[Federal Register Volume 76, Number 147 (Monday, August 1, 2011)]
[Notices]
[Pages 45820-45825]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19331]
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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
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
fiscal year (FY) 2012 fee rates for certain domestic and foreign
facility reinspections, failure to comply with a recall order, and
importer reinspections that are mandated in the Federal Food, Drug, and
Cosmetic Act (the FD&C Act), amended by the FDA Food Safety
Modernization Act (FSMA). These fees are effective on October 1, 2011,
and will remain in effect through September 30, 2012. Invoices for
these fees for FY 2012 will be issued using the fee schedule
established in this document. FDA is accepting comments to this
document and intends to consider such comments in implementing these
user fees in FY 2013.
DATES: Submit either electronic or written comments by October 31,
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
FSMA (Pub. L. 111-353), section 743 of the FD&C Act (21 U.S.C.
379j-31), establishes three different kinds of fees. The fees are
assessed for the costs of the following activities: (1) Certain
domestic and foreign facility reinspections (section 743(a)(1)(A)), (2)
failure to comply with a recall order under section 423 or 412(f) of
the FD&C Act (section 743(a)(1)(B)), and (3) certain importer
reinspections (section 743(a)(1)(D)).
Fees for each of these activities are to be established to capture
100 percent of the costs of each activity for each year (sections
743(b)(2)(A), (B), and (D) of the FD&C Act), and must be made available
solely to pay for the costs of each activity for which the fee was
incurred (section 743(b)(3) of the FD&C Act.
These fees are effective on October 1, 2011, and will remain in
effect through September 30, 2012. FDA is accepting comments to this
document and intends to consider such comments, as well as experience
and additional data gained in implementing these user fees in FY 2012,
in implementing these user fees in FY 2013.
II. Estimating the Average Cost of a Supported Direct FDA Work Hour for
FY 2012
FDA is required to estimate 100 percent of its cost for each
activity and assess fees for FY 2012. In each year, the costs of salary
(or personnel compensation) and benefits for FDA employees account for
between 50 and 60 percent of the funds available to, and used by, FDA.
Almost all of the remaining funds (or the operating funds) available to
FDA are used to support FDA employees for paying rent, travel, utility,
information technology, and other operating costs.
A. Estimating the Full Cost Per Direct Work Hour in FY 2010
In general, the starting point for estimating the full cost per
direct work hour is to estimate the cost of a full-time-equivalent
(FTE) or paid staff year for the relevant activity. This is most
reasonably done by dividing the total funds allocated to the elements
of FDA primarily responsible for carrying out the activities for which
fees are being collected by the total FTEs allocated to those
activities, using information from the most recent FY for which data
are available. For the purposes of the FSMA fee provisions, primary
responsibility for the activities for which fees will be collected
rests with FDA's Office of Regulatory Affairs (ORA), which carries out
inspection and other field-based activities on behalf of FDA's product
centers, including the Center for Food Safety and Applied Nutrition
(CFSAN) and the Center for Veterinary Medicine (CVM), which have FSMA
implementation responsibilities. Thus, as the starting point for
estimating the full cost per direct work hour, FDA will use the total
funds allocated to ORA for CFSAN and CVM related field activities. The
most recent FY with available data is FY 2010. In that year, FDA
obligated a total of $626,095,116 for the Office of Regulatory Affairs
(ORA) in carrying out work related to programs of the CFSAN and CVM,
excluding the costs of foreign inspection travel. These are the staff
primarily conducting the work related to the reinspection and recall
activities
[[Page 45821]]
for which fees would be charged. The obligated total amount paid for
salary, benefits, and operating costs of 2,701 FTEs or paid staff years
utilized by ORA in FY 2010, but exclude the cost of foreign inspection
travel. Dividing $626,095,116 by 2,701 FTEs, results in an average cost
of $231,801 per paid staff year, excluding the costs of foreign
inspection travel.
