[Federal Register Volume 76, Number 227 (Friday, November 25, 2011)]
[Notices]
[Pages 72712-72713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-30471]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0841]


Agency Emergency Processing Under the Office of Management and 
Budget Review; Submission for Office of Management and Budget Review; 
Comment Request; Food and Drug Administration Food Safety Modernization 
Act: Economic Hardship Fee Reduction Guidance

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995 (PRA). The proposed collection of 
information concerns a guidance document that outlines the criteria and 
the process through which firms may request a reduction of fees based 
on severe economic hardship of the FDA Food Safety Modernization Act 
(FSMA) reinspection and recall user fees that are mandated by the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act).

DATES: Fax written comments on the collection of information by 
December 15, 2011. FDA is requesting OMB approval of this emergency 
processing by January 6, 2012.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: (202) 395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-New and 
title ``FDA Food Safety Modernization Act: Economic Hardship Fee 
Reduction Guidance.'' Also include the FDA docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, (301) 796-3793.

SUPPLEMENTARY INFORMATION: FDA has requested emergency processing of 
this proposed collection of information under section 3507(j) of the 
PRA (44 U.S.C. 3507(j) and 5 CFR 1320.13). FDA requests permission to 
use the emergency clearance procedures to obtain OMB approval of the 
information collection related to the economic hardship fee reduction 
guidance. FDA expects to use a print-and-mail or an email form for fee 
reduction requests. If FDA were to use the normal clearance procedures, 
the approval of the information collection would not be finalized in 
time to issue invoices in January 2012. FDA seeks OMB approval of the 
information collection by January 6, 2012, so the Agency can issue such 
guidance no later than January 2012.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

FDA Food Safety Modernization Act: Economic Hardship Fee Reduction 
Guidance (OMB Control Number 0910-NEW)

    On January 4, 2011, the President signed into law FSMA (Pub. L. 
111-353). Section 743 of the FD&C Act (21 U.S.C. 379j-31) amended by 
FSMA, requires FDA to consider the burden of fee amounts on small 
businesses.
    Section 743(b)(2)(B)(iii) of FD&C Act states, ``* * *the Secretary 
shall publish in the Federal Register a proposed set of guidelines in 
consideration of the burden of fee amounts on small business. Such 
consideration may include reduced fee amounts for small businesses.* * 
*'' Before publishing such guidelines, FDA believes it is important to 
gather additional information related to small business burdens 
associated with fees to set forth criteria and a rational for such 
criteria for when a user fee reduction is appropriate. Therefore, FDA 
published a document in the Federal Register of August 1, 2011 (76 FR 
45818) (FRN) to seek public comments and information to assist the 
Agency to develop such guidelines. FDA will review the comments 
(comment period closes on November 30, 2011) and then develop the 
proposed set of guidelines; these will likely be implemented in fiscal 
year (FY) 2013. However, FDA recognizes that, meanwhile, for some small 
businesses the reinspection or the recall user fees, which went into 
effect on October 1, 2011, could impose severe economic hardship and 
there may be unique circumstances in which some relief would be 
appropriate. During FY 2012, FDA will consider waiving some or all of 
an invoiced fee based on a severe economic hardship. FDA intends to 
protect businesses and preserve free competitive enterprise.
    FDA is currently developing a guidance to outline the criteria and 
the process through which firms may request a reduction of fees based 
on economic hardship. FDA wants to consider the public comments from 
the small business FRN before finalizing such guidance. Also, in the 
recent ``Guidance for Industry: Implementation of the Fee Provisions of 
Section 107 of the FDA Food Safety Modernization Act'' that published 
in the Federal Register of October 6, 2011 (76 FR 62073), FDA stated 
that it would ``not intend to issue invoices for reinspection or recall 
order fees until this guidance document has been finalized.'' 
Therefore, FDA needs to publish such guidance soon after November 30, 
2011, in order to: (1) Issue invoices and (2) provide important 
information for qualified firms to apply for fee reductions, which will 
help them to sustain their businesses. Given such a short timeframe, 
use of the normal clearance process to obtain OMB approval under the 
PRA for the information collection related to the economic hardship fee 
reduction guidance is likely to cause delay of publishing such guidance 
and subsequently cause delay of issuing invoices. The fees, required by 
FSMA, are to cover 100 percent of the costs of certain reinspection and 
recall order activities conducted by FDA.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 72713]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                              Activity                                  Number of      Responses per     Total annual   Average  burden    Total hours
                                                                       Respondents       Respondent       responses      per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Request for reduction of fees collected under section 743 of the                235                1              235                2              470
 FD&C Act..........................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA estimates that 510 facilities will be subject to the 
reinspection and the recall fees under section 743 of the FD&C Act. Of 
these facilities, we estimate that 46 percent will be small businesses 
with annual gross sales under $250,000. Therefore, 46 percent of 510 
equals to 235 respondents. Each respondent will submit 1 request for 
reduction of fees. Total annual responses are 235. The average burden 
is 2 hours, giving a total of 470 hours annual burden.

    Dated: November 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-30471 Filed 11-22-11; 11:15 am]
BILLING CODE 4160-01-P