Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2018, 35954-35957 [2017-16184]
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35954
Federal Register / Vol. 82, No. 147 / Wednesday, August 2, 2017 / Notices
their participants, the contexts in which
they are operated, and their promising
practices. The implementation study
will also assess whether the PJAC
interventions are implemented as
intended (implementation fidelity) as
well as how the treatment implemented
differed from the status quo (treatment
contrast). The detailed descriptions will
assist in interpreting program impacts
and identifying program features and
conditions necessary for effective
program replication or improvement.
Key activities of the implementation
study will include: (1) A Management
Information System (MIS) for collection
and analysis of program participation
data to track participant engagement in
PJAC activities; (2) semi-structured
interviews with program staff and staff
from selected community partner
organizations; (3) semi-structured
interviews with program participants to
learn about their experiences in PJAC;
and (4) a staff questionnaire to gather
broader quantitative information on
program implementation and staff
experiences.
2. Impact Study: The goal of the
impact study is to provide rigorous
estimates of the effectiveness of the six
programs using an experimental
research design. Program applicants
who are eligible for PJAC services will
be randomly assigned to either a
program group that is offered program
services or to a control group that is not
offered those services. The random
assignment process will require child
support program staff to complete a
brief data entry protocol. The impact
study will rely on administrative data
from state and county child support
systems, court records, criminal justice
records, and data from the National
Directory of New Hires. Administrative
records data will be used to estimate
impacts on child support payments,
enforcement actions, contempt
proceedings, jail stays, and employment
and earnings. The impact study will
also include a follow-up survey of
participants that will be administered
approximately 12 months after random
assignment to a subset of the sample.
The survey will gather information on
participant experiences with the child
support program and family court,
family relationships, parenting and coparenting, informal child support
payments, and job characteristics. In an
effort to enhance response rates, the
PJAC survey firm will attempt to track
survey sample members at a few points
over the 12-month follow-up period in
order to stay in touch with them and
gather updated contact information from
them.
3. Benefit-Cost Study: The benefit-cost
study will estimate the costs and
benefits associated with the
implementation and impact of the PJAC
interventions. The study will examine
the costs and benefits from the
perspective of the government,
noncustodial parents, custodial parents
and their children, and society. Once
measured, particular impacts or
expenditures will constitute benefits or
costs, depending on which analytical
perspective is considered. For each of
the perspectives, pertinent benefits and
costs will be added together to
determine the net value of the program.
Key hypothesized benefits and costs to
be assessed include increased PJAC
intervention costs, reduced costs for
contempt actions, increased payments
from non-custodial parents, reduced
court costs, and reduced jail time,
among others. The benefit-cost study
will rely on the results of the impact
study, analysis of participation data
from the MIS, and results of a staff time
study in order to quantify various PJACrelated costs and benefits.
This 30-Day Notice covers the
following data collection activities: (1)
Staff data entry for random assignment;
(2) Study MIS to track program
participation; (3) Staff and community
partner interview topic guide; (4)
Participant interview topic guide; and
(5) Participant survey tracking letter.
Respondents: Respondents for the
first information collection phase
include study participants and grantee
staff and community partners. Specific
respondents per instrument are noted in
the burden table below.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
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Staff data entry for random assignment ..............................
Study MIS to track program participation ............................
Staff and community partner interview topic guide .............
Participant interview topic guide ..........................................
Participant survey tracking letter .........................................
Estimated Total Annual Burden
Hours: 6,760.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 330
C Street SW., Washington, DC 20201.
Attention: Reports Clearance Officer. All
requests should be identified by the title
of the information collection. Email
address: infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
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Number of
responses per
respondent
120
120
150
180
3,000
150
150
2
1
3
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
Robert Sargis,
Reports Clearance Officer.
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Total burden
hours
0.05
1.00
1.00
1.00
0.10
Total annual
burden hours
900
18,000
300
180
900
300
6,000
100
60
300
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:
[FR Doc. 2017–16254 Filed 8–1–17; 8:45 am]
BILLING CODE 4184–01–P
Average
burden hours
per response
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
fiscal year (FY) 2018 fee rates for certain
SUMMARY:
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sradovich on DSKBCFCHB2PROD with NOTICES
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 reinspectionrelated 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,’’ (https://
www.fda.gov/Food/
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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GuidanceRegulation/
GuidanceDocuments
RegulatoryInformation/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.
