Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Drug Abuse (NIDA)

Funding Opportunity Title

NIDA Mentored Clinical Scientists Development Program Award in Drug Abuse and Addiction (K12)

Activity Code

K12 Clinician Scientist Award (Program) (PSA)

Announcement Type

Reissue of PAR-10-177

Related Notices

  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
  • November 27, 2013 (NOT-OD-14-027) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after January 25, 2014. Forms-C applications are required for due dates on or after January 25, 2014.
  • August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.

Funding Opportunity Announcement (FOA) Number

PAR-13-163

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.279

Funding Opportunity Purpose

This funding opportunity announcement (FOA) encourages applications for institutional research career development (K12) programs that propose to support intensive supervised research training and career development experiences for clinician scientists (scholars) leading to research independence in the area of drug abuse and addiction. For this FOA, clinician scientists may include (but are not limited to) physicians, clinical psychologists, epidemiologists, doctoral-level social workers,  pharmacists, and behavioral scientists. Scholars are expected to be supported for 3-5 years on consecutive 12-month appointments. Candidates selected for support as scholars must hold a doctorate and commit a minimum of 9 person-months (equivalent to 75% of full-time professional effort) to conducting clinical research and career development activities associated with the proposed program.

Key Dates
Posted Date

March 28, 2013

Open Date (Earliest Submission Date)

May 12, 2013

Letter of Intent Due Date(s)

May 12, 2013; May 12, 2014; May 12, 2015

Application Due Date(s)

June 12, 2013; June 12, 2014; June 12, 2015, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

September 7, 2013; September 7, 2014; September 7, 2015, by 5:00 PM local time of applicant organization.

Scientific Merit Review

October/November 2013, October/November 2014, and October/November 2015

Advisory Council Review

January 2014, January 2015, and January 2016

Earliest Start Date

April 2014, April 2015, and April 2016

Expiration Date

September 8, 2015

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide including the Supplemental Instructions to the SF424 (R&R) for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


A compatible version of Adobe Reader is required for download. For Assistance downloading this or any Grants.gov application package, please contact Grants.gov Customer Support at http://www07.grants.gov/contactus/contactus.jsp.
Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The overall goal of the NIH Research Career Development programs is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation’s biomedical, behavioral, and clinical needs.  More information about Career programs may be found at the NIH Extramural Training Mechanisms website. This FOA encourages applications from organizations that propose creative and innovative institutional research career development programs in the mission area(s) of the NIH.

Purpose and Background Information

The purpose of the NIDA Mentored Clinical Scientists Development Award in Drug Abuse and Addiction (K12) is to encourage institutions to develop and/or sustain programs that support intensive, mentored research training and career development experiences for clinician scientists (scholars). It is expected that these programs will provide scholars the mentoring, training, and research experiences necessary for research independence in the area of drug abuse and addiction. Each award is intended to support scholars for 3-5 years of consecutive 12-month appointments.

Applications for this award must propose a comprehensive career development and research plan that has: (1) intrinsic research importance in the area of drug abuse and addiction and is within the mission of NIDA, (2) will serve as a suitable vehicle for learning the methodology, theories, and concepts needed for a well-trained, independent clinician researcher in the area of drug abuse and addiction; and (3) will ensure high research productivity. Research areas of interest at NIDA include, but are not limited to: translational research; epidemiology; health services; prevention; treatment; clinical neurosciences; genetics; HIV/AIDS; medical consequences; and pharmacotherapeutic development. The proposed institutional research career development program may complement other, ongoing research training and career development programs at the applicant institution, but the proposed career development experiences must be distinct from those career development programs currently receiving Federal support.

Programs should include both didactic training and supervised research experiences designed to accommodate research candidates with varying levels of experience and at different stages of their career. For example, a scholar with limited experience in a given field of research may find it appropriate to engage in a structured, phased developmental program, including a designated period of didactic training followed by a period of supervised research experience. Although scholars with limited research experience can be appointed to the program, they are expected to be prepared to apply for independent research funding by completion of the program.

