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 Drug Abuse (NIDA), (http://www.nida.nih.gov)

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

Announcement Type
This Funding Opportunity Announcement (FOA) is a reissue of PAR-07-346.

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

• March 28, 2013 - This PAR has been reissued as PAR-13-163.
• June 8, 2012 - See Notice NOT-DA-12-015. NIDA will terminate PAR-10-177 on September 8, 2012 and will release a new K12 FOA with a once per year receipt date.
• January 7, 2011 - See Notice NOT-DA-11-004 The purpose of this Notice is to clarify the use of T32 Data Tables for applications.
• September 29, 2010 (NOT-OD-11-008) - Updated Electronic Application Forms Required for F, K, T and D Submissions with Due Dates of January 25, 2011 and Beyond. Adobe B1 forms are required for due dates on or after January 25, 2011.
• August 16, 2010 - IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Program Announcement (PA) Number: PAR-10-177

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF 424 Research and Related (R&R) forms and the SF 424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.279

Key Dates
Release/Posted Date: April 27, 2010
Opening Date: May 12, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): A letter of intent is not required
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due Dates(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission/Receipt Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information to Be Available Date (URL Activation Date): Not Applicable
Expiration/Closing Date: (New Date September 8, 2012 per NOT-DA-12-015), Original Date May 8, 2013

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

• Purpose: The goal of NIH-supported career development programs is to help ensure that a diverse pool of highly trained scientists is available in adequate numbers and in appropriate research areas to address the Nation’s biomedical, behavioral, and clinical research needs. 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. Candidates selected for support as scholars must hold a clinical or research doctorate and can commit a minimum of 9 person-months (equivalent to 75% of full-time professional effort) conducting clinical research and career development activities associated with the proposed program.
• Mechanism of Support: This FOA will use the NIH Institutional Research Career Development K12 grant mechanism. K12 programs may not be transferred from one institution to another. (See section VI.2.)
• Funds Available and Anticipated Number of Awards: 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. The total amount awarded and the number of awards will depend upon the mechanism numbers, quality, duration, and costs of the applications received.
• Budget and Project Period: Direct costs are limited to $500,000. The project period duration for this funding opportunity may range from 3 to 5 years.
• Application Institutional Career Development Plan Component Page Length: Items 2-5 (Background, Career Development Program Plan [uploaded using Program Plan], Recruitment and Retention Plan to Enhance Diversity, and Plan for Instruction in the Responsible Conduct of Research) are limited to a combined total of 25 pages, including tables, graphs, figures, diagrams, and charts (see Section 8 of the SF424 (R&R) Application Guide)
• 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 institutional research career development career development program 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. Program directors should be established clinical-researchers in the area of drug abuse and addiction with acknowledged accomplishments in research training, scientific expertise, leadership, and administrative skills. For exceptions, see section III.
• Number of PDs/PIs: More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application.
• Number of Applications: Applicant organizations may submit more than one application, provided each application is scientifically distinct.
• Resubmissions: Applicant may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).
• Renewals: Renewal applications are allowed for this institutional research career development program
• Application Materials: See Section IV.1 for application materials.
  General Information: For general information on SF424 (R&R) Application and Electronic Submission, see these Web sites:
  • SF424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm
  • General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/
• 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. Institutional Research Career Development Program Objectives

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

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

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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Institutional Career Development Program Objectives

Purpose and Background Information

The goal of NIH-supported career development programs is to help ensure that a diverse pool of highly trained scientists is available in adequate numbers and in appropriate research areas to address the Nation’s biomedical, behavioral, and clinical research needs. 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 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. 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 provide for comprehensive career development and research training in research designs and methodologies in the area of drug abuse and addiction, including 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, scholars are expected to be prepared to apply for independent research funding by completion of the program.

Clinical research is defined in this FOA as: 1) Patient-oriented research, which is research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. This research includes: (a) mechanisms of human disease, (b) therapeutic interventions; (c) clinical trials, and (d) development of new technologies; 2) Epidemiologic and behavioral studies; 3) Outcomes research and health services research. Using this definition, clinical research areas of interest at NIDA in drug abuse and addiction include, but are not limited to: epidemiology; health services; prevention; treatment; clinical neurosciences; genetics; and medical consequences of drug abuse, including HIV/AIDS.

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.

In particular, short-term rotations (2 to 3 months in duration at a given institution) must be supervised, and should be designed to take advantage of drug abuse related educational or research experiences not available at the applicant institution, complementing the training and experiences occurring at the applicant institution. Applicants will not need to be able to identify particular scholars, but must describe the selection criteria and process. In addition, applicants should indicate their plans to direct scholars they will appoint to short-term rotations to describe the purpose, goals and activities of each short-term rotation. They should also indicate that they will require scholars to present a clear justification that they will serve to gain knowledge and/or experience that will clearly complement his or her career goals. The application should indicate how the Program will evaluate the pertinence of this or other structural components, and also how success in meeting these goals will be monitored and measured. If the short-term rotation option is included in the proposed program, a Resource Format page (PHS 398) must be included in the application for each participating site.

HIV/AIDS Counseling and Testing Policy for the National Institute on Drug Abuse: Researchers funded by NIDA who are conducting research in community outreach settings, clinical, hospital settings, or clinical laboratories and have ongoing contact with clients at risk for HIV infection, are strongly encouraged to provide HIV risk reduction education and counseling. HIV counseling should include offering HIV testing available on-site or by referral to other HIV testing service for persons at risk for HIV infection including injecting drug users, crack cocaine users, and sexually active drug users and their sexual partners. For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html.

National Advisory Council on Drug Abuse (NACDA) Recommended Guidelines: The NACDA has developed guidelines that focus on unique challenges that arise in conducting substance abuse and addiction research. Potential applicants are highly encouraged to obtain and review these recommendations if the Program scholars, mentors, or any other participants will be conducting research involving: 1) administration of drugs to human subjects or 2) children and adolescents. The guidelines are available on NIDA’s Home Page at www.drugabuse.gov by following the Funding hyperlink to Clinical Research: Information, Policies & Guidance.

