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 Dental and Craniofacial Research (NIDCR), (http://www.nidcr.nih.gov)

Title: NIDCR Individual Predoctoral Dental Scientist Fellowship

Announcement Type
This is a reissue of PA-02-004 , which was previously released on October 2, 2001.

Update: The following updates relating to this announcement have been issued:

Program Announcement (PA) Number: PAR-05-034

Catalog of Federal Domestic Assistance Number(s)
93.121

Key Dates
Release Date: December 23, 2004
Application Receipt Dates(s): Standard NRSA receipt dates of April 5, August 5 and December 5 http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): June-July, October-November and February-March
Council Review Date(s) : October, January and May
Earliest Anticipated Start Date: December, April and July
Expiration Date: January 3, 2008 (now January 8, 2008 per NOT-OD-07-093)

Due Dates for E.O. 12372
Not applicable.

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

  Section I. Funding Opportunity Description
    1. Research Objectives

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

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

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

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

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

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

  Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement
Section I. Funding Opportunity Description

1. Research Objectives

Purpose

The National Institute of Dental and Craniofacial Research (NIDCR) seeks new National Research Service Award (NRSA) applications for an Individual Predoctoral Dental Scientist Fellowship (PDSF). The purpose of the PDSF is to offer an integrated dental and graduate research training program that leads to attainment of both the D.D.S./D.M.D. and Ph.D. (or equivalent) degrees. There is a critical need for clinician-scientists with the dental training and research experience to conduct basic and clinical research in areas relevant to the mission of the NIDCR, which is to improve the oral health of all people. The PDSF provides an approach to expanding the cadre of well-trained oral health scientists by stimulating early commitment to research careers by outstanding dental students. The NIDCR anticipates that graduates of the PDSF will be able to bring into basic and clinical studies of dental, oral and craniofacial health and disease the fundamental knowledge and insight from such fields as microbiology and microbial pathogenesis, immunology and immunotherapy, infectious diseases, AIDS and oral manifestations of immunosuppression, developmental biology, mammalian genetics, mammalian cell regulation, pharmacogenetics, molecular and cellular neurobiology, biotechnology and biomaterials, epidemiology, clinical trials methodology, behavioral and social sciences, biostatistics and health services research.

Research Training Objectives

An individual PDSF must provide integrated clinical and graduate research training required to obtain the D.D.S./D.M.D. and Ph.D. (or equivalent) degrees. Applicants for the NIDCR PDSF awards must propose to conduct research in areas of high priority/public health significance to dental, oral and craniofacial conditions and document that the proposed graduate program and research project offers them an opportunity to develop expert research skills and knowledge leading to a research career in the sciences involved with dental, oral and craniofacial health and disease.

Each fellow's program must offer two distinct and integrated components. A clinical component must ensure the acquisition of requisite clinical knowledge and technical expertise in order to meet the requirements for a D.D.S./D.M.D. degree and to obtain a license to practice dentistry. A scientific component must be a doctoral (Ph.D. or equivalent) level program that ensures development of knowledge and research skills in scientific areas relevant to dental, oral and craniofacial health and disease. The research training experience must provide a strong foundation in research design, methods and analytic techniques; the development or enhancement of the fellow's ability to conceptualize and think through research problems with increasing independence; experience in conducting, presenting and publishing independent research; the opportunity to interact with members of the scientific community at meetings and workshops (including NIH sponsored meetings); and the development and documentation of a well thought-out career plan to increase the applicant's ability to secure federal support for his/her research.

The applicant's program should be under the guidance and supervision of a committed sponsor or mentor who is an active and established investigator in the area of the applicant's proposed research. Usually, a mentor will be the doctoral thesis advisor. The mentor must be committed to continue this involvement throughout the individual's total period of development under the award. A co-mentor, representing the clinical component, also may be named. Where feasible, women and minority mentors should be involved as role models.

