2011-25831. 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.

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 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 (§ 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 (§ 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.