Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2019, 48636-48639 [2018-20912]
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48636
Federal Register / Vol. 83, No. 187 / Wednesday, September 26, 2018 / Notices
products without approved new drug
applications violates section 301(a) and
(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(a) and (d)).
Drug products that are listed in the table
that are in inventory on October 26,
2018 may continue to be dispensed
until the inventories have been depleted
or the drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
Dated: September 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–20947 Filed 9–25–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0007]
Animal Generic Drug User Fee Rates
and Payment Procedures for Fiscal
Year 2019
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the fee rates and payment
procedures for fiscal year (FY) 2019
generic new animal drug user fees. The
Federal Food, Drug, and Cosmetic Act
(FD&C Act), as amended by the Animal
Generic Drug User Fee Amendments of
2018 (AGDUFA III), authorizes FDA to
collect user fees for certain abbreviated
applications for generic new animal
drugs, for certain generic new animal
drug products, and for certain sponsors
of such abbreviated applications for
generic new animal drugs and/or
investigational submissions for generic
new animal drugs. This notice
establishes the fee rates for FY 2019.
FOR FURTHER INFORMATION CONTACT: Visit
FDA’s website at https://www.fda.gov/
ForIndustry/UserFees/AnimalGeneric
DrugUserFeeActAGDUFA/default.htm,
or contact Lisa Kable, Center for
Veterinary Medicine (HFV–10), Food
and Drug Administration, 7500 Standish
Pl., Rockville, MD 20855, 240–402–
6888, Lisa.Kable@fda.hhs.gov. For
general questions, you may also email
the Center for Veterinary Medicine
(CVM) at cvmagdufa@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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SUMMARY:
I. Background
Section 741 of the FD&C Act (21
U.S.C. 379j–21) establishes three
different types of user fees: (1) Fees for
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certain types of abbreviated applications
for generic new animal drugs; (2) annual
fees for certain generic new animal drug
products; and (3) annual fees for certain
sponsors of abbreviated applications for
generic new animal drugs and/or
investigational submissions for generic
new animal drugs (21 U.S.C. 379j–
21(a)). When certain conditions are met,
FDA will waive or reduce fees for
generic new animal drugs intended
solely to provide for a minor use or
minor species indication (21 U.S.C.
379j–21(d)).
For FY 2019 through FY 2023, the
FD&C Act establishes a yearly base
revenue amount and percentages for
each of these fee categories (21 U.S.C.
379j–21(b)). Base revenue amounts
established for fiscal years after FY 2019
are subject to adjustment for inflation
and workload. Workload increases will
be adjusted for excess collections after
FY 2020 (21 U.S.C. 379j–21(c)). The
target revenue amounts for each fee
category for FY 2019, are as follows: For
application fees, the target revenue
amount is $4,584,000; for product fees,
the target revenue amount is $6,876,000;
and for sponsor fees, the target revenue
amount is $6,876,000.
For FY 2019, the generic new animal
drug user fee rates are: $424,444 for
each abbreviated application for a
generic new animal drug other than
those subject to the criteria in section
512(d)(4) of the FD&C Act (21 U.S.C.
360b(d)(4)); $212,222 for each
abbreviated application for a generic
new animal drug subject to the criteria
in section 512(d)(4); $15,486 for each
generic new animal drug product;
$150,098 for each generic new animal
drug sponsor paying 100 percent of the
sponsor fee; $112,574 for each generic
new animal drug sponsor paying 75
percent of the sponsor fee; and $75,049
for each generic new animal drug
sponsor paying 50 percent of the
sponsor fee. FDA will issue invoices for
FY 2019 product and sponsor fees by
December 31, 2018. These fees will be
due by January 31, 2019. The
application fee rates are effective for all
abbreviated applications for a generic
new animal drug submitted on or after
October 1, 2018, and will remain in
effect through September 30, 2019.
Applications will not be accepted for
review until FDA has received full
payment of related application fees and
any other fees owed under the Animal
Generic Drug User Fee program
(AGDUFA program).
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II. Revenue Amount for FY 2019
A. Statutory Fee Revenue Amounts
AGDUFA III, Title II of Public Law
115–234, specifies that the aggregate
revenue amount for FY 2019 for all
generic new animal drug user fee
categories is $18,336,000 (rounded to
the nearest thousand dollars) (21 U.S.C.
379j–21(b)(1)).
B. Inflation Adjustment to Fee Revenue
Amount
AGDUFA III specifies that the annual
fee revenue amount is to be adjusted for
inflation increases for FY 2020 and
subsequent fiscal years, using two
separate adjustments—one for personnel
compensation and benefits (PC&B) and
one for non-PC&B costs (see 21 U.S.C.
379j–21(c)(2)). The component of the
inflation adjustment for payroll costs
shall be one plus the average annual
percent change in the cost of all PC&B
paid per full-time equivalent position at
FDA for the first 3 of the 4 preceding
fiscal years, multiplied by the average
proportion of PC&B costs to total FDA
costs for the first 3 of the 4 preceding
fiscal years. The statute specifies that
the portion of the inflation adjustment
for non-payroll costs is the average
annual percent change that occurred in
the Consumer Price Index for urban
consumers (Washington-Baltimore, DC–
MD–VA–WV; not seasonally adjusted;
all items less food and energy; annual
index) for the first 3 of the preceding 4
years of available data multiplied by the
proportion of all costs other than PC&B
costs to total FDA costs. Because the
adjustment for inflation does not take
effect until FY 2020, FDA will not
adjust the FY 2019 fee revenue amount
for inflation.
