Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2019, 44277-44280 [2018-18802]
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Federal Register / Vol. 83, No. 169 / Thursday, August 30, 2018 / Notices
3. Updated background section that
includes a brief history of the
development program and the status of
product development and clinical data
to date, if applicable.
4. Proposed agenda, including
estimated times needed for discussion
of each agenda item.
5. List of questions for discussion
with a brief summary of each question
that explains the need or context for the
question.
6. Updated programs/shells for
simulations, if applicable.
7. Summary of new information that
is available to support discussions.
amozie on DSK3GDR082PROD with NOTICES1
E. Meeting Summaries
A meeting summary will be sent to
the sponsor within 60 days of each
meeting.
IV. Paperwork Reduction Act of 1995
F. Disclosure
To promote innovation and to provide
better clarity on the acceptance of
different types of trial designs, trial
designs developed through the pilot
program may be presented by FDA (e.g.,
in a guidance or public workshop) as
case studies, including while the drug
studied in the trial has not yet been
approved by FDA. Accordingly, before
FDA grants the initial meeting under
this pilot program, FDA and the sponsor
must agree on the information that FDA
may include in these public case
studies. The specific information to be
disclosed will depend on the content of
each application, but FDA intends to
focus on information that is beneficial to
advancing the use of CIDs, and those
elements relevant to the understanding
of the CID and its potential use in a
clinical trial intended to support
regulatory approval. Generally, the
Agency does not anticipate that the case
studies will need to include information
such as molecular structure, the
sponsor’s name, product name, subjectlevel data, recruitment strategies,
adverse events, or a complete
description of study eligibility criteria.
FDA does anticipate that the following
information will generally need to be
disclosed to facilitate discussion of the
proposed CID: Study endpoints to the
degree necessary to describe the design
(e.g., overall survival in the context of
a time to event analysis), target
population, sample size and power
determination, null and alternative
hypotheses, key operating
characteristics, assumed rates for
dichotomous outcomes or mean and
variance for continuous outcomes,
simulation objectives, simulation
scenarios, assumptions (e.g., dropout
rate, rate of enrollment), modeling
characteristics, critical study design
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characteristics including any adaptive
elements (e.g., decision criteria to add/
drop a dose, etc.), and, if a Bayesian
approach, how Bayesian methods are
being used for design and/or analysis
purposes.
It is important that sponsors wishing
to participate in the pilot program
identify aspects of the design and
analysis that they consider nondisclosable and provide a rationale for
withholding the information.
Participation in the pilot program,
including any agreement on information
disclosure, will be voluntary and at the
discretion of the sponsor. Sponsors that
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may seek regulatory input through other
existing channels.
This notice refers to collections of
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the Office of Management and Budget
(OMB) under the Paperwork Reduction
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collection of information resulting from
formal meetings between sponsors or
applicants and FDA has been approved
under OMB control number 0910–0429.
The collection of information in 21 CFR
part 312 (investigational new drug
applications) has been approved under
OMB control number 0910–0014.
Dated: August 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–18801 Filed 8–29–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–4119]
Food Safety Modernization Act ThirdParty Certification Program User Fee
Rate for Fiscal Year 2019
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
fiscal year (FY) 2019 annual fee rate for
recognized accreditation bodies and
accredited certification bodies, and the
fee rate for accreditation bodies
applying to be recognized in the thirdparty certification program that is
authorized by the Federal Food, Drug,
and Cosmetic Act (FD&C Act), as
amended by the FDA Food Safety
Modernization Act (FSMA). We are also
announcing the fee rate for certification
SUMMARY:
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bodies that are applying to be directly
accredited by FDA.
DATES: This fee is effective October 1,
2018.
FOR FURTHER INFORMATION CONTACT:
Donald Prater, Office of Foods and
Veterinary Medicine, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 3234, Silver Spring,
MD 20993, 301–348–3007.
SUPPLEMENTARY INFORMATION:
I. Background
Section 307 of FSMA, Accreditation
of Third-Party Auditors, amended the
FD&C Act to create a new provision,
section 808, under the same name.
Section 808 of the FD&C Act (21 U.S.C.
384d) directs FDA to establish a
program for accreditation of third-party
certification bodies 1 conducting food
safety audits and issuing food and
facility certifications to eligible foreign
entities (including registered foreign
food facilities) that meet our applicable
requirements. Under this provision, we
established a system for FDA to
recognize accreditation bodies to
accredit certification bodies, except for
limited circumstances in which we may
directly accredit certification bodies to
participate in the third-party
certification program.
Section 808(c)(8) of the FD&C Act
directs FDA to establish a
reimbursement (user fee) program by
which we assess fees and require
reimbursement for the work FDA
performs to establish and administer the
third-party certification program under
section 808 of the FD&C Act. The user
fee program for the third-party
certification program was established by
a final rule entitled ‘‘Amendments to
Accreditation of Third-Party
Certification Bodies To Conduct Food
Safety Audits and To Issue
Certifications To Provide for the User
Fee Program’’ (81 FR 90186, December
14, 2016).
The FSMA FY 2019 third-party
certification program user fee rate
announced in this notice is effective on
October 1, 2018, and will remain in
effect through September 30, 2019.
