82 FR 35954 - Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2018
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 147 (August 2, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 147 (August 2, 2017)
| Page Range | 35954-35957 | |
| FR Document | 2017-16184 |
[Federal Register Volume 82, Number 147 (Wednesday, August 2, 2017)] [Notices] [Pages 35954-35957] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-16184] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-4281] Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2018 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2018 fee rates for certain [[Page 35955]] 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, 2017, and will remain in effect through September 30, 2018. FOR FURTHER INFORMATION CONTACT: Jason Lewis, Office of Management, Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., Rm. 2046, Rockville, MD 20857, 301-796-5957, email: Jason.Lewis@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background Section 107 of FSMA (Pub. L. 111-353) added section 743 to the FD&C Act (21 U.S.C. 379j-31) to provide FDA with the authority to assess and collect fees from, in part: (1) The responsible party for each domestic facility and the U.S. agent for each foreign facility subject to a reinspection, to cover reinspection-related costs; (2) the responsible party for a domestic facility and an importer who does not comply with a recall order, to cover food \1\ recall activities associated with such order; and (3) each importer subject to a reinspection to cover reinspection-related costs (sections 743(a)(1)(A), (B), and (D) of the FD&C Act). Section 743 of the FD&C Act directs FDA to establish fees for each of these activities based on an estimate of 100 percent of the costs of each activity for each year (sections 743(b)(2)(A)(i), (ii), and (iv)), and these fees must be made available solely to pay for the costs of each activity for which the fee was incurred (section 743(b)(3)). These fees are effective on October 1, 2017, and will remain in effect through September 30, 2018. 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 2018. II. Estimating the Average Cost of a Supported Direct FDA Work Hour for FY 2018 FDA is required to estimate 100 percent of its costs for each activity in order to establish fee rates for FY 2018. 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 2018 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. The FY 2018 FDA-wide average cost for payroll (salaries and benefits) is $154,638; non-payroll--including equipment, supplies, IT, general and administrative overhead--is $89,224; and rent, including cost allocation analysis and adjustments for other rent and rent- related costs, is $23,922 per paid staff year, excluding travel costs. Summing the average cost of an FTE for payroll, non-payroll, and rent, brings the FY 2018 average fully supported cost to $267,783 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 2018 prior to including domestic or foreign travel costs as applicable for the activity. To calculate an hourly rate, FDA must divide the FY 2018 average fully supported cost of $267,783 per FTE by the average number of supported direct FDA work hours in FY 2016--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 2016 ------------------------------------------------------------------------ ------------------------------------------------------------------------ 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 = 1,160 Assignments........................................ ------------------------------------------------------------------------ Dividing the full-time equivalent in FY 2018 ($267,783) by the total number of supported direct work hours available for assignment in FY 2016 (1,160) results in an average fully supported cost of $231 (rounded to the nearest dollar), excluding inspection travel costs, per supported direct work hour in FY 2016. B. Adjusting FY 2016 Travel Costs for Inflation To Estimate FY 2018 Travel Costs To adjust the hourly rate for FY 2018, FDA must estimate the cost of inflation in each year for FY 2017 and FY 2018. 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 2017 inflation rate to be 1.5468 percent; this rate was published in the FY 2017 PDUFA user fee rates notice in the Federal Register [[Page 35956]] (July 28, 2016, 81 FR 49674). Utilizing the method set forth in section 736(c)(1) of the FD&C Act, FDA has calculated an inflation rate of 1.5468 percent for 2017 and 1.6868 percent for 2018, and FDA intends to use these inflation rates to make inflation adjustments for FY 2018 for several of its user fee programs; the derivation of this rate will be published in the Federal Register in the FY 2018 notice for the PDUFA user fee rates. In FY 2016, FDA's Office of Regulatory Affairs (ORA) spent a total of $5,185,331 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 9,755 CFSAN and CVM domestic inspections, which averages a total of $532 per inspection. These inspections average 33.61 