C. Workload Adjustment to Inflation
Adjusted Fee Revenue Amount
The fee revenue amounts established
in AGDUFA III for FY 2020 and
subsequent fiscal years are also subject
to adjustment to account for changes in
FDA’s review workload. A workload
adjustment will be applied to the
inflation adjusted fee revenue amount
(21 U.S.C. 379j–21(c)(3)).
AGDUFA III specifies that FDA shall
calculate the weighted average of the
change in the total number of each of
the four types of applications and
submissions specified in the workload
adjustment provision (abbreviated
applications for generic new animal
drugs, manufacturing supplemental
abbreviated applications for generic new
animal drugs, investigational generic
new animal drug study submissions,
and investigational generic new animal
drug protocol submissions). Because the
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adjustment for workload does not take
effect until FY 2020, FDA will not
adjust the FY 2019 fee revenue amount
for workload changes.
D. Reduction of Workload-Based
Increase by Amount of Certain Excess
Collections
Under section 741(c)(3)(B) of the
FD&C Act, for FYs 2021 through 2023,
if application of the workload
adjustment increases the amount of fee
revenues established for the fiscal year,
as adjusted for inflation, the fee revenue
increase will be reduced by the amount
of any excess collections, for the second
preceding fiscal year, up to the amount
of the fee revenue increase. Since this
provision will not take effect until FY
2021, FDA will not reduce the FY 2019
fee revenue amount for excess
collections.
E. FY 2019 Fee Revenue Amounts
AGDUFA III specifies that the revenue
amount of $18,336,000 (rounded to the
nearest thousand dollars) for FY 2019 is
to be divided as follows: 25 percent, or
a total of $4,584,000, is to come from
application fees; 37.5 percent, or a total
of $6,876,000, is to come from product
fees; and 37.5 percent, or a total of
$6,876,000, is to come from sponsor fees
(21 U.S.C. 379j–21(b)).
III. Abbreviated Application Fee
Calculations for FY 2019
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A. Application Fee Revenues and
Numbers of Fee-Paying Applications
Each person that submits an
abbreviated application for a generic
new animal drug shall be subject to an
application fee, with limited exceptions
(21 U.S.C. 379j–21(a)(1)). The term
‘‘abbreviated application for a generic
new animal drug’’ means an abbreviated
application for the approval of any
generic new animal drug submitted
under section 512(b)(2) (21 U.S.C. 379j–
21(k)(1)). The application fees are to be
set so that they will generate $4,584,000
in fee revenue for FY 2019.
To set fees for abbreviated
applications for generic new animal
drugs to realize $4,584,000, FDA must
first make some assumptions about the
number of fee-paying abbreviated
applications it will receive during FY
2019.
The Agency knows the number of
applications that have been submitted
in previous years. That number
fluctuates annually. FDA is making
estimates and applying different
assumptions for two types of full fee
submissions: Original submissions of
abbreviated applications for generic new
animal drugs and ‘‘reactivated’’
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submissions of abbreviated applications
for generic new animal drugs. Any
original submissions of abbreviated
applications for generic new animal
drugs that were received by FDA before
July 1, 2008, were not assessed fees (21
U.S.C. 379j–21(a)(1)(A)). Some of these
non-fee-paying submissions were later
resubmitted on or after July 1 because
the initial submission was not approved
by FDA (i.e., FDA marked the
submission as incomplete and requested
additional non-administrative
information) or because the original
submission was withdrawn by the
sponsor. Abbreviated applications for
generic new animal drugs resubmitted
on or after July 1, 2008, are subject to
user fees. In this notice, FDA refers to
these resubmitted applications as
‘‘reactivated’’ applications.
Also, under AGDUFA III, an
abbreviated application for an animal
generic drug subject to the criteria in
section 512(d)(4) of the FD&C Act and
submitted on or after October 1, 2013,
shall be subject to 50 percent of the fee
applicable to all other abbreviated
applications for a generic new animal
drug (21 U.S.C. 379j–21(a)(1)(C)(ii)).
Regarding original submissions of
abbreviated applications for generic new
animal drugs, FDA is assuming that the
number of applications for which fees
will be paid in FY 2019 will equal the
average number of submissions over the
five most recently completed years of
the AGDUFA program (FY 2013–FY
2017).
The average number of original
submissions of abbreviated applications
for generic new animal drugs over the
five most recently completed years is
9.2 applications not subject to the
criteria in section 512(d)(4) of the FD&C
Act and 3.2 submissions subject to the
criteria in section 512(d)(4). Each of the
submissions described under section
512(d)(4) of the FD&C Act pays 50
percent of the fee paid by the other
applications and will be counted as one
half of a fee. Adding all of the
applications not subject to the criteria in
section 512(d)(4) of the FD&C Act and
50 percent of the number that are
subject to such criteria results in a total
of 10.8 anticipated full fees.
In prior years, FDA had estimated the
number of reactivations of abbreviated
applications for generic new animal
drugs that had been originally submitted
prior to July 1, 2008. Over the years, that
number has decreased to the point that
FDA no longer expects to receive any
reactivations of applications initially
submitted prior to July 1, 2008, and will
include no provision for them in its fee
estimates. Should such a submission be
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48637
made, the submitter will be expected to
pay the appropriate fee.
Based on the previous assumptions,
FDA is estimating that it will receive a
total of 10.8 fee-paying generic new
animal drug applications in FY 2019
(9.2 original applications paying a full
fee and 3.2 applications paying a half
fee).