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

Section II. Award Information

1. Mechanism of Support

This FOA will use the NIH Institutional Research Career Development (K12) award mechanism. The PDs/PIs (if multiple PD/PI option is used) will be solely responsible for planning, directing, and executing the proposed institutional career development program.

This FOA uses just-in-time information concepts (see SF424 (R&R) Application Guide). It also uses the non-modular budget format. Applicants must complete and submit detailed categorical budget requests using the SF24 Research and Related (R&R) Budget Component found in the application package for this FOA.

Institutional career development grant support is renewable. Institutional career development grant support is for new and renewal (formerly competing continuation ) applications. It is recommended that applicants contact the scientific/research contact listed in Section VII concerning the submission of a renewal (formerly competing continuation ) application. Only one resubmission (formerly revision/amendments ) of a previously reviewed grant application may be submitted. See NOT-OD-09-003, NOT-OD-09-016

2. Funds Available

Because the nature and scope of the proposed institutional career development program 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 NIDA provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

The total project period for an application submitted in response to this funding opportunity may not exceed 5 years. Although the size of award may vary with the scope of the institutional research career development program proposed, it is expected that applications will stay within $500,000 of direct costs annually.

Facilities and Administrative (F&A) costs requested by consortium participants, if applicable, are not included in the direct cost limitation. See NOT-OD-05-004.

Allowable Costs

Allowable costs must be consistent with NIH policy and be reasonable, allocable, well documented and fully justified for the institutional career development program proposed in the application. Grant funds may not be used to supplant funds otherwise available at the applicant institution. Note that instructions for completing the budget information in the SF 424 (R&R) application, using the Research & Related (R&R) budget, are included in Section IV, Selecting the Appropriate Budget Component.

Personnel: Individuals designing, directing, and implementing the career development program may request salary and fringe benefits appropriate for the person months devoted to the program. 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 specifically identified and justified. These expenses must be itemized in Sections A and B, as appropriate, of the R&R Budget.

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 (see Other Program-Related Expenses below).

Program Administration Costs: If applicable and justified, the costs of a Research Administrator, Program Coordinator, and/or program assistant with responsibilities directly associated with the institutional career development program can be requested, and salaries must be commensurate with institutional policy for similar positions, and specifically identified and justified. When applicable, this expense must be itemized in Section A or B, as appropriate.

Costs for staff assistance cannot exceed a total of 12 person-months effort when combined.

Other Program-Related Expenses: Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses must be justified as specifically required by the proposed program and must not duplicate items generally available for similar programs at the applicant institution. These expenses must be itemized in Sections C, D, and F, as appropriate.

Requests for equipment and supplies must be for reasonable, modest laboratory related expenses that are directly attributable to the scholars research projects. Requests for travel expenses can include up to $1,200 per Advisory Committee member to help defray travel costs for the required annual meeting.

Scholar Costs: 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 Section B (scholar salaries) and F (other program-related expenses) as appropriate.

NIDA provides a salary for K12 scholars of up to 100% of the individual’s 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 (percent effort). In addition, NIDA will allow for funds up to $50,000 annually 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 duplicate any costs/benefits allowed for the salaried scholars in the K12 program. These expenses must be specifically identified, reasonable, and justified. Expenses for foreign travel must be exceptionally well justified.

Items that may NOT be supported with K12 funds include: Salaries for support of ancillary personnel, i.e. mentors, Advisory Committee members, secretarial, and administrative assistance, etc.

Facilities and Administrative (F&A) Costs: F&A costs for the applicant organization and consortium participants will be reimbursed at 8 percent of modified total direct costs (excluding tuition, fees, and equipment).

NIH Grants Policy: 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 institutions/organizations are eligible to apply:

• Public/State Controlled Institution of Higher Education
• Private Institution 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
• Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
• Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education)
• For-Profit Organization (Other than Small Business)
• U.S. Territory or Possession

Foreign institutions are not eligible to apply in response to this FOA.

In many cases, it is anticipated that the proposed institutional research career development program will complement other ongoing research training and career development programs occurring at the applicant institution and that a substantial number of program faculty will have active research projects in which participants may gain relevant experiences consistent with their research interests and goals.

Institutions with existing K12 or other training 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.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed career development program 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 support.

The PD/PI should be a clinical researcher. The PD/PI may be a basic or other non-clinical researcher on a multiple PD/PI application, as long as the proposed curriculum (and associated program, if applicable) is translational in nature and at least one PD/PI is a clinical researcher. The PD/PI should be established in the area of drug abuse and addiction, with a documented record of superior accomplishment, scientific expertise, leadership, and administrative skills. The PD/PI should have experience in the design, implementation, and management of drug abuse related research training and/or career development programs for developing clinical investigators, and must 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.

The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required. (See Section VI.3. Reporting. )

More than one PD/PI (i.e., 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 and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (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 grant 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 the multiple PD/PI option, 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 http://grants.nih.gov/grants/multi_pi.

For background information on the Multiple PD/PI initiative, see http://grants.nih.gov/grants/multi_pi/index.htm.

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

Applications lacking an Advisory Committee, recruitment plan, evaluation plan, or a description of institutional commitment will be considered incomplete and will not be reviewed. An acceptable plan for training in the responsible conduct of research is required prior to award.

Sponsoring Institution: The sponsoring institution must assure support for the proposed institutional career development program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and relevant resources that can contribute to the planned program. Applicant institutions must also guarantee the required protected time for the scholars selected for support. The application must include a letter explaining the institutional commitment to the proposed institutional research career development program (see Section IV.6, item 14).

