Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

U.S. Food and Drug Administration (FDA)

Components of Participating Organizations

National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)

Funding Opportunity Title

Pathway to Independence Award in Tobacco Regulatory Research (K99/R00 - Independent Clinical Trial Not Allowed)

Activity Code

K99/R00 Career Transition Award/Research Transition Award

Announcement Type

Reissue of RFA-OD-13-016

Related Notices
  • February 7, 2020 - This PA has been reissued as RFA-OD-20-009.
  • October 30, 2019 - NIH Extension Policy for Eligibility Window for Pathway to Independence Awards (K99/R00). See Notice NOT-OD-20-011.
  • August 23, 2019 - Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-137.
  • July 26, 2019 - Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-128.
  • November 26, 2018 - NIH & AHRQ Announce Upcoming Updates to Application Instructions and Review Criteria for Career Development Award Applications. See Notice NOT-OD-18-229.
  • June 4, 2018 - Notice of Pre-Application Webinar and FAQs for RFAs: RFA-OD-18-005, RFA-OD-18-006, RFA-OD-18-007 and RFA-OD-18-008. See Notice NOT-OD-18-187.
Funding Opportunity Announcement (FOA) Number

RFA-OD-18-007

Companion Funding Opportunity

RFA-OD-18-008, K99/R00 Career Transition Award/Research Transition Award,

RFA-OD-18-005, Mentored Research Scientist Career Development Award K01,

RFA-OD-18-006, K01 Research Scientist Development Award - Research & Training

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

93.077

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary study to a clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor. Applicants proposing a clinical trial or an ancillary study to an ongoing clinical trial as lead investigator, should apply to the companion FOA RFA-OD-18-008.

The purpose of the Pathway to Independence Award in Tobacco Regulatory Research (K99/R00) is to increase and maintain a strong cohort of new and talented independent investigators conducting research that will inform the development and evaluation of regulations on tobacco product manufacturing, distribution, and marketing. This program is designed to facilitate a timely transition of outstanding postdoctoral researchers with a research and/or clinical doctorate degree from mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions. This program will provide independent NIH research support during this transition in order to help awardees launch competitive, independent research careers.

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.

The awards under this FOA will be administered by NIH using funds made available through the CTP and the FSPTCA (P.L. 111-31).

Key Dates

Posted Date

May 15, 2018

Open Date (Earliest Submission Date)

June 19, 2018

Letter of Intent Due Date(s)

For the first round, because of the application due date, the LOIs are due 30 days prior to the first application date.

Subsequent LOI due dates are due 60 days prior to the application due date.

Application Due Date(s)

July 19, 2018, November 8, 2018, July 19, 2019, November 8, 2019), by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

Late applications will be accepted for this Funding Opportunity Annoucement

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

October 2018, February 2019, October 2019, February 2020

Advisory Council Review

January 2019, May 2019, January 2020, May 2020

Earliest Start Date

April 2019, July 2019, April 2020, July 2020

Expiration Date

November 9, 2019

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Career Development (K) Instructions in the SF424 (R&R) Application Guide, 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.


Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information


Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

The overall goal of the NIH Research Career Development 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. NIH Institutes and Centers (ICs) support a variety of mentored and non-mentored career development award programs designed to foster the transition of new investigators to research independence and to support established investigators in achieving specific objectives. Candidates should review the different career development (K) award programs to determine the best program to support their goals. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

The objective of the NIH Pathway to Independence Award (K99/R00) is to help outstanding postdoctoral researchers complete needed, mentored training and transition in a timely manner to independent, tenure-track or equivalent faculty positions. The K99/R00 award is intended to foster the development of a creative, independent research program that will be competitive for subsequent independent funding and that will help advance the mission of the NIH. Applicants must have no more than 4 years of postdoctoral research experience at the time of the initial or the subsequent resubmission application. The K99/R00 award is intended for individuals who require at least 12 months of mentored research training and career development (K99 phase) before transitioning to the R00 award phase of the program. Consequently, the strongest applicants will require, and will propose, a well-conceived plan for 1 2 years of substantive mentored research training and career development that will help them become competitive candidates for tenure-track faculty positions and prepare them to launch robust, independent research programs. An individual who cannot provide a compelling rationale for at least one year of additional mentored research training at the time of award is not a strong candidate for this award.

Individuals must be in mentored, postdoctoral training positions to be eligible to apply to the K99/R00 program. If an applicant achieves independence (any faculty or non-mentored research position) before a K99 award is made, neither the K99, nor the R00 award, will be made. The K99/R00 award will provide up to 5 years of support in two phases. The initial (K99) phase will provide support for up to 2 years of mentored postdoctoral research training and career development. The second (R00) phase will provide up to 3 years of independent research support, which is contingent on satisfactory progress during the K99 phase and an approved, independent, tenure-track (or equivalent) faculty position. The two award phases are intended to be continuous in time. Therefore, although exceptions may be possible in limited circumstances, R00 awards will generally only be made to those K99 PDs/PIs who accept independent, tenure-track (or equivalent) faculty positions by the end of the K99 award period.

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 Tobacco Control Act, the Tobacco Regulatory Science Program.

Program Scope and Research Objectives

The FDA and NIH share interest in supporting research that could inform FDA's tobacco regulatory authorities. 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. 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.

Science will inform the FDA in regulation of tobacco products in order to reduce the public health toll from tobacco product use in the United States. This FOA is focused on the following seven FDA CTP interest areas. Only applications proposing research projects relevant to one or more of these seven areas will be considered for funding.

SCIENTIFIC INTEREST AREAS

Toxicity - Understanding how tobacco products and changes to tobacco product characteristics affect their potential to cause morbidity and mortality, including animal and cell culture models as well as novel alternative toxicology approaches that test the toxicity of tobacco smoke, aerosols, or specific constituents in tobacco. Given the chronic nature of the human health effects of tobacco products, the assessment of both chronic and acute tobacco product toxicity is important. Assays that can address chronic toxicity resulting from long term tobacco use are a priority and an important piece of the evaluation of the human health effects of tobacco products. Priorities include toxicological assays (in vivo and in vitro) to compare toxicity across different types of tobacco products within the same class including electronic nicotine delivery systems (ENDS), cigars, waterpipes and smokeless tobacco; how product design characteristics (and changes in those characteristics) impact constituent exposure and toxicity from tobacco products; biomarkers to assess exposure, as well as biomarkers to assess harm or toxicity of non-cigarette tobacco products, including ENDS.