B. Application Fee Rates for FY 2019
FDA must set the fee rates for FY 2019
so that the estimated 10.8 abbreviated
applications that pay the fee will
generate a total of $4,584,000. To
generate this amount, the fee for a
generic new animal drug application
will have to be $424,444 and for those
applications that are subject to the
criteria set forth in section 512(d)(4) of
the FD&C Act, 50 percent of that
amount, or $212,222.
IV. Generic New Animal Drug Product
Fee Calculations for FY 2019
A. Product Fee Revenues and Numbers
of Fee-Paying Products
The generic new animal drug product
fee must be paid annually by the person
named as the applicant in an
abbreviated application or supplemental
abbreviated application for a generic
new animal drug product submitted for
listing under section 510 of the FD&C
Act (21 U.S.C. 360), and who had an
abbreviated application or supplemental
abbreviated application for a generic
new animal drug product pending at
FDA after September 1, 2008 (see 21
U.S.C. 379j–21(a)(2)). The term ‘‘generic
new animal drug product’’ means each
specific strength or potency of a
particular active ingredient or
ingredients in final dosage form
marketed by a particular manufacturer
or distributor, which is uniquely
identified by the labeler code and
product code portions of the national
drug code, and for which an abbreviated
application for a generic new animal
drug or supplemental abbreviated
application for a generic new animal
drug has been approved (21 U.S.C. 379j–
21(k)(6)). The product fees are to be set
so that they will generate $6,876,000 in
fee revenue for FY 2019.
To set generic new animal drug
product fees to realize $6,876,000, FDA
must make some assumptions about the
number of products for which these fees
will be paid in FY 2019. FDA gathered
data on all generic new animal drug
products that have been submitted for
listing under section 510 of the FD&C
Act and matched this to the list of all
persons who FDA estimated would have
an abbreviated new animal drug
application or supplemental abbreviated
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application pending after September 1,
2008. As of June 2018, FDA estimates a
total of 448 products submitted for
listing by persons who had an
abbreviated application for a generic
new animal drug or supplemental
abbreviated application for a generic
new animal drug pending after
September 1, 2008. Based on this, FDA
believes that a total of 448 products will
be subject to this fee in FY 2019.
In estimating the fee revenue to be
generated by generic new animal drug
product fees in FY 2019, FDA is
estimating that one percent of the
products invoiced, or four products,
will qualify for minor use/minor species
fee waiver (see 21 U.S.C. 379j–21(d)).
FDA has made this estimate at one
percent this year, based on historical
data over the past five completed years
of the AGDUFA program.
Accordingly, the Agency estimates
that a total of 444 (448 minus 4)
products will be subject to product fees
in FY 2019.
B. Product Fee Rates for FY 2019
FDA must set the fee rates for FY 2019
so that the estimated 444 products that
pay fees will generate a total of
$6,876,000. To generate this amount
will require the fee for a generic new
animal drug product, rounded to the
nearest dollar, to be $15,486.
V. Generic New Animal Drug Sponsor
Fee Calculations for FY 2019
A. Sponsor Fee Revenues and Numbers
of Fee-Paying Sponsors
The generic new animal drug sponsor
fee must be paid annually by each
person who: (1) Is named as the
applicant in an abbreviated application
for a generic new animal drug, except
for an approved application for which
all subject products have been removed
from listing under section 510 of the
FD&C Act, or has submitted an
investigational submission for a generic
new animal drug that has not been
terminated or otherwise rendered
inactive and (2) had an abbreviated
application for a generic new animal
drug, supplemental abbreviated
application for a generic new animal
drug, or investigational submission for a
generic new animal drug pending at
FDA after September 1, 2008 (see 21
U.S.C. 379j–21(k)(7) and 379j–21(a)(3),
respectively). A generic new animal
drug sponsor is subject to only one such
fee each fiscal year (see 21 U.S.C. 379j–
21(a)(3)(C)). Applicants with more than
six approved abbreviated applications
will pay 100 percent of the sponsor fee;
applicants with more than one and
fewer than seven approved abbreviated
applications will pay 75 percent of the
sponsor fee; and applicants with one or
fewer approved abbreviated
applications will pay 50 percent of the
sponsor fee (see 21 U.S.C. 379j–
21(a)(3)(C)). The sponsor fees are to be
set so that they will generate $6,876,000
in fee revenue for FY 2019.
To set generic new animal drug
sponsor fees to realize $6,876,000, FDA
must make some assumptions about the
number of sponsors who will pay these
fees in FY 2019. Based on the number
of firms that meet this definition and the
average number of firms paying fees at
each level over the five most recently
completed years of the AGDUFA
program (FY 2013 through FY 2017),
FDA estimates that in FY 2019, 14
sponsors will pay 100 percent fees, 19
sponsors will pay 75 percent fees, and
37 sponsors will pay 50 percent fees.
That totals the equivalent of 46.75 full
sponsor fees (14 × 100 percent or 14,
plus 19 × 75 percent or 14.25, plus 37
× 50 percent or 18.5).
FDA estimates that about two percent
of all of these sponsors, or 0.94, may
qualify for a minor use/minor species
fee waiver (see 21 U.S.C. 379j–21(d)).
FDA has made the estimate of the
percentage of sponsors that will not pay
fees at two percent this year, based on
historical data over the past five
completed years of the AGDUFA
program.
Accordingly, the Agency estimates
that the equivalent of 45.81 full sponsor
fees (46.75 minus 0.94) are likely to be
paid in FY 2019.
