
[Federal Register Volume 76, Number 194 (Thursday, October 6, 2011)]
[Notices]
[Pages 62073-62074]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25831]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0721]


Guidance for Industry on Implementation of the Fee Provisions of 
the FDA Food Safety Modernization Act; 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 ``Implementation of 
the Fee Provisions of Section 107 of the FDA Food Safety Modernization 
Act.'' FDA is issuing this guidance to provide answers to common 
questions that might arise about the new fee provisions and FDA's plans 
for their implementation in fiscal year (FY) 2012.

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

ADDRESSES: Submit written requests for single copies of this guidance 
to the Office of Regulatory Affairs, Office of Resource Management, 
12420 Parklawn Dr., Rm. 2012, Rockville, MD 20857. Send one self-
addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.
    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.

FOR FURTHER INFORMATION CONTACT: Amy Waltrip, Office of Regulatory 
Affairs, Office of Resource Management, 12420 Parklawn Dr., Rm. 2012, 
Rockville, MD 20857, 301-796-8811.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Implementation of the Fee Provisions of Section 107 of the 
FDA Food Safety Modernization Act.'' The purpose of the guidance 
document is to provide

[[Page 62074]]

guidance to industry on the implementation of the fee provisions of 
section 107 of the FDA Food Safety Modernization Act of 2011 (FSMA) 
(Pub. L. 111-353). Section 107 of FSMA amended section 743 of the 
Federal Food, Drug, and Cosmetic Act to provide FDA with the authority 
to collect fees related to food. In the Federal Register of August 1, 
2011 (76 FR 45820), FDA published a notice establishing fee rates for 
FY 2012 for domestic and foreign facility reinspections, recall orders, 
and importer reinspections. On October 1, 2011, FDA will begin 
implementation of the fee provisions of section 107 of FSMA. The 
guidance document is intended to provide answers to common questions 
that might arise about the new fee provisions and FDA's plans for their 
implementation in FY 2012.
    This guidance is being issued consistent with FDA's good guidance 
practices (GGP) regulation (Sec.  10.115 (21 CFR 10.115)). This 
guidance is being implemented without prior public comment because the 
Agency has determined that prior public participation is not feasible 
or appropriate (Sec.  10.115(g)(2)). The Agency made this determination 
because the fee provisions of FSMA are currently being implemented, and 
guidance is needed to help effectuate the implementation. The guidance 
provides information necessary for affected persons to understand the 
implementation of these FSMA fee provisions. Although this guidance 
document is immediately in effect, it remains subject to comment in 
accordance with the Agency's GGP regulation.
    The guidance 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 to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding the 
guidance document. It is only necessary to send one set of comments. It 
is no longer necessary to send two copies of mailed 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.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance 
document at either http://www.fda.gov/RegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Always access an FDA 
guidance document by using FDA's Web site listed previously to find the 
most current version of the guidance.

    Dated: September 30, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-25831 Filed 10-5-11; 8:45 am]
BILLING CODE 4160-01-P