Addiction - Understanding the effect of tobacco product characteristics on addiction and abuse liability. Priorities include impact of changes in tobacco product characteristics (such as flavors, product design) on dependence; differences in dependence and tobacco use patterns with use of low nicotine content cigarettes in context with other tobacco products; the amounts of nicotine delivered to ENDS users during experimentation, regular ENDS use, dual use of ENDS and cigarettes, and cigarette smoking quit attempts; correlation of ENDS use behaviors with pharmacokinetic and pharmacodynamics effects of nicotine and other HPHCs delivered by ENDS.

Health Effects - Understanding the short and long term health effects of tobacco products. Highest priority areas include cardiovascular or respiratory health effects, including inflammation. Other health effects including cancer, oral health or reproductive health may be included within projects but should not be the primary focus of the application. Priorities include impact of changes in tobacco product characteristics (such as flavors, product design) on human health; biomarkers to assess short and long-term effects of non-cigarette tobacco products; clinical evaluations to distinguish changes in cell function/physiology specific to tobacco exposure (e.g., ENDS aerosol exposure) known to indicate longer term disease development and progression.

Behavior - Understanding the knowledge, attitudes, and behaviors related to tobacco product use and changes in tobacco product characteristics. Priorities include changes in tobacco product characteristics (such as flavors, product design, packaging) impact on tobacco use behaviors including experimentation, initiation, dual/poly use, transition to non-flavored products, and cessation; innovative methods and measures to assess tobacco use behaviors; measures, methods, or study designs to assess the likely impact of novel and/or potential modified risk tobacco products on tobacco behavior, including perceptions, susceptibility, experimentation, adoption, switching, and use (including dual use); measures (e.g., attitudes, perceptions, intentions) to best predict future behaviors of non-cigarette tobacco product use, including current and established users of cigars, waterpipe, and ENDS.

Communications Understanding how to effectively communicate to the public and vulnerable populations regarding nicotine and the health effects of tobacco products, including media campaigns, and digital media. Priorities include messages to effectively communicate about nicotine and the harms of non-cigarette tobacco product use; methods and messages for communicating complex scientific concepts to the general public, including risk and harms of tobacco use taking into account unintended consequences.

Marketing Influences Understanding why people become susceptible to using tobacco products (both classes of products and products within classes) and transitions between experimentation, initiation to regular use and dual use. Topics may include tobacco industry marketing such as advertising, point-of-sale, digital media, and promotions. Priorities include methods, measures, and study designs to best assess the impact of tobacco product advertising, and promotion restrictions on users and non-users of tobacco including marketing of novel and/or potential modified risk tobacco products; impact of potential marketing restrictions on youth experimentation, initiation, use and cessation.

Impact Analysis Understanding impact of potential FDA regulatory actions. Priorities include evaluation of policies at the state and community level that fall within FDA CTP regulatory authorities; methods and measures (e.g., behavioral economics, population modeling) to estimate the range of potential impacts on behavior and health of potential FDA regulatory actions such as products standards addressing toxicity, appeal, and addiction.

The term "characteristic" used above, encompasses materials, ingredients (including additives and flavors), design, composition, heating source and other features of a tobacco product including harmful and potentially harmful constituents. Product characteristics can be incorporated into all of the above topics.

Applications may focus on one or more classes of tobacco products. If a vulnerable population will be included, applicants will be expected to identify the population and how the population is important to the research question, taking into account the impact on population health. Vulnerable populations include:

  • Youth and young adults
  • Race/ethnicity
  • Low SES
  • Rural populations
  • People with mental health or medical co-morbidities
  • Military/veterans
  • The LBGTQ community
  • Pregnant women/women of reproductive age

NON-RESPONSIVE RESEARCH TOPICS

Although the following research topics may be within FDA CTP's regulatory authorities to fund, they are not covered by this FOA and will be deemed non-responsive:

  • Studies of short term health effects and/or acute topography/clinical pharmacology testing of early generation ENDS products
  • Mechanistic studies/basic science of disease development unless biomarkers of harm with predictive value for disease development associated with tobacco product use is an outcome
  • Short-term studies of the acute effects of reduced nicotine content cigarettes
  • When addressing chronic toxicity, short-term studies (i.e., 90 days or less) of acute or subchronic toxicity without a rationale explaining how shorter studies are relevant to long-term effects
  • Graphic health warnings for cigarette packages and advertisements
  • Communicating harmful and potentially harmful constituents to the public
  • Impacts of marketing restrictions on adults
  • Descriptive studies of demographics and/or risk perceptions that describe only exposure to advertising without linking exposure to tobacco use behaviors

Projects must propose research aims that are within the regulatory authority of FDA CTP and the scientific interest areas identified in this FOA in order to be considered responsive to this FOA. Research proposed must be specific to the United States population and provide information that will be useful to United States regulations. As such, investigators are strongly encouraged to discuss whether their application is responsive to this FOA with a Scientific/Research Contact, listed in Section VII, prior to submission of their application. Additional information, including research priorities and a Frequently Asked Questions document can be found at:http://prevention.nih.gov/tobacco/.