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
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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 ...................
Less: .....................................
10 paid holidays ................
20 days of annual leave ...
10 days of sick leave ........
12.5 days of training .........
26.5 days of general administration ....................
26.5 days of travel ............
2 hours of meetings per
week ..............................
Net Supported Direct
FDA Work Hours
Available for Assignments .........................
2,080
........................
¥80
¥160
¥80
¥100
¥184
¥212
¥104
= 1,160
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
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(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 $54) for
each direct hour of work requiring
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collect fees from ‘‘the responsible party
for each domestic facility (as defined in
section 415(b) (21 U.S.C. 350d(b))) and
the United States agent for each foreign
TABLE 2—FSMA FEE SCHEDULE FOR facility subject to a reinspection’’ to
cover reinspection-related costs.
FY 2018
Section 743(a)(2)(A)(i) of the FD&C
Act defines the term ‘‘reinspection’’
Fee rates for
Fee category
FY 2018
with respect to domestic facilities as ‘‘1
($)
or more inspections conducted under
section 704 subsequent to an inspection
Hourly rate if domestic travel
conducted under such provision which
is required .........................
$248
identified non-compliance materially
Hourly rate if foreign travel is
required .............................
285 related to a food safety requirement of
th[e] Act, specifically to determine
whether compliance has been achieved
III. Fees for Reinspections of Domestic
to the Secretary’s satisfaction.’’
or Foreign Facilities Under Section
The FD&C Act does not contain a
743(a)(1)(A)
definition of ‘‘reinspection’’ specific to
A. What will cause this fee to be
foreign facilities. In order to give
assessed?
meaning to the language in section
743(a)(1)(A) of the FD&C Act to collect
The fee will be assessed for a
fees from the U.S. agent of a foreign
reinspection conducted under section
facility subject to a reinspection, the
704 of the FD&C Act (21 U.S.C. 374) to
Agency is using the following definition
determine whether corrective actions
of ‘‘reinspection’’ for purposes of
have been implemented and are
assessing and collecting fees under
effective and compliance has been
section 743(a)(1)(A), with respect to a
achieved to the Secretary of Health and
foreign facility, ‘‘1 or more inspections
Human Services’ (the Secretary) (and,
conducted by officers or employees duly
by delegation, FDA’s) satisfaction at a
designated by the Secretary subsequent
facility that manufactures, processes,
to such an inspection which identified
packs, or holds food for consumption
non-compliance materially related to a
necessitated as a result of a previous
food safety requirement of the FD&C
inspection (also conducted under
Act, specifically to determine whether
section 704) of this facility, which had
compliance has been achieved to the
a final classification of Official Action
Secretary’s (and, by delegation, FDA’s)
Indicated (OAI) conducted by or on
satisfaction.’’
behalf of FDA, when FDA determined
This definition allows FDA to fulfill
the non-compliance was materially
the mandate to assess and collect fees
related to food safety requirements of
from the U.S. agent of a foreign facility
the FD&C Act. FDA considers such non- in the event that an inspection reveals
compliance to include non-compliance
non-compliance materially related to a
with a statutory or regulatory
food safety requirement of the FD&C
requirement under section 402 of the
Act, causing one or more subsequent
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.
compliance has been achieved to the
343(w)). However, FDA does not
Secretary’s (and, by delegation, FDA’s)
consider non-compliance that is
satisfaction. By requiring the initial
materially related to a food safety
inspection to be conducted by officers
requirement to include circumstances
or employees duly designated by the
where the non-compliance is of a
Secretary, the definition ensures that a
technical nature and not food safety
foreign facility would be subject to fees
related (e.g., failure to comply with a
only in the event that FDA, or an entity
food standard or incorrect font size on
designated to act on its behalf, has made
a food label). Determining when nonthe requisite identification at an initial
compliance, other than under sections
inspection of non-compliance materially
402 and 403(w) of the FD&C Act, is
related to a food safety requirement of
materially related to a food safety
the FD&C Act. The definition of
requirement of the FD&C Act may
‘‘reinspection-related costs’’ in section
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
to provide additional information about and a foreign facility reinspection, as
the circumstances under which FDA
described in section 743(a)(1)(A).
would consider non-compliance to be
B. Who will be responsible for paying
materially related to a food safety
this fee?
requirement of the FD&C Act.