II. Estimating the Average Cost of a
Supported Direct FDA Work Hour for
FY 2019
In each year, the costs of salary (or
personnel compensation) and benefits
1 For the reasons explained in the third-party
certification final rule (80 FR 74570 at 74578–
74579, November 27, 2015), and for consistency
with the implementing regulations for the thirdparty certification program in 21 CFR parts 1, 11,
and 16, this notice uses the term ‘‘third-party
certification body’’ rather than the term ‘‘third-party
auditor’’ used in section 808(a)(3) of the FD&C Act.
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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.
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A. Estimating the Full Cost per Direct
Work Hour in FY 2019
Full-time Equivalent (FTE) reflects the
total number of regular straight-time
hours—not including overtime or
holiday hours—worked by employees,
divided by the number of compensable
hours applicable to each fiscal year.
Annual leave, sick leave, compensatory
time off, and other approved leave
categories are considered ‘‘hours
worked’’ for purposes of defining FTE
employment.
In general, the starting point for
estimating the full cost per direct work
hour is to estimate the cost of an FTE
or paid staff year. Calculating an
Agency-wide total cost per FTE requires
three primary cost elements: Payroll,
non-payroll, and rent.
We have used an average of past year
cost elements to predict the FY 2019
cost. The FY 2019 FDA-wide average
cost for payroll (salaries and benefits) is
$157,731; non-payroll—including
equipment, supplies, information
technology, general and administrative
overhead—is $91,008; and rent,
including cost allocation analysis and
adjustments for other rent and rentrelated costs, is $24,400 per paid staff
year, excluding travel costs.
Summing the average cost of an FTE
for payroll, non-payroll, and rent, brings
the FY 2019 average fully supported
cost to $273,139 per FTE, excluding
travel costs. FDA will use this base unit
fee in determining the hourly fee rate for
third-party certification user fees for FY
2019 prior to including travel costs as
applicable for the activity.
To calculate an hourly rate, FDA must
divide the FY 2019 average fully
supported cost of $273,139 per FTE by
the average number of supported direct
FDA work hours in FY 2017—the last
FY for which data are available. See
table 1.
TABLE 1—SUPPORTED DIRECT FDA the fee, we are using the travel cost rate
WORK HOURS IN A PAID STAFF for foreign travel because we anticipate
that the vast majority of onsite
YEAR IN FY 2017—Continued
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 ..................
¥184
¥212
¥104
= 1,160
Dividing the average fully supported
FTE cost in FY 2019 ($273,139) by the
total number of supported direct work
hours available for assignment in FY
2017 (1,160) results in an average fully
supported cost of $235 (rounded to the
nearest dollar), excluding travel costs,
per supported direct work hour in FY
2019.
B. Adjusting FY 2017 Travel Costs for
Inflation To Estimate FY 2019 Travel
Costs
To adjust the hourly rate for FY 2019,
FDA must estimate the cost of inflation
in each year for FY 2018 and FY 2019.
FDA uses the method prescribed for
estimating inflationary costs under the
Prescription Drug User Fee Act
(PDUFA) provisions of the FD&C Act
(section 736(c)(1) (21 U.S.C. 379h(c)(1)),
the statutory method for inflation
adjustment in the FD&C Act that FDA
has used consistently. FDA previously
determined the FY 2018 inflation rate to
be 1.6868 percent; this rate was
published in the FY 2018 PDUFA user
fee rates notice in the Federal Register
(82 FR 43244, September 14, 2017).
Utilizing the method set forth in section
736(c)(1) of the FD&C Act, FDA has
calculated an inflation rate of 1.6868
percent for FY 2018 and 1.7708 percent
for FY 2019, and FDA intends to use
this inflation rate to make inflation
adjustments for FY 2019 for several of
its user fee programs; the derivation of
this rate is published in the Federal
Register in the FY 2019 notice for the
PDUFA user fee rates (83 FR 37504 at
37505, August 1, 2018). The
compounded inflation rate for FYs 2018
and 2019, therefore, is 1.034875 (or
3.4875 percent) (1 plus 1.6868 percent
times 1 plus 1.7708 percent).
The average fully supported cost per
TABLE 1—SUPPORTED DIRECT FDA
supported direct FDA work hour,
WORK HOURS IN A PAID STAFF excluding travel costs, of $235 already
YEAR IN FY 2017
takes into account inflation as the
calculation above is based on FY 2019
Total number of hours in a paid
predicted costs. FDA will use this base
staff year ...............................
2,080
unit fee in determining the hourly fee
Less:
10 paid holidays ....................
¥80 rate for third-party certification program
20 days of annual leave .......
¥160 fees for FY 2019 prior to including
10 days of sick leave ............
¥80 travel costs as applicable for the
12.5 days of training .............
