Procedures for Oversight of the Horseracing Integrity and Safety Authority's Annual Budget, 18034-18037 [2023-06023]
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18034
Federal Register / Vol. 88, No. 58 / Monday, March 27, 2023 / Rules and Regulations
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2023 season. A reduction in the
operational volume at the New York
airports would also aid in reducing the
severity of significant NAS impact days.
In addition, because New York-DCA
is a high frequency market for multiple
carriers, the FAA recognizes this market
is a likely target for carriers to
consolidate flights while retaining their
network connectivity. If carriers choose
to reduce their schedules in the New
York-DCA market, the FAA encourages
carriers to utilize their DCA slots to
operate to other destinations, to the
extent that is practical. However, if
carriers are unable to utilize their DCA
slots elsewhere, it would be necessary to
provide relief to DCA slots that are
impacted by the reduction in operations
at the New York airports.
Finally, carriers should be aware that
the N90 staffing shortfalls will not form
a sufficient basis for relief going forward
because carriers will have had sufficient
opportunity to plan and take remedial
action under this waiver policy. The
FAA does not foresee providing
additional post-hoc relief associated
with ATC staffing given the
extraordinary relief provided here.
Given this relief, operational impacts
associated with N90 staffing during the
summer 2023 scheduling season will
not have been beyond the carriers
control and will not serve as a valid
basis for a waiver.
Decision
The FAA has determined the postpandemic effects on N90 staffing meets
the applicable waiver standards and
warrants a limited waiver of minimum
slot usage requirements at JFK and LGA
to allow carriers to return up to 10
percent of their slots at each airport
voluntarily as well as impacted
operations between DCA and the New
York airports. In addition, the FAA has
determined the post-pandemic effects
on N90 staffing warrants a limited
policy for prioritizing returned
operations at EWR to allow carriers to
return 10 percent of their approved
operating timings voluntarily, for
purposes of establishing a carrier’s
operational baseline in the next
corresponding season. Carriers wishing
to return their slots and approved
operating timings voluntarily must do
so before April 30, 2023 to be eligible
for this waiver. If carriers participating
in this limited waiver at EWR
subsequently operate unapproved
flights at that airport, those carriers will
forfeit their scheduling preference to an
equal number of returned approved
operating timings chosen at the FAA’s
discretion for the subsequent equivalent
traffic season. Additionally, any other
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relief from minimum slot usage
requirements or standard level 2
processes already in effect at JFK, LGA,
or EWR will factor into the 10 percent
of allowable returns. In other words, any
returns made under a relief policy
already in effect when this notice is
published will count towards the
carrier’s 10 percent of allowable returns.
Further, the FAA encourages carriers to
up-gauge aircraft serving the affected
airports to the extent possible to
maintain passenger throughput and
minimally impact consumers.
The FAA will not reallocate the
returned slots or approved operating
timings at JFK, LGA, or EWR, as the goal
is to reduce the volume of operations in
the New York region. Carriers are
encouraged to utilize their DCA slots in
other markets before returning them to
the FAA. In the event DCA slots are
returned under this waiver, other
carriers will have an opportunity to
operate the slots on an ad hoc basis
without historic precedence to serve
markets other than New York.
The FAA will treat as used the
specific slots returned in accordance
with the conditions in this document for
the period from May 15, 2023, through
September 15, 2023. The relief is subject
to the following conditions:
1. The specific slots and approved
operating timings must be returned to
the FAA before April 30, 2023.
2. This waiver applies only to slots
that have corresponding, scheduled
operations during the period of the
grant. A carrier temporarily returning a
slot to FAA for relief under this waiver
must identify corresponding scheduled
operation. FAA may validate
information against published schedule
data as of March 14, 2023, and other
operational data maintained by FAA.
Slots returned without an associated
scheduled and cancelled operation will
not receive relief.
3. Slots or approved operating timings
newly allocated for initial use before
October 28, 2023, are not eligible for
relief.
4. Slots authorized at DCA by
Department of Transportation or FAA
exemptions are not eligible for relief.
Issued in Washington, DC, on March 22,
2023.
Marc A. Nichols,
Chief Counsel.
Alyce Hood-Fleming,
Vice President, System Operations Services.
[FR Doc. 2023–06313 Filed 3–22–23; 4:15 pm]
BILLING CODE 4910–13–P
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FEDERAL TRADE COMMISSION
16 CFR Part 1
Procedures for Oversight of the
Horseracing Integrity and Safety
Authority’s Annual Budget
Federal Trade Commission.
Final rule.
AGENCY:
ACTION:
The Federal Trade
Commission (‘‘Commission’’) is issuing
rules pursuant to the Horseracing
Integrity and Safety Act (‘‘Act’’) to
provide procedures for the
Commission’s oversight of the annual
budget of the Horseracing Integrity and
Safety Authority (‘‘Authority’’).
DATES: This rule is effective on March
27, 2023.
FOR FURTHER INFORMATION CONTACT: John
H. Seesel (202–326–2702), Office of the
General Counsel, Federal Trade
Commission, 600 Pennsylvania Avenue
NW, Washington, DC 20580.
SUPPLEMENTARY INFORMATION: The
Horseracing Integrity & Safety Act,1
enacted on December 27, 2020, and
amended on December 29, 2022, directs
the Federal Trade Commission to
oversee the activities of a private, selfregulatory organization called the
Horseracing Integrity and Safety
Authority.
The Act, in subsection 15 U.S.C.
