Food Safety Modernization Act Voluntary Qualified Importer Program User Fee Rate for Fiscal Year 2020, 35680-35683 [2019-15742]
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35680
Federal Register / Vol. 84, No. 142 / Wednesday, July 24, 2019 / Notices
support to maximize the effectiveness of
the 54 Senior Medicare Patrol (SMP)
projects in Medicare fraud prevention
outreach and education. The
administrative supplement for FY 2019
will be for $554,532, bringing the total
award for FY 2019 to $1,194,532. With
this supplemental funding, NEI3A will
develop a targeted marketing and
outreach campaign. This includes
development of an SMP national video,
which will seek to increase awareness of
health care fraud and educate the public
on when to contact their SMP to report
health care fraud, errors, or abuse. An
advertisement campaign will be
developed to utilize on a national scale
and reach Top 20 Markets including
Good Morning America and early
evening prime time news broadcasts. In
addition, NEI3A will explore the
possibility of updating one of their
previously developed projects, the
Personal Health Care Journal, including
the possibility of providing a
technologically up-to-date SMP
application (app). This app would
provide beneficiaries with helpful
health care tips, important health care
contact information, and a place to log
their health care appointments for later
comparison with Medicare Summary
Notices (MSNs) and Explanations of
Benefits (EOBs). This tool would be
useful in preventing, detecting, and if
needed, reporting any health care fraud,
errors, or abuse. Lastly, NEI3A will
utilize supplemental funding to expand
existing contracts with SMP Subject
Matter Experts.
Program Name: Senior Medicare
Patrol National Resource Center
(SMPRC).
Recipient: Northeast Iowa Area
Agency on Aging, Inc. (NEI3A).
Period of Performance: The award
will be issued for the current project
period of September 1, 2019 through
August 31, 2020.
Total Award Amount: $1,194,532 in
FY 2019.
Award Type: Cooperative Agreement
Supplement.
Statutory Authority: Health Insurance
Portability and Accountability Act
(HIPAA) of 1996, Public Law 104–191.
Basis for Award: NEI3A is currently
funded to carry out the SMPRC Project
for the period of September 1, 2017
through August 31, 2020. Much work
has already been completed and further
tasks are currently being accomplished.
It would be unnecessarily time
consuming and disruptive to the
SMPRC project and the beneficiaries
being served for ACL to establish a new
grantee at this time when critical
services are presently being provided in
an efficient manner.
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NEI3A is uniquely placed to complete
work under the SMPRC grant. Since
2003, NEI3A has effectively operated
the SMPRC. NEI3A has a proven track
record for providing assistance through
successful working relationships with
SMP grantees, is centrally located in a
geographic location that boasts low
costs, and also houses the State Health
Insurance Assistance Program National
Technical Assistance Center (SHIP TA
Center). By housing both Centers,
NEI3A is able to successfully leverage
existing activities to lower overall cost
and therefore expand capability of
serving their target audience.
NEI3A accomplishes its mission by
developing and sharing tools, resources,
best practices, and strategies for
reducing health care fraud, waste, and
abuse via its online library, electronic
and print publications, webinars, and
training and technical assistance.
NEI3A is successfully meeting all
programmatic goals under the current
SMPRC grant.
FOR FURTHER INFORMATION CONTACT: For
further information or comments
regarding this program supplement,
contact Rebecca Kinney, U.S.
Department of Health and Human
Services, Administration for
Community Living, Center for Integrated
Programs, Office of Healthcare
Information and Counseling; telephone
(202) 795–7375; email Rebecca.Kinney@
acl.hhs.gov.
Dated: July 18, 2019.
Mary Lazare,
Principal Deputy Administrator,
Administration for Community Living.
[FR Doc. 2019–15694 Filed 7–23–19; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–3406]
Food Safety Modernization Act
Voluntary Qualified Importer Program
User Fee Rate for Fiscal Year 2020
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
fiscal year (FY) 2020 annual fee rate for
importers approved to participate in the
Voluntary Qualified Importer Program
(VQIP) that is authorized by the Federal
Food, Drug, and Cosmetic Act (FD&C
Act), as amended by the FDA Food
Safety Modernization Act (FSMA). This
SUMMARY:
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fee is effective August 1, 2019, and will
remain in effect through December 31,
2019.
FOR FURTHER INFORMATION CONTACT:
Donald Prater, Office of Food Policy and
Response, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 3202, Silver Spring,
MD 20993, 301–348–3007.
SUPPLEMENTARY INFORMATION:
I. Background
Section 302 of FSMA, Voluntary
Qualified Importer Program, amended
the FD&C Act to create a new provision,
section 806, under the same name.
Section 806 of the FD&C Act (21 U.S.C.
