Fee Rates Under the Over-the-Counter Monograph Drug User Fee Program for Fiscal Year 2021
| Published date | 26 March 2021 |
| Citation | 86 FR 16223 |
| Record Number | 2021-06361 |
| Section | Notices |
| Court | Food And Drug Administration |
16223
Federal Register / Vol. 86, No. 57 / Friday, March 26, 2021 / Notices
1
FDA is required to publish OMUFA fee rates
under section 744M(a)(4) of the FD&C Act. FDA
published an earlier version of this notice in the
Federal Register on December 29, 2020. That notice
was withdrawn by the Department of Health and
Human Services (HHS) on January 6, 2021 (see
https://www.federalregister.gov/documents/2021/
01/06/2021-00030/withdrawal-of-fda-notice-
regarding-fee-rates-under-the-over-the-counter-
monograph-drug-user-fee). FDA has updated and is
republishing the OMUFA fee rates for FY 2021
consistent with the January 12, 2021, HHS notice
described below (and with the concurrence of HHS
that publication of this fee-setting notice does not
require prior notice and comment).
2
See HHS Federal Register notice of January 12,
2021, https://www.federalregister.gov/documents/
2021/01/12/2021-00237/notice-that-persons-that-
entered-the-over-the-counter-drug-market-to-
supply-hand-sanitizer-during.
a hearing on December 14, 2020. Mr.
Whalen failed to request a hearing
within the timeframe prescribed by
regulation and has, therefore, waived
his opportunity for a hearing and
waived any contentions concerning his
debarment (21 CFR part 12).
II. Findings and Order
Therefore, the Assistant
Commissioner, Office of Human and
Animal Food Operations, under section
306(b)(3)(C) of the FD&C Act, under
authority delegated to the Assistant
Commissioner, finds that Mr. Whalen
has been convicted of felonies under
Federal law for conduct relating to the
importation into the United States of
any drug or controlled substance. FDA
finds that the offenses should be
accorded a debarment period of 10 years
as provided by section 306(c)(2)(A)(iii)
of the FD&C Act.
As a result of the foregoing finding,
Mr. Whalen is debarred for a period of
10 years from importing or offering for
import any drug into the United States,
effective (see
DATES
). Pursuant to section
301(cc) of the FD&C Act (21 U.S.C.
331(cc)), the importing or offering for
import into the United States of any
drug or controlled substance by, with
the assistance of, or at the direction of
Mr. Whalen is a prohibited act.
Any application by Mr. Whalen for
termination of debarment under section
306(d)(1) of the FD&C Act should be
identified with Docket No. FDA–2020–
N–2002 and sent to the Dockets
Management Staff (see
ADDRESSES
). The
public availability of information in
these submissions is governed by 21
CFR 10.20(j).
Publicly available submissions will be
placed in the docket and will be
viewable at https://www.regulations.gov
or at the Dockets Management Staff (see
ADDRESSES
) between 9 a.m. and 4 p.m.,
Monday through Friday, 240–402–7500.
Dated: March 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–06219 Filed 3–25–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–2246]
Fee Rates Under the Over-the-Counter
Monograph Drug User Fee Program for
Fiscal Year 2021
AGENCY
: Food and Drug Administration,
HHS.
ACTION
: Notice.
SUMMARY
: The Food and Drug
Administration (FDA or the Agency) is
announcing the fee rates under the
Over-the-Counter (OTC) Monograph
Drug user fee program for fiscal year
(FY) 2021. On March 27, 2020, new
provisions were added to the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) by the Coronavirus Aid, Relief, and
Economic Security (CARES) Act, which
authorize FDA to assess and collect user
fees from qualifying manufacturers of
OTC monograph drugs and submitters
of OTC monograph order requests. FDA
refers to the OTC Monograph Drug user
fee program as ‘‘OMUFA’’ throughout
this document. This notice publishes
the OMUFA fee rates for FY 2021.
FOR FURTHER INFORMATION CONTACT
:
David Haas, Office of Financial
Management, Food and Drug
Administration, 4041 Powder Mill Rd.,
Rm. 61075, Beltsville, MD 20705–4304,
240–402–9845.