3052(f), sets forth certain requirements
for the Authority’s budget. On the
revenue side, as for initial funding, the
Authority is to obtain loans,2 and
generally it ‘‘may borrow funds toward
the funding of its operations.’’ 3 After
the program effective date of July 1,
2022, the Authority performs an annual
calculation of the ‘‘amount required’’
from each State in which covered
horseracing takes place, which estimates
the amount required from each State ‘‘to
fund the State’s proportionate share of
the horseracing anti-doping and
medication control program and the
racetrack safety program for the next
calendar year’’ and ‘‘to liquidate the
State’s proportionate share of any loan
or funding shortfall.’’ 4 The amount
required by each State is calculated
under the Assessment Methodology
rule 5 and must be ‘‘based on,’’ among
SUMMARY:
1 15
U.S.C. 3051 through 3060.
15 U.S.C. 3052(f)(1)(A).
3 Id. 3052(f)(1)(B).
4 Id. 3052(f)(1)(C)(i).
5 The Assessment Methodology proposed rule
was published in the Federal Register and
approved by the Commission after a period of
public comment. See Fed. Trade Comm’n, Notice of
HISA Assessment Methodology Proposed Rule, 87
FR 9349 (Feb. 28, 2022), https://www.federal
register.gov/documents/2022/02/18/2022-03717/
hisa-assessment-methodology-rule (containing the
2 See
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other things, ‘‘the annual budget of the
Authority for the following calendar
year.’’ 6
On the expenditure side of the budget,
the Act provides that the ‘‘initial
budget’’ requires approval by a twothirds supermajority of the Authority’s
Board of Directors, as does any
‘‘subsequent budget that exceeds the
budget of the preceding calendar year by
more than 5 percent.’’ 7 The Act has two
more relevant provisions: ‘‘A proposed
increase in the amount required under
this subparagraph’’—in other words, the
Authority’s budget—‘‘shall be reported
to the Commission.’’ 8 And: ‘‘The
Commission shall publish in the
Federal Register such a proposed
increase and provide an opportunity for
public comment.’’ 9
The Act does not specify whether the
Authority’s proposed budget takes effect
upon the closing of the public-comment
period or whether the Commission is to
consider the public comments and then
decide whether to approve or
disapprove the Authority’s proposed
budget. On the one hand, the
Authority’s budget is not listed among
the eleven enumerated items in 15
U.S.C. 3053(a) that ‘‘shall not take effect
unless . . . approved by the
Commission.’’ 10 On the other hand,
what the Authority submits (in the
event of an increase in the amount
required) is a ‘‘proposed increase,’’
which implies that a Commission
decision to approve or disapprove the
proposal will follow.11 Although the Act
does not identify criteria by which the
Commission should evaluate the
text of the Assessment Methodology proposed rule
as submitted by the Authority); Fed. Trade Comm’n,
Order Approving the Assessment Methodology Rule
Proposed by the Horseracing Integrity & Safety
Auth., at 1 (Apr. 1, 2022), available at https://
www.ftc.gov/system/files/ftc_gov/pdf/
Order%20re%20HISA%20Assessment%20
Methodology.pdf. The Authority later submitted a
proposed rule modification to Assessment
Methodology, which was also published in the
Federal Register and approved by the Commission
after a period of public comment. See Fed. Trade
Comm’n, Notice of HISA Assessment Methodology
Proposed Rule Modification, 87 FR 67915 (Nov. 10,
2022), https://www.federalregister.gov/documents/
2022/11/10/2022-24609/hisa-assessmentmethodology-rule-modification; Fed. Trade
Comm’n, Order Approving the Assessment
Methodology Rule Modification Proposed by the
Horseracing Integrity & Safety Auth., at 1 (Jan. 9,
2023), available at https://www.ftc.gov/system/files/
ftc_gov/pdf/order_re_hisa_assessment_
methodology_modification_not_signed_002_0.pdf.
6 15 U.S.C. 3052(f)(1)(C)(ii)(I)(aa).
7 Id. 3052(f)(1)(C)(iii)(I), (II). Implicitly,
subsequent budgets that do not exceed by more
than 5 percent the budget of the preceding calendar
year require only a simple majority of the
Authority’s Board of Directors.
8 Id. 3052(f)(1)(C)(iv)(I).
9 Id. 3052(f)(1)(C)(iv)(II).
10 Id. 3053(b)(2).
11 Id. 3052(f)(1)(C)(iv)(I), (II) (emphasis added).
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Authority’s proposed budget, in
December 2022 Congress conferred on
the Commission the power to issue rules
‘‘as the Commission finds necessary or
appropriate to ensure the fair
administration of the Authority . . . or
otherwise in furtherance of the purposes
of this Act.’’ 12
The Commission hereby exercises this
newly granted rulemaking authority to
clarify the Commission’s role in
approving and overseeing the
Authority’s budget, as well as the
public’s role in providing comment, and
to set forth clear requirements as to the
Authority’s budget. Specifically, the
Commission adds a new subpart U to
part 1 of its Rules of Practice, to provide
procedures for the Commission’s
oversight of the Authority’s budget.13
I. Section 1.150—Authority’s Proposed
Budget Submissions
Section 1.150 provides for the
Authority’s proposed annual budget to
use the calendar year as its fiscal year
and to be submitted to the Commission
by September 1 of the preceding year.