384b) directs FDA to establish a
program to provide for the expedited
review and importation of food offered
for importation by importers who have
voluntarily agreed to participate in such
program, and a process, consistent with
section 808 of the FD&C Act (21 U.S.C.
384d), for the issuance of a facility
certification to accompany a food
offered for importation by importers
participating in the VQIP.
Section 743 of the FD&C Act (21
U.S.C. 379j–31) authorizes FDA to
assess and collect fees from each
importer participating in VQIP to cover
FDA’s costs of administering the
program. Each fiscal year, fees are to be
established based on an estimate of 100
percent of the costs for the year. The fee
rates must be published in a Federal
Register notice not later than 60 days
before the start of each fiscal year
(section 743(b)(1) of the FD&C Act).
After FDA approves a VQIP application,
the user fee must be paid before October
1, the start of the VQIP fiscal year, to
begin receiving benefits for that VQIP
fiscal year.
The FSMA FY 2020 VQIP user fee rate
announced in this notice is effective on
August 1, 2019, and will remain in
effect through December 31, 2019. The
FY 2020 VQIP user fee will support
benefits from October 1, 2019, through
September 30, 2020.
II. Estimating the Average Cost of a
Supported Direct FDA Work Hour for
FY 2020
Each fiscal year, fees are to be
established based on an estimate of 100
percent of the costs for the year. In each
year, the costs of salary (or personnel
compensation) and benefits for FDA
employees account for between 50 and
60 percent of the funds available to, and
used by, FDA. Almost all of the
remaining funds (operating funds)
available to FDA are used to support
FDA employees for paying rent, travel,
utility, information technology, and
other operating costs.
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A. Estimating the Full Cost per Direct
Work Hour in FY 2020
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 2020
cost. The FY 2020 FDA-wide average
cost for payroll (salaries and benefits) is
$160,885; non-payroll—including
equipment, supplies, information
technology, general and administrative
overhead—is $92,828; and rent,
including cost allocation analysis and
adjustments for other rent and rentrelated costs, is $24,888 per paid staff
year, excluding travel costs.
Summing the average cost of an FTE
for payroll, non-payroll, and rent, brings
the FY 2020 average fully supported
cost to $278,602 per FTE, excluding
travel costs. FDA will use this base unit
fee in determining the hourly fee rate for
VQIP user fees for FY 2020 prior to
including travel costs as applicable for
the activity.
To calculate an hourly rate, FDA must
divide the FY 2020 average fully
supported cost of $278,602 per FTE by
the average number of supported direct
FDA work hours in FY 2018—the last
FY for which data are available. See
table 1.
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TABLE 1—SUPPORTED DIRECT FDA
WORK HOURS IN A PAID STAFF
YEAR IN FY 2018
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 ...................
2,080
¥80
¥160
¥80
¥100
¥184
¥212
¥104
Net Supported Direct FDA Work Hours
Available for Assignments ..................
1,160
Dividing the average fully supported
FTE cost in FY 2020 ($278,602) by the
total number of supported direct work
hours available for assignment in FY
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2018 (1,160) results in an average fully
supported cost of $240 (rounded to the
nearest dollar), excluding travel costs,
per supported direct work hour in FY
2020.
B. Adjusting FY 2018 Travel Costs for
Inflation To Estimate FY 2020 Travel
Costs
To adjust the hourly rate for FY 2020,
FDA must estimate the cost of inflation
in each year for FY 2019 and FY 2020.
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 2019 inflation rate to
be 1.7708 percent; this rate was
published in the FY 2019 PDUFA user
fee rates notice in the Federal Register
(83 FR 37504, August 1, 2018). Utilizing
the method set forth in section 736(c)(1)
of the FD&C Act, FDA has calculated an
inflation rate of 1.7708 percent for FY
2019 and 2.3964 percent for FY 2020,
and FDA intends to use this inflation
rate to make inflation adjustments for
FY 2020 for several of its user fee
programs; the derivation of this rate is
published in the Federal Register in the
FY 2020 notice for the PDUFA user fee
rates. The compounded inflation rate for
FYs 2019 and 2020, therefore, is
1.042096 (or 4.2096 percent) (1 plus
1.7708 percent times 1 plus 2.3964
percent).
The average fully supported cost per
supported direct FDA work hour,
excluding travel costs, of $240 already
takes into account inflation as the
calculation above is based on FY 2020
predicted costs. FDA will use this base
unit fee in determining the hourly fee
rate for VQIP fees for FY 2020 prior to
including domestic or foreign travel
costs as applicable for the activity. For
the purpose of estimating the fee, we are
using the travel cost rate for both
domestic and foreign travel because we
anticipate that a portion of onsite
assessments made by FDA under this
program will require foreign travel in
addition to domestic travel.