Within the framework of this Program’s longstanding commitment to excellence and projected need for investigators in particular areas of research, attention must be given to recruiting scholars from racial or ethnic groups underrepresented in the biomedical, behavioral and clinical sciences, individuals with disabilities, and individuals from disadvantaged backgrounds.

Further, programs are required to appoint an advisory committee to provide oversight of the development, implementation, and evaluation of recruitment strategies, the recruitment and retention of candidates, and the evaluation of the overall effectiveness of the program.  A detailed evaluation plan is also required. For other requirements, see Section III, Eligibility Information.

Clinician scientist is defined in this FOA as an investigator who has a: 1) medical doctorate, public health doctorate, or other doctorate related to human healthcare; and/or an investigator with a 2) research doctorate and either clinical responsibilities or direct interaction with human subjects. Using this definition, clinician scientists may include physicians, clinical psychologists, epidemiologists, social workers, pharmacists, behavioral scientists, etc.

Optional and Special Considerations

Structuring the Program within a consortium of institutions; the use of short-term rotations; or other strategies to enhance the participation and research training experience of scholars are encouraged. Short-term rotations and other options must be designed to fall within the scope of the goals of the proposed K12 program, should take advantage of drug abuse related educational or research experiences not available at the applicant institution, and must be supervised.

Special Considerations:

HIV/AIDS Counseling and Testing Policy for the National Institute on Drug Abuse:  In light of recent significant advances in rapid testing for HIV and in effective treatments for HIV, NIDA has revised its 2001 policy on HIV counseling and testing.  NIDA-funded researchers are strongly encouraged to provide and/or refer research subjects to HIV risk reduction education and education about the benefits of HIV treatment, counseling and testing, referral to treatment, and other appropriate interventions to prevent acquisition and transmission of HIV.  This policy applies to all NIDA funded research conducted domestically or internationally.  For more information seehttp://grants.nih.gov/grants/guide/notice-files/NOT-DA-07-013.html.

National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects: 

The National Advisory Council on Drug Abuse (NACDA) recognizes the importance of research involving the administration of drugs with abuse potential, and dependence or addiction liability, to human subjects.   Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects.  The guidelines are available on NIDA's Web site at  http://www.drugabuse.gov/funding/clinical-research/nacda-guidelines-administration-drugs-to-human-subjects

Points to Consider Regarding Tobacco Industry Funding of NIDA Applicants:

The National Advisory Council on Drug Abuse (NACDA) encourages NIDA and its grantees to consider the points it has set forth with regard to existing or prospective sponsored research agreements with tobacco companies or their related entities and the impact of acceptance of tobacco industry funding on NIDA's credibility and reputation within the scientific community.  Please see (http://www.drugabuse.gov/about-nida/advisory-boards-groups/national-advisory-council-drug-abuse-nacda/council-statements/points-to-consider-regarding-) for details.

Data Harmonization for Substance Abuse and Addiction via the PhenX Toolkit: 

NIDA strongly encourages investigators involved in human-subjects studies to employ a common set of tools and resources that will promote the collection of comparable data across studies and to do so by incorporating the measures from the Core and Specialty collections, which are available in the Substance Abuse and Addiction Collection of the PhenX Toolkit (www.phenxtoolkit.org).  Please see NOT-DA-12-008 (http://grants.nih.gov/grants/guide/notice-files/NOT-DA-12-008.html) for further details.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Renewal
Resubmission
Revision

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Direct costs are limited to $500,000.

Award Project Period

The project period duration may range from 3 to 5 years.

Other Award Budget Information
Personnel Costs

Individuals designing, directing, and implementing the career development program may request salary and fringe benefits appropriate for the person months devoted to the program. It is expected that the Program Director will devote not less than 1 person-months and no more than 2.5 person-months effort to this K12 program. Advisory Committee members cannot be compensated except for travel. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. If mentoring interactions and other activities with scholars are considered a regular part of an individual's academic duties, then mentoring and other interactions with scholars are non-reimbursable from grant funds.