Under section 743(a)(1)(A) of the
The FD&C Act states that this fee is to
FD&C Act, FDA is directed to assess and be paid by the responsible party for each
foreign inspection travel. FDA will use
these rates in charging fees in FY 2018
when foreign travel is required.
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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)
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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
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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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0007]
Animal Generic Drug User Fee Rates
and Payment Procedures for Fiscal
Year 2018
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
fee rates and payment procedures for
fiscal year (FY) 2018 generic new
animal drug user fees. The Federal
Food, Drug, and Cosmetic Act (the
FD&C Act), as amended by the Animal
Generic Drug User Fee Amendments of
2013 (AGDUFA II), authorizes FDA to
collect user fees for certain abbreviated
applications for generic new animal
drugs, for certain generic new animal
drug products, and for certain sponsors
of such abbreviated applications for
generic new animal drugs and/or
investigational submissions for generic
SUMMARY:
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35957
new animal drugs. This notice
establishes the fee rates for FY 2018.
FOR FURTHER INFORMATION CONTACT: Visit
FDA’s Web site at https://www.fda.gov/
ForIndustry/UserFees/AnimalGeneric
DrugUserFeeActAGDUFA/default.htm,
or contact Lisa Kable, Center for
Veterinary Medicine (HFV–10), Food
and Drug Administration, 7519 Standish
Pl., Rockville, MD 20855, 240–402–
6888. For general questions, you may
also email the Center for Veterinary
Medicine (CVM) at cvmagdufa@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 741 of the FD&C Act (21
U.S.C. 379j–21) establishes three
different types of user fees: (1) Fees for
certain types of abbreviated applications
for generic new animal drugs; (2) annual
fees for certain generic new animal drug
products; and (3) annual fees for certain
sponsors of abbreviated applications for
generic new animal drugs and/or
investigational submissions for generic
new animal drugs (21 U.S.C. 379j–
21(a)). When certain conditions are met,
FDA will waive or reduce fees for
generic new animal drugs intended
solely to provide for a minor use or
minor species indication (21 U.S.C.
379j–21(d)).
For FY 2014 through FY 2018, the
FD&C Act establishes aggregate yearly
base revenue amounts for each of these
fee categories (21 U.S.C. 379j–21(b)).
Base revenue amounts established for
fiscal years after FY 2014 are subject to
adjustment for workload (21 U.S.C.
379j–21(c)). The target revenue amounts
for each fee category for FY 2018, after
the adjustment for workload, are as
follows: For application fees, the target
revenue amount is $2,355,000; for
product fees, the target revenue amount
is $3,532,000; and for sponsor fees, the
target revenue amount is $3,532,000.
For FY 2018, the generic new animal
drug user fee rates are: $193,000 for
each abbreviated application for a
generic new animal drug other than
those subject to the criteria in section
512(d)(4) of the FD&C Act (21 U.S.C.
360b(d)(4)); $96,500 for each
abbreviated application for a generic
new animal drug subject to the criteria
in section 512(d)(4); $8,195 for each
generic new animal drug product;
$76,250 for each generic new animal
drug sponsor paying 100 percent of the
sponsor fee; $57,188 for each generic
new animal drug sponsor paying 75
percent of the sponsor fee; and $38,125
for each generic new animal drug
sponsor paying 50 percent of the
sponsor fee. FDA will issue invoices for
E:\FR\FM\02AUN1.SGM
02AUN1
Agencies
[Federal Register Volume 82, Number 147 (Wednesday, August 2, 2017)]
[Notices]
[Pages 35954-35957]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16184]
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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.
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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,''
(https://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 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
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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 = 1,160
Assignments........................................
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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 $54) for each direct hour of
work requiring foreign inspection travel. FDA will use these rates in
charging fees in FY 2018 when foreign travel is required.
Table 2--FSMA Fee Schedule for FY 2018
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Fee rates for
Fee category FY 2018 ($)
------------------------------------------------------------------------
Hourly rate if domestic travel is required.............. $248
Hourly rate if foreign travel is required............... 285
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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
[[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