[Federal Register Volume 76, Number 201 (Tuesday, October 18, 2011)]
[Notices]
[Page 64354]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-26815]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0529]


Burden of Food and Drug Administration Food Safety Modernization 
Act Fee Amounts on Small Business; 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, ``Burden 
of Food and Drug Administration Food Safety Modernization Act Fee 
Amounts on Small Business; Request for Comments'' that appeared in the 
Federal Register of August 1, 2011 (76 FR 45818). In that document, FDA 
announced the establishment of a docket to obtain information that 
would be used to formulate a proposed set of guidelines in 
consideration of the burden of fee amounts on small business, as set 
forth in the FDA Food Safety Modernization Act (FSMA). In particular, 
the Agency requested public comments on whether a reduction of fees or 
other consideration for small business was appropriate, and if so, what 
factors the Agency should consider for each. In addition, the Agency 
requested public comment on how small business should be defined or 
recognized. 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 or 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: Alexis Nazario-Negron, Office of 
Financial Management, Food and Drug Administration, 1350 Piccard Dr., 
Rm. 210E, Rockville, MD 20850, 301-796-7223, Alexis.Nazario-Negron@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of August 1, 2011 (76 FR 45818), FDA 
published a notice with a 78-day comment period to request comments on 
the burden of FSMA fee amounts on small business. FSMA provides the 
Agency with authority under section 743 of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) 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 what burdens 
these fees might impose on small business, and whether and how the 
Agency should alleviate such burdens. In particular, the Agency is 
seeking public comments on whether a reduction of fees or other 
consideration for small business is appropriate, and if so, what 
factors the Agency should consider for each. In addition, the Agency is 
seeking public comment on how small business should be defined or 
recognized. The Agency has received a request for an extension of the 
comment period. The request conveyed concern that the current 78-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 until November 30, 2011. The Agency believes that this 
extension allows adequate time for interested persons to submit 
comments without significantly delaying the development of a proposed 
set of guidelines in consideration of the burden of the fee amounts on 
small business, as required by section 743(b)(2)(B)(iii) of the FD&C 
Act.

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 12, 2011.
David Dorsey,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2011-26815 Filed 10-17-11; 8:45 am]
BILLING CODE 4160-01-P