Not all of the FTEs required to support the activities for which
fees will be collected are conducting direct work such as inspecting or
reinspecting facilities, examining imports, or monitoring recalls. Data
collected over a number of years and used consistently in other FDA
user fee programs (e.g., under the Prescription Drug User Fee Act
(PDUFA) and the Medical Device User Fee and Modernization Act (MDUFMA))
show that every seven FTEs who perform direct FDA work require three
indirect and supporting FTEs. These indirect and supporting FTEs
function in budget, facility, human resource, information technology,
planning, security, administrative support, legislative liaison, legal
counsel, program management, and other essential program areas. On
average, two of these indirect and supporting FTEs are located in ORA
or the FDA center where the direct work is being conducted, and one of
them is located in the Office of the Commissioner. To get the fully
supported cost of an FTE, FDA needs to multiply the average cost of an
FTE by 1.43, to take into account the indirect and supporting
functions. The 1.43 factor is derived by dividing the 10 fully
supported FTEs by 7 direct FTEs. In FY 2010, the average cost of an FTE
was $231,801. Multiplying this amount by 1.43 results in an average
fully supported cost of $331,476 per FTE, excluding the cost of foreign
inspection travel.
To calculate an hourly rate, FDA must divide the average fully
supported cost of $331,476 per FTE by the average number of supported
direct FDA work hours. See table 1.
Table 1--Supported Direct FDA Work Hours in a Paid Staff Year
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Total number of hours in a paid staff year.............. 2,080
Less:
10 paid holidays...................................... 80
20 days of annual leave............................... 160
10 days of sick leave................................. 80
10 days of training................................... 80
2 hours of meetings per week.......................... 80
Net Supported Direct FDA Work Hours Available for 1,600
Assignments............................................
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Dividing the average fully supported cost of an FTE in FY 2010
($331,476) by the total number of supported direct work hours available
for assignment (1,600) results in an average fully supported cost of
$207 (rounded to the nearest dollar), excluding foreign inspection
travel costs, per supported direct work hour in FY 2010--the last FY
for which data are available.
B. Adjusting FY 2010 Costs for Inflation to Estimate FY 2012 Costs
To adjust the hourly rate for FY 2012, FDA must estimate cost of
inflation in each year for FY 2011 and FY 2012. FDA uses the method
prescribed for estimating inflationary costs under the PDUFA provisions
of the FD&C Act (section 736(c)(1) (21 U.S.C. 379h(c)(1))), the only
provision the FD&C Act that provides a method for estimating future
inflationary costs. The inflationary adjustment specified in these
provisions, since FY 2008, is the greater of the following amounts: (1)
The total percentage change that occurred in the Consumer Price Index
(CPI) (all items; U.S. city average) during the 12-month period ending
June 30 preceding the FY for which fees are being set; (2) the total
percentage pay change for the previous FY for Federal employees
stationed in the Washington, DC metropolitan area; or (3) the average
annual change in cost, per FDA FTE, of all personnel compensation and
benefits paid per FTE over the previous five of the most recent six
FYs. PDUFA IV provides for this adjustment to be cumulative and
compounded annually after FY 2008 (see section 736(c)(1)).
For FY 2012, the first factor is the CPI increase for the 12-month
period ending in June 2011. The CPI for June 2011 was 225.722 and the
CPI for June 2010 was 217.965. (These CPI figures are available on the
Bureau of Labor Statistics Web site at http://data.bls.gov/cgi-bin/surveymost?bls by checking the first box under ``Price Indexes'' and
then clicking ``Retrieve Data'' at the bottom of the page. FDA has
verified the Web site addresses throughout this document, but is not
responsible for any subsequent changes to the Web sites after this
document publishes in the Federal Register.) The CPI for June 2011 is
3.559 percent higher than the CPI for the previous 12-month period.
The second factor for the FY 2012 inflationary increase is the
increase in pay for the previous FY (FY 2011 in this case) for Federal
employees stationed in the Washington, DC metropolitan area. (This
figure is published by the Office of Personnel Management, and can be
found on the Web site at http://www.opm.gov/oca/11tables/html/dcb.asp
above the salary table. For FY 2011, the inflationary increase was 0.00
percent.
