Document ID: FDA-2014-D-0917-0001
Agency: fda
Document Type: Notice
Title: Small Entity Compliance Guide: Requirements for the Submission of
Data Needed To Calculate User Fees for Domestic Manufacturers and
Importers of Tobacco Products; Availability
Posted Date: 2014-07-16T04:00Z

[Federal Register Volume 79, Number 136 (Wednesday, July 16, 2014)]
[Notices]
[Page 41585]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16590]

[[Page 41585]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0917]

Small Entity Compliance Guide: Requirements for the Submission of 
Data Needed To Calculate User Fees for Domestic Manufacturers and 
Importers of Tobacco Products; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Requirements for the 
Submission of Data Needed to Calculate User Fees for Domestic 
Manufacturers and Importers of Tobacco Products--Small Entity 
Compliance Guide'' for a final rule published in the Federal Register 
of July 10, 2014. This small entity compliance guide (SECG) is intended 
to set forth in plain language the requirements of the regulation and 
to help small businesses understand and comply with the regulation.

DATES: Submit either electronic or written comments on the SECG at any 
time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Center for Tobacco Products, Food and Drug Administration, 
Document Control Center, ATTN: Office of Small Business Assistance, 
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.
    Submit electronic comments on the guidance 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. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Nancy Boocker or Annette Marthaler, 
Center for Tobacco Products, Food and Drug Administration, Document 
Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver 
Spring, MD 20993-0002, 1-877-287-1373, CTPRegulations@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of July 10, 2014 (79 FR 39302), FDA issued 
a final rule to add 21 CFR part 1150 to require domestic manufacturers 
and importers of tobacco products to submit to FDA information needed 
to calculate the amount of user fees assessed under the Federal Food, 
Drug, and Cosmetic Act. In compliance with section 212 of the Small 
Business Regulatory Enforcement Fairness Act (Pub. L. 104-121), FDA is 
making available this SECG stating in plain language the legal 
requirements of the July 10, 2014, final rule, set forth in 21 CFR part 
1150.
    FDA is issuing this SECG as level 2 guidance consistent with FDA's 
good guidance practices regulation (21 CFR 10.115(c)(2)). The SECG 
represents the Agency's current thinking on this topic. It does not 
create or confer any rights for or on any person and does not operate 
to bind FDA or the public. An alternative approach may be used if such 
approach satisfies the requirements of the applicable statutes and 
regulations.

II. Comments

    Interested persons may submit either electronic comments regarding 
this document 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. 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: July 10, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-16590 Filed 7-15-14; 8:45 am]
BILLING CODE 4164-01-P