In FY 2018 FDA’s Office of Regulatory
Affairs (ORA) spent a total of $6,027,291
for domestic regulatory inspection travel
costs and General Services
Administration Vehicle cost 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 9,976 CFSAN and CVM
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domestic inspections, which averages a
total of $604 per inspection by 35.44
hours per inspection results in a total
and an additional cost of $17 (rounded
to the nearest dollar) per hour spent for
domestic inspection travel cost in FY
2018. To adjust for the $17 per hour
inflationary increases in FY 2019 and
FY 2020, FDA must multiply it by the
same inflation factor mentioned
previously in this document (1.042096
or 4.2096 percent), which results in an
estimated cost of $18 (rounded to the
nearest dollar) per paid hour in addition
to $240 for a total of $258 per paid hour
($240 plus $18) for each direct hour of
work requiring domestic inspection
travel. FDA will use these rates in
charging fees in FY 2020 when domestic
travel is required.
In FY 2018, the ORA spent a total of
$3,229,335 on 455 foreign inspection
trips related to FDA’s CFSAN and CVM
field activities programs, which
averaged a total of $7,097 per foreign
inspection trip. These trips averaged 3
weeks (or 120 paid hours) per trip.
Dividing $7,097 per trip by 120 hours
per trip results in a total and an
additional cost of $59 (rounded to the
nearest dollar) per paid hour spent for
foreign inspection travel costs in FY
2018. To adjust $59 for inflationary
increases in FY 2019 and FY 2020, FDA
must multiply it by the same
compounded inflation factor mentioned
previously in this document (1.042096
or 4.2096 percent), which results in an
estimated cost of $61 (rounded to the
nearest dollar) per paid hour in addition
to $240 for a total of $301 per paid hour
($240 plus $61) for each direct hour of
work requiring foreign inspection travel.
FDA will use these rates in charging fees
in FY 2020 when foreign travel is
required for the VQIP.
TABLE 2—FSMA FEE SCHEDULE FOR
FY 2020
Fee category
Hourly rate without travel ................
Hourly rate if domestic travel is required ...........................................
Hourly rate if foreign travel is required ...........................................
Fee rates
for FY 2020
$240
258
301
III. Fees for Importers Approved To
Participate in the Voluntary Qualified
Importer Program Under Section 743 of
the FD&C Act
FDA assesses fees for VQIP annually.
Table 3 provides an overview of the fees
for FY 2020.
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TABLE 3—FSMA VQIP USER FEE
SCHEDULE FOR FY 2020
Fee category
Fee rates
for FY 2020
VQIP User Fee ................................
$16,681
Section 743 of the FD&C Act requires
that each importer participating in VQIP
pay a fee to cover FDA’s costs of
administering the program. This fee
represents the estimated average cost of
the work FDA performs in reviewing
and evaluating a VQIP importer. At this
time, FDA is not offering an adjusted fee
for small businesses. As required by
section 743(b)(2)(B)(iii) of the FD&C Act,
FDA previously published a set of
guidelines in consideration of the
burden of the VQIP fee on small
businesses and provided for a period of
public comment on the guidelines (80
FR 32136, June 5, 2015). While we did
receive some comments in response,
they did not address the questions
posed, i.e., how a small business fee
reduction should be structured, what
percentage of fee reduction would be
appropriate, or what alternative
structures FDA might consider in order
to indirectly reduce fees for small
businesses by charging different fee
amounts to different VQIP participants.
We plan on monitoring costs and
collecting data to determine if, in future
fiscal years, we will provide for a small
business fee reduction. Consistent with
section 743(b)(2)(B)(iii), we will adjust
the fee schedule for small businesses
only through notice and comment
rulemaking.
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, 39 person-hours
to review a VQIP application (including
communication provided through the
VQIP Importer’s Help Desk), 16 personhours for an onsite performance
evaluation of a domestic VQIP importer
(including travel and other steps
necessary for a fully supported FTE to
complete and document an onsite
assessment), and 34 person-hours for an
onsite performance evaluation of a
foreign VQIP importer (including travel
and other steps necessary for a fully
supported FTE to complete and
document an onsite assessment).
Additional costs include maintenance
costs of information technology of
administering benefits of the program.
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These costs are estimated to be $2,209
per VQIP importer.
FDA employees are likely to review
applications from their worksites, so we
use the fully supported FTE hourly rate
excluding travel, $240/hour, to calculate
the portion of the user fee attributable
to those activities: $240/hour × (39
hours) = $9,360.
FDA employees will conduct a VQIP
inspection to verify the eligibility
criteria and full implementation of the
food safety and food defense systems
established in the Quality Assurance
Program. A VQIP importer may be
located inside or outside of the United
States. We have used an estimate that
up to 20 percent of VQIP importers may
be located outside of the United States.