For FY 2012, the third factor is the average change in FDA's cost
for compensation and benefits per FTE over the previous five of the
most recent six FYs (FY 2006 through FY 2010). The data on total
compensation and benefits paid and numbers of FTEs paid, from which the
average cost per FTE can be derived, are published in FDA's
Justification of Estimates for Appropriations Committees. Table 2 of
this document summarizes the actual costs and FTE data for the
specified FYs, and provides the percent changes from the previous FYs
and the average percent change over the previous five of the most
recent six FYs, which is 3.72 percent.
Table 2--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change
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Average
FY 2005 FY 2006 FY 2007 FY 2008 FY 2009 FY 2010 for latest
5 years
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Total PC&B........................... $1,077,604,000 $1,114,704,000 $1,144,369,000 $1,215,627,000 $1,464,445,000 $1,634,108,000 ...........
Total FTE............................ 9,910 9,698 9,569 9,811 11,413 12,526 ...........
PC&B per FTE......................... $108,739 $114,942 $119,591 $123,905 $128,314 $130,457 ...........
% Change from Previous Year.......... 5.75% 5.70% 4.05% 3.61% 3.56% 1.67% 3.72%
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Taking all three factors into consideration, the inflationary
increase for FY 2012 is 3.72 percent. The average percent change over
the previous five of the most recent six FYs is 3.72 percent which is
greater than the CPI change
[[Page 45822]]
during the 12-month period ending June 30 preceding the FY for which
fees are being set (3.559 percent), and the increase in pay for the
previous FY (FY 2011 in this case) for Federal employees stationed in
the Washington, DC metropolitan area (0.00 percent). Therefore, the
average percent change in PC&B cost per FTE (3.72 percent) becomes the
inflation adjustment for the fee revenue for FY 2012.
The inflationary adjustment for FY 2011 under the same provisions
in section 736(c)(1) of the FD&C Act was 4.53 percent--the average
percent change over the previous five of the most recent six FYs (FY
2005 through FY 2009). This 4.53 percent is greater than the CPI
increase during the 12-month period ending June 30 preceding the FY for
which fees were being set on June 30, 2010 (1.053 percent), and the
increase in pay for FY 2010 for Federal employees stationed in
Washington, DC (2.42 percent).
Section 736(c)(1) of the FD&C Act requires the inflationary
adjustment to be cumulative and compounded. This factor for FY 2012
(3.72 percent) is compounded by adding 1 and then multiplying by 1 plus
the inflationary adjustment factor for FY 2011 (4.53 percent), to
account for the 2 years of inflationary adjustments since FY 2010. The
result of this multiplication (1.0372 times 1.0453) becomes the
inflationary adjustment for FY 2012, which is 1.0842, or an increase of
8.42 percent over FY 2010 costs.
Increasing FY 2010 average fully supported cost per supported
direct FDA work hour of $207 (excluding foreign inspection travel
costs) by 8.42 percent yields an inflationary adjusted cost of $224 per
a supported direct work hour in FY 2012, excluding foreign inspection
travel costs. This is the unit cost that FDA will use in billing the
reinspection and the recall activities for FY 2012 if no foreign travel
is required for the activity.
In FY 2010, ORA spent a total of $1,010,900 on a total of 91
foreign inspection trips related to FDA's food and veterinary medicine
programs, which averaged a total of $11,109 per foreign inspection
trip. These trips averaged 3 weeks (or 120 paid hours) per trip.
Dividing $11,109 per trip by 120 hours per trip results in a total and
an additional cost of $93 per paid hour spent for foreign inspection
travel costs in FY 2010. To adjust $93 for inflationary increases in FY
2011 and FY 2012, FDA must multiply it by the same inflation factor
mentioned previously in this document (1.0842) which results in an
estimated cost of $101 dollars per paid hour in addition to $224 for a
total of $335 per paid hour ($224 plus $101) for each direct hour of
work requiring foreign inspection travel. These are the rates that FDA
will use in charging fees in FY 2012 when foreign travel is required.