SUPPLEMENTARY INFORMATION
:
I. Background
Section 744M of the FD&C Act (21
U.S.C. 379j-72), as added by the CARES
Act, authorizes FDA to assess and
collect: (1) Facility fees from qualifying
owners of OTC monograph drug
facilities and (2) fees from submitters of
qualifying OTC monograph order
requests. These fees are to support
FDA’s OTC monograph drug activities,
which are detailed in section 744L(6) of
the FD&C Act and include various FDA
activities associated with OTC
monograph drugs and inspection of
facilities associated with such products.
For OMUFA purposes:
•An OTC monograph drug is a
nonprescription drug without an
approved new drug application which is
governed by the provisions of section
505G of the FD&C Act (21 U.S.C. 355h)
(see section 744L(5) of the FD&C Act);
•An OTC monograph drug facility
(MDF) is a foreign or domestic business
or other entity that, in addition to
meeting other criteria, is engaged in
manufacturing or processing the
finished dosage form of an OTC
monograph drug (see section 744L(10)
of the FD&C Act);
•A contract manufacturing
organization (CMO) facility is an OTC
monograph drug facility where neither
the owner nor any affiliate of the owner
or facility sells the OTC monograph
drug produced at such facility directly
to wholesalers, retailers, or consumers
in the United States (see section 744L(2)
of the FD&C Act); and
•An OTC Monograph Order Request
(OMOR) is a request for an
administrative order, with respect to an
OTC monograph drug, which is
submitted under section 505G(b)(5) of
the FD&C Act (see section 744L(7) of the
FD&C Act).
Under section 744M(a)(1)(A) of the
FD&C Act, a facility fee for FY 2021
shall be assessed with respect to each
facility that is identified as an OTC
monograph drug facility during the
period from January 2020 through
December 2020. Consistent with the
statute, FDA will assess and collect
facility fees with respect to the two
types of OTC monograph drug
facilities—MDF and CMO facilities. A
full facility fee will be assessed to each
qualifying person that owns a facility
identified as an MDF (see section
744M(a)(1)(A) of the FD&C Act), and a
reduced facility fee of two-thirds will be
assessed to each qualifying person that
owns a facility identified as a CMO
facility (see section 744M(a)(1)(B)(ii) of
the FD&C Act). The facility fees are due
45 days after the date of publication of
this notice (see section 744M(a)(1)(D)(i)
of the FD&C Act).
1
As discussed in greater detail below:
•OTC monograph drug facilities are
exempt from FY 2021 facility fees if
they had ceased OTC monograph drug
activities, and updated their registration
with FDA to that effect, prior to
December 31, 2019 (see section
744M(a)(1)(B)(i) of the FD&C Act).
•Entities that registered with FDA
during the Coronavirus Disease 2019
(COVID–19) pandemic whose sole
activity with respect to OTC monograph
drugs during the pandemic consists (or
had consisted) of manufacturing OTC
hand sanitizer products are not
identified as OTC monograph drug
facilities subject to OMUFA facility
fees.
2
In addition to facility fees, the Agency
is authorized to assess and collect fees
from submitters of OMORs, except for
OMORs which request certain safety-
related changes (as discussed below).
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Under OMUFA, a Tier 1 OMOR is defined as
any OMOR which is not a Tier 2 OMOR (see section
744L(8) of the FD&C Act). Tier 2 OMORs are
detailed in section 744L(9) of the FD&C Act.
4
These OMUFA fees are for FY 2021, per section
744M(a) of the FD&C Act.
5
Although under section 744M(c)(4)(A) of the
FD&C Act, FDA was to publish this notice not later
than the second Monday in May 2020, we note that
under section 744M(f)(1) of the FD&C Act, OMUFA
fees ‘‘shall be collected and available for obligation
only to the extent and in the amount provided in
advance in appropriations Acts.’’ An appropriation
of FY 2021 OMUFA fees was provided under
section 123 of the Continuing Appropriations Act,
2021, Division A of Public Law 116–159 (October
1, 2020). Additionally, as described above, this
notice republishes the FY 2021 OMUFA fees
following withdrawal of the Agency’s earlier
December 29, 2020, fee notice.
