Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics To Treat Pain and Addiction; Public Hearing; Correction, 43737-43738 [2019-18090]
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Federal Register / Vol. 84, No. 163 / Thursday, August 22, 2019 / Proposed Rules
2.5 percent of total non-interest
expenses. The FDIC believes that effects
in excess of these thresholds typically
represent significant effects for FDICsupervised institutions. For the reasons
described below and under section
605(b) of the RFA, the FDIC certifies
that this proposed rule will not have a
significant economic effect on a
substantial number of small entities.
The FDIC supervises 3,489 depository
institutions,13 of which 2,674 are
considered small entities for the
purposes of RFA.14 The proposed rule
will only affect institutions currently
engaged in arranging, issuing or acting
as servicer for privately placed
securitizations of asset-backed
securities, or likely to do so as a result
of the proposed rule. The FDIC knows
of no small FDIC-insured institution
that is currently acting in this capacity.
The FDIC believes that acting as
arranger, issuer or servicer for privately
placed ABS requires a level of resources
and capital markets expertise that
would preclude a substantial number of
small FDIC-insured institutions from
becoming involved in these activities.
Accordingly, the FDIC concludes that
the proposed rule will not have a
significant impact on a substantial
number of small entities. For the
reasons described above and pursuant to
5 U.S.C. 605(b), the FDIC certifies that
the proposed rule will not have a
significant economic impact on a
substantial number of small entities.
The FDIC invites comments on all
aspects of the supporting information
provided in this RFA section. In
particular, would this rule have any
significant effects on small entities that
the FDIC has not identified?
C. Plain Language
Section 722 of the Gramm-LeachBliley Act 15 requires the Federal
banking agencies to use plain language
in all proposed and final rules
published after January 1, 2000. The
FDIC has sought to present the proposed
rule in a simple and straightforward
manner, and invites comment on the
use of plain language. For example:
• Has the FDIC organized the material
to suit your needs? If not, how could
this material be better organized?
• Are the requirements in the
proposed rule clearly stated? If not, how
could the rule be stated more clearly?
• Does the proposed rule contain
language or jargon that is unclear? If so,
which language requires clarification?
13 FDIC-supervised institutions are set forth in 12
U.S.C. 1813(q)(2).
14 FDIC Call Report, December 31, 2018.
15 Public Law 106–102, sec. 722, 113 Stat. 1338,
1471 (1999).
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• What else could the FDIC do to
make the proposed rule easier to
understand?
D. Riegle Community Development and
Regulatory Improvement Act of 1994
Pursuant to section 302(a) of the
Riegle Community Development and
Regulatory Improvement Act (RCDRIA),
in determining the effective date and
administrative compliance requirements
for new regulations that impose
additional reporting, disclosure, or other
requirements on insured depository
institutions, each federal banking
agency must consider, consistent with
principles of safety and soundness and
the public interest, any administrative
burdens that such regulations would
place on insured depository institutions,
including small depository institutions,
and customers of depository
institutions, as well as the benefits of
such regulations.16 In addition, section
302(b) of RCDRIA requires new
regulations and amendments to
regulations that impose additional
reporting, disclosures, or other new
requirements on insured depository
institutions generally to take effect on
the first day of a calendar quarter that
begins on or after the date on which the
regulations are published in final
form.17
The FDIC has determined that the
proposed rule would not impose
additional reporting, disclosure, or other
requirements; therefore the
requirements of RCDRIA do not apply.
However, the FDIC invites any
comments that will inform its
consideration of RCDRIA.
List of Subjects in 12 CFR Part 360
Banks, Banking, Bank deposit
insurance, Holding companies, National
banks, Participations, Reporting and
recordkeeping requirements, Savings
associations, Securitizations.
43737
2. Revise § 360.6(b)(2)(i)(A) to read as
follows:
■
§ 360.6 Treatment of financial assets
transferred in connection with a
securitization or participation.
*
*
*
*
*
(b) * * *
(2) * * *
(i) * * *
(A) In the case of an issuance of
obligations that is subject to 17 CFR part
229, subpart 229.1100 (Regulation AB of
the Securities and Exchange
Commission (Regulation AB)), the
documents shall require that, on or prior
to issuance of obligations and at the
time of delivery of any periodic
distribution report and, in any event, at
least once per calendar quarter, while
obligations are outstanding, information
about the obligations and the securitized
financial assets shall be disclosed to all
potential investors at the financial asset
or pool level, as appropriate for the
financial assets, and security-level to
enable evaluation and analysis of the
credit risk and performance of the
obligations and financial assets. The
documents shall require that such
information and its disclosure, at a
minimum, shall comply with the
requirements of Regulation AB.