B. Sponsor Fee Rates for FY 2019
FDA must set the fee rates for FY 2019
so that the estimated equivalent of 45.81
full sponsor fees will generate a total of
$6,876,000. To generate this amount
will require the 100 percent fee for a
generic new animal drug sponsor,
rounded to the nearest dollar, to be
$150,098. Accordingly, the fee for those
paying 75 percent of the full sponsor fee
will be $112,574, and the fee for those
paying 50 percent of the full sponsor fee
will be $75,049.
VI. Fee Schedule for FY 2019
The fee rates for FY 2019 are
summarized in table 1.
TABLE 1—FY 2019 FEE RATES
Fee rate for
FY 2019
Generic new animal drug user fee category
Abbreviated Application Fee for Generic New Animal Drug except those subject to the criteria in section 512(d)(4) .....................
Abbreviated Application Fee for Generic New Animal Drug subject to the criteria in section 512(d)(4) ...........................................
Generic New Animal Drug Product Fee ..............................................................................................................................................
100 Percent Generic New Animal Drug Sponsor Fee 1 ......................................................................................................................
75 Percent Generic New Animal Drug Sponsor Fee 1 ........................................................................................................................
50 Percent Generic New Animal Drug Sponsor Fee 1 ........................................................................................................................
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1 An
$424,444
212,222
15,486
150,098
112,574
75,049
animal drug sponsor is subject to only one fee each fiscal year.
VII. Fee Waiver or Reduction;
Exemption From Fees
The types of fee waivers and
reductions that applied last fiscal year
still exist for FY 2019. However, a new
exemption from fees was established by
AGDUFA III, as follows:
Fees will not apply to any person who
not later than September 30, 2023,
submits to CVM a supplemental
abbreviated application relating to a
generic new animal drug approved
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under section 512 of the FD&C Act,
solely to add the application number to
the labeling of the drug in the manner
specified in section 502(w)(3) of the
FD&C Act (21 U.S.C. 352(w)(3)), if that
person otherwise would be subject to
user fees under AGDUFA based only on
the submission of the supplemental
abbreviated application (21 U.S.C. 379j–
21(d)(2).
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VIII. Procedures for Paying FY 2019
Generic New Animal Drug User Fees
A. Abbreviated Application Fees and
Payment Instructions
The FY 2019 fee established in the
new fee schedule must be paid for an
abbreviated new animal drug
application subject to fees under
AGDUFA III that is submitted on or after
October 1, 2018. The payment must be
made in U.S. currency from a U.S. bank
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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 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 write
your application’s unique Payment
Identification Number, beginning with
the letters ‘‘AG’’, on the upper righthand corner of your completed Animal
Generic Drug User Fee Cover Sheet.
Also write the FDA post office box
number (P.O. Box 979033) on the
enclosed check, bank draft, or money
order. Mail the payment and a copy of
the completed Animal Generic Drug
User Fee Cover Sheet to: Food and Drug
Administration, P.O. Box 979033, 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. If the
payment amount is not applied, the
invoice amount would be referred to
collections. 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. 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.
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 979033, 1005
Convention Plaza, St. Louis, MO 63101.
(Note: This address is for courier
delivery only. If you have any questions
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concerning courier delivery, contact
U.S. Bank at 314–418–4013. This phone
number is only for questions about
courier delivery.)
It is important that the fee arrives at
the bank at least a day or two before the
abbreviated application arrives at FDA’s
CVM. FDA records the official
abbreviated application receipt date as
the later of the following: The date the
application was received by CVM, or the
date U.S. Bank notifies FDA that your
payment in the full amount has been
received, or when the U.S. Department
of the Treasury notifies FDA of
payment. U.S. Bank and the United
States Treasury are required to notify
FDA within 1 working day, using the
Payment Identification Number
described previously.
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 application.)
B. Application Cover Sheet Procedures
Step One—Create a user account and
password. Log onto the AGDUFA
website at https://www.fda.gov/
ForIndustry/UserFees/AnimalGeneric
DrugUserFeeActAGDUFA/
ucm137049.htm and scroll down the
page until you find the link ‘‘Create
AGDUFA User Fee Cover Sheet.’’ Select
that link and follow the directions. For
security reasons, each firm submitting
an application will be assigned an
organization identification number, and
each user will also be required to set up
a user account and password the first
time you use this site. Online
instructions will walk you through this
process.
Step Two—Create an Animal Generic
Drug User Fee Cover Sheet, transmit it
to FDA, and print a copy. After logging
into your account with your user name
and password, complete the steps
required to create an Animal Generic
Drug User Fee Cover Sheet. One cover
sheet is needed for each abbreviated
animal drug application. Once you are
satisfied that the data on the cover sheet
is accurate and you have finalized the
cover sheet, you will be able to transmit
it electronically to FDA and you will be
able to print a copy of your cover sheet
showing your unique Payment
Identification Number.
Step Three—Send the payment for
your application as described in section
VIII.A.
Step Four—Please submit your
application and a copy of the completed
Animal Generic Drug User Fee Cover
Sheet to the following address: Food
and Drug Administration, Center for
Veterinary Medicine, Document Control
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48639
Unit (HFV–199), 7500 Standish Pl.,
Rockville, MD 20855.
C. Product and Sponsor Fees
By December 31, 2018, FDA will issue
invoices and payment instructions for
product and sponsor fees for FY 2019
using this fee schedule. Fees will be due
by January 31, 2019. FDA will issue
invoices in November 2019 for any
products and sponsors subject to fees for
FY 2019 that qualify for fees after the
December 2018 billing.