Limited program-related administrative and clerical salary costs associated distinctly with the program that are not normally provided by the applicant organization may be direct charges to the grant only when they are in accordance with applicable cost principles. For institutions covered by OMB Circular A-21, this type of training program may qualify as a “major project” where administrative salaries are allowable as a direct cost. When specifically identified and justified, these expenses must be itemized in Sections A and B, as appropriate, of the R&R Budget.

Participant Scholar Costs

Participant Scholars are those individuals who benefit from the proposed activities and experiences involved in the career development program. Scholar costs must be justified as specifically required for the proposed career development program and based on institutional policies for salaries paid to individuals in similar positions, regardless of the source of funds. These expenses must be itemized in the proposed budget.

NIDA provides K12 scholars with their institutional base annual salary up to a maximum of $90,000 annually. Note that the salary allowance will be commensurate with the actual number of person-months committed to program related activities.  In addition, NIDA will allow for funds up to $50,000 annually per scholar for research-related costs—examples include consultants, supplies, equipment, technical personnel, travel, and statistical services. Short-term rotation costs are included in the allowed $50,000. However, costs allowed for the short-term rotation may not be duplicative. These expenses must be specifically identified, reasonable, and justified.

Other Program Related Expenses
 

Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses may be included in the proposed budget. These expenses must be justified as specifically required by the proposed program and must not duplicate items generally available at the applicant institution. These expenses must be itemized.

The costs of a Research Administrator, Program Coordinator, and/or Program Assistant with responsibilities directly associated with the K12 program may also be requested, but these costs must be justified and salaries must be commensurate with institutional policy for similar positions.

Requests for equipment and supplies may also be made, but these must be reasonable and modest, such as laboratory related expenses that are directly attributable to the scholars' research projects.

Travel expenses up to $1,200 per Advisory Committee member are permitted, to help defray travel costs related to functions and responsibilities associated with the K12 program.

Salaries for support of ancillary personnel; i.e., mentors, Advisory Committee members, PD(s)/PI(s) will not be supported.

Indirect Costs

Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees, consortium costs in excess of $25,000, and expenditures for equipment), rather than on the basis of a negotiated rate agreement.

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

Eligible Organizations

Higher Education Institutions

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

Governments

Other

The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.

In many cases, it is anticipated that the proposed program will complement other ongoing research training, research education, and career development programs occurring at the applicant institution and that a substantial number of program faculty will have active research projects in which participating scholars may gain relevant experiences consistent with their research interests and goals. Institutions with existing K12 programs must explain what distinguishes this program from the others, how their programs will synergize with one another, if applicable, and make it clear that the pool of faculty, potential scholars, and resources are robust enough to support additional programs.

If multiple sites are involved in the institutional career development program, the applicant institution must be one of these sites for the program.  The need for and use of multiple sites must be justified.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her 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.

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.

The PD/PI should be an established clinical researcher or clinician scientist in the area of drug abuse and addiction. The PD/PI may be a basic or other non-clinical researcher on a multiple PD/PI application, as long as at least one PD/PI is a clinical researcher. The PD/PI should further be able to demonstrate a superior record of preparation of postdoctoral clinicians for independent research and high research productivity. The PD/PI must be able to demonstrate access to departmental or other funds for a scholar in the event of a gap in his or her mentor’s research funding. 

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is programmatically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Mentors

Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors. Mentors should have research expertise and experience relevant to the proposed program. Mentors must be committed to continue their involvement throughout the total period of the award.

Each scholar appointed to the program must have a primary mentor. Additional mentors are optional. All proposed mentors should be 1) investigators in the area of drug abuse and addiction, 2) have a successful record of providing the type of career development and training activities required under this award, and 3) have a successful record of engendering his or her scholars’ independence as evidenced by scholars’ research productivity and ability to obtain independent research funding. Proposed mentors should have independent NIH research funding (e.g., R01, R21, P50) or equivalent at the time of the K12 award and be committed to mentoring the scholars throughout their total period of development under the award.