SPECIAL CONSIDERATIONS

Applicants should keep the following special considerations in mind as they prepare their applications:

  • Data Harmonization for Tobacco Regulatory Research via the PhenX Toolkit: NIH and FDA encourage investigators involved in human-subjects studies to employ a common set of tools and resources that will promote the collection of comparable data across studies and to do so by incorporating the measures from the Core and Specialty collections, which are available in the Tobacco Regulatory Research Collection of the PhenX Toolkit (www.phenxtoolkit.org).
  • Tobacco Industry Funding of Applicants: The FDA CTP has adopted the following guidance regarding tobacco industry funding of applicants responding to this FOA.
  • The National Advisory Council on Drug Abuse (NACDA) has set forth points with regard to existing or prospective sponsored research agreements with tobacco companies or their related entities and the impact of acceptance of tobacco industry funding on NIDA's credibility and reputation within the scientific community. Please see (https://www.drugabuse.gov/about-nida/advisory-boards-groups/national-advisory-council-drug-abuse-nacda/council-statements/points-to-consider-regarding-tobacco-industry-funding-nida) for details. While this guidance was originally issued for NIDA applicants, it is relevant for all applications submitted under this FOA.
  • Recommended Guidelines for the Administration of Drugs to Human Subjects: NACDA also recognizes the importance of research involving the administration of drugs with abuse potential, and dependence or addiction liability, to human subjects. Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's Web site at https://www.drugabuse.gov/funding/clinical-research/nacda-guidelines-administration-drugs-to-human-subjects.

See Section VIII. Other Information for award authorities and regulations.

Special Note

The NIH participating institutes invite K99 applications from candidates interested in pursuing careers in regulatory science as it relates to the regulation of tobacco products and the FDA's new authorities under the Family Smoking Prevention and Tobacco Control Act. 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 Webinar

The NIH anticipates holding one or more pre-application webinars to which all interested prospective applicants are invited. NIH Program and Review staff persons will explain the goals and objectives of the Mentored Research Scientist 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 webinars will be available at http://prevention.nih.gov/tobacco/.

Travel

The NIH will require awardees to travel to and participate in up to 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.

Note: This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary study to a clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor. Applicants proposing a clinical trial or an ancillary study to an ongoing clinical trial as lead investigator, should apply to the companion FOA RFA-OD-18-008.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information
Funding Instrument

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

Application Types Allowed

New
Resubmission

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

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials
Note: Applicants may propose to gain experience in a clinical trial led by a mentor/co-mentor as part of their research career development.

Need help determining whether you are doing a clinical trial?

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.

FDA intends to commit $1.5 million to support 6-10 awards to FOA Pathway to Independence Award in Tobacco Regulatory Research (K99/R00 - Independent Clinical Trial Not Allowed) and Pathway to Independence Award in Tobacco Regulatory Research (K99/R00 - Independent Clinical Trial Required). Awards are contingent upon funds available from the FDA 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 5 years.

Other Award Budget Information
Salary

FDA CTP will contribute up to $ 90,000 per year toward the salary of the career award recipient. Further guidance on budgeting for career development salaries is provided in the SF424 (R&R) Application Guide. See also NOT-OD-17-094

Intramural: Budget details for the mentored phase will be negotiated with the sponsoring intramural laboratory Institute/Center and salary will be consistent with that offered new scientists in similar positions. Funding will be provided by the FDA Center for Tobacco Products.

Extramural: Mentored candidates at an extramural sponsoring institution/organization will be supported by NIH extramural funds. The requested 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 with equivalent qualifications, rank, and responsibilities in the department concerned. Further guidance on budgeting for career development salaries is provided in the SF424 (R&R) Application Guide.

The total salary may not exceed the legislatively mandated salary cap.

See: https://grants.nih.gov/grants/policy/salcap_summary.htm.

Independent Phase (R00) The total cost for the independent phase (R00) may not exceed $249,000 per year. This amount includes salary, fringe benefits, research costs, and applicable indirect costs. Indirect costs will be reimbursed at the extramural sponsoring institution's indirect cost rate. Indirect costs requested by consortium participants are included in the total cost limitation.

Other Program-Related Expenses

FDA CTP will 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 expenses may include (a) tuition and fees related to career development activities; (b) supplies, equipment and technical personnel; c) travel to research and grantee 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

For the extramural K99 phase, Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs. For the R00 phase, indirect costs will be reimbursed at the extramural sponsoring institution's indirect cost rate.

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

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

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)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations

The sponsoring institution may be private (profit or nonprofit) or public, including the NIH Intramural Programs and other Federal laboratories.

The applicant institution will be the mentored phase (K99) institution. All institution/organization types listed above are eligible for both the mentored (K99) and independent (R00) phase, with the following exceptions: (1) Eligible agencies of the Federal government, such as the NIH intramural program, are eligible only for the mentored phase; and (2) Eligibility of organizations, other than institutions of higher education, for the R00 phase depends on the nature of the appointment, and the ability of the PD/PI to conduct independent tobacco regulatory science research and apply for NIH research (R01 or R01-equivalent) grants.

Foreign Institutions

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

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

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 mentor and 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.

K99/R00 applicants must have no more than 4 years of postdoctoral research experience as of the relevant application due date regardless of whether it is a new or resubmission application. Individuals must be in mentored, postdoctoral training positions to be eligible to apply to the K99/R00 program. If an applicant achieves independence (i.e., any faculty or non-mentored research position) before a K99 award is made, neither the K99 award, nor the R00 award, will be issued.

Parental leave or other well-justified leave for personal or family situations of generally less than 12 months duration (e.g., family care responsibilities, disability or illness, active military duty) is not included in the 4-year eligibility limit. In addition, time spent conducting postgraduate clinical training that does not involve research is not considered as part of the 4-year research training eligibility limit. Only time dedicated to research activities would count toward the 4-year limit.

Additional clarifications are provided under Frequently Asked Questions. Potential candidates are encouraged to discuss their individual situation with an NIH Institute or Center Scientific Program Contact before applying. - See more at: NOT-OD-15-013, and NOT-OD-15-153.

There is no citizenship requirement for K99 applicants. An applicant may be a citizen or a non-citizen national of the United States, 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), or be a non-U.S. citizen.

For applications submitted on behalf of non-U.S. citizens with temporary U.S. visas, visa status during each phase of the K99/R00 award must allow the PD/PI to conduct the proposed research at the applicant institution. For the K99 phase of the award, the applicant institution is responsible for determining and documenting, in the K99 application, that the candidate's visa will allow him or her to remain in the U.S. long enough to complete the K99 phase of the award. For the R00 phase of the award, the U.S institution at which the R00 phase of the award will be conducted is responsible for determining and documenting, in the R00 application, that the PD/PI's visa will allow the PD/PI to remain in the U.S. for the duration of the R00 award.

