80 FR 46020 - Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 148 (August 3, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 148 (August 3, 2015)
| Page Range | 46020-46023 | |
| FR Document | 2015-18906 |
[Federal Register Volume 80, Number 148 (Monday, August 3, 2015)] [Notices] [Pages 46020-46023] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-18906] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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: [email protected]. 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. --------------------------------------------------------------------------- \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)). --------------------------------------------------------------------------- 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 ------------------------------------------------------------------------ ------------------------------------------------------------------------ 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............................................. ------------------------------------------------------------------------ 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 ------------------------------------------------------------------------ Fee rates Fee category for FY 2016 ------------------------------------------------------------------------ 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
![46020 Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices
This draft guidance establishes Dated: July 29, 2015. 100 percent of the costs of each activity
standard dissolution methodology and Leslie Kux, for each year (sections 743(b)(2)(A)(i),
specifications that are appropriate for Associate Commissioner for Policy. (ii), and (iv)), and these fees must be
BCS class 1 and class 3 drugs. The [FR Doc. 2015–18968 Filed 7–31–15; 8:45 am] made available solely to pay for the
availability of these standards will BILLING CODE 4164–01–P costs of each activity for which the fee
facilitate the rapid development of was incurred (section 743(b)(3)). These
dissolution methodology and related fees are effective on October 1, 2015,
specifications for these classes during DEPARTMENT OF HEALTH AND and will remain in effect through
drug development and application HUMAN SERVICES September 30, 2016. Section
review. 743(b)(2)(B)(iii) of the FD&C Act directs
Food and Drug Administration
This draft guidance is being issued FDA to develop a proposed set of
consistent with FDA’s good guidance [Docket No. FDA–2015–N–0007] guidelines in consideration of the
practices regulation (21 CFR 10.115). burden of fee amounts on small
Food Safety Modernization Act businesses. As a first step in developing
The draft guidance, when finalized, will Domestic and Foreign Facility
represent the Agency’s current thinking these guidelines, FDA invited public
Reinspection, Recall, and Importer comment on the potential impact of the
on Dissolution Testing and Reinspection Fee Rates for Fiscal Year
Specification Criteria for Immediate- fees authorized by section 743 of the
2016
Release Solid Oral Dosage Forms FD&C Act on small businesses (76 FR
Containing Biopharmaceutics AGENCY: Food and Drug Administration, 45818, August 1, 2011). The comment
Classification System Class 1 and 3 HHS. period for this request ended November
Drugs. It does not create or confer any ACTION: Notice. 30, 2011. As stated in FDA’s September
rights for or on any person and does not 2011 ‘‘Guidance for Industry:
SUMMARY: The Food and Drug Implementation of the Fee Provisions of
operate to bind FDA or the public. An Administration (FDA) is announcing the
alternative approach may be used if Section 107 of the FDA Food Safety
fiscal year (FY) 2016 fee rates for certain Modernization Act,’’ (http://
such approach satisfies the domestic and foreign facility
requirements of the applicable statutes www.fda.gov/Food/Guidance
reinspections, failures to comply with a
and regulations. Regulation/GuidanceDocuments
recall order, and importer reinspections
that are authorized by the Federal Food, RegulatoryInformation/FoodDefense/
II. Comments ucm274176.htm), because FDA
Drug, and Cosmetic Act (the FD&C Act),
as amended by the FDA Food Safety recognizes that for small businesses the
Interested persons may submit either
Modernization Act (FSMA). These fees full cost recovery of FDA reinspection
electronic comments regarding this
are effective on October 1, 2015, and or recall oversight could impose severe
document to http://www.regulations.gov
will remain in effect through September economic hardship, FDA intends to
or written comments to the Division of
30, 2016. consider reducing certain fees for those
Dockets Management (see ADDRESSES). It
is only necessary to send one set of FOR FURTHER INFORMATION CONTACT: firms. FDA does not intend to issue
comments. Identify comments with the Jason Lewis, Office of Resource invoices for reinspection or recall order
docket number found in brackets in the Management, Office of Regulatory fees until FDA publishes a guidance
heading of this document. Received Affairs, Food and Drug Administration, document outlining the process through
comments may be seen in the Division 12420 Parklawn Dr., Rm. 2046, which firms may request a reduction in
of Dockets Management between 9 a.m. Rockville, MD 20857, 301–796–5957, fees.
and 4 p.m., Monday through Friday, and email: Jason.Lewis@fda.hhs.gov. In addition, as stated in the
will be posted to the docket at http:// SUPPLEMENTARY INFORMATION: September 2011 Guidance, FDA is in
www.regulations.gov. I. Background the process of considering various
issues associated with the assessment
III. The Paperwork Reduction Act of Section 107 of FSMA (Pub. L. 111– and collection of importer reinspection
1995 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
This draft guidance refers to will be used to determine any importer
the authority to assess and collect fees
previously approved collections of reinspection fees assessed in FY 2016.