The research training program should be carried out in a research-intensive environment that includes appropriate human and technical resources and is demonstrably committed to research training in the particular program proposed by the applicant so that the applicant can grow as a creative scientist. The interdisciplinary program for the fellow should maximize the research and educational resources of his/her academic institution(s) and any collaborating organizations. The program should be tailored to meet the unique research and clinical development needs of the fellow and ensure that the individual completes the program with requisite competencies. The sequence in which the two components are offered and their integration should be based on the specific circumstances and organization of the training institution and should represent what is deemed most desirable, feasible and efficient by the administration of the dental and graduate institutions.

The application must include evidence that instruction in the principles of responsible conduct of research will be incorporated into the proposed research training plan. Applications without plans for training in responsible conduct of research will be considered incomplete and will be returned without review.

Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the Individual Predoctoral National Research Service Awards for D.D.S./Ph.D. Fellowships (F30) mechanism to provide combined dental school and predoctoral PhD support. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

Although NRSAs are not usually made for training leading to a health professional degree, or for training that is part of a clinical residency leading to an advanced dental specialty, this program is specifically designed to support training in an established, combined DDS/PhD program.

2. Funds Available

Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

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

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

Citizenship: By the time of award, individuals 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.

Degree Requirements: The applicant must have a baccalaureate degree and show evidence of both high academic performance in the sciences and substantial interest in research in areas of high priority to the NIDCR. The applicant must be enrolled in a DDS/DMD program at an accredited dental school, accepted in a related scientific PhD (or an equivalent degree) program, and supervised by a senior, recognized mentor in that scientific discipline when the application is submitted. The typical applicant will apply during the first year of dental school for funding to begin in the second year. Trainees must begin their PDSF not later than the third year of dental school. Individuals currently enrolled in a joint DDS/DMD-PhD program are eligible for consideration as trainees. Dental students who obtained a PhD prior to entering dental school and desire to pursue another research doctorate are not eligible.

Sponsor: Before submitting a fellowship application, the applicant must identify an individual who will serve as a sponsor (also called mentor or supervisor). The sponsor will directly supervise the training and research experience, and should currently be funded to conduct independent peer-reviewed research in the area of the candidate's proposed research project.

Sponsoring Institution: As mentioned above, the applicant must be enrolled in a D.D.S./D.M.D. program at an accredited dental school and accepted in a related scientific Ph.D. program. The institutional setting must be a domestic private or public institution. The sponsoring institution must have staff and facilities available on site to provide a suitable environment for performing high-quality research training.

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

3. Other-Special Eligibility Criteria

Awards must be activated within six months of receipt of award notice (see below for application receipt, review, and start dates). No funds may be disbursed until the individual has started training under the award and an Activation Notice (PHS 416-5) has been submitted to and accepted by the NIDCR.

Individuals are required to pursue their DDS/DMD-PhD training program on a full-time basis, devoting at least 40 hours per week to the training program.

Section IV. Application Submission Instructions

1. Address to Request Application Information

The PHS 416-1 application 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

The Individual National Research Service Award application PHS 416-1 (rev 6/2002) must be used in applying for fellowships. This form is available on the Internet at: http://grants.nih.gov/grants/funding/416/phs416.htm. Instructions for completing the application are available at http://grants.nih.gov/grants/funding/416/phs416-1.pdf.

The applicant's sponsoring institution 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. The D&B number should be entered on line 12 of the face page of the PHS 416-1 form.

See Section VI.2 Administrative and National Policy Requirements for additional information.

At least three completed letters of reference in sealed envelopes must be attached to the application. Applications without the required number of reference letters will be returned without review.

Applicants are advised to pay special attention to the following important items in PHS 416-1:

Part 1: (Prepared by Applicant):

Page 1 (Face page)

Item 1. Title of Research Training Proposal. Enter “Individual Predoctoral Dental Scientist Fellowship”

Item 2. Level of Fellowship. Enter “predoctoral”

Item 8. Degree Sought During Proposed Award. Enter both the dental (DDS or DMD) and Ph.D. (or equivalent) with expected completion dates for each.

Form Page 4

Item 23. Scholastic Performance. In addition to the information requested in the application, applicants should provide scores for DAT, GRE, and other exams relevant to dental and graduate school that they have taken recently.

Form Page 6

Item 30a. Activities Under Award. Applicants should describe how they expect to divide their time between dental and graduate school, e.g., dental school courses, graduate school courses, research, research training, etc., during both the school year and the summer for each year of the program. A minimum of 40 hours/week is required for support under the NRSA program.