6
See section 744L(10)(A); see also section
744L(10)(A)(iii) of the FD&C Act, excluding from
the definition of ‘‘OTC monograph drug facility’’
those facilities whose manufacturing or processing
consists solely of a narrow range of specified
activities (e.g., placement of outer overpackaging on
products already in final packaged form); cf section
744A(6)(A)(ii) of the FD&C Act. See also 21 CFR
207.1 (addressing drug establishment registration),
stating that ‘‘[m]anufacture means each step in the
manufacture, preparation, propagation,
compounding, or processing of a drug,’’ and
indicating that ‘‘the term ‘manufacture, preparation,
propagation, compounding, or processing,’ as used
in section 510 of the Federal Food, Drug, and
Cosmetic Act, includes relabeling, repackaging, and
salvaging activities.’’
There are two levels of OMOR fees,
based on whether the OMOR at issue is
a Tier 1 or Tier 2 OMOR.
3
For FY 2021, the OMUFA fee rates are
as follows: Tier 1 OMOR fees
($500,000), Tier 2 OMOR fees
($100,000), MDF facility fees ($20,322),
and CMO facility fees ($13,548). These
fees are for the period from October 1,
2020, through September 30, 2021.
4
This document is issued pursuant to
sections 744M(a)(4) and (c)(4)(A)
5
of the
FD&C Act and describes the calculations
used to set the OMUFA facility fees and
OMOR fees for FY 2021 in accordance
with the directives in the statute.
II. Facility Fee Revenue Amount for FY
2021
A. Base Fee Revenue Amount
Under OMUFA, FDA sets annual
facility fees to generate the total facility
fee revenues for each fiscal year
established by section 744M(b) of the
FD&C Act. The yearly base revenue
amount is the starting point for setting
annual facility fee rates. The base
revenue amount for FY 2021 is
$8,000,000 (see section 744M(b)(3)(A) of
the FD&C Act).
B. Fee Revenue Adjustment for Inflation
Under OMUFA, the annual base
revenue amount for facility fees is
adjusted for inflation for FY 2022 and
each subsequent FY (see section
744M(c)(1) of the FD&C Act). Because
the adjustment for inflation does not
apply until FY 2022, the FY 2021
facility fee revenue is not subject to an
inflation adjustment by FDA.
C. Fee Revenue Adjustment for
Additional Direct Cost
Under OMUFA, $14,000,000 is added
to the facility fee revenues for FY 2021
to account for additional direct costs
(see section 744M(c)(3)(A) of the FD&C
Act).
D. Fee Revenue Adjustment for
Operating Reserve
Under OMUFA, FDA may further
increase the FY 2021 facility fee revenue
and fees if such an adjustment is
necessary in order to provide up to 3
weeks of operating reserves of carryover
user fees for OTC monograph drug
activities (see section 744M(c)(2)(A) of
the FD&C Act). However, under the
statute, if the carryover balance exceeds
10 weeks of operating reserves, FDA is
required to decrease fees to provide for
not more than 10 weeks of operating
reserves of carryover user fees (see
section 744M(c)(2)(C) of the FD&C Act).
FDA is applying the operating reserve
adjustment to increase the FY 2021
facility fee revenue and fees to enable
the Agency to maintain 3 weeks of
operating reserves of carryover user fees.
To determine the 3-week operating
reserve amount, the FY 2021 annual
base revenue adjusted for additional
direct costs (i.e., $8,000,000 +
$14,000,000 = $22,000,000), is divided
by 52, and then multiplied by 3. The 3-
week operating reserve amount for FY
2021 is $1,269,231.
As a result of the above calculations,
the final FY 2021 OMUFA target facility
fee revenue is $23,269,000 (rounded to
the nearest thousand dollars).
III. Determination of FY 2021 OMOR
Fees
Under OMUFA, the FY 2021 Tier 1
OMOR fee is $500,000 and the Tier 2
OMOR fee is $100,000 (see section
744M(a)(2)(A)(i) and (ii) of the FD&C
Act, respectively). OMOR fees are not
included in the OMUFA target revenue
calculation, which is based on the
facility fees (see section 744M(b)(1) of
the FD&C Act).