from, in part: (1) The responsible party
information that are subject to review by for each domestic facility and the U.S. II. Estimating the Average Cost of a
the Office of Management and Budget agent for each foreign facility subject to Supported Direct FDA Work Hour for
(OMB) under the Paperwork Reduction a reinspection, to cover reinspection- FY 2016
Act of 1995 (44 U.S.C. 3501–3520). The related costs; (2) the responsible party
collections of information in 21 CFR for a domestic facility and an importer FDA is required to estimate 100
parts 312 and 314 have been approved who does not comply with a recall percent of its costs for each activity in
under OMB control numbers 0910–0014 order, to cover food 1 recall activities order to establish fee rates for FY 2016.
and 0910–0001, respectively. associated with such order; and (3) each In each year, the costs of salary (or
importer subject to a reinspection to personnel compensation) and benefits
IV. Electronic Access cover reinspection-related costs for FDA employees account for between
mstockstill on DSK4VPTVN1PROD with NOTICES
(sections 743(a)(1)(A), (B), and (D) of the 50 and 60 percent of the funds available
Persons with access to the Internet
FD&C Act). Section 743 of the FD&C Act to, and used by, FDA. Almost all of the
may obtain the document at either
directs FDA to establish fees for each of remaining funds (operating funds)
http://www.fda.gov/Drugs/Guidance these activities based on an estimate of
ComplianceRegulatoryInformation/ available to FDA are used to support
Guidances/default.htm or http:// 1 The term ‘‘food’’ for purposes of this document
FDA employees for paying rent, travel,
www.regulations.gov. has the same meaning as such term in section 201(f)
utility, information technology, and
of the FD&C Act (21 U.S.C. 321(f)). other operating costs.
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![46022 Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices
TABLE 2—FSMA FEE SCHEDULE FOR facility subject to a reinspection’’ to the party to whom FDA will send the
FY 2016 cover reinspection-related costs. invoice for any fees that are assessed
Section 743(a)(2)(A)(i) of the FD&C under this section.
Fee rates Act defines the term ‘‘reinspection’’ C. How much will this fee be?
Fee category for FY with respect to domestic facilities as ‘‘1
2016 or more inspections conducted under The fee is based on the number of
section 704 subsequent to an inspection direct hours spent on such
Hourly rate if domestic travel is reinspections, including time spent
conducted under such provision which
required ..................................... $221
identified non-compliance materially conducting the physical surveillance
Hourly rate if foreign travel is re-
quired ........................................ 315 related to a food safety requirement of and/or compliance reinspection at the
th[e] Act, specifically to determine facility, or whatever components of
whether compliance has been achieved such an inspection are deemed
III. Fees for Reinspections of Domestic
to the Secretary’s satisfaction.’’ necessary, making preparations and
or Foreign Facilities Under Section
The FD&C Act does not contain a arrangements for the reinspection,
743(a)(1)(A)
definition of ‘‘reinspection’’ specific to traveling to and from the facility,
A. What will cause this fee to be foreign facilities. In order to give preparing any reports, analyzing any
assessed? meaning to the language in section samples or examining any labels if
743(a)(1)(A) of the FD&C Act to collect required, and performing other activities
The fee will be assessed for a
fees from the U.S. agent of a foreign as part of the OAI reinspection until the
reinspection conducted under section
facility subject to a reinspection, the facility is again determined to be in
704 of the FD&C Act (21 U.S.C. 374) to
Agency is using the following definition compliance. The direct hours spent on
determine whether corrective actions
of ‘‘reinspection’’ for purposes of each such reinspection will be billed at
have been implemented and are
assessing and collecting fees under the appropriate hourly rate shown in
effective and compliance has been
section 743(a)(1)(A), with respect to a table 2 of this document.
achieved to the Secretary of Health and
foreign facility, ‘‘1 or more inspections
Human Services’ (the Secretary) (and, IV. Fees for Non-Compliance With a
conducted by officers or employees duly
by delegation, FDA’s) satisfaction at a Recall Order Under Section 743(a)(1)(B)
designated by the Secretary subsequent
facility that manufactures, processes, A. What will cause this fee to be
to such an inspection which identified
packs, or holds food for consumption assessed?
non-compliance materially related to a
necessitated as a result of a previous food safety requirement of the FD&C
inspection (also conducted under The fee will be assessed for not
Act, specifically to determine whether complying with a recall order under
section 704) of this facility, which had compliance has been achieved to the
a final classification of Official Action section 423(d) (21 U.S.C. 350l(d)) or
Secretary’s (and, by delegation, FDA’s) section 412(f) of the FD&C Act (21
Indicated (OAI) conducted by or on satisfaction.’’
