Fellowships for Human Embryonic Stem Cell Research

PA Number: PA-05-013

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 Institute of General Medical Sciences (NIGMS), (http://www.nigms.nih.gov)
National Heart, Lung and Blood Institute (NHLBI), (http://www.nhlbi.nih.gov)
National Institute of Child Health and Development (NICHD), (http://www.nichd.nih.gov)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), (http://www.niddk.nih.gov)
National Institute on Deafness and Other Communication Disorders (NIDCD), (http://www.nidcd.nih.gov)
National Institute of Environmental Health Sciences (NIEHS), (http://www.niehs.nih.gov)

Announcement Type
New

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

Catalog of Federal Domestic Assistance Number(s)
93.173, 93.223, 93.837, 93.838, 93.839, 93.847, 93.848, 93.849, 93.859, 93.865, 93.894.

Key Dates

Standard dates for Individual Kirschstein-NRSA Awards apply. See http://grants2.nih.gov/grants/funding/submissionschedule.htm for details. Applications must be mailed on or before the receipt dates for individual NRSA Fellowships.

Release Date: November 10, 2004
Application Receipt Dates: See http://grants2.nih.gov/grants/funding/submissionschedule.htm.
Peer Review Date: June-July, October-November, and February-March.
Institute Second Level Review Dates : September-October, January-February, May-June .
Earliest Anticipated Start Date: December 5, 2005
Expiration Date: January 3, 2008 (now January 8, 2008 per NOT-OD-07-093)

Due Dates for E.O. 12372
Not Applicable

Executive Summary

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 Training Objectives

The purpose of this PA is to increase the numbers of biomedical scientists who are pursuing research involving human embryonic stem cells (HESC). The recent availability of HESC for federally funded research affords a unique opportunity for investigators to use these cells to address research questions of interest to the mission of the NIH and its component ICs. Although HESCs have great potential to yield important information on the fundamental properties of cells and disease processes, remarkably little is known about the properties of HESC that distinguish them from more differentiated cells. Furthermore, very few scientists have had the opportunity to be trained in their use, or to explore the questions that can be addressed to advantage, using HESC. Consequently, only a few post-doctoral fellows and established investigators are currently engaged in HESC research, and more investigators must be trained to accelerate the pace of HESC research. Indeed, the NIH Stem Cell Task Force has identified the paucity of skilled researchers and lack of training environments for career enrichment as one of the rate limiting steps in the advancement of HESC research.

This announcement specifically aims to encourage applications for F32 individual postdoctoral fellowships from promising candidates with the potential to become productive, independent investigators in HESC-related research. It also aims to encourage applications for F33 senior fellowships from experienced scientists who wish to make major changes in the direction of their research or who wish to broaden their scientific background by acquiring new capabilities in HESC research. Only approved HESC lines listed on the NIH Human Embryonic Stem Cell Registry http://stemcells.nih.gov/registry/ may be used for research training activities. The Description (Item # 22) of the application must provide the registry identifying numbers of the HESC lines to be used.

The goal of this Fellowship Program in HESC research is to train highly skilled research scientists to pursue research problems on the basic characteristics of HESC and their applications to the study of disease. It is expected that these individuals will acquire expertise in the growth and maintenance of HESC that will enable them to pursue research that includes:

Participating Institutes will support fellowships that address any of the research areas that they typically support and that also involve HESC (see the websites listed with the Institute's name at the beginning of this announcement for more details of research areas supported by each Institute).

Section II. Award Information


1. Mechanism(s) of Support

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

2. Funds Available

The number of awards will depend on the quality of applications and funds available. 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 website at http://grants.nih.gov/training/nrsa.htm. The awarding NIH institute 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 seven 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. NIH support does not provide fringe benefits for any fellows supported by the NRSA programs.

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.

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 six 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.

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 if the applicant is not already at the site when the award is made. 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.

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.

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:

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research training 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. Further details of the Kirschstein-NRSA F32 award mechanism can be found at http://grants.nih.gov/grants/guide/pa-files/PA-03-067.html. Details of the Kirschstein-NRSA F33 award mechanism can be found at http://grants.nih.gov/grants/guide/pa-files/PA-00-131.html.

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.

Before an 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 seven years beyond one of the above qualifying degrees, have had at least seven years of post-degree relevant research or professional experience, and have established an independent research career.

The Center for Scientific Review (CSR) will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

2. Cost Sharing

There is no required cost sharing.

3. Other-Special Eligibility Criteria

F32 awardees may receive up to three 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 two years. Applicants must consider any prior Kirschstein-NRSA postdoctoral research training in determining the duration of fellowship support that may be requested. Training beyond the three-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 third 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.

