Participating Organization(s)	National Institutes of Health (NIH) U.S. Food and Drug Administration (FDA)
Components of Participating Organizations	Office of Disease Prevention (ODP) National Cancer Institute (NCI) National Institute on Alcohol Abuse and Alcoholism (NIAAA) National Institute on Drug Abuse (NIDA) National Institute of Environmental Health Sciences (NIEHS)
Funding Opportunity Title	Transition Career Development Award in Tobacco Control Regulatory Research (K22)
Activity Code	K22 Career Transition Award
Announcement Type	New
Related Notices	January 24, 2014 - See Notice NOT-DA-14-004. Notice of Availability of Nicotine Research Cigarettes through NIDA's Drug Supply Program. October 18, 2013 - See Notice NOT-OD-14-003. Guidance on Resumption of NIH Extramural Activities Following the Recent Lapse in Appropriations. August 21, 2013: Removed reference to ASIST in section IV.3, since ASIST is curently only available for multi-project aplications. August 16, 2013 - See Notice NOT-OD-13-103. Tenure Track Eligibility Clarification for this RFA. July 16, 2013 - See Notice NOT-OD-13-088. Notice Announcing Pre-Application Webinar and FAQ page.
Funding Opportunity Announcement (FOA) Number	RFA-OD-13-015
Companion Funding Opportunity	RFA-OD-13-014, K01Mentored Research Scientist Award RFA-OD-13-016, K99/R00 Pathway to Independence Award RFA-OD-13-013, K08 Clinical Investigator Award
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.077
Funding Opportunity Purpose	The purpose of the Transition Career Development Award in Tobacco Control Regulatory Research (K22) is to facilitate the transition of investigators in mentored, non-independent research positions in biomedical, behavioral, and social sciences to independent faculty research positions conducting research that will inform the development and evaluation of regulations on tobacco product manufacturing, distribution, and marketing. This goal is achieved by providing protected time through salary and research support for the initial 3 years of the first independent tenure-track faculty position, or its equivalent. Research projects must address the research priorities related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) as mandated by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31. Participating NIH Institutes invite K22 applications from mentored, non-independent investigators who (1) have earned a terminal clinical or research doctorate; (2) have at least 2 years of postdoctoral training in research at the time of submission of the initial application; (3) have no more than a total of 7 years of mentored, non-independent research training experience after the terminal clinical or research doctorate at the time of application; (4) have not already had or have an individual career development award from the Federal Government; and (5) do not already have a full-time tenure-track assistant professor faculty position, or its equivalent in mentored, non-independent (with a research or health-professional doctoral degree or equivalent) positions in biomedical or behavioral sciences. A clinical faculty member who does not hold an independent research faculty position may be eligible for this K22 award and should contact the appropriate IC Scientific Contact for guidance. Mentored, non-independent investigators in NIH intramural laboratories are eligible to apply for this K22 award. Candidates must also be pursuing careers in research areas supported by the NIH to address the research priorities related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP). The awards under this FOA will be administered by NIH using funds made available through the CTP and the FSPTCA (P.L. 111-31).

Posted Date	June 28, 2013
Open Date (Earliest Submission Date)	September 2, 2013
Letter of Intent Due Date(s)	September 2, 2013
Application Due Date(s)	(Extended to November 1, 2013 per NOT-OD-14-003), OriginallyOctober 2, 2013, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	February 2014
Advisory Council Review	May 2014
Earliest Start Date	July 2014
Expiration Date	(Extended to November 2, 2013 per NOT-OD-14-003), OriginallyOctober 3, 2013
Due Dates for E.O. 12372	Not Applicable

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

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

The overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

Doctoral-level investigators pursuing careers in biomedical, behavioral and social science research often require extended periods of mentored research training beyond their original doctoral degrees (e.g., PhD, MD, or MD/PhD). However, because of the prolonged training experiences often needed for biomedical, behavioral and social science researchers, there is a wealth of talented new investigators still in mentored, non-independent positions. These include investigators at domestic extramural institutions/organizations, as well as investigators working in Federal research groups. Many such investigators need additional protected time to develop successful independent research programs.

The objective of the Career Development Award in Tobacco Control Regulatory Research (K22) program is to support mentored, non-independent investigators in transitioning to their first independent tenure-track faculty research positions, or their equivalent, with an enhanced probability of success for obtaining independent NIH or other research project grant support.

