Part 1. Overview Information
The National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) are collaborating to support the next generation of researchers dedicated to tobacco regulatory science. This initiative, known as the Mentored Research Scientist Career Development Award in Tobacco Regulatory Research (K01), offers a unique opportunity for individuals holding research or health-professional doctoral degrees to advance their careers. While the title may mention “Air Products Phd Career Development Program Salary”, this article will focus on a distinct and vital program within the public health sector, specifically detailing the NIH/FDA K01 award which, while not directly related to “Air Products PhD Career Development Program Salary”, is a significant career development opportunity for PhD holders seeking research careers with competitive salary prospects in tobacco regulatory science. This program is designed to foster intensive, mentored career development experiences, ultimately leading to independent research careers focused on informing tobacco product regulation.
Participating organizations include the NIH, encompassing various components such as the Office of Disease Prevention (ODP), National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI), National Institute on Drug Abuse (NIDA), National Institute of Environmental Health Sciences (NIEHS), and the FDA’s Center for Tobacco Products (CTP). This collaborative effort underscores the broad scope and importance of tobacco regulatory research across different facets of public health.
This Funding Opportunity Announcement (FOA) RFA-OD-22-023, a reissue of RFA-OD-20-008, provides support through the Mentored Research Scientist Career Development Award (K01). It’s crucial to note that this specific FOA is tailored for research proposals not involving independent clinical trials. A companion FOA (RFA-OD-22-024) is available for those proposing clinical trials. This distinction ensures that researchers focusing on various aspects of tobacco regulation, including but not limited to product design, toxicity, addiction, health effects, behavior, communication, marketing influences, and impact analysis, have appropriate funding avenues.
Key dates for application submissions are outlined in detail, with deadlines in February, November, July, and March of each cycle. The expiration date of this particular announcement is September 20, 2024, following a Notice of Early Expiration (NOT-OD-24-172). Applicants are urged to adhere strictly to the SF424 (R&R) Application Guide and any program-specific instructions to avoid delays or rejection of their applications.
Key Dates
Application Due Dates | Review and Award Cycles |
---|---|
New | Renewal / Resubmission / Revision (as allowed) |
February 21, 2023 | February 21, 2023 |
November 14, 2023 | November 14, 2023 |
July 12, 2024 | July 12, 2024 * |
March 12, 2025 | March 12, 2025 * |
All applications are due by 5:00 PM local time of applicant organization. Early submission is highly recommended to allow ample time for error correction during the submission process. The expiration date for this FOA is September 20, 2024.
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
The NIH Research Career Development program is committed to cultivating a diverse and highly skilled scientific workforce to address critical national health challenges. The Mentored Research Scientist Development Award (K01) is a cornerstone of this program, offering substantial salary and research support for a protected period (3-5 years). This period is dedicated to intensive research career development under expert mentorship, aimed at enabling recipients to achieve research independence and compete for major research project grants (e.g., R01).
This FOA specifically seeks to support investigators with the expertise to conduct cutting-edge research related to the regulation of tobacco products. All research proposals must align with the priorities of the FDA Center for Tobacco Products, as mandated by the Family Smoking Prevention and Tobacco Control Act (FSPTCA).
Background
Since 2009, the FDA has been regulating tobacco products, expanding its authority in 2016 to include all tobacco products, from traditional cigarettes to electronic nicotine delivery systems (ENDS) and more. This regulatory power is grounded in the FD&C Act and the FSPTCA, empowering the FDA to establish tobacco product standards to safeguard public health.
The FSPTCA provides the FDA with crucial authority over tobacco product manufacturing, marketing, and distribution. Research funded through this FOA is intended to bolster the scientific evidence base that informs the FDA’s regulatory actions, ensuring they are grounded in the best available science.
Program Scope and Research Objectives
The FDA and NIH are united in their goal to support research that directly informs the FDA’s tobacco regulatory responsibilities. The research areas encouraged by this FOA are designed to expand the scientific foundation for effective tobacco product regulation aimed at protecting public health.
This FOA highlights specific Scientific Domains aligned with the FDA CTP mission, including:
- Product Composition and Design: Analyzing chemical constituents and developing measurement methods across diverse tobacco products.
- Toxicity: Evaluating the toxicity of tobacco products and their components using various models.
- Addiction: Investigating the impact of product characteristics on addiction and abuse liability.
- Health Effects: Studying the short- and long-term health consequences of tobacco product use, excluding conventional cigarettes.
- Behavior: Understanding knowledge, attitudes, perceptions, and behaviors related to tobacco product use.