Candidates for the K99/R00 award must have a clinical or research doctorate (including PhD, MD, DO, DC, ND, DDS, DMD, DVM, ScD, DNS, PharmD or equivalent doctoral degrees). Clinicians (including those with MD, DDS, DVM and other licensed health professionals) in a clinical faculty position that denotes independence in clinical responsibilities but not in research may also be eligible for the K99/R00 award.

Individuals are NOT eligible if they:

  • Have currently or previously held an independent research faculty or tenure-track faculty position, or its equivalent, in academia, industry or elsewhere; or
  • Have more than 4 years of related postdoctoral research training at the time of initial application or resubmission; or
  • Have been an independent PD/PI on NIH research grants (e.g. R01, R03, R21), NIH career development awards (e.g., K01, K07, K08, K23, K25), or other peer-reviewed NIH or non-NIH research grants over $100,000 direct costs per year, or project leaders on sub-projects of program project (P01) or center (P50) grants.

Ph.D. (or equivalent research doctorate degree) candidates in positions other than postdoctoral fellow positions: It is recognized that some institutions appoint postdoctoral fellows in positions with other titles although they are still in non-independent, mentored training positions. Candidates in such positions are encouraged to obtain confirmation of their eligibility from the relevant IC before they begin to prepare their applications. It is incumbent upon the candidate to provide evidence that his or her position complies with the intent of this eligibility requirement. If a potential applicant is in a position that is not clearly identifiable as a postdoctoral training position, the request for an exception must be accompanied by an official statement of the institution's policy (e.g. published position description in an official institutional document) which documents the position as a mentored, postdoctoral training position.

Clinicians (including those with M.D., D.D.S, D.V.M. and other licensed professionals) in positions not designated as postdoctoral positions: Following clinical training or fellowship training periods, clinicians often obtain a clinical faculty position that denotes 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 K99/R00 award, and should contact a Program Director at the relevant NIH Institute 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 awards (see K Kiosk) available for junior faculty development.

The following is provided as an aid to distinguish independent from non-independent positions: However, it is not sufficient merely to cite one or more of the following items to document eligibility.

Evidence for non-independence may include:

  • The candidate's research is entirely funded by another investigator's grants.
  • The candidate's research is conducted entirely in another investigator's assigned space.
  • According to institutional policy, the candidate cannot hire postdoctoral fellows or technical staff or be the responsible supervisor of graduate students.
  • According to institutional policy, the candidate is not allowed to submit an application as the PD/PI of an NIH research grant application (e.g., R01).
  • The candidate lacks other rights and privileges of faculty, such as attendance at faculty meetings.

Conversely, evidence for independence, and therefore lack of eligibility, includes:

  • The candidate has a full-time faculty position.
  • The candidate received a start-up package for support of his/her independent research.
  • The candidate has research space dedicated to his/her own research.
  • The candidate may attend faculty meetings, be the responsible supervisor for graduate students, and/or hire technical support or postdoctoral fellows.
  • The candidate is eligible to apply for independent research funding as the PD/PI of an NIH research grant.
2. Cost Sharing

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

3. Additional Information on Eligibility
Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct, and each is from a different candidate.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. An individual may not have two or more competing NIH career development applications pending review concurrently. In addition, NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).
Level of Effort

At the time of award, the candidate must have a "full-time" appointment at the academic institution. Candidates are required to commit a minimum of 75% of full-time appointment(i.e., a minimum of 9 person-months) to their program of career development during the mentored phase. Candidates may engage in other duties as part of the remaining 25% of their full-time appointment not covered by this award, as long as such duties do not interfere with or detract from the proposed career development program.

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.

After the receipt of the award, adjustments to the required level of effort may be made in certain circumstances. See NOT-OD-09-036 for more details.

R00 Phase. Although candidates are required to devote no less than 75% of their full-time, 12-month appointment to research (i.e., full-time for 9 person-months), the required 9 person-months of research effort need not be devoted exclusively to the R00-supported research.

Mentor(s)

Before submitting the application, the candidate must identify a mentor(s) who will supervise the proposed career development and research experience. The mentor should be an active investigator in the area of the proposed research and be committed both to the career development of the candidate and to the direct supervision of the candidate's research. At least one member of the supervisory mentoring team must have expertise in the field of tobacco research as it relates to the regulation of tobacco products and FDA's regulatory authorities. The mentor must document the availability of sufficient research support and facilities for high-quality research. Candidates are encouraged to identify more than one mentor, i.e., a mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research career development program. In such cases, one individual must be identified as the primary mentor who will coordinate the candidate's research. The candidate must work with the mentor(s) in preparing the application. The mentor, or a member of the mentoring team, should have a successful track record of mentoring individuals at the candidate's career stage. Where feasible, women, individuals from diverse racial and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models.

Institutional Environment

The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified to serve as mentor(s) in biomedical, behavioral, or clinical research. The institution must demonstrate a commitment to the development of the candidate as a productive, independent investigator with research projects that address 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. The institution must also be willing to allow the protected time needed by the candidate. The candidate, mentor(s), and institution must describe a research career development program that will maximize the use of this environment, including available facilities and resources.

Section IV. Application and Submission Information
1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

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

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

Letter of Intent

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

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

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

The letter of intent should be emailed to:

Tobacco Regulatory Science Program
Office of Disease Prevention

Email: TRSP@nih.gov

Or mailed 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

Page Limitations

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

Instructions for Application Submission

The following section supplements the instructions found in the SF 424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

Other Project Information

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

Project Summary/Abstract

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

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

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Career Development Award Supplemental Form

The PHS 398 Career Development Award Supplemental Form is comprised of the following sections:

  • Candidate
  • Research Plan
  • Other Candidate Information
  • Mentor, Co-Mentor, Consultant, Collaborators
  • Environment & Institutional Commitment to the Candidate
  • If all dates are on/after Jan 25, delete Human Subject Section below
  • Other Research Plan Sections
  • Appendix

All instructions in the SF424 (R&R) Application Guide must be followed.