The submission of the proposed budget
is required regardless of whether the
Authority’s budget contains a ‘‘proposed
increase in the amount required’’ as
compared to the previous year.14 The
Commission believes that its oversight
of the Authority’s budget is best
performed consistently rather than only
when the amount required increases. In
short, annual rather than less-frequent
budget oversight is a baseline
requirement ‘‘to ensure the fair
administration of the Authority.’’ 15 The
Authority’s submission must contain: an
indication of the vote of its Board of
Directors; sufficient revenue and
expenditure information, broken out by
line item, as would be required for
members of the Board of Directors to
exercise their fiduciary duty of care; and
a comparison of the current year’s actual
revenues and expenditures with those
that were approved. The submission
should address the Commission’s
budget approval decision criteria: that
the proposed budget serves the goals of
the Horseracing Integrity and Safety Act
in a prudent and cost-effective manner,
utilizing commercially reasonable terms
with all outside vendors, and that its
anticipated revenues are sufficient to
meet its anticipated expenditures. If the
12 Consolidated Appropriations Act, 2023, H.R.
2617, 117th Cong., Division O, Title VII (2022) (to
be codified at 15 U.S.C. 3053(e)).
13 In addition, the Commission intends in the
near future to engage in further rulemaking
prescribing oversight of non-budgetary aspects of
the Authority’s operations.
14 15 U.S.C. 3052(f)(1)(C)(iv).
15 Id. 3053(e).
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18035
Commission determines that the
proposed budget as submitted satisfies
the requirements, the Commission will
publish the proposed budget in the
Federal Register for 14 days of public
comment.
In addition, and notwithstanding the
September 1 deadline for submission of
the Authority’s next year’s budget to the
Commission, § 1.150 requires the
Authority to post its anticipated budget
for the following year as early as is
practicable in the preceding year. The
Authority’s posting of its planned next
year’s budget shall include an invitation
to the public to submit comments to the
Authority concerning any aspect of the
planned annual budget. The Authority
is required to post those public
comments as they arrive on its website
and to review the comments in order to
ascertain whether to revise the budget in
any manner. Further, § 1.150 requires
the Authority to promptly provide the
public comments that it receives to the
Commission, together with an
assessment of such public comments
that the Authority believes would assist
the Commission’s evaluation of the
planned budget.
II. Section 1.151—Commission Decision
on Authority’s Proposed Budget
Section 1.151 provides that the
Authority’s proposed budget takes effect
only if approved by the Commission.
This provision mirrors others in the Act
that require proposals made by the
Authority, such as for rules and rule
modifications, to receive Commission
approval before they take effect. For
ease of administration and to account
for the time the Commission may take
to render a decision on the proposed
budget, the Authority is permitted to
conditionally collect fees, and State
racing commissions (and covered
persons in States that do not elect to
remit fees) are permitted to pay, based
on the annual budget as approved by the
Authority’s Board of Directors.
The criteria by which the Commission
will decide whether to approve or
disapprove the Authority’s proposed
budget are in § 1.151(c), which provides
that the Commission will approve the
proposed budget if the Commission
determines, on balance, the proposed
budget serves the goals of the Act in a
prudent and cost-effective manner,
utilizing commercially reasonable terms
with all outside vendors, and
anticipated revenues are sufficient to
meet its anticipated expenditures. With
respect to revenues and expenditures,
the Commission may also modify any
line item. The Commission will publish
the Authority’s proposed budget in the
Federal Register for 14 days of public
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comment. Public comments are
welcomed as to both whether the
submission satisfies the Commission’s
decisional criteria and whether the
Commission should modify any line
items.
III. Section 1.152—Deviation From
Approved Budget
Section 1.152 sets forth what happens
in circumstances in which actual
revenues or expenditures deviate from
those approved in the annual budget.
When the Authority determines that, for
a given expenditure’s line item, the
actual expenditure is likely to exceed
the approved expenditure by more than
10 percent, it must immediately notify
the Commission. Such a notice must
indicate whether the Authority proposes
to repurpose money from the line item
of another expenditure to make up the
difference for the expenditure whose
likely actual amount will exceed the
approved amount. So, too, when the
Authority determines that its overall
expenditures will exceed its approved
expenditures, it must immediately
notify the Commission. Such a notice
must indicate the means by which the
Authority intends to make up the
difference, such as obtaining loans. For
both overall-expenditure and line-item
deviations, the Commission retains the
right to disapprove the proposed
repurposing or means of making up the
difference, which it must do within
seven business days of receiving the
Authority’s notice. If the Commission
takes no action, the Authority’s proposal
takes effect as an amendment to its
budget.
Because these rules relate solely to
agency procedure and practice,
publication for notice and comment is
not required under the Administrative
Procedure Act. 5 U.S.C. 553(b).16
List of Subjects in 16 CFR Part 1
Administrative practice and
procedure.
For the reasons set forth in the
preamble, the Federal Trade
Commission amends title 16, chapter I,
subchapter A of the Code of Federal
Regulations as follows:
PART 1—GENERAL PROCEDURES
1. The authority citation for part 1
continues to read as follows:
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■
Authority: 15 U.S.C. 46; 15 U.S.C. 57a; 5
U.S.C. 552; 5 U.S.C. 601 note.
16 For this reason, the requirements of the
Regulatory Flexibility Act, 5 U.S.C. 601(2), 604(a),
are also inapplicable. Likewise, the amendments do
not modify any FTC collections of information
within the meaning of the Paperwork Reduction
Act, 44 U.S.C. 3501 through 3521.
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■
2. Add subpart U to read as follows:
Subpart U—Procedures for Oversight
of the Horseracing Integrity and Safety
Authority’s Annual Budget
Sec.
1.150 Authority’s proposed budget
submissions.
1.151 Commission’s decision on
Authority’s proposed budget.