- Communications: Developing effective public communication strategies regarding nicotine and tobacco product health effects.
- Marketing Influences: Examining the impact of tobacco marketing on product use behaviors.
- Impact Analysis: Assessing the potential and actual impact of FDA regulatory actions.
Research proposals are encouraged to focus on populations disproportionately affected by tobacco-related risks, such as youth, young adults, socioeconomically disadvantaged groups, racial and ethnic minorities, and others.
SCIENTIFIC DOMAINS: Detailed Priorities
Product Composition and Design:
- Developing standardized smoking and aerosol-generating regimens for HPHC measurement.
- Identifying and quantifying constituents in novel tobacco products like ENDS.
- Determining the relationship between ENDS design parameters and aerosol constituent yields.
- Analyzing waterpipe design and materials in relation to smoke constituent yields.
- Creating internationally recognized analytical methods for diverse tobacco types.
- Developing methods to assess nicotine release in smokeless tobacco products.
- Characterizing the antimicrobial activity of e-liquid components like PG and VG.
- Determining the link between humectant concentration and water activity in various tobacco products.
- Investigating factors contributing to ENDS battery overheating and safety incidents.
Toxicity:
- Evaluating toxicity from complex exposures to ENDS aerosol, waterpipe smoke, and smokeless tobacco.
- Analyzing how product design impacts constituent exposure and toxicity.
- Identifying biomarkers for exposure and harm from non-cigarette tobacco products.
- Assessing the toxicological impact of nicotine, flavors, and other constituents across varying use patterns.
Addiction:
- Examining the impact of product characteristics (flavors, design, nicotine formulation) on dependence and use behaviors.
- Correlating ENDS use behaviors with pharmacokinetic and pharmacodynamic effects.
- Investigating the relationship between ENDS flavors and cessation interest and attempts.
- Identifying biomarkers of exposure in ENDS users, including dual users.
- Analyzing the impact of synthetic coolants on product abuse liability and use behaviors.
Health Effects:
- Investigating the impact of product characteristics on human health, focusing on non-cigarette products.
- Analyzing biomarkers of exposure and harm from novel product use.
- Assessing the association between exclusive use of non-cigarette products and disease risk.
- Identifying biomarkers to assess short- and long-term health effects of novel tobacco products.
- Examining the link between cigar and waterpipe use and disease risk.
Behavior:
- Analyzing the impact of product characteristics on tobacco use preferences and behaviors across age groups.
- Developing innovative methods to assess tobacco use knowledge, attitudes, and perceptions.
- Creating measures and study designs to predict future use of non-cigarette tobacco products.
- Assessing the impact of ENDS and heated tobacco products on precursors to use and use behaviors.
Communications:
- Identifying effective tobacco education messages to prevent initiation, especially among youth.
- Developing methods to track attention to digital tobacco education messages.
- Creating strategies to enhance engagement with digital tobacco education.
- Identifying messages to communicate risks of nicotine and relative harms of different tobacco products.
- Developing methods to communicate complex scientific concepts about tobacco risks.
- Evaluating the effectiveness of warnings for non-cigarette tobacco products.
- Developing educational messages about the health effects of cigars, waterpipe, ENDS, and novel products.
Marketing Influences:
- Developing methods to assess the impact of marketing restrictions on tobacco product use.
- Understanding the components of ENDS marketing that most impact youth and young adults.
- Analyzing how labeling and marketing impact abuse liability and appeal.
- Examining the impact of marketing restrictions on initiation and use behaviors across age groups.
- Investigating the impact of digital tobacco marketing on youth initiation and sustained use.
Impact Analysis:
- Evaluating the impact of tobacco control policies (flavor bans, age restrictions, warnings) on use behaviors.
- Assessing the impact of marketing authorizations for new tobacco products.
- Conducting behavioral economics and modeling studies to estimate the impact of potential FDA actions.
- Evaluating the differential impact of regulatory actions on specific populations.
- Performing health risk analysis to estimate the public health impacts of FDA regulatory actions.
Non-Responsive Research
Certain research topics are deemed non-responsive to this FOA, including:
- Short-term health effects studies of early generation ENDS.
- Mechanistic studies without a focus on biomarkers of harm related to tobacco use.
- Studies developing graphic health warnings for cigarettes.
- Communicating HPHCs to the public.
- Impacts of marketing restrictions on adults (except for newly authorized products).
- Descriptive studies of advertising exposure without linking to use behaviors.
- Retailer compliance studies not linked to user behaviors or marketing.