hours per inspection. Dividing $532 per inspection by 33.61 hours per inspection results in a total and an additional cost of $16 (rounded to the nearest dollar) per hour spent for domestic inspection travel costs in FY 2016. To adjust for the $16 per hour additional domestic cost inflation increases for FY 2017 and FY 2018, FDA must multiply the FY 2017 PDUFA inflation rate adjustor (1.015468) times the FY 2018 PDUFA inflation rate adjustor (1.016868) times the $16 additional domestic cost, which results in an estimated cost of $17 (rounded to the nearest dollar) per paid hour in addition to $231 for a total of $248 per paid hour ($231 plus $17) for each direct hour of work requiring domestic inspection travel. FDA will use these rates in charging fees in FY 2018 when domestic travel is required. In FY 2016, ORA spent a total of $2,166,592 on 344.31 foreign inspection trips related to FDA's CFSAN and CVM field activities programs, which averaged a total of $6,293 per foreign inspection trip. These trips averaged 3 weeks (or 120 paid hours) per trip. Dividing $6,293 per trip by 120 hours per trip results in a total and an additional cost of $52 (rounded to the nearest dollar) per paid hour spent for foreign inspection travel costs in FY 2016. To adjust $52 for inflationary increases in FY 2017 and FY 2018, FDA must multiply it by the same inflation factors mentioned previously in this document (1.015468, 1.016868), which results in an estimated cost of $54 (rounded to the nearest dollar) per paid hour in addition to $231 for a total of $285 per paid hour ($231 plus $54) for each direct hour of work requiring foreign inspection travel. FDA will use these rates in charging fees in FY 2018 when foreign travel is required. Table 2--FSMA Fee Schedule for FY 2018 ------------------------------------------------------------------------ Fee rates for Fee category FY 2018 ($) ------------------------------------------------------------------------ Hourly rate if domestic travel is required.............. $248 Hourly rate if foreign travel is required............... 285 ------------------------------------------------------------------------ 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 [[Page 35957]] 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. 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. 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 25, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-16184 Filed 8-1-17; 8:45 am] BILLING CODE 4164-01-P
![35954 Federal Register / Vol. 82, No. 147 / Wednesday, August 2, 2017 / Notices
their participants, the contexts in which offered those services. The random perspective of the government,
they are operated, and their promising assignment process will require child noncustodial parents, custodial parents
practices. The implementation study support program staff to complete a and their children, and society. Once
will also assess whether the PJAC brief data entry protocol. The impact measured, particular impacts or
interventions are implemented as study will rely on administrative data expenditures will constitute benefits or
intended (implementation fidelity) as from state and county child support costs, depending on which analytical
well as how the treatment implemented systems, court records, criminal justice perspective is considered. For each of
differed from the status quo (treatment records, and data from the National the perspectives, pertinent benefits and
contrast). The detailed descriptions will Directory of New Hires. Administrative costs will be added together to
assist in interpreting program impacts records data will be used to estimate determine the net value of the program.
and identifying program features and impacts on child support payments, Key hypothesized benefits and costs to
conditions necessary for effective enforcement actions, contempt be assessed include increased PJAC
program replication or improvement. proceedings, jail stays, and employment intervention costs, reduced costs for
Key activities of the implementation and earnings. The impact study will contempt actions, increased payments
study will include: (1) A Management also include a follow-up survey of from non-custodial parents, reduced
Information System (MIS) for collection participants that will be administered court costs, and reduced jail time,
and analysis of program participation approximately 12 months after random among others. The benefit-cost study
data to track participant engagement in assignment to a subset of the sample. will rely on the results of the impact
PJAC activities; (2) semi-structured The survey will gather information on study, analysis of participation data
interviews with program staff and staff participant experiences with the child from the MIS, and results of a staff time
from selected community partner support program and family court, study in order to quantify various PJAC-
organizations; (3) semi-structured family relationships, parenting and co- related costs and benefits.
