83_FR_35804 83 FR 35659 - Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2019

83 FR 35659 - Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2019

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 145 (July 27, 2018)

Page Range35659-35662
FR Document2018-16069

The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2019 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 (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). These fees are effective on October 1, 2018, and will remain in effect through September 30, 2019.

Federal Register, Volume 83 Issue 145 (Friday, July 27, 2018) 
[Federal Register Volume 83, Number 145 (Friday, July 27, 2018)]
[Notices]
[Pages 35659-35662]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-16069]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2775]


Food Safety Modernization Act Domestic and Foreign Facility 
Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal 
Year 2019

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) 2019 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 (FD&C Act), as amended by the FDA Food Safety 
Modernization Act (FSMA). These fees are effective on October 1, 2018, 
and will remain in effect through September 30, 2019.

FOR FURTHER INFORMATION CONTACT: Jason Lewis, Office of Management, 
Office of Regulatory Affairs, Food and Drug Administration, 12420 
Parklawn Dr., Rm. 2406, Rockville, MD 20857,

[[Page 35660]]

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 (section 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 (section 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, 2018, and will 
remain in effect through September 30, 2019. 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 2019.

II. Estimating the Average Cost of a Supported Direct FDA Work Hour for 
FY 2019

    FDA is required to estimate 100 percent of its costs for each 
activity to establish fee rates for FY 2019. 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 (IT), and other operating 
costs.

A. Estimating the Full Cost per Direct Work Hour in FY 2019

    Full-time equivalent (FTE) reflects the total number of regular 
straight-time hours--not including overtime or holiday hours--worked by 
employees, divided by the number of compensable hours applicable to 
each fiscal year. Annual leave, sick leave, compensatory time off, and 
other approved leave categories are considered ``hours worked'' for 
purposes of defining FTE employment.
    In general, the starting point for estimating the full cost per 
direct work hour is to estimate the cost of an FTE or paid staff year. 
Calculating an Agency-wide total cost per FTE requires three primary 
cost elements: Payroll, non-payroll, and rent.
    We have used an average of past year cost elements to predict the 
FY 2019 cost. The FY 2019 FDA-wide average cost for payroll (salaries 
and benefits) is $157,731; non-payroll--including equipment, supplies, 
IT, general and administrative overhead--is $91,008; and rent, 
including cost allocation analysis and adjustments for other rent and 
rent-related costs, is $24,400 per paid staff year, excluding travel 
costs.
    Summing the average cost of an FTE for payroll, non-payroll, and 
rent, brings the FY 2019 average fully supported cost to $273,139 per 
FTE, excluding travel costs. FDA will use this base unit fee in 
determining the hourly fee rate for reinspection and recall order fees 
for FY 2019 prior to including domestic or foreign travel costs as 
applicable for the activity.
    To calculate an hourly rate, FDA must divide the FY 2019 average 
fully supported cost of $273,139 per FTE by the average number of 
supported direct FDA work hours in FY 2017--the last FY for which data 
are available. See table 1.

Table 1--Supported Direct FDA Work Hours in a Paid Staff Year in FY 2017
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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
12.5 days of training........................................       -100
26.5 days of general administration..........................       -184
26.5 days of travel..........................................       -212
2 hours of meetings per week.................................       -104
                                                              ----------
Net Supported Direct FDA Work Hours Available for Assignments      1,160
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    Dividing the average fully supported FTE cost in FY 2019 ($273,139) 
by the total number of supported direct work hours available for 
assignment in FY 2017 (1,160) results in an average fully supported 
cost of $235 (rounded to the nearest dollar), excluding inspection 
travel costs, per supported direct work hour in FY 2019.