Dated: September 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–20912 Filed 9–25–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program: List of Petitions Received
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
HRSA is publishing this
notice of petitions received under the
National Vaccine Injury Compensation
Program (the Program), as required by
the Public Health Service (PHS) Act, as
amended. While the Secretary of HHS is
named as the respondent in all
proceedings brought by the filing of
petitions for compensation under the
Program, the United States Court of
Federal Claims is charged by statute
with responsibility for considering and
acting upon the petitions.
FOR FURTHER INFORMATION CONTACT: For
information about requirements for
filing petitions, and the Program in
general, contact Lisa L. Reyes, Clerk of
Court, United States Court of Federal
Claims, 717 Madison Place NW,
Washington, DC 20005, (202) 357–6400.
For information on HRSA’s role in the
Program, contact the Director, National
Vaccine Injury Compensation Program,
5600 Fishers Lane, Room 08N146B,
Rockville, MD 20857; (301) 443–6593,
or visit our website at: https://
www.hrsa.gov/vaccinecompensation/
index.html.
SUPPLEMENTARY INFORMATION: The
Program provides a system of no-fault
compensation for certain individuals
who have been injured by specified
childhood vaccines. Subtitle 2 of Title
XXI of the PHS Act, 42 U.S.C. 300aa–
10 et seq., provides that those seeking
SUMMARY:
E:\FR\FM\26SEN1.SGM
26SEN1
Agencies
[Federal Register Volume 83, Number 187 (Wednesday, September 26, 2018)]
[Notices]
[Pages 48636-48639]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20912]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-0007]
Animal Generic Drug User Fee Rates and Payment Procedures for
Fiscal Year 2019
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the fee rates and payment procedures for fiscal year (FY) 2019 generic
new animal drug user fees. The Federal Food, Drug, and Cosmetic Act
(FD&C Act), as amended by the Animal Generic Drug User Fee Amendments
of 2018 (AGDUFA III), authorizes FDA to collect user fees for certain
abbreviated applications for generic new animal drugs, for certain
generic new animal drug products, and for certain sponsors of such
abbreviated applications for generic new animal drugs and/or
investigational submissions for generic new animal drugs. This notice
establishes the fee rates for FY 2019.
FOR FURTHER INFORMATION CONTACT: Visit FDA's website at https://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/default.htm, or contact Lisa Kable, Center for Veterinary Medicine
(HFV-10), Food and Drug Administration, 7500 Standish Pl., Rockville,
MD 20855, 240-402-6888, [email protected]. For general questions,
you may also email the Center for Veterinary Medicine (CVM) at
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Section 741 of the FD&C Act (21 U.S.C. 379j-21) establishes three
different types of user fees: (1) Fees for certain types of abbreviated
applications for generic new animal drugs; (2) annual fees for certain
generic new animal drug products; and (3) annual fees for certain
sponsors of abbreviated applications for generic new animal drugs and/
or investigational submissions for generic new animal drugs (21 U.S.C.
379j-21(a)). When certain conditions are met, FDA will waive or reduce
fees for generic new animal drugs intended solely to provide for a
minor use or minor species indication (21 U.S.C. 379j-21(d)).
For FY 2019 through FY 2023, the FD&C Act establishes a yearly base
revenue amount and percentages for each of these fee categories (21
U.S.C. 379j-21(b)). Base revenue amounts established for fiscal years
after FY 2019 are subject to adjustment for inflation and workload.
Workload increases will be adjusted for excess collections after FY
2020 (21 U.S.C. 379j-21(c)). The target revenue amounts for each fee
category for FY 2019, are as follows: For application fees, the target
revenue amount is $4,584,000; for product fees, the target revenue
amount is $6,876,000; and for sponsor fees, the target revenue amount
is $6,876,000.
For FY 2019, the generic new animal drug user fee rates are:
$424,444 for each abbreviated application for a generic new animal drug
other than those subject to the criteria in section 512(d)(4) of the
FD&C Act (21 U.S.C. 360b(d)(4)); $212,222 for each abbreviated
application for a generic new animal drug subject to the criteria in
section 512(d)(4); $15,486 for each generic new animal drug product;
$150,098 for each generic new animal drug sponsor paying 100 percent of
the sponsor fee; $112,574 for each generic new animal drug sponsor
paying 75 percent of the sponsor fee; and $75,049 for each generic new
animal drug sponsor paying 50 percent of the sponsor fee. FDA will
issue invoices for FY 2019 product and sponsor fees by December 31,
2018. These fees will be due by January 31, 2019. The application fee
rates are effective for all abbreviated applications for a generic new
animal drug submitted on or after October 1, 2018, and will remain in
effect through September 30, 2019. Applications will not be accepted
for review until FDA has received full payment of related application
fees and any other fees owed under the Animal Generic Drug User Fee
program (AGDUFA program).
II. Revenue Amount for FY 2019
A. Statutory Fee Revenue Amounts
AGDUFA III, Title II of Public Law 115-234, specifies that the
aggregate revenue amount for FY 2019 for all generic new animal drug
user fee categories is $18,336,000 (rounded to the nearest thousand
dollars) (21 U.S.C. 379j-21(b)(1)).