¥100 activity. For the purpose of estimating
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assessments made by FDA under this
program will require foreign travel. In
FY 2017, the Office of Regulatory Affairs
spent a total of $2,566,050 on 480
foreign inspection trips related to FDA’s
Center for Food Safety and Applied
Nutrition and Center for Veterinary
Medicine field activities programs,
which averaged a total of $5,346 per
foreign inspection trip. These trips
averaged 3 weeks (or 120 paid hours)
per trip. Dividing $5,346 per trip by 120
hours per trip results in a total and an
additional cost of $45 (rounded to the
nearest dollar) per paid hour spent for
foreign inspection travel costs in FY
2017. To adjust $45 for inflationary
increases in FY 2018 and FY 2019, FDA
must multiply it by the same inflation
factor mentioned previously in this
document (1.034875 or 3.4875 percent),
which results in an estimated cost of
$47 (rounded to the nearest dollar) per
paid hour in addition to $235 for a total
of $282 per paid hour ($235 plus $47)
for each direct hour of work requiring
foreign inspection travel. FDA will use
these rates in charging fees in FY 2019
when travel is required for the thirdparty certification program.
TABLE 2—FSMA FEE SCHEDULE FOR
FY 2019
Fee category
Hourly rate without travel .........
Hourly rate if travel is required
Fee rates
for
FY 2019
$235
282
III. Fees for Accreditation Bodies and
Certification Bodies in the Third-Party
Certification Program Under Section
808(c)(8) of the FD&C Act
The third-party certification program
assesses application fees and annual
fees. In FY 2019, the only fees that
could be collected by FDA under
section 808(c)(8) of the FD&C Act are
the initial application fee for
accreditation bodies seeking
recognition, the annual fee for
recognized accreditation bodies, the
annual fee for certification bodies
accredited by a recognized accreditation
body, and the initial application fee for
a certification body seeking direct
accreditation from FDA. Table 3
provides an overview of the fees for FY
2019.
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TABLE 3—FSMA THIRD-PARTY CER- $13,536. The estimated average cost of
TIFICATION PROGRAM USER FEE the work FDA performs in total for
reviewing an initial application for
SCHEDULE FOR FY 2019
Fee category
Initial Application Fee for Accreditation Body Seeking
Recognition ...........................
Annual Fee for Recognized Accreditation Body ....................
Annual Fee for Accredited Certification Body ........................
Initial Application Fee for a Certification Body Seeking Direct
Accreditation from FDA .........
Fee rates
for
FY 2019
$38,211
1,775
2,219
38,211
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A. Application Fee for Accreditation
Bodies Applying for Recognition in the
Third-Party Certification Program Under
Section 808(c)(8) of the FD&C Act
Section 1.705(a)(1) (21 CFR
1.705(a)(1)) establishes an application
fee for accreditation bodies applying for
initial recognition that represents the
estimated average cost of the work FDA
performs in reviewing and evaluating
initial applications for recognition of
accreditation bodies.
The fee is based on the fully
supported FTE hourly rates and
estimates of the number of hours it
would take FDA to perform relevant
activities. These estimates represent
FDA’s current thinking, and as the
program evolves, FDA will reconsider
the estimated hours. We estimate that it
would take, on average, 60 person-hours
to review an accreditation body’s
submitted application, 48 person-hours
for an onsite performance evaluation of
the applicant (including travel and other
steps necessary for a fully supported
FTE to complete an onsite assessment),
and 45 person-hours to prepare a
written report documenting the onsite
assessment.
FDA employees are likely to review
applications and prepare reports from
their worksites, so we use the fully
supported FTE hourly rate excluding
travel, $235/hour, to calculate the
portion of the user fee attributable to
those activities: $235/hour × (60 hours
+ 45 hours) = $24,675. FDA employees
will likely travel to foreign countries for
the onsite performance evaluations
because most accreditation bodies are
anticipated to be located in foreign
countries. For this portion of the fee we
use the fully supported FTE hourly rate
for work requiring travel, $282/hour, to
calculate the portion of the user fee
attributable to those activities: $282/
hour × 48 hours (i.e., two fully
supported FTEs × ((2 travel days × 8
hours) + (1 day onsite × 8 hours))) =
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recognition for an accreditation body
based on these figures would be $24,675
+ $13,536 = $38,211. Therefore, the
application fee for accreditation bodies
applying for recognition in FY 2019 will
be $38,211.
B. Annual Fee for Accreditation Bodies
Participating in the Third-Party
Certification Program Under Section
808(c)(8) of the FD&C Act
To calculate the annual fee for each
recognized accreditation body, FDA
takes the estimated average cost of work
FDA performs to monitor performance
of a single recognized accreditation
body and annualizes that over the
average term of recognition. At this time
we assume an average term of
recognition of 5 years. We also assume
that FDA will monitor 10 percent of
recognized accreditation bodies onsite.
As the program proceeds, we will adjust
the term of recognition as appropriate.
We estimate that for one performance
evaluation of a recognized accreditation
body, it would take, on average (taking
into account that not all recognized
accreditation bodies would be
monitored onsite), 24 hours for FDA to
conduct records review, 8 hours to
prepare a report detailing the records
review and onsite performance
evaluation, and 4.8 hours of onsite
performance evaluation (i.e., 10 percent
× two fully supported FTEs × ((2 travel
days × 8 hours)) + (1 day onsite × 8
hours))). Using the fully supported FTE
hourly rates in table 2, the estimated
average cost of the work FDA performs
to monitor performance of a single
recognized accreditation body would be
$7,520 ($235/hour × (24 hours + 8
hours)) plus $1,354 ($282/hour × 4.8
hours), which is $8,874. Annualizing
this amount over 5 years would lead to
an annual fee for recognized
accreditation bodies of $1,775 for FY
2019.
