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 on Deafness and Other Communication Disorders (NIDCD), (http://www.nidcd.nih.gov/)  

Title: National Mentoring Networks to Enhance the Clinician-Investigator Workforce in Deafness and Other Communication Disorders (U24)
  
Announcement Type
New

Request For Applications (RFA) Number: RFA-DC-11-001

Catalog of Federal Domestic Assistance Number(s)
93.173

Key Dates
Release Date:  October 1, 2010
Letters of Intent Receipt Date(s): January 17, 2011
Application Receipt Dates(s): February 17, 2011
Peer Review Date(s): May/June 2011
Council Review Date(s): August 2011
Earliest Anticipated Start Date: September 2011 
Additional Information To Be Available Date (Url Activation Date):
Expiration Date: February 18, 2011

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

• Purpose. This funding opportunity announcement (FOA), issued by the National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH), solicits Resource-Related Research Projects-Cooperative Agreement (U24) applications from institutions/organizations that propose to develop and pilot research mentoring networks for budding clinician-scientists on a national scale.  These networks will recruit and nurture promising clinically-trained individuals seeking to establish an independent research trajectory in deafness and other communication disorders within their careers, but requiring ongoing mentorship to achieve this goal.  This nurturance will be achieved through matching these protégés to highly qualified, committed research mentors and facilitating ongoing contact between the mentors and protégés.
• Mechanism of Support. This FOA will utilize the NIH Resource-Related Research Projects- Cooperative Agreement (U24) award mechanism.
• Funds Available and Anticipated Number of Awards. The NIDCD expects to award up to $1.125 million for this funding opportunity in FY11, for up to three awards.
• Budget and Project Period.  The total project period for an application submitted in response to this funding opportunity may not exceed three years.  Direct costs are limited to $400,000 over a three-year project period, with a limit of $250,000 in direct costs allowed for Year One.
• Application Research Strategy Length: The U24 Research Strategy section may not exceed 12 pages, including tables, graphs, figures, diagrams, and charts.  See http://grants1.nih.gov/grants/funding/funding_program.htm,
• Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.
• Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
• Number of PDs/PIs. More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application.
• Number of Applications. Applicants may submit more than one application, provided they are scientifically distinct.
• Resubmissions. Resubmission applications are not permitted in response to this FOA.  
• Renewals. Renewal applications are not permitted in response to this FOA.   
• Special Date(s). This FOA uses non-standard due dates. See Receipt, Review and Anticipated Start Dates
• Application Materials. See Section IV.1 for application materials.
  Hearing Impaired.  Telecommunications for the hearing impaired are available at: TTY: (301) 451-5936

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
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. Dispute Resolution 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

This FOA, issued by the National Institute on Deafness and Other Communication Disorders (NIDCD), solicits Resource-Related Research Projects-Cooperative Agreement (U24) applications from institutions/organizations that propose to develop and pilot new national mentoring networks to: 1) increase the numbers of physician and non-physician clinician-scientists in the NIDCD research career development pipeline; and 2) facilitate the research career development of the most promising such individuals as active, independent clinician-investigators in hearing, balance, smell, taste, voice, speech and language.

Background

The NIDCD recognizes the compelling need to recruit clinically trained individuals into its research enterprise to facilitate translation of fundamental scientific discoveries and clinical observations within its scientific mission bi-directionally between “bench and bedside.”

Scientific mentorship is widely recognized as an important factor for the development of an independent research career.  A systematic review of the literature on the role of mentoring in the development of careers in academic medicine reveals that individuals  who had a mentor allocated more time to research and were more likely to complete research projects, publish their results, and win grant support than their unmentored counterparts [Sambunjak, et al., JAMA, 2006: 296(9): 1103-1115].  Indeed, the absence of effective mentoring is often cited as a critical barrier for career success.  Clinically-trained individuals seeking to develop a research career trajectory in tandem with the refinement of their clinical skills face formidable challenges during the formative years of their careers, at a time when they are heavily tasked with clinical, teaching and administrative responsibilities. Their success is critically dependent upon effective scientific and career-building mentorship in addition to other factors (e.g., a supportive departmental chair and departmental culture, successful clinician-scientist role models within their institutions). 