Table 3--FSMA Fee Schedule for FY 2012
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Fee rates
Fee category for FY 2012
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Hourly rate if no foreign travel is required............... $224
Hourly rate if foreign travel is required.................. 335
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Congress directed FDA to publish, within 180 days of enactment of
FSMA, a proposed set of guidelines in consideration of the burden of
fee amounts on small business (section 743(b)(2)(B)(iii) of the FD&C
Act). Such consideration may include reduced fee amounts for small
businesses. FDA believes it is important to gather additional
information before publishing such guidelines. Therefore, the Agency is
publishing a separate document in this issue of the Federal Register
requesting public input to help the Agency understand what factors
should be taken into account when drafting the proposed guidelines. The
Agency intends to consider the comments received and then publish for
comment a proposed set of guidelines on the considerations of the
burden of fee amounts on small business. Any adjustment to the fee
schedule for small business must be done through notice and comment
rulemaking (see section 743(b)(2)(B)(iii)). Thus, there will be no
separate small business fees published for FY 2012 (table 3 of this
document) and the published fees in this document will apply to all
businesses in FY 2012.
FDA recognizes, however, that for some small businesses the full
cost recovery of FDA reinspection or recall oversight could impose
severe economic hardship, and there may be unique circumstances in
which some relief would be appropriate. Thus, during FY 2012, FDA will
consider waiving in limited cases some or all of an invoiced fee based
on a severe economic hardship, the nature and extent of the underlying
violation, and other relevant factors.
III. Fees for Reinspections of Domestic or Foreign Facilities Under
Section 743(a)(1)(A)
A. What will cause this fee to be assessed?
The fee will be assessed for a reinspection conducted under section
704 of the FD&C Act to determine whether corrective actions have been
implemented and are effective and compliance has been achieved to the
Secretary of Health and Human Services' (the Secretary) (and, by
delegation, FDA's) satisfaction at a facility that manufactures,
processes, packs or holds food \1\ for consumption necessitated as a
result of a previous inspection (also conducted under section 704) of
this facility which had a final classification of Official Action
Indicated (OAI) conducted by or on behalf of FDA, when FDA determined
the non-compliance was materially related to food safety requirements
of the FD&C Act. FDA considers such non-compliance to include non-
compliance with a statutory or regulatory requirement under section 402
of the FD&C Act (21 U.S.C. 342) and section 403(w) of the FD&C Act (21
U.S.C. 343(w)). However, FDA does not consider non-compliance that is
materially related to a food safety requirement to include
circumstances where the non-compliance is of a technical nature and not
food safety related (e.g., failure to comply with a food standard or
incorrect font size on a food label). Determining when non-compliance,
other than under section 402 and 403(w) of the FD&C Act, is materially
related to food safety may depend on the facts of a particular
situation. FDA may consider issuing guidance to provide additional
information about the circumstances under which FDA would consider when
non-compliance is materially related to a food safety requirement.
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\1\ The term ``food'' for purposes of this document has the same
meaning as such term in section 201(f) of the FD&C Act (21 U.S.C.
321(f)).
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Under section 743(a)(1)(A) of the FD&C Act, FDA shall assess and
collect fees from ``the responsible party for each domestic facility
(as defined in section 415(b) (21 U.S.C. 350d)) and the United States
agent for each foreign facility subject to a reinspection'' to cover
reinspection-related costs.
Section 743(a)(2)(A)(i) of the FD&C Act defines the term
``reinspection'' with respect to domestic facilities as ``1 or more
inspections conducted under section 704 subsequent to an inspection
conducted under such provision which identified non-compliance
materially related to a food safety requirement of th[e] Act,
specifically to determine whether compliance has been achieved to the
Secretary's satisfaction.''