Candidate Section

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

Candidate Information and Goals for Career Development

Candidate's Background

  • Describe the candidate's commitment to a career in a biomedical, behavioral, or clinical research field relevant to the mission of one of the participating NIH ICs.
  • Describe the candidate's potential to develop into a successful, independent investigator.
  • Describe the candidate's commitment to a career in a biomedical or behavioral research field relevant to the mission of tobacco regulatory science as it relates to the FDA CTP tobacco regulatory authorities.

Career Goals and Objectives

  • Describe the candidate's current and long-term research and career objectives.
  • Present a scientific history that: (1) shows a logical progression from the candidate's prior research and training experiences to the training and research experiences proposed for the mentored phase of the award (K99) and subsequently to the independent phase of the award (R00); and (2) justifies the need for further mentored career development to become an independent research investigator.
  • If currently supported by an institutional training grant or individual fellowship award (such as provided through the Ruth L. Kirschstein NRSA program), describe the candidate's current research training or fellowship program.
  • Describe how the candidate plans to separate scientifically from his/her mentor and advance to research independence.

Candidate's Plan for Career Development/Training Activities During Award Period

  • A systematic plan should be presented for obtaining the biomedical, behavioral, or clinical science background, research experience, and career development activities necessary to launch the stated independent research career. Describe current activities and how they relate to the candidate's career development plans and career goals. Describe proposed activities, e.g., those that will lead to new and/or enhanced research skills and knowledge, as well as related skills such as grant-writing, communication, leadership, and laboratory management. The career development plan must be specifically tailored to meet the needs of the candidate and the goal of achieving independence as a researcher.
  • Describe how the skills and knowledge obtained during the mentored phase will enhance research productivity and facilitate the development of new approaches and directions for investigation. Describe how the career development plan will promote the candidate's success and transition to scientific independence. Candidates must justify the need for the award, particularly the mentored (K99) phase, and must provide a convincing case that the proposed period of support (1-2 years as a mentored candidate followed by up to 3 years as an independent scientist) will substantially enhance his/her career and/or will allow the pursuit of a novel or promising approach to a particular research problem. Candidates should make clear why additional mentored research training and career development are critical before transitioning to research independence and pursuit of the proposed independent phase research.
  • The candidate must describe a plan, including a timeline with milestones, for evaluation of his/her progress during the mentored phase and for the transition to the independent phase.
  • The candidate and K99-phase mentor (see below) must describe a specific plan for the transition to the independent phase.

Research Plan Section

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

Research Strategy

  • The research plan must span both phases of the K99/R00 award. The candidate should clearly indicate the research planned for each phase. This narrative should describe what the candidate will accomplish during the mentored phase research that will enable him/her to launch an independent research program (i.e., what does the candidate still need to accomplish during the mentored phase in order to compete successfully once independence is achieved).
  • The research plan should state the significance, innovation and approach of the proposed research during the K99 and R00 phases of the award. The research plan should provide a detailed rationale, experimental approach, and expected/alternative outcomes for the proposed studies. Although it is anticipated that candidates will be best able to describe their current and past research, the research plan for the R00 phase of the award should be described in sufficient detail for reviewers to evaluate the merit of this component of the application.
  • Describe the relationship between the mentor's research and the candidate's proposed research. Describe how the candidate will gain independence from his/her mentors and separate his/her scientific research program from that of the mentor(s).
  • 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 proposal will address one or more of the seven FDA CTP research priorities is strongly advised.
  • The research should address an important problem or critical barrier to progress in the field of tobacco regulatory science.
  • If the applicant is proposing to gain experience in a clinical trial, ancillary study to a clinical trial or a clinical trial feasibility study as part of his or her research career development, describe the relationship of the proposed research project to the clinical trial.

Training in the Responsible Conduct of Research

  • All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). See SF424 (R&R) Application Guide for instructions.

Mentor, Co-Mentor, Consultant, Collaborators Section

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

  • The application must include a statement from the primary mentor that provides: 1) information on his/her research qualifications and previous experience as a research supervisor; 2) a plan describing the nature of the supervision and mentoring that will occur during the proposed K99 award period, including how the candidate's scientific and professional independence will be promoted; 3) a description of the elements of the planned research training and career development, including any formal course-work; 4) a plan for transitioning the candidate from the mentored phase to the independent phase of the award and a description of how the mentor will help the candidate achieve scientific independence from his/her mentor(s); 5) a statement identifying the components of the proposed research that the K99 applicant can take when he/she transitions to research independence and that can be part of his/her independent (R00) phase award; and 6) when appropriate, a statement affirming any resources and reagents that can be taken by the applicant to the independent phase of the award. If the primary mentor has limited training experience, a co-mentor with a strong, successful track record as a mentor should be included.
  • The mentor should have sufficient independent research support to cover the costs of the proposed K99 research project in excess of the allowable costs of this award, and should state that needed costs will be covered. If funds are needed beyond what will be provided by the mentor, the source of additional funds should be identified and documented in a letter signed by the responsible individual.
  • Similar information must be provided by all co-mentors. If more than one mentor is proposed, the respective areas of expertise, the responsibility of each, and the nature of the involvement with the candidate should be explicitly described. Co-mentors should describe clearly how they will coordinate with the primary mentor and the candidate to provide an integrated mentoring effort.
  • The primary mentor must agree to write and provide annual and mid-year evaluations of the candidate's progress for the initial mentored phase as required in the annual progress report.
  • The mentor must agree to assist the candidate in transitioning to an independent research position by guiding the candidate during the job search and negotiation process and by commenting on the R00 phase application.
  • If the applicant is proposing to gain experience in a clinical trial as part of his or her research career development, the mentor or a member of the mentoring team must include a statement to document leadership of the clinical trial, and appropriate expertise to guide the applicant in any proposed clinical trials research experience.