B. Adjusting FY 2017 Travel Costs for Inflation To Estimate FY 2019 
Travel Costs

    To adjust the hourly rate for FY 2019, FDA must estimate the cost 
of inflation in each year for FY 2018 and FY 2019. FDA uses the method 
prescribed for estimating inflationary costs under the Prescription 
Drug User Fee Act (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 2018 inflation rate to be 1.6868 percent; this rate 
was published in the FY 2018 PDUFA user fee rates notice in the Federal 
Register (September 14, 2017, 82 FR 43244). Utilizing the method set 
forth in section 736(c)(1) of the FD&C Act, FDA has calculated an 
inflation rate of 1.6868 percent for 2018 and 1.7708 percent for 2019, 
and FDA intends to use these inflation rates to make inflation 
adjustments for FY 2019 for several of its user fee programs; the 
derivation of this rate will be published in the Federal Register in 
the FY 2019 notice for the PDUFA user fee rates.
    The average fully supported cost per supported direct FDA work 
hour, excluding travel costs of $235 already takes into account 
inflation as the calculation above is based on FY 2019

[[Page 35661]]

predicted costs. FDA will use this base unit fee in determining the 
hourly fee rate for reinspection and recall order fees for FY 2019 
prior to including domestic or foreign travel costs as applicable for 
the activity. In FY 2017, FDA's Office of Regulatory Affairs (ORA) 
spent a total of $5,846,091 for domestic regulatory inspection travel 
costs and General Services Administration Vehicle costs related to 
FDA's Center for Food Safety and Applied Nutrition (CFSAN) and Center 
for Veterinary Medicine (CVM) field activities programs. The total ORA 
domestic travel costs spent is then divided by the 10,289 CFSAN and CVM 
domestic inspections, which averages a total of $568 per inspection. 
These inspections average 34.05 hours per inspection. Dividing $568 per 
inspection by 34.05 hours per inspection results in a total and an 
additional cost of $17 (rounded to the nearest dollar) per hour spent 
for domestic inspection travel costs in FY 2017. To adjust for the $17 
per hour additional domestic cost inflation increases for FY 2018 and 
FY 2019, FDA must multiply the FY 2018 PDUFA inflation rate adjustor 
(1.016868) times the FY 2019 PDUFA inflation rate adjustor (1.017708) 
times the $17 additional domestic cost, which results in an estimated 
cost of $18 (rounded to the nearest dollar) per paid hour in addition 
to $235 for a total of $253 per paid hour ($235 plus $18) for each 
direct hour of work requiring domestic inspection travel. FDA will use 
these rates in charging fees in FY 2019 when domestic travel is 
required.
    In FY 2017, ORA spent a total of $2,566,050 on 480 foreign 
inspection trips related to FDA's CFSAN and CVM field activities 
programs, which averaged a total of $5,346 per foreign inspection trip. 
These trips averaged 3 weeks (or 120 paid hours) per trip. Dividing 
$5,346 per trip by 120 hours per trip results in a total and an 
additional cost of $45 (rounded to the nearest dollar) per paid hour 
spent for foreign inspection travel costs in FY 2017. To adjust $45 for 
inflationary increases in FY 2018 and FY 2019, FDA must multiply it by 
the same inflation factors mentioned previously in this document 
(1.016868 and 1.107708), which results in an estimated cost of $47 
(rounded to the nearest dollar) per paid hour in addition to $235 for a 
total of $282 per paid hour ($235 plus $47) for each direct hour of 
work requiring foreign inspection travel. FDA will use these rates in 
charging fees in FY 2019 when foreign travel is required.

                 Table 2--FSMA Fee Schedule for FY 2019
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                                                           Fee rates for
                      Fee category                            FY 2019
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Hourly rate if domestic travel is required..............            $253
Hourly rate if foreign travel is required...............             282
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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

[[Page 35662]]