B. Inflation Adjustment to Fee Revenue Amount
AGDUFA III specifies that the annual fee revenue amount is to be
adjusted for inflation increases for FY 2020 and subsequent fiscal
years, using two separate adjustments--one for personnel compensation
and benefits (PC&B) and one for non-PC&B costs (see 21 U.S.C. 379j-
21(c)(2)). The component of the inflation adjustment for payroll costs
shall be one plus the average annual percent change in the cost of all
PC&B paid per full-time equivalent position at FDA for the first 3 of
the 4 preceding fiscal years, multiplied by the average proportion of
PC&B costs to total FDA costs for the first 3 of the 4 preceding fiscal
years. The statute specifies that the portion of the inflation
adjustment for non-payroll costs is the average annual percent change
that occurred in the Consumer Price Index for urban consumers
(Washington-Baltimore, DC-MD-VA-WV; not seasonally adjusted; all items
less food and energy; annual index) for the first 3 of the preceding 4
years of available data multiplied by the proportion of all costs other
than PC&B costs to total FDA costs. Because the adjustment for
inflation does not take effect until FY 2020, FDA will not adjust the
FY 2019 fee revenue amount for inflation.
C. Workload Adjustment to Inflation Adjusted Fee Revenue Amount
The fee revenue amounts established in AGDUFA III for FY 2020 and
subsequent fiscal years are also subject to adjustment to account for
changes in FDA's review workload. A workload adjustment will be applied
to the inflation adjusted fee revenue amount (21 U.S.C. 379j-21(c)(3)).
AGDUFA III specifies that FDA shall calculate the weighted average
of the change in the total number of each of the four types of
applications and submissions specified in the workload adjustment
provision (abbreviated applications for generic new animal drugs,
manufacturing supplemental abbreviated applications for generic new
animal drugs, investigational generic new animal drug study
submissions, and investigational generic new animal drug protocol
submissions). Because the
[[Page 48637]]
adjustment for workload does not take effect until FY 2020, FDA will
not adjust the FY 2019 fee revenue amount for workload changes.
D. Reduction of Workload-Based Increase by Amount of Certain Excess
Collections
Under section 741(c)(3)(B) of the FD&C Act, for FYs 2021 through
2023, if application of the workload adjustment increases the amount of
fee revenues established for the fiscal year, as adjusted for
inflation, the fee revenue increase will be reduced by the amount of
any excess collections, for the second preceding fiscal year, up to the
amount of the fee revenue increase. Since this provision will not take
effect until FY 2021, FDA will not reduce the FY 2019 fee revenue
amount for excess collections.
E. FY 2019 Fee Revenue Amounts
AGDUFA III specifies that the revenue amount of $18,336,000
(rounded to the nearest thousand dollars) for FY 2019 is to be divided
as follows: 25 percent, or a total of $4,584,000, is to come from
application fees; 37.5 percent, or a total of $6,876,000, is to come
from product fees; and 37.5 percent, or a total of $6,876,000, is to
come from sponsor fees (21 U.S.C. 379j-21(b)).
III. Abbreviated Application Fee Calculations for FY 2019
A. Application Fee Revenues and Numbers of Fee-Paying Applications
Each person that submits an abbreviated application for a generic
new animal drug shall be subject to an application fee, with limited
exceptions (21 U.S.C. 379j-21(a)(1)). The term ``abbreviated
application for a generic new animal drug'' means an abbreviated
application for the approval of any generic new animal drug submitted
under section 512(b)(2) (21 U.S.C. 379j-21(k)(1)). The application fees
are to be set so that they will generate $4,584,000 in fee revenue for
FY 2019.
To set fees for abbreviated applications for generic new animal
drugs to realize $4,584,000, FDA must first make some assumptions about
the number of fee-paying abbreviated applications it will receive
during FY 2019.
The Agency knows the number of applications that have been
submitted in previous years. That number fluctuates annually. FDA is
making estimates and applying different assumptions for two types of
full fee submissions: Original submissions of abbreviated applications
for generic new animal drugs and ``reactivated'' submissions of
abbreviated applications for generic new animal drugs. Any original
submissions of abbreviated applications for generic new animal drugs
that were received by FDA before July 1, 2008, were not assessed fees
(21 U.S.C. 379j-21(a)(1)(A)). Some of these non-fee-paying submissions
were later resubmitted on or after July 1 because the initial
submission was not approved by FDA (i.e., FDA marked the submission as
incomplete and requested additional non-administrative information) or
because the original submission was withdrawn by the sponsor.
Abbreviated applications for generic new animal drugs resubmitted on or
after July 1, 2008, are subject to user fees. In this notice, FDA
refers to these resubmitted applications as ``reactivated''
applications.
Also, under AGDUFA III, an abbreviated application for an animal
generic drug subject to the criteria in section 512(d)(4) of the FD&C
Act and submitted on or after October 1, 2013, shall be subject to 50
percent of the fee applicable to all other abbreviated applications for
a generic new animal drug (21 U.S.C. 379j-21(a)(1)(C)(ii)).
Regarding original submissions of abbreviated applications for
generic new animal drugs, FDA is assuming that the number of
applications for which fees will be paid in FY 2019 will equal the
average number of submissions over the five most recently completed
years of the AGDUFA program (FY 2013-FY 2017).
The average number of original submissions of abbreviated
applications for generic new animal drugs over the five most recently
completed years is 9.2 applications not subject to the criteria in
section 512(d)(4) of the FD&C Act and 3.2 submissions subject to the
criteria in section 512(d)(4). Each of the submissions described under
section 512(d)(4) of the FD&C Act pays 50 percent of the fee paid by
the other applications and will be counted as one half of a fee. Adding
all of the applications not subject to the criteria in section
512(d)(4) of the FD&C Act and 50 percent of the number that are subject
to such criteria results in a total of 10.8 anticipated full fees.
