Tobacco Product Manufacturing Practice; Establishment of a Public Docket

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Chapter I
[Docket No. FDA-2013-N-0227]

Tobacco Product Manufacturing Practice; Establishment of a Public Docket

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 Cosmetic Act (the FD&C Act) and giving FDA authority to regulate tobacco product manufacturing, distribution, and marketing. The new provisions include, among other things, the authority to issue regulations related to tobacco product manufacturing practice in order to protect the public health and to assure that tobacco products are in compliance with the FD&C Act. Specifically, section 906(e) of the FD&CAct (21 U.S.C. 387f(e)) provides that “in applying manufacturing restrictions to tobacco, the Secretary shall * * * prescribe regulations (which may differ based on the type of tobacco product involved) requiring that the methods used in, and the facilities and controls used for, the manufacture, preproduction design validation (including a process to assess the performance of a tobacco product), packing, and storage of a tobacco product conform to current good manufacturing practice, or hazard analysis and critical control point methodology.”

On January 10, 2012, a group of 13 tobacco companies submitted to FDA: (1) Recommendations for good manufacturing practice regulations, (2) a preamble to the recommended regulations, and (3) a cover letter with a meeting request (Ref. 1). The preamble, as noted in the cover letter, provides the participating tobacco companies' common perspective and interpretation of the recommended regulations. On May 2, 2012, representatives of the tobacco companies met with FDA to present an overview of their recommendations and their approach to developing them.

FDA is establishing a 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.

II. Comments

Interested persons may submit either electronic comments regarding the tobacco companies' recommendations to http://www.regulations.gov or written comments to the Division of Dockets Management (seeADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Reference

The following reference has been placed on display in the Division of Dockets Management (seeADDRESSES) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and is available electronically at http://www.regulations.gov.

1. Recommendations for Tobacco Product Good Manufacturing Practices Regulation and Request for Meeting, submitted to FDA, January 10, 2012.

Dated: March 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-06288 Filed 3-15-13; 11:15 am]
BILLING CODE 4160-01-P

Attachments

 (4) Return to top

Cover Letter From RJ Reynolds to FDA re Reference 1 Recommendations for Tobacco Product Good Manufacturing Practices Regulation...

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Attachment 1 Proposed Tobacco Product GMP Regulations re Reference 1 Recommendations for Tobacco Product Good Manufacturing...

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Attachment 2 Preamble for Proposed Tobacco Product GMP Regulation re Reference 1 Recommendations for Tobacco Product Good...

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See Attachment Orders 1 Thru 3 re Cover Letter Attachments 1 and 2

Reason Restricted: This attachment is restricted to show metadata only. The reason is - See Attachment Orders 1 Thru 3 re Cover Letter Attachments 1 and 2
 

 
 
Comment Period Closed
May 20 2013, at 11:59 PM ET
ID: FDA-2013-N-0227-0001
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Document Information

Date Posted: Mar 19, 2013
RIN: Not Assigned
CFR: 21 CFR Chapter I
Federal Register Number: 2013-06288
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Comments

19
Comments Received*
See attached file(s)
Attached, please find comments on the Tobacco Good Manufacturing Practice Proposed Regulations, submitted by Cheyenne International, LLC.

Docket Information

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Related Dockets: None
Related RINs: None
Related Documents: None
Related Comments:

* This count refers to the total comment/submissions received on this document, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document.

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