
[Federal Register Volume 80, Number 206 (Monday, October 26, 2015)]
[Notices]
[Pages 65229-65231]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27111]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1282]


National Environmental Policy Act; Environmental Assessments for 
Tobacco Products; Categorical Exclusions--Small Entity Compliance 
Guide; 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) is announcing the 
availability of a guidance for industry entitled ``National 
Environmental Policy Act; Environmental Assessments for Tobacco 
Products; Categorical Exclusions--Small Entity Compliance Guide.'' This 
guidance is intended to help small businesses understand the recent 
changes to FDA's National Environmental Policy Act (NEPA)-implementing 
regulations, which will allow certain classes of actions on tobacco 
product marketing applications to be excluded from the requirements to 
prepare an environmental assessment (EA) or an environmental impact 
statement (EIS). This will decrease the amount of time required for 
industry to complete, and for FDA to review, applications.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

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

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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-2013-N-1282 for ``National Environmental Policy Act; Environmental 
Assessments for Tobacco Products; Categorical Exclusions--Small Entity 
Compliance Guide.'' 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 this 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 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your request or include a fax number to which 
the guidance document may be sent. See the SUPPLEMENTARY INFORMATION 
section for information on electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Katherine Collins, Center for Tobacco 
Products, Food and Drug Administration, 10903 New Hampshire Ave., 
Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., 
Silver Spring, MD 20993-0002, CTPRegulations@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``National Environmental Policy Act; Environmental Assessments 
for Tobacco Products; Categorical Exclusions--Small Entity Compliance 
Guide.'' This guidance is intended to help small businesses understand 
and comply with FDA's implementation of NEPA and the Council on 
Environmental Quality (CEQ) regulations for classes of actions for 
tobacco products as provided by the final rule. Specifically, this 
guidance is intended to help small businesses understand which classes 
of actions for tobacco products require at least the preparation of an 
EA, and how to apply for categorical exclusions if they qualify based 
on their particular circumstance.
    NEPA and CEQ regulations require each Federal Agency to assess, as 
an integral part of its decisionmaking process, the environmental 
impacts of any proposed Federal action to ascertain the environmental 
consequences of that action on the quality of the human environment and 
to ensure that the interested and affected public is appropriately 
informed (42 U.S.C. 4332(2); 40 CFR 1506.6). FDA regulations governing 
its responsibilities under NEPA are codified at 21 CFR part 25, and the 
CEQ regulations are codified at 40 CFR parts 1500 to 1508.
    CEQ oversees FDA's compliance with NEPA. For major Federal actions 
that may have a significant environmental impact, FDA can either 
prepare an EIS or prepare an EA. An EA provides sufficient information 
and analysis for FDA to determine whether to prepare an EIS or issue a 
finding of no significant impact (21 CFR 25.20; 40 CFR 1501.4). FDA is 
responsible for the scope and content of an EA and generally requires 
an applicant to prepare an EA and make necessary corrections to it (21 
CFR 25.40(b)).
    Categorically excluded actions refer to a category of actions that 
have been found not to individually or cumulatively have a significant 
effect on the quality of the human environment and which do not 
normally require the preparation of an EA or EIS (40 CFR 1508.4). 
However, as required under 21 CFR 25.21 and 40 CFR 1508.4, FDA will 
require preparation of at least an EA for any specific action that 
normally would be excluded if extraordinary circumstances are present 
such that the specific proposed action may have the potential to 
significantly affect the quality of the human environment. In 
compliance with section 212 of the Small Business Regulatory 
Enforcement Fairness Act (Pub. L. 104-121), FDA is making available 
this small entity compliance guide stating in plain language the legal 
requirements of the September 24, 2015, final rule, set forth in 21 CFR 
part 25.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance

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practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on NEPA and environmental assessments for 
tobacco products including categorical exclusions. 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.

III. Electronic Access

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

    Dated: October 20, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27111 Filed 10-23-15; 8:45 am]
BILLING CODE 4164-01-P