FDA employees are likely to prepare
for and report on the performance
evaluation of a domestic VQIP importer
at an FTE’s worksite, so we use the fully
supported FTE hourly rate excluding
travel, $240/hour, to calculate the
portion of the user fee attributable to
those activities: $240/hour × (8 hours) =
$1,920. For the portion of the fee
covering onsite evaluation of a domestic
VQIP importer, we use the fully
supported FTE hourly rate for work
requiring domestic travel, $258/hour, to
calculate the portion of the user fee
attributable to those activities: $258/
hour × 8 hours (i.e., one fully supported
FTE × (1 day onsite × 8 hours)) = $2,064.
Therefore, the total cost of conducting
the domestic performance evaluation of
a VQIP importer is determined to be
$2,064 + $1,920 = $3,984.
Coordination of the onsite
performance evaluation of a foreign
VQIP importer is estimated to take place
at an FTE’s worksite, so we use the fully
supported FTE hourly rate excluding
travel, $240/hour, to calculate the
portion of the user fee attributable to
those activities: $240/hour × (10 hours)
= $2,400. For the portion of the fee
covering onsite evaluation of a foreign
VQIP importer, we use the fully
supported FTE hourly rate for work
requiring foreign travel, $301/hour, to
calculate the portion of the user fee
attributable to those activities: $301/
hour × 24 hours (i.e., one fully
supported FTE × ((2 travel days × 8
hours) + (1 day onsite × 8 hours))) =
$7,224. Therefore, the total cost of
conducting the foreign performance
evaluation of a VQIP importer is
determined to be $2,400 + $7,224 =
$9,624.
Therefore, the estimated average cost
of the work FDA performs in total for
approving an application for a VQIP
importer based on these figures would
be $2,209 + $9,360 + ($3,984 × 0.8) +
($9,624 × 0.2) = $16,681.
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IV. How must the fee be paid?
An invoice will be sent to VQIP
importers approved to participate in the
program. Payment must be made prior
to October 1, 2019, in order to be
eligible for VQIP participation for the
benefit year beginning October 1, 2019.
FDA will not refund the VQIP user fee
for any reason.
The payment must be made in U.S.
currency from a U.S. bank by one of the
following methods: Wire transfer,
electronically, check, bank draft, or U.S.
postal money order made payable to the
Food and Drug Administration. The
preferred payment method is online
using an electronic check (Automated
Clearing House (ACH), also known as
eCheck) or credit card (Discover, VISA,
MasterCard, American Express). Secure
electronic payments can be submitted
using the User Fees Payment Portal at
https://userfees.fda.gov/pay or the
Pay.gov payment option, which is
available to you after you submit a cover
sheet. (Note: Only full payments are
accepted. No partial payments can be
made online.) Once you have found
your invoice, select ‘‘Pay Now’’ to be
redirected to Pay.gov. Electronic
payment options are based on the
balance due. Payment by credit card is
available only for balances less than
$25,000. If the balance exceeds this
amount, only the ACH option is
available. Payments must be made using
U.S. bank accounts as well as U.S. credit
cards.
When paying by check, bank draft, or
U.S. postal money order, please include
the invoice number. Also write the FDA
post office box number (P.O. Box
979108) on the enclosed check, bank
draft, or money order. Mail the payment
and a copy of the invoice to: Food and
Drug Administration, P.O. Box 979108,
St. Louis, MO 63197–9000.
When paying by wire transfer, it is
required that the invoice number is
included; without the invoice number
the payment may not be applied. The
originating financial institution may
charge a wire transfer fee. If the
financial institution charges a wire
transfer fee, it is required to add that
amount to the payment to ensure that
the invoice is paid in full. For
international wire transfers, please
inquire with the financial institutions
prior to submitting the payment. Use the
following account information when
sending a wire transfer: U.S. Department
of the Treasury, TREAS NYC, 33 Liberty
St., New York, NY 10045, Account
Name: Food and Drug Administration,
Account No.: 75060099, Routing No.:
021030004, Swift No.: FRNYUS33.
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Federal Register / Vol. 84, No. 142 / Wednesday, July 24, 2019 / Notices
To send a check by a courier such as
Federal Express, the courier must
deliver the check and printed copy of
the cover sheet to: U.S. Bank, Attn:
Government Lockbox 979108, 1005
Convention Plaza, St. Louis, MO 63101.
(Note: This address is for courier
delivery only. If you have any questions
concerning courier delivery, contact
U.S. Bank at 314–418–4013. This phone
number is only for questions about
courier delivery.)
The tax identification number of FDA
is 53–0196965. (Note: In no case should
the payment for the fee be submitted to
FDA with the invoice.)
