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) (www.nidcr.nih.gov)

Title: NIDCR Individual NRSA Predoctoral Dental Scientist Fellowship (F30)

Announcement Type:
This is a reissue of PAR-05-034.

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

Note: The PHS 416-1 (rev. 9/2008) must be used for December 2008 application receipt dates. See also: NOT-OD-09-004.

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government the NIH will gradually transition each grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. For more information and an initial timeline, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-035.html.  NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html).

Funding Opportunity Announcement (FOA) Number: PAR-08-119


Catalog of Federal Domestic Assistance Number(s):
93.121

 
Key Dates
Release Date: March 27, 2008
Application Receipt Dates(s): Standard NRSA receipt dates of April 8, August 8 and December 8 http://grants1.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): Standard NRSA receipt dates of April 8, August 8 and December 8 http://grants1.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s) : Standard NRSA receipt dates of April 8, August 8 and December 8 http://grants1.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date: Standard NRSA receipt dates of April 8, August 8 and December 8 http://grants1.nih.gov/grants/funding/submissionschedule.htm
Expiration Date:  New Date June 12, 2009 (See NOT-OD-09-106) January 8, 2011

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 Training Objectives

Section II. Award Information
    1. Mechanism 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 and Instructions
    1. Address to Request Application Information
    2. Content and Form of Application Submission
       A. Fellowship Appointments
       B. Budget and Related Issues
    3. Submission Dates
      A. Receipt, 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 and Information

Section V. Application Review Information
  1. Criteria
  2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Resource Sharing Plan(s)
  3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
    1. Award Notices
    2. Administrative and National Policy Requirements
    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 Training Objectives

Background and Objectives

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 DDS/DMD and PhD (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 expand 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 to 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 DDS/DMD and PhD (or equivalent) degrees.  Applicants for the NIDCR PDSF awards must propose to conduct research in areas of high priority to the NIDCR and 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 a scientific field relevant to 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 DDS/DMD degree and to obtain a license to practice dentistry.  A scientific component must be a doctoral (PhD 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 who is an active and established investigator in the area of the applicant's proposed research.  Usually, a sponsor will be the doctoral thesis advisor.  The sponsor must be committed to continue this involvement throughout the individual's total period of development under the award.  A co-sponsor, representing the clinical component, also may be named.  When feasible, women and minority sponsors 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.

Individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds are encouraged to apply for NIH support.

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the Individual Predoctoral National Research Service Awards for DDS/PhD Fellowships (F30) mechanism to provide combined dental school and predoctoral PhD support.  As an applicant, the candidate and his/her sponsor will be jointly 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 NIDCR 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 sponsoring organization has any of the following characteristics:

The sponsoring institution must have staff and facilities available on site to provide a suitable environment for performing high-quality research training.   An applicant must include in the application the name of his/her sponsor who will supervise the training and research experience.

1.B. Eligible Individuals

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

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 sponsor in that scientific discipline when the application is submitted.  The typical applicant will apply during the first or second year of dental school.  However, individuals can apply and begin their PDSF at any point during their training.  Individuals currently enrolled in a joint DDS/DMD-PhD program are eligible for consideration as fellows and encouraged to apply for a PDSF.  Dental students who obtained a PhD prior to entering dental school and desire to pursue another research doctorate are not eligible. 

Individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds: Such individuals are encouraged to apply for NIH grants and may also consider applying to the Ruth L. Kirschstein National Research Service Awards for Individual Predoctoral Fellowships (F31) to Promote Diversity in Health-Related Research (PA-07-106).

2. Cost Sharing or Matching

There is no required cost sharing.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria
 
Duration of Support: Individuals may receive up to six years of aggregate Kirschstein-NRSA support at the predoctoral level, including any combination of support from institutional training grants (T32) and individual fellowship awards (F30). However, it is not possible to have concurrent NRSA support (e.g., F30 and T32). Applicants must consider any prior NRSA predoctoral research training in determining the duration of support requested. Accurate information regarding previous Kirschstein-NRSA support must be included in the application and will be considered at the time of award.

