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. 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.  Successful awardees will also participate in the larger TCORS activities, including twice-monthly investigator meetings to expand the impact of their work.

Eligibility

Eligibility requirements need to be met as of date of submission, no waivers allowed.

UCSF Faculty in any series (Ladder Rank, In Residence, Clinical X, Health Science Clinical, Adjunct) in all ranks (Instructor, Assistant, Associate, Full Professor) may apply.  Appointees to the Professional Research Series and to the Librarian Series may apply.  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. 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 priorities are listed at https://prevention.nih.gov/tobacco-regulatory-science-program/tobacco-regulatory-research-priorities; 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.

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, Lisa Postow, PhD, at [email protected] , phone (301) 827-7843 about their ideas to ensure that they are relevant to FDA's regulatory priorities. When you email Dr. Postow tell her that you are planning to apply for developmental funds through the UCSF TCORS.  NIH has promised rapid responses on these relevance questions.  If Dr. Postow 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. Postow stating that she considers your application in scope for FDA funding.  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. Sometimes this process takes a while, so do not wait for the last minute.

For more information about the UCSF TCORS, see https://tobacco.ucsf.edu/tobacco-centers-regulatory-science .

Selection of Awardees

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. Only ONE application as PI (PI1 or PI2) is permitted per cycle.

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 timetable)

§   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 using the UCSF TCORS Development and Pilot Projects Transmittal to NIH and FDA form. 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

If you are proposing human subjects research (including a clinical trial) that has more than minimal risk, your proposal needs to include an IRB-approved Data Safety Monitoring Panel consistent with NHLBI rules (available at https://www.nhlbi.nih.gov/grants-and-training/policies-and-guidelines/nhlbi-policy-data-and-safety-monitoring-extramural-clinical-studies).  “Minimal risk” means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.  If you have any questions about whether you need to include a DSMP, contact Dr. Lisa Postow at NHLBI ([email protected]).

§   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) and please round up to the nearest thousand (i.e. instead of $49,869, list $50,000).

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) Salary

 

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. PI salary support limit of 10% does not apply to this RAP grant.

5. Budget Justification: Fully justify all costs.

*NIH base salary cap. Fully justify all requests.

General guideline: PI partial salary support should not exceed 10% of the requested award budget NOT 10% of PI salary.  An amount over 10% of the award budget must be well justified. Multiple PIs can decide how to distribute the 10% salary support among themselves (e.g., 5%/5% or 6%/4%).

  • General Automobile and Employee Liability (GAEL) can be included in the requested budget
  • 10% includes SALARY & BENEFITS
  • 10% IS A GUIDLINE
  • The award amount is DIRECT COST ONLY

6. NIH Bio-sketch of Principal Investigator(s) and Co-Investigator(s) and UCSF Faculty Mentor(s) (5 page maximum): Use Form Version F (https://grants.nih.gov/grants/forms/biosketch-blankformat.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 Dr. Postow’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.