In practice, however, practitioners in the primary clinical disciplines managing communication disorders, i.e., otolaryngologists, speech-language pathologists, and audiologists, often have difficulty identifying qualified and available research mentors and clinician-scientist role models.  Uncertainties about the viability of the clinician-scientist career track in the short- and long-terms (e.g., prospects for winning research grant funding), sizeable educational debt, and a desire to strike a favorable balance between work and personal life/family demands further challenge the recruitment of new clinician-investigators into the biomedical and behavioral research pipelines.  It has long been the case that clinicians comprise a very modest percentage of the overall portfolio of NIDCD-funded investigators.  Hence, there would be significant value in establishing research mentoring networks on a national scale to aid in the career development of clinician-scientists in the NIDCD scientific mission areas.

The critical role of mentoring in research on human communication has been discussed at numerous NIDCD-sponsored workshops and conferences over the years. Specifically, the concept of research mentoring networks has been discussed with and endorsed by representatives of several professional and voluntary societies [e.g., Triological Society, Association for Chemoreception Sciences, American Speech-Language-Hearing Association] serving both clinical and non-clinical disciplines associated with the NIDCD scientific mission.  However, without the direction and fiscal support of the NIDCD, sustainable national research mentoring networks for clinically-trained individuals focused on communication disorders are unlikely to materialize.

Access to a national network of skilled mentors, who have proven records of scientific accomplishment and independent NIH research support, is envisioned to substantively assist budding clinician-scientists achieve their career goal of forging an independent research trajectory.  A national mentoring network can help protégés achieve this goal through facilitating the achievement of landmarks, including, but not limited to: 1) expanding their concepts on what a clinician-investigator can and should become; 2) forging an appropriate research agenda; 3) crafting and winning competitive NIH research grants; 4) establishing and managing a research laboratory;  5) overcoming specific technical stumbling blocks in their research efforts; 6) identifying and networking with potential research collaborators and established investigators, and forging fruitful collaborations; 7) facilitating successful transitions from one career stage to another (e.g., from clinical fellowship training to a tenure-track faculty position), including academic tenure and promotion; 8) effectively balancing professional and personal life demands; and, 9) facilitating leadership development.

Scope

Each mentoring network will focus its efforts either on one specific clinical discipline/health profession (e.g., otolaryngology, audiology) relating to the NIDCD scientific mission, or on one or more scientific mission areas (e.g., voice research, balance research) of the Institute.  In the latter case, prospective protégés may be sought from diverse clinical disciplines.  The mentoring enterprise will focus upon prospective protégés from the postgraduate clinical training stage through the tenured academic faculty career stages (or the equivalents in  non-academic research institutions) keenly interested in integrating an independent research track in fundamental, translational or patient-oriented research in deafness and other communication disorders into their career trajectories, but requiring ongoing mentorship to accomplish this goal.  Specifically, the target group of protégés shall focus primarily on those budding clinician-investigators not yet prepared to craft, or have been unsuccessful in submitting, a competitive mentored clinician-scientist research career development (K-) award or an NIDCD Small Grant (R03) application, but may include practicing clinicians at the midcareer stage no longer eligible or appropriate for these programs, but keenly interested in research career mentoring.  Mentoring networks may propose to include individuals from a single career stage or may propose to bridge several career stages, but should provide a rationale for the career stage(s) of focus.  The scope of mentorship shall encompass both scientific and non-scientific domains, and can include: didactic directed study; laboratory-based research experiences; counseling on career planning/building, laboratory-building and management, grantwriting, balancing life/work demands, etc., as appropriate to the individual protégé, and involve both formal and informal interactions between mentors and protégés.  While an in-person component to the mentoring process is required, applicants are encouraged to consider incorporating contemporary communication modalities, such as social networking, into their project plans, as appropriate.  The overall objective of the national networks mentoring process will be to nurture clinically trained individuals to become independent investigators competitive for NIH research funding in hearing, balance, smell, taste, voice, speech or language.

The structure and constituents of the proposed mentoring network plan should be well-reasoned and appropriately grounded in: 1) experience with the research training and career development of clinically trained professionals; 2) pedagogic theory; and, 3) the social science literature on mentoring.  These networks shall incorporate the database and personnel infrastructure to identify prospective protégés and mentors, forge meaningful mentoring relationships (protégé-mentor “match-making”) and facilitate ongoing contact between mentors and protégés through providing travel funds for face-to-face meetings, when needed, and for the compensation of mentors for their professional effort.

This FOA is intended to facilitate the development of new mentoring networks within the scientific spectrum of the NIDCD research mission, and not as a support vehicle for  existing mentoring networks serving a broader range of scientific domains and/or professional disciplines.  Applications proposing to support  existing national mentoring networks, as currently configured, will be deemed non-responsive and will not be reviewed.  Adaptations of existing mentoring network programs (e.g., the addition of unique components) to meet the goals and requirements of this initiative may be considered responsive to this FOA.