V. What are the consequences of not
paying this fee?
Dated: July 19, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–15742 Filed 7–23–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request Information
Collection Request Title: Health Center
Patient Survey, OMB No. 0915–0368—
Reinstatement
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
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Notice.
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than September 23,
2019.
SUMMARY:
Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, Maryland 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Health Center Patient Survey, OMB No.
0915–0368—Reinstatement
Abstract: The Health Center Program,
administered by HRSA, is authorized
under section 330 of the Public Health
Service Act, most recently amended by
section 50901(b) of the Bipartisan
Budget Act of 2018, Public Law 115–
123. Health centers are communitybased and patient-directed organizations
that deliver affordable, accessible,
quality, and cost-effective primary
health care services to patients
regardless of their ability to pay. Nearly
1,400 health centers operate
approximately 12,000 service delivery
sites that provide primary health care to
more than 27 million people in every
U.S. state, the District of Columbia,
Puerto Rico, the U.S. Virgin Islands, and
the Pacific Basin. In the past, HRSA has
conducted the Health Center Patient
Survey (HCPS), which surveys patients
of HRSA-supported health centers. The
HCPS collects information about
sociodemographic characteristics,
health conditions, health behaviors,
access to and utilization of health care
ADDRESSES:
The consequences of not paying these
fees are outlined in Section J of ‘‘FDA’s
Voluntary Qualified Importer Program;
Guidance for Industry’’ document
(available at https://www.fda.gov/
media/92196/download). If the user fee
is not paid before October 1, a VQIP
importer will not be eligible to
participate in VQIP. For the first year a
VQIP application is approved, if the
user fee is not paid before October 1,
2019, you are not eligible to participate
in VQIP. If you subsequently pay the
user fee, FDA will begin your benefits
after we receive the full payment. The
user fee may not be paid after December
31, 2019. For a subsequent year, if you
do not pay the user fee before October
1, FDA will send a Notice of Intent to
Revoke your participation in VQIP. If
you do not pay the user fee within 30
days of the date of the Notice of Intent
to Revoke, we will revoke your
participation in VQIP.
AGENCY:
ACTION:
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35683
services, and satisfaction with health
care received at HRSA-supported health
centers. The reinstatement of the HCPS
will utilize the same modules from the
2014 HCPS (OMB #0915–0368).
Overarching improvements to the
survey instrument will streamline the
questionnaire to minimize burden and
standardize questions with other
national surveys to enable comparative
analyses with a particular focus on HHS
and HRSA priority areas (e.g., mental
health and substance use). Survey
results come from in-person, one-on-one
interviews with patients who are
selected as nationally representative of
the Health Center Program patient
population.
Need and Proposed Use of the
Information: The HCPS is unique
because it focuses on comprehensive,
nationally representative, individual
level data from the perspective of health
center patients. By investigating how
well HRSA-supported health centers
meet health care needs of the medically
underserved and how patients perceive
their quality of care, the HCPS serves as
an empirically based resource to inform
HRSA policy, funding, and planning
decisions.
Likely Respondents: Patients at
HRSA-supported health centers.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. Compared to the previous
HCPS, the estimated burden hours for
an individual respondent remain the
same in this reinstatement. However,
the total annual burden hours and
number of survey respondents is
anticipated to increase in order to reflect
the growing number of patients served
by the Health Center Program. The total
annual burden hours estimated for this
ICR are summarized in the table below.
E:\FR\FM\24JYN1.SGM
24JYN1
Agencies
[Federal Register Volume 84, Number 142 (Wednesday, July 24, 2019)]
[Notices]
[Pages 35680-35683]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15742]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-3406]
Food Safety Modernization Act Voluntary Qualified Importer
Program User Fee Rate for Fiscal Year 2020
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) 2020 annual fee rate for importers approved to
participate in the Voluntary Qualified Importer Program (VQIP) that is
authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as
amended by the FDA Food Safety Modernization Act (FSMA). This fee is
effective August 1, 2019, and will remain in effect through December
31, 2019.
FOR FURTHER INFORMATION CONTACT: Donald Prater, Office of Food Policy
and Response, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 1, Rm. 3202, Silver Spring, MD 20993, 301-348-3007.
SUPPLEMENTARY INFORMATION:
I. Background
Section 302 of FSMA, Voluntary Qualified Importer Program, amended
the FD&C Act to create a new provision, section 806, under the same
name. Section 806 of the FD&C Act (21 U.S.C. 384b) directs FDA to
establish a program to provide for the expedited review and importation
of food offered for importation by importers who have voluntarily
agreed to participate in such program, and a process, consistent with
section 808 of the FD&C Act (21 U.S.C. 384d), for the issuance of a
facility certification to accompany a food offered for importation by
importers participating in the VQIP.