Scholars: Individuals to be supported by the institutional career development program must be at the career level for which the planned program is intended. Scholars are expected to devote a minimum of 9 person-months (75% of full-time professional effort) during the appointment on the K12 award.

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 significant change in the field of study has occurred; or when there has been a significant hiatus in the research career; and the aggregate total of NIH mentored career awards support for the candidate will not exceed 6 years, Please see Notice DA-06-013 for instructions on obtaining NIDA-approval prior to appointment of these candidates. 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.

Each scholar must be assigned a primary mentor (additional mentors are optional), and the proposed research experience must be designed to provide a strong foundation for applications for independent research funding. K12 scholars should be strongly encouraged to apply for independent research grant support (e.g. R01, R21, 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 (50% effort) and hold concurrent support from their career award and a competing NIH research grant on which they are Principal Investigator or Subproject Director.

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 (http://grants.nih.gov/grants/guide/notice-files/NOT-DA-06-013.html). 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.

Scholar Citizenship and Residency Requirement: Only U.S. citizens or non-citizen nationals, or individuals lawfully admitted for permanent residence who have a currently valid Permanent Resident Card (USCIS Form I-551), or some other verification of legal admission as a permanent resident prior to admission into the K12 program, are eligible for scholar support from this program. Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually persons born in lands that are not states but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible.

Mentors: Mentors will interact closely with the scholar, and should have research expertise and experience relevant to the proposed career development program. Mentors must be committed to continue their involvement throughout the total period of the scholar s career development under this award. Describe the eligibility criteria and responsibilities of program mentors.

Each scholar appointed to the program must have a primary mentor. Additional mentors are optional. All proposed mentors must be 1) recognized as accomplished investigators in the area of drug abuse and addiction, 2) actively involved in drug abuse related clinical research, 3) have a successful record of providing the type of career development and training activities required under this award, and 4) 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 must 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.

Advisory Committee:

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. However, 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.

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.

Number of Applications: Applicant organizations may submit more than one application, provided each application is scientifically distinct.

Resubmissions: Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement).Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications are permitted only a single amendment (A1). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Original new and competing renewal applications that were submitted prior to January 25, 2009 are permitted two amendments (A1 and A2). For these grandfathered applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.

Renewals: Renewal applications are allowed for this institutional research career development (K12) program.

Section IV. Application and Submission Information

To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the Apply for Grant Electronically button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

Registration:

Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered on-time (see 3.C.1 for more information about on-time submission).

A one-time registration is required for institutions/organizations at both:

• Grants.gov (http://www.grants.gov/applicants/get_registered.jsp) and
• eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm)

PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Registered

• Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov registration process.
• If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.
• The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.
• Direct questions regarding Grants.gov registration to:
  Grants.gov Customer Support
  Contact Center Phone: 800-518-4726
  Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
  Email [email protected]

2) Organizational/Institutional Registration in the eRA Commons

• To find out if an organization is already Commons-registered, see the "List of Grantee Organizations Registered in NIH eRA Commons.
• Direct questions regarding the Commons registration to:
  eRA Commons Help Desk
  Phone: 301-402-7469 or 866-504-9552 (Toll Free)
  TTY: 301-451-5939
  Business hours M-F 7:00 a.m. 8:00 p.m. Eastern Time
  Email [email protected]

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

• The individual(s) designated as PDs/PIs on the application must be registered also in the NIH eRA Commons. In the case of multiple PDs/PIs, all PDs/PIs must be registered and be assigned the PI role in the eRA Commons prior to the submission of the application.
• Each PD/PI must hold a PD/PI account in the Commons. Applicants should not share a Commons account for both an Authorized Organization Representative/Signing Official (AOR/SO) role and a PD/PI role; however, if they have both a PD/PI role and an Internet Assisted Review (IAR) role, both roles should exist under one Commons account.
• When multiple PDs/PIs are proposed, all PDs/PIs at the applicant organization must be affiliated with that organization. PDs/PIs located at another institution need not be affiliated with the applicant organization, but must be affiliated with their own organization to be able to access the Commons.
• This registration/affiliation must be done by the AOR/SO or his/her designee who is already registered in the Commons.

Both the PDs/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo -- Telephone 301-710-0267, Email: [email protected].

Telecommunications for the hearing impaired: TTY: (301) 451-5936

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Training Program Plan Component (for Institutional Research Career Development Program)
PHS398 Checklist
SF 424 Research & Related Budget (R&R)

Optional Components:
PHS398 Cover Letter

Research and Related Subaward Budget Attachment(s) Form

Applications with Multiple PDs/PIs

When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

Information for the Contact PD/PI should be entered on the SF424(R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the research training program plan section, 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. A single Contact PD/PI must be designated for the purpose of communicating with the NIH, although other individuals may contact the NIH on behalf of the Contact PD/PI when necessary.

If budget allocation is planned, the distribution of resources to specific components of the program 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.

Applications Involving a Single Institution

When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

Application Involving Multiple Institutions

When multiple institutions are involved, one institution must be designated as the prime institution, and funding for the other institutions(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Budget Sub-award Budget Attachments(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the sub-award budget form.

Evaluation Plan

The application must describe an evaluation plan to review and determine the quality and effectiveness of the career development program. This should include plans to obtain feedback from current and former scholars to help identify weaknesses in the program and to provide suggestions for program improvements, as well as plans for assessing scholars career development and progression, including publications, and subsequent positions. Evaluation results should be included in future renewal applications and as part of the Final Progress Report.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review and Anticipated Start Dates
Opening Date: May 12, 2010 (Earliest date an application may be submitted to Grants.gov).
Application Due Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward

3.A.1. Letter of Intent

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

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

3.C. Application Processing

3.C.1. Submitting On-Time

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed.

All applications must meet the following criteria to be considered on-time :

• All registrations must be complete prior to the submission deadline
• The application must receive a Grants.gov tracking number and timestamp (or eRA help desk ticket confirming a system issue preventing submission) by 5:00 p.m. local time on the submission deadline date.
• Any system identified errors/warnings must be corrected and the submission process completed within the error correction window.

Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

Submission to Grants.gov is not the last step applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

3.C.2. Two Day Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.

Please note that the following caveats apply:

• Initial application submission must be on-time.
• The AOR/institutions is expected to enforce that application changes made within the error correction window are restricted to those necessary to address system-identified errors/warnings. NIH may reject any application that includes additional changes.
• Proof of on-time submission (e.g., Grants.gov timestamp and tracking number) and description of all changes made within the window must be documented in the PHS 398 Cover Letter component of the application.

3.C.3. Viewing an Application in the eRA Commons

Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.

• If everything is acceptable, no further action is necessary. The application will automatically move forward to the Division of Receipt and Referral in the Center for Scientific Review for processing after two weekdays, excluding Federal holidays.
• Prior to the submission deadline, the AOR/SO can Reject the assembled application and submit a changed/corrected application within the two-day viewing window. This option should be used if it is determined that some part of the application was lost or did not transfer correctly during the submission process, the AOR/SO will have the option to Reject the application and submit a Changed/Corrected application. In these cases, please contact the eRA Help Desk to ensure that the issues are addressed and corrected. Once rejected, applicants should follow the instructions for correcting errors in Section 2.12 of the SF 424 (R&R) application guide, including the requirement for cover letters on late applications. The Reject feature should also be used if you determine that warnings are applicable to your application and need to be addressed now. Remember, warnings do not stop further application processing. If an application submission results in warnings (but no errors), it will automatically move forward after two week days if no action is taken. Some warnings need to be addressed later in the process.
• If the two-day window falls after the submission deadline, the AOR/SO will have the option to Reject the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or didn t transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue.
• If the AOR/SO chooses to Reject the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted, but it will be subject to the NIH late policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment.
• Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two week days.

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

There will be an acknowledgement of receipt of applications from Grants.gov and the Commonshttps://commons.era.nih.gov/commons/. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the application status in the Commons.

The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

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.

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 or renewal award if such costs: are necessary to conduct the project, and 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 or renewal 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 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

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD(s)/PI(s) to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

PHS 398 Research Training Program Plan Component Sections

Page limitations of the Research Career Development Program Plan (uploaded using the PHS398 Research Training Program Plan) component must be followed as outlined in the SF424 (R&R) Application Guide, Section 8, Supplemental Instructions for the Institutional NRSA Application.

• The Introduction (required for a resubmission application) is limited to 3 pages.
• The Introduction (required for a revision application) is limited to 1 page.
• Items 2-5 (Background, Program Plan, Recruitment and Retention Plan to Enhance Diversity, and Plan for Instruction I the Responsible Conduct of Research) of the (Research Career Development Program Plan (uploaded using the PHS398 Research Training Program Plan) application may not exceed 25 pages, including tables, graphs, figures, diagrams, and charts.
• While each Item 2-5 needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Items 2-5 as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. When validating for page limits, the eRA Commons will not count the white space created by breaking the text into separate files for uploading.

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, with the following requirements for K12 applications:

• Introduction to Application (Item 1): (for Resubmission or Revision only): same as instructed in 8.7.
• Background (Item 2): Provide the rationale for the proposed program, relevant background history, and the need for the career development program proposed. Indicate how the proposed program will foster the research careers of selected individuals. Summarize the research career development activities of the major participating unit(s) and department(s) represented in the proposed program. Include the names and roles of participating faculty members planned to contribute to the program.
• Program Plan (Item 3): Include the following sections: Program Administration, Program Faculty, Proposed Career Development Program, Program Evaluation, Candidates/Scholars, and Institutional Environment and Commitment to the Program.
• Program Administration (Item 3): Describe the acknowledged strengths, leadership and administrative skills, and scientific expertise of the PD/PI. Include active research and the planned strategy to be used to oversee and monitor the program. The PD/PI must further 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. For applications with multiple PDs/PI(s), 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. A plan must also be provided for the appointment of an Advisory Committee to monitor the progress of the Scholars. For details, see Research and Related Other Project Information Component, Item 12, below.
• Program Faculty (Item 3): Describe the complementary expertise and experiences of the proposed mentors for the scholars. Include active research and other scholarly activities in which the mentors are engaged, as well as their funding histories and commitments to mentoring.
• Proposed Career Development Program (Item 3): Provide an overview of the proposed program: Describe the immediate and long-term objectives of the program, including strategies and career development activities that will be used to ensure that the objectives of the FOA are met. Include information about planned courses, curricula, seminars, workshops, or tutorials which will be incorporated into the career development program and mentored research experiences and activities. Institutions with existing K12 or other institutional career development training programs must explain what distinguishes this proposal from the others, how the programs will synergize, if applicable, and make it clear that the faculty, potential scholars, 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, such as bidirectional monitoring, multiple levels of mentoring, and well-defined policies and expectations for scholars. The PD/PI should also describe past research career development activities/experiences including those of mentors, documenting the success of former scholars in seeking independent research funding and establishing independent productive scientific careers.
• Program Evaluation (Item 3): Describe an evaluation plan to review and determine the effectiveness of the program. This should include plans to obtain feedback from current and former scholars to help identify weaknesses and to provide suggestions for program improvements, as well as plans for assessing scholars career development and progression including degree completion (if applicable), publications, and subsequent positions. Evaluation results should be included in future competing continuation (renewal) applications and as part of the Final Progress Report. If short-term rotations are being proposed, then the program evaluation plan should include measures to evaluate the effectiveness of these short-term rotations.
• Candidates/Scholars (Item 3): Describe in general terms the pool of potential candidates including information about the types of prior clinical and research training and career level required for the program. Do not name prospective Scholars. Describe the criteria to be used for candidate evaluation in the selection of Scholars. Describe plans to recruit candidates, including those from economically, socially, or culturally disadvantaged backgrounds, individuals with disabilities or from racial or ethnic groups that are currently underrepresented in biomedical, behavioral, or clinical sciences and explain how these plans will be implemented. Provide brief summaries of career development plans that the Program will employ. The application should contain a description of how the career development plan will be tailored to the needs of the prospective scholar candidates, taking into account their past experiences and competences, and should distinguish the plan from fellowship training. The appointment of Scholars should be documented by a Statement of Appointment Form (Form 2271) and submitted to the funding IC.
• Institutional Environment and Commitment to the Program (Item 3): 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. Provide information establishing the commitment of the applicant institution, the Project Director/Principal Investigator (PD/PI), the Research Administrator, if any, and the faculty mentors to providing developmental experiences that lead to independence in biomedical, behavioral, and/or clinical research relevant to the mission of the NIDA. 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 PDs/PIs, other faculty and mentors, and the required protected time for scholars (9 person months, equivalent to 75%) selected for the program. The sponsoring institution should also have a well-established record of success in developing independent clinical investigators, and have a track record of collaborations inside the institution(s) proposed.
• Recruitment and Retention Plan to Enhance Diversity (Item 4): The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation’s capacity to address and eliminate health disparities.