- Studies of health professional knowledge of ENDS and other tobacco products.
Applicants are strongly encouraged to consult with NIH/FDA program staff to confirm the responsiveness of their proposed research prior to submission.
SPECIAL CONSIDERATIONS
- Tobacco Industry Funding: Applicants should be aware of guidance regarding tobacco industry funding, which may impact the perceived credibility of research in this area.
- Administration of Drugs to Human Subjects: Applicants planning research involving drug administration to human subjects should review NACDA guidelines.
Special Note: This FOA is specifically for candidates pursuing careers in regulatory science related to tobacco products and FDA authorities.
Pre-Application Webinar Information: A pre-application webinar was previously held, and resources are available online for prospective applicants. Note that research priorities have been updated in this FOA.
Travel: Awardees are required to attend the biennial Tobacco Regulatory Science Meeting in the Washington D.C. area, with travel funds provided by the award.
Clinical Trial Note: This FOA is not for independent clinical trials, but applicants can gain experience in clinical trials led by mentors.
Section II. Award Information
This funding is provided through Grants, supporting approved projects and activities. New and Resubmission applications are allowed. Clinical trials are not allowed under this FOA as lead investigator, but experience in clinical trials under mentorship is permitted.
The FDA intends to allocate $500,000 to support approximately 3 awards across this FOA and its companion FOA. Funding is contingent on available funds and meritorious applications.
Award Budget:
- Salary: FDA CTP will contribute up to $90,000 per year towards salary plus fringe benefits. Institutional salary supplementation is allowed but not from federal HHS funds.
- Other Program-Related Expenses: FDA CTP will contribute $60,000 per year for research development costs, including tuition, fees, supplies, equipment, technical personnel, travel to relevant meetings, and statistical services. Mentor salaries and administrative support are not allowed.
- Indirect Costs: Reimbursed at 8% of modified total direct costs.
Award Project Period: The project period cannot exceed 5 years.
Section III. Eligibility Information
1. Eligible Applicants:
Eligible organizations include:
- Higher Education Institutions (Public, Private, HBCUs, HSIs, TCCUs, etc.)
- Nonprofit Organizations (with and without 501(c)(3) status)
- For-Profit Organizations (Small and Large Businesses)
- Governments (State, County, City, Tribal)
- U.S. Territories
- Other (Independent School Districts, Public Housing Authorities, Faith-based Organizations, Regional Organizations)
Foreign Institutions are NOT eligible to apply.
Required Registrations:
- Applicant Organizations: Must register and maintain registrations in SAM, eRA Commons, and Grants.gov. Registration can take significant time.
- PDs/PIs: Must have an eRA Commons account and be registered with ORCID, linked to their eRA Commons profile.
Eligible Individuals (PD/PI):
- Open to any candidate with necessary skills and resources. Encourages applications from underrepresented groups.
- Must be a U.S. citizen, non-citizen national, or permanent resident by the time of award.
- Current and former PDs/PIs of major NIH research grants (R01, P01, P50, K awards like K01, K07, K08, K22, K23, K25, K76, K99/R00) are generally not eligible. Exceptions exist for smaller grants (R03, R21/R33, R34/U34, R36, SBIR/STTR) and certain K awards (K38, K12, KL2).
- Candidates must possess a research or health-professional doctoral degree.
- This FOA supports individuals training in new fields or re-entering research after a hiatus.
2. Cost Sharing: Cost sharing is not required.
3. Additional Information on Eligibility:
- Number of Applications: Organizations can submit multiple applications if each is scientifically distinct and from a different candidate. Individuals cannot have overlapping career development applications under review.
- Level of Effort: Candidates must have a full-time appointment and commit a minimum of 75% effort (9 person-months) to the career development program.
- Mentor(s): Candidates must identify a mentor or mentoring team with expertise in tobacco regulatory research and a track record of mentorship.
- Institutional Environment: Applicant institutions must have a strong research and career development record and commit to the candidate’s development in tobacco regulatory science.
Section IV. Application and Submission Information
1. Requesting an Application Package: Application packages are accessible through ASSIST and Grants.gov.
2. Content and Form of Application Submission:
- Strictly adhere to the SF424 (R&R) Application Guide and FOA instructions.
- Letter of Intent: Recommended but not required, due 60 days prior to application due date, emailed to the Tobacco Regulatory Science Program.
- Page Limitations: Follow SF424 Application Guide page limits.
- Data Management and Sharing Plan: Required, attached in the Other Plan(s) section.