Letters of Support from Collaborators, Contributors and Consultants

  • Signed statements must be provided by all collaborators and/or consultants confirming their participation in the project and describing their specific roles. Collaborators and consultants do not need to provide their biographical sketches unless also listed as senior/key personnel. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration.
  • Advisory committee members (if applicable): Signed statements must be provided by each member of the proposed advisory committee. These statements should confirm their participation, describe their specific roles, and document the expertise they will contribute. Unless also listed as senior/key personnel, these individuals do not need to provide their biographical sketches.

Environmental and Institutional Commitment to the Candidate

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

Description of Institutional Environment

  • The sponsoring 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.
  • 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.

Institutional Commitment to the Candidate's Research Career Development

  • The sponsoring institution must provide a statement of commitment to the candidate's development into a productive, independent tobacco regulatory science investigator, i.e. conducting the proposed mentored research and career development during the K99 phase and competing for, and transitioning to, a tenure-track assistant professor position at an academic institution. While the K99 phase sponsoring institution is not responsible for sponsoring the applicant during the R00 phase, it should be supportive of the candidate prior to initiation of the R00 phase.
  • Provide assurance that the candidate will be able to devote a minimum of 9 person-months (75% of full-time appointment) to the development of his/her research program. The remaining effort should be devoted to activities related to the development of the candidate's career as an independent scientist.
  • Provide assurance that the research facilities, resources, and training opportunities, including faculty capable of productive collaboration with the candidate, will be available for the candidate's planned career development and research programs during the K99 award period.
  • Provide assurance that appropriate time and support for any proposed mentor(s) and/or other staff consistent with the career development plan will be available during the K99 award period.
  • For individuals in postdoctoral positions with other titles although still in non-independent, mentored training positions, provide evidence of eligibility for the K99/R00 program.
  • If the candidate is not a U.S. Citizen or permanent resident, the sponsoring institution must include information about the candidate's visa status, an assurance that the candidate's visa provides sufficient time to complete the K99 phase of the award at a U.S. institution, and assurance that there are no known obstacles (e.g. home country requirement) to the candidate obtaining a visa at the time of the R00 transition.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide. 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 publicly in support of regulation, institutions of higher education, hospitals, and other non-profit organizations are subject to the Freedom of Information Act (FOIA) as outlined in 2 CFR 200 (http://gpo.gov/fdsys/pkg/CFR-2015-title2-vol1/pdf/CFR-2015-title2-vol1-part200.pdf) and Section 2.3.11.2.2 of the NIH Grants Policy Statement.

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

  • Do not complete Section 4 Protocol Synopsis information or Section 5 - Other Clinical Trial-related Attachments.

Delayed Onset Study

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide must be followed.

Reference Letters

Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when reference letters will be accepted. 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.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and Times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. 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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

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.

7. Other Submission Requirements and Information

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission contact the Application Submission Contacts in Section VII.

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 and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive to the scientific interest areas identified in this FOA, and/or proposing work outside FDA-CTP's regulatory authority will not be reviewed.

In order to expedite review, applicants are requested to notify the Tobacco Regulatory Science Program by email at TRSP@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

Important Update: See NOT-OD-18-229 for updated review language for due dates on or after January 25, 2019.

1. Criteria

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

For this particular announcement, note the following: Reviewers should evaluate the candidate's potential for developing an independent tobacco regulatory science research program that will make important contributions to the field, taking into consideration the years of research experience and the likely value of the proposed research career development as a vehicle for developing a successful, independent research program.

Overall Impact

Reviewers should provide their assessment of the likelihood that the proposed career development and research plan will enhance the candidate's potential for a productive, independent scientific research career in a health-related field, taking into consideration the criteria below in determining the overall impact score.

Scored Review Criteria

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

Candidate

  • Based on the candidate's prior research and training experience, track record, referee's evaluations, and the quality and originality of prior research and the current application, what is the candidate's potential to become a highly successful, independent investigator who will contribute significantly to his/her chosen field of biomedical, behavioral, or clinical related research?
  • Considering the years of postdoctoral research experience to date, what is the candidate's record of research productivity, including the quality of peer-reviewed scientific publications?
  • What is the quality of the candidate's pre- and postdoctoral research training, with respect to development of appropriate scientific and technical expertise?
  • Given the candidate's prior training, proposed career development plan, and the referees' evaluations, is it reasonable to expect that the candidate will be able to achieve an independent, tenure-track or equivalent faculty position within the time period requested for the K99 phase of this award?

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

  • Are the content and duration of the proposed components of the career development plan appropriate and well-justified for the candidate's current stage of scientific and professional development and proposed research career goals?
  • To what extent does the proposed career development plan enhance or augment the applicant's research training and skills acquisition to date?
  • Is the proposed career development plan likely to contribute substantially to the scientific and professional development of the candidate, and facilitate his/her successful transition to independence?
  • To what extent are the plans for evaluating the K99 awardee's progress adequate and appropriate for guiding the applicant towards a successful transition to the independent phase of the award?
  • To what extent are the mentor's research qualifications and experience, scientific stature, and mentoring track record appropriate for the applicant's career development needs in order to foster his/her development into a productive tobacco regulatory science researcher?
  • Is the proposed career development plan likely to contribute substantially to the scientific and professional development of the candidate, and facilitate his/her successful transition to independence?
  • Is the timeline planned for transition to the independent phase of the award appropriate for the candidate's current stage of scientific and professional development, anticipated productivity, and the career development proposed for the K99 phase of the award?
  • If proposed, will the clinical trial experience contribute to the applicant's research career development in tobacco regulatory science?

