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Mentored Research Scientist Career Development Award in Tobacco Regulatory Research (K01 - Independent Clinical Trial Required)

Grants to USA Investigators at Nonprofits, IHEs, For-Profits, and
Agencies for Clinical Trial Research on Tobacco Regulations

Agency Type:


Funding Source:

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US Department of Health and Human Services - National Institutes of Health (NIH)

LOI Date:


Deadline Date:

11/08/19 5:00 PM Local Time of Applicant


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Grants to USA and territories principal investigators affiliated with nonprofits, IHEs, for-profits, local, state, and Tribal governments, school districts, and organizations for clinical trial-based research projects on tobacco regulations. Required registrations may take several weeks to complete. Funding is intended to support researchers involved in a clinical trial feasibility study, an independent clinical trial, or a separate ancillary study to an existing trial, as part of their research and career development.

The objective of the NIH Mentored Research Scientist Development Award (K01) is to provide salary and research support for a sustained period of "protected time" (3-5 years) for intensive research career development, under the guidance of an experienced mentor, or sponsor in the biomedical, behavioral or clinical sciences leading to research independence. The expectation is that, through this sustained period of research career development and training, awardees will launch independent research careers and become competitive for new research project grant (e.g., R01) funding.

Investigators who have the quality and breadth of training necessary to conduct cutting-edge research related to the regulation, manufacture, distribution and marketing of tobacco products are needed. All applicants responding to this FOA are expected to propose research that responds to the priorities of the FDA Center for Tobacco Products as outlined in the Program Scope and Research Objectives.

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. 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
- Addiction
- Health Affects
- Behavior
- Communications
- Marketing Influences
- Impact Analysis

For more information on these interest areas and a list of special considerations, see the RFP on the URL For Full Text link below.

GrantWatch ID#:

GrantWatch ID#: 183688

Estimated Total Program Funding:


Number of Grants:


Estimated Size of Grant:

- FDA CTP will contribute up to $ 90,000 per year toward the salary of the career award recipient.
- FDA CTP will contribute $ 60,000 per year toward the research development costs of the award recipient.

Term of Contract:

The total project period may not exceed 5 years.

Earliest Start Date: April 2019, July 2019, April 2020, July 2020


  • City or township governments
  • County governments
  • For profit organizations other than small businesses
  • Independent school districts
  • Indian housing authorities
  • Native American tribal governments (Federally recognized)
  • Native American tribal organizations (other than Federally funded tribal governments)
  • Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
  • Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
  • Private institutions of higher education
  • Public and State controlled institutions of higher education
  • Public housing authorities
  • See RFP and/or Grant Guidelines for full eligibility
  • Small businesses
  • Special district governments
  • State governments

Additional Eligibility Criteria:

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)

- 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)
- U.S. Territory or Possession

- 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

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.

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.

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

Current and former PDs/PIs on NIH research project (R01), program project (P01), center grants (P50), sub-projects of program project (P01), sub-projects of center grants (P50), other major individual career development awards (e.g., K01, K07, K08, K22, K23, K25, K76, K99/R00), or the equivalent are not eligible. Current and former PDs/PIs of an NIH Small Grant (R03), Exploratory/Developmental Grant (R21), Dissertation Award (R36), or SBIR/STTR (R41, R42, R43, R44) remain eligible, as do PD/PIs of Transition Scholar (K38) awards and individuals appointed to institutional K programs (K12, KL2).

Candidates for the K01 award must have a research or health-professional doctoral degree.

Pre-Application Information:

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

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.

Scientific Merit Review: October 2018, February 2019, October 2019, February 2020

Advisory Council Review: January 2019, May 2019, January 2020, May 2020

There are several options available to submit your application through to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to and eRA Commons to track your application. Check with your institutional officials regarding availability.
3. Use Workspace to prepare and submit your application and eRA Commons to track your application.

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)
- System for Award Management (SAM) (formerly CCR)
- 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 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.

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.

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.

How to apply:

View this opportunity on

Contact Information:

Before starting your grant application, please review the funding source's website listed below for updates/changes/addendums/conferences/LOIs.

The letter of intent should be emailed to:

Tobacco Regulatory Science Program
Office of Disease Prevention

Or mailed to TRSP at the address below:

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

Apply online using ASSIST:

NCI Contact for Matters Concerning the K01 Mechanism

Sergei Radaev, PhD
National Cancer Institute (NCI)
Telephone: 240-276-5630

NCI Contact for Scientific Questions

Rachel Grana Mayne, PhD
National Cancer Institute (NCI)
Telephone: 240-276-5899

NHLBI Contact for Matters Concerning the K01 Mechanism

Lora Reineck, MD
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0222

NHLBI Contact for Scientific Questions

Lisa Postow, PhD
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-877-7843

NIDA Contact for Matters Concerning the K01 Mechanism

Michele Rankin, PhD
National Institute of Drug Abuse (NIDA)
Telephone: 301-480-3832

NIDA Contact for Scientific Questions

Mary Kautz, PhD
National Institute of Drug Abuse (NIDA)
Telephone: 301-443-3206

CFDA Number:


Funding or Pin Number:

RFA-OD-18-006 (RFA-OD-18-005, K01 Research Scientist Development Award - Research & Training RFA-OD-18-007, K99/R00 Career Transition Award/Research Transition Award RFA-OD-18-008, K99/R00 Career Transition Award/Research Transition Award

URL for Full Text (RFP):

Geographic Focus:

USA: Alabama;   Alaska;   Arizona;   Arkansas;   California;   Colorado;   Connecticut;   Delaware;   Florida;   Georgia;   Hawaii;   Idaho;   Illinois;   Indiana;   Iowa;   Kansas;   Kentucky;   Louisiana;   Maine;   Maryland;   Massachusetts;   Michigan;   Minnesota;   Mississippi;   Missouri;   Montana;   Nebraska;   Nevada;   New Hampshire;   New Jersey;   New Mexico;   New York City;   New York;   North Carolina;   North Dakota;   Ohio;   Oklahoma;   Oregon;   Pennsylvania;   Rhode Island;   South Carolina;   South Dakota;   Tennessee;   Texas;   Utah;   Vermont;   Virginia;   Washington, DC;   Washington;   West Virginia;   Wisconsin;   Wyoming

USA Territories: American Samoa (USA)   Guam (USA)   Puerto Rico (USA)   Virgin Islands (USA)   Northern Mariana Islands (USA)