C. Annual Fee for Certification Bodies
Accredited by a Recognized
Accreditation Body in the Third-Party
Certification Program Under Section
808(c)(8) of the FD&C Act
To calculate the annual fee for a
certification body accredited by a
recognized accreditation body, FDA
takes the estimated average cost of work
FDA performs to monitor performance
of a single certification body accredited
by a recognized accreditation body and
annualizes that over the average term of
accreditation. At this time we assume an
average term of accreditation of 4 years.
This fee is based on the fully supported
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44279
FTE hourly rates and estimates of the
number of hours it would take FDA to
perform relevant activities. We estimate
that FDA would conduct, on average,
the same activities, for the same amount
of time to monitor certification bodies
accredited by a recognized accreditation
body as we would to monitor an
accreditation body recognized by FDA.
Using the fully supported FTE hourly
rates in table 2, the estimated average
cost of the work FDA performs to
monitor performance of a single
accredited certification body would be
$7,520 ($235/hour × (24 hours + 8
hours)) plus $1,354 ($282/hour × 4.8
hours), which is $8,874. Annualizing
this amount over 4 years would lead to
an annual fee for accredited certification
bodies of $2,219 for FY 2019.
D. Initial Application Fee for
Certification Bodies Seeking Direct
Accreditation From FDA in the ThirdParty Certification Program Under
Section 808(c)(8) of the FD&C Act
Section 1.705(a)(3) establishes an
application fee for certification bodies
applying for direct accreditation from
FDA that represents the estimated
average cost of the work FDA performs
in reviewing and evaluating initial
applications for direct accreditation of
certification bodies.
The fee is based on the fully
supported FTE hourly rates and
estimates of the number of hours it
would take FDA to perform relevant
activities. These estimates represent
FDA’s current thinking, and as the
program evolves, FDA will reconsider
the estimated hours. We estimate that it
would take, on average, 60 person-hours
to review a certification body’s
submitted application, 48 person-hours
for an onsite performance evaluation of
the applicant (including travel and other
steps necessary for a fully supported
FTE to complete an onsite assessment),
and 45 person-hours to prepare a
written report documenting the onsite
assessment.
FDA employees are likely to review
applications and prepare reports from
their worksites, so we use the fully
supported FTE hourly rate excluding
travel, $235/hour, to calculate the
portion of the user fee attributable to
those activities: $235/hour × (60 hours
+ 45 hours) = $24,675. FDA employees
will likely travel to foreign countries for
the onsite performance evaluations
because most certification bodies are
anticipated to be located in foreign
countries. For this portion of the fee we
use the fully supported FTE hourly rate
for work requiring travel, $282/hour, to
calculate the portion of the user fee
attributable to those activities: $282/
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hour × 48 hours (i.e., two fully
supported FTEs × ((2 travel days × 8
hours) + (1 day onsite × 8 hours))) =
$13,536. The estimated average cost of
the work FDA performs in total for
reviewing an initial application for
direct accreditation of a certification
body based on these figures would be
$24,675 + $13,536 = $38,211. Therefore,
the application fee for certification
bodies applying for direct accreditation
from FDA in FY 2019 will be $38,211.
IV. Estimated Fees for Accreditation
Bodies and Certification Bodies in
Other Fee Categories for FY 2019
Section 1.705(a) also establishes
application fees for recognized
accreditation bodies submitting renewal
applications and certification bodies
applying for renewal of direct
accreditation. Section 1.705(b) also
establishes annual fees for certification
bodies directly accredited by FDA.
Although we will not be collecting
these other fees in FY 2019, for
transparency and planning purposes, we
have provided an estimate of what these
fees would be for FY 2019 based on the
fully supported FTE hourly rates for FY
2019 and estimates of the number of
hours it would take FDA to perform
relevant activities as outlined in the
Final Regulatory Impact Analysis for the
Third-Party Certification Regulation.
Table 4 provides an overview of the
estimated fees for other fee categories.
VI. What are the consequences of not
paying this fee?
The consequences of not paying these
fees are outlined in 21 CFR 1.725. If
FDA does not receive an application fee
with an application for recognition, the
application will be considered
incomplete and FDA will not review the
application. If a recognized
accreditation body fails to submit its
annual user fee within 30 days of the
due date, we will suspend its
recognition. If the recognized
accreditation body fails to submit its
annual user fee within 90 days of the
due date, we will revoke its recognition.
If an accredited certification body fails
to pay its annual fee within 30 days of
the due date, we will suspend its
accreditation. If the accredited
certification body fails to pay its annual
fee within 90 days of the due date, we
will withdraw its accreditation.
Dated: August 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–18802 Filed 8–29–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Biomedical
Imaging and Bioengineering; Notice of
Closed Meeting
Pursuant to section 10(d) of the
TABLE 4—ESTIMATED FEE RATES FOR
OTHER FEE CATEGORIES UNDER Federal Advisory Committee Act, as
amended, notice is hereby given of a
THE FSMA THIRD-PARTY CERTIFImeeting.