Research Plan

  • Is the proposed K99 phase research significant and scientifically sound?
  • Is there a strong scientific premise for the project?
  • Has the candidate presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?
  • Has the candidate presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
  • Are the scientific and technical merits of the K99 research appropriate for developing the research skills described in the career development plan, and appropriate for developing a highly successful R00 research program?
  • Is the proposed R00 phase research significant, scientifically sound, and a logical extension of the K99 phase research? Is there evidence of long-term viability of the proposed R00 phase research plan?
  • Does the R00 phase project address an innovative hypothesis or challenge existing paradigms? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies?
  • To what extent is the proposed R00 phase research likely to foster the career of the candidate as a successful, independent investigator in biomedical, behavioral, or clinical research?
  • To what extent is the proposed R00 phase research likely to foster the career of the candidate as an independent investigator in tobacco regulatory research?
  • If proposed, will the clinical trial experience contribute to the research project?

Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)

  • To what extent does the mentor(s) have a strong track record in training future independent researchers?
  • To what extent are the mentor's research qualifications and experience, scientific stature, and mentoring track record appropriate for the applicant's career development needs?
  • Is the supervision proposed for the mentored phase of support adequate, and is the commitment of the mentor(s) to the applicant's career development appropriate and sufficient?
  • Does the mentor describe an acceptable plan for clear separation of the candidate's research and research career from the mentor's research, including identifying the components of the research plan that the K99 candidate may take to an independent research position?
  • Are the consultants'/collaborators' research and/or mentoring qualifications appropriate for their roles in the proposed K99 phase of the award? Do they provide letters of support that affirm their commitment? If applicable, are the Advisory Committee members' qualifications appropriate for their roles in the proposed K99 phase of the award? Do they provide letters of support that affirm their commitment?
  • Does the mentor provide an appropriate plan that addresses the candidate's training needs, and that is likely to foster the candidate's continued development and transition to independence?
  • To what extent are the mentor(s) research qualifications and experience, scientific stature, and mentoring track record appropriate for the applicant's career development needs in order to foster his/her development into a productive tobacco regulatory science researcher?
  • If the applicant is proposing to gain experience in a clinical trial as part of his or her research career development, is there evidence of the appropriate expertise, experience, and ability on the part of the mentor(s) to guide the applicant during participation in the clinical trial?

Environment & Institutional Commitment to the Candidate

  • To what extent does the institution provide a high quality environment appropriate for the candidate's development during the K99 phase of the award?
  • To what extent are the research facilities and educational opportunities, including collaborating faculty, adequate and appropriate for the candidate's research and career development goals during the K99 phase of the award? Is adequate evidence provided that the K99 sponsoring institution is strongly committed to fostering the candidate's development and preparation for transition to independence?
  • Is there adequate assurance that the required minimum of 9 person-months (75% of the candidate's full-time appointment) will be devoted directly to the research training, career development, and research activities proposed for the K99 phase of the award?
Additional Review Criteria

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

Protections for Human Subjects

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 Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. 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

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

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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

Training in the Responsible Conduct of Research

All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the level of experience of the applicant, including any prior instruction or participation in RCR as appropriate for the applicant's career stage, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the mentor(s) and other faculty involvement in the fellow's instruction; 4) Duration of Instruction - the number of contact hours of instruction (at least eight contact hours are required); and 5) Frequency of Instruction instruction must occur during each career stage and at least once 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. See also: NOT-OD-10-019.

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) Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), 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 Council or Board. 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.
3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date

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

Section VI. Award Administration Information
1. Award Notices

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

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

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

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

There will not be a formal Notice of Award (NoA) associated with the K99 phase of the award conducted in the NIH intramural program. The awarding Institute will transmit to the successful candidate an approval letter which will include the terms and conditions of the NIH intramural "K99" award, as well as expectations for the transition to the R00 phase of the award.

2. Administrative and National Policy Requirements

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

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person's race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator's scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant's integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 "Federal awarding agency review of risk posed by applicants." This provision will apply to all NIH grants and cooperative agreements except fellowships.

Transition to the Independent Phase

Transition from the mentored phase to the independent phase is intended to be continuous in time and, except in unusual, extenuating circumstances, the awarding NIH Institute/Center will not extend the K99 phase beyond the 2-year limit. ICs may, at their discretion, make exceptions to this time limitation when individuals have been invited for faculty job interviews but final decisions have not yet been made by the potential R00 institution or, rarely, because of unusual, extenuating circumstances. To activate the independent phase of the grant, individuals must have been offered and accepted a tenure-track, full-time assistant professor position (or equivalent) by the end of the K99 project period.

An eligible R00 institution will have appropriate infrastructure to support the proposed research program and a history of external research funding. Applicants are free to apply for independent phase positions within the NIH intramural research program (IRP). However, should the individual accept such a position in the IRP, the independent phase of the award will not be activated. This is because NIH intramural scientists are supported directly by NIH intramural funds and are not eligible for NIH extramural grant awards. Such outcomes are consistent with the goals of the K99/R00 award initiative. Eligibility of for-profit organizations for the R00 phase depends on the nature of the appointment, and the ability of the PD/PI to conduct independent research and apply for NIH R01 or R01-equivalent research grants. PIs are encouraged to discuss job offers at for-profit organizations with NIH Program staff well in advance of accepting such an offer.

To avoid potential problems in activating the independent phase, applicants are strongly encouraged to contact their NIH program official as soon as plans to apply for and, assume an independent position develop, and not later than 6 months prior to the termination of the K99 phase of the award.

At that time, individuals should discuss plans for transition to, and application for, the R00 phase with their NIH program official. The application for the R00 phase of the award should be submitted no later than 2 months prior to the proposed activation date of the R00 award by the R00 phase grantee organization.

The independent phase institution will submit an application on behalf of the candidate for the R00 award using the PHS 398 Application. The R00 application must include:

  • A new face page signed by the R00 phase institutional representative;
  • A new project description page (the project summary or abstract should be updated to reflect current plans for the R00 phase);
  • Detailed budget pages for a non-modular budget;
  • Biographical sketches;
  • A new Resources page;
  • A brief description of progress made during the K99 phase that will serve as the Final Progress Report for the K99 phase;
  • An updated research plan (the specific aims should be updated to reflect current plans for the R00 phase and the updated research plan should be briefly described in less than 5 pages);
  • Updated Protections for Human Subjects and Inclusion of Women, Minorities and Children (as appropriate);
  • Updated Vertebrate Animals (as appropriate);
  • Updated Biohazards (as appropriate); and
  • A new checklist.