interviews with program participants to parenting, informal child support
learn about their experiences in PJAC; payments, and job characteristics. In an This 30-Day Notice covers the
and (4) a staff questionnaire to gather effort to enhance response rates, the following data collection activities: (1)
broader quantitative information on PJAC survey firm will attempt to track Staff data entry for random assignment;
program implementation and staff survey sample members at a few points (2) Study MIS to track program
experiences. over the 12-month follow-up period in participation; (3) Staff and community
2. Impact Study: The goal of the order to stay in touch with them and partner interview topic guide; (4)
impact study is to provide rigorous gather updated contact information from Participant interview topic guide; and
estimates of the effectiveness of the six them. (5) Participant survey tracking letter.
programs using an experimental 3. Benefit-Cost Study: The benefit-cost Respondents: Respondents for the
research design. Program applicants study will estimate the costs and first information collection phase
who are eligible for PJAC services will benefits associated with the include study participants and grantee
be randomly assigned to either a implementation and impact of the PJAC staff and community partners. Specific
program group that is offered program interventions. The study will examine respondents per instrument are noted in
services or to a control group that is not the costs and benefits from the the burden table below.
ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden Total annual
Instrument responses per burden hours
respondents hours burden hours
respondent per response
Staff data entry for random assignment .............................. 120 150 0.05 900 300
Study MIS to track program participation ............................ 120 150 1.00 18,000 6,000
Staff and community partner interview topic guide ............. 150 2 1.00 300 100
Participant interview topic guide .......................................... 180 1 1.00 180 60
Participant survey tracking letter ......................................... 3,000 3 0.10 900 300
Estimated Total Annual Burden having its full effect if OMB receives it DEPARTMENT OF HEALTH AND
Hours: 6,760. within 30 days of publication. Written HUMAN SERVICES
Additional Information: Copies of the comments and recommendations for the
proposed collection may be obtained by proposed information collection should Food and Drug Administration
writing to the Administration for be sent directly to the following: Office [Docket No. FDA–2017–N–4281]
Children and Families, Office of of Management and Budget, Paperwork
Planning, Research and Evaluation, 330 Reduction Project, Email: OIRA_ Food Safety Modernization Act
C Street SW., Washington, DC 20201. SUBMISSION@OMB.EOP.GOV, Attn: Domestic and Foreign Facility
Attention: Reports Clearance Officer. All Desk Officer for the Administration for Reinspection, Recall, and Importer
requests should be identified by the title Children and Families. Reinspection Fee Rates for Fiscal Year
of the information collection. Email 2018
sradovich on DSKBCFCHB2PROD with NOTICES
address: infocollection@acf.hhs.gov. Robert Sargis,
Reports Clearance Officer.
AGENCY: Food and Drug Administration,
OMB Comment: OMB is required to HHS.
[FR Doc. 2017–16254 Filed 8–1–17; 8:45 am]
make a decision concerning the ACTION: Notice.
collection of information between 30 BILLING CODE 4184–01–P
and 60 days after publication of this SUMMARY: The Food and Drug
document in the Federal Register. Administration (FDA) is announcing the
Therefore, a comment is best assured of fiscal year (FY) 2018 fee rates for certain
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(July 28, 2016, 81 FR 49674). Utilizing foreign inspection travel. FDA will use collect fees from ‘‘the responsible party
the method set forth in section 736(c)(1) these rates in charging fees in FY 2018 for each domestic facility (as defined in
of the FD&C Act, FDA has calculated an when foreign travel is required. section 415(b) (21 U.S.C. 350d(b))) and
inflation rate of 1.5468 percent for 2017 the United States agent for each foreign
and 1.6868 percent for 2018, and FDA TABLE 2—FSMA FEE SCHEDULE FOR facility subject to a reinspection’’ to
intends to use these inflation rates to FY 2018 cover reinspection-related costs.
make inflation adjustments for FY 2018 Section 743(a)(2)(A)(i) of the FD&C
for several of its user fee programs; the Fee rates for Act defines the term ‘‘reinspection’’
derivation of this rate will be published Fee category FY 2018 with respect to domestic facilities as ‘‘1
in the Federal Register in the FY 2018 ($) or more inspections conducted under
notice for the PDUFA user fee rates. section 704 subsequent to an inspection
Hourly rate if domestic travel
In FY 2016, FDA’s Office of is required ......................... $248
conducted under such provision which
Regulatory Affairs (ORA) spent a total of Hourly rate if foreign travel is identified non-compliance materially
$5,185,331 for domestic regulatory required ............................. 285 related to a food safety requirement of
inspection travel costs and General th[e] Act, specifically to determine
Services Administration Vehicle costs III. Fees for Reinspections of Domestic whether compliance has been achieved
related to FDA’s Center for Food Safety or Foreign Facilities Under Section to the Secretary’s satisfaction.’’