In prior years, FDA had estimated the number of reactivations of
abbreviated applications for generic new animal drugs that had been
originally submitted prior to July 1, 2008. Over the years, that number
has decreased to the point that FDA no longer expects to receive any
reactivations of applications initially submitted prior to July 1,
2008, and will include no provision for them in its fee estimates.
Should such a submission be made, the submitter will be expected to pay
the appropriate fee.
Based on the previous assumptions, FDA is estimating that it will
receive a total of 10.8 fee-paying generic new animal drug applications
in FY 2019 (9.2 original applications paying a full fee and 3.2
applications paying a half fee).
B. Application Fee Rates for FY 2019
FDA must set the fee rates for FY 2019 so that the estimated 10.8
abbreviated applications that pay the fee will generate a total of
$4,584,000. To generate this amount, the fee for a generic new animal
drug application will have to be $424,444 and for those applications
that are subject to the criteria set forth in section 512(d)(4) of the
FD&C Act, 50 percent of that amount, or $212,222.
IV. Generic New Animal Drug Product Fee Calculations for FY 2019
A. Product Fee Revenues and Numbers of Fee-Paying Products
The generic new animal drug product fee must be paid annually by
the person named as the applicant in an abbreviated application or
supplemental abbreviated application for a generic new animal drug
product submitted for listing under section 510 of the FD&C Act (21
U.S.C. 360), and who had an abbreviated application or supplemental
abbreviated application for a generic new animal drug product pending
at FDA after September 1, 2008 (see 21 U.S.C. 379j-21(a)(2)). The term
``generic new animal drug product'' means each specific strength or
potency of a particular active ingredient or ingredients in final
dosage form marketed by a particular manufacturer or distributor, which
is uniquely identified by the labeler code and product code portions of
the national drug code, and for which an abbreviated application for a
generic new animal drug or supplemental abbreviated application for a
generic new animal drug has been approved (21 U.S.C. 379j-21(k)(6)).
The product fees are to be set so that they will generate $6,876,000 in
fee revenue for FY 2019.
To set generic new animal drug product fees to realize $6,876,000,
FDA must make some assumptions about the number of products for which
these fees will be paid in FY 2019. FDA gathered data on all generic
new animal drug products that have been submitted for listing under
section 510 of the FD&C Act and matched this to the list of all persons
who FDA estimated would have an abbreviated new animal drug application
or supplemental abbreviated
[[Page 48638]]
application pending after September 1, 2008. As of June 2018, FDA
estimates a total of 448 products submitted for listing by persons who
had an abbreviated application for a generic new animal drug or
supplemental abbreviated application for a generic new animal drug
pending after September 1, 2008. Based on this, FDA believes that a
total of 448 products will be subject to this fee in FY 2019.
In estimating the fee revenue to be generated by generic new animal
drug product fees in FY 2019, FDA is estimating that one percent of the
products invoiced, or four products, will qualify for minor use/minor
species fee waiver (see 21 U.S.C. 379j-21(d)). FDA has made this
estimate at one percent this year, based on historical data over the
past five completed years of the AGDUFA program.
Accordingly, the Agency estimates that a total of 444 (448 minus 4)
products will be subject to product fees in FY 2019.
B. Product Fee Rates for FY 2019
FDA must set the fee rates for FY 2019 so that the estimated 444
products that pay fees will generate a total of $6,876,000. To generate
this amount will require the fee for a generic new animal drug product,
rounded to the nearest dollar, to be $15,486.
V. Generic New Animal Drug Sponsor Fee Calculations for FY 2019
A. Sponsor Fee Revenues and Numbers of Fee-Paying Sponsors
The generic new animal drug sponsor fee must be paid annually by
each person who: (1) Is named as the applicant in an abbreviated
application for a generic new animal drug, except for an approved
application for which all subject products have been removed from
listing under section 510 of the FD&C Act, or has submitted an
investigational submission for a generic new animal drug that has not
been terminated or otherwise rendered inactive and (2) had an
abbreviated application for a generic new animal drug, supplemental
abbreviated application for a generic new animal drug, or
investigational submission for a generic new animal drug pending at FDA
after September 1, 2008 (see 21 U.S.C. 379j-21(k)(7) and 379j-21(a)(3),
respectively). A generic new animal drug sponsor is subject to only one
such fee each fiscal year (see 21 U.S.C. 379j-21(a)(3)(C)). Applicants
with more than six approved abbreviated applications will pay 100
percent of the sponsor fee; applicants with more than one and fewer
than seven approved abbreviated applications will pay 75 percent of the
sponsor fee; and applicants with one or fewer approved abbreviated
applications will pay 50 percent of the sponsor fee (see 21 U.S.C.
379j-21(a)(3)(C)). The sponsor fees are to be set so that they will
generate $6,876,000 in fee revenue for FY 2019.
To set generic new animal drug sponsor fees to realize $6,876,000,
FDA must make some assumptions about the number of sponsors who will
pay these fees in FY 2019. Based on the number of firms that meet this
definition and the average number of firms paying fees at each level
over the five most recently completed years of the AGDUFA program (FY
2013 through FY 2017), FDA estimates that in FY 2019, 14 sponsors will
pay 100 percent fees, 19 sponsors will pay 75 percent fees, and 37
sponsors will pay 50 percent fees. That totals the equivalent of 46.75
full sponsor fees (14 x 100 percent or 14, plus 19 x 75 percent or
14.25, plus 37 x 50 percent or 18.5).