The Career Development Award in Tobacco Control Regulatory Research (K22) will provide up to 3 years of support for the most promising and exceptionally talented mentored, non-independent investigators who 1) have earned a terminal clinical or research doctorate; (2) have at least 2 years of postdoctoral training in research at the time of submission of the initial application; (3) have no more than a total of 7 years of mentored, non-independent research training experience after the terminal clinical or research doctorate at the time of application; (4) have not already had or have an individual career development award from the Federal Government; and (5) do not already have a full-time tenure-track assistant professor faculty position, or its equivalent in mentored, non-independent (with a research or health-professional doctoral degree or equivalent) positions in biomedical or behavioral sciences. A clinical faculty member who does not hold an independent research faculty position may be eligible for this K22 award and should contact the appropriate IC Scientific Contact for guidance. Mentored, non-independent investigators in NIH intramural laboratories are eligible to apply for this K22 award. Candidates must also be pursuing careers in research areas supported by the NIH to address the research priorities related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP). The awards under this FOA will be administered by NIH using funds made available through the CTP and the FSPTCA (P.L. 111-31). NIH believes that the creativity and innovation of new independent investigators in their early career stages play an integral role in addressing our Nation’s biomedical, behavioral, and social science research needs.

The expectation is that, through this sustained period of research career development and transition, awardees will launch independent research careers in science that informs the regulation of tobacco products and become competitive for new research project grant (R01 or equivalent) funding.

Background

The awards under this FOA will be administered by NIH using designated funds from the FDA CTP for tobacco regulatory science mandated by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31. The NIH and the FDA have formed an interagency partnership to foster research that can inform FDA's regulatory authorities over the manufacture, marketing, and distribution of tobacco products within the framework of the Family Smoking Prevention and Tobacco Control Act (FSPTCA).

The FDA and NIH share interest in supporting research that could inform FDA's regulatory authorities over the manufacture, marketing, and distribution of tobacco products. To that end, the research encouraged by this FOA is expected to provide additional scientific data to the research base to inform regulation of tobacco products to protect public health.

Science will inform the FDA in regulation of the manufacture, marketing, and distribution of tobacco products in order to reduce the public health toll from tobacco product use in the United States. Although a vast and sound science base exists with regard to numerous areas related to the FSPTCA, new research will provide additional science for the FDA to consider as it implements the FSPTCA.

Research consistent with the scope of this FOA includes the following ten FDA CTP interest areas. Only applications proposing research projects relevant to one or more of these ten areas will be considered for funding.

1. Nicotine dependence threshold among youth and adults and impact of nicotine reduction on tobacco product use behavior (e.g., topography, compensation, switching, multiple use, initiation, cessation, relapse)

2. Cigar (small, large, cigarillos) initiation, use (including transitions to other tobacco products and multiple use), perceptions, dependence and toxicity

3. Smokeless tobacco initiation, use (including transitions to other tobacco products and multiple use), perceptions, dependence and toxicity

4. E-cigarettes initiation, use (including transitions to other tobacco products and multiple use), perceptions, dependence, toxicity

5. Other tobacco product (e.g., hookah, pipes, dissolvables) initiation, use (including transitions to other tobacco products and multiple use), perceptions, dependence, toxicity

6. The impact of tobacco product characteristics, (e.g., ingredients, constituents, components, additives such as flavors, and labeling and marketing) on initiation, especially among youth and other vulnerable populations

7. Toxicity thresholds for each of the 20 harmful and potentially harmful constituents identified in the March 2012 Guidance for Industry http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm297752.htm

8. Computational/mathematical modeling and simulation and/or statistical modeling of the public health impact of FDA/CTP regulation of potential modified risk tobacco products, e.g., product standards, communications regarding risks of tobacco products

9. Consumer perceptions of tobacco products including the impact of labeling and marketing

10. Effective communication strategies regarding harmful and potentially harmful constituents and risks of tobacco products

Vulnerable populations referenced in research questions include, but are not limited to age, gender, race, ethnicity, income, occupation, geographic location, people with mental health or medical co-morbidities, the military/veterans, the lesbian, gay, bi-sexual, transgendered, questioning (LGBTQ) community, and pregnant women/women of reproductive age.

Special Note

Applicants are strongly encouraged to discuss whether their research ideas are responsive to this FOA with a Scientific/Research Contact listed in Section VII. Agency Contacts, and to review Frequently Asked Questions associated with this FOA at http://prevention.nih.gov/tobacco.