An OMOR fee is generally assessed to
each person who submits an OMOR (see
section 744M(a)(2)(A) of the FD&C Act).
OMOR fees are due on the date of the
submission of the OMOR (see section
744M(a)(2)(B) of the FD&C Act). The
payor should submit the OMOR fee that
applies to the type of OMOR they are
submitting (i.e., Tier 1 or Tier 2). FDA
will determine whether the requestor
has submitted the appropriate OMOR
fee following receipt of the OMOR and
the fee.
An OMOR fee will not be assessed if
the OMOR seeks to make certain safety
changes with respect to an OTC
monograph drug. Specifically, no fee
will be assessed if FDA finds that the
OMOR seeks to change the drug facts
labeling of an OTC monograph drug in
a way that would add to or strengthen:
(1) A contraindication, warning, or
precaution; (2) a statement about risk
associated with misuse or abuse; or (3)
an instruction about dosage and
administration that is intended to
increase the safe use of the OTC
monograph drug (see section
744M(a)(2)(C) of the FD&C Act).
IV. Facility Fee Calculations
A. Facility Fee Revenues and Fees
For FY 2021, facility fee rates are
being established to generate a total
target revenue amount, as determined
under the statute, equal to $23,269,000
(rounded to the nearest thousand
dollars). FDA used the methodology
described below to determine the
appropriate number of MDF and CMO
facilities to be used in setting the
OMUFA facility fees for FY 2021. FDA
took into consideration that the CMO
facility fee is equal to two-thirds of the
amount of the MDF facility fee (see
section 744M(a)(1)(B)(ii) of the FD&C
Act).
B. Calculating the Number of Qualifying
Facilities and Setting the Facility Fees
Under the statute, certain information
submitted to FDA for drug
establishment registration purposes
under section 510 of the FD&C Act is
also used for OMUFA fee-setting (see
section 744M(d) of the FD&C Act). Thus,
for FY 2021, FDA utilized the Agency’s
Electronic Drug Registration and Listing
System (eDRLS) to calculate the number
of qualifying MDF or CMO facilities that
engage in the manufacturing or
processing of the finished dosage form
of an OTC monograph drug. In order to
apply the statutory fee-setting
calculations, FDA assessed which OTC
monograph drug facilities had selected
in eDRLS the business operation
qualifiers of ‘‘manufactures human over-
the-counter drug products produced
under a monograph’’ or ‘‘contract
manufacturing for human over-the-
counter drug products produced under
a monograph’’ and indicated at least one
of the following business operations:
finished dosage form manufacture,
label, manufacture, pack, relabel, or
repack.
6
FDA analyzed eDRLS
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7
Under section 744M(a)(1) of the FD&C Act,
‘‘Each person that owns a facility identified as an
OTC monograph drug facility on December 31 of
the fiscal year or at any time during the preceding
12-month period shall be assessed an annual fee for
each such facility.’’ For purposes of FY 2021 facility
fees, that time period is January 1, 2020, through
December 31, 2020.
8
See https://www.federalregister.gov/documents/
2021/01/12/2021-00237/notice-that-persons-that-
entered-the-over-the-counter-drug-market-to-
supply-hand-sanitizer-during (86 FR 2420).
9
See https://www.phe.gov/emergency/news/
healthactions/phe/Pages/2019-nCoV.aspx.
10
The term ‘‘hand sanitizer’’ commonly refers to
consumer antiseptic rubs. However, because the
HHS notice referred to ‘‘persons that entered the
over-the-counter drug market to supply hand
sanitizer products in response to the COVID–19
Public Health Emergency’’ (86 FR 2420), we are
using the same terminology—‘‘hand sanitizer
products’’—to refer to OTC monograph drug
products intended for use (without water) as
antiseptic hand rubs or antiseptic hand wipes by
consumers or health care personnel, including
products manufactured or prepared consistent with
the Agency’s ‘‘Temporary Policy for Preparation of
Certain Alcohol-Based Hand Sanitizer Products
During the Public Health Emergency (COVID–19)
Guidance for Industry’’ (see https://www.fda.gov/
media/136289/download). Our use of the term
‘‘hand sanitizer products’’ in this notice to refer to
antiseptic hand rubs and antiseptic hand wipes
intended for use by consumers or health care
personnel does not alter any existing regulatory
distinctions between these products.
