
[Federal Register Volume 80, Number 148 (Monday, August 3, 2015)]
[Notices]
[Pages 46020-46023]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18906]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0007]


Food Safety Modernization Act Domestic and Foreign Facility 
Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal 
Year 2016

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) 2016 fee rates for certain domestic and foreign 
facility reinspections, failures to comply with a recall order, and 
importer reinspections that are authorized by the Federal Food, Drug, 
and Cosmetic Act (the FD&C Act), as amended by the FDA Food Safety 
Modernization Act (FSMA). These fees are effective on October 1, 2015, 
and will remain in effect through September 30, 2016.

FOR FURTHER INFORMATION CONTACT: Jason Lewis, Office of Resource 
Management, Office of Regulatory Affairs, Food and Drug Administration, 
12420 Parklawn Dr., Rm. 2046, Rockville, MD 20857, 301-796-5957, email: 
Jason.Lewis@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 107 of FSMA (Pub. L. 111-353) added section 743 to the FD&C 
Act (21 U.S.C. 379j-31) to provide FDA with the authority to assess and 
collect fees from, in part: (1) The responsible party for each domestic 
facility and the U.S. agent for each foreign facility subject to a 
reinspection, to cover reinspection-related costs; (2) the responsible 
party for a domestic facility and an importer who does not comply with 
a recall order, to cover food \1\ recall activities associated with 
such order; and (3) each importer subject to a reinspection to cover 
reinspection-related costs (sections 743(a)(1)(A), (B), and (D) of the 
FD&C Act). Section 743 of the FD&C Act directs FDA to establish fees 
for each of these activities based on an estimate of 100 percent of the 
costs of each activity for each year (sections 743(b)(2)(A)(i), (ii), 
and (iv)), and these fees must be made available solely to pay for the 
costs of each activity for which the fee was incurred (section 
743(b)(3)). These fees are effective on October 1, 2015, and will 
remain in effect through September 30, 2016. Section 743(b)(2)(B)(iii) 
of the FD&C Act directs FDA to develop a proposed set of guidelines in 
consideration of the burden of fee amounts on small businesses. As a 
first step in developing these guidelines, FDA invited public comment 
on the potential impact of the fees authorized by section 743 of the 
FD&C Act on small businesses (76 FR 45818, August 1, 2011). The comment 
period for this request ended November 30, 2011. As stated in FDA's 
September 2011 ``Guidance for Industry: Implementation of the Fee 
Provisions of Section 107 of the FDA Food Safety Modernization Act,'' 
(http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/FoodDefense/ucm274176.htm), 
because FDA recognizes that for small businesses the full cost recovery 
of FDA reinspection or recall oversight could impose severe economic 
hardship, FDA intends to consider reducing certain fees for those 
firms. FDA does not intend to issue invoices for reinspection or recall 
order fees until FDA publishes a guidance document outlining the 
process through which firms may request a reduction in fees.
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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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    In addition, as stated in the September 2011 Guidance, FDA is in 
the process of considering various issues associated with the 
assessment and collection of importer reinspection fees. The fee rates 
set forth in this notice will be used to determine any importer 
reinspection fees assessed in FY 2016.

II. Estimating the Average Cost of a Supported Direct FDA Work Hour for 
FY 2016

    FDA is required to estimate 100 percent of its costs for each 
activity in order to establish fee rates for FY 2016. 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 (operating 
funds) available to FDA are used to support FDA employees for paying 
rent, travel, utility, information technology, and other operating 
costs.

[[Page 46021]]

A. Estimating the Full Cost per Direct Work Hour in FY 2014

    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 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. For the 
purposes of the reinspection and recall order fees authorized by 
section 743 of the FD&C Act (the fees that are the subject of this 
notice), primary responsibility for the activities for which fees will 
be collected rests with FDA's Office of Regulatory Affairs (ORA). ORA 
carries out inspections 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). 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 was FY 
2014. In that year, FDA obligated a total of $669,055,119 for ORA in 
carrying out the CFSAN and CVM related field activities work, excluding 
the cost of inspection travel. In that same year, the number of ORA 
staff primarily conducting the CFSAN and CVM related field activities 
was 3,016 FTEs or paid staff years. Dividing $669,055,119 by 3,016 FTEs 
results in an average cost of $221,835 per paid staff year, excluding 
travel costs.
    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) 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 2014, the average cost of an FTE 
was $221,835. Multiplying this amount by 1.43 results in an average 
fully supported cost of $317,224 per FTE, excluding the cost of 
inspection travel.
    To calculate an hourly rate, FDA must divide the average fully 
supported cost of $317,224 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 2014 
($317,224) by the total number of supported direct work hours available 
for assignment (1,600) results in an average fully supported cost of 
$198 (rounded to the nearest dollar), excluding inspection travel 
costs, per supported direct work hour in FY 2014--the last FY for which 
data are available.