Item 30b. Research Training Proposal. All applicants should provide a research plan, including a description of a research proposal in which they will be involved as part of their training. The plan should include substantive detail that adds to the information about time allocations requested in Item 30a.

Part 2: Facilities and Commitment (Prepared by Sponsor):

Form Page 8

Items 33 and 34. Sponsor's Previous Fellows/Trainees, Training Plan, Environment, and Research Facilities. The sponsor must describe past experience in the guidance of other research trainees and fellows. In addition, the sponsor must describe in detail his/her commitment to and proposed role in guiding the individual applicant. The chairman of the graduate committee for the PhD program must also describe the institutional commitment to research training and career development, the quality of the facilities and related resources (e.g., equipment, laboratory space, computer time, subject populations) and the availability of research support.

The application must include evidence that training in the principles of responsible conduct of research will be incorporated in the research experience of each fellow. This should be presented under Item 34. Issues such as conflict of interest, data recording and retention, professional standards and codes of conduct, responsible authorship, protection of human subjects, and ethics in biological and behavioral research can provide the substantive base of such training.

Special Program Requirements, Allowable Costs and related information

A. Fellowship Appointments

All fellows are required to pursue their research training full time, normally defined as 40 hours per week or as specified by the sponsoring institution in accordance with its own policies. Under unusual or pressing personal circumstances, a fellow may submit a written request to the NIH awarding office to permit less than full-time training.

No fellow may receive more than 5 years of aggregate NRSA support at the predoctoral level or 3 years of support at the postdoctoral level, including any combination of support from institutional training grants and individual fellowship awards.

Any exception to the maximum period of support requires a waiver from the NIH awarding office based on review of a justification from the individual and sponsoring institution. The fellow must make the request in writing to the NIH awarding office. The fellow's sponsor and an Authorized Organizational Official (AOO ) who is authorized to act for the applicant institution and to assume the obligations imposed by the Federal laws, regulations, requirements, and conditions that apply to grant applications or grant awards must endorse the request. The request must specify the amount of additional support for which approval is sought. Individuals seeking additional support beyond the third year of postdoctoral support are strongly advised to consult with their PO before submitting a waiver request.

Some generally recognized categories under which NIH may grant exceptions include the following:

Requests for additional time that do not arise from either of the above-described circumstances will be considered only if they are accompanied by an exceptionally strong justification.

B. Budget and Related Issues

Allowable Costs

Stipends: A stipend is provided as a subsistence allowance for Kirschstein-NRSA fellows to help defray living expenses during the research training experience. It is not provided as a condition of employment with either the Federal government or the sponsoring institution. Stipends must be paid in accordance with stipend levels established by NIH, which are based on a 12-month full-time training appointment. In the event of early termination, the stipend will be prorated according to the amount of time spent in training, and NIH will issue a revised NRFA. No departure from the standard stipend provided by NIH under the fellowship may be negotiated by the sponsoring institution with the fellow.

The annual stipend for predoctoral individuals will remain fixed for the period of support, unless the stipend level is changed in the NIH annual appropriation. Applicants may obtain information about current stipend levels and other policy documents from the URL for "NIH Training Related Policy Documents": http://grants.nih.gov/training/nrsa.htm.

Tuition and Fees and health insurance: The NIDCR 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 Policy Guidelines on the NIH website at http://grants.nih.gov/training/nrsa.htm.

Institutional Allowance: An allowance of up to $2,500 per predoctoral fellow per twelve month period will be provided to the sponsoring institution to help defray such expenses as research supplies, equipment, and related items for the individual fellows, and to otherwise offset, to the extent possible, appropriate administrative costs of graduate research training. The allowance is provided only upon official activation of the award, and the sponsoring institution is expected to administer the allowance and disburse the funds. If an individual fellow is in a training status for less than six months of the award year, only one-half of that year's allowance may be charged to the grant.

Travel: An additional allowance of up to $800 per year will be provided for travel to scientific meetings.