11
See 86 FR 2420. The January 12, 2021, HHS
notice explained that fees would be assessed on
entities that ‘‘manufacture, distribute, and sell over-
the-counter drugs in addition to hand sanitizer’’
and entities that ‘‘continue to manufacture (as
opposed to hold, distribute, or sell existing
inventories) hand sanitizer products as of December
31 of the year immediately following the year
during which the COVID–19 Public Health
Emergency is terminated.’’
registration data from January 1, 2020,
through December 31, 2020,
7
based on
information provided by facilities in
eDRLS.
Those facilities that only manufacture
the Active Pharmaceutical Ingredient
(API) of an OTC monograph drug do not
meet the definition of an OTC
monograph drug facility (see section
744L(10)(A)(i)(II)) of the FD&C Act).
Likewise, a facility is not an OTC
monograph drug facility if its only
manufacturing or processing activities
are one or more of the following: (1)
Production of clinical research supplies;
(2) testing; or (3) placement of outer
packaging on packages containing
multiple products, for such purposes as
creating multipacks, when each
monograph drug product contained
within the overpackaging is already in
a final packaged form prior to placement
in the outer overpackaging (see section
744L(10)(A)(iii) of the FD&C Act).
Further, in a January 12, 2021,
Federal Register notice, the Department
of Health and Human Services (HHS)
clarified that ‘‘persons that entered into
the over-the-counter drug industry for
the first time in order to supply hand
sanitizers during the COVID–19 Public
Health Emergency are not persons
subject to the facility fee the Secretary
is authorized to collect’’ under section
744M of the FD&C Act.
8
As the January
12, 2021, HHS notice explained, persons
that were not registered with FDA as
drug manufacturers prior to the COVID–
19 Public Health Emergency, which
then later registered with FDA for the
purpose of producing hand sanitizers,
‘‘are not ‘identified . . .facilit[ies]’
under section 744M of the FD&C Act, 21
U.S.C. 379j-72, and are thus not subject
to the facility fee contained therein’’ (86
FR 2421). As further explained in the
HHS notice, ‘‘imposing facility fees on
these entities is inconsistent with
Congress’ stated intent elsewhere in the
CARES Act.’’ Section 2308 of the
CARES Act provides a temporary
exemption from excise taxes for
distilled spirits ‘‘use[d] in or contained
in hand sanitizer produced and
distributed in a manner consistent with
any guidance issued by the Food and
Drug Administration that is related to
the outbreak of [COVID–19].’’ As stated
in the HHS notice, ‘‘[i]t is unlikely
Congress intended to save these entities
from excise taxes only to impose tens of
thousands of dollars in facility fees from
an unfamiliar regulator.’’ (86 FR 2420 at
2421)
Accordingly, as stated in the January
12, 2021, HHS Notice, FDA will not
assess OMUFA facility fees upon those
firms that first registered with FDA on
or after the January 27, 2020 declaration
of the COVID–19 Public Health
Emergency (PHE),
9
solely for purposes of
manufacturing hand sanitizer
products
10
during the PHE.
11
We note,
however, that under the FD&C Act,
whether an entity is subject to OMUFA
fees has no bearing on whether the
entity or the entity’s products are
subject to other requirements under the
FD&C Act. FDA will continue to use its
regulatory compliance and enforcement
tools to protect consumers, including
from potentially dangerous or subpotent
hand sanitizers.
In addition, FDA will not assess a
facility fee if the identified OTC
monograph drug facility: (1) Has ceased
all activities related to OTC monograph
drugs prior to December 31 of the year
immediately preceding the applicable
fiscal year and (2) has updated its
eDRLS registration to reflect that change
(per section 744M(a)(1)(B)(i) of the
FD&C Act). As the applicable fiscal year
for fee-setting under this notice is FY
2021, the year immediately preceding
the applicable fiscal year is FY 2020.