Scholars

Scholars to be supported by the institutional career development program must be clinician scientists (see definition in Section I) and be at the career level for which the planned program is intended. Scholars are expected to devote a minimum of 9 person-months during the appointment on the K12 award.

Each scholar must be assigned a primary mentor (additional mentors, although optional, are encouraged), and the proposed research experience must be designed to provide a strong foundation for applications for independent research funding.

In general, candidates for selection to the program cannot have had a previous mentored career development award. Programs may consider these candidates only when a major change in the field of study has occurred; or when there has been a substantial hiatus in the research career; and the aggregate total of NIH mentored career awards support for the candidate will not exceed 6 years. Prior NIDA Research Training Committee approval is required to appoint an individual with a prior mentored career development award to a NIDA K12 program.

Candidates should also be aware that both during and following appointment to a K12 program, scholars may not submit an application to NIDA for any other mentored NIH career award (K01, K08, K23, K25, K99) without prior approval from NIDA’s Research Training Committee. Since NIDA’s K12 programs are designed to prepare scholars to apply for independent research funding in the substance abuse field, application for NIDA-support for additional career mentoring is strongly discouraged.

In addition, current and former Principal Investigators on NIH research project grants or equivalent non-PHS peer-reviewed research grants over $100,000 direct costs per year are ineligible.

K12 scholars should be strongly encouraged to apply for independent research grant support (e.g., R01, R03) during the award. Scholars in the last two years of career award support may reduce effort on the career award to a minimum of 6 person-months and hold concurrent support from their career award and a competing PHS research grant on which they are Principal Investigator or Subproject Director.

Details on citizenship requirements are available in the NIH Grants Policy Statement.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

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.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

The letter of intent should be sent to: NIDALetterofIntent@mail.nih.gov

Page Limitations

All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

SF424(R&R) Cover

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA).

SF424(R&R) Project/Performance Site Locations

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA).

SF424 (R&R) Other Project Information Component

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA), with the following additional modifications:

Substitute all references to “trainees” in the SF424 (R&R) Application Guide with “scholars” and all references to “training” in the SF424 (R&R) Application Guide with “career development”.

Other Attachments

Project Summary /Abstract. Provide an abstract of the entire application, including the long-term goals and objectives of the program. Include the rationale and design of the program, the planned duration of the program and the projected number of scholars, including their levels (i.e., postdoctoral, faculty).

Advisory Committee. A plan must be provided for the appointment of an Advisory Committee to monitor progress. Composition, responsibilities and desired expertise, frequency of meetings, and other relevant information should be included, as well as a plan for Advisory Committee approval and selection of participants. The Advisory Committee will be responsible for general oversight, guidance, and evaluation of the Program, and should consist of a chair and four or more other members (no more than the corresponding number of scholars on the respective K12 program) appointed by the Program Director(s). Committee members must be: (1) recognized as accomplished investigators in the area of drug abuse and addiction, (2) actively involved in drug abuse related basic or clinical research, (3) have a successful record of providing the type of training required under this award, and (4) have a successful record of engendering scholars’ independence as evidenced by scholars’ research productivity and their ability to obtain independent research funding.  Although members may be either internal or external to the applicant institution, appointment of at least some external members is encouraged. The types of expertise expected for the Advisory Committee should be described. Supplemental duties that may be assigned to the Advisory Committee, at the discretion of the Program Director(s), include: establishing selection criteria for candidates; reviewing education and career development plans (e.g., formal coursework, mentors, and research experiences) and providing interim monitoring and evaluation of each scholar's progress with recommendations for modifications in the plan.