Information that is unknown or not
available to the sponsor or the issuer
after reasonable investigation may be
omitted if the issuer includes a
statement in the offering documents
disclosing that the specific information
is otherwise unavailable;
*
*
*
*
*
Federal Deposit Insurance Corporation.
By order of the Board of Directors.
Dated at Washington, DC, on July 16, 2019.
Robert E. Feldman,
Executive Secretary.
[FR Doc. 2019–15536 Filed 8–21–19; 8:45 am]
BILLING CODE 6714–01–P
Authority and Issuance
For the reasons set forth in the
preamble, the Federal Deposit Insurance
Corporation proposes to amend 12 CFR
part 360 as follows:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PART 360—RESOLUTION AND
RECEIVERSHIP RULES
21 CFR Part 15
1. The authority citation for part 360
continues to read as follows:
■
Authority: 12 U.S.C.
1821(d)(1),1821(d)(10)(C), 1821(d)(11),
1821(e)(1), 1821(e)(8)(D)(i), 1823(c)(4),
1823(e)(2); Sec. 401(h), Public Law 101–73,
103 Stat. 357.
Fmt 4702
Standards for Future Opioid Analgesic
Approvals and Incentives for New
Therapeutics To Treat Pain and
Addiction; Public Hearing; Correction
AGENCY:
Food and Drug Administration,
HHS.
Notification of public hearing;
request for comments; correction.
U.S.C. 4802(a).
17 12 U.S.C. 4802(b).
Frm 00009
[Docket No. FDA–2019–N–2514]
ACTION:
16 12
PO 00000
Food and Drug Administration
Sfmt 4702
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22AUP1
43738
Federal Register / Vol. 84, No. 163 / Thursday, August 22, 2019 / Proposed Rules
SUMMARY: The Food and Drug
Administration (FDA) is correcting a
notice entitled ‘‘Standards for Future
Opioid Analgesic Approvals and
Incentives for New Therapeutics To
Treat Pain and Addiction; Public
Hearing’’ that appeared in the Federal
Register of June 21, 2019. The document
was published with incorrect presenter
registration and slide deck submission
deadlines. This document corrects those
deadlines.
FOR FURTHER INFORMATION CONTACT:
Nicole Zelenak, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6429,
Silver Spring, MD 20993–0002, 301–
796–9030.
SUPPLEMENTARY INFORMATION: In the
Federal Register of Friday, June 21,
2019 (84 FR 29112), in FR Doc. 2019–
13219, on page 29114, the following
correction is made:
On page 29114, in the first column, in
the ‘‘Presenter’’ bulleted paragraph, the
fourth and fifth sentences ‘‘Presenters
must register no later than August 9,
2019. Slide decks are due to CDERPublicMeeting@fda.hh.gov in PDF or
PowerPoint format no later than August
23, 2019.’’ are corrected to read
‘‘Presenters must register no later than
September 6, 2019. Slide decks are due
to CDER-PublicMeeting@fda.hh.gov in
PDF or PowerPoint format no later than
September 6, 2019.’’
Dated: August 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–18090 Filed 8–21–19; 8:45 am]
BILLING CODE 4164–01–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R09–OAR–2018–0713: FRL–9998–36–
Region 9]
Revisions to California State
Implementation Plan; Antelope Valley
Air Quality Management District and
Ventura County Air Pollution Control
District; Nonattainment New Source
Review Requirements for the 2008
8-Hour Ozone Standard
Environmental Protection
Agency (EPA).
AGENCY:
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ACTION:
Proposed rule.
SUMMARY: The Environmental Protection
Agency (EPA) is proposing to approve
two state implementation plan (SIP)
revisions submitted by the State of
California addressing the nonattainment
new source review (NNSR)
requirements for the 2008 8-hour ozone
National Ambient Air Quality Standards
(NAAQS) and one SIP revision
regarding a permit rule. These SIP
revisions address the Antelope Valley
Air Quality Management District
(AVAQMD or District) and Ventura
County Air Pollution Control District
(VCAPCD or District) portions of the
California SIP. This action is being
taken pursuant to the Clean Air Act
(CAA or ‘‘Act’’) and its implementing
regulations.