1.152 Deviation from approved budget.
§ 1.150 Authority’s proposed budget
submissions.
(a) Mandatory annual submission.
The Authority must submit a proposed
annual budget to the Commission every
year, irrespective of whether there is a
‘‘proposed increase in the amount
required’’ under 15 U.S.C.
3052(f)(1)(C)(iv). The submission of the
proposed budget for the following year
must be made by September 1 of the
current year, following the procedures
set forth in § 1.143. The Authority’s
annual budget will use the calendar year
as its fiscal year.
(b) Public comments. In addition to
submitting its planned budget to the
Commission by September 1 of the
preceding year, the Authority shall post
such planned budget on its own website
as early as is practicable, with an
invitation to the public to submit
comments to the Authority on any
aspect of the planned next year’s
budget. The Authority shall post such
comments on its website upon their
arrival and shall review them to
ascertain whether to revise the budget in
any manner. In addition, the Authority
shall promptly forward to the
Commission:
(1) Any such public comments that it
receives; and
(2) An assessment of such public
comments that it believes would assist
the Commission’s evaluation of the
Authority’s planned budget.
(c) Contents of submission—(1)
Indication of Board vote. The
Authority’s proposed budget must be
approved by a majority of its Board of
Directors (or, in the case of its initial
budget or a budget that exceeds the
preceding year’s budget by 5 percent or
more, a two-thirds supermajority) and
must state the Board vote on the motion
to approve the budget.
(2) Revenue information. The
proposed budget must identify both the
estimated amount required from each
State racing commission as calculated
under 15 U.S.C. 3052(f) and all other
sources of Authority revenue as well as
any loans proposed to be obtained by
the Authority.
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(3) Expenditure information. The
proposed budget must identify
expenditures separately for:
(i) The racetrack safety program;
(ii) The anti-doping and medication
control program;
(iii) All other programmatic
expenditures other than for racetrack
safety and anti-doping and medication
control, such as the administration of
the Authority or its technological needs;
(iv) Repayment of any loans; and
(v) Any funding shortfall incurred.
(4) Line items. For both revenue and
expenditure information, the
Authority’s proposed budget must
provide sufficient information, by line
item, as would be required for members
of the Authority’s Board of Directors to
exercise their fiduciary duty of care. For
example, the proposed budget’s
expenditure information for anti-doping
and medication control might include
separate line items for in-house salaries,
the costs of testing of laboratory
samples, the costs of arbitrators, and all
the costs associated with contracting
with an anti-doping and medication
control enforcement agency. The
proposed budget must include a
narrative component that provides a
brief explanation of each line item’s
utility in carrying out the purposes of
the Horseracing Integrity and Safety Act.
(5) Comparison of approved budget to
actual revenues and expenditures. The
proposed budget must provide a
comparison showing, for each approved
line item, the actual revenues and
expenditures for the current year along
with a narrative component explaining
why any line item is anticipated to
deviate by 10 percent or more during
the current year.
(d) Approval and publication of
submission. The Commission will
publish the Authority’s proposed budget
in the Federal Register if the
Commission determines that the
proposed budget contains sufficient
information for the members of the
Board of Directors of the Authority to
exercise their fiduciary duty of care and
meets the requirements of this subpart.
Members of the public will then have 14
days in which to file comments on the
proposed budget.
§ 1.151 Commission’s decision on
Authority’s proposed budget.
(a) Commission approval required.
The Authority’s proposed budget takes
effect only if approved by the
Commission. The Commission will
approve or disapprove the proposed
budget after considering the public
comments filed and the Commission’s
internal review per the submission
requirements in § 1.150. The
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Commission will vote on the
Authority’s proposed budget no later
than November 1.
(b) Conditional collection of fees
allowed. The notice required to be sent
to State racing commissions estimating
the amount required from each State for
the subsequent year must state that the
amount required is based on the
proposed annual budget, as approved by
the Board of Directors, which takes
effect only if approved by the
Commission. The State racing
commissions (or covered persons in
States that do not elect to remit fees)
may nevertheless elect to remit fees, and
the Authority may conditionally collect
them, even before the Commission
approves the proposed budget. If the
Commission makes any modifications to
line items under paragraph (d) of this
section that have the net effect of
reducing the budget, the Authority must
refund any State racing commission or
covered person that has conditionally
paid by the proportionate amount owed
within 30 days. If the Commission
makes any modifications to line items
under paragraph (d) of this section that
have the net effect of increasing the
budget, the Authority may obtain loans
to make up the difference or may
account for the difference as a funding
shortfall incurred in the subsequent
year’s proposed budget.
(c) Decisional criteria. The
Commission will approve the proposed
budget if the Commission determines
that, on balance, the proposed budget
serves the goals of the Horseracing
Integrity and Safety Act in a prudent
and cost-effective manner, utilizing
commercially reasonable terms with all
outside vendors, and that its anticipated
revenues are sufficient to meet its
anticipated expenditures.
(d) Modification of line items. In its
decision on the proposed budget, the
Commission may modify the amount of
any line item.
(e) Public comments. Public
comments on the Authority’s proposed
budget should provide commenters’
views as to the decisional criteria and
whether any line items should be
modified.
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§ 1.152
Deviation from approved budget.
(a) When notice to the Commission is
required. The Authority may deviate
from the approved budget’s expenditure
information in a year as to any line item
by up to 10 percent in a year. If the
Authority determines that it is likely to
expend more than the approved
expenditure of any line item by 10
percent or more, or if it will exceed its
approved total expenditure by any
amount, it must notify the Commission
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immediately upon such a
determination.