Applications responding to this FOA shall incorporate the following specific program objectives and tasks:

• Develop the physical and/or virtual, leadership and administrative infrastructure for the national mentoring network;
• Develop the content and tools (e.g., information technology tools, protégé and mentor databases, educational/training materials) to serve the goals of the mentoring network;
• Formulate recruitment plans for identifying: 1) a sufficient number of promising clinically-trained protégés; and, 2) qualified, outstanding clinician and non-clinician researchers who commit to serve as the research and career planning mentors for these budding clinician-scientists;
• Develop a plan for: 1) matching protégés to appropriate mentors on a national scale, 2) facilitating contact between both parties, 3) formulating a customized career development plan for each protégé, and, 4) guiding the preparation and pre-submission review of research project and career development  grant applications;
• Follow-up with protégés to ensure their mentorship needs have been met;
• Identify a set of outcome measures to assess whether the program has achieved its goals;
• Pilot the network and maintain its mentor/protégé database;
• Evaluate the network’s effectiveness to date and its future promise and needs; and
• Develop a plan for the continued management and utilization of the network (beyond the funding period) through potential non-Federal sources of support.

It is expected that applicants will propose innovative and feasible strategies for recruiting a pool of potential protégés to participate in the mentoring network.  The pool of recruited  mentors should adequately represent the breadth of the scientific field(s) of focus, and should be diverse with respect to gender, race and ethnicity.  In addition to scientific appropriateness, the mentor-protégé matching process should carefully consider issues of gender, race and ethnic diversity.  The mentoring network is intended to operate on a national scale, and not to target one institution, a consortium of institutions or a specific geographic region.  Protégés will generally be matched to one or more mentor(s) beyond their home institutions and, often, beyond their local region.

A customized research career development plan shall be developed jointly by the mentor-protégé team for each protégé.  This plan shall stipulate specific goals and a timetable for the achievement of each benchmark, and the mentor-protégé team shall regularly evaluate the protégé’s progress towards achieving these benchmarks.  The career development plan should consider the institutional and departmental expectations from the protégés, in addition to their scientific and research-related goals.   Furthermore, a plan shall be developed to evaluate the performance of each mentor actively engaged in mentoring through the network.

An applicant organization may wish to partner with other organizations, whether research institutions or professional and voluntary societies, to develop and build the national mentoring network.

It is expected that the prototype network will be fully developed in Year One and piloted in Years Two and Three of the project period.  Furthermore, an evaluation of the national mentoring network shall be conducted in Year Three.

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

Section II. Award Information

1. Mechanism of Support

This funding opportunity will use the Resource-Related Research Projects-Cooperative Agreement (U24) award mechanism(s). The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see https://grants.nih.gov/grants/funding/phs398/phs398.html). 

This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".  Plans concerning continuation of the cooperative agreement projects beyond the original period of award, conversion of these to grants or contracts, and reissuance of this FOA are yet undetermined by the NIDCD.

2. Funds Available

The estimated amount of funds available for support of up to three projects awarded as a result of this announcement is $1,125,000 for fiscal year 2011. Direct costs are limited to $400,000 per award across a three-year project period, with a limit of $250,000 in direct costs allowed for Year One. Future year amounts will depend on annual appropriations.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the 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.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education
• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Small Businesses
• For-Profit Organizations (Other than Small Businesses)
• State Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribally Designated Organizations
• County Governments
• City or Township Governments
• Special District Governments
• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• U.S. Territory or Possession
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Regional Organizations
• Other(s):
  • Eligible Agencies of the Federal Government
  • Faith-based or Community-based Organizations.

1.B. Eligible Individuals

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

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a “team science” approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at https://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application.  Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see https://grants.nih.gov/grants/multi_pi.

The PI/PD must be actively engaged in research that is relevant to the mission of the NIDCD and have a track record of research and/or career planning/building mentorship of clinician-scientists.  Given the skills, knowledge, and resources necessary to conceptualize, design and pilot a national mentoring network, multiple PDs/PIs (see above) may be appropriate.  If multiple PDs/PIs are designated on the applicaton, then at least one of these individuals should meet the aforementioned expectation.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may submit more than one application, provided they are scientifically distinct.

Resubmissions.  Resubmission applications are not permitted in response to this FOA. 

Renewals.  Renewal applications are not permitted in response to this FOA.