Pre-Application Conference Call

The NIH anticipates holding one or more pre-application conference calls or web-based teleconferences to which all interested prospective applicants are invited. NIH Program and Review staff persons will explain the goals and objectives of the Transition Career Development Award in Tobacco Control Regulatory Research for research relevant to the FSPTCA, discuss the application peer review process, and answer questions. Information about the pre-application conference calls will be available at http://prevention.nih.gov/tobacco/.

Travel

The NIH will also require awardees to travel to and participate in one workshop in the Washington D.C. area per year beginning in the first year and continuing through the last year of the award. The tobacco regulatory research and/or career development workshop will be organized by NIH and FDA, with the timing of the workshop at the discretion of the Government. Funds from the award must be used for this travel.

Funding Instrument	Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed	NewThe OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The awards under this FOA will be administered by NIH using designated funds from the FDA CTP for tobacco regulatory science. Funds allocated by the FDA CTP for this FOA are expected to be approximately $0.5M. The NIH expects to make 2-3 awards, contingent upon FDA allocations and the submission of a sufficient number of meritorious applications.
Award Budget	Award budgets are composed of salary and other program-related expenses, as described below.
Award Project Period	The total project period may not exceed 3 years.

Salary	FDA will contribute $90,000 per year toward the salary of the career award recipient. Mentored career awards require the candidate to devote a minimum of 9 person-months (75% of full-time professional effort) to conducting health-related research. The remaining effort may be devoted to other research pursuits and activities consistent with the objectives of the award. For information regarding NIH policy on determining full-time professional effort for career awards, see NOT-OD-04-056. The total salary requested must be based on a full-time staff appointment. The salary must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. The sponsoring institution may supplement the FDA salary contribution up to a level that is consistent with the institution's salary scale. However, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the career award.
Other Program-Related Expenses	FDAwill contribute $60,000 per year toward the research development costs of the award recipient, which must be justified and consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities. Research development costs may be used for the following expenses: (a) tuition and fees related to career development; (b) research expenses, such as supplies, equipment and technical personnel; c) travel to research meetings or training; and (d) statistical services including personnel and computer time. Salary for mentors, secretarial and administrative assistants, etc. is not allowed.
Indirect Costs	Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs.

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

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

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

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Governments

• Eligible Agencies of the Federal Government

NIH intramural laboratories and other eligible agencies of the Federal Government are eligible to apply for the mentored phase of the K22 mechanism on behalf of intramural candidates. They are not eligible to apply for the independent phase.

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

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

• System for Award Management (SAM) must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov Manage Entity function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
• Grants.gov
• eRA Commons

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

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

Any candidate with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. Multiple PDs/PIs are not allowed.

By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status).

Mentored, Non-independent Investigators:

At the time of the initial application submission (or resubmission), candidates for this award must (1) have earned a terminal clinical or research doctorate (including PhD, MD, DO, DC, ND, DDS, DMD, DVM, ScD, DNS, PharmD, or equivalent doctoral degree) or a combined research doctorate/clinical degree; (2) have at least 2 years of postdoctoral training in research at the time of submission of the initial application (e.g., postdoctoral fellow, postdoctoral associate, clinical fellow, clinical associate or equivalent); (3) have no more than a total of 7 years of mentored, non-independent research training experience after the terminal clinical or research doctorate at the time of application; (4) have not already obtained an individual career development award from the Federal Government; and (5) have not already had or have a full-time tenure-track assistant professor faculty position, or its equivalent.

Clinicians:

Following clinical training or fellowship training periods, clinicians (including those with MD, DDS, DVM degrees and other licensed professionals) may obtain clinical faculty positions that denote independence in clinical responsibilities, but not in research. A clinical faculty member who does not hold an independent research faculty position may be eligible for the K22 award and should contact the Scientific Contact from the appropriate participating IC for guidance. Clinicians in such positions are encouraged to obtain confirmation of their eligibility before they begin to prepare their applications. Such individuals may also wish to consider other career development awards available for junior faculty development.

Other Candidates:

Some institutions appoint postdoctoral fellows in positions with other titles, although they are still in mentored, non-independent training positions. Candidates in such positions are encouraged to obtain confirmation of their eligibility before they begin to prepare their applications. It is incumbent upon the candidate to provide evidence that he/she is in a mentored, non-independent position.