December 31 of FY 2020 is December
31, 2019. Thus, FDA will not assess a
FY 2021 facility fee with respect to an
OTC monograph drug facility that, prior
to December 31, 2019, had ceased all
activities related to OTC monograph
drugs and updated its eDRLS
registration to that effect.
FDA considered a number of factors
that could affect collection of the target
revenue, including that FY 2021 is the
first year of this new user fee program
and uncertainties related to the effects
of the COVID–19 PHE. In undertaking
the statutorily-directed fee calculations,
the Agency made certain assumptions,
including that: (1) Facilities using
expired business operation qualifier
codes within their electronic
registration (also known as Structured
Product Labeling) codes in eDRLS were
no longer manufacturing and marketing
OTC monograph drugs; (2) facilities that
have deregistered in eDRLS have exited
the market; (3) facilities that FDA
believes registered incorrectly as OTC
monograph drug facilities (for example,
because the associated drug listings for
these facilities did not include OTC
monograph drugs but instead indicated
such products as OTC drug products
under an approved drug application or
OTC animal drug products) were not
engaged in manufacturing or processing
the finished dosage form of an OTC
monograph drug; and (4) facilities that
registered but did not have an active
OTC monograph drug product listing
associated in their registration profile
were not manufacturing or processing
such drug products.
Each establishment paying the facility
fee is counted as one fee-paying unit.
The total estimate of fee-paying units is
further analyzed to determine the
number of respective MDF and CMO
fee-paying units.
Based on the data obtained from
eDRLS, FDA estimates there will be
1,184 fee-paying units. The Agency
estimates that 90 percent (1,184 × .90 =
1,066, rounded) will incur the MDF fee
and 10 percent (1,184 × .10 = 118,
rounded) will incur the CMO fee.
To determine the number of full fee-
paying equivalents (the denominator) to
be used in setting the OMUFA fees, FDA
assigns a value of 1 to each MDF (1,066)
and a value of
2
⁄
3
to each CMO (118 ×
2
⁄
3
= 79) for a full facility equivalent of
1,145 (rounded). The target fee revenue
of $23,269,000 is then divided by 1,145
for an MDF fee of $20,322 and a CMO
fee of $13,548.
V. Fee Schedule for FY 2021
The fee rates for FY 2021 are
displayed in table 1.
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T
ABLE
1—F
EE
S
CHEDULE FOR
FY
2021
Fee category FY 2021
fee rates
OMOR:
Tier 1 ................................... $500,000
Tier 2 ................................... 100,000
Facility Fees:
MDF ..................................... 20,322
CMO .................................... 13,548
VI. Fee Payment Options and
Procedures
The new fee rates are for the period
from October 1, 2020, through
September 30, 2021. To pay the OMOR,
MDF, and CMO fees, complete an OTC
Monograph User Fee Cover Sheet,
available at: https://userfees.fda.gov/
OA_HTML/omufaCAcdLogin.jsp. A user
fee identification (ID) number will be
generated. Payment must be made in
U.S. currency by electronic check or
wire transfer, payable to the order of the
Food and Drug Administration. The
preferred payment method is online
using electronic check (Automated
Clearing House (ACH) also known as
eCheck) or credit card for payments
under $25,000 (Discover, VISA,
MasterCard, American Express).
FDA has partnered with the U.S.
Department of the Treasury to use
Pay.gov, a web-based payment
application, for online electronic
payment. The Pay.gov feature is
available on the FDA website after
completing the OTC Monograph User
Fee Cover Sheet and generating the user
fee ID number. Secure electronic
payments can be submitted using the
User Fees Payment Portal at https://
userfees.fda.gov/pay (Note: only full
payments are accepted. No partial
payments can be made online). Once an
invoice is located, ‘‘Pay Now’’ should be
selected to be redirected to Pay.gov.
Electronic payment options are based on
the balance due. Payment by credit card
is available for balances that are 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.
For payments made by wire transfer,
include the unique user fee ID number
to ensure that the payment is applied to
the correct fee(s). Without the unique
user fee ID number, the payment may
not be applied, which could result in
FDA not filing an OMOR request, for
example, and other penalties. The
originating financial institution may
charge a wire transfer fee. Applicable
wire transfer fees must be included with
payment to ensure fees are fully paid.