and Applied Nutrition (CFSAN) and 743(a)(1)(A) The FD&C Act does not contain a
Center for Veterinary Medicine (CVM) definition of ‘‘reinspection’’ specific to
field activities programs. The total ORA A. What will cause this fee to be foreign facilities. In order to give
domestic travel costs spent is then assessed? meaning to the language in section
divided by the 9,755 CFSAN and CVM The fee will be assessed for a 743(a)(1)(A) of the FD&C Act to collect
domestic inspections, which averages a reinspection conducted under section fees from the U.S. agent of a foreign
total of $532 per inspection. These 704 of the FD&C Act (21 U.S.C. 374) to facility subject to a reinspection, the
inspections average 33.61 hours per Agency is using the following definition
determine whether corrective actions
inspection. Dividing $532 per of ‘‘reinspection’’ for purposes of
have been implemented and are
inspection by 33.61 hours per assessing and collecting fees under
effective and compliance has been
inspection results in a total and an section 743(a)(1)(A), with respect to a
achieved to the Secretary of Health and
additional cost of $16 (rounded to the foreign facility, ‘‘1 or more inspections
Human Services’ (the Secretary) (and,
nearest dollar) per hour spent for conducted by officers or employees duly
by delegation, FDA’s) satisfaction at a
domestic inspection travel costs in FY designated by the Secretary subsequent
facility that manufactures, processes,
2016. To adjust for the $16 per hour to such an inspection which identified
packs, or holds food for consumption
additional domestic cost inflation non-compliance materially related to a
necessitated as a result of a previous
increases for FY 2017 and FY 2018, FDA food safety requirement of the FD&C
inspection (also conducted under Act, specifically to determine whether
must multiply the FY 2017 PDUFA
section 704) of this facility, which had compliance has been achieved to the
inflation rate adjustor (1.015468) times
a final classification of Official Action Secretary’s (and, by delegation, FDA’s)
the FY 2018 PDUFA inflation rate
Indicated (OAI) conducted by or on satisfaction.’’
adjustor (1.016868) times the $16
behalf of FDA, when FDA determined This definition allows FDA to fulfill
additional domestic cost, which results
the non-compliance was materially the mandate to assess and collect fees
in an estimated cost of $17 (rounded to
related to food safety requirements of from the U.S. agent of a foreign facility
the nearest dollar) per paid hour in
the FD&C Act. FDA considers such non- in the event that an inspection reveals
addition to $231 for a total of $248 per
paid hour ($231 plus $17) for each compliance to include non-compliance non-compliance materially related to a
direct hour of work requiring domestic with a statutory or regulatory food safety requirement of the FD&C
inspection travel. FDA will use these requirement under section 402 of the Act, causing one or more subsequent
rates in charging fees in FY 2018 when FD&C Act (21 U.S.C. 342) and section inspections to determine whether
domestic travel is required. 403(w) of the FD&C Act (21 U.S.C. compliance has been achieved to the
In FY 2016, ORA spent a total of 343(w)). However, FDA does not Secretary’s (and, by delegation, FDA’s)
$2,166,592 on 344.31 foreign inspection consider non-compliance that is satisfaction. By requiring the initial
trips related to FDA’s CFSAN and CVM materially related to a food safety inspection to be conducted by officers
field activities programs, which requirement to include circumstances or employees duly designated by the
averaged a total of $6,293 per foreign where the non-compliance is of a Secretary, the definition ensures that a
inspection trip. These trips averaged 3 technical nature and not food safety foreign facility would be subject to fees
weeks (or 120 paid hours) per trip. related (e.g., failure to comply with a only in the event that FDA, or an entity
Dividing $6,293 per trip by 120 hours food standard or incorrect font size on designated to act on its behalf, has made
per trip results in a total and an a food label). Determining when non- the requisite identification at an initial
additional cost of $52 (rounded to the compliance, other than under sections inspection of non-compliance materially
nearest dollar) per paid hour spent for 402 and 403(w) of the FD&C Act, is related to a food safety requirement of
foreign inspection travel costs in FY materially related to a food safety the FD&C Act. The definition of
2016. To adjust $52 for inflationary requirement of the FD&C Act may ‘‘reinspection-related costs’’ in section
increases in FY 2017 and FY 2018, FDA depend on the facts of a particular 743(a)(2)(B) of the FD&C Act relates to
situation. FDA intends to issue guidance both a domestic facility reinspection
sradovich on DSKBCFCHB2PROD with NOTICES
must multiply it by the same inflation
factors mentioned previously in this to provide additional information about and a foreign facility reinspection, as
document (1.015468, 1.016868), which the circumstances under which FDA described in section 743(a)(1)(A).