Accordingly the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis. The NIH is particularly interested in encouraging the recruitment and retention of the following classes of candidates:

A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see http://www.nsf.gov/statistics/nsf07308/content.cfm?pub_id=3633&id=3). In addition, it is recognized that under-representation can vary from setting to setting and individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program.

B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.

C. Individuals from disadvantaged backgrounds who are defined as:

1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at HHS - Poverty Guidelines, Research, and Measurement. For individuals from low income backgrounds, the institution must be able to demonstrate that such candidates have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professional Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.

2. Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.

Recruitment and retention plans related to a disadvantaged background (C1 and C2) are most applicable to high school and perhaps undergraduate candidates, but would be more difficult to justify for individuals beyond that level of achievement. Under extraordinary circumstances the PHS may, at its discretion, consider an individual beyond the undergraduate level to be from a disadvantaged background. Such decisions will be made on a case-by-case basis, based on appropriate documentation.

Competing continuation and non-competing applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period. Information must be included on successful and unsuccessful recruitment strategies including aggregate information on the distribution of:

• Scholars who applied for admission or positions within the department(s)/programs(s) relative to the career development program,
• Scholars who were offered admission to or a position within the department(s)/program(s),
• Scholars actually enrolled in the academic program relevant to the career development program,
• Scholars who were appointed to the research career development program.

For those Scholars who were enrolled in the career development program, the report should include information about the duration of research career development and whether those Scholars finished their training in good standing.

This Program Announcement requires all applicants to submit a recruitment and retention plan to enhance diversity (see SF424, Section 8.7. Research Training Program Plan Components, Item 4, Recruitment and Retention to Enhance Diversity). Additional information on the required Recruitment and Retention Plan to Enhance Diversity is available at Frequently Asked Questions Recruitment and Retention Plan to Enhance Diversity (Diversity FAQs).

• Instruction in the Responsible Conduct of Research (Item 5): For detailed guidance on Instruction in Responsible Conduct of Research, please refer to NOT-OD-10-019. Every scholar supported by this training grant must receive instruction in the responsible conduct of research. Describe the plan to provide scholars with such instruction. The plan must address five components: format; subject matter; faculty participation; duration of instruction; and frequency of instruction. Renewal (Type 2) applications must, in addition, describe changes in formal instruction over the past project period and plans for the future that address any weaknesses in the current instruction plan. All training faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period must be named in the application.
• Applications lacking a plan for instruction in the responsible conduct of research will be considered incomplete and will not be reviewed.
• Progress Report (Item 6): For renewal applications only, provide brief summaries of the overall career development program that has been successful in preparing scholars for careers as independent investigators. Include information on the career outcomes of all scholars who have entered your program over the course of the award. Include measures of success consistent with the nature and duration of the training period, and additional information helpful in evaluating the impact of your program.
• Select Agent Research (Item 9): If participating faculty proposed in the career development program are conducting or plan to conduct research involving select agents in which scholars may participate, follow the instructions in SF424, Section 5.5, and include information in PHS398 Research Training Program Plan, Item 9, Select Agent Research.
• Multiple PD/PI Leadership Plan (Item 10): If multiple PD/PIs are proposed, explain in the Program Plan your rationale for how this will facilitate program administration.
• Letters of Support (Item 14): Provide the sponsoring institution’s letter of commitment and support (see Section III.3.)
• Appendix (Item 15): Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).Do not use the Appendix to circumvent the page limitations of the Research Career Development Plan component. An application that does not comply with the required page limitations may be delayed in the review process.

SF424 R&R Cover Component

• Item 8. Type of Application: Unless stated in the applicable FOA, institutional K12 awards are usually renewable. Therefore, the applicant should generally check new or renewal. PDs/PIs should check the specific FOA to determine the types of applications that will be accepted.
• Item 12. Proposed Project (Start and Ending Dates): The requested period of support is usually five years for K12 programs.
• Item 14. Project Director/Principal Investigator (PD/PI) Contact Information: Provide the name of the PD/PI who will direct the institutional program. The PD/PI is the individual who is responsible for providing the scientific and administrative leadership in the development and implementation of the proposed program.

Project/Performance Site Locations Component

Indicate where the career development program described in the Research and Career Development Plans will be conducted. Include collaborating sites, if appropriate.

If multiple sites are involved in the institutional career development program, the applicant institution must be one of these sites for the program. A justification must be included for sites other than the applicant institution in the program narrative.