Responsiveness Criteria.  Applications must follow the supplementary instructions provided in Section IV.6.  Applications must have a section describing quantifiable milestones.

 The sponsoring institution/organization must provide evidence of commitment to and support of the proposed program, e.g., by providing resources such as facilities, staff and faculty time, and computer services necessary for the development of the proposed program.  Applications lacking quantifiable milestones or institutional commitment will be considered non-responsive and will not be reviewed.

Section IV. Application and Submission Information

1.Address to Request Application Information

The current PHS 398 application instructions are available at https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.

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

2.Content and Form of Application Submission

Prepare all applications using the PHS 398 application forms and in accordance with the PHS 398 Application Guide (https://grants.nih.gov/grants/funding/phs398/phs398.html).

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

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs

When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a – 3h for all PD/PIs. NIH requires one PD/PI be designated as the “contact PD/PI” for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the “Contact PD/PI, et. al.” The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the section of the Research Plan entitled, “Multiple PD/PI Leadership Plan”, must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators. 

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award (NoA).

Additional information is available in the PHS 398 grant application instructions.

3. Submission Dates and Times

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

3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date(s): January 17, 2011
Application Receipt Date(s): February 17, 2011
Peer Review Date(s): May/June 2011
Council Review Date(s): August 2011
Earliest Anticipated Start Date(s): September 2011

3.A.1. Letter of Intent

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

• Descriptive title of proposed research
• Name, address, and telephone number of the Principal Investigator
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Daniel A. Sklare, Ph.D.
Division of Scientific Programs
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, MSC-7180
Executive Plaza South, Room 400C
Bethesda, MD 20892
Telephone: (301) 496-1804
FAX: (301) 402-6251
Email: sklared@nidcd.nih.gov  

3.B. Sending an Application to the NIH  

Applications must be prepared using the forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

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

At the time of submission, two additional copies of the application and all copies of the appendix material (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html) must be sent to:

Melissa J. Stick, Ph.D., M.P.H.
Scientific Review Branch
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, MSC-7180
Executive Plaza South, 400C
Bethesda, MD 20892
Telephone: (301) 496-8683
FAX: (301) 402-6250
Email: melissa_stick@nih.gov  

3.C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed.  Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute. Incomplete and/or non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

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 NIH Grants Policy Statement.   

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement https://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)
 
6. Other Submission Requirements

Awardees must agree to the “Cooperative Agreement Terms and Conditions of Award” in Section VI.2.A,  “Award Administration Information.”

Supplementary Application Instructions

PHS398 Research Plan Sections

All application instructions outlined in the PHS398 Application Instructions are to be followed, with the following additional requirements:

• Specific Aims is limited to 1 page.
• Research Strategy, including tables, graphs, figures, diagrams, and charts is limited to 12 pages. See Table of Page Limits.

Biographical Sketch. For the PI(s)/PD(s), include any mentoring awards and honors and any research resource and database construction and management experience in the Biographical Sketch.  For all key personnel, provide the following information on each individual’s mentoring track record: the total number of individuals at the predoctoral, postdoctoral and early career level mentored to dates; and the details on the most recent 10 proteges (protégé’s name, degree(s), career stages, inclusive dates when the protégés was mentored, and the protégé’s current position and institutional affiliation.

Specific Aims. (1 page) In addition to the instructions accompanying the PHS 398 form, describe the overall goals and measurable objectives that the applicant institution/organization intends to accomplish through the proposed program.

Research Strategy (12 pages)

Significance. In addition to the instructions accomplanying the PHS 398 form, explain how the proposed project will develop an infrastructure that has the potential to launch/forge and sustain an effective and vibrant national mentoring network for enhancing the clinician-scientist workforce in the NIDCD scientific mission.

Innovation. In addition to the instructions accompanying the PHS 398 form, describe how the network will incorporate novel features, such as novel communication formats to encourage and enhance interactions between participants (e.g., protégé’s and mentors).

Approach. In addition to other unique elements appropriate for the particular application, include the following components:

1. Objective and rationale for proposed mentoring network.  Provide a concentual overview of the proposed network, including the rationale and pedagogic, social scientific and database engineering principles underlying its design and content.  Describe the vision for the proposed project and how it will leverage existing resources and programs, and partner with and complement other efforts, including NIDCD-supported institutional training programs, as applicable.  Provide programmatic detail on the structure of the network, including its format(s), planned content areas, components, and tools, as applicable.  Describe the criteria and process by which mentors and protégés will be identified and matched, and how mentor-protégé relationships will be forged, monitored and assessed.