Describe how the Advisory Committee will function in providing oversight of the development, implementation, and evaluation of recruitment strategies, the recruitment and retention of candidates, and the evaluation of the overall effectiveness of the program. Note that proposed Advisory Committee members should not be named in the application, particularly if they include individuals from outside the institution. However, renewal applications with Advisory Committees should include names of existing external advisors. Please name your file “Advisory_Committee.pdf" and include in Other Attachments.

One annual K12 Advisory Committee member meeting is required—additional meetings throughout the year are highly encouraged. Applicants may propose meetings using alternative media rather than face-to-face meetings or some combination, so long as their objectives can be met.

The filename provided for each “Other Attachment” will be the name used for the bookmark in the electronic application in eRA Commons.

SF424(R&R) Senior/Key Person Profile Expanded

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA).

PHS 398 Cover Page Supplement

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA).

PHS 398 Checklist

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA).

PHS 398 Training Subaward Budget Attachment(s) Form

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA).

Research & Related (R&R) Budget Component

Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

PHS 398 Research Training Program Plan

All Supplemental Instructions to the SF424 (R&R) for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application must be followed, with the following additional instructions:

Substitute all references to “trainees” in the SF424 (R&R) Application Guide with “scholars” and all references to “training” in the SF424 (R&R) Application Guide with “career development.”

Institutional Training Data Tables are not required. Any data tables included in the application must be included within the Program Plan section.

Applications lacking an Advisory Committee, recruitment plan, evaluation plan, a description of institutional commitment, or any other required component below will be considered incomplete and will not be reviewed.

Program Plan

Program Administration. Describe the strengths, leadership and administrative skills, and scientific expertise of the Training PD/PI. Include the planned strategy and administrative structure to be used to oversee and monitor the program. For applications with multiple PDs/PIs, address the Leadership Plan and how the combined knowledge, skills and experience of the individual PDs/PIs will enhance the likelihood of success of the program. When a program administrator position is planned, a description of the scientific expertise, leadership, and administrative capabilities essential to coordinate a program for developing investigators must be included in the application.

Program Faculty. Describe in general terms the complementary expertise and experiences of the proposed mentors. Provide an overview of their active research and other scholarly activities, as well as track records of mentoring and training.

Proposed Training. Provide an overview of the proposed program: Describe the immediate and long-term objectives of the program, including activities that will be used to ensure that the objectives of the program are met. Include information about planned courses, curricula, seminars, workshops, or tutorials that will be incorporated into the training program and mentored research experiences and activities. Institutions with existing training or career development programs must explain what distinguishes this program from the others, how the programs will synergize, if applicable, and justify that the faculty, pool of potential trainees, and resources are robust enough to support additional programs. The description should include planned strategies to be used to ensure that the objectives are met. The PD/PI should also describe past research career development activities/experiences including those of mentors, documenting the success of former trainees in establishing independent productive scientific careers.

Short-term rotation or other strategies to enhance the participation and research training experience of scholars, if used, should be well described and justified. Applicants will not need to be able to identify particular scholars, but must describe the selection criteria and process. Applicants should indicate that they will require scholars to present a clear justification of how their specific rotations will serve to gain knowledge and/or experience that will clearly complement their career goals. If the short-term rotation option is included in the proposed program, a Consortium/Contractual Arrangement (PHS 398 Research Plan) must be included in the application for each participating site that is not the applicant site.

Program Evaluation. Describe an evaluation plan to review and determine the effectiveness of the program. This should include plans to obtain feedback from current and former trainees to help identify weaknesses and to provide suggestions for program improvements, as well as plans for assessing trainees’ career development and progression, including metrics such as degree completion (if applicable), publications, and subsequent positions. Specified evaluation metrics should be tied to the goals of the program. Evaluation results should be included in future renewal applications and in the Final Progress Report.