behalf of FDA, when FDA determined U.S.C. 350a(f)) to cover food recall
This definition allows FDA to fulfill activities associated with such order
the non-compliance was materially the mandate to assess and collect fees
related to food safety requirements of performed by the Secretary (and by
from the U.S. agent of a foreign facility delegation, FDA) (section 743(a)(1)(B) of
the FD&C Act. FDA considers such non- in the event that an inspection reveals
compliance to include non-compliance the FD&C Act). Non-compliance may
non-compliance materially related to a include the following: (1) Not initiating
with a statutory or regulatory food safety requirement of the FD&C
requirement under section 402 of the a recall as ordered by FDA; (2) not
Act, causing one or more subsequent conducting the recall in the manner
FD&C Act (21 U.S.C. 342) and section inspections to determine whether
403(w) of the FD&C Act (21 U.S.C. specified by FDA in the recall order; or
compliance has been achieved to the (3) not providing FDA with requested
343(w)). However, FDA does not Secretary’s (and, by delegation, FDA’s)
consider non-compliance that is information regarding the recall, as
satisfaction. By requiring the initial ordered by FDA.
materially related to a food safety inspection to be conducted by officers
requirement to include circumstances or employees duly designated by the B. Who will be responsible for paying
where the non-compliance is of a Secretary, the definition ensures that a this fee?
technical nature and not food safety foreign facility would be subject to fees Section 743(a)(1)(B) of the FD&C Act
related (e.g., failure to comply with a only in the event that FDA, or an entity states that the fee is to be paid by the
food standard or incorrect font size on designated to act on its behalf, has made responsible party for a domestic facility
a food label). Determining when non- the requisite identification at an initial (as defined in section 415(b) of the
compliance, other than under sections inspection of non-compliance materially FD&C Act) and an importer who does
402 and 403(w) of the FD&C Act, is related to a food safety requirement of not comply with a recall order under
materially related to a food safety the FD&C Act. The definition of section 423 or under section 412(f) of
requirement of the FD&C Act may ‘‘reinspection-related costs’’ in section the FD&C Act. In other words, the party
depend on the facts of a particular 743(a)(2)(B) of the FD&C Act relates to paying the fee would be the party that
situation. FDA intends to issue guidance both a domestic facility reinspection received the recall order.
to provide additional information about and a foreign facility reinspection, as
the circumstances under which FDA C. How much will this fee be?
described in section 743(a)(1)(A).
would consider non-compliance to be The fee is based on the number of
materially related to a food safety B. Who will be responsible for paying
mstockstill on DSK4VPTVN1PROD with NOTICES
direct hours spent on taking action in
requirement of the FD&C Act. this fee? response to the firm’s failure to comply
Under section 743(a)(1)(A) of the The FD&C Act states that this fee is to with a recall order. Types of activities
FD&C Act, FDA is directed to assess and be paid by the responsible party for each could include conducting recall audit
collect fees from ‘‘the responsible party domestic facility (as defined in section checks, reviewing periodic status
for each domestic facility (as defined in 415(b) of the FD&C Act) and by the U.S. reports, analyzing the status reports and
section 415(b) (21 U.S.C. 350d(b))) and agent for each foreign facility (section the results of the audit checks,
the United States agent for each foreign 743(a)(1)(A) of the FD&C Act). This is conducting inspections, traveling to and
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![Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices 46023
from locations, and monitoring product information to http:// dealing in the interest of consumers,
disposition. The direct hours spent on www.regulations.gov. Submit written under the authority set forth in section
each such recall will be billed at the comments and scientific data and 401 of the Federal Food, Drug, and
appropriate hourly rate shown in table information to Division of Dockets Cosmetic Act (the FD&C Act) (21 U.S.C.
2 of this document. Management (HFA–305), Food and Drug 341). Some of these standards of
Administration, 5630 Fishers Lane, Rm. identity (e.g., the standard of identity for
V. How must the fees be paid?
1061, Rockville, MD 20852. soft-ripened cheese in § 133.182 (21 CFR
An invoice will be sent to the FOR FURTHER INFORMATION CONTACT: 133.182)) permit the manufacture of
responsible party for paying the fee after Andrew Yeung, Center for Food Safety cheese from unpasteurized milk. These
FDA completes the work on which the and Applied Nutrition (HFS–316), Food standards of identity specify that the
invoice is based. Payment must be made and Drug Administration, 5100 Paint
within 90 days of the invoice date in process for cheese manufactured from
Branch Pkwy., College Park, MD 20740– unpasteurized milk include an aging
U.S. currency by check, bank draft, or 3835, 240–402–1541, andrew.yeung@
U.S. postal money order payable to the period. A typical aging period is not less
fda.hhs.gov. than 60 days at not less than 35 °F (see
order of the Food and Drug
Administration. Detailed payment SUPPLEMENTARY INFORMATION: § 133.182(a) in the standard of identity
information will be included with the for soft-ripened cheese).
