[Federal Register Volume 76, Number 208 (Thursday, October 27, 2011)]
[Notices]
[Page 66723]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-27845]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0528]


Food Safety Modernization Act Domestic and Foreign Facility 
Reinspections, Recall, and Importer Reinspection User Fee Rates for 
Fiscal Year 2012; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending the 
comment period to November 30, 2011, for the notice entitled, ``Food 
Safety Modernization Act Domestic and Foreign Facility Reinspections, 
Recall, and Importer Reinspection User Fee Rates for Fiscal Year 2012'' 
that appeared in the Federal Register of August 1, 2011 (76 FR 45820). 
In that document, FDA announced the establishment of a docket to obtain 
comments that would be considered in establishing the fee rates for 
fiscal year (FY) 2013. In particular, the Agency provided the current 
FY 2012 fees and requested public comments to the document and intends 
to consider such comments, as well as experience and additional data 
gained in implementing these fees in FY 2012, in establishing the fee 
rates for FY 2013. The Agency is taking this action in response to 
requests for an extension to allow interested persons additional time 
to submit comments.

DATES: Submit either electronic or written comments by November 30, 
2011.

ADDRESSES: Submit electronic comments 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, 12420 Parklawn Dr., rm. 
2012, Rockville, MD 20857, (301) 796-8811, email: 
Amy.Waltrip@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of August 1, 2011 (76 FR 45820), FDA 
published a notice with a 90-day comment period to request comments on 
the establishment of domestic and foreign facility reinspections, non-
compliance with recall order, and importer reinspection FY 2012 user 
fees. The FDA Food Safety Modernization Act provides the Agency with 
authority under section 743 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379j-31) to assess and collect fees, including those for 
costs associated with certain domestic and foreign facility 
reinspections, failure to comply with a recall order, and importer 
reinspections. The Agency is seeking public comment on the established 
FY 2012 user fees. In particular, the Agency is seeking public comments 
intending to consider such comments, as well as experience and 
additional data gained in implementing these user fees in FY 2012, in 
establishing the fee rates for FY 2013. The Agency has received a 
request for an extension of the comment period. The request conveyed 
concern that the current 90-day comment period does not allow 
sufficient time to develop a meaningful or thoughtful response to the 
notice.
    FDA has considered the request and is extending the comment period 
for the notice for 30 days until November 30, 2011. The Agency believes 
that this extension allows adequate time for interested persons to 
submit comments.

II. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments on this 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.

    Dated: October 24, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-27845 Filed 10-26-11; 8:45 am]
BILLING CODE 4160-01-P