Research and Related (R&R) Other Project Information Component

• Item 7. Project Summary/Abstract: (Do not exceed 1 page): Provide an abstract of the entire application, including the long-term goals and objectives of the program, key elements of the career development plan, and brief descriptions of planned research projects. Include the rationale and design of the program, the planned duration and projected number of scholars, including their levels (i.e., predoctoral, postdoctoral, faculty).
• Item 8. Project Narrative: Using no more than two or three sentences, describe the relevance of this institutional career development program to public health. In this section, use plain language that can be understood by a general, lay audience.
• Item 9. Bibliography & References Cited: This item should be used only to cite reference supporting the need, rationale, and approach for the institutional career development program described in the PHS 398 Research Training Program Plan. Note that the Literature Cited section is captured in this section (unlike the placement in the PHS 398). Do not include lists of publications of project directors, mentors and scholars in this section, as this information will be included in the biosketches.
• Item 10. Facilities & Other Resources: Describe in an attachment the institutional environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program.
• Item 12. Other Attachments: Advisory Committee: A plan must be provided for the appointment of an Advisory Committee to monitor the progress of the Scholars. Composition, responsibilities, frequency of meetings, and other relevant information should be included. Describe the composition of the Advisory Committee, identifying the role and the desired expertise of members. A plan for Advisory Committee approval and selection of Scholars should be included. 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 career development program. Letters of support from potential Advisory Committee members are encouraged. In addition, provide details of the required annual meeting of the Advisory Committee and any additional meetings.

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 must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

Data Sharing Plan: Not Applicable.

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.

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 http://grants.nih.gov/grants/gwas/.

The proposed sharing plan, after negotiation with the applicant when necessary, will be made a condition of the award. Evaluation of annual non-competing progress reports will include assessment of the dissemination practice by the grantee. The adequacy of the resources sharing plan and will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., Reporting.

Senior/Key Person Profile(s) Component

The PD/PI: The PD/PI must be registered in the eRA Commons and be assigned the PI role within the Commons. Follow the instructions in Part I.2 which provides information regarding required registration in the eRA Commons.

Key Personnel must include the PD/PI (or multiple PDs/PIs,) as well as any other key persons,involved in developing, implementing, directing, monitoring, evaluating, etc., who are integral to and have key roles in the proposed institutional research career development program.

See Section 4.5 of the Grants.gov Application Guide SF424 (R&R)

Complete the Profile for the PD/PI according to instructions in Section 4.5 of the Grants.gov Application Guide SF424 (R&R).

Multiple-Program Directors may be proposed only if the FOA to which you are responding indicated the multiple PD/PIs will be accepted. If multiple PD/PIs are proposed, explain in the Program Plan your rationale for how this will facilitate program administration. If your application involves Multiple PD/PIs, follow the directions in Section 4.5 to designate the Contact PI and to assign the PD/PI role to other Senior/Key Persons. Additionally, the application must include a Multi-PD/PI Leadership Plan.

Complete the Profiles for Other Senior/Key Persons according to instructions in Section 4.5 of the Grants.gov Application Guide SF424 (R&R)

The PD/PI, applicable faculty and any other individuals whose contributions are critical to the development, management and execution of the Institutional Career Development Program Plan in a substantive, measurable way (whether or not salaries are reimbursed) should be identified as Senior/Key Persons. These would include the multiple PDs/PIs, if applicable, and other program staff. Since these efforts are not project related research endeavors, they should not be identified in Other Support information.

Other Personnel: See R&R Budget Component Research & Related Budget, Item B below.

Budget Component

Institutional Research Career Development Program applications will use the non-modular budget format (Research & Related Budget component) and "Just-in-Time" concepts. See Sections II and Section IV for budgetary guidance. Instructions for completing the R&R Budget Component are provided below. Information regarding allowable costs is provided in the specific FOA. The R&R Budget component includes three separate data entry screens (1) Sections A and B; (2) Sections C through E; and (3) Sections F through K. Applicants must complete a separate detailed budget for each year of support requested.

R&R Budget Component Research & Related Budget: Complete for each budget period requested.

A. Senior/Key Person: complete for all senior/key persons associated with the institutional career development program. The PD/PI (or multiple PDs/PIs) must be included here.

B. Other Personnel: complete for all other personnel (including clerical and program administrative staff) associated with the institutional career development program. Include here the salary costs proposed for the planned scholars, identifying as the Project Role Scholar .

C. Equipment: self-explanatory.

D. Travel: include here any travel funds requested for senior/key persons and other personnel (i.e. those persons identified in Sections A. and B.) associated with the program.

E. Participant/Trainee Support Costs: Do not complete this budget category (does not apply to K12 programs).

F. Other Direct Costs: Include the funds requested for research development costs allowed for the scholars in the program, using lines 8-10 (when necessary), and itemize as appropriate and allowed for institutional career development program.

G. Indirect Costs: Indirect costs are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees and expenditures for equipment) rather than on the basis of a negotiated rate agreement.

K. Budget Justification: provide a detailed justification for each category for which funds are requested. For Section F, itemize each category of support costs per scholar and justify. Provide an explanation for all scholar research and development costs in the Budget Justification.

Although many of the sections of this application are separate PDF attachments, page limitations referenced in the instructions and/or funding opportunity announcement must still be followed. Agency validations will include checks for page limits (and use of appropriate font). Some accommodation will be made for sections that, when combined, must fit within a specified limitation.

Text attachments should be generated using word processing software and then converted to PDF using PDF generating software. Avoid scanning text attachments to convert to PDF since that causes problems for the agency handling the application. In addition, be sure to save files with descriptive file names.

When attaching a PDF document to the actual forms, please note you are attaching an actual document, not just pointing to the location of an externally stored document. Therefore, if you revise the document after it has been attached, you must delete the previous attachment and then reattach the revised document to the application form. Use the View Attachment button to determine if the correct version has been attached.

Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year

Applicants requesting $500,000 or more in direct costs for any year (excluding consortium F&A costs) must carry out the following steps:

1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as plans are being developed for the study;

2) Obtain agreement from the IC staff that the IC will accept the application for consideration for award; and,

3) Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the application.

This policy applies to all new, renewal, revision, or resubmission applications. See NOT-OD-02-004.

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

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.

Review Process

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

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

• Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned an overall impact/priority score;
• Receive a written critique; and
• Receive a second level of review by the NIDA national advisory council.

The goals of NIH-supported research training, education, and career development programs are to help ensure that a diverse pool of highly trained scientists is available in adequate numbers and in appropriate scientific areas to address the Nation s biomedical, behavioral, and clinical research needs.

The NIH K12 grant mechanism is a specialized mechanism designed to foster the development of biomedical, behavioral, and clinical researchers through creative and innovative institutional career development programs.

Overall Impact: Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the institutional research career development program to exert a sustained, powerful influence on the activities involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the proposed program).

Scored Review Criteria: Reviewers will consider each of the five 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. For example, a project that by its nature is not innovative may be essential to advance a field.

Career Development Program Plan and Environment:

• Does the proposed program clearly outline a plan to recruit and develop well-qualified new investigators in an area relevant to the objectives of the FOA?
• Is the career development plan likely to contribute significantly to the scientific development of the scholars?
• How will implementation of the proposed program advance the objectives of this funding opportunity announcement?
• Is there evidence of an adequate pool of potential scholars who could benefit from receiving career development support?
• Does the career development plan seem appropriate to promote the professional development of the scholars?
• 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 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 there evidence of appropriate collaboration among participating programs, departments, and institutions?
• 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?
• Are adequate plans provided for coordination and communication between multiple sites (if appropriate)? Is there sufficient assurance that the required effort of the PD/PI, mentors and scholars will be devoted directly to the research training, career development, and related activities?
• When applicable, is there adequate documentation describing the responsibilities of the advisory committee with regard to the provision of input, guidance and oversight of the program?
• Does the background information for advisory committee members indicate the relevance to the program plan for career development?
• Are adequate research facilities and relevant resources being made available for the planned program?
• For programs submitting competing renewal applications, what is the quality, overall impact, and effectiveness of their program in developing new independent investigators?
• For institutions with other K12 programs, what is the effectiveness of the plan to keep the career development activities of the proposed program distinct from that offered by the other K12 Programs?
• Is the required annual meeting of the advisory committee adequately described?

Program Director(s)/Principal Investigator(s) (PD/PIs):

• 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?
• 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 records appropriate for the proposed career development program?
• Are the PD(s)/PI(s) currently engaged in research relevant to the scientific area of the proposed program?
• Does the PD/PI(s) demonstrate access to departmental or other funds for a scholar in the event of a gap in his or her mentor’s research funding?

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 mentor s roles in providing guidance and scientific advice to the scholars acceptable?
• Are the mentors currently engaged in relevant research?
• Do the mentors have strong records as substance abuse researchers, including successful competition for research support in areas directly related to the proposed program?

Candidates/Scholars:

• What is the quality of plans to identify, recruit, and select candidates, with a commitment to research relevant to the mission of the FOA, and the potential to develop as independent researchers?
• 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?
• How useful is the research plan as a vehicle for ensuring research training for all Scholars as described in the career development plan?
• What is the likelihood that the career development plan will contribute significantly to the scientific development of the scholars?
• Does the program include a plan to recruit, identify, and select candidates with a commitment to research relevant to the objectives of the FOA?
• Does the program description include a plan to recruit a diverse group of scholars locally and nationally?
• 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?
• For Renewal applications: Has the program been adequately evaluated and has the level of success been satisfactory? Do the results of the evaluation document a continued need for support for this program? Is the approach for the next project period responsive to the results of the program s evaluation?

Additional Review Criteria

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

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.

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.

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 http://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: When reviewing a Resubmission application (formerly called an amended application), 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 program.

Renewal Applications: When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period. In addition, the committee will consider the following:

• Has the career development program successfully achieved its stated objectives during the prior project period?
• Has the research career development program successfully recruited a diverse pool of scholars (if applicable)? Has the PD/PI effectively shaped the recruitment plan in response to recruitment outcomes?
• Has the program been innovative in the past and does it continue to demonstrate innovation?

Additional Review Considerations

As applicable for the program 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.

Diversity Recruitment and Retention Plan: Peer reviewers will separately evaluate the diversity recruitment and retention plan after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds.

Training in the Responsible Conduct of Research: Reviewers will evaluate plans for instruction in responsible conduct of research as well as the past record of instruction in responsible conduct of research, where applicable. Reviewers will specifically address five Instructional Components, Format, Subject Matter, Faculty Participation, Duration and Frequency, taking into account the characteristics of institutional programs, detailed in NOT-OD-10-019. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE. Applications with unacceptable plans will not be funded until the applicant provides an acceptable, revised plan.

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:

When relevant, reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:

• Data Sharing Plan: (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm)
• Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html)
• Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html

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 institutional career development program and the number of proposed scholars.

Selection Process

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

• Scientific merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed Institutional Career Development Program 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 NIH 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.

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

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 NIDA to the grantee business official.

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

Termination of Award: When a grantee institution plans to terminate an award, program and grants management staff at the NIH funding component must be notified in writing as soon as possible.

Change of Institution: The institutional career development program may not be transferred from one institution to another.

Change of Program: Awards are made for a specific program under the guidance and leadership of a particular PD/PI. A change in any of these parameters requires prior approval by the responsible program officer in the NIH funding component. A rationale must be provided for any proposed changes in the aims of the original, peer-reviewed program. If the new program does not satisfy this requirement, the award will be terminated.