- Candidate Information: Detail candidate background, career goals, and development plan, emphasizing commitment to tobacco regulatory science.
- Research Plan: Present a sound research project aligned with career development goals and FDA CTP research priorities.
- Responsible Conduct of Research (RCR) Training: Include a plan for RCR instruction.
- Mentor Section: Provide mentor qualifications, mentoring plan, and commitment to the candidate’s career progression.
- Institutional Environment and Commitment: Describe institutional research strengths and commitment to the candidate’s development in tobacco regulatory science.
- Resource Sharing Plan: Address data sharing as per NIH guidelines.
- Appendix: Limited items allowed, see SF424 guide.
- Human Subjects and Clinical Trials Information: Complete required forms if applicable.
- Reference Letters: Submitted separately through eRA Commons, ensure timely submission.
3. Unique Entity Identifier and SAM: Ensure compliance with unique entity identifier and SAM registration requirements.
4. Submission Dates and Times: Adhere to deadlines in Part 1. Submit early to address potential issues.
5. Intergovernmental Review (E.O. 12372): Not applicable.
6. Funding Restrictions: Standard NIH funding restrictions apply. Awards are not subject to SNAP and require prior approval for carryover.
7. Other Submission Requirements and Information: Electronic submission via Grants.gov is mandatory. Complete all registrations. Notify the Tobacco Regulatory Science Program via email upon submission. Follow policy for post-submission materials.
Section V. Application Review Information
1. Criteria:
Reviewers will assess applications based on the following scored criteria, focusing on the candidate’s potential to develop an independent tobacco regulatory science research program:
- Candidate: Potential for independence, prior training and experience, commitment to research career.
- Career Development Plan: Likelihood of contributing to scientific development and independence, plan appropriateness, mentoring quality, integration into the research community, and plan for independent funding application.
- Research Plan: Scientific merit, relevance to career goals, appropriateness for career stage, potential for independent research line, and impact on tobacco regulation.
- Mentor(s): Mentor qualifications, mentoring plan quality, experience fostering independence, research productivity, and support adequacy.
- Environment & Institutional Commitment: Institutional commitment to candidate’s effort and development, research facilities and resources, quality of the development environment.
Additional Review Criteria: Human subjects protections, inclusion of women, minorities, and individuals across the lifespan, vertebrate animal use, biohazards.
Additional Review Considerations: Resource Sharing Plans, Responsible Conduct of Research Training, Select Agent Research, Key Biological/Chemical Resources, Budget and Period of Support.
2. Review and Selection Process: Applications undergo scientific peer review by NIH Scientific Review Groups and Advisory Councils. Applications may undergo a selection process prioritizing those with highest merit. Appeals of initial peer review are not accepted. Funding decisions consider scientific merit, fund availability, and program relevance.
3. Anticipated Announcement and Award Dates: Summary statements are accessible via eRA Commons after review. Refer to Part 1 for key dates.
Section VI. Award Administration Information
1. Award Notices: Just-in-time information may be requested. Notice of Award (NoA) is the official authorization document. Comply with funding restrictions. Costs incurred before NoA are at recipient’s risk.
2. Administrative and National Policy Requirements: NIH Grants Policy Statement applies. Awards are subject to various regulations and policies, including civil rights laws, non-discrimination, and FAPIIS requirements.
Data Management and Sharing: Adhere to NIH Data Management and Sharing Policy and approved plan.
3. Reporting: Annual Research Performance Progress Reports (RPPRs), financial statements, and a final RPPR are required. Mid-Period Progress Reports (MPPRs) are due every six months. Compliance with Federal Funding Accountability and Transparency Act (FFATA) and FAPIIS reporting requirements is necessary.
4. Evaluation: NIH may request information to evaluate program effectiveness from databases and participants.
Section VII. Agency Contacts
Detailed contact information is provided for:
- Application Submission (eRA Service Desk, Grants.gov Customer Support, General Grants Information)
- Scientific/Research Contacts (NCI, NHLBI, NIDA, NIEHS Contacts for K01 Mechanism and Scientific Questions)
- Peer Review Contact (Center for Scientific Review)
- Financial/Grants Management Contacts (NCI, NHLBI, NIDA, NIEHS)
Section VIII. Other Information
Refer to recently issued trans-NIH policy notices and the NIH Grants Policy Statement. NIH Loan Repayment Programs (LRPs) are available for early-stage investigators.
Authority and Regulations: Awards are authorized under Sections 301 and 405 of the Public Health Service Act and relevant Federal Regulations.
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