Informing Tobacco Product Regulation

Project Award Amount:  $50,000

Description
The Tobacco Center of Regulatory Science (TCORS) is a large center grant housed in UCSF’s Center for Tobacco Control Research and Education. The Center seeks to develop improved models (broadly defined) to inform tobacco product regulatory strategies that integrate (1) economic impacts of tobacco use on health costs, (2) risk perceptions, perceived acceptability, consumer responses to pro-tobacco marketing and anti-tobacco messages and other behavioral and social determinants of tobacco use, and (3) rapid changes in health risk due to tobacco use and secondhand smoke exposure as manifest in cardiovascular and pulmonary dysfunction.  This work is designed to inform US Food and Drug Administration (and similar agencies around the world) efforts to develop evidence-based regulations for tobacco products (including how these products are marketed) as well as related public education efforts.

The TCORS award provides money that we can award to faculty and senior postdoctoral fellows with innovative research ideas to expand or deepen the reach of our existing TCORS center.  Pilot awards are typically used: (1) to initiate a project or (2) to gather preliminary data that will lead to a larger research project or (3) to quickly develop findings that will inform the FDA Center for Tobacco Products in regulation of the manufacture, marketing, and distribution of tobacco products in order to reduce the public health toll from tobacco product use in the United States.  The current FDA Center for Tobacco Products (CTP) research interest areas are listed at  http://prevention.nih.gov/tobacco/research.aspx; projects are not, however, limited to these specific areas so long as there is a clear connection to informing FDA regulatory and educational decisions on tobacco.

Some topics of current high interest include the diversity of tobacco products, reducing addiction, adverse health consequences of tobacco use, measuring and reducing toxicity of tobacco products, communications, marketing of tobacco products, and economics and policy.

1.    The award level for this program is $50,000 in direct costs. Salary for Principal Investigator, research staff, and fellows may be requested as part of the budget.

2.    The number of grants awarded is determined by funding available.

3.    The funding period is one year. Participating in twice-a-month meetings of the TCORS investigators and semiannual and final progress reports is required.

4.    Standard NIH human and animal research approvals apply.

5.    The UCSF TCORS principal investigator will verify eligibility for funding (in terms of scope) before any grant is awarded.

Eligibility

  •  NOTE: Eligibility requirement need to be met as of date of submission


UCSF faculty in any series may apply (Instructor, Assistant Professor, Associate Professor, Professor.) Senior postdoctoral fellows can also apply.

Designation of Research Mentor
All award applications from individuals who are instructors or senior postdoctoral fellows require the designation of a faculty research mentor. This mentor should be an individual who has primary responsibility for overseeing the research career development of the applicant—usually assigned through the applicant's department. Reviewers will be instructed to ensure active engagement of the mentor, who must be specifically named.

Criteria for Review and Evaluation of Applications
Applications that are complete and meet eligibility requirements will be evaluated for scientific and technical merit in accordance with typical NIH review criteria: 1. Significance, particularly in terms of tobacco product regulation, 2. Approach, 3. Innovation, 4. Investigator, 5. Environment. Each of these criteria will be addressed and considered in assigning the overall application score.

The funds for these developmental projects come from a Tobacco Center for Regulatory Science (TCORS) center grant awarded to UCSF by NIH using funds from the FDA. Because of this arrangement we can only fund projects that will inform the FDA's regulation of tobacco products and their marketing, including policy development and public education. Potential applicants should fill out the  UCSF TCORS Development and Pilot Projects Transmittal to NIH and FDA form describing the proposed project and send it to the UCSF TCORS program officer, Mark Parascandola, PhD, at paramark@mail.nih.gov, phone 301-841-5474 about their ideas to ensure that they are relevant to FDA's regulatory priorities. When you email Mark tell him that you are planning to apply for developmental funds through the UCSF TCORS.  They have promised rapid responses on these relevance questions.  If Mark says "yes," include, in your single PDF proposal you will upload to the RAP portal, the completed form and a copy of the email from Dr. Parascandola stating that he considers your application in scope for FDA funding.  If he says "no" or does not respond promptly and you want to pursue the issue, please contact Stanton Glantz, PI for the UCSF TCORS, and he will have further discussions with NIHSometimes this process takes a while, so do not wait for the last minute.

For more information about the UCSF TCORS, see http://www.tobacco.ucsf.edu/tobacco-center-regulatory-science-tcors.