NIH Intramural Candidates:

Individuals affiliated with an NIH Intramural Laboratory may apply (specific information is available for intramural candidates on the Electronic Submission Intranet link available only to users internal to NIH).

Individuals are NOT eligible for the K22 award if they:

• Have less than 2 years of postdoctoral training in research at the time of initial application; or
• Have more than a total of 7 years of mentored, non-independent research training after the terminal clinical or research doctorate at the time of application; or
• Have currently or have previously held an independent research faculty or tenure-track faculty position, or its equivalent, in academia, industry, or elsewhere; or
• Have currently or have previously held another NIH career development award (e.g., K01, K07, K08, K18, K22, K23, K25, K99, K99/R00); or
• Have been an independent PD/PI on an NIH research project grant (e.g., R01, R29), program project (P01), center grants (P50), sub-projects of program project (P01), sub-projects of center grants (P50); or
• Have currently or have previously held other peer-reviewed NIH (except R03, R21, Dissertation Award (R36), or SBIR/STTR (R41, R42, R43, R44)) or non-NIH research grants or career development awards over $100,000 in direct costs per year; or
• Have no affiliation with a domestic extramural institution or Federal institution at the time of initial application or resubmission.

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

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

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

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Individuals are eligible for a K22 award if they have been, or currently are, the PD/PI of an NIH R03 or R21 grant or a PHS or non-Federal award that duplicates the provisions or research goals of an R03 or R21 grant.

Individuals are NOT eligible to apply if they have pending an application for any other PHS career development award, an NIH institute-specific K22, or a Pathway to Independence Award (K99/R00). Individuals are not eligible to apply if they have been or are currently a PD/PI on an NIH research grant (such as R01, R29, P01) or a subproject leader on a Program Project (P01) or Center Grant (P50), or a non-NIH equivalent to these grants/awards.

At the time of award, the candidate must have a full-time appointment at the awardee institution. Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the relevant Institute or Center prior to preparing an application to discuss their eligibility. Under certain circumstances, an awardee may submit a written request to the awarding component requesting a reduction in minimum required percent effort, which will be considered on a case-by-case basis. Details on this policy are provided in NOT-OD-09-036.

Career Development Award in Tobacco Control Regulatory Research K22 award recipients are expected to apply for NIH or other independent research project grant support (R01 or equivalent) prior to the end of the 2nd year of support. Recipients may hold concurrent research support, and, under certain circumstances, salary support from the final 2 years of their K22 award and a competing NIH research project grant when recognized as the PD(s)/PI(s) or subproject Director of the research project grant. See NOT-OD-08-065.

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

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

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

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

Letter of Intent

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

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

• Descriptive title of proposed research
• Name, address, and telephone number of the PI
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Tobacco Regulatory Science Program
Office of Disease Prevention
6100 Executive Blvd.
Room 3B01, MSC 7530
Bethesda, MD 20892-7530 (use Rockville, MD 20852 for Express Mail)
Telephone: 301-451-7464
FAX: 301-480-2230
Email: [email protected]

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

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.

Project Summary/Abstract

Include a description of your current research and the research you propose to continue in the independent phase.

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed, with the following additional instructions:

Candidate Information

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Candidate s Background

• For individuals in postdoctoral and similar positions (i.e. still in training), describe current training and research efforts of the candidate.
• Describe prior training and research efforts, and how they relate to the objectives and long-term career plans of the candidate.
• Provide evidence of the candidate's potential to develop into a successful independent investigator. Usually this is evident from publications, prior research interests and experience, and letters of reference.
• Describe the candidate’s commitment to a career in a biomedical or behavioral research field relevant to the mission of the NIH and tobacco regulatory science as it relates to the FDA CTP tobacco regulatory authorities.

Career Goals and Objectives

• Describe a systematic plan that: (1) shows a logical progression from prior research and training experiences to the research and career development activities that will occur, and then to independent investigator status; (2) justifies the need for further career development to become an independent investigator; (3) utilizes the relevant research and educational resources of the institution; and (4) describes the candidate's current, as well as long-term, research and career objectives.
• Describe how the candidate's long term objectives, career goals and his/her research will inform tobacco regulatory science as it relates to the FDA CTP tobacco regulatory authorities.