results in an estimated cost of $54 would consider non-compliance to be
(rounded to the nearest dollar) per paid materially related to a food safety B. Who will be responsible for paying
hour in addition to $231 for a total of requirement of the FD&C Act. this fee?
$285 per paid hour ($231 plus $54) for Under section 743(a)(1)(A) of the The FD&C Act states that this fee is to
each direct hour of work requiring FD&C Act, FDA is directed to assess and be paid by the responsible party for each
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![Federal Register / Vol. 82, No. 147 / Wednesday, August 2, 2017 / Notices 35957
domestic facility (as defined in section checks, reviewing periodic status new animal drugs. This notice
415(b) of the FD&C Act) and by the U.S. reports, analyzing the status reports and establishes the fee rates for FY 2018.
agent for each foreign facility (section the results of the audit checks, FOR FURTHER INFORMATION CONTACT: Visit
743(a)(1)(A) of the FD&C Act). This is conducting inspections, traveling to and FDA’s Web site at https://www.fda.gov/
the party to whom FDA will send the from locations, and monitoring product ForIndustry/UserFees/AnimalGeneric
invoice for any fees that are assessed disposition. The direct hours spent on DrugUserFeeActAGDUFA/default.htm,
under this section. each such recall will be billed at the or contact Lisa Kable, Center for
C. How much will this fee be? appropriate hourly rate shown in table Veterinary Medicine (HFV–10), Food
2. and Drug Administration, 7519 Standish
The fee is based on the number of Pl., Rockville, MD 20855, 240–402–
direct hours spent on such V. How must the fees be paid?
6888. For general questions, you may
reinspections, including time spent An invoice will be sent to the also email the Center for Veterinary
conducting the physical surveillance responsible party for paying the fee after Medicine (CVM) at cvmagdufa@
and/or compliance reinspection at the FDA completes the work on which the fda.hhs.gov.
facility, or whatever components of invoice is based. Payment must be made
such an inspection are deemed SUPPLEMENTARY INFORMATION:
within 90 days of the invoice date in
necessary, making preparations and U.S. currency by check, bank draft, or I. Background
arrangements for the reinspection, U.S. postal money order payable to the
traveling to and from the facility, Section 741 of the FD&C Act (21
order of the Food and Drug U.S.C. 379j–21) establishes three
preparing any reports, analyzing any Administration. Detailed payment
samples or examining any labels if different types of user fees: (1) Fees for
information will be included with the certain types of abbreviated applications
required, and performing other activities invoice when it is issued.
as part of the OAI reinspection until the for generic new animal drugs; (2) annual
facility is again determined to be in VI. What are the consequences of not fees for certain generic new animal drug
compliance. The direct hours spent on paying these fees? products; and (3) annual fees for certain
each such reinspection will be billed at sponsors of abbreviated applications for
Under section 743(e)(2) of the FD&C
the appropriate hourly rate shown in generic new animal drugs and/or
Act, any fee that is not paid within 30
table 2. investigational submissions for generic
days after it is due shall be treated as a
new animal drugs (21 U.S.C. 379j–
IV. Fees for Non-Compliance With a claim of the U.S. Government subject to
21(a)). When certain conditions are met,
Recall Order Under Section 743(a)(1)(B) provisions of subchapter II of chapter 37
FDA will waive or reduce fees for
of title 31, United States Code.