CATION PROGRAM
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
$21,350 property such as patentable material,
and personal information concerning
individuals associated with the grant
28,999 applications, the disclosure of which
would constitute a clearly unwarranted
21,056
invasion of personal privacy.
Estimated
fee rates
for
FY 2019
Fee category
Renewal application fee for recognized accreditation body ...
Renewal application fee for directly accredited certification
body ......................................
Annual fee for certification body
directly accredited by FDA ....
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V. How must the fee be paid?
Accreditation bodies seeking initial
recognition must submit the application
fee with the application.
For recognized accreditation bodies
and accredited certification bodies, an
invoice will be sent annually. Payment
must be made within 30 days of the
invoice date. Detailed payment
information will be included with the
invoice when it is issued.
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Name of Committee: National Institute of
Biomedical Imaging and Bioengineering
Special Emphasis Panel, NIBIB Team-based
R25 Review (2019/01).
Date: September 24, 2018.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute of Biomedical Imaging and
Bioengineering, 6707 Democracy Blvd., Suite
920, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Ruixia Zhou, Ph.D.,
Scientific Review Officer, National Institute
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of Biomedical Imaging and Bioengineering,
National Institutes of Health, 6707
Democracy Blvd., Suite 957, Bethesda, MD
20892, 301–496–4773, zhour@mail@nih.gov.
Dated: August 23, 2018.
David D. Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–18769 Filed 8–29–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Toxicology Program Board of
Scientific Counselors; Announcement
of Meeting; Request for Comments
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
This notice announces the
next meeting of the National Toxicology
Program (NTP) Board of Scientific
Counselors (BSC). The BSC, a federally
chartered, external advisory group
composed of scientists from the public
and private sectors, will review and
provide advice on programmatic
activities. This meeting is by webcast
only and is open to the public.
Registration is requested for oral
comment and is required to access the
webcast. Information about the meeting
and registration are available at https://
ntp.niehs.nih.gov/go/165.
DATES:
Meeting: October 9, 2018; 1:00—4:00
p.m. (EDT).
Written Public Comment
Submissions: Deadline is October 1,
2018.
Oral Comments: Deadline is October
1, 2018.
Registration to view the webcast:
Deadline October 9, 2018.
Registration to view the meeting via
the webcast is required.
ADDRESSES:
Meeting Webpage: The preliminary
agenda, registration, and other meeting
materials are at https://ntp.niehs.nih.gov/
go/165.
Webcast: The meeting will be
webcast; the URL will be provided to
those who register for viewing.
FOR FURTHER INFORMATION CONTACT: Dr.
Mary Wolfe, Designated Federal Official
for the BSC, Office of Liaison, Policy
and Review, Division of NTP, NIEHS,
P.O. Box 12233, K2–03, Research
Triangle Park, NC 27709. Phone: 984–
287–3209, Fax: 301–451–5759, Email:
wolfe@niehs.nih.gov. Hand Deliver/
Courier address: 530 Davis Drive, Room
K2130, Morrisville, NC 27560.
SUMMARY:
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]]>Agencies
[Federal Register Volume 83, Number 169 (Thursday, August 30, 2018)]
[Notices]
[Pages 44277-44280]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-18802]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-4119]
Food Safety Modernization Act Third-Party Certification Program
User Fee Rate for Fiscal Year 2019
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
fiscal year (FY) 2019 annual fee rate for recognized accreditation
bodies and accredited certification bodies, and the fee rate for
accreditation bodies applying to be recognized in the third-party
certification program that is authorized by the Federal Food, Drug, and
Cosmetic Act (FD&C Act), as amended by the FDA Food Safety
Modernization Act (FSMA). We are also announcing the fee rate for
certification bodies that are applying to be directly accredited by
FDA.
DATES: This fee is effective October 1, 2018.
FOR FURTHER INFORMATION CONTACT: Donald Prater, Office of Foods and
Veterinary Medicine, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 3234, Silver Spring, MD 20993, 301-348-3007.
SUPPLEMENTARY INFORMATION:
I. Background
Section 307 of FSMA, Accreditation of Third-Party Auditors, amended
the FD&C Act to create a new provision, section 808, under the same
name. Section 808 of the FD&C Act (21 U.S.C. 384d) directs FDA to
establish a program for accreditation of third-party certification
bodies \1\ conducting food safety audits and issuing food and facility
certifications to eligible foreign entities (including registered
foreign food facilities) that meet our applicable requirements. Under
this provision, we established a system for FDA to recognize
accreditation bodies to accredit certification bodies, except for
limited circumstances in which we may directly accredit certification
bodies to participate in the third-party certification program.
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\1\ For the reasons explained in the third-party certification
final rule (80 FR 74570 at 74578-74579, November 27, 2015), and for
consistency with the implementing regulations for the third-party
certification program in 21 CFR parts 1, 11, and 16, this notice
uses the term ``third-party certification body'' rather than the
term ``third-party auditor'' used in section 808(a)(3) of the FD&C
Act.
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Section 808(c)(8) of the FD&C Act directs FDA to establish a
reimbursement (user fee) program by which we assess fees and require
reimbursement for the work FDA performs to establish and administer the
third-party certification program under section 808 of the FD&C Act.