(b) Line-item deviations of more than
10 percent. If the Authority determines
that it is likely to expend more than the
approved expenditure of any line item
by 10 percent or more, its notice to the
Commission must indicate whether it
intends to repurpose funds from one or
more different line items to cover the
increased expenditure. The Commission
retains the discretion to disapprove
such a proposed repurposing. The
Commission must issue any decision to
disapprove a proposed repurposing
within 7 business days of receiving
notice of the Authority’s proposal to
repurpose funds from another line item.
If the Commission takes no action, the
Authority’s proposal takes effect as an
amendment to its approved budget.
(c) Total expenditure deviation. If the
Authority determines that it is likely to
expend more than the total approved
expenditure, its notice to the
Commission must indicate by what
means it proposes to cover the
difference. The Commission retains the
discretion to disapprove the proposed
means of covering the difference. The
Commission must issue any decision to
disapprove a proposed means of
covering the difference within 7
business days of receiving notice of the
Authority’s proposal to cover the
difference. If the Commission takes no
action, the Authority’s proposal takes
effect as an amendment to its approved
budget.
By direction of the Commission,
Commissioner Wilson not participating.
April J. Tabor,
Secretary.
[FR Doc. 2023–06023 Filed 3–24–23; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–0986]
Change of Address; Technical
Amendment
Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION: Final rule; technical
amendment.
AGENCY:
The Food and Drug
Administration (FDA, Agency, or we) is
amending its regulations to update the
address, email address, and office name
SUMMARY:
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for the Office of Policy, Legislation, and
International Affairs, Office of Global
Policy and Strategy. This technical
amendment is to ensure accuracy and
clarity in the Agency’s regulations and
is nonsubstantive.
DATES: This rule is effective March 27,
2023.
FOR FURTHER INFORMATION CONTACT: Jeff
Nelligan, Office of Global Policy and
Strategy, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 3438, Silver Spring,
MD 20993, 301–796–8814,
Jeff.Nelligan@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
amending 21 CFR part 312 to update the
name of an office, its physical address,
and instructions for sending
certifications via email. Publication of
this document constitutes final action
on the changes under the
Administrative Procedure Act (5 U.S.C.
553). FDA has determined that notice
and public comment are unnecessary
because this amendment to the
regulations provides only technical
changes to update organizational
information.
List of Subjects in 21 CFR Part 312
Drugs, Exports, Imports,
Investigations, Labeling, Medical
research, Reporting and recordkeeping
requirements, Safety.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 312 is
amended as follows:
PART 312—INVESTIGATIONAL NEW
DRUG APPLICATION
1. The authority citation for part 312
continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 355, 360bbb, 371; 42 U.S.C. 262.
2. In § 312.110, revise paragraph (b)(4)
introductory text to read as follows:
■
§ 312.110
Import and export requirements.
*
21 CFR Part 312
Sfmt 4700
18037
*
*
*
*
(b) * * *
(4) Except as provided in paragraph
(b)(5) of this section, the person
exporting the drug sends an email
certification to the Office of Global
Policy and Strategy at OGPSExecSec@
fda.hhs.gov, or a written certification to
the Office of Global Policy and Strategy
(HFG–1), Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 3420, Silver Spring,
MD 20993, at the time the drug is first
exported and maintains records
documenting compliance with this
paragraph (b)(4). The certification shall
E:\FR\FM\27MRR1.SGM
27MRR1
Agencies
[Federal Register Volume 88, Number 58 (Monday, March 27, 2023)]
[Rules and Regulations]
[Pages 18034-18037]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06023]
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FEDERAL TRADE COMMISSION
16 CFR Part 1
Procedures for Oversight of the Horseracing Integrity and Safety
Authority's Annual Budget
AGENCY: Federal Trade Commission.
ACTION: Final rule.
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SUMMARY: The Federal Trade Commission (``Commission'') is issuing rules
pursuant to the Horseracing Integrity and Safety Act (``Act'') to
provide procedures for the Commission's oversight of the annual budget
of the Horseracing Integrity and Safety Authority (``Authority'').
DATES: This rule is effective on March 27, 2023.
FOR FURTHER INFORMATION CONTACT: John H. Seesel (202-326-2702), Office
of the General Counsel, Federal Trade Commission, 600 Pennsylvania
Avenue NW, Washington, DC 20580.
SUPPLEMENTARY INFORMATION: The Horseracing Integrity & Safety Act,\1\
enacted on December 27, 2020, and amended on December 29, 2022, directs
the Federal Trade Commission to oversee the activities of a private,
self-regulatory organization called the Horseracing Integrity and
Safety Authority.
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\1\ 15 U.S.C. 3051 through 3060.
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The Act, in subsection 15 U.S.C. 3052(f), sets forth certain
requirements for the Authority's budget. On the revenue side, as for
initial funding, the Authority is to obtain loans,\2\ and generally it
``may borrow funds toward the funding of its operations.'' \3\ After
the program effective date of July 1, 2022, the Authority performs an
annual calculation of the ``amount required'' from each State in which
covered horseracing takes place, which estimates the amount required
from each State ``to fund the State's proportionate share of the
horseracing anti-doping and medication control program and the
racetrack safety program for the next calendar year'' and ``to
liquidate the State's proportionate share of any loan or funding
shortfall.'' \4\ The amount required by each State is calculated under
the Assessment Methodology rule \5\ and must be ``based on,'' among
[[Page 18035]]
other things, ``the annual budget of the Authority for the following
calendar year.'' \6\
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\2\ See 15 U.S.C. 3052(f)(1)(A).