Career Development/Training Activities During Award Period

• The candidate is responsible for the preparation of the career development plan. A timeline, including a publication plan, is strongly encouraged.
• Provide a description of the career development plan, incorporating consideration of the candidate's goals and prior experience. Include a plan to obtain the necessary research experience to launch an independent career.
• The career development plan must be tailored to the needs of the individual candidate with the ultimate goal of achieving independence as a researcher.
• Although not required, an advisory committee may be formed to assist with the development of the program of study and to monitor the candidate’s progress during the career development program.
• The candidate must submit a competitive research grant (R01 or equivalent) by year 2 of the award. The process and schedule for how this is to be accomplished must be outlined in the application.
• The candidate must justify the need for the K22 award and must provide a convincing case that the proposed period of support (3 years) will substantially enhance his/her career and allow the pursuit of a novel or promising approach to a particular research problem that will inform the development and evaluation of regulations on tobacco product manufacturing, distribution, and marketing.
• The career development plan must be tailored to the needs of the individual candidate with the ultimate goal of achieving independence as a researcher and must include travel and participation in one workshop in the Washington D.C. area per year beginning in the first year and continuing through the last year of the award with the timing of the workshop at the discretion of the Government. Awardees must also plan to travel to and participate in at least one conference or workshop annually where in later years they will be expected to present their research.

Training in the Responsible Conduct of Research

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.

Statements of Support

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed, with the following additional instructions:

Statements by Mentor, Co-mentor(s), Consultants, Contributors

• Signed statements must be provided by all consultants/collaborators confirming their participation in the project and describing their specific roles. Collaborators and consultants are generally not directly involved in the development of the career of the candidate as an independent investigator.
• Collaborators and consultants should document the appropriate expertise in the proposed areas of consulting/collaboration and provide their biographical sketches.
• Any other opportunities for the candidate's professional growth should also be documented in these statements.

Environmental and Institutional Commitment to the Candidate

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed, with the following additional instructions:

Description of Institutional Environment

• The submitting institution must describe the scientific environment, including the faculty, resources, and facilities that will be available to the candidate in securing a tenure-track assistant professor faculty position, or its equivalent, in a domestic academic institution and its appropriateness to conduct tobacco regulatory research that will inform CTP regulatory authorities.

Institutional Commitment to the Candidate’s Research Career Development

• The submitting institution must provide a statement that describes its commitment to assisting the candidate in his/her career progression to a tenure-track assistant professor faculty position, or its equivalent.
• The submitting institution must provide a statement of its commitment to assist in the candidate’s development into a productive, independent investigator for a career in tobacco regulatory science.

Research Plan

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed, with the following additional instructions:

Research Strategy

• A sound research project that is consistent with the candidate s level of research development and objectives of his/her career development plan must be provided. The research description should demonstrate not only the quality of the candidate’s research thus far but also the novelty, significance, creativity and approach, as well as the ability of the candidate to carry out the proposed research.
• Only applications that focus on tobacco regulatory science relevant to the Family Smoking Prevention and Tobacco Control Act will be considered responsive to this FOA. As this FOA is funded by the NIH via support from the FDA Center for Tobacco Products (CTP), all research conducted must fall within the regulatory authority of the FDA CTP. Indicating how your career plan will address one or more of the ten FDA CTP research priorities is strongly advised.
• The research should address an important problem or a critical barrier to progress in the field of tobacco regulatory science.

Budget

Be sure to budget for the required travel (see section above on Career Development/Training Activities during award period).

General Guidance for Budget for the Application Process:

• The SF424 (R&R) Detailed Budget component should be used with the instructions found in Part I.4.7 (R&R Budget Component) of the Application Guide. However, for K22 applications, only limited budget information is required and candidates will also need to follow the special instructions in Part I.7.4 of the SF 424 (R&R) [Supplemental Instructions for Career Development Awards], noting the special instructions that modify Section 4.7.
• In budget section A (Senior/Key Persons), include base salary, person months, and requested salary and fringe benefit information for only the candidate. Base salary and requested salary and fringe benefits should reflect actual levels. Any adjustments based on limits for this FOA will be made at the time of the award. Sections B-E should be left blank. If a dollar amount is required, enter 0 (zero) in the appropriate box. The total Research Development Support amount requested for each year will be entered in Section F, Materials and Supplies. In Section H enter Modified Total Direct Costs under Indirect Cost Type. The Indirect Cost rate is 8% of modified total direct cost. The Indirect Cost amount should be entered under Funds Requested. Totals for Sections F, G, and H will be calculated automatically for each year as well as for the Cumulative Budget. Within the direct cost limitation for research development support, provide a detailed description with justification for all equipment, supplies, and personnel that will be used to help achieve the career development and research objectives of this award.