The FD&C Act does not contain a definition of ``reinspection''
specific to foreign facilities. In order to give meaning to the
language in section
[[Page 45823]]
743(a)(1)(A) of the FD&C Act to collect fees from the United States
agent of a foreign facility subject to a reinspection, the Agency is
using the following definition, of ``reinspection,'' for purposes of
assessing and collecting fees under section 743(a)(1)(A) of the FD&C
Act, with respect to a foreign facility: ``1 or more inspections
conducted by officers or employees duly designated by the Secretary
subsequent to such an inspection which identified non-compliance
materially related to a food safety requirement of the FD&C Act,
specifically to determine whether compliance has been achieved to the
Secretary's (and, by delegation, FDA's) satisfaction.''
This definition allows FDA to fulfill the mandate to assess and
collect fees from the United States agent of a foreign facility in the
event that an inspection reveals non-compliance materially-related to a
food safety requirement causing one or more subsequent inspections to
determine whether compliance has been achieved to the Secretary's (and,
by delegation, FDA's) satisfaction. By requiring the initial inspection
to be conducted by officers or employees duly designated by the
Secretary, the definition ensures that a foreign facility would be
subject to fees only in the event that FDA, or an entity designated to
act on its behalf, has made the requisite identification at an initial
inspection of non-compliance materially related to a food-safety
requirement of the FD&C Act. The definition of ``reinspection-related
costs,'' as defined in section 743(a)(2)(B) of the FD&C Act, relates to
both a domestic facility reinspection and a foreign facility
reinspection, as described in section 743(a)1)(A) of the FD&C Act.
B. Who will be responsible for paying this fee?
The FD&C Act states that this fee is to be paid by the responsible
party for each domestic facility (as defined in section 415(b) of the
FD&C Act) and by the United States agent for each foreign facility
(section 743(a)(1)(A) of the FD&C Act). This is the party to whom FDA
will send the invoice for any fees that are assessed under this
section.
C. How much will this fee be?
The fee is based on the number of direct hours spent on such
reinspections, including time spent conducting the physical
surveillance and/or compliance reinspection at the facility, or
whatever components of such an inspection are deemed necessary, making
preparations and arrangements for the reinspection, traveling to and
from the facility, preparing any reports, analyzing any samples or
examining any labels if required, and performing other activities as
part of the OAI reinspection until the facility is again determined to
be in compliance. The direct hours spent on each such reinspection will
be billed at the appropriate hourly rate shown in table 3 of this
document.
IV. Fees for Non-Compliance With a Recall Order Under Section
743(a)(1)(B)
A. What will cause this fee to be assessed?
The fee will be assessed for not complying with a recall order
under section 423(d) or 412(f) of the FD&C Act to cover food recall
activities associated with such order performed by the Secretary (and
by delegation, FDA) (section 743(a)(1)(B) of the FD&C Act).
Noncompliance may include the following: (1) Not initiating a recall as
ordered by FDA; (2) not conducting the recall in the manner specified
by FDA in the recall order; or (3) not providing FDA with requested
information regarding the recall, as ordered by FDA.
B. Who will be responsible for paying this fee?
Section 743(a)(1)(B) of the FD&C Act states that the fee is to be
paid by the responsible party for a domestic facility (as defined in
section 415(b) of the FD&C Act and an importer who does not comply with
a recall order under section 423 or under section 412(f) of the FD&C
Act. In other words, the party paying the fee would be the party that
received the recall order.
C. How much will this fee be?
The fee is based on the number of direct hours spent on taking
action in response to the firm's failure to comply with a recall order.
Types of activities could include conducting recall audit checks,
reviewing periodic status reports, analyzing the status reports and the
results of the audit checks, conducting inspections, traveling to and
from locations, and monitoring product disposition. The direct hours
spent on each such recall will be billed at the appropriate hourly rate
shown in table 3 of this document.
V. Fees for Import Reinspection/Reexamination Under Section
743(a)(1)(D)
A. What will cause this fee to be assessed?
Under section 743(a)(2)(A)(ii) of the FD&C Act, for a fee to be
assessed, there must be two sets of examinations. First, there must be
an examination conducted under section 801 of the FD&C Act (21 U.S.C.
381), which must identify noncompliance materially related to a food
safety requirement of the FD&C Act.