Section 743 of the FD&C Act (21 U.S.C. 379j-31) authorizes FDA to
assess and collect fees from each importer participating in VQIP to
cover FDA's costs of administering the program. Each fiscal year, fees
are to be established based on an estimate of 100 percent of the costs
for the year. The fee rates must be published in a Federal Register
notice not later than 60 days before the start of each fiscal year
(section 743(b)(1) of the FD&C Act). After FDA approves a VQIP
application, the user fee must be paid before October 1, the start of
the VQIP fiscal year, to begin receiving benefits for that VQIP fiscal
year.
The FSMA FY 2020 VQIP user fee rate announced in this notice is
effective on August 1, 2019, and will remain in effect through December
31, 2019. The FY 2020 VQIP user fee will support benefits from October
1, 2019, through September 30, 2020.
II. Estimating the Average Cost of a Supported Direct FDA Work Hour for
FY 2020
Each fiscal year, fees are to be established based on an estimate
of 100 percent of the costs for the year. In each year, the costs of
salary (or personnel compensation) and benefits for FDA employees
account for between 50 and 60 percent of the funds available to, and
used by, FDA. Almost all of the remaining funds (operating funds)
available to FDA are used to support FDA employees for paying rent,
travel, utility, information technology, and other operating costs.
[[Page 35681]]
A. Estimating the Full Cost per Direct Work Hour in FY 2020
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 2020 cost. The FY 2020 FDA-wide average cost for payroll (salaries
and benefits) is $160,885; non-payroll--including equipment, supplies,
information technology, general and administrative overhead--is
$92,828; and rent, including cost allocation analysis and adjustments
for other rent and rent-related costs, is $24,888 per paid staff year,
excluding travel costs.
Summing the average cost of an FTE for payroll, non-payroll, and
rent, brings the FY 2020 average fully supported cost to $278,602 per
FTE, excluding travel costs. FDA will use this base unit fee in
determining the hourly fee rate for VQIP user fees for FY 2020 prior to
including travel costs as applicable for the activity.
To calculate an hourly rate, FDA must divide the FY 2020 average
fully supported cost of $278,602 per FTE by the average number of
supported direct FDA work hours in FY 2018--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 2018
------------------------------------------------------------------------
------------------------------------------------------------------------
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 2020 ($278,602)
by the total number of supported direct work hours available for
assignment in FY 2018 (1,160) results in an average fully supported
cost of $240 (rounded to the nearest dollar), excluding travel costs,
per supported direct work hour in FY 2020.
B. Adjusting FY 2018 Travel Costs for Inflation To Estimate FY 2020
Travel Costs
To adjust the hourly rate for FY 2020, FDA must estimate the cost
of inflation in each year for FY 2019 and FY 2020. 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 2019 inflation rate to be 1.7708 percent; this rate
was published in the FY 2019 PDUFA user fee rates notice in the Federal
Register (83 FR 37504, August 1, 2018). Utilizing the method set forth
in section 736(c)(1) of the FD&C Act, FDA has calculated an inflation
rate of 1.7708 percent for FY 2019 and 2.3964 percent for FY 2020, and
FDA intends to use this inflation rate to make inflation adjustments
for FY 2020 for several of its user fee programs; the derivation of
this rate is published in the Federal Register in the FY 2020 notice
for the PDUFA user fee rates. The compounded inflation rate for FYs
2019 and 2020, therefore, is 1.042096 (or 4.2096 percent) (1 plus
1.7708 percent times 1 plus 2.3964 percent).
The average fully supported cost per supported direct FDA work
hour, excluding travel costs, of $240 already takes into account
inflation as the calculation above is based on FY 2020 predicted costs.
FDA will use this base unit fee in determining the hourly fee rate for
VQIP fees for FY 2020 prior to including domestic or foreign travel
costs as applicable for the activity. For the purpose of estimating the
fee, we are using the travel cost rate for both domestic and foreign
travel because we anticipate that a portion of onsite assessments made
by FDA under this program will require foreign travel in addition to
domestic travel.
In FY 2018 FDA's Office of Regulatory Affairs (ORA) spent a total
of $6,027,291 for domestic regulatory inspection travel costs and
General Services Administration Vehicle cost 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 9,976 CFSAN and CVM domestic
inspections, which averages a total of $604 per inspection by 35.44
hours per inspection results in a total and an additional cost of $17
(rounded to the nearest dollar) per hour spent for domestic inspection
travel cost in FY 2018. To adjust for the $17 per hour inflationary
increases in FY 2019 and FY 2020, FDA must multiply it by the same
inflation factor mentioned previously in this document (1.042096 or
4.2096 percent), which results in an estimated cost of $18 (rounded to
the nearest dollar) per paid hour in addition to $240 for a total of
$258 per paid hour ($240 plus $18) for each direct hour of work
requiring domestic inspection travel. FDA will use these rates in
charging fees in FY 2020 when domestic travel is required.