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 growth and maintenance of HESC or have specific plans to obtain the requisite training, and must document the availability of research support and facilities for high-quality HESC 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, applicants may propose postdoctoral training experiences at their doctorate institution or at the institution where they have 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 their training involving HESC 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 for the purpose of receiving training to expand their research capabilities.

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 over positions 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/forms.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

Individuals must submit the application using the Ruth L. Kirschstein National Research Service Award Individual Fellowship Form (PHS 416-1, rev. 06/02) available at http://grants.nih.gov/grants/forms.htm. APPLICATIONS MUST INCLUDE AT LEAST THREE SEALED LETTERS OF REFERENCE. APPLICATIONS WITHOUT AT LEAST THREE LETTERS OF REFERENCE MAY 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 PHS 416-1 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.

The applicant should identify the number of this PA in Item Three.

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

Applications must be mailed on or before the receipt date described below (Section IV.3.A).

3.A. Receipt, Review and Anticipated Start Dates

Standard dates for Individual Kirschstein-NRSA Awards apply. See http://grants1.nih.gov/grants/funding/submissionschedule.htm for details.

Application Receipt Dates: April 5, August 5, and December 5.
Peer Review Date: June-July, October-November, and February-March.
Institute Second Level Review Dates : September-October, January-February, May-June .
Earliest Anticipated Start Date: December 5, 2005

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity.

3.B. Sending an Application to the NIH

Applications must be prepared using the Ruth L. Kirschstein National Research Service Award Individual Fellowship Form as described above. Submit a signed, typewritten original of the application (including the Checklist, Personal Data form, AT LEAST THREE SEALED REFERENCE LETTERS, and all other required materials) and two exact, clear, single-sided photocopies of the signed application, 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)

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 and Reporting Procedures: 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 the award. 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.

Note: Incomplete applications will not be reviewed.

Note: Applicants submitting applications that are within the scientific purview of the NIDCD should send, at the time of submission, one of these copies and all sets of appendix materials, if any, to:

Chief, Scientific Review Branch
Division of Extramural Research
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400-C - MSC-7180
Bethesda, MD 20892-7180
Telephone: (301) 496-8683
ATTN: NRSA postdoctoral OR senior fellowship

3.C. Application Processing

Applications must be sent on or before the application receipt dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm. Applications will be evaluated for completeness by CSR.

The NIH will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

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

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, trainees supported under the Kirschstein-NRSA are 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.

Funds for continuation beyond the initial year are determined by the success described in the continuation application (PHS 416-9), the timely submission of any required forms, and the availability of funds.

6. Other Submission Requirements

Only approved HESC lines listed on the NIH Human Embryonic Stem Cell Registry http://stemcells.nih.gov/registry/ may be used for research training activities. The Description (Item # 22) of the application must provide the registry identifying numbers of the HESC lines to be used.

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

Applications submitted for this funding opportunity will be assigned to the ICs on the basis of established PHS referral guidelines.

Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.

Applications receive two sequential levels of review. The first level is an assessment of the merit of the research training proposal by a Scientific Review Group (SRG), composed primarily of non-government scientists selected for their competence in research and research training in a scientific area related to the application. Staff within the assigned funding Institute or Center provides a second level of review. Following the second-level review, the program official will notify applicants within the funding range of the final disposition of the application. Any questions on SRG recommendations and funding possibilities should be directed to the appropriate Institute program official.

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

3. Merit Review Criteria

The scientific review group will address and consider each of the following criteria in assigning the application's overall score, weighting them as appropriate for each application.

The review criteria focus on four main components:

The application does not need to be strong in all categories to be judged likely to deserve a high priority score.

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:

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 on page 21 of the PHS 416-1 fellowship application instructions (rev. 6/2002) will be assessed.

3.B. Additional Review Considerations

Budget: The reasonableness of the requested period of support in relation to the proposed training and the applicant's prior training experience. The priority score should not be affected by the evaluation of the requested period of support

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

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 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.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.

A formal notification in the form of a Notice of Grant Award (NGA) will be provided electronically to the applicant organization. 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. 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 six 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. Such a request must be countersigned by the Sponsor and an institutional official.

2. Administrative Requirements

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.

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 Website 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.

Data Sharing: It is the policy of the DHHS that the results and accomplishments of all funded activities should be made available to the public. This policy also applies to individuals supported by individual Kirschstein-NRSA postdoctoral and senior fellowships The sponsoring institution should place no restrictions on the publication of results in a timely manner.

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.

Only approved HESC lines listed on the NIH Human Embryonic Stem Cell Registry http://stemcells.nih.gov/registry/ may be used for research training activities. The abstract of the application must provide the registry identifying numbers of the HESC lines to be used.