\3\ Id. 3052(f)(1)(B).
\4\ Id. 3052(f)(1)(C)(i).
\5\ The Assessment Methodology proposed rule was published in
the Federal Register and approved by the Commission after a period
of public comment. See Fed. Trade Comm'n, Notice of HISA Assessment
Methodology Proposed Rule, 87 FR 9349 (Feb. 28, 2022), https://www.federalregister.gov/documents/2022/02/18/2022-03717/hisa-assessment-methodology-rule (containing the text of the Assessment
Methodology proposed rule as submitted by the Authority); Fed. Trade
Comm'n, Order Approving the Assessment Methodology Rule Proposed by
the Horseracing Integrity & Safety Auth., at 1 (Apr. 1, 2022),
available at https://www.ftc.gov/system/files/ftc_gov/pdf/Order%20re%20HISA%20Assessment%20Methodology.pdf. The Authority
later submitted a proposed rule modification to Assessment
Methodology, which was also published in the Federal Register and
approved by the Commission after a period of public comment. See
Fed. Trade Comm'n, Notice of HISA Assessment Methodology Proposed
Rule Modification, 87 FR 67915 (Nov. 10, 2022), https://www.federalregister.gov/documents/2022/11/10/2022-24609/hisa-assessment-methodology-rule-modification; Fed. Trade Comm'n, Order
Approving the Assessment Methodology Rule Modification Proposed by
the Horseracing Integrity & Safety Auth., at 1 (Jan. 9, 2023),
available at https://www.ftc.gov/system/files/ftc_gov/pdf/order_re_hisa_assessment_methodology_modification_not_signed_002_0.pdf.
\6\ 15 U.S.C. 3052(f)(1)(C)(ii)(I)(aa).
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On the expenditure side of the budget, the Act provides that the
``initial budget'' requires approval by a two-thirds supermajority of
the Authority's Board of Directors, as does any ``subsequent budget
that exceeds the budget of the preceding calendar year by more than 5
percent.'' \7\ The Act has two more relevant provisions: ``A proposed
increase in the amount required under this subparagraph''--in other
words, the Authority's budget--``shall be reported to the Commission.''
\8\ And: ``The Commission shall publish in the Federal Register such a
proposed increase and provide an opportunity for public comment.'' \9\
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\7\ Id. 3052(f)(1)(C)(iii)(I), (II). Implicitly, subsequent
budgets that do not exceed by more than 5 percent the budget of the
preceding calendar year require only a simple majority of the
Authority's Board of Directors.
\8\ Id. 3052(f)(1)(C)(iv)(I).
\9\ Id. 3052(f)(1)(C)(iv)(II).
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The Act does not specify whether the Authority's proposed budget
takes effect upon the closing of the public-comment period or whether
the Commission is to consider the public comments and then decide
whether to approve or disapprove the Authority's proposed budget. On
the one hand, the Authority's budget is not listed among the eleven
enumerated items in 15 U.S.C. 3053(a) that ``shall not take effect
unless . . . approved by the Commission.'' \10\ On the other hand, what
the Authority submits (in the event of an increase in the amount
required) is a ``proposed increase,'' which implies that a Commission
decision to approve or disapprove the proposal will follow.\11\
Although the Act does not identify criteria by which the Commission
should evaluate the Authority's proposed budget, in December 2022
Congress conferred on the Commission the power to issue rules ``as the
Commission finds necessary or appropriate to ensure the fair
administration of the Authority . . . or otherwise in furtherance of
the purposes of this Act.'' \12\
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\10\ Id. 3053(b)(2).
\11\ Id. 3052(f)(1)(C)(iv)(I), (II) (emphasis added).
\12\ Consolidated Appropriations Act, 2023, H.R. 2617, 117th
Cong., Division O, Title VII (2022) (to be codified at 15 U.S.C.
3053(e)).
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The Commission hereby exercises this newly granted rulemaking
authority to clarify the Commission's role in approving and overseeing
the Authority's budget, as well as the public's role in providing
comment, and to set forth clear requirements as to the Authority's
budget. Specifically, the Commission adds a new subpart U to part 1 of
its Rules of Practice, to provide procedures for the Commission's
oversight of the Authority's budget.\13\
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\13\ In addition, the Commission intends in the near future to
engage in further rulemaking prescribing oversight of non-budgetary
aspects of the Authority's operations.
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I. Section 1.150--Authority's Proposed Budget Submissions
Section 1.150 provides for the Authority's proposed annual budget
to use the calendar year as its fiscal year and to be submitted to the
Commission by September 1 of the preceding year. The submission of the
proposed budget is required regardless of whether the Authority's
budget contains a ``proposed increase in the amount required'' as
compared to the previous year.\14\ The Commission believes that its
oversight of the Authority's budget is best performed consistently
rather than only when the amount required increases. In short, annual
rather than less-frequent budget oversight is a baseline requirement
``to ensure the fair administration of the Authority.'' \15\ The
Authority's submission must contain: an indication of the vote of its
Board of Directors; sufficient revenue and expenditure information,
broken out by line item, as would be required for members of the Board
of Directors to exercise their fiduciary duty of care; and a comparison
of the current year's actual revenues and expenditures with those that
were approved. The submission should address the Commission's budget
approval decision criteria: that the proposed budget serves the goals
of the Horseracing Integrity and Safety Act in a prudent and cost-
effective manner, utilizing commercially reasonable terms with all
outside vendors, and that its anticipated revenues are sufficient to
meet its anticipated expenditures. If the Commission determines that
the proposed budget as submitted satisfies the requirements, the
Commission will publish the proposed budget in the Federal Register for
14 days of public comment.
