
[Federal Register Volume 81, Number 175 (Friday, September 9, 2016)]
[Notices]
[Pages 62505-62506]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21686]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0600]


Health Document Submission Requirements for Tobacco Products; 
Revised Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a revised draft guidance for industry entitled ``Health 
Document Submission Requirements for Tobacco Products.'' The revised 
draft guidance is intended to assist persons making certain document 
submissions to FDA as required by the Family Smoking Prevention and 
Tobacco Control Act (Tobacco Control Act).

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment of this 
revised draft guidance before it begins work on the final version of 
the guidance, submit either electronic or written comments on the draft 
guidance by October 11, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2009-D-0600 for ``Health Document Submission Requirements for 
Tobacco Products.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at http://www.regulations.gov or at the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the revised draft 
guidance to the Center for Tobacco Products, Food and Drug 
Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-2000. Send two self-addressed 
adhesive labels to assist that office in processing your requests. See

[[Page 62506]]

the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.

FOR FURTHER INFORMATION CONTACT: Katherine Collins, Center for Tobacco 
Products, Food and Drug Administration, Document Control Center, Bldg. 
71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-2000, 
1-877-287-1373, email: AskCTP@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a revised draft guidance for 
industry entitled ``Health Document Submission Requirements for Tobacco 
Products.'' We are issuing this draft guidance consistent with our good 
guidance practices (GGP) regulation (21 CFR 10.115). The draft 
guidance, when finalized, is intended to assist persons making certain 
document submissions to FDA as required by the Tobacco Control Act.
    The Tobacco Control Act, enacted on June 22, 2009, amends the FD&C 
Act and provides FDA with the authority to regulate the manufacture, 
marketing, and distribution of tobacco products to protect the public's 
health (Pub. L. 111-31). Among other things, the Tobacco Control Act 
adds section 904(a)(4) to the FD&C Act (21 U.S.C. 387d(a)(4)), 
requiring each tobacco product manufacturer or importer, or agents 
thereof to submit all documents developed after June 22, 2009, that 
relate to any ``health, toxicological, behavioral, or physiological 
effects of current or future tobacco products, their constituents 
(including smoke constituents), ingredients, components, and 
additives.''
    The revised draft guidance includes guidance for manufacturers or 
importers of products that are newly deemed as tobacco products that 
are subject to Chapter IX of the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act). Cigarettes, cigarette tobacco, roll-your-own tobacco, 
and smokeless tobacco were immediately subject to the tobacco 
provisions of the FD&C Act, including section 904(a)(4), and to FDA's 
regulatory authority. As for other types of tobacco products, section 
901(b) of the FD&C Act (21 U.S.C. 387a) grants FDA authority to deem 
those products subject to the law as well. Pursuant to that authority, 
FDA issued a rule deeming all other products that meet the statutory 
definition of ``tobacco product'', set forth in section 201(rr) of the 
FD&C Act, except for accessories of those products, as subject to the 
FD&C Act (81 FR 28974). FDA published the final rule on May 10, 2016 
(81 FR 28974), and it became effective on August 8, 2016. Manufacturers 
and importers of tobacco products that have been deemed subject to the 
FD&C Act are now required to comply with Chapter IX of the FD&C Act, 
including section 904(a)(4).

II. Significance of Guidance

    FDA is issuing this revised draft guidance consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
when finalized, represents the current thinking of FDA on health 
document submission requirements. It does not establish any rights for 
any person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

II. Paperwork Reduction Act of 1995

    This revised draft guidance also refers to previously approved 
collections of information found in FDA statute. The revised draft 
guidance includes information and recommendations for how to provide 
health document submissions. The collections of information in section 
904(a)(4) of the FD&C Act have been approved under OMB control number 
0910-0654.

IV. Electronic Access

    Persons with access to the Internet may obtain an electronic 
version of the draft guidance at either http://www.regulations.gov or 
http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm.

    Dated: August 31, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21686 Filed 9-8-16; 8:45 am]
 BILLING CODE 4164-01-P