Selection of Awardees

Funding decisions are made independently by each funding agency based on several factors – scientific review score, alignment of proposal to funder’s strategic goals, proposal research area of focus, and specifically called out eligibility or other requirements like membership in a center, affiliation with a specific school or relevance to a stated auxiliary topic. 
TO APPLY:

STEP 1) Complete the electronic application form 
STEP 2) 
Upload your proposal as a SINGLE PDF that includes all the things listed in numeric order in the instructions below. Do not include form fields in your PDF document.

Instructions for Proposal PDF

Please write your proposal following the instructions listed below and create one single PDF file. Do not include form fields in your PDF document.

Proposal Length: Maximum 6 pages, including figures and tables, excluding table of contents and literature cited.
Format Requirements: Arial font; 11 pt; minimum 0.5 inch for all margins; no appendices; include page numbers and table of contents.

Resubmissions
Definition: same research topic with an amended application or research plan rather than a new research topic and new research plan.
Requirements: Please use up to one extra page to introduce your revised proposal, addressing the issues raised in the review, and any additional changes to your proposal. A new letter from the Chair is not required if the resubmission is within 2 cycles (one skipped cycle max). You will include the old letter and state your resubmission is within 2 cycles and new letter is not required. Make sure the new changes are highlighted in bold or italic font so the reviewers can easily see where and how the proposal has changed. Do not use track changes.

1. P.I. Name(s) - Optionally, you may apply with two PIs. If funded, PI1 will be the primary contact for the award set up and management. If the proposal has multiple PIs, both PI1 and PI2 need to meet the eligibility criteria listed for this grant mechanism.

2. Project Title

3. Proposal (maximum 6 pages, including figures and tables, [A-G] excluding literature cited)

§   Aims

§   Background and Significance

§   Preliminary studies

§   Experimental Design and Methods (include time-table)

§   i) Hypothesis, ii) Rationale, iii) Experimental approach, iv) Interpretation of results

§   Explain how this pilot project is will contribute to the development of tobacco regulatory science (max 500 characters). Attach emails from NIH confirming NIH’s ruling that it does.

§   Human Subjects: describe patients, specimens, and/or human subject data that will be used in your research, and describe the methods that will be used to protect subjects and/or information

§   Understanding of and commitment to following security and confidentiality guidelines for all Protected Health Information (PHI)

§   Literature cited (not included in the page limit)

4. Detailed Budget ($50,000 maximum direct costs per proposal) Use the NIH PHS 398 form "Page Detailed Budget for Initial Budget Period" (http://grants.nih.gov/grants/funding/phs398/fp4.doc) to prepare your budget.

 

Allowable

Not Allowable

PI Salary *

X

 

Co-Investigator(s)

 

 

Post Doc Salary

X

 

Administrative Support

 

X

Supplies

X

 

Equipment

X

 

Software

X

 

Personal Computers

X

 

Mailing

X

 

Tuition

 

X

Travel

X

 

Research Staff Support (e.g. RSA; Lab. Technician)

X

 

Patient Care

 

X

 

*NIH base salary cap. Generally PI salary support should not exceed 10% of the budget, anything over 10% must be well justified. Multiple PIs can decide how to distribute that 10% salary support among themselves (e.g., 5%/5% or 6%/4%)

5. Budget Justification: Fully justify all costs.

6. NIH Bio-sketch of Principal Investigator(s) and Co-Investigator(s) and UCSF Faculty Mentor(s) (5 page maximum): Use Form (http://grants.nih.gov/grants/funding/424/SF424R-R_biosketchsample_VerC.docx) with other support pages. Include active and pending proposals. Include percent effort, total direct costs (current year) and potential overlap with the current proposal. Include bio-sketch for both PIs of a multi-PI application.

7. Letter(s) of Support: provide a letter of support from the department chair or other unit head. In addition, for junior investigators, department chairs/unit heads should comment on the independence of the applicant and availability of research space and other resources for the proposed research. Include the letter of support at the end of your PDF proposal and address it to the RAP Committee. If there are multiple PIs, a letter of support is required for each. If PIs are in the same department, the chair can vouch for both PIs in a single letter. Include bio-sketches for all PIs of a multi-PI application.

8. Include the email with Mark Parascandola's signature in the ONE single proposal PDF you will upload.

9. Include the UCSF TCORS Development and Pilot Projects Transmittal to NIH and FDA form filled out in the ONE single proposal PDF you will upload.  Read the Criteria for Review and Evaluation of Applications, you need to be pre-approved before submitting to RAP.