The user fee program for the third-party certification program was
established by a final rule entitled ``Amendments to Accreditation of
Third-Party Certification Bodies To Conduct Food Safety Audits and To
Issue Certifications To Provide for the User Fee Program'' (81 FR
90186, December 14, 2016).
The FSMA FY 2019 third-party certification program user fee rate
announced in this notice is effective on October 1, 2018, and will
remain in effect through September 30, 2019.
II. Estimating the Average Cost of a Supported Direct FDA Work Hour for
FY 2019
In each year, the costs of salary (or personnel compensation) and
benefits
[[Page 44278]]
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.
A. Estimating the Full Cost per Direct Work Hour in FY 2019
Full-time Equivalent (FTE) reflects the total number of regular
straight-time hours--not including overtime or holiday hours--worked by
employees, divided by the number of compensable hours applicable to
each fiscal year. Annual leave, sick leave, compensatory time off, and
other approved leave categories are considered ``hours worked'' for
purposes of defining FTE employment.
In general, the starting point for estimating the full cost per
direct work hour is to estimate the cost of an FTE or paid staff year.
Calculating an Agency-wide total cost per FTE requires three primary
cost elements: Payroll, non-payroll, and rent.
We have used an average of past year cost elements to predict the
FY 2019 cost. The FY 2019 FDA-wide average cost for payroll (salaries
and benefits) is $157,731; non-payroll--including equipment, supplies,
information technology, general and administrative overhead--is
$91,008; and rent, including cost allocation analysis and adjustments
for other rent and rent-related costs, is $24,400 per paid staff year,
excluding travel costs.
Summing the average cost of an FTE for payroll, non-payroll, and
rent, brings the FY 2019 average fully supported cost to $273,139 per
FTE, excluding travel costs. FDA will use this base unit fee in
determining the hourly fee rate for third-party certification user fees
for FY 2019 prior to including travel costs as applicable for the
activity.
To calculate an hourly rate, FDA must divide the FY 2019 average
fully supported cost of $273,139 per FTE by the average number of
supported direct FDA work hours in FY 2017--the last FY for which data
are available. See table 1.
Table 1--Supported Direct FDA Work Hours in a Paid Staff Year in FY 2017
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Total number of hours in a paid staff year................. 2,080
Less:
10 paid holidays......................................... -80
20 days of annual leave.................................. -160
10 days of sick leave.................................... -80
12.5 days of training.................................... -100
26.5 days of general administration...................... -184
26.5 days of travel...................................... -212
2 hours of meetings per week............................. -104
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Net Supported Direct FDA Work Hours Available for = 1,160
Assignments...........................................
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Dividing the average fully supported FTE cost in FY 2019 ($273,139)
by the total number of supported direct work hours available for
assignment in FY 2017 (1,160) results in an average fully supported
cost of $235 (rounded to the nearest dollar), excluding travel costs,
per supported direct work hour in FY 2019.
B. Adjusting FY 2017 Travel Costs for Inflation To Estimate FY 2019
Travel Costs
To adjust the hourly rate for FY 2019, FDA must estimate the cost
of inflation in each year for FY 2018 and FY 2019. FDA uses the method
prescribed for estimating inflationary costs under the Prescription
Drug User Fee Act (PDUFA) provisions of the FD&C Act (section 736(c)(1)
(21 U.S.C. 379h(c)(1)), the statutory method for inflation adjustment
in the FD&C Act that FDA has used consistently. FDA previously
determined the FY 2018 inflation rate to be 1.6868 percent; this rate
was published in the FY 2018 PDUFA user fee rates notice in the Federal
Register (82 FR 43244, September 14, 2017). Utilizing the method set
forth in section 736(c)(1) of the FD&C Act, FDA has calculated an
inflation rate of 1.6868 percent for FY 2018 and 1.7708 percent for FY
2019, and FDA intends to use this inflation rate to make inflation
adjustments for FY 2019 for several of its user fee programs; the
derivation of this rate is published in the Federal Register in the FY
2019 notice for the PDUFA user fee rates (83 FR 37504 at 37505, August
1, 2018). The compounded inflation rate for FYs 2018 and 2019,
therefore, is 1.034875 (or 3.4875 percent) (1 plus 1.6868 percent times
1 plus 1.7708 percent).
The average fully supported cost per supported direct FDA work
hour, excluding travel costs, of $235 already takes into account
inflation as the calculation above is based on FY 2019 predicted costs.
FDA will use this base unit fee in determining the hourly fee rate for
third-party certification program fees for FY 2019 prior to including
travel costs as applicable for the activity. For the purpose of
estimating the fee, we are using the travel cost rate for foreign
travel because we anticipate that the vast majority of onsite
assessments made by FDA under this program will require foreign travel.