FDA estimates that about two percent of all of these sponsors, or
0.94, may qualify for a minor use/minor species fee waiver (see 21
U.S.C. 379j-21(d)). FDA has made the estimate of the percentage of
sponsors that will not pay fees at two percent this year, based on
historical data over the past five completed years of the AGDUFA
program.
Accordingly, the Agency estimates that the equivalent of 45.81 full
sponsor fees (46.75 minus 0.94) are likely to be paid in FY 2019.
B. Sponsor Fee Rates for FY 2019
FDA must set the fee rates for FY 2019 so that the estimated
equivalent of 45.81 full sponsor fees will generate a total of
$6,876,000. To generate this amount will require the 100 percent fee
for a generic new animal drug sponsor, rounded to the nearest dollar,
to be $150,098. Accordingly, the fee for those paying 75 percent of the
full sponsor fee will be $112,574, and the fee for those paying 50
percent of the full sponsor fee will be $75,049.
VI. Fee Schedule for FY 2019
The fee rates for FY 2019 are summarized in table 1.
Table 1--FY 2019 Fee Rates
------------------------------------------------------------------------
Fee rate for
Generic new animal drug user fee category FY 2019
------------------------------------------------------------------------
Abbreviated Application Fee for Generic New Animal Drug $424,444
except those subject to the criteria in section
512(d)(4)..............................................
Abbreviated Application Fee for Generic New Animal Drug 212,222
subject to the criteria in section 512(d)(4)...........
Generic New Animal Drug Product Fee..................... 15,486
100 Percent Generic New Animal Drug Sponsor Fee \1\..... 150,098
75 Percent Generic New Animal Drug Sponsor Fee \1\...... 112,574
50 Percent Generic New Animal Drug Sponsor Fee \1\...... 75,049
------------------------------------------------------------------------
\1\ An animal drug sponsor is subject to only one fee each fiscal year.
VII. Fee Waiver or Reduction; Exemption From Fees
The types of fee waivers and reductions that applied last fiscal
year still exist for FY 2019. However, a new exemption from fees was
established by AGDUFA III, as follows:
Fees will not apply to any person who not later than September 30,
2023, submits to CVM a supplemental abbreviated application relating to
a generic new animal drug approved under section 512 of the FD&C Act,
solely to add the application number to the labeling of the drug in the
manner specified in section 502(w)(3) of the FD&C Act (21 U.S.C.
352(w)(3)), if that person otherwise would be subject to user fees
under AGDUFA based only on the submission of the supplemental
abbreviated application (21 U.S.C. 379j-21(d)(2).
VIII. Procedures for Paying FY 2019 Generic New Animal Drug User Fees
A. Abbreviated Application Fees and Payment Instructions
The FY 2019 fee established in the new fee schedule must be paid
for an abbreviated new animal drug application subject to fees under
AGDUFA III that is submitted on or after October 1, 2018. The payment
must be made in U.S. currency from a U.S. bank
[[Page 48639]]
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 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 write your application's unique Payment Identification Number,
beginning with the letters ``AG'', on the upper right-hand corner of
your completed Animal Generic Drug User Fee Cover Sheet. Also write the
FDA post office box number (P.O. Box 979033) on the enclosed check,
bank draft, or money order. Mail the payment and a copy of the
completed Animal Generic Drug User Fee Cover Sheet to: Food and Drug
Administration, P.O. Box 979033, 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. If the payment amount is not applied, the invoice amount would
be referred to collections. 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. 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.
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 979033, 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.)
It is important that the fee arrives at the bank at least a day or
two before the abbreviated application arrives at FDA's CVM. FDA
records the official abbreviated application receipt date as the later
of the following: The date the application was received by CVM, or the
date U.S. Bank notifies FDA that your payment in the full amount has
been received, or when the U.S. Department of the Treasury notifies FDA
of payment. U.S. Bank and the United States Treasury are required to
notify FDA within 1 working day, using the Payment Identification
Number described previously.
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
application.)
B. Application Cover Sheet Procedures
Step One--Create a user account and password. Log onto the AGDUFA
website at https://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/ucm137049.htm and scroll down the
page until you find the link ``Create AGDUFA User Fee Cover Sheet.''
Select that link and follow the directions. For security reasons, each
firm submitting an application will be assigned an organization
identification number, and each user will also be required to set up a
user account and password the first time you use this site. Online
instructions will walk you through this process.
Step Two--Create an Animal Generic Drug User Fee Cover Sheet,
transmit it to FDA, and print a copy. After logging into your account
with your user name and password, complete the steps required to create
an Animal Generic Drug User Fee Cover Sheet. One cover sheet is needed
for each abbreviated animal drug application. Once you are satisfied
that the data on the cover sheet is accurate and you have finalized the
cover sheet, you will be able to transmit it electronically to FDA and
you will be able to print a copy of your cover sheet showing your
unique Payment Identification Number.
Step Three--Send the payment for your application as described in
section VIII.A.
Step Four--Please submit your application and a copy of the
completed Animal Generic Drug User Fee Cover Sheet to the following
address: Food and Drug Administration, Center for Veterinary Medicine,
Document Control Unit (HFV-199), 7500 Standish Pl., Rockville, MD
20855.
C. Product and Sponsor Fees
By December 31, 2018, FDA will issue invoices and payment
instructions for product and sponsor fees for FY 2019 using this fee
schedule. Fees will be due by January 31, 2019. FDA will issue invoices
in November 2019 for any products and sponsors subject to fees for FY
2019 that qualify for fees after the December 2018 billing.
Dated: September 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20912 Filed 9-25-18; 8:45 am]
BILLING CODE 4164-01-P