Complete all sections using the general guidance above with the following modifications:

• For the period of support, indicate the total period of support being requested: 3 years.
• For Senior/Key personnel, list the name of the PD/PI only.
• The maximum direct cost budget for research costs is $60,000 for each year

Resource Sharing Plan

Research findings generated from this FOA may be used to provide scientific evidence informing the regulation of the manufacture, distribution, and marketing of tobacco products to protect public health. If research data are cited publically, institutions of higher education, hospitals, and other non-profit organizations are subject to the Freedom of Information Act (FOIA) as outlined in Revised Circular A-110 (http://www.whitehouse.gov/omb/circulars_a110/).

Appendix

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

Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when letters of reference will be accepted (letters are due by the application due date as described in the Notice). Applications lacking the appropriate required reference letters will not be reviewed. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Submit Referee Information link and not through Grants.gov.

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

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

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

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

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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

Awards funded under this FOA are not subject to SNAP authorities and do not have authority for the carryover of unobligated balances from budget period to any subsequent budget period without prior written approval from NIH. Special reporting requirements also apply, as described in Section VI.3. Reporting.

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

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

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

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by FDA and components of participating organizations, NIH. Applications that are incomplete and/or non-responsive will not be reviewed. Applicants are strongly encouraged to discuss whether their research ideas are responsive to this FOA with a Scientific/Research Contact listed in Section VII, and to review Frequently Asked Questions associated with this FOA at http://prevention.nih.gov/tobacco.

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

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers should provide their assessment of the likelihood for the candidate to maintain a strong research program, taking into consideration the criteria below in determining the overall impact score.

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Candidate

• Does the candidate have the potential to develop as an independent and productive researcher?
• What is the quality of the postdoctoral research training in terms of research experience(s), didactic experiences, and other experiences (e.g., special skills, perspectives, techniques), and has it enhanced the candidate's ability to pursue an independent research career?
• What is the scientific productivity during the postdoctoral period of research training?
• Is the candidate committed to an independent research career that will be focused on problems clearly relevant to tobacco regulatory science?
• Does the candidate have the potential ability to successfully manage an independent tobacco regulatory science research project?
• Do the letters of reference from at least three well-established scientists address the above review criteria, and do they demonstrate evidence that the candidate has a high potential for becoming an independent investigator in tobacco regulatory science?

Career Development Plan/ Career Goals & Objectives/ Plan to Provide Mentoring

• What is the likelihood that the plan will contribute substantially to the scientific development of the candidate leading to scientific independence?
• Are the content, scope, phasing, and duration of the career development plan appropriate when considered in the context of prior training/research experience and the stated training and research objectives for achieving research independence?
• Are there adequate plans for monitoring and evaluating the candidate’s research and career development progress?
• Are plans to integrate the candidate into the tobacco regulatory research community and present the research findings to the research community appropriate?
• Are there adequate plans to assist the candidate in preparing an application for NIH or other independent research grant support (R01 or equivalent) prior to the end of the 2nd year of support?

Research Plan

• Keep the relevant sentences for your activity code and delete the rest. If your activity code isn t listed, choose applicable sentences from the standard sentences listed below.
• Are the scientific and technical merits of the research question, design, and methodology appropriate in the context of prior training and experience?
• Is the proposed research project appropriate for the candidate s stage of research development and as a vehicle for development of the research skills described in the career development plan?
• Is the proposed research relevant to the stated career objectives?
• To what extent is the proposed research likely to foster the career of the candidate as an independent investigator in tobacco regulatory science research?
• If appropriate, are there adequate plans for the protection of human and animal subjects and for the safety of the research environment and conformance with the NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research and Inclusion of Children Participating in Research Involving Human Subjects?
• Does the project address an important issue or a critical barrier in the field?
• If the aims of the project are achieved, how will scientific knowledge and/or technical capability be improved? How will successful completion of the aims affect the concepts, methods, and technologies related to the manufacture, distribution, and marketing of tobacco products?
  
  

Consultant(s), Collaborator(s)

• Is adequate information provided that clearly documents expertise in the proposed area(s) of consulting/collaboration?
• Have the proposed consultant(s) and collaborator(s) provided evidence of commitment to the candidate and the candidate’s project?
• Do the proposed consultant(s)/collaborator(s) provide the required expertise for successful conduct of the research project?
  