Any comments must arrive by
September 23, 2019.
ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–R09–
OAR–2018–0713 at https://
www.regulations.gov, or via email to
R9AirPermits@epa.gov. For comments
submitted at Regulations.gov, follow the
online instructions for submitting
comments. Once submitted, comments
cannot be removed or edited from
Regulations.gov. For either manner of
submission, the EPA may publish any
comment received to its public docket.
Do not submit electronically any
information you consider to be
Confidential Business Information (CBI)
or other information whose disclosure is
restricted by statute. Multimedia
submissions (audio, video, etc.) must be
accompanied by a written comment.
The written comment is considered the
official comment and should include
discussion of all points you wish to
make. The EPA will generally not
consider comments or comment
contents located outside of the primary
submission (i.e., on the web, cloud, or
other file sharing system). For
additional submission methods, please
contact the person identified in the FOR
FURTHER INFORMATION CONTACT section.
For the full EPA public comment policy,
information about CBI or multimedia
submissions, and general guidance on
making effective comments, please visit
https://www2.epa.gov/dockets/
commenting-epa-dockets.
FOR FURTHER INFORMATION CONTACT:
Manny Aquitania, EPA Region IX, 75
Hawthorne St., San Francisco, CA
DATES:
PO 00000
Frm 00010
Fmt 4702
Sfmt 4702
94105; (415) 972–3977,
aquitania.manny@epa.gov.
SUPPLEMENTARY INFORMATION:
Throughout this document, the terms
‘‘we,’’ ‘‘us,’’ and ‘‘our’’ refer to EPA.
Table of Contents
I. Background and Purpose
II. The State’s Submittal
A. What did the State submit?
B. What is the purpose of the submitted
certification letters?
C. What is the purpose of the submitted
permit rule?
III. Analysis of Nonattainment New Source
Review Requirements
A. Antelope Valley Air Quality
Management District (AVAQMD)
B. Ventura County Air Pollution Control
District (VCAPCD)
IV. Proposed Action and Public Comment
V. Incorporation by Reference
VI. Statutory and Executive Order Reviews
I. Background and Purpose
On May 10, 2019, EPA published a
notice of proposed rulemaking regarding
the NNSR requirements for the 2008 8hour ozone NAAQS and one SIP
revision regarding a permit rule. The
EPA received one comment, stating that
Section V, Incorporation by Reference of
the proposed rule, contained a minor
administrative error regarding what
provisions were to be incorporated by
reference. In response, Section V of
today’s Federal Register notice now
clearly states we are proposing to
incorporate into the SIP Ventura County
Rule 10, ‘‘Required Permits’’.
On March 12, 2008, the EPA
promulgated a revised 8-hour ozone
NAAQS of 0.075 parts per million
(ppm).1 Upon promulgation of a new or
revised NAAQS, the CAA requires the
EPA to designate as nonattainment any
area that is violating the NAAQS based
on the three most recent years of
ambient air quality data. The two
California air districts that are subject to
this action were designated
nonattainment for the 2008 8-hour
ozone NAAQS on April 30, 2012, using
years 2009–2011 ambient air quality
data.2 At the time of designation, the
AVAQMD was classified as a severe
ozone nonattainment area as part of the
Mojave Desert Air Basin and VCAPCD
was classified as a serious ozone
nonattainment area as part of the South
Central Coast Air Basin.
1 73
2 77
E:\FR\FM\22AUP1.SGM
FR 16436 (March 27, 2008).
FR 30088 (May 21, 2012).
22AUP1
]]>Agencies
[Federal Register Volume 84, Number 163 (Thursday, August 22, 2019)]
[Proposed Rules]
[Pages 43737-43738]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18090]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 15
[Docket No. FDA-2019-N-2514]
Standards for Future Opioid Analgesic Approvals and Incentives
for New Therapeutics To Treat Pain and Addiction; Public Hearing;
Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of public hearing; request for comments;
correction.
-----------------------------------------------------------------------
[[Page 43738]]
SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
entitled ``Standards for Future Opioid Analgesic Approvals and
Incentives for New Therapeutics To Treat Pain and Addiction; Public
Hearing'' that appeared