Scholar Candidates. Describe in general terms the pool of potential candidates including information about the types of prior clinical and research training and the expected career level required for the program. Do not name prospective scholars. Describe plans to recruit candidates and explain how these plans will be implemented (see also section on Recruitment and Retention Plan to Enhance Diversity). Describe the evaluation criteria to be used in the selection of scholars. Provide brief summaries of  career development plans that the program will employ. The application should contain a description of how  career development plans will be tailored to the needs of the prospective candidates, taking into account their past experiences and competences.

Institutional Environment and Commitment to the Program. The application must include a statement from the applicant institution describing the commitment to the planned program. The institution must assure that essential time will be allowed for the PD(s)/PI(s), other faculty and mentors, and the required protected time for scholars (9 person months, equivalent to 75% of full-time professional effort) selected for the program. Also describe the research infrastructure, facilities, etc., that are available and accessible to this Program. This includes the existence of funded laboratories and research space and activities that will meet and sustain the needs of the Program.

Recruitment and Retention Plan to Enhance Diversity

Individuals are required to comply with the instructions for Recruitment and Retention Plan to Enhance Diversity as provided in Chapter 8 of the SF424 (R&R) Application Guide. 

Plan for Instruction in the Responsible Conduct of Research

Individuals are required to comply with the instructions for Plan for Instruction in the Responsible Conduct of Research as provided in Chapter 8 of the SF424 (R&R) Application Guide. 

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

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.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

NIDA support beyond the initial five-year project period is not guaranteed and is dependent upon the availability of appropriated funds and success in competition for renewed support. In the event that there is no further support, no phase-out funds will be provided. Thus, the applicant institution must have plans in place to provide continued support to remaining scholars in the event that funding from the NIDA is not available.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of 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 score to reflect their assessment of the likelihood for the program to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific 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.

Career Development Program and Environment

Does the proposed program clearly outline a plan to recruit and develop well-qualified junior investigators for successful careers as biomedical or clinical researchers? Is the research plan appropriate for producing independent clinician researchers in the area of drug abuse and addiction by the end of the project period? Is there evidence of an adequate pool of potential scholars who could benefit from receiving career development support? Are the content and duration of any proposed didactic, training-related, and research-related activities of the program appropriate? Are appropriate timelines indicated for career progression and transition to independence? Does the institutional environment (e.g., research facilities and other relevant resources) in which the program will be conducted contribute to the probability of success? Does the proposed career development program benefit from unique features of the scientific environment, subject populations, or employ useful collaborative arrangements? Is the institutional commitment to the proposed program appropriate? If multiple sites are participating, is this adequately justified in terms of the career development and research experiences provided, and are there plans provided for coordination and communication between the sites? Is there sufficient assurance that the required effort of the PD/PI, mentors and scholars will be devoted directly to the proposed career development and research related activities? Is there adequate documentation describing the responsibilities of the advisory committee with regard to the provision of input, guidance and oversight of the program? Is the required annual meeting of the Advisory Committee adequately described?

Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))

Do the PD/PI and Research Administrator (if applicable), have the experience to develop, direct and administer the proposed program?  Does the leadership team bring complementary and integrated expertise to the program? Especially for multiple PD/PI applications, are the roles and responsibilities of the PDs/PIs designated, and the governance and organizational structure clear and appropriate? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure program objectives? Are the research qualifications, scientific stature, previous leadership and mentoring experience, and track record(s) appropriate for the proposed career development program? Is the PD/PI currently engaged in research relevant to the scientific area of the proposed program?

Mentors

Do the mentors have expertise and experience, as well as track records of past mentoring and training? Are the quality and extent of the mentors’ roles in providing guidance and scientific advice to the scholars acceptable? Are the mentors currently engaged in relevant research and do they have the research funding to support their scholars' research?

Candidates/Scholars

Is a recruitment plan proposed with strategies likely to attract high quality scholar candidates? Are there well-defined and well-justified recruitment and selection strategies? Is there evidence of a sufficiently large, competitive scholar pool to warrant the proposed size of the career development program? Do the scholars demonstrate commitment to developing independent research careers in the relevant areas? Is there an appropriate plan for the content, the phasing, and the proposed duration of the career development plan for achieving scientific independence for the prospective candidates? What is the likelihood that the career development plan will contribute significantly to the scientific development of the scholars? Does the plan for selection of the scholars include all of the eligibility criteria stated in the FOA?