Change of PD/PI: If change of the PD/PI is necessary, support of the award is not automatic but may be continued with prior written approval by the NIH funding component, provided that the following conditions are met. The current PD/PI or the grantee institution must submit a written request for the change, signed by the appropriate institutional business official, to the responsible program and grants management staff of the NIH funding component that describes the reasons for the change. The Biographical Sketch of the proposed PD/PI, including a complete listing of active research grant support, must be provided. The information in the request must establish that the goals of the original peer-reviewed institutional career development program will remain unchanged under the direction of the new PD/PI and that the new PD/PI has the appropriate research and administrative expertise to lead the program. This request must be submitted sufficiently in advance of the requested effective date to allow the necessary time for review.

3. Reporting

Complete applications with detailed budgets and progress reports are required annually.

When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

The Progress Report should provide information on the development and implementation of the proposed career development program (including training and education in the responsible conduct of research), any modifications to the career development program as originally proposed, details about the applicant pool and the participating scholars including their career level(s), gender, and racial/ethnic backgrounds (if applicable), updates on the evaluation of the program, and a list of any publications and/or other materials arising from the program.

This report should provide information about changes in the Program, a summary of any ongoing evaluation results , a summary report from the Program Advisory Committee (including information about newly selected candidates, if applicable), and a description of the research and career progress of each candidate. An overview of each scholar's research accomplishments and goals for the coming year should be clearly stated. These Annual Progress Reports will be closely monitored by NIH staff to ensure that the grant is achieving the goals of the program and to confirm that the institution is continuing to meet its goal of recruiting promising investigators, and facilitating their career development

Information to Include in Progress Reports (Examples):

• A brief introductory description of the program objective.
• Biographical sketches of new or replacement mentors
• Advisory Committee roles and activities during the past budget period
• Progress statements for each Scholar describing the ongoing research and didactic training experiences, as well as specific plans for the upcoming year. Include any information about the scholars efforts to obtain independent support
• Mentors reports describing performance and progress of each Scholar
• Description of course work, seminars, and other activities associated with the program
• Description of actions associated with the training in the responsible conduct of research
• Any recommended changes to improve the program, including those resulting from feedback from current or former trainees (e.g., new mentors, changes in courses, recruitment strategies).

Under this FOA, the K12 grant is not subject to the Streamlined Noncompeting Application Process (SNAP). While the K12 is subject to Expanded Authorities, the one exception to this is that carryover of funds from one fiscal year to the next must be approved by the NIDA Grants Administration staff (see Inquiries).

3.A. Additional Reporting Requirements

Financial Status Report (FSR): An annual FSR is required and must be submitted within 90 days of the end of each budget period. Continuation support will not be provided until the required form is submitted and accepted.

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. Accordingly, award recipients are hereby notified that they may be contacted after completion of this award for periodic updates on various aspects of program development, implementation, and other information helpful in evaluating the impact of this program.

Publication and Sharing of Research Results: Investigators are encouraged to submit reports of their findings for publication to the journals of their choice. For each publication that results from this award, NIH support should be acknowledged by a footnote in language similar to the following: This project was supported by NIH grant number ________. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.

Failure by the grantee institution to submit the 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. Forms may be found on the NIH Website at http://grants.nih.gov/grants/forms.htm.

Final Reports: A final Progress Report and Financial Status Report are required when an award is terminated. Evaluation results should be included as part of the Final Progress Report.

Scholar Selection Requirements: The institution must submit a completed Statement of Appointment (PHS Form 2271) for each scholar selected or returning to the K12 program. This form must be submitted to the awarding IC at or before the start of each scholar’s appointment or re-appointment. When applicable, a notarized statement verifying possession of permanent residency documentation must be submitted with the Statement of Appointment (PHS Form 2271). Forms may be found on the NIH Website at http://grants.nih.gov/grants/forms.htm

If registered in the NIH eRA Commons, grantees may submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at https://commons.era.nih.gov/commons/.

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:

Debra Grossman, M.A.
Division of Clinical Neuroscience and Behavioral Research
6001 Executive Blvd., Room 3153
Bethesda, MD 20892-9545
Telephone: (301) 443-2249
Email: [email protected]

Aria Davis Crump, Sc.D.
Division of Epidemiology, Services and Prevention Research
6001 Executive Blvd., Room 5153, MSC 9589
Bethesda, MD 20892-9589
Telephone: (301) 301-443-6504
Fax: (301) 443-2636
Email: [email protected]

Beth Babecki, M.A.
Training Coordinator
Division of Basic Neurosciences and Behavioral Research
6001 Executive Blvd., Room 4263, MSC 9555
Bethesda, MD 20892-9555
Telephone: (301) 435-0899
Fax: (301) 594-6043
Email: [email protected]

Steve Oversby, Psy.D., R.N.
Medication Research Grants Branch
Division of Pharmacotherapies
6001 Executive Blvd., Suite 4123
Bethesda, MD 20892-9551
Telephone: (301) 435-0762
Fax: (301) 443-9649
Email: [email protected]

Mimi M. Ghim, Ph.D.
Office of Science Policy and Communications
6001 Executive Blvd., Room 5232
Bethesda, MD 20892-9591
Telephone: (301) 443-6071
Email: [email protected]

2. Peer Review Contacts:

Teresa Levitin, Ph.D.
Director
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Blvd., Suite 220, MSC 8401
Bethesda, MD 20892-8401
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-2755
Fax: (301) 443-0538
Email: [email protected]

3. Financial or Grants Management Contacts:

Carol Alderson
Deputy Grants Management Officer
Grants Management Branch
Office of Management
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 4218
Bethesda, MD 20892-9560
Telephone: (301) 933-6196
Fax: (301) 594-6849
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

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

Human Subjects Protection:
Federal regulations (45 CFR 46) 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, http://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 (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions, on issues related to institutional policies and local institutional review board (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 http://grants.nih.gov/grants/gwas/.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/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. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

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

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

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

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-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, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) 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 HHS Office for Civil Rights (OCR).

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

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

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 Part 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 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/.