3. Submission Dates and Times
Applications must be mailed on or before the receipt date described at http://grants.nih.gov/grants/funding/submissionschedule.htm. Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates

Application Receipt Date: April 5 August 5 December 5
Peer Review Date: June October March
Council Review Date: September January May
Earliest Anticipated Start Date: December April July

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

Submit the application package according to the instructions for the PHS 416-1 (http://grants.nih.gov/grants/funding/416/phs416.htm)

Applications should be addressed 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 to the Center of Scientific Review, one additional copy of the completed and signed application and the appendix materials (if any) to:

H. George Hausch, PhD
Acting Director, Division of Extramural Activities
National Institute of Dental and Craniofacial Research
Building 45, Room 4AN-44F
45 Center Drive
Bethesda, MD 20892-6402

3.C. Application Processing

Applications must be submitted on or before the application receipt dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/funding/submissionschedule.htm.

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 (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. Reporting)

6. Other Submission Requirements

Plan for Sharing Research Data
Not applicable to NRSA Fellowships.

Sharing Research Resources
Not applicable to NRSA Fellowships.

Section V. Application Review Information

1. Criteria

The responsibility for award decisions resides solely with authorized program staff of the NIDCR. The following criteria will be used in making award decisions: (1) overall merit of the application as determined by peer review; (2) relevance of the application to the mission and research training priorities of the NIDCR; (3) program balance; and (4) availability of funds. The role of peer review is to assess the extent to which the applicant is likely to complete a successful training program and to pursue a research career involving dental, oral and craniofacial health and disease. Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Upon receipt, all F30 fellowship applications will be reviewed for completeness by the Center for Scientific Review. Incomplete applications will be returned to the applicant without further consideration. Fellowship applications that are complete will be evaluated for merit by an appropriate peer review group convened by the NIDCR Scientific Review Branch. As part of the merit review, all applications will receive a written critique and will be assigned a priority score.

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

The NIDCR PDSF is designed to train future generations of outstanding clinician-scientists committed to pursuing a research career involving dental, oral and craniofacial health and disease. The PDSF is a mechanism for research training, not exclusively one for performing a research project. Therefore, the review of an application will be based on the following: the candidate, the research training plan, the sponsor, and the institutional environment/commitment. In addition to the information in the PHS 416-1 application form, information contained in the letters of reference will also be used in evaluating these factors. The final priority score will reflect the overall evaluation of the entire application.

Candidate:

Research Training Plan:

Sponsor:

Institutional Environment/Commitment:

2.A. Additional Review Considerations

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.

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.

Care and Use of Vertebrate Animals in Research: No Kirschstein-NRSA Individual Fellowship involving vertebrate animals will be made to a sponsoring institution unless that institution is operating in accordance with an approved Animal Welfare Assurance and provides verification that the Institutional Animal Care and Use Committee (IACUC) has reviewed and approved the proposed activity in accordance with the PHS policy. No award to an individual will be made unless that individual is affiliated with an institution that has an Animal Welfare Assurance and that accepts responsibility for compliance with the PHS policy.

Responsible Conduct of Research: Kirschstein-NRSA individual fellowship applicants must include, as part of their application, 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.

While NIH does not establish specific curricula or formal requirements, applicants are encouraged to creatively tailor a plan to meet their own needs in relation to the proposed research training. It may include participating in formal activities, such as established courses (credit or noncredit) either as an instructor or a student, or informal activities, such as discussion groups. Possible coverage could include conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, policies for the use of animals and/or human subjects, and organizational (rather than individual) responsibilities for scientific integrity.

2.C. Sharing Research Data
Not applicable to NRSA Fellowships.

2.D. Sharing Research Resources
Not applicable to NRSA Fellowships.

3. Anticipated Announcement and Award Dates

Refer to the receipt/review schedule in Section IV.3.A. Awards must be activated within six months of receipt of award notice. No funds may be disbursed until the individual has started training under the award and an Activation Notice (PHS 416-5) has been submitted to and accepted by the NIH awarding component.

Section VI. Award Administration Information

1. Award Notices

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

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 organization. The notice of award 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.

NGAs are sent via e-mail to the office of the Administrative Official named in item 14 on the Face Page of the PHS 416-1 (rev. 6/2002) application form.

