NIH: Office of Disease Prevention

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FAQs - Clinical Studies Involving Electronic Cigarettes and INDs

NIDA has published a series of Frequently Asked Questions (FAQs) about Investigational New Drug (IND) applications for studies of electronic cigarettes (e-cigarettes) in humans. This FAQ helps investigators determine the need for submitting an IND to FDA, and outlines steps to get the process started. Because FDA makes determinations about investigational new drug applications (INDs) on a case-by-case basis, investigators should discuss their study protocol with FDA regarding any questions on whether the IND requirements apply to their planned clinical investigation. This document does not take the place of Institutional Review Board (IRB) requirements, FDA regulations, or NIH policies.

CTP-Supported Tobacco Regulatory Research Projects Search Tool

In addition to the research that the Center for Tobacco Products (CTP) supports though the NIH, CTP also conducts its own research and supports research projects through partnerships with different governmental agencies such as the Centers for Disease Control and FDA’s National Center for Toxicological Research. To learn more about CTP’s full research portfolio, CTP has a research project search tool that provides access to information about the research projects in CTP’s research portfolio. Currently, this tool includes active research projects funded by CTP’s Office of Science in fiscal year 2013. Subsequent updates to the tool will include projects funded in previous years, new projects, and projects funded by other CTP offices. This tool includes research-based projects only, and does not include those that support infrastructure purchases such as equipment.

Public Committees and Meetings

NIH TRSP Webinar: The FDA Docket and Public Comments

On June 20, 2014, the Tobacco Regulatory Science Program (TRSP) held a webinar for researchers on submitting comments to the FDA Docket. The webinar discussed the public comment/docket process and suggestions on submitting comments for public record on proposed FDA regulation. Allison Hoffman, Ph.D., Associate Director for Science Coordination and Communication, Center for Tobacco Products, FDA presented and answered questions.

FDA recently published the proposed rule Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products (Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014). With this publication, tobacco regulatory scientists have had questions about submitting comments to the docket—a process unfamiliar to many researchers. This webinar:

  • Explained what dockets are and how they are used
  • Walked participants through the process of submitting comments to a docket
  • Provided suggestions for ensuring that comments are effective and useful
  • Provided an opportunity for researchers to ask questions about the submission process.

More information about the proposed rule and resources can be found at the sites below:

Frequently Asked Questions

Several webinar participants asked questions about submitting comments to dockets – here are some helpful links where interested persons can find more information about how to submit as well as answers to frequently asked questions: Comment on Proposed Regulations and Submit Petitions and Frequently Asked Questions. If interested persons have further questions about the comment process they can contact FDA Dockets Management, (301) 827-6860. Hours are 9 a.m. to 4 p.m., Eastern time, Monday through Friday.

Tobacco Products Scientific Advisory Committee (TPSAC)

Topics reviewed by TPSAC:
  • Menthol in Cigarettes
  • Dissolvable Tobacco Products
  • Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke

FDA Center for Tobacco Products Research Program: Expanding the Research Base for Tobacco Product Regulation
(February 2012; archived webcast available)

Tobacco Regulatory Science Publications