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 
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 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16069 Filed 7-26-18; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices 35659 www.regulations.gov and insert the I. Background III. Electronic Access docket number, found in brackets in the Atherectomy is an interventional heading of this document, into the Persons interested in obtaining a copy procedure performed to debulk ‘‘Search’’ box and follow the prompts of the draft guidance may do so by atherosclerotic plaque from diseased and/or go to the Dockets Management downloading an electronic copy from arteries. Atherectomy has been used in Staff, 5630 Fishers Lane, Rm. 1061, treatment of both coronary and the internet. A search capability for all Rockville, MD 20852. peripheral arterial disease. FDA has Center for Devices and Radiological developed this draft guidance for Health guidance documents is available You may submit comments on any guidance at any time (see 21 CFR members of industry who submit and at https://www.fda.gov/MedicalDevices/ 10.115(g)(5)). FDA staff who review premarket DeviceRegulationandGuidance/ submissions for atherectomy devices GuidanceDocuments/default.htm. This An electronic copy of the guidance guidance document is also available at used in the peripheral vasculature. document is available for download https://www.regulations.gov. Persons When finalized, this guidance is from the internet. See the unable to download an electronic copy intended to provide recommendations SUPPLEMENTARY INFORMATION section for for information to include in premarket of ‘‘Peripheral Vascular Atherectomy information on electronic access to the notifications (510(k)) for peripheral Devices—Premarket Notification guidance. Submit written requests for a vascular atherectomy devices (e.g., [510(k)] Submissions’’ may send an single hard copy of the draft guidance descriptive characteristics, labeling, email request to CDRH-Guidance@ document entitled ‘‘Peripheral Vascular biocompatibility, sterility, non-clinical, Atherectomy Devices—Premarket fda.hhs.gov to receive an electronic animal, and clinical performance copy of the document. Please use the Notification [510(k)] Submissions’’ to testing). the Office of the Center Director, document number 16013 to identify the Guidance and Policy Development, II. Significance of Guidance guidance you are requesting. Center for Devices and Radiological This draft guidance is being issued IV. Paperwork Reduction Act of 1995 Health, Food and Drug Administration, consistent with FDA’s good guidance 10903 New Hampshire Ave., Bldg. 66, practices regulation (21 CFR 10.115). This draft guidance refers to Rm. 5431, Silver Spring, MD 20993– The draft guidance, when finalized, will previously approved collections of 0002. Send one self-addressed adhesive represent the current thinking of FDA information found in FDA regulations. label to assist that office in processing on ‘‘Peripheral Vascular Atherectomy These collections of information are your request. Devices—Premarket Notification subject to review by the Office of FOR FURTHER INFORMATION CONTACT: [510(k)] Submissions.’’ It does not Management and Budget (OMB) under establish any rights for any person and the Paperwork Reduction Act of 1995 Misti Malone, Center for Devices and is not binding on FDA or the public. (44 U.S.C. 3501–3520). The collections Radiological Health, Food and Drug You can use an alternative approach if of information in the following FDA Administration, 10903 New Hampshire it satisfies the requirements of the regulations and guidance have been Ave., Bldg. 66, Rm. 120, Silver Spring, applicable statutes and regulations. This approved by OMB as listed in the MD 20993–0002, 301–796–2520. guidance is not subject to Executive following table: SUPPLEMENTARY INFORMATION: Order 12866. OMB Control 21 CFR part Topic No. 807, subpart E .......................................... Premarket Notification .................................................................................................. 0910–0120 812 ............................................................ Investigational Device Exemption ................................................................................ 0910–0078 820 ............................................................ Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation ..... 0910–0073 807, subparts A through D ....................... Electronic Submission of Medical Device Registration and Listing ............................. 0910–0625 50, 56 ........................................................ Protection of Human Subjects: Informed Consent; Institutional Review Boards ........ 0910–0755 56 .............................................................. Institutional Review Boards .......................................................................................... 0910–0130 58 .............................................................. Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies ..... 0910–0119 801.150(a)(2) and (e) ............................... Agreement for Shipments of Devices for Sterilization ................................................. 0910–0131 Dated: July 20, 2018. DEPARTMENT OF HEALTH AND fiscal year (FY) 2019 fee rates for certain Leslie Kux, HUMAN SERVICES domestic and foreign facility Associate Commissioner for Policy. reinspections, failures to comply with a Food and Drug Administration recall order, and importer reinspections [FR Doc. 2018–16029 Filed 7–26–18; 8:45 am] BILLING CODE 4164–01–P [Docket No. FDA–2018–N–2775] that are authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as Food Safety Modernization Act amended by the FDA Food Safety Domestic and Foreign Facility Modernization Act (FSMA). These fees Reinspection, Recall, and Importer are effective on October 1, 2018, and Reinspection Fee Rates for Fiscal Year will remain in effect through September amozie on DSK3GDR082PROD with NOTICES1 2019 30, 2019. AGENCY: Food and Drug Administration, FOR FURTHER INFORMATION CONTACT: HHS. Jason Lewis, Office of Management, ACTION: Notice. Office of Regulatory Affairs, Food and SUMMARY: The Food and Drug Drug Administration, 12420 Parklawn Administration (FDA) is announcing the Dr., Rm. 2406, Rockville, MD 20857, VerDate Sep<11>2014 17:38 Jul 26, 2018 Jkt 244001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\27JYN1.SGM 27JYN1