Service Payback: As required by the NIH Revitalization Act of 1993, postdoctoral fellows incur a service obligation of one 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 two years will have paid off their first year obligation by the end of the second 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 two years after termination of Kirschstein-NRSA support and must be performed on a continuous basis. For individuals who fail to fulfill their service obligation, 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 three 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, and awarded funds may not be expended during this time.

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.

3. Award Criteria

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

Awardees will be required to submit the PHS 416-9 Continuation of an Individual National Research Service Award (NRSA) annually (http://grants.nih.gov/grants/forms.htm) 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:

Marion M. Zatz, Ph.D.
Division of Genetics and Developmental Biology
National Institute of General Medical Sciences (NIGMS)
Building 45, Room 2AS.25
45 Center Drive MSC-6200
Bethesda, MD 20892-6200
Telephone: (301) 594-0943
FAX: (301) 480-2228
Email: zatzm@nigms.nih.gov

Ellen M. Werner, Ph.D.
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute (NHLBI)
6701 Rockledge Dr. MSC 7950
Bethesda, MD 20892-7950 (for overnight or courier delivery, delete MSC, insert Room 10156, and change zip to 20817)
Telep hone: 301-435-0061
Email: wernere@mail.nih.gov

Steven L. Klein, Ph.D.
Developmental Biology, Genetics & Teratology Branch
National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 4B01
Rockville, MD 20852
Telephone: (301) 496 5541
Email: sk56d@nih.gov

Daniel A. Sklare, Ph.D.
Division of Scientific Programs
National Institute of Deafness and Other Communication Disorders (NIDCD)
Building 31, Room 400C
6120 Executive Blvd., MSC-7180
Bethesda, MD 20892-7180
Telephone: (301) 496-1804
Email: sklared@nidcd.nih.gov

James Hyde, Ph.D.
Division of Diabetes, Endocrinology, and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Blvd., Room 609 MSC 5460
Bethesda, MD  20892-5460
Telephone:  (301) 594-7692
Email:  jh486z@nih.gov

Judith Podskalny, Ph.D.
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Blvd., Room 667, MSC 5450
Bethesda, MD  20892-5450
Telephone:  (301) 594-8876
Email:  jp53s@nih.gov

Terry Rogers Bishop, Ph.D.
Division of Kidney, Urologic, and Hematologic Disorders
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Blvd., Room 619, MSC 5458
Bethesda, MD  20892-5458
Telephone:  (301) 594-7717
Email:  tb232j@nih.gov

Carol Shreffler, Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences (NIEHS)
P.O. Box 12233
Research Triangle park, NC 27709
Telephone: (919) 541-1445
Email: Shreffl1@niehs.nih.gov

2. Peer Review Contacts:

Not applicable

3. Financial or Grants Management Contacts:

Marcia Cohn
Grants Management
NIGMS
Building 45, Room 2AN.44E
45 Center Drive MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-3918
Email: cohnm@nigms.nih.gov

Ann Marie Brasile Mejac
Grants Administrator
Grants Operations Branch
NHLBI
Two Rockledge Center, Room 7160B
6701 Rockledge Drive
Bethesda, MD 20892-7926, Express Mail Zip 20817
Phone#(301) 435-0177
Email: brasilea@nhlbi.nih.gov

Annette Hanopole
Chief Grants Management Officer
NICHD
6100 Executive Blvd, Room 8A01 MSC 7510
Rockville, Maryland 20892
Express Mail Zip: 20852
Fax: 301.402.0915
Phone: 301.496.5001
Email: hanopola@mail.nih.gov

Christopher Myers
Chief, Grants Management Branch
NIDCD
6120 Executive Blvd, Room 400B MSC 7180
Bethesda, MD 20892-7180
Telephone: 301-402-0909
FAX: 301-4026250
Email: myersc@mail.nih.gov

Overnight Delivery Address:
6120 Executive Blvd, Room 400B
Rockville, MD 20852

Donna Huggins
Grants Management
NIDDK
6707 Democracy Boulevard, Room 711
Bethesda, MD 20892-5456
Telephone:  (301) 594-8848
FAX:  (301) 480-3504
Email:  dh48z@nih.gov

Lisa M. Archer
NIEHS
Grants Management Branch
Division of Extramural Research and Training
Post Office Box 12233 MD/EC-22
79 TW Alexander Drive, Bldg 4401, Room 3406 (fed-x address)
Research Triangle Park, NC  27709
919/541-0751   fax 919/541-2860
Email:  archer@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, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

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 the 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:

Kirschstein-NRSA awards are made under the authorization of Section 487 of the Public Health Service Act as amended (42 USC 288 and under Federal Regulations 42 CFR 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.

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.

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/.


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