In FY 2018, the ORA spent a total of $3,229,335 on 455 foreign
inspection trips related to FDA's CFSAN and CVM field activities
programs, which averaged a total of $7,097 per foreign inspection trip.
These trips averaged 3 weeks (or 120 paid hours) per trip. Dividing
$7,097 per trip by 120 hours per trip results in a total and an
additional cost of $59 (rounded to the nearest dollar) per paid hour
spent for foreign inspection travel costs in FY 2018. To adjust $59 for
inflationary increases in FY 2019 and FY 2020, FDA must multiply it by
the same compounded inflation factor mentioned previously in this
document (1.042096 or 4.2096 percent), which results in an estimated
cost of $61 (rounded to the nearest dollar) per paid hour in addition
to $240 for a total of $301 per paid hour ($240 plus $61) for each
direct hour of work requiring foreign inspection travel. FDA will use
these rates in charging fees in FY 2020 when foreign travel is required
for the VQIP.
Table 2--FSMA Fee Schedule for FY 2020
------------------------------------------------------------------------
Fee rates for
Fee category FY 2020
------------------------------------------------------------------------
Hourly rate without travel.............................. $240
Hourly rate if domestic travel is required.............. 258
Hourly rate if foreign travel is required............... 301
------------------------------------------------------------------------
III. Fees for Importers Approved To Participate in the Voluntary
Qualified Importer Program Under Section 743 of the FD&C Act
FDA assesses fees for VQIP annually. Table 3 provides an overview
of the fees for FY 2020.
[[Page 35682]]
Table 3--FSMA VQIP User Fee Schedule for FY 2020
------------------------------------------------------------------------
Fee rates for
Fee category FY 2020
------------------------------------------------------------------------
VQIP User Fee.......................................... $16,681
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Section 743 of the FD&C Act requires that each importer
participating in VQIP pay a fee to cover FDA's costs of administering
the program. This fee represents the estimated average cost of the work
FDA performs in reviewing and evaluating a VQIP importer. At this time,
FDA is not offering an adjusted fee for small businesses. As required
by section 743(b)(2)(B)(iii) of the FD&C Act, FDA previously published
a set of guidelines in consideration of the burden of the VQIP fee on
small businesses and provided for a period of public comment on the
guidelines (80 FR 32136, June 5, 2015). While we did receive some
comments in response, they did not address the questions posed, i.e.,
how a small business fee reduction should be structured, what
percentage of fee reduction would be appropriate, or what alternative
structures FDA might consider in order to indirectly reduce fees for
small businesses by charging different fee amounts to different VQIP
participants. We plan on monitoring costs and collecting data to
determine if, in future fiscal years, we will provide for a small
business fee reduction. Consistent with section 743(b)(2)(B)(iii), we
will adjust the fee schedule for small businesses only through notice
and comment rulemaking.
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, 39 person-hours to review a
VQIP application (including communication provided through the VQIP
Importer's Help Desk), 16 person-hours for an onsite performance
evaluation of a domestic VQIP importer (including travel and other
steps necessary for a fully supported FTE to complete and document an
onsite assessment), and 34 person-hours for an onsite performance
evaluation of a foreign VQIP importer (including travel and other steps
necessary for a fully supported FTE to complete and document an onsite
assessment). Additional costs include maintenance costs of information
technology of administering benefits of the program. These costs are
estimated to be $2,209 per VQIP importer.
FDA employees are likely to review applications from their
worksites, so we use the fully supported FTE hourly rate excluding
travel, $240/hour, to calculate the portion of the user fee
attributable to those activities: $240/hour x (39 hours) = $9,360.
FDA employees will conduct a VQIP inspection to verify the
eligibility criteria and full implementation of the food safety and
food defense systems established in the Quality Assurance Program. A
VQIP importer may be located inside or outside of the United States. We
have used an estimate that up to 20 percent of VQIP importers may be
located outside of the United States.
FDA employees are likely to prepare for and report on the
performance evaluation of a domestic VQIP importer at an FTE's
worksite, so we use the fully supported FTE hourly rate excluding
travel, $240/hour, to calculate the portion of the user fee
attributable to those activities: $240/hour x (8 hours) = $1,920. For
the portion of the fee covering onsite evaluation of a domestic VQIP
importer, we use the fully supported FTE hourly rate for work requiring
domestic travel, $258/hour, to calculate the portion of the user fee
attributable to those activities: $258/hour x 8 hours (i.e., one fully
supported FTE x (1 day onsite x 8 hours)) = $2,064. Therefore, the
total cost of conducting the domestic performance evaluation of a VQIP
importer is determined to be $2,064 + $1,920 = $3,984.
