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Proposed Rule2013-062882013-03-19

Tobacco Product Manufacturing Practice; Establishment of a Public Docket

Health and Human Services Department, Food and Drug Administration

Abstract

The Food and Drug Administration (FDA) is establishing a public docket to obtain input on recommendations for regulations on good manufacturing practice for tobacco products that were submitted to FDA by a group of 13 tobacco companies (tobacco companies' recommendations). FDA is establishing this docket to provide an opportunity for all interested parties to comment on the tobacco companies' recommendations and to share information that will improve FDA's understanding of the tobacco industry and its manufacturing operations.

Action & Dates

Action
Establishment of a public docket; request for comments.
Dates
Submit electronic or written comments on the tobacco companies' recommendations by May 20, 2013.

CFR References

Public Comment

Comments Close
2013-05-20

Document Excerpt

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration 21 CFR Chapter I [Docket No. FDA-2013-N-0227] AGENCY: Food and Drug Administration, HHS. ACTION: Establishment of a public docket; request for comments. SUMMARY: The Food and Drug Administration (FDA) is establishing a public docket to obtain input on recommendations for regulations on good manufacturing practice for tobacco products that were submitted to FDA by a group of 13 tobacco companies (tobacco companies' recommendations). FDA is establishing this docket to provide an opportunity for all interested parties to comment on the tobacco companies' recommendations and to share information that will improve FDA's understanding of the tobacco industry and its manufacturing operations. DATES: Submit electronic or written comments on the tobacco companies' recommendations by May 20, 2013. ADDRESSES: Submit electronic comments to http://www.regulations.gov . Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Andrea Bautista, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 877-287-1373, email: andrea.bautista@fda.hhs.gov . SUPPLEMENTARY INFORMATION: I. Background On June 22, 2009, the Family Smoking Prevention and Tobacco Control Act ( Pub. L. 111-31 ; 123 Stat. 1776) was signed into law, amending the Federal Food, Drug, and

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Full Document

Citation: 78 FR 16824