Training beyond the 6-year aggregate limit may be possible under rare and exceptional circumstances, but a waiver from the NIDCR is required. Individuals seeking Kirschstein-NRSA support beyond the sixth year are strongly advised to consult with relevant NIDCR staff before preparing a justification. Any waiver will require a detailed justification of the need for additional research training. Waiver requests should be discussed with the program officer at the NIDCR at least six months prior to the termination date of the fellowship and should be submitted to the program officer prior to the termination date of the fellowship.

Sponsor:  Before submitting a fellowship application, the applicant must identify an individual who will serve as a sponsor (also called sponsor 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

DDS/DMD program at an accredited dental school and accepted in a related scientific PhD program.  The sponsoring institution must be a domestic private or public institution, and must have staff and facilities available on site to provide a suitable environment for performing high-quality research training.

While the sponsoring institution must be domestic, an individual may request support for part of their research training abroad. In such cases, the applicant is required to provide detailed justification for the foreign research training, including the reasons why the facilities, the sponsor, or other aspects of the proposed experience are more appropriate than training in a domestic setting. The justification is evaluated in terms of the scientific advantages of the foreign training as compared to the training available domestically. Foreign research training will be considered for funding only when the scientific advantages are clear.

Section IV. Application Submission Instructions


1. Address to Request Application Information

The PHS 416-1 application is available at http://grants1.nih.gov/grants/funding/416/phs416.htm in an interactive format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

Applications must be prepared using the Ruth L. Kirschstein National Research Service Award Individual Fellowship Application Form (PHS 416-1). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 12 of the face page of the PHS 416-1 form.

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

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 but 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 should 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.

At least three completed, sealed reference letters must be submitted with the application or it may be delayed in review or returned to the applicant without review.

Special Program Requirements, Allowable Costs and related information

A. Fellowship Appointments

All PDSF fellows are required to pursue their DDS/DMD-PhD training program and/or dental training full time basis, devoting at least 40 hours per week to the training program, 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.

PDSF fellows may receive 6 years of aggregate NRSA support at the predoctoral 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) must endorse the request. The request must specify the amount of additional support for which approval is sought.

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 should consult with Institute Program Staff for the latest stipend level.  Alternatively, 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:  The NIDCR will offset the combined cost of tuition and fees at the following rate:  60 percent of the level requested by the applicant institution, up to $21,000 per year for the dual degree program.  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 (includes health insurance):  An allowance of up to $4,200 per predoctoral fellow per twelve month period will be provided to the sponsoring institution to help defray such expenses as health insurance, 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. A full description of the Institutional policy is contained within the NRSA Policy Guidelines on the NIH website at: http://grants.nih.gov/training/nrsa.htm.

Supplementation of Stipends, Compensation, and Other Income: The sponsoring institution is allowed to provide funds to the fellow in addition to the stipend paid by the NHLBI. Such additional amounts either may be in the form of an augmented stipend (supplementation) or in the form of compensation, 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.

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.

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, or as defined by the sponsoring institution in accordance with its own policies. In addition, compensation may not be paid from a research grant supporting the fellow's research training experience.

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

Educational Loans or G.I. Bill: An individual may make use of Federal educational loan funds and assistance under the Veterans Readjustment Benefits Act (G.I. Bill). Such funds are not considered supplementation or compensation.

Facilities and administrative (F&A) costs: F&A costs are not allowed on individual fellowship awards.

3. Submission Dates

Applications must be mailed on or before the receipt date described at http://grants1.nih.gov/grants/funding/submissionschedule.htm.

3.A. Receipt, Review and Anticipated Start Dates

Application Receipt Dates: Standard dates for individual Kirschstein-NRSA applications apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.

Peer Review Date: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.