In FY 2017, the Office of Regulatory Affairs spent a total of
$2,566,050 on 480 foreign inspection trips related to FDA's Center for
Food Safety and Applied Nutrition and Center for Veterinary Medicine
field activities programs, which averaged a total of $5,346 per foreign
inspection trip. These trips averaged 3 weeks (or 120 paid hours) per
trip. Dividing $5,346 per trip by 120 hours per trip results in a total
and an additional cost of $45 (rounded to the nearest dollar) per paid
hour spent for foreign inspection travel costs in FY 2017. To adjust
$45 for inflationary increases in FY 2018 and FY 2019, FDA must
multiply it by the same inflation factor mentioned previously in this
document (1.034875 or 3.4875 percent), which results in an estimated
cost of $47 (rounded to the nearest dollar) per paid hour in addition
to $235 for a total of $282 per paid hour ($235 plus $47) for each
direct hour of work requiring foreign inspection travel. FDA will use
these rates in charging fees in FY 2019 when travel is required for the
third-party certification program.
Table 2--FSMA Fee Schedule for FY 2019
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Fee rates
Fee category for FY
2019
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Hourly rate without travel................................. $235
Hourly rate if travel is required.......................... 282
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III. Fees for Accreditation Bodies and Certification Bodies in the
Third-Party Certification Program Under Section 808(c)(8) of the FD&C
Act
The third-party certification program assesses application fees and
annual fees. In FY 2019, the only fees that could be collected by FDA
under section 808(c)(8) of the FD&C Act are the initial application fee
for accreditation bodies seeking recognition, the annual fee for
recognized accreditation bodies, the annual fee for certification
bodies accredited by a recognized accreditation body, and the initial
application fee for a certification body seeking direct accreditation
from FDA. Table 3 provides an overview of the fees for FY 2019.
[[Page 44279]]
Table 3--FSMA Third-Party Certification Program User Fee Schedule for FY
2019
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Fee rates
Fee category for FY
2019
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Initial Application Fee for Accreditation Body Seeking $38,211
Recognition...............................................
Annual Fee for Recognized Accreditation Body............... 1,775
Annual Fee for Accredited Certification Body............... 2,219
Initial Application Fee for a Certification Body Seeking 38,211
Direct Accreditation from FDA.............................
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A. Application Fee for Accreditation Bodies Applying for Recognition in
the Third-Party Certification Program Under Section 808(c)(8) of the
FD&C Act
Section 1.705(a)(1) (21 CFR 1.705(a)(1)) establishes an application
fee for accreditation bodies applying for initial recognition that
represents the estimated average cost of the work FDA performs in
reviewing and evaluating initial applications for recognition of
accreditation bodies.
The fee is based on the fully supported FTE hourly rates and
estimates of the number of hours it would take FDA to perform relevant
activities. These estimates represent FDA's current thinking, and as
the program evolves, FDA will reconsider the estimated hours. We
estimate that it would take, on average, 60 person-hours to review an
accreditation body's submitted application, 48 person-hours for an
onsite performance evaluation of the applicant (including travel and
other steps necessary for a fully supported FTE to complete an onsite
assessment), and 45 person-hours to prepare a written report
documenting the onsite assessment.
FDA employees are likely to review applications and prepare reports
from their worksites, so we use the fully supported FTE hourly rate
excluding travel, $235/hour, to calculate the portion of the user fee
attributable to those activities: $235/hour x (60 hours + 45 hours) =
$24,675. FDA employees will likely travel to foreign countries for the
onsite performance evaluations because most accreditation bodies are
anticipated to be located in foreign countries. For this portion of the
fee we use the fully supported FTE hourly rate for work requiring
travel, $282/hour, to calculate the portion of the user fee
attributable to those activities: $282/hour x 48 hours (i.e., two fully
supported FTEs x ((2 travel days x 8 hours) + (1 day onsite x 8
hours))) = $13,536. The estimated average cost of the work FDA performs
in total for reviewing an initial application for recognition for an
accreditation body based on these figures would be $24,675 + $13,536 =
$38,211. Therefore, the application fee for accreditation bodies
applying for recognition in FY 2019 will be $38,211.
B. Annual Fee for Accreditation Bodies Participating in the Third-Party
Certification Program Under Section 808(c)(8) of the FD&C Act
To calculate the annual fee for each recognized accreditation body,
FDA takes the estimated average cost of work FDA performs to monitor
performance of a single recognized accreditation body and annualizes
that over the average term of recognition. At this time we assume an
average term of recognition of 5 years. We also assume that FDA will
monitor 10 percent of recognized accreditation bodies onsite. As the
program proceeds, we will adjust the term of recognition as
appropriate. We estimate that for one performance evaluation of a
recognized accreditation body, it would take, on average (taking into
account that not all recognized accreditation bodies would be monitored
onsite), 24 hours for FDA to conduct records review, 8 hours to prepare
a report detailing the records review and onsite performance
evaluation, and 4.8 hours of onsite performance evaluation (i.e., 10
percent x two fully supported FTEs x ((2 travel days x 8 hours)) + (1
day onsite x 8 hours))). Using the fully supported FTE hourly rates in
table 2, the estimated average cost of the work FDA performs to monitor
performance of a single recognized accreditation body would be $7,520
($235/hour x (24 hours + 8 hours)) plus $1,354 ($282/hour x 4.8 hours),
which is $8,874. Annualizing this amount over 5 years would lead to an
annual fee for recognized accreditation bodies of $1,775 for FY 2019.