2. Adminstrative structure involving PDs/PIs and advisory committee (if applicable). Describe the PDs/PIs’ commitment to developing and implementing the proposed network.  Provide evidence the PDs/PIs and their team (if applicable) have the requisite skills to develop, coordinate and administer a national mentoring network for budding clinician-scientists that is based on sound pedagogic and mentoring principles.

3. Mentors. Describe the projected number of mentors who will participate in the mentoring network and their requisite qualifications.  Do not name specific individuals, but provide descriptive detail.  Describe the planned recruitment process for mentors, as well as eligibility, selection, evaluation, and removal/dismissal criteria.  Describe the mentors’ responsibilities.

4. Proteges. Describe the pool from which from which protégés will be recruited (including its anticipated size and qualifications) and criteria for protégé eligibility and selection.  Describe strategies that will be used to outreach and disseminate information on the mentoring network to this pool, recruitment strategies, and retention strategies.  Describe planned methods for reviewing the protégés’ progress and for identifying and addressing any challenges and problems.

5. Timeline. Provide a timeline for the development, piloting and implementation of the mentoring network, including projected, concrete milestones.  Outline an evaluation plan to assess the performance of the mentoring network and needed improvements to it.

Budget

This FOA uses non-modular budget formats described in the PHS 398 application instructions (see https://grants.nih.gov/grants/funding/phs398/phs398.html). 

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See https://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance 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 should be explained in Resource Sharing section of the application. See https://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(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): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible.  A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition.  For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and https://grants.nih.gov/grants/gwas/.

Section V. Application Review Information

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

2. Review and Selection Process

Review Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIDCD and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

• Undergo a selection process in which only those applications deemed to have the highest scientific and technical merit, generally the top half of applications under review, will be discussed and assigned an impact/priority score.
• Receive a written critique.
• Receive a second level of review by the National Deafness and Other Communication Disorders Advisory Council.

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability.  As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system. 

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the project proposed). 

Scored Review Criteria

Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each.  An application does not need to be strong in all categories to be judged likely to have major scientific impact.  For example, a project that by its nature is not innovative may be essential to advance a field.

Significance.  Does the project address an important problem or a critical barrier to progress in the field?  If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?  How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? To what extent will implementation of the proposed program advance the objectives of this funding opportunity announcement?

Investigator(s).  Are the PD/PIs, collaborators, and other researchers well suited to the project?  If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training?  If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?  If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Is the PD/PI’s time commitment sufficient to achieve the stated goals? Does the leadership team collectively have the requisite scientific, administrative, information technology development and management expertise and experience to develop and pilot the proposed national mentoring network?

Innovation.  Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?  Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense?  Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Does the application propose an innovative approach to recruiting, mentoring and nurturing budding clinician-scientists in the NIDCD scientific mission areas?  Does the overall strategy leverage current knowledge and experience in the research career development of clinician scientists, contemporary communication methods and other innovative tools?  Does the program leverage and expand upon (but not duplicate) existing ongoing research career mentoring programs and resources directed to the target pool within the Nation?

Approach.  Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  Are potential problems, alternative strategies, and benchmarks for success presented?   If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Is the overall strategy based on sound pedagogic principles, appropriate consideration of the professional training and roles and career stage(s) of the protégés, and appropriate consideration of creating a national mentoring network infrastructure?  Is the scientific focus and/or target protégé pool well-defined, well-justified and likely compatible with the development of a successful mentoring network?

Environment.  Will the scientific environment in which the work will be done contribute to the probability of success?  Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?  Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Are the institutional or multi-institutional resources and infrastructure available appropriate to identify, recruit and match the pools of potential mentors and protégés?

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Mentors.  Are plans in place that suggest the feasibility of recruiting sufficient numbers of mentors with appropriate research and mentoring expertise to support the type, number and career level of clinically-trained protégés proposed in the application?  Are the criteria for mentors, including eligibility, recruitment, retention and expections for their participation sufficiently detailed and appropriate to support the proposed mentoring program?

Proteges. Are plans in place that suggest the feasibility of recruiting sufficient numbers of the clinically-trained protégés at the desired career stage who have keen research interests in deafness and other communication disorders and a commitment to forge a clinician-scientist career trajectory?  Are the criteria for protégés, including eligibility, recruitment, retention, and expectations for their participation sufficiently detailed, appropriate and rigorous to support the proposed mentoring program?