Questions about wire transfer fees
should be addressed to the financial
institution. The account information for
wire transfers is as follows: U.S.
Department of the Treasury, TREAS
NYC, 33 Liberty St., New York, NY
10045, Acct. No.: 75060099, Routing
No.: 021030004, SWIFT: FRNYUS33. If
needed, FDA’s tax identification
number is 53–0196965.
If you are assessed an FY 2021
OMUFA facility fee and believe your
facility is not an OTC monograph drug
facility as described in this notice,
please contact CDERCollections@
fda.hhs.gov.
Dated: March 23, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–06361 Filed 3–25–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1682]
Ursula Wing: Final Debarment Order
AGENCY
: Food and Drug Administration,
HHS.
ACTION
: Notice.
SUMMARY
: The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) debarring
Ursula Wing for a period of 5 years from
importing or offering for import any
drug into the United States. FDA bases
this order on a finding that Ms. Wing
was convicted of one felony count
under Federal law for conspiracy to
defraud the United States. Ms. Wing
was given notice of the proposed
debarment and an opportunity to
request a hearing to show why she
should not be debarred within the
timeframe prescribed by regulation. Ms.
Wing failed to request a hearing. Ms.
Wing’s failure to respond and request a
hearing constitutes a waiver of her right
to a hearing concerning this matter.
DATES
: This order is applicable March
26, 2021.
ADDRESSES
: Submit applications for
termination of debarment to the Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852,
240–402–7500, or at https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT
:
Jaime Espinosa, Division of Enforcement
(ELEM–4029), Office of Strategic
Planning and Operational Policy, Office
of Regulatory Affairs, Food and Drug
Administration, 12420 Parklawn Dr.,
Rockville, MD 20857, 240–402–8743, or
at debarments@fda.hhs.gov.
SUPPLEMENTARY INFORMATION
:
I. Background
Section 306(b)(1)(D) of the FD&C Act
(21 U.S.C. 335a(b)(1)(D)) permits
debarment of an individual from
importing or offering for import any
drug into the United States if FDA finds,
as required by section 306(b)(3)(C) of the
FD&C Act, that the individual has been
convicted of a felony for conduct
relating to the importation into the
United States of any drug or controlled
substance. On July 10, 2020, Ms. Wing
was convicted, as defined in section
306(l)(1) of the FD&C Act, in the U.S.
District Court for the Western District of
Wisconsin, when the court accepted her
plea of guilty and entered judgment
against her for the felony offense of
conspiracy to defraud the United States
in violation of 18 U.S.C. 371.
FDA’s finding that debarment is
appropriate is based on this felony
conviction referenced herein. The
factual basis for this conviction is as
follows: As contained in count 1 of the
indictment in Ms. Wing’s case, filed on
June 26, 2019, to which she pleaded
guilty, from in or about June 2016 and
continuing to on or about June 21, 2018,
she operated a blog under the name ‘‘the
Macrobiotic Stoner’’ and a fake jewelry
business under the name ‘‘Morocco
International Inc.’’ Ms. Wing used both
entities to sell unapproved and
misbranded prescription drugs to
consumers in the United States and
around the world and to process
payments for those drugs. Throughout
the course of this conspiracy Ms. Wing
did not possess a valid wholesale drug
distribution license, pharmacy license,
or a license to prescribe prescription
drugs. She was also not registered under
section 510 of the FD&C Act (21 U.S.C.
360) as a person who owns or operates
an establishment engaged in the
manufacture, preparation, propagation,
compounding, or processing of a drug.
As part of this conspiracy, Ms. Wing
imported foreign-sourced prescription
drugs in wholesale quantities from India
into the United States. The imported
drugs contained U.S. Customs
Declaration Forms falsely stating that
the contents were ‘‘personal supply
medication’’ and did not contain any
dangerous articles or articles prohibited
by postal or customs regulations. The
drugs Ms. Wing imported were foreign
versions of mifepristone and
misoprostol. There are two 200 mg
mifepristone tablets that are FDA-
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