C. Annual Fee for Certification Bodies Accredited by a Recognized
Accreditation Body in the Third-Party Certification Program Under
Section 808(c)(8) of the FD&C Act
To calculate the annual fee for a certification body accredited by
a recognized accreditation body, FDA takes the estimated average cost
of work FDA performs to monitor performance of a single certification
body accredited by a recognized accreditation body and annualizes that
over the average term of accreditation. At this time we assume an
average term of accreditation of 4 years. This fee is based on the
fully supported FTE hourly rates and estimates of the number of hours
it would take FDA to perform relevant activities. We estimate that FDA
would conduct, on average, the same activities, for the same amount of
time to monitor certification bodies accredited by a recognized
accreditation body as we would to monitor an accreditation body
recognized by FDA. Using the fully supported FTE hourly rates in table
2, the estimated average cost of the work FDA performs to monitor
performance of a single accredited certification body would be $7,520
($235/hour x (24 hours + 8 hours)) plus $1,354 ($282/hour x 4.8 hours),
which is $8,874. Annualizing this amount over 4 years would lead to an
annual fee for accredited certification bodies of $2,219 for FY 2019.
D. Initial Application Fee for Certification Bodies Seeking Direct
Accreditation From FDA in the Third-Party Certification Program Under
Section 808(c)(8) of the FD&C Act
Section 1.705(a)(3) establishes an application fee for
certification bodies applying for direct accreditation from FDA that
represents the estimated average cost of the work FDA performs in
reviewing and evaluating initial applications for direct accreditation
of certification bodies.
The fee is based on the fully supported FTE hourly rates and
estimates of the number of hours it would take FDA to perform relevant
activities. These estimates represent FDA's current thinking, and as
the program evolves, FDA will reconsider the estimated hours. We
estimate that it would take, on average, 60 person-hours to review a
certification body's submitted application, 48 person-hours for an
onsite performance evaluation of the applicant (including travel and
other steps necessary for a fully supported FTE to complete an onsite
assessment), and 45 person-hours to prepare a written report
documenting the onsite assessment.
FDA employees are likely to review applications and prepare reports
from their worksites, so we use the fully supported FTE hourly rate
excluding travel, $235/hour, to calculate the portion of the user fee
attributable to those activities: $235/hour x (60 hours + 45 hours) =
$24,675. FDA employees will likely travel to foreign countries for the
onsite performance evaluations because most certification bodies are
anticipated to be located in foreign countries. For this portion of the
fee we use the fully supported FTE hourly rate for work requiring
travel, $282/hour, to calculate the portion of the user fee
attributable to those activities: $282/
[[Page 44280]]
hour x 48 hours (i.e., two fully supported FTEs x ((2 travel days x 8
hours) + (1 day onsite x 8 hours))) = $13,536. The estimated average
cost of the work FDA performs in total for reviewing an initial
application for direct accreditation of a certification body based on
these figures would be $24,675 + $13,536 = $38,211. Therefore, the
application fee for certification bodies applying for direct
accreditation from FDA in FY 2019 will be $38,211.
IV. Estimated Fees for Accreditation Bodies and Certification Bodies in
Other Fee Categories for FY 2019
Section 1.705(a) also establishes application fees for recognized
accreditation bodies submitting renewal applications and certification
bodies applying for renewal of direct accreditation. Section 1.705(b)
also establishes annual fees for certification bodies directly
accredited by FDA.
Although we will not be collecting these other fees in FY 2019, for
transparency and planning purposes, we have provided an estimate of
what these fees would be for FY 2019 based on the fully supported FTE
hourly rates for FY 2019 and estimates of the number of hours it would
take FDA to perform relevant activities as outlined in the Final
Regulatory Impact Analysis for the Third-Party Certification
Regulation. Table 4 provides an overview of the estimated fees for
other fee categories.
Table 4--Estimated Fee Rates for Other Fee Categories Under the FSMA
Third-Party Certification Program
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Estimated
fee rates
Fee category for FY
2019
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Renewal application fee for recognized accreditation body.. $21,350
Renewal application fee for directly accredited 28,999
certification body........................................
Annual fee for certification body directly accredited by 21,056
FDA.......................................................
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V. How must the fee be paid?
Accreditation bodies seeking initial recognition must submit the
application fee with the application.
For recognized accreditation bodies and accredited certification
bodies, an invoice will be sent annually. Payment must be made within
30 days of the invoice date. Detailed payment information will be
included with the invoice when it is issued.
VI. What are the consequences of not paying this fee?
The consequences of not paying these fees are outlined in 21 CFR
1.725. If FDA does not receive an application fee with an application
for recognition, the application will be considered incomplete and FDA
will not review the application. If a recognized accreditation body
fails to submit its annual user fee within 30 days of the due date, we
will suspend its recognition. If the recognized accreditation body
fails to submit its annual user fee within 90 days of the due date, we
will revoke its recognition. If an accredited certification body fails
to pay its annual fee within 30 days of the due date, we will suspend
its accreditation. If the accredited certification body fails to pay
its annual fee within 90 days of the due date, we will withdraw its
accreditation.
Dated: August 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-18802 Filed 8-29-18; 8:45 am]
BILLING CODE 4164-01-P