Environment & Institutional Commitment to the Candidate

• Does the submitting institution provide an appropriate scientific environment, including the faculty, resources, and facilities that will be available to the candidate in securing a tenure-track assistant professor faculty position, or its equivalent, in a domestic academic institution?
• Does the submitting institution provide a statement that describes its commitment to assist the candidate in career progression to a tenure-track assistant professor position, or its equivalent?
• Does the submitting institution provide a statement of commitment in assisting in the candidate’s development into a productive, independent investigator?

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

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

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.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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

Training in the Responsible Conduct of Research

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

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

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

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Appeals for initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Councils. Council approved applications will be provided to FDA by the NIH Tobacco Regulatory Science Program (TRSP) in priority score order in a Funding Plan. TRSP will notify the NIH ICs of approved applications for funding.. The following will be considered in making funding decisions:

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

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

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

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

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

There will not be a formal Notice of Award (NoA) for applications until an institution has been identified by the candidate and approved by the NIH in collaboration with the FDA CTP and this approved institution will be issued the award. The NIH will initially notify candidates who have successfully competed for funding with a Letter of Intent to Commit Funds. Candidates will then have up to 12 months from the date of the letter to accept an appointment in a domestic academic institution that has offered a position at the Assistant Professor level or an equivalent tenure-track faculty position (e.g., Assistant Member, Laboratory Head, Principal Investigator, etc.), at which the candidate is expected to establish his/her own independent research program, prepare applications for regular (non-career development) research project funding, and act as a PI(s)/PD(s) on such independent research projects.

A preliminary budget for research expenses for all three years will be required as part of the application. Upon securing a tenure-track faculty position, or its equivalent, an updated application with a revised budget will be submitted by the new sponsoring institution to the NIH. Detailed instructions for submitting a revised budget will be included with the Letter of Intent to Commit Funds. NIH in conjunction with the FDA CTP will review the new updated application to ensure that all programmatic requirements have been met prior to issuance of the award.

Before the NIH issues the NoA, the sponsoring institution will need to provide a description of the institutional environment for the following:

• Describe the institution’s scientific environment, including the resources and facilities that will be available to the candidate to perform the proposed research plan.
• Describe how the institutional research environment is particularly suited for the development of the candidate's research career and the pursuit of the proposed research plan and progression to independence.
• The institution must document a strong, well-established research and career development program related to the candidate's area of interest, including a high-quality research environment with key faculty members and other investigators capable of productive collaboration with the candidate.
• The applicant institution must demonstrate or give reasonable assurances that it has the capacity to prepare the applicant for a career in tobacco regulatory science.

The sponsoring institution will also need to provide a description of the institutional commitment to the candidate's career development for the following:

• The institution must provide a statement of commitment to the candidate’s development into a productive, independent investigator, and to meeting the requirements of the award.
• The institution must provide a clear statement that describes the commitment to the career progression of the candidate (e.g., tenure-track position).
• The institution must provide a statement that the institutional commitment to the candidate is not contingent upon receipt of this career award.
• The institution must provide a startup package and salary equivalent to those provided to a newly hired tenure-track faculty member who does not have a K22 award.
• The institution must provide a statement with assurances that the candidate will be able to spend a minimum of 75% effort (9 calendar months) in the conduct of research and career development activities associated with this award, with the remaining 25% effort devoted to other research, clinical, and teaching activities only if these activities are consistent with the goals of the Transition Career Development Award in Tobacco Control Regulatory Research K22 award.
• The institution must provide the candidate with the appropriate facilities and other resources to perform the proposed research plan, including laboratory and office space, and for which the amounts should be indicated.

In addition, the candidate and the new sponsoring institution will also need to provide a revised budget according to the following:

• The SF424 (R&R) Detailed Budget component should be used with the instructions found in Part I.4.7 (R&R Budget Component) of the Application Guide. However, for K22 applications, only limited budget information is required and candidates will also need to follow the special instructions in Part I.7.4 of the SF 424 (R&R) [Supplemental Instructions for Career Development Awards], noting the special instructions that modify Section 4.7.
• In budget section A (Senior/Key Persons), include base salary, person months and requested salary and fringe benefit information for only the candidate. Base salary, and requested salary and fringe benefits should reflect actual levels. Any adjustments based on NIH policy limits will be made at the time of the award. Sections B-E should be left blank. If a dollar amount is required, enter 0 (zero) in the appropriate box. The total Research Development Support amount requested for each year will be entered in Section F, Materials and Supplies. In Section H enter Modified Total Direct Costs under Indirect Cost Type. The Indirect Cost rate is 8% of modified total direct cost. The Indirect Cost amount should be entered under Funds Requested. Totals for Sections F, G, and H will be calculated automatically for each year as well as for the Cumulative Budget. Within the direct cost limitation for research development support, provide a detailed description with justification for all equipment, supplies and personnel that will be used to help achieve the career development and research objectives of this award.