Coordination of the onsite performance evaluation of a foreign VQIP
importer is estimated to take place at an FTE's worksite, so we use the
fully supported FTE hourly rate excluding travel, $240/hour, to
calculate the portion of the user fee attributable to those activities:
$240/hour x (10 hours) = $2,400. For the portion of the fee covering
onsite evaluation of a foreign VQIP importer, we use the fully
supported FTE hourly rate for work requiring foreign travel, $301/hour,
to calculate the portion of the user fee attributable to those
activities: $301/hour x 24 hours (i.e., one fully supported FTE x ((2
travel days x 8 hours) + (1 day onsite x 8 hours))) = $7,224.
Therefore, the total cost of conducting the foreign performance
evaluation of a VQIP importer is determined to be $2,400 + $7,224 =
$9,624.
Therefore, the estimated average cost of the work FDA performs in
total for approving an application for a VQIP importer based on these
figures would be $2,209 + $9,360 + ($3,984 x 0.8) + ($9,624 x 0.2) =
$16,681.
IV. How must the fee be paid?
An invoice will be sent to VQIP importers approved to participate
in the program. Payment must be made prior to October 1, 2019, in order
to be eligible for VQIP participation for the benefit year beginning
October 1, 2019. FDA will not refund the VQIP user fee for any reason.
The payment must be made in U.S. currency from a U.S. bank by one
of the following methods: Wire transfer, electronically, check, bank
draft, or U.S. postal money order made payable to the Food and Drug
Administration. The preferred payment method is online using an
electronic check (Automated Clearing House (ACH), also known as eCheck)
or credit card (Discover, VISA, MasterCard, American Express). Secure
electronic payments can be submitted using the User Fees Payment Portal
at https://userfees.fda.gov/pay or the Pay.gov payment option, which is
available to you after you submit a cover sheet. (Note: Only full
payments are accepted. No partial payments can be made online.) Once
you have found your invoice, select ``Pay Now'' to be redirected to
Pay.gov. Electronic payment options are based on the balance due.
Payment by credit card is available only for balances less than
$25,000. If the balance exceeds this amount, only the ACH option is
available. Payments must be made using U.S. bank accounts as well as
U.S. credit cards.
When paying by check, bank draft, or U.S. postal money order,
please include the invoice number. Also write the FDA post office box
number (P.O. Box 979108) on the enclosed check, bank draft, or money
order. Mail the payment and a copy of the invoice to: Food and Drug
Administration, P.O. Box 979108, St. Louis, MO 63197-9000.
When paying by wire transfer, it is required that the invoice
number is included; without the invoice number the payment may not be
applied. The originating financial institution may charge a wire
transfer fee. If the financial institution charges a wire transfer fee,
it is required to add that amount to the payment to ensure that the
invoice is paid in full. For international wire transfers, please
inquire with the financial institutions prior to submitting the
payment. Use the following account information when sending a wire
transfer: U.S. Department of the Treasury, TREAS NYC, 33 Liberty St.,
New York, NY 10045, Account Name: Food and Drug Administration, Account
No.: 75060099, Routing No.: 021030004, Swift No.: FRNYUS33.
[[Page 35683]]
To send a check by a courier such as Federal Express, the courier
must deliver the check and printed copy of the cover sheet to: U.S.
Bank, Attn: Government Lockbox 979108, 1005 Convention Plaza, St.
Louis, MO 63101. (Note: This address is for courier delivery only. If
you have any questions concerning courier delivery, contact U.S. Bank
at 314-418-4013. This phone number is only for questions about courier
delivery.)
The tax identification number of FDA is 53-0196965. (Note: In no
case should the payment for the fee be submitted to FDA with the
invoice.)
V. What are the consequences of not paying this fee?
The consequences of not paying these fees are outlined in Section J
of ``FDA's Voluntary Qualified Importer Program; Guidance for
Industry'' document (available at https://www.fda.gov/media/92196/download). If the user fee is not paid before October 1, a VQIP
importer will not be eligible to participate in VQIP. For the first
year a VQIP application is approved, if the user fee is not paid before
October 1, 2019, you are not eligible to participate in VQIP. If you
subsequently pay the user fee, FDA will begin your benefits after we
receive the full payment. The user fee may not be paid after December
31, 2019. For a subsequent year, if you do not pay the user fee before
October 1, FDA will send a Notice of Intent to Revoke your
participation in VQIP. If you do not pay the user fee within 30 days of
the date of the Notice of Intent to Revoke, we will revoke your
participation in VQIP.
Dated: July 19, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15742 Filed 7-23-19; 8:45 am]
BILLING CODE 4164-01-P