Second, subsequent to the first examination, there must be 1 or
more additional examinations conducted under section 801. These
additional examinations must be conducted specifically to determine
whether compliance has been achieved to the Secretary's (and, by
delegation, FDA's) satisfaction. Moreover, per section 743(a)(1)(D) of
the FD&C Act, an importer subject to a reinspection will be assessed a
fee to cover reinspection-related costs.
FDA has determined that at least the following four specific
situations will cause a fee to be assessed:
1. Reconditioning of Imported Food
FDA reviews food that is imported or offered for import to
determine admissibility into the United States (see, e.g., section
801(a) of the FD&C Act). Food is subject to refusal of admission if,
among other reasons, (a) it appears to be adulterated or misbranded, or
(b) if it is a dietary supplement subject to section 761 of the FD&C
Act (21 U.S.C. 379aa-1), FDA has credible evidence or information
indicating that the responsible person has not complied with a
requirement of that section or has not allowed access to records
described in that section. When FDA initiates a refusal of admission,
often referred to as detaining the product, notice is given to the
owner or consignee. If the detention is based on one of the reasons
just described, the owner or consignee of the food may request
permission to recondition the food under section 801(b) of the FD&C
Act. When the basis is that the food appears to be adulterated or
misbranded, the request can be to bring the food into compliance by
relabeling or other action, such as heat treatment, or to render it
other than a food, drug, device, or cosmetic. When the basis relates to
section 761 (serious adverse event reporting for dietary supplements),
the request can be for the responsible person, as defined in section
761, to take action to ensure that the responsible person is in
compliance with section 761.
A request for reconditioning is made after FDA has determined that
the food is subject to refusal of admission under section 801(a) of the
FD&C Act. For the purpose of section 743 of the FD&C Act, FDA considers
its review of information for the purpose of determining whether an
article of food is admissible to be ``an examination conducted under
section 801.'' If that review leads FDA to determine that the food is
subject to
[[Page 45824]]
refusal of admission under section 801(a), FDA considers that to mean
that its examination ``identified noncompliance'' for the purpose of
section 743. This examination could involve, for example, a laboratory
analysis of physical samples of the product or a review of the
product's label. It could also involve reviewing other information FDA
obtains, such as reviewing sample results from a reliable third party,
relevant epidemiological evidence, or the results from an FDA or third
party inspection of a facility where the food was processed. A
detention without physical examination could also be based on
information contained in an import alert.
When food is on an import alert, it typically means that FDA has
concluded there is sufficient evidence or other information to detain
without physical examination of future shipments of the imported food
(e.g., that future shipments appear to be adulterated or misbranded)
and they are subject to refusal unless the owner or consignee shows the
product is compliant (e.g., through third-party laboratory analysis).
FDA considers situations where FDA's review of information leads it to
conclude that food should be placed on an import alert for detention
without physical examination to be ``an examination conducted under
section 801 [that] identified noncompliance'' for the purposes of
section 743. FDA's Regulatory Procedures Manual (RPM), Chap. 9,
discusses the types of reviews FDA conducts, and the types of
information it reviews, in determining whether to detain a product or
to place a product on an import alert.
For a fee to be assessed under section 743, FDA's determination
that the food is subject to refusal of admission must be on a basis
materially related to food safety requirements (see section III.A of
this document for a discussion about ``materially related to food
safety requirements'').
If FDA authorizes a request for reconditioning, the reconditioning
operations are carried out under the supervision of either FDA or U.S.
Customs and Border Protection (CBP) (section 801(b) of the FD&C Act; 21
CFR 1.96(a)). FDA considers the review and approval of the request, as
well as this supervision to be ``1 or more examinations conducted under
section 801 * * * specifically to determine whether compliance has been
achieved'' to FDA's satisfaction.
2. Importer Seeking Admission of an Article That Has Been Detained
If FDA has determined that an article of food is subject to refusal
of admission under section 801(a) of the FD&C Act, FDA gives notice of
this to the owner or consignee, who then has an opportunity to
introduce evidence regarding the admissibility of the food (section
801(a) of the FD&C Act; 21 CFR 1.94(a)). As discussed previously in
this document, where FDA has reviewed information for the purpose of
admissibility and determined that the food is subject to refusal of
admission under section 801, FDA considers that it has conducted ``an
examination conducted under section 801 [that] identified
noncompliance.'' This includes situations where FDA's review determines
that food should be placed on an import alert for detention without
physical examination.