35660 Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices 301–796–5957, email: Jason.Lewis@ which firms may request a reduction in To calculate an hourly rate, FDA must fda.hhs.gov. fees. divide the FY 2019 average fully In addition, as stated in the supported cost of $273,139 per FTE by SUPPLEMENTARY INFORMATION: September 2011 Guidance, FDA is in the average number of supported direct I. Background the process of considering various FDA work hours in FY 2017—the last issues associated with the assessment FY for which data are available. See Section 107 of FSMA (Pub. L. 111– and collection of importer reinspection table 1. 353) added section 743 to the FD&C Act fees. The fee rates set forth in this notice (21 U.S.C. 379j–31) to provide FDA with will be used to determine any importer TABLE 1—SUPPORTED DIRECT FDA the authority to assess and collect fees reinspection fees assessed in FY 2019. WORK HOURS IN A PAID STAFF from, in part: (1) The responsible party II. Estimating the Average Cost of a YEAR IN FY 2017 for each domestic facility and the U.S. Supported Direct FDA Work Hour for agent for each foreign facility subject to FY 2019 Total number of hours in a paid staff a reinspection, to cover reinspection- year ...................................................... 2,080 FDA is required to estimate 100 Less: related costs; (2) the responsible party 10 paid holidays ...................................... ¥80 percent of its costs for each activity to for a domestic facility and an importer 20 days of annual leave .......................... ¥160 establish fee rates for FY 2019. In each 10 days of sick leave .............................. ¥80 who does not comply with a recall year, the costs of salary (or personnel 12.5 days of training ............................... ¥100 order, to cover food 1 recall activities compensation) and benefits for FDA 26.5 days of general administration ........ ¥184 associated with such order; and (3) each 26.5 days of travel .................................. ¥212 employees account for between 50 and importer subject to a reinspection to 2 hours of meetings per week ................ ¥104 60 percent of the funds available to, and cover reinspection-related costs (section used by, FDA. Almost all of the Net Supported Direct FDA Work Hours 743(a)(1)(A), (B), and (D) of the FD&C remaining funds (operating funds) Available for Assignments ................... 1,160 Act). Section 743 of the FD&C Act available to FDA are used to support directs FDA to establish fees for each of FDA employees for paying rent, travel, Dividing the average fully supported these activities based on an estimate of utility, information technology (IT), and FTE cost in FY 2019 ($273,139) by the 100 percent of the costs of each activity other operating costs. total number of supported direct work for each year (section 743(b)(2)(A)(i), hours available for assignment in FY (ii), and (iv)), and these fees must be A. Estimating the Full Cost per Direct 2017 (1,160) results in an average fully made available solely to pay for the Work Hour in FY 2019 supported cost of $235 (rounded to the costs of each activity for which the fee Full-time equivalent (FTE) reflects the nearest dollar), excluding inspection was incurred (section 743(b)(3)). These total number of regular straight-time travel costs, per supported direct work fees are effective on October 1, 2018, hours—not including overtime or hour in FY 2019. and will remain in effect through holiday hours—worked by employees, B. Adjusting FY 2017 Travel Costs for September 30, 2019. Section divided by the number of compensable Inflation To Estimate FY 2019 Travel 743(b)(2)(B)(iii) of the FD&C Act directs