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\14\ 15 U.S.C. 3052(f)(1)(C)(iv).
\15\ Id. 3053(e).
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In addition, and notwithstanding the September 1 deadline for
submission of the Authority's next year's budget to the Commission,
Sec. 1.150 requires the Authority to post its anticipated budget for
the following year as early as is practicable in the preceding year.
The Authority's posting of its planned next year's budget shall include
an invitation to the public to submit comments to the Authority
concerning any aspect of the planned annual budget. The Authority is
required to post those public comments as they arrive on its website
and to review the comments in order to ascertain whether to revise the
budget in any manner. Further, Sec. 1.150 requires the Authority to
promptly provide the public comments that it receives to the
Commission, together with an assessment of such public comments that
the Authority believes would assist the Commission's evaluation of the
planned budget.
II. Section 1.151--Commission Decision on Authority's Proposed Budget
Section 1.151 provides that the Authority's proposed budget takes
effect only if approved by the Commission. This provision mirrors
others in the Act that require proposals made by the Authority, such as
for rules and rule modifications, to receive Commission approval before
they take effect. For ease of administration and to account for the
time the Commission may take to render a decision on the proposed
budget, the Authority is permitted to conditionally collect fees, and
State racing commissions (and covered persons in States that do not
elect to remit fees) are permitted to pay, based on the annual budget
as approved by the Authority's Board of Directors.
The criteria by which the Commission will decide whether to approve
or disapprove the Authority's proposed budget are in Sec. 1.151(c),
which provides that the Commission will approve the proposed budget if
the Commission determines, on balance, the proposed budget serves the
goals of the Act in a prudent and cost-effective manner, utilizing
commercially reasonable terms with all outside vendors, and anticipated
revenues are sufficient to meet its anticipated expenditures. With
respect to revenues and expenditures, the Commission may also modify
any line item. The Commission will publish the Authority's proposed
budget in the Federal Register for 14 days of public
[[Page 18036]]
comment. Public comments are welcomed as to both whether the submission
satisfies the Commission's decisional criteria and whether the
Commission should modify any line items.
III. Section 1.152--Deviation From Approved Budget
Section 1.152 sets forth what happens in circumstances in which
actual revenues or expenditures deviate from those approved in the
annual budget. When the Authority determines that, for a given
expenditure's line item, the actual expenditure is likely to exceed the
approved expenditure by more than 10 percent, it must immediately
notify the Commission. Such a notice must indicate whether the
Authority proposes to repurpose money from the line item of another
expenditure to make up the difference for the expenditure whose likely
actual amount will exceed the approved amount. So, too, when the
Authority determines that its overall expenditures will exceed its
approved expenditures, it must immediately notify the Commission. Such
a notice must indicate the means by which the Authority intends to make
up the difference, such as obtaining loans. For both overall-
expenditure and line-item deviations, the Commission retains the right
to disapprove the proposed repurposing or means of making up the
difference, which it must do within seven business days of receiving
the Authority's notice. If the Commission takes no action, the
Authority's proposal takes effect as an amendment to its budget.
Because these rules relate solely to agency procedure and practice,
publication for notice and comment is not required under the
Administrative Procedure Act. 5 U.S.C. 553(b).\16\
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\16\ For this reason, the requirements of the Regulatory
Flexibility Act, 5 U.S.C. 601(2), 604(a), are also inapplicable.
Likewise, the amendments do not modify any FTC collections of
information within the meaning of the Paperwork Reduction Act, 44
U.S.C. 3501 through 3521.
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List of Subjects in 16 CFR Part 1
Administrative practice and procedure.
For the reasons set forth in the preamble, the Federal Trade
Commission amends title 16, chapter I, subchapter A of the Code of
Federal Regulations as follows:
PART 1--GENERAL PROCEDURES
0
1. The authority citation for part 1 continues to read as follows:
Authority: 15 U.S.C. 46; 15 U.S.C. 57a; 5 U.S.C. 552; 5 U.S.C.
601 note.
0
2. Add subpart U to read as follows:
Subpart U--Procedures for Oversight of the Horseracing Integrity
and Safety Authority's Annual Budget
Sec.
1.150 Authority's proposed budget submissions.
1.151 Commission's decision on Authority's proposed budget.
1.152 Deviation from approved budget.
Sec. 1.150 Authority's proposed budget submissions.
(a) Mandatory annual submission. The Authority must submit a
proposed annual budget to the Commission every year, irrespective of
whether there is a ``proposed increase in the amount required'' under
15 U.S.C. 3052(f)(1)(C)(iv). The submission of the proposed budget for
the following year must be made by September 1 of the current year,
following the procedures set forth in Sec. 1.143. The Authority's
annual budget will use the calendar year as its fiscal year.
(b) Public comments. In addition to submitting its planned budget
to the Commission by September 1 of the preceding year, the Authority
shall post such planned budget on its own website as early as is
practicable, with an invitation to the public to submit comments to the
Authority on any aspect of the planned next year's budget. The
Authority shall post such comments on its website upon their arrival
and shall review them to ascertain whether to revise the budget in any
manner. In addition, the Authority shall promptly forward to the
Commission:
(1) Any such public comments that it receives; and
(2) An assessment of such public comments that it believes would
assist the Commission's evaluation of the Authority's planned budget.