If the owner or consignee chooses to submit evidence regarding
admissibility, FDA reviews the information to determine whether--
despite the appearance that the product is adulterated, misbranded, or
otherwise subject to refusal of admission--the food is compliant and
admissible into the United States. The evidence the owner or consignee
submits varies. Depending on the circumstances, it could include, for
example, the results of laboratory analyses of samples conducted on the
owner/consignee's behalf to show the product is not contaminated. FDA
considers its review of the evidence submitted to be ``1 or more
examinations conducted under section 801 * * * specifically to
determine whether compliance has been achieved'' to FDA's satisfaction.
Not all situations where the owner/consignee provides information
or evidence to demonstrate compliance will result in the assessment of
a fee. An example is if a food, not subject to an Import Alert, is
detained based on an appearance of adulteration or misbranding, but
information is presented that demonstrates that the food is not
adulterated or misbranded. FDA considers such a situation to be one in
which a fee is not assessed.
A fee may or may not be assessed under certain circumstances
related to food that is detained based on an import alert for detention
without physical examination covering food from a particular geographic
region or country. FDA may place a region or country on an import alert
if there appears to be an ongoing problem or condition in that region
or country such that it causes the appearance of a violation for future
shipments of imported articles originating there. If food from a region
or country is subject to an import alert and is subsequently detained
based on the overarching import alert, the owner or consignee may seek
admission by providing evidence that the problem or conditions
regarding the food it is importing have been resolved. Alternatively,
the owner or consignee may provide evidence that the problems or
conditions that led to the alert, even if widespread in the region or
country, did not apply to its food and, thus, it did not need to
resolve any compliance-related issues. FDA considers the latter
situation to be one in which a fee is not assessed. A fee may be
assessed, however, when FDA reviews compliance information specific to
the food being imported or specific to a particular processor in
determining whether to issue a region- or country-wide import alert. An
example is a situation where FDA analyzed samples of food from
Processor A and found it to be contaminated, the food is later placed
on a region- or country-wide import alert, and the owner or consignee
is now importing or offering for import food from Processor A. If the
owner or consignee seeks admission of the food by providing third party
laboratory analyses to show the food is not contaminated, FDA's review
of this information would be ``1 or more examinations conducted under
section 801 * * * specifically to determine whether compliance has been
achieved'' to FDA's satisfaction.
3. Entity Requesting Removal From an Import Alert for Detention Without
Physical Examination
Once placed on import alert, food imported from a particular firm,
region, or country may remain in this status until FDA has sufficient
evidence or other information, such as information that removes the
appearance of the violation that led to the initial placement on import
alert. Depending on the situation that led to the import alert, FDA's
RPM Chapter 9 or the import alert itself may explain the types of
information that should be provided.
As discussed previously in this document, where FDA has reviewed
information and determined that food should be placed on an import
alert for detention without physical examination, it considers that it
has conducted 1 or more examinations conducted under section 801 that
identified noncompliance.
Where an entity requests removal of food from an import alert and
provides supporting information, FDA considers its review of this
information, along with any other related examination it undertakes in
considering the request, to be ``1 or more examinations conducted under
section 801 * * * specifically to determine whether compliance has been
achieved'' to FDA's satisfaction.
[[Page 45825]]
As discussed in section V.A.2 of this document, some requests for
removal from region- or country-wide import alerts will not lead to the
assessment of a fee. Fees would only be assessed in situations where,
in issuing the alert, FDA reviewed compliance information specific to a
particular person or entity sufficiently related to the request for
removal. An example of such a situation is where FDA analyzed samples
of food from Processor A and found it to be contaminated, the food is
then placed on a region- or country-wide import alert, and FDA receives
a request to remove food from Processor A from the import alert.
