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HHS/FDA

RIN: 0910-AG59

Publication ID: Spring 2011

Title: ●Requirements for the Testing and Reporting of Tobacco Product Constituents, Ingredients, and Additives
Abstract: Section 915 of the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act, requires FDA to promulgate regulations that require the testing and reporting of tobacco product constituents, ingredients, and additives, including smoke constituents that the agency determines should be tested to protect the public health.
Agency: Department of Health and Human Services(HHS)	Priority: Other Significant
RIN Status: First time published in the Unified Agenda	Agenda Stage of Rulemaking: Proposed Rule Stage
Major: Undetermined	Unfunded Mandates: Undetermined
CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: PL 111-31, The Family Smoking Prevention and Tobacco Control Act, sec 101(b)

Legal Deadline:

Action	Source	Description	Date
Final	Statutory	sec 915(a) of the Family Smoking Prevention and Tobacco Control Act	04/00/2013

Overall Description of Deadline: Final rule must issue no later than 36 months after April 1, 2010--see sec. 915(a) of the Federal Food, Drug, and Cosmetic Act and sec. 6 of the Family Smoking Prevention and Tobacco Control Act.

Timetable:

Action	Date	FR Cite
NPRM	01/00/2012
NPRM Comment Period End	04/00/2012

Regulatory Flexibility Analysis Required: Yes	Government Levels Affected: Undetermined
Small Entities Affected: Businesses	Federalism: Undetermined
Included in the Regulatory Plan: No
RIN Data Printed in the FR: Yes
Agency Contact: Carol Drew Regulatory Counsel Department of Health and Human Services Food and Drug Administration Office of Good Clinical Practice, WO 32, Room 5105, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone:301 796-3505 Email: carol.drew@fda.hhs.gov