hours applicable to each fiscal year. Costs FDA to develop a proposed set of Annual leave, sick leave, compensatory guidelines in consideration of the time off, and other approved leave To adjust the hourly rate for FY 2019, burden of fee amounts on small categories are considered ‘‘hours FDA must estimate the cost of inflation businesses. As a first step in developing worked’’ for purposes of defining FTE in each year for FY 2018 and FY 2019. these guidelines, FDA invited public employment. FDA uses the method prescribed for comment on the potential impact of the In general, the starting point for estimating inflationary costs under the fees authorized by section 743 of the estimating the full cost per direct work Prescription Drug User Fee Act FD&C Act on small businesses (76 FR hour is to estimate the cost of an FTE (PDUFA) provisions of the FD&C Act 45818, August 1, 2011). The comment or paid staff year. Calculating an (section 736(c)(1) (21 U.S.C. 379h(c)(1)), period for this request ended November Agency-wide total cost per FTE requires the statutory method for inflation 30, 2011. As stated in FDA’s September three primary cost elements: Payroll, adjustment in the FD&C Act that FDA 2011 ‘‘Guidance for Industry: non-payroll, and rent. has used consistently. FDA previously Implementation of the Fee Provisions of We have used an average of past year determined the FY 2018 inflation rate to Section 107 of the FDA Food Safety cost elements to predict the FY 2019 be 1.6868 percent; this rate was Modernization Act,’’ (http:// cost. The FY 2019 FDA-wide average published in the FY 2018 PDUFA user www.fda.gov/Food/ cost for payroll (salaries and benefits) is fee rates notice in the Federal Register GuidanceRegulation/ $157,731; non-payroll—including (September 14, 2017, 82 FR 43244). GuidanceDocuments equipment, supplies, IT, general and Utilizing the method set forth in section RegulatoryInformation/FoodDefense/ administrative overhead—is $91,008; 736(c)(1) of the FD&C Act, FDA has ucm274176.htm), because FDA and rent, including cost allocation calculated an inflation rate of 1.6868 recognizes that for small businesses the analysis and adjustments for other rent percent for 2018 and 1.7708 percent for full cost recovery of FDA reinspection and rent-related costs, is $24,400 per 2019, and FDA intends to use these or recall oversight could impose severe paid staff year, excluding travel costs. inflation rates to make inflation economic hardship, FDA intends to Summing the average cost of an FTE adjustments for FY 2019 for several of consider reducing certain fees for those for payroll, non-payroll, and rent, brings its user fee programs; the derivation of firms. FDA does not intend to issue the FY 2019 average fully supported this rate will be published in the amozie on DSK3GDR082PROD with NOTICES1 invoices for reinspection or recall order cost to $273,139 per FTE, excluding Federal Register in the FY 2019 notice fees until FDA publishes a guidance travel costs. FDA will use this base unit for the PDUFA user fee rates. document outlining the process through fee in determining the hourly fee rate for The average fully supported cost per reinspection and recall order fees for FY supported direct FDA work hour, 1 The term ‘‘food’’ for purposes of this document 2019 prior to including domestic or excluding travel costs of $235 already has the same meaning as such term in section 201(f) foreign travel costs as applicable for the takes into account inflation as the of the FD&C Act (21 U.S.C. 321(f)). activity. calculation above is based on FY 2019 VerDate Sep<11>2014 17:38 Jul 26, 2018 Jkt 244001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\27JYN1.SGM 27JYN1

Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices 35661 predicted costs. FDA will use this base TABLE 2—FSMA FEE SCHEDULE FOR facility subject to a reinspection’’ to unit fee in determining the hourly fee FY 2019 cover reinspection-related costs. rate for reinspection and recall order Section 743(a)(2)(A)(i) of the FD&C fees for FY 2019 prior to including Fee rates Act defines the term ‘‘reinspection’’ Fee category with respect to domestic facilities as ‘‘1 domestic or foreign travel costs as for FY 2019 applicable for the activity. In FY 2017, or more inspections conducted under FDA’s Office of Regulatory Affairs Hourly rate if domestic travel section 704 subsequent to an inspection is required ......................... $253 conducted under such provision which (ORA) spent a total of $5,846,091 for Hourly rate if foreign travel is domestic regulatory inspection travel identified non-compliance materially required ............................. 282 related to a food safety requirement of costs and General Services Administration Vehicle costs related to th[e] Act, specifically to determine III. Fees for Reinspections of Domestic whether compliance has been achieved FDA’s Center for Food Safety and or Foreign Facilities Under Section Applied Nutrition (CFSAN) and Center to the Secretary’s satisfaction.’’ 743(a)(1)(A) The FD&C Act does not contain a for Veterinary Medicine (CVM) field A. What will cause this fee to be definition of ‘‘reinspection’’ specific to activities programs. The total ORA foreign facilities. In order to give domestic travel costs spent is then assessed? meaning to the language in section divided by the 10,289 CFSAN and CVM 743(a)(1)(A) of the FD&C Act to collect The fee will be assessed for a domestic inspections, which averages a fees from the U.S. agent of a foreign reinspection conducted under section total of $568 per inspection. These facility subject to a reinspection, the 704 of the FD&C Act (21 U.S.C. 374) to inspections average 34.05 hours per Agency is using the following definition determine whether corrective actions inspection. Dividing $568 per have been implemented and are of ‘‘reinspection’’ for purposes of inspection by 34.05 hours per effective and compliance has been assessing and collecting fees under inspection results in a total and an achieved to the Secretary of Health and section 743(a)(1)(A), with respect to a additional cost of $17 (rounded to the Human Services’ (the Secretary) (and, foreign facility, ‘‘1 or more inspections nearest dollar) per hour spent for by delegation, FDA’s) satisfaction at a conducted by officers or employees duly domestic inspection travel costs in FY facility that manufactures, processes, designated by the Secretary subsequent 2017. To adjust for the $17 per hour packs, or holds food for consumption to such an inspection which identified additional domestic cost inflation necessitated as a result of a previous non-compliance materially related to a increases for FY 2018 and FY 2019, FDA inspection (also conducted under food safety requirement of the FD&C must multiply the FY 2018 PDUFA section 704) of this facility, which had Act, specifically to determine whether inflation rate adjustor (1.016868) times a final classification of Official Action compliance has been achieved to the the FY 2019 PDUFA inflation rate Indicated (OAI) conducted by or on Secretary’s (and, by delegation, FDA’s) adjustor (1.017708) times the $17 behalf of FDA, when FDA determined satisfaction.’’ additional domestic cost, which results the non-compliance was materially This definition allows FDA to fulfill in an estimated cost of $18 (rounded to related to food safety requirements of the mandate to assess and collect fees the nearest dollar) per paid hour in the FD&C Act. FDA considers such non- from the U.S. agent of a foreign facility addition to $235 for a total of $253 per compliance to include non-compliance in the event that an inspection reveals paid hour ($235 plus $18) for each with a statutory or regulatory non-compliance materially related to a direct hour of work requiring domestic requirement under section 402 of the food safety requirement of the FD&C inspection travel. FDA will use these FD&C Act (21 U.S.C. 342) and section Act, causing one or more subsequent rates in charging fees in FY 2019 when 403(w) of the FD&C Act (21 U.S.C. inspections to determine whether domestic travel is required. 343(w)). However, FDA does not compliance has been achieved to the consider non-compliance that is Secretary’s (and, by delegation, FDA’s) In FY 2017, ORA spent a total of satisfaction. By requiring the initial $2,566,050 on 480 foreign inspection materially related to a food safety requirement to include circumstances inspection to be conducted by officers trips related to FDA’s CFSAN and CVM or employees duly designated by the field activities programs, which where the non-compliance is of a technical nature and not food safety Secretary, the definition ensures that a averaged a total of $5,346 per foreign foreign facility would be subject to fees inspection trip. These trips averaged 3 related (e.g., failure to comply with a food standard or incorrect font size on only in the event that FDA, or an entity weeks (or 120 paid hours) per trip. designated to act on its behalf, has made Dividing $5,346 per trip by 120 hours a food label). Determining when non- compliance, other than under sections the requisite identification at an initial per trip results in a total and an inspection of non-compliance materially additional cost of $45 (rounded to the 402 and 403(w) of the FD&C Act, is materially related to a food safety related to a food safety requirement of nearest dollar) per paid hour spent for the FD&C Act. The definition of foreign inspection travel costs in FY requirement of the FD&C Act may depend on the facts of a particular ‘‘reinspection-related costs’’ in section 2017. To adjust $45 for inflationary increases in FY 2018 and FY 2019, FDA situation. FDA intends to issue guidance 743(a)(2)(B) of the FD&C Act relates to must multiply it by the same inflation to provide additional information about both a domestic facility reinspection the circumstances under which FDA and a foreign facility reinspection, as factors mentioned previously in this described in section 743(a)(1)(A). document (1.016868 and 1.107708), would consider non-compliance to be which results in an estimated cost of materially related to a food safety B. Who will be responsible for paying amozie on DSK3GDR082PROD with NOTICES1 $47 (rounded to the nearest dollar) per requirement of the FD&C Act. this fee? paid hour in addition to $235 for a total Under section 743(a)(1)(A) of the The FD&C Act states that this fee is to of $282 per paid hour ($235 plus $47) FD&C Act, FDA is directed to assess and be paid by the responsible party for each for each direct hour of work requiring collect fees from ‘‘the responsible party domestic facility (as defined in section foreign inspection travel. FDA will use for each domestic facility (as defined in 415(b) of the FD&C Act) and by the U.S. these rates in charging fees in FY 2019 section 415(b) (21 U.S.C. 350d(b))) and agent for each foreign facility (section when foreign travel is required. the United States agent for each foreign 743(a)(1)(A) of the FD&C Act). This is VerDate Sep<11>2014 17:38 Jul 26, 2018 Jkt 244001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\27JYN1.SGM 27JYN1