Complete all sections using the general guidance above with the following modifications:

• List the name, role on project and percent effort for all project personnel (salaried or unsalaried).
• Identify all consultants by name and organizational affiliation and describe the services to be performed.
• Provide a brief narrative justification for any major budget items, other than personnel, that are requested for the conduct of the project. Describe specific resources committed by the institution to support the candidate’s research.
• Facilities and administration (F & A) costs will be calculated at the time of the award at eight percent of modified total direct costs (exclusive of tuition, fees, and equipment).

Any application awarded in response to this FOA will also require awardees to participate in conference calls or webinars as needed. Telephone conferences and/or webinars will be set up by the NIH awarding institutes with awardees on an as needed basis in order to keep all awardees informed of progress, events, issues, or new resources for tobacco regulatory research and career development.

Awardees will also be asked to travel to and participate in one workshop in the Washington D.C. area per year beginning in the first year and continuing through the last year of the award. This workshop will be on tobacco regulatory research and/or career development, which NIH and FDA will organize, with the timing of the workshop at the discretion of the Government. Funds from the award must be used for this travel. Awardees will be informed as early as possible to allow them to reserve time in their schedule, make necessary travel arrangements, and prepare for posters. Awardees must also plan to travel to and participate in at least one conference or workshop annually where in later years they will be expected to present their research. Funds from the award must also be used for annual travel to a conference or workshop.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants. More specifically, for K Awards, visit the Research Career Development ( K ) Awardees section of the NIH Grants Policy Statement.

The research findings generated from this FOA may be used to provide scientific evidence informing the regulation of the manufacture, distribution, and marketing of tobacco products to protect public health. If the research data are cited publically, institutions of higher education, hospitals, and other non-profit organizations are subject to the Freedom of Information Act (FOIA) as outlined in Revised Circular A-110 (http://www.whitehouse.gov/omb/circulars_a110/) and section 2.3.11.2.3 of the NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/nihgps_2011/nihgps_ch2.htm#info_confidentiality).

Awards pursuant to this funding opportunity are contingent upon the availability of funds.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement. The Additional Instructions for Preparing Continuation Career Development Award (CDA) Progress Reports, must be followed.

Requirement for Interim Reports

In addition to the annual reports, Interim Reports will be due six months following the project start date and six months from the beginning of the budget period every year of award. Electronic copies should be sent to the Grants Management Specialist listed on the Notice of Grant Award. The Interim Report will use the Non-Competing Continuation Progress Report; PHS 2590 (Revised 06/2009) http://grants.nih.gov/grants/funding/2590/2590.htm. The Interim Report should include: Form Page 1, Form Page 1-Continuation, Project/Performance Site Format Page - use only if additional space is needed; Form Page 5: Progress Report Summary (which must include the Mentors' Report) and Continuation Page as needed. The scientific summary should be a maximum of two (2) pages.

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

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

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

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

Because of the difference in individual Institute and Center (IC) program requirements for this FOA, prospective applications MUST consult the Table of IC-Specific Information, Requirements, and Staff Contacts, to make sure that their application is responsive to the requirements of one of the participating NIH ICs. Prior consultation with NIH staff is strongly encouraged.

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Telephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Jeanette F. Korczak, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5642
Email: [email protected]

Abraham P. Bautista, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-9737
Email: [email protected]

Beth Babecki
National Institue on Drug Abuse (NIDA)
Telephone: 301-435-0899
Fax: 301-594-6043
Email: [email protected]

Carol Shreffler, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1445
Email: [email protected]

Raymond Jacobson, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-996-7702
Email: [email protected]

Tracie H. McGraw
National Cancer Institute (NCI)
Telephone: 301-631-3020
Email: [email protected]

Judy S. Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: [email protected]

Carol Alderson
National Institute on Drugy Abuse (NIDA)
Telephone: 301-933-6196
Email: [email protected]

Wanda Boggs
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-316-4638
Email: [email protected]

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

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.