
[Federal Register Volume 78, Number 53 (Tuesday, March 19, 2013)]
[Proposed Rules]
[Pages 16824-16825]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06288]


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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.

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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&C

[[Page 16825]]

Act (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 (see ADDRESSES). 
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 (see ADDRESSES) 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