Training Record

Is there evidence of a successful past training record of the PD/PI and mentors, including the success of former scholars in seeking independent support and establishing productive scientific careers? Does the program have a rigorous evaluation plan to assess the quality and effectiveness of the training?     

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.   

Protections for Human Subjects

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.  

Inclusion of Women, Minorities, and Children 

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Vertebrate Animals

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Biohazards

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the committee will consider whether the program has successfully achieved its stated objectives during the prior project period, including on the Recruitment and Retention Plan to Enhance Diversity, and Training in the Responsible Conduct of Research. The committee will also consider whether the program has been adequately evaluated. The results of the evaluation should document a continued need for support for this program. If not completely successful, the committee will also consider any progress. The application should describe the program’s accomplishments over the past funding period(s), and if applicable, propose changes that would improve or strengthen the career development experience. The approach for the next project period should also be responsive to the results of the program’s evaluation. There should be evidence of a successful past training record of the PD/PI and mentors, including the success of former scholars in seeking independent support and establishing productive scientific careers.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

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

Recruitment & Retention Plan to Enhance Diversity

Peer reviewers will separately evaluate the recruitment and retention plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups. The review panel’s evaluation will be included in an administrative note in the summary statement. Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Training in the Responsible Conduct of Research

Taking into account the specific characteristics of the career development program, level of scholar experience, and the particular circumstances of the scholars, the reviewers will address the following questions.  Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework and/or real-time discussion groups?  Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety?  Do the plans adequately describe how faculty will participate in the instruction?  Does the plan meet the minimum requirements for RCR, i.e., eight contact hours of instruction every four years?  Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Select Agent 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).

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIDA, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the NIDA National Advisory Council. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.      

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

The Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) and financial statements as described in the NIH Grants Policy Statement are required annually. Continuation support will not be provided until the required forms are submitted and accepted. Chapter 8 of the SF424 (R&R) Application Guide, Additional Instructions for Preparing a Progress Report for an Institutional Research Training Grant, Including Ruth L. Kirschstein National Research Service Awards, must be followed.

Failure by the grantee institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Other Reporting Requirements

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award as described in the NIH Grants Policy Statement. Evaluation results should be included as part of the final Progress Report.

4. Evaluation

In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Debra Grossman, M.A.
Division of Clinical Neuroscience and Behavioral Research, NIDA
Telephone: (301) 443-2249
Email:dgrossma@mail.nih.gov

Aria Davis Crump, Sc.D.
Division of Epidemiology, Services and Prevention Research, NIDA
Telephone: (301) 443-6504
Email:acrump@nida.nih.gov

Beth Babecki, M.A.
Division of Basic Neurosciences and Behavioral Research, NIDA
Telephone: (301) 435-0899
Email:mb128t@nih.gov

Kevin Walton, Ph.D.
Division of Pharmacotherapies and Medical Consequences of Drug Abuse, NIDA
Telephone: (301) 435-0762
Email:kevin.walton@nih.gov

Mimi M. Ghim, Ph.D.
Office of Science Policy and Communications, NIDA
Telephone: (301) 443-6071
Email:ghimm@nida.nih.gov

Peer Review Contact(s)

Mark Swieter, Ph.D.
Office of Extramural Affairs, NIDA
Telephone: (301) 435-1389
Email: mswieter@nida.nih.gov

Financial/Grants Management Contact(s)

Carol Alderson
Grants Management Branch, NIDA
Telephone: (301) 933-6196
Email:aldersoc@nida.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

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 Part 52 and 45 CFR Parts 74 and 92.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices



NIH Office of Extramural Research Logo
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®



Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.