I. Background
invoice when it is issued. The aging period for cheese
A 2012 review of outbreaks of manufactured from unpasteurized milk
VI. What are the consequences of not foodborne illness that occurred in the
paying these fees? was presumed to act as a control
United States between 1993 and 2006
measure to reduce the risk that
Under section 743(e)(2) of the FD&C that were attributed to dairy products
pathogens would be present when the
Act, any fee that is not paid within 30 determined that more than 50 percent of
the outbreaks reviewed in the study cheese was consumed. However, the
days after it is due shall be treated as a
involved cheese, with the remaining available data and information raise
claim of the U.S. Government subject to
provisions of subchapter II of chapter 37 outbreaks being attributable to fluid questions about the safety of cheese
of title 31, United States Code. milk (Ref. 1). Forty-two percent of the manufactured from unpasteurized milk,
65 cheese-associated outbreaks (i.e., 27 even when aged. For example, research
Dated: July 28, 2015. has demonstrated that pathogens such
Leslie Kux,
outbreaks) were attributable to products
manufactured from unpasteurized milk, as E. coli O157:H7 can survive a 60-day
Associate Commissioner for Policy. aging period in a hard cheese such as
even though the contribution of
[FR Doc. 2015–18906 Filed 7–31–15; 8:45 am] Cheddar cheese (Refs. 3 and 4). In
unpasteurized dairy products to all
BILLING CODE 4164–01–P
dairy product consumption in the addition, a 1997 memorandum from a
United States during the time period subcommittee of the National Advisory
under study was estimated at below 1 Committee on Microbiological Criteria
DEPARTMENT OF HEALTH AND for Foods stated that the scientific
percent (on a weight or volume base)
HUMAN SERVICES
(Ref. 1). The 65 analyzed outbreaks due literature confirms that pathogens can
Food and Drug Administration to cheese made from unpasteurized milk survive the 60-day aging process for
resulted in 641 associated illnesses with cheeses manufactured using
[Docket No. FDA–2015–N–2596] 131 hospitalizations (i.e., a unpasteurized milk (Ref. 5). More
hospitalization rate of more than 20 recently, the results of the FDA/Health
Understanding Potential Intervention
percent). Pathogens associated with Canada QRA suggest that the 60-day
Measures To Reduce the Risk of
Foodborne Illness From Consumption these outbreaks included Listeria aging period for soft-ripened cheese may
of Cheese Manufactured From monocytogenes, Escherichia coli (E. increase the risk of listeriosis from
Unpasteurized Milk coli) O157, Salmonella, and others (Ref. consumption of soft-ripened cheese by
1). All of these pathogens can cause allowing more time for L.
AGENCY: Food and Drug Administration, significant illness and even death. monocytogenes, if present, to multiply
HHS. FDA and Health Canada recently (rather than decrease) as the soft-
ACTION: Notice; request for comments collaborated on the development of a ripened cheese ages (Ref. 6).
and for scientific data and information. model to evaluate the impact of factors,
such as the microbiological status of FDA recognizes that there is broad
SUMMARY: The Food and Drug milk used in cheese production, various diversity in cheese manufacturing
Administration (FDA or we) is cheese manufacturing steps, conditions operations and approaches and that
requesting comments and scientific data during distribution and storage, and many factors go into ensuring the safety
and information that would assist us in cross-contamination during processing of the food. Many types of raw milk
identifying and evaluating intervention and handling, on the public health risk cheeses are made using traditional
measures that might have an effect on of listeriosis from consumption of soft- methods that require a successful
the presence of bacterial pathogens in ripened cheese. Elsewhere in this issue balance involving the quality of the
cheeses manufactured from of the Federal Register, we are milk, the equipment, and the
unpasteurized milk. We are taking this announcing the release of the ‘‘Joint environment, including ensuring the
action in light of scientific data on Food and Drug Administration/Health presence of bacteria critical to the
potential health risks associated with nature of the cheese while preventing
mstockstill on DSK4VPTVN1PROD with NOTICES
Canada—Santé Canada Quantitative
consumption of cheese made from Assessment of the Risk of Listeriosis the introduction or growth of pathogens.
unpasteurized milk. From Soft-Ripened Cheese In issuing this call for data and
DATES: Submit either electronic or Consumption in the United States and information, we are particularly
written comments and scientific data Canada’’ (the FDA/Health Canada QRA) interested in learning more about the
and information by November 2, 2015. (Ref. 2). standards and practices in use by the
ADDRESSES: Submit electronic FDA establishes food standards of growing artisanal cheese manufacturing
comments and scientific data and identity, to promote honesty and fair community.
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Document Created: 2018-02-23 10:52:02
Document Modified: 2018-02-23 10:52:02
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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: [email protected] | |
| FR Citation | 80 FR 46020 |
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