(c) Contents of submission--(1) Indication of Board vote. The
Authority's proposed budget must be approved by a majority of its Board
of Directors (or, in the case of its initial budget or a budget that
exceeds the preceding year's budget by 5 percent or more, a two-thirds
supermajority) and must state the Board vote on the motion to approve
the budget.
(2) Revenue information. The proposed budget must identify both the
estimated amount required from each State racing commission as
calculated under 15 U.S.C. 3052(f) and all other sources of Authority
revenue as well as any loans proposed to be obtained by the Authority.
(3) Expenditure information. The proposed budget must identify
expenditures separately for:
(i) The racetrack safety program;
(ii) The anti-doping and medication control program;
(iii) All other programmatic expenditures other than for racetrack
safety and anti-doping and medication control, such as the
administration of the Authority or its technological needs;
(iv) Repayment of any loans; and
(v) Any funding shortfall incurred.
(4) Line items. For both revenue and expenditure information, the
Authority's proposed budget must provide sufficient information, by
line item, as would be required for members of the Authority's Board of
Directors to exercise their fiduciary duty of care. For example, the
proposed budget's expenditure information for anti-doping and
medication control might include separate line items for in-house
salaries, the costs of testing of laboratory samples, the costs of
arbitrators, and all the costs associated with contracting with an
anti-doping and medication control enforcement agency. The proposed
budget must include a narrative component that provides a brief
explanation of each line item's utility in carrying out the purposes of
the Horseracing Integrity and Safety Act.
(5) Comparison of approved budget to actual revenues and
expenditures. The proposed budget must provide a comparison showing,
for each approved line item, the actual revenues and expenditures for
the current year along with a narrative component explaining why any
line item is anticipated to deviate by 10 percent or more during the
current year.
(d) Approval and publication of submission. The Commission will
publish the Authority's proposed budget in the Federal Register if the
Commission determines that the proposed budget contains sufficient
information for the members of the Board of Directors of the Authority
to exercise their fiduciary duty of care and meets the requirements of
this subpart. Members of the public will then have 14 days in which to
file comments on the proposed budget.
Sec. 1.151 Commission's decision on Authority's proposed budget.
(a) Commission approval required. The Authority's proposed budget
takes effect only if approved by the Commission. The Commission will
approve or disapprove the proposed budget after considering the public
comments filed and the Commission's internal review per the submission
requirements in Sec. 1.150. The
[[Page 18037]]
Commission will vote on the Authority's proposed budget no later than
November 1.
(b) Conditional collection of fees allowed. The notice required to
be sent to State racing commissions estimating the amount required from
each State for the subsequent year must state that the amount required
is based on the proposed annual budget, as approved by the Board of
Directors, which takes effect only if approved by the Commission. The
State racing commissions (or covered persons in States that do not
elect to remit fees) may nevertheless elect to remit fees, and the
Authority may conditionally collect them, even before the Commission
approves the proposed budget. If the Commission makes any modifications
to line items under paragraph (d) of this section that have the net
effect of reducing the budget, the Authority must refund any State
racing commission or covered person that has conditionally paid by the
proportionate amount owed within 30 days. If the Commission makes any
modifications to line items under paragraph (d) of this section that
have the net effect of increasing the budget, the Authority may obtain
loans to make up the difference or may account for the difference as a
funding shortfall incurred in the subsequent year's proposed budget.
(c) Decisional criteria. The Commission will approve the proposed
budget if the Commission determines that, on balance, the proposed
budget serves the goals of the Horseracing Integrity and Safety Act in
a prudent and cost-effective manner, utilizing commercially reasonable
terms with all outside vendors, and that its anticipated revenues are
sufficient to meet its anticipated expenditures.
(d) Modification of line items. In its decision on the proposed
budget, the Commission may modify the amount of any line item.
(e) Public comments. Public comments on the Authority's proposed
budget should provide commenters' views as to the decisional criteria
and whether any line items should be modified.
Sec. 1.152 Deviation from approved budget.
(a) When notice to the Commission is required. The Authority may
deviate from the approved budget's expenditure information in a year as
to any line item by up to 10 percent in a year. If the Authority
determines that it is likely to expend more than the approved
expenditure of any line item by 10 percent or more, or if it will
exceed its approved total expenditure by any amount, it must notify the
Commission immediately upon such a determination.
(b) Line-item deviations of more than 10 percent. If the Authority
determines that it is likely to expend more than the approved
expenditure of any line item by 10 percent or more, its notice to the
Commission must indicate whether it intends to repurpose funds from one
or more different line items to cover the increased expenditure. The
Commission retains the discretion to disapprove such a proposed
repurposing. The Commission must issue any decision to disapprove a
proposed repurposing within 7 business days of receiving notice of the
Authority's proposal to repurpose funds from another line item. If the
Commission takes no action, the Authority's proposal takes effect as an
amendment to its approved budget.
(c) Total expenditure deviation. If the Authority determines that
it is likely to expend more than the total approved expenditure, its
notice to the Commission must indicate by what means it proposes to
cover the difference. The Commission retains the discretion to
disapprove the proposed means of covering the difference. The
Commission must issue any decision to disapprove a proposed means of
covering the difference within 7 business days of receiving notice of
the Authority's proposal to cover the difference. If the Commission
takes no action, the Authority's proposal takes effect as an amendment
to its approved budget.
By direction of the Commission, Commissioner Wilson not
participating.
April J. Tabor,
Secretary.
[FR Doc. 2023-06023 Filed 3-24-23; 8:45 am]
BILLING CODE 6750-01-P