2. Administrative and National Policy Requirements

For more information and detailed requirements, please refer to the NIH Grants Policy, particularly the section regarding the Individual Fellowships of the Ruth L. Kirschstein National Research Service Awards, http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part10.htm#_Toc54600187.

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.

3. Reporting

Progress reports must be submitted for non-competing continuation support in accordance with the instructions accompanying the Ruth L. Kirschstein National Research Service Award Individual Fellowship Progress Report for Continuation Support Form PHS 416-9 http://grants.nih.gov/grants/funding/416-9/phs416-9.htm. Report form pages are available in pdf-fillable and rtf formats. Inadequate or incomplete progress reports may be returned to the fellow for revision and may result in a delay of continued support. For Kirschstein-NRSA individual fellowship awards, the final progress report is required as part of the Termination Notice.

Activation Notice: Immediately upon the initiation of training, the individual must complete and sign the Ruth L. Kirschstein Individual Fellowship Activation Notice (Form PHS 416-5), obtain the signature of the AOO, and forward the notice along with the Payback Agreement (required only for postdoctoral fellows in their first 12 months of Kirschstein-NRSA support) to the NIH awarding office.

For Kirschstein-NRSA fellows paid directly by NIH, the Activation Notice is required at the start of each award year. The form should not be submitted before the fellow actually begins training. Stipend checks are issued when both the Activation Notice and the Payback Agreement (required only for postdoctoral fellows in their first 12 months of Kirschstein-NRSA support) are received by the NIH awarding office.

For fellows whose stipend is paid through the institution, the Activation Notice is required for the initial year only. The Activation Notice may be submitted up to 30 days before the individual begins training if necessary for payroll purposes. However, the institution must not release any funds until the individual has started training. Furthermore, if the individual does not begin research training on the day indicated, the institution must notify the NIH awarding office immediately. Competing continuation awards must be activated on the day following the end of the last budget period of the previous award.

Termination Notice: The Ruth L. Kirschstein National Research Service Award Termination Notice (Form PHS 416-7) (along with the Activation Notice and the NRFA) is the basis for validating the total period of Kirschstein-NRSA support and establishing the amount of payback obligation for each Kirschstein-NRSA fellow. For individual fellowships, a reminder of this reporting requirement may be sent to the fellow by the NIH awarding office before the scheduled termination date. For early terminations, the completed form will be required immediately upon receipt of notification from the fellow or an AOO. The lack of timely and accurate information on this form could adversely affect the payback process. For additional information on early termination, see “ Changes in the Project” in this section.

Financial Reporting : An annual or final FSR is not required on Kirschstein-NRSA individual fellowship awards.

Publications and Sharing of Research Results : NIH supports the practical application and sharing of outcomes of funded research. Therefore, recipients of Kirschstein-NRSA fellowships should make the results and accomplishments of their activities available to the research community and to the public at large. The sponsoring institution should assist the fellow in such activities, including the potential commercialization of inventions. No restrictions should be placed on the publication of results.

Kirschstein-NRSA fellows are encouraged to submit reports of their findings to the journals of their choice for publication. Responsibility for direction of the project should not be ascribed to NIH. However, NIH awarding office support must be acknowledged by a footnote in language similar to the following: “This research was supported by the National Institutes of Health under Ruth L. Kirschstein National Research Service Award (number) from the (name of NIH IC).” In addition, Federal funding must be acknowledged as provided in “ Public Policy Requirements and Objectives—Availability of Information—Acknowledgment of Federal Funding.”

Copyright : Except as otherwise provided in the conditions of the award, when a publication or similar copyrightable material is developed from work supported by NIH, the author is free to arrange for copyright without approval of the NIH awarding office. Any such copyrighted materials shall be subject to a royalty-free, nonexclusive, and irrevocable license to the Federal government to reproduce them, translate them, publish them, and use and dispose of them, and to authorize others to do so for Federal government purposes.

Inventions and Patents : Fellowships funded primarily for educational purposes are not subject to invention reporting requirements nor does NIH have any rights to inventions under those awards (as specified in 37 CFR 401.1(b)). Kirschstein-NRSA fellows training at NIH represent an exception to this policy. Those fellows are subject to the provisions of EO 10096 and NIH determines the disposition of rights to any invention conceived or actually reduced to practice during the period of the fellowship.