35662 Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices the party to whom FDA will send the from locations, and monitoring product 9567. Information about PCSFN, invoice for any fees that are assessed disposition. The direct hours spent on including details about the upcoming under this section. each such recall will be billed at the meeting, can be obtained at appropriate hourly rate shown in table www.fitness.gov. C. How much will this fee be? 2 of this document. SUPPLEMENTARY INFORMATION: The The fee is based on the number of direct hours spent on such V. How must the fees be paid? primary functions of the PCSFN include reinspections, including time spent (1) advising the President, through the An invoice will be sent to the Secretary, concerning progress made in conducting the physical surveillance responsible party for paying the fee after and/or compliance reinspection at the carrying out the provisions of Executive FDA completes the work on which the Order 13265, as amended by Executive facility, or whatever components of invoice is based. Payment must be made such an inspection are deemed Order 13824, and recommending to the within 90 days of the invoice date in President, through the Secretary, actions necessary, making preparations and U.S. currency by check, bank draft, or arrangements for the reinspection, to accelerate such progress; (2) U.S. postal money order payable to the recommending to the Secretary a traveling to and from the facility, order of the Food and Drug preparing any reports, analyzing any national strategy to expand children’s Administration. Detailed payment participation in youth sports, encourage samples or examining any labels if information will be included with the required, and performing other activities regular physical activity, including invoice when it is issued. active play and promote good nutrition as part of the OAI reinspection until the facility is again determined to be in VI. What are the consequences of not for all Americans. Recommendations compliance. The direct hours spent on paying these fees? may address, but are not necessarily each such reinspection will be billed at Under section 743(e)(2) of the FD&C limited to, increasing awareness of the the appropriate hourly rate shown in Act, any fee that is not paid within 30 benefits of participation in sports and table 2 of this document. days after it is due shall be treated as a regular physical activity, as well as the claim of the U.S. Government subject to importance of good nutrition; promoting IV. Fees for Non-Compliance With a private and public sector strategies to Recall Order Under Section 743(a)(1)(B) provisions of subchapter II of chapter 37 of title 31, United States Code. increase participation in sports, A. What will cause this fee to be encourage regular physical activity, and Dated: July 24, 2018. improve nutrition; developing metrics assessed? Leslie Kux, that gauge youth sports participation The fee will be assessed for not Associate Commissioner for Policy. and physical activity to inform efforts complying with a recall order under [FR Doc. 2018–16069 Filed 7–26–18; 8:45 am] that will improve participation in sports section 423(d) (21 U.S.C. 350l(d)) or BILLING CODE 4164–01–P and regular physical activity among section 412(f) of the FD&C Act (21 young Americans; and establishing a U.S.C. 350a(f)) to cover food recall national and local strategy to recruit activities associated with such order DEPARTMENT OF HEALTH AND volunteers who will encourage and performed by the Secretary (and by HUMAN SERVICES support youth participation in sports delegation, FDA) (section 743(a)(1)(B) of and regular physical activity, through the FD&C Act). Non-compliance may Meeting of the President’s Council on include the following: (1) Not initiating coaching, mentoring, teaching, or Sports, Fitness, and Nutrition administering athletic and nutritional a recall as ordered by FDA; (2) not conducting the recall in the manner AGENCY: President’s Council on Sports, programs. The Council’s performance of specified by FDA in the recall order; or Fitness, and Nutrition, Office of the these functions shall take into account (3) not providing FDA with requested Assistant Secretary for Health, Office of the Department of Health and Human information regarding the recall, as the Secretary, Department of Health and Services’ Physical Activity Guidelines ordered by FDA. Human Services. for Americans, including consideration for youth with disabilities. B. Who will be responsible for paying ACTION: Notice of meeting. The Council shall meet, at a this fee? SUMMARY: As stipulated by the Federal minimum, one time per fiscal year. The Section 743(a)(1)(B) of the FD&C Act Advisory Committee Act, the U.S. meeting will be held to (1) assess states that the fee is to be paid by the Department of Health and Human ongoing Council activities; and, (2) responsible party for a domestic facility Services (HHS) is hereby giving notice discuss and plan future projects and (as defined in section 415(b) of the that the President’s Council on Sports, programs. The agenda for the planned FD&C Act) and an importer who does Fitness, and Nutrition (PCSFN) will meeting is being developed and will be not comply with a recall order under hold its annual meeting. The meeting posted at www.fitness.gov when it has section 423 or under section 412(f) of will be open to the public. been finalized. the FD&C Act. In other words, the party The meeting that is scheduled to be DATES: The meeting will be held on paying the fee would be the party that held on September 21, 2018, is open to September 21, 2018, from 9:30 a.m. to the public and the media. Every effort received the recall order. 12:30 p.m. will be made to provide reasonable C. How much will this fee be? ADDRESSES: Newseum, Knight accommodations for persons with The fee is based on the number of Conference Center 7th Floor, 555 disabilities and/or special needs who direct hours spent on taking action in Pennsylvania Ave. NW, Washington, DC wish to attend the meeting. Persons amozie on DSK3GDR082PROD with NOTICES1 response to the firm’s failure to comply 20001. with disabilities and/or special needs with a recall order. Types of activities FOR FURTHER INFORMATION CONTACT: Ms. should call (240) 276–9567 no later than could include conducting recall audit Holli M. Richmond, Executive Director, close of business Monday, September checks, reviewing periodic status Office of the President’s Council on 10, 2018, to request accommodations. reports, analyzing the status reports and Sports, Fitness, and Nutrition, Tower Members of the public who wish to the results of the audit checks, Building, 1101 Wootton Parkway, Suite attend the meeting are asked to pre- conducting inspections, traveling to and 560, Rockville, MD 20852, (240) 276– register by sending an email to VerDate Sep<11>2014 17:38 Jul 26, 2018 Jkt 244001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\27JYN1.SGM 27JYN1


Document Created: 2018-07-27 04:04:30
Document Modified: 2018-07-27 04:04:30
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactJason Lewis, Office of Management, Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., Rm. 2406, Rockville, MD 20857, 301-796-5957, email: [email protected]
FR Citation83 FR 35659 
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