Institute Second Level Review Dates: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.

Earliest Anticipated Start Date: http://grants.nih.gov/grants/funding/submissionschedule.htm   

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. Following the instructions on page I-31 of the PHS 416-1, submit a signed, typewritten original and one copy of the application (including the Checklist, Personal Data form, at least three, sealed reference letters, and all other required materials 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)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, one additional copy of the application and all copies of the appendix materials must be sent to:

Lynn Mertens King, PhD
Chief, Scientific Review Branch
National Institute of Dental and Craniofacial Research
National Institutes of Health
6701 Democracy Blvd, Rm 662
Bethesda, MD 20892-4878
Courier service zip code 20817

3.C. Application Processing

Applications must be submitted on or before the application receipt dates described above (Section IV.3.A.) and at http://grants1.nih.gov/grants/funding/submissionschedule.htm.

Upon receipt applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.

The NIH will not accept any application in response to this FOA 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.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

These awards are also subject to the NRSA policies (see http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600187).

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

Internal Revenue Code Section 117 applies to the tax treatment of all scholarships and fellowships. The Tax Reform Act of 1986, Public Law 99-514, impacts on the tax liability of all individuals supported under the NRSA program. Under that section, non-degree candidates are required to report as gross income all stipends and any monies paid on their behalf for 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 IRS and Treasury Department released regulations in January 2005 (Revenue Procedure 2005-11) clarifying the student exception to the FICA (Social Security and Medicare) taxes for students employed by a school, college, or university where the student is pursuing a course of study. Our understanding is that these final regulations do not apply to or impact Kirschstein-NRSA programs or awards. An NRSA stipend is provided by the NIH as a subsistence allowance for Kirschstein-NRSA fellows to help defray living expenses during the research training experience. NRSA recipients are not considered employees of the Federal government or the grantee institution for purposes of the award. We must note that the NIH takes no position on the status of a particular payer, nor does it have the authority to dispense tax advice. The interpretation and implementation of the tax laws are the domain of the IRS.

Individuals should consult their local IRS office about the applicability of the tax laws to their situation and for information on their tax obligations.

Future Year Support

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

6. Other Submission Requirements and Information

Part I (Applicant Information)

Item 1.  Title of Research Training Proposal.  Choose a descriptive title that is specifically appropriate.

Item 2.  Level of Fellowship.  Type in “predoctoral”

Item 3. The applicant should identify the number of this Funding Opportunity Announcement (FOA), and type in “NIDCR Individual NRSA Predoctoral Dental Scientist Fellowship (F30)”

Item 5. Training Under Proposed Award. Identify the PhD discipline according to the NIH Lexicon of NRSA disciplines found in the PHS 416-1 instructions.

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

Item 21. Activities Planned Under this Award. Using the chart provided, specify by year the activities (research, course work, etc.) you will be involved in under the proposed award and estimate the percentage of time to be devoted to each activity.

Applicants to this FOA may request up to six years of total NRSA predoctoral support.

Applicant/Fellow Biosketch, Part C. 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 taken recently.

Part II  Sponsor and Co-Sponsor Information

The sponsor must currently be funded to conduct independent research (e.g., Principal Investigator on an R01 or equivalent) and must describe past experience in the guidance of other research trainees and fellows. 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 department’s commitment to and proposed role in guiding the individual applicant and any modifications to the department’s usual PhD requirements that are necessary to facilitate this applicant’s special needs.  Additionally, the quality of the facilities and related resources (e.g., equipment, laboratory space, computer time, available research support, etc.) must be described.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm).

(a) Data Sharing Plan: Not Applicable.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS):  Not Applicable.

Section V. Application Review Information


1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

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 NIDCR on the basis of established PHS referral guidelines.

Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIDCR an in accordance with NIH review procedure (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.  Applications receive two sequential levels of review. The first level is an assessment of the merit of the research training 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. After the SRG meeting, the Scientific Review Officer (SRO), a designated Federal official who coordinates the review of applications for the SRG, prepares a written summary of the review of each application and forwards it to the NIDCR Program Staff. Staff within the NIDCR provides a second level of review. 

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

The following will be considered in making funding decisions:

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 Criteria

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

Resubmission Applications (formerly “revised/amended” applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

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.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate. 

2.B. Additional Review Considerations

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. The plan will be discussed after the overall determination of merit, so that the review panel's evaluation of the plan will not be a factor in the determination of the priority score. The plan will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note of the summary statement. Regardless of the priority score, an application with an unacceptable plan will not be funded until the applicant provides a revised acceptable plan. Staff in the NIH awarding component will judge the acceptability of the revised plan.

No award will be made if an application lacks this component.

2.C. Resource Sharing Plan(s)

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.

3. Anticipated Announcement and Award Dates

Not applicable

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the applicant will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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/archive/grants/policy/nihgps_2003/index.htm

A formal notification in the form of a Notice of Research Fellowship Award (NRFA) will be provided to the applicant organization. The notice of award signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NRFA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NRFA will be mailed to the business official.

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) has been submitted to the NIH. Any costs incurred before receipt of the NGA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
 
2. Administrative 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://grants1.nih.gov/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.htm and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

Service Payback. Recipients of Kirschstein-NRSA F30 awards do not incur service payback.

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 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 NIDCR for an unpaid leave of absence.

Part-time Training. 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 NIDCR 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 fellow 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.

Inventions. Fellowships made primarily for educational purposes are exempted from the PHS invention requirements. F30 awards will not contain any provision giving PHS rights to inventions made by the fellow.

Publication and Sharing of Research Results.  NIH supports the practical application and sharing of outcomes of funded research. Therefore, fellows should make the results and accomplishments of their Kirschstein-NRSA fellowship activities available to the research community and to the public at large. The grantee organization should assist fellows in these activities, including the potential commercialization of inventions. No restrictions should be placed on the publication of results in a timely manner.

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

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.

3. Reporting

Activation Notice: An awardee has up to six months from the issue date on the Notice of Research Fellowship Award to activate the award using the Ruth L. Kirschstein National Research Service Award Individual Fellowship Activation Notice (PHS 416-5) available at http://grants.nih.gov/grants/forms.htm.  The NIDCR 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 authorized institutional official.

Application for Continued Support: The fellow will be required to submit the form PHS 416-9, Continuation of an Individual National Research Service Award, annually (http://grants.nih.gov/grants/forms.htm) as required in the NIH Grants Policy Statement. The report is due two months before the beginning date of the next budget period and must include information related to the current year's progress as well as the plans for the coming year.

Termination Notice: When support ends, the fellow must submit a Termination Notice (PHS 416-7) to the NIH within 30 days following termination. Forms may be found at http://grants.nih.gov/grants/forms.htm

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
Chief, Research Training and Career Development Branch
National Institute of Dental and Craniofacial Research, NIH
6701 Democracy Blvd, Rm 690
Bethesda MD 20892-4878
Phone# 301-594-2765
FAX# 301-402-7033
Email: kevin.hardwick@nih.gov


2. Peer Review Contact:

Lynn Mertens King, PhD
Chief, Scientific Review Branch
National Institute of Dental and Craniofacial Research
6701 Democracy Blvd. Rm 662
Bethesda, MD 20892-4878
Courier service zip code 20817
Telephone: (301) 594-5006
FAX: (301) 480-8303
Email: Lynn.King@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
6701 Democracy Blvd, Rm 656
Bethesda, Maryland 20892
Telephone:  (301) 594-4798
FAX:  (301) 480-3562
Email:  dr258t@nih.gov or rutbergd@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.

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.

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (“NIH Policy for Data and Safety Monitoring,” NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

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://grants1.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/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

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 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 funding opportunity 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.

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.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

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 FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance 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.

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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