A. What will cause this fee to be generic new animal drugs intended
assessed? Dated: July 25, 2017. solely to provide for a minor use or
Leslie Kux, minor species indication (21 U.S.C.
The fee will be assessed for not
Associate Commissioner for Policy. 379j–21(d)).
complying with a recall order under For FY 2014 through FY 2018, the
[FR Doc. 2017–16184 Filed 8–1–17; 8:45 am]
section 423(d) (21 U.S.C. 350l(d)) or
BILLING CODE 4164–01–P FD&C Act establishes aggregate yearly
section 412(f) of the FD&C Act (21
base revenue amounts for each of these
U.S.C. 350a(f)) to cover food recall
fee categories (21 U.S.C. 379j–21(b)).
activities associated with such order
DEPARTMENT OF HEALTH AND Base revenue amounts established for
performed by the Secretary (and by
HUMAN SERVICES fiscal years after FY 2014 are subject to
delegation, FDA) (section 743(a)(1)(B) of
adjustment for workload (21 U.S.C.
the FD&C Act). Non-compliance may Food and Drug Administration 379j–21(c)). The target revenue amounts
include the following: (1) Not initiating
for each fee category for FY 2018, after
a recall as ordered by FDA; (2) not [Docket No. FDA–2017–N–0007] the adjustment for workload, are as
conducting the recall in the manner
specified by FDA in the recall order; or Animal Generic Drug User Fee Rates follows: For application fees, the target
(3) not providing FDA with requested and Payment Procedures for Fiscal revenue amount is $2,355,000; for
information regarding the recall, as Year 2018 product fees, the target revenue amount
ordered by FDA. is $3,532,000; and for sponsor fees, the
AGENCY: Food and Drug Administration, target revenue amount is $3,532,000.
B. Who will be responsible for paying HHS. For FY 2018, the generic new animal
this fee? ACTION: Notice. drug user fee rates are: $193,000 for
Section 743(a)(1)(B) of the FD&C Act each abbreviated application for a
states that the fee is to be paid by the SUMMARY: The Food and Drug generic new animal drug other than
responsible party for a domestic facility Administration (FDA) is announcing the those subject to the criteria in section
(as defined in section 415(b) of the fee rates and payment procedures for 512(d)(4) of the FD&C Act (21 U.S.C.
FD&C Act) and an importer who does fiscal year (FY) 2018 generic new 360b(d)(4)); $96,500 for each
not comply with a recall order under animal drug user fees. The Federal abbreviated application for a generic
section 423 or under section 412(f) of Food, Drug, and Cosmetic Act (the new animal drug subject to the criteria
the FD&C Act. In other words, the party FD&C Act), as amended by the Animal in section 512(d)(4); $8,195 for each
paying the fee would be the party that Generic Drug User Fee Amendments of generic new animal drug product;
2013 (AGDUFA II), authorizes FDA to $76,250 for each generic new animal
sradovich on DSKBCFCHB2PROD with NOTICES
received the recall order.
collect user fees for certain abbreviated drug sponsor paying 100 percent of the
C. How much will this fee be? applications for generic new animal sponsor fee; $57,188 for each generic
The fee is based on the number of drugs, for certain generic new animal new animal drug sponsor paying 75
direct hours spent on taking action in drug products, and for certain sponsors percent of the sponsor fee; and $38,125
response to the firm’s failure to comply of such abbreviated applications for for each generic new animal drug
with a recall order. Types of activities generic new animal drugs and/or sponsor paying 50 percent of the
could include conducting recall audit investigational submissions for generic sponsor fee. FDA will issue invoices for
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Document Created: 2017-08-02 07:09:41
Document Modified: 2017-08-02 07:09:41
| 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 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 | 82 FR 35954 |
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