Milestones.  Are appropriate milestones provided for the design, implementation and evaluation of the prototype mentoring network?  Is the plan feasible and appropriate for implementation of the mentoring network?  Is an appropriate plan proposed for the generation and regular review of customized milestones and benchmarks for the protégés?

 Partnerships and Collaborations. Are there adequate plans for ensuring effective communication and coordination among the PDs/PIs, NIDCD project coordinator/program officers, and other members of the leadership team?  Are the nature and extent of the partnerships explained? Is there appropriate evidence of commitment by the key partners to planning and implementation of the proposed mentoring network?  Where partnerships are proposed, are there plans to monitor their effectiveness?

Protections for Human Subjects.  For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects  and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.  For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children.  When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.  For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals.  The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information, see https://grants.nih.gov/grants/olaw/VASchecklist.pdf.

Biohazards.  Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmission Applications. Resubmissions are not applicable to this FOA.

Renewal Applications. Renewals are not applicable to this FOA.

Revision Applications. Revisions are not applicable to this FOA.

Additional Review Considerations

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations. Foreign organizations are not allowed for this FOA.

Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans.  Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:  1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

Budget and Period Support.  Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Selection Process

The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by peer review
• Availability of funds
• Relevance of the proposed project to program priorities  

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 PD/PI 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.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (https://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 (https://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).  

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

2. A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for: defining objectives and approaches and for planning and conducting the proposed research.  S/he will assume responsibility and accountability to the applicant organization and to the NIDCD for performance and proper conduct of all supported research, in accordance with the Terms and Conditions of Award.  The PD(s)/PI(s) will be a member of the leadership team.  

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

2. A.2. NIH Responsibilities
 
An NIH Project Coordinator will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

The NIDCD Project Coordinator interacts scientifically with the leadership team and may provide appropriate assistance, including assisting in research planning, suggesting possible content and tools within the scope of the Program’s objectives and activities, presenting experimental findings from published sources, participating in the design of the mentoring network, pariticpating in recruitment and evaluation activities, participating in the analysis of results, and advising in management and technical performance.  The NIDCD Project Coordinator will be a member of the leadership team.  In all cases, the role of the NIDCD will be to assist and facilitate, and not to direct activities.

The Project Coordinator can recommend that information concerning NIDCD-funded/sponsored research training and career development programs be made available to the leadership team.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.  The assigned program director may also serve as the NIH Project Coordinator.

2.A.3. Collaborative Responsibilities

A leadership team composed of the PD(s)/PI(s), key co-investigator(s), NIDCD Project Coordinator, and NIDCD Program Official (if different from from the Project Scientist) will be established in each program and assist in monitoring and developing the content and direction of the program.  The leadership team will meet periodically to review progress, establish priorities, and plan and design activities.  The frequency of meetings, not fewer than three per year, will be determined by the PD/PI, who will be responsible for scheduling and for preparing concise minutes, which will be delivered to the leadership team members within 30 days of the meeting.  Virtual meetings may be appropriate.

The principal end-products are expected to include: 1) an effective administrative structure fo a national mentoring network; 2) effective strategies for recruiting qualified mentors and protégés to the network and for their retention as members of the network; and 3) development of appropriate content and tools, as applicable.  

2.A.4. Dispute Resolution Process
 
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

The progress report is expected to describe the development and efforts to pilot the proposed mentoring network, modifications from the originally proposed conceptualization, details about the applicant pool and mentor pool, and the success of efforts to meet the targeted milestones during each year of the award.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Daniel A. Sklare, Ph.D.
Division of Scientific Programs
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Room 400C
6120 Executive Boulevard, MSC-7180
Bethesda, MD 20892
Telephone: (301) 496-1804
FAX: (301) 402-6251
Email: sklared@nidcd.nih.gov  

2. Peer Review Contacts:

Melissa J. Stick, Ph.D., M.P.H.
Scientific Review Branch
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Room 400C
6120 Executive Boulevard, MSC-7180
Bethesda, MD 20892
Telephone: (301) 496-8683
FAX: (301) 402-6250
Email: melissa_stick@nih.gov  

3. Financial or Grants Management Contacts:

Christopher Myers
Chief, Grants Management Branch
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Room 400C
6120 Executive Boulevard, MSC-7180
Bethesda, MD 20892
Telephone: (301) 402-0909
FAX: (301) 402-1758
Email: myersc@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 (https://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (https://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

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

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

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (https://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see https://grants.nih.gov/grants/gwas/.

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 https://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.

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

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (https://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 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  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 https://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. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for 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 at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at https://grants.nih.gov/grants/policy/policy.htm.

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

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