4. Destruction of Food That Has Been Refused Admission
If a product is refused admission under section 801(a) of the FD&C
Act, it must be exported within 90 days of the document of refusal or
it is subject to destruction by CBP (section 801(a) of the FD&C Act).
In practice, when a product is destroyed, destruction is often
conducted by the owner or consignee under the supervision of FDA or
CBP. Where FDA conducts a review and/or approves a destruction proposal
and such supervision of destruction occurs, FDA considers this to be
``1 or more examinations conducted under section 801 * * * specifically
to determine whether compliance has been achieved'' to FDA's
satisfaction.
B. Who will be responsible for paying this fee?
The importer that is subject to the additional examinations that
are described in section V.A of this document is responsible for paying
the fee, according to section 743(a)(1)(D) of the FD&C Act.
1. Reconditioning of Imported Food
For reconditioning, the entity that is responsible for the
reconditioning is responsible for paying the fee. The request for
reconditioning can only be made by the owner or consignee of the food
(21 CFR 1.95). If ownership changes, the new owner will be responsible
for the reconditioning if that new owner executes a bond and obtains a
new authorization (21 CFR 1.96(d)).
2. Importer Seeking Admission of an Article That Has Been Detained
The entity that introduces evidence regarding admissibility is
responsible for paying this fee. This is the owner or consignee of the
food that is being imported or offered for import. (Section 801(a) of
the FD&C Act; 21 CFR 1.83(b) and 1.94(a).)
3. Entity Requesting Removal From an Import Alert for Detention Without
Physical Examination.
FDA considers the entity that requests removal of the food from the
import alert to be the importer subject to the examination and, thus,
responsible for paying this fee.
4. Destruction of Food That Has Been Refused Admission
FDA considers the entity that destroys the product under FDA or CBP
supervision to be the importer subject to the examination and, thus,
responsible for paying this fee.
C. How much will this fee be?
The fee is to cover all expenses incurred in connection with
arranging, conducting, and evaluating the results of the one or more
additional examinations that are described in section V.A of this
document.
For reconditioning, section 801(c) of the FD&C Act directs the
owner or consignee to pay all expenses in connection with the
supervision of reconditioning with respect to food and certain other
FDA-regulated products. Those parties have been paying these expenses,
but FDA did not have authority to retain those fees. FDA considers the
enactment of section 743 of the FD&C Act to mean that, for food, FDA is
now authorized to assess and retain these fees, but only with respect
to the reconditioning of food and only if the other conditions of
section 743 are met. If a fee is authorized under section 743 for a
particular article of food, FDA considers this to mean it cannot
collect a fee related to reconditioning that article under section
801(c).
For destruction, section 801(c) of the FD&C Act also directs the
owner or consignee to pay all expenses in connection with the
destruction of food and certain other FDA-regulated products under
section 801(a). However, neither FDA nor CBP have had the authority to
retain those fees. FDA considers the enactment of section 743 of the
FD&C Act to mean that, for food, FDA is now authorized to assess and
retain these fees, but only with respect to the destruction of food and
only if the other conditions of section 743 are met. If a fee is
authorized under section 743 for a particular article of food, FDA
considers this to mean it cannot collect a fee related to destruction
of that article under section 801(c) of the FD&C Act.
The direct hours spent on each such import reinspections will be
billed at the appropriate hourly rate shown in table 3 of this
document.
VI. How must the fees be paid?
An invoice will be sent to the responsible party for paying the fee
after FDA completes the work on which the invoice is based. Payment
must be made within 30 days of the invoice date in U.S. currency by
check, bank draft, or U.S. postal money order payable to the order of
the Food and Drug Administration. Detailed payment information will be
included with the invoice when it is issued.
VII. What are the consequences of not paying these user fees?
Under section 743(e)(2) of the FD&C Act, any fee that is not paid
within 30 days after it is due shall be treated as a claim of the
United States Government subject to provisions of subchapter II of
chapter 37 of title 31, United States Code.
VIII. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding 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: July 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-19331 Filed 7-29-11; 8:45 am]
BILLING CODE 4160-01-P