These materials should be sent directly to the awarding Institute or Center (IC). The original application plus one copy (preferably in PDF format) are to be mailed (or e-mailed) to the Financial or Grants Management contact person of the awarding NIH Institute or Center listed in the Notice of Award. The R00 application will be evaluated by extramural Program staff of the awarding component for completeness and appropriateness to the program.

Two additional documents are included with the R00 application. A letter from the R00 Department or Division Chairman must be submitted that describes the R00 institution's commitment to the candidate and plans for his/her career development (see below). If not already provided, the final evaluation statement by the K99 phase mentor, must be provided.

In addition to space, facilities, resources, and other support needed to conduct the proposed research, the sponsoring institution must provide protected research time (minimum of 9 person-months or 75% of the candidate's full time appointment) at least for the duration of the R00 award. The start-up package and other institutional support must be described in detail and must be comparable to that given to other faculty recently hired into tenure-track or equivalent faculty positions. Institutions must provide a startup and salary package equivalent to that provided to a newly hired faculty member who does not have a grant; R00 funds may not be used to offset the typical startup package or to offset the usual institutional commitment to provide salary for tenure-track (or equivalent) assistant professors who are hired without grant support. The R00 sponsoring institution must describe the candidate's academic appointment, bearing in mind that it must be tenure-track assistant professor (or equivalent), and confirm that the appointment is not contingent on the transfer of the award to the institution. The R00 phase institution must describe how the awardee's ability to apply for and secure independent research grant (R01) support will be fostered and supported during the R00 phase of the award. The R00 award requires that a minimum of 9 person-months (75% full time appointment) be devoted to research activities. Consequently, teaching, clinical duties and other non-research activities should be minimal during the R00 award period. NIH staff may review start-up packages and other commitments between the institution and candidate prior to activating the independent phase of the award. It is suggested that the applicant and/or the hiring institution discuss the institutional commitment with the relevant NIH institute Program Official prior to finalizing the offer. NIH will not activate the independent phase if the institutional commitment is deemed inadequate. Applicants who are approved to transition will receive a Notice of Award for the R00, the dollar amount, and the new recipient organization (if applicable).

The K99/R00 award is intended to facilitate successful transition to independence. Consequently, a requirement for activation of the R00 phase is successful completion of this transition. Applicants are encouraged (but not required) to apply for independent positions at departments and institutions different from where they conducted their mentored research. It is important for all applicants, but especially so for applicants who intend to stay at the mentored phase institution for the independent phase, to provide a plan by which they will separate from their mentor and advance to independence. Awardees are also encouraged to include a plan and timeline for submitting an independent research grant application in a research area relevant to the mission of an NIH awarding component.

Candidates who are not approved to transition will receive written notification from the awarding component communicating the rationale for the disapproval. This notification typically will be sent within 60 days of receipt of the R00 application.

Although the financial plans of the NIH Institute or Center provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

Termination of the K99 award phase

If transition from the K99 phase at an extramural institution to the R00 phase occurs at the originally scheduled end date of the K99 award, then no specific steps to terminate the K99 award are necessary. If the transition at an extramural institution occurs prior to the scheduled end date, then a revised Notice of Award will be issued to terminate the K99 phase award. Carry-over of unspent funds from a partially completed year in the K99 phase into the R00 phase may be permitted.

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement. The Supplemental Instructions for Individual Career Development (K) RPPRs must be followed. The Mentor's Report must include an annual and mid-year evaluation statement of the candidate's progress.

A final RPPR, 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.

A mid-year report will be due every six (6) months following the project start date, as well as the annual progress report. Electronic copies should be sent to the Grants Management Specialist listed on the Notice of Grant Award. The scientific summary should be a maximum of two (2) pages.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

4. Evaluation

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

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)

Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)

Telephone: 301-945-7573

Scientific/Research Contact(s)

NCI Contact for Matters Concerning the K99 Mechanism

Sergei Radaev, PhD
National Cancer Institute (NCI)
Telephone: 240-276-5630
Email: sergei.radaev@nih.gov

NCI Contact for Scientific Questions

Rachel Grana Mayne, PhD
National Cancer Institute (NCI)
Telephone: 240-276-5899
Email: rachel.mayne@nih.gov

NHLBI Contact for Matters Concerning the K99/R00 Mechanism

Lora Reineck, MD
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0222
Email: lora.reineck@nih.gov

NHLBI Contact for Scientific Questions

Lisa Postow, PhD
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-877-7843
Email: lisa.postow@nih.gov

NIDA Contact for Matters Concerning the K99/R00 Mechanism

Michele Rankin, PhD
National Institute of Drug Abuse (NIDA)
Telephone: 301-480-3832
Email: michele.rankin@nih.gov

NIDA Contact for Scientific Questions

Mary Kautz, PhD
National Institute of Drug Abuse (NIDA)
Telephone: 301-443-3206
Email: mary.kautz@nih.gov

NIEHS Contact for Matters Concerning the K99/R00 Mechanism

Carol Shreffler, PhD
National Institutes of Environmental Sciences (NIEHS)
Telephone: 984-287-3322
Email: carol.shreffler@nih.gov

NIEHS Contact for Scientific Questions

Fred Tyson, PhD
National Institutes of Environmental Sciences (NIEHS)
Telephone: 984-287-3334
Email: fred.tyson@nih.gov

Peer Review Contact(s)

Weijia Ni, PhD
Center for Scientific Review (CSR)
Telephone: 301-594-3292
Email: weijia.ni@nih.gov

Financial/Grants Management Contact(s)

Carol Perry
National Cancer Institute (NCI)
Telephone: 240-276-6282
Email: carol.perry@nih.gov

Judy Sint
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-480-1307
Email: judy.sint@nih.gov

Amy Bucheimer
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-6694
Email: amy.bucheimer@nih.gov

Michelle Victalino
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-316-4666
Email: michelle.victalino@nih.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

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