Informing Tobacco Product Regulation (New)

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 $40,000 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 principle investigator will verify eligibility for funding (in terms of scope) before any grant is awarded.

Eligibility
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, 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 are encouraged to contact the UCSF TCORS program officer, Stephanie Land, at Stephanie.Land@NIH.gov, about their ideas to ensure that they are relevant to FDA's regulatory priorities. When you email Stephanie tell her that you are planning to apply for developmental funds through the UCSF TCORS.  They have promised rapid responses on these relevance questions.  If Stephanie says "yes," attach copies of the email correspondence to your application.  If she 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 NIH.  For more information about the UCSF TCORS, see http://www.tobacco.ucsf.edu/tobacco-center-regulatory-science-tcors.

 

Instructions

Please write your proposal following the instructions listed below:

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.

Please create one single PDF file including all of the following information:

  1. Project Title
  2. Amount Requested - $
  3. P.I. Name(s) - Optionally, you may apply with two PIs. If choosing that option, include all information for both PIs (PI1 and PI2); if funded, PI1 will be the primary contact for the award set up and management.
  • Title
  • Department/Affiliation
  • Email address
  • Box No. (or address)
  • Phone
  1. Abstract (one paragraph, maximum 300 words)
  2. Co-Investigator Names (max five) same eligibility criteria as the PI
  • Titles
  • Department/Affiliation
  • Email address
  • Box No. (or address)
  • Phone
  1. Research Mentor(s) (for applications from postdoctoral fellows)
  • Titles
  • Department/Affiliation
  • Email address
  • Box No. (or address)
  • Phone
  1. PI 1 (contact PI) Grant Administrator (Indicate a post-award financial analyst in your Dept. that will help you manage this grant and be our main contact if you are awarded):
  • Title
  • Mailing Address:
  • Email
  • Box No. (or address)
  • Phone
  1. Human Subjects. Indicate if Human Stem Cells will be used or not. Supply the following:
  • CHR date of approval
  • CHR approval number
  • Specify if pending
  1. Human Stem Cells.  Indicate if Human Stem Cells will be used or not. Supply the following:
  • GESCR date of approval
  • GESCR approval number
  • Specify if pending
  1. Animal Subjects.  Indicate if Animal subjects will be used or not. Supply the following:
  • IACUC date of approval
  • IACUC approval number
  • Specify if pending
  1. Specify if you have been funded in the past 5 years by any of the following UCSF agencies: List titles of grants in detail. Include enough information to allow RAP to understand their content. Specify dollar amounts awarded and source of funds.
  • CTSI-SOS
  • REAC
  • CFAR
  • ARI
  • Cancer Center-MZHF
  • NCOEWH
  • Academic Senate
  • Departmental Startup Funds
  • Other UCSF (explain)
  1. 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)

13.  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.

Basic Science Award Program Budget

Allowable

Not Allowable

PI Salary *

X

 

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. Fully justify all requests. Normally PI partial salary support should not exceed 10%. Multiple PIs can decide how to distribute that 10% salary support among themselves (e.g., 5%/5% or 6%/4%)

14.  Budget Justification: Fully justify all costs.

15.  NIH Bio-sketch of Principal Investigator(s) and Co-Investigator(s) and UCSF Faculty Mentor(s) (4 page maximum): Use Form "PHS 398/2590" from the NIH grant applications (http://grants.nih.gov/grants/funding/phs398/biosketch.doc) 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.

  1. 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 Executive 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.

Fill out the electronic application form and upload your proposal PDF