B. Adjusting FY 2014 Costs for Inflation To Estimate FY 2016 Costs

    To adjust the hourly rate for FY 2016, FDA must estimate the cost 
of inflation in each year for FY 2015 and FY 2016. 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 
statutory method for inflation adjustment in the FD&C Act that FDA has 
used consistently. FDA previously determined the FY 2015 inflation rate 
to be 2.0813; this rate was published in the FY 2015 PDUFA user fee 
rates notice in the Federal Register of August 1, 2014 (79 FR 44807). 
Utilizing the method set forth in section 736(c)(1) of the FD&C Act, 
FDA has calculated an inflation rate of 2.0266 percent for FY 2016, and 
FDA intends to use this inflation rate to make inflation adjustments 
for FY 2016 for several of its user fee programs; the derivation of 
this rate is published in the Federal Register in the FY 2016 notice 
for the PDUFA user fee rates. The compounded inflation rate for FYs 
2015 and 2016, therefore, is 4.150 percent (1 plus 2.0813 percent times 
1 plus 2.0266 percent).
    Increasing the FY 2014 average fully supported cost per supported 
direct FDA work hour of $198 (excluding inspection travel costs) by 
4.150 percent yields an inflationary adjusted estimated cost of $206 
per a supported direct work hour in FY 2016, excluding inspection 
travel costs. FDA will use this base unit fee in determining the hourly 
fee rate for reinspection and recall order fees for FY 2016 prior to 
including domestic or foreign travel costs as applicable for the 
activity.
    In FY 2014, ORA spent a total of $4,536,206 for domestic regulatory 
inspection travel costs and General Services Administration Vehicle 
costs related to FDA's CFSAN and CVM field activities programs. The 
total ORA domestic travel costs spent is then divided by the 10,392 
CFSAN and CVM domestic inspections, which averages a total of $437 per 
inspection. These inspections average 31.64 hours per inspection. 
Dividing $437 per inspection by 31.64 hours per inspection results in a 
total and an additional cost of $14 per hour spent for domestic 
inspection travel costs in FY 2014. To adjust $14 for inflationary 
increases in FY 2015 and FY 2016, FDA must multiply it by the same 
inflation factor mentioned previously in this document (1.04150), which 
results in an estimated cost of $15 dollars per paid hour in addition 
to $206 for a total of $221 per paid hour ($206 plus $15) for each 
direct hour of work requiring domestic inspection travel. FDA will use 
these rates in charging fees in FY 2016 when domestic travel is 
required.
    In FY 2014, ORA spent a total of $3,209,009 on 255 foreign 
inspection trips related to FDA's CFSAN and CVM field activities 
programs, which averaged a total of $12,584 per foreign inspection 
trip. These trips averaged 3 weeks (or 120 paid hours) per trip. 
Dividing $12,584 per trip by 120 hours per trip results in a total and 
an additional cost of $105 per paid hour spent for foreign inspection 
travel costs in FY 2014. To adjust $105 for inflationary increases in 
FY 2015 and FY 2016, FDA must multiply it by the same inflation factor 
mentioned previously in this document (1.04150), which results in an 
estimated cost of $109 dollars per paid hour in addition to $206 for a 
total of $315 per paid hour ($206 plus $109) for each direct hour of 
work requiring foreign inspection travel. FDA will use these rates in 
charging fees in FY 2016 when foreign travel is required.

[[Page 46022]]



                 Table 2--FSMA Fee Schedule for FY 2016
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                                                               Fee rates
                         Fee category                            for FY
                                                                  2016
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Hourly rate if domestic travel is required...................       $221
Hourly rate if foreign travel is required....................        315
------------------------------------------------------------------------

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 (21 U.S.C. 374) 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 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 sections 402 and 403(w) of the FD&C Act, 
is materially related to a food safety requirement of the FD&C Act may 
depend on the facts of a particular situation. FDA intends to issue 
guidance to provide additional information about the circumstances 
under which FDA would consider non-compliance to be materially related 
to a food safety requirement of the FD&C Act.
    Under section 743(a)(1)(A) of the FD&C Act, FDA is directed to 
assess and collect fees from ``the responsible party for each domestic 
facility (as defined in section 415(b) (21 U.S.C. 350d(b))) 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 743(a)(1)(A) of the FD&C Act to collect fees from 
the U.S. 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), 
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 U.S. agent of a foreign facility in the event 
that an inspection reveals non-compliance materially related to a food 
safety requirement of the FD&C Act, 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'' 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).

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 U.S. 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 2 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) (21 U.S.C. 350l(d)) or section 412(f) of the FD&C 
Act (21 U.S.C. 350a(f)) 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). Non-compliance 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

[[Page 46023]]

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 2 of this document.

V. 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 90 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.

VI. What are the consequences of not paying these 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 U.S. 
Government subject to provisions of subchapter II of chapter 37 of 
title 31, United States Code.

    Dated: July 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18906 Filed 7-31-15; 8:45 am]
BILLING CODE 4164-01-P


