH institute may grant an extension of the activation period upon receipt of a specific request from the fellow.

A payback Agreement Form (PHS 6031) must accompany the Activation Notice for any award that occurs during the individual's initial 12 months of Kirschstein-NRSA postdoctoral support. When support ends, the fellow must submit a Termination Notice (PHS 416-7) to the NIH. If the fellow has a payback obligation, he or she must notify the NIH of any change in address and submit Annual Payback Activities Certification Forms (PHS 6031-1) until the payback service obligation is satisfied. Forms will be provided to awardees by the NIH awarding component. Forms may also be found on the NIH Web site at http://grants.nih.gov/grants/forms.htm.

Inventions and Publications. Fellowships made primarily for educational purposes are exempted from the PHS invention requirements. F32 awards will not contain any provision giving PHS rights to inventions made by the awardee.

Copyrights. Except as otherwise provided in the terms and conditions of the award, the recipient is free to arrange for copyright without approval when publications, data, or other copyrightable works are developed in the course of work under a PHS grant-supported project or activity. Any such copyrighted or copyrightable works shall be subject to a royalty-free, nonexclusive, and irrevocable license to the Government to reproduce, publish, or otherwise use them, and to authorize others to do so for Federal Government purposes.

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 416-9 annually (http://grants.nih.gov/grants/funding/416-9/phs416-9.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:

Gregory J. Downing, D.O., Ph.D.
Director, Office of Technology and Industrial Relations
Office of the Director
National Cancer Institute
Building 31, Room 10A-52, MSC 2580
31 Center Drive
Bethesda, MD 20892-2580
Telephone: (301) 496-1550
FAX: (301) 496-7807
Email: downingg@mail.nih.gov

2. Peer Review Contacts:

Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-3428
FAX: (301) 402-0275
E-mail: ncirefof@dea.nci.nih.gov

3. Financial or Grants Management Contacts:

Kathy Dunn
Grants Management Specialist
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, EPS Room 243
Bethesda, MD 20892
Rockville, MD 20852 (for express mail)
Telephone: (301) 846-6829
FAX: (301) 846-5720
E-mail: dunnkath@mail.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); and 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 at 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 (http://grants.nih.gov/grants/policy/data_sharing) or state why this is not possible.

Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, State, and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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 at http://grants.nih.gov/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 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 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 (see http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

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

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

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR web site (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. Kirschstein-NRSA Awards are made under the authorization of Section 487 of the Public Health Service Act as amended (42 USC 288) and Title 42 of the Code of Federal Regulations, Part 66. 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 Loan Repayment Program (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 percent 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/.


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