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 Contact:

Kevin S. Hardwick, DDS, MPH
Extramural Training Officer
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AS13
Bethesda, MD 20892
Telephone: (301) 594-2765
FAX: (301) 402-7033
Email: kevin.hardwick@nih.gov

2. Peer Review Contact:

H. George Hausch, PhD
Acting Director, Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health
45 Center Drive, Room 4AN-44F
Bethesda, MD 20892-6402
Telephone: (301) 594-2904
FAX: (301) 480-8303
Email: George.Hausch@nih.gov

3. Financial or Grants Management Contact:

Dede Rutberg, MBA
Grants Management Specialist
Grants Management Branch
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AN44J
Bethesda, Maryland 20892-6402
Telephone:  (301) 594-4798
FAX:  (301) 480-3562
Email:  dr258t@nih.gov or rutbergd@mail.nih.gov

Section VIII. Other Information

Required Federal Citations

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.

Kirschstein-NRSA individual fellowship awards involving use of human subjects must comply with the requirements for their protection (see “ Public Policy Requirements and Objectives—Requirements Affecting the Rights and Welfare of Individuals as Research Subjects, Patients, or Recipients of Services—Human Subjects”). For additional information on human subjects requirements, refer to the Kirschstein-NRSA individual fellowship application instructions (http://grants.nih.gov/grants/funding/416/phs416.htm) or contact OHRP.

Monitoring Plan and Data and Safety Monitoring Board:
Research involving clinical trials must include provisions to ensure the safety of participants and the validity and integrity of the data. A monitoring plan establishes the overall framework for data and safety monitoring. It should describe the entity that will be responsible for monitoring and how adverse events will be reported to IRBs, NIH, and FDA. The frequency of monitoring will depend on potential risks, complexity, and the nature of the trial.

NIH specifically requires the establishment of DSMBs for multi-site clinical trials involving interventions that entail potential risks to the subject and, generally, for Phase III clinical trials. Although Phase I and Phase II clinical trials also may use DSMBs, smaller clinical trials may not require this type of oversight, and alternative monitoring plans may be appropriate.

Fellows also should refer to the NIH Policy for Data and Safety Monitoring at http://grants.nih.gov/grants/guide/notice-files/not98-084.html, “ Public Policy Requirements and Objectives—Requirements Affecting the Rights and Welfare of Individuals as Research Subjects, Patients, or Recipients of Services—Data and Safety Monitoring” in Subpart A, and the instructions in the PHS 416-1 application.

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/guide/notice-files/NOT-OD-04-042.html). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/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:
Pursuant to the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43), NIH requires that women and members of minority groups and their subpopulations 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 (see “ Public Policy Requirements and Objectives—Requirements for Inclusiveness in Research Design”).

Individuals proposing clinical research should read the NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research–Amended, October 2001, available on the NIH website at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.

Inclusion of Children as Participants in Clinical Research:
NIH policy requires that children (individuals under the age of 21) be included in all human subjects research conducted or supported by NIH, unless there are scientific and ethical reasons not to include them (see “ Public Policy Requirements and Objectives—Requirements for Inclusiveness in Research Design”).

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.

Responsible Conduct of Research:
Kirschstein-NRSA individual fellowship applicants must include, as part of their application, 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.

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.

Use of Animals in Research:
Kirschstein-NRSA individual fellowship awards involving use of vertebrate animals must comply with the requirements for their protection specified in “ Public Policy Requirements and Objectives—Requirements Affecting the Right and Welfare of Individuals as Research Subjects, Patients, or Recipients of Services—Animal Welfare.” For additional information on vertebrate animals, refer to the Kirschstein-NRSA individual fellowship application instructions or contact the Office of Laboratory Animal Welfare (OLAW) (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part14.htm#olaw).

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

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

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance No. 93.121. Awards are made under authorization of section 487 of the Public Health Service Act as amended (42 USC 288) and administered under Title 42 of the Code of Federal Regulations, Part 66.

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


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