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U.S. Department of Health and Human Services

Tobacco Products

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Comment Opportunities

The Center for Tobacco Products (CTP) uses public dockets through the Federal Register to solicit information from all stakeholders on a number of specific issues related to implementation of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).  Learn More About Dockets, Guidance, Laws, and Regulations.

 

OPEN DOCKETS FOR PUBLIC COMMENT: 

NAME: Draft Guidance for Industry; Availability: Modified Risk Tobacco Product Applications
ACTION: Notice.
Docket No. FDA-2012-D-0071
DATES: Although you can submit written or electronic comments on this guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit electronic or written comments on the draft guidance by June 4, 2012. Submit electronic or written comments on the proposed collection of information by June 4, 2012.
SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Modified Risk Tobacco Product Applications.'' The draft guidance provides information about submitting applications for modified risk tobacco products under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The draft guidance describes the information that the FD&C Act requires you to submit in your modified risk tobacco product application and the scientific evidence FDA recommends you submit to support your application. The draft guidance also permits the filing of a single application for any modified risk tobacco product that is also a new tobacco product under the FD&C Act. 

NAME: Draft Guidance for Industry; Availability: Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke
ACTION: Notice.
Docket No. FDA-2012-D-0049
DATES: Although you can comment on any guidance at any time (21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by June 4, 2012. Submit either electronic or written comments on the proposed collection of information by June 4, 2012.
SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under Section 904(a)(3) of the Federal Food, Drug, and Cosmetic Act.'' The purpose of this draft guidance is to assist persons reporting to FDA the quantities of harmful and potentially harmful constituents (HPHCs) in tobacco products and tobacco smoke under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The draft guidance explains that FDA does not intend, at this time, to enforce reporting on the entire established HPHC list where a manufacturer or importer
completes testing and reporting for an abbreviated list of HPHCs within the timeframes specified in the guidance.

NAME: Small Entity Compliance Guide; Further Amendments to General Regulations of the FDA to Incorporate Tobacco Products
ACTION: Notice.
Docket No. FDA-2011-N-0121
DATES: Submit either electronic or written comments on the SECG at any time.
SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Further Amendments to General Regulations of the Food and Drug Administration to
Incorporate Tobacco Products--Small Entity Compliance Guide'' for a final rule published in the Federal Register of February 2, 2012. This small entity compliance guide (SECG) is intended to set forth in plain language the requirements of the regulation and to help small businesses understand and comply with the regulation.

NAME: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Experimental Study of Graphic Cigarette Warning Labels
ACTION: Notice.
Docket No. FDA-2012-N-0273
DATES: Submit either electronic or written comments on the collection of information by May 29, 2012.
SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Experimental Study of Graphic Cigarette Warning Labels that is being conducted in support of the graphic label provision of the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act).
 

NAME: Small Entity Compliance Guide: Required Warnings for Cigarette Packages and Advertisements; Availability
ACTION: Notice.
Docket No. FDA-2011-N-0568
DATES: Submit either electronic or written comments on the SECG at any time.
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Required Warnings for Cigarette Packages and Advertisements--Small Entity Compliance Guide'' for a final rule published in the Federal Register on June 22, 2011. This small entity compliance guide (SECG) is intended to set forth in plain language the requirements of the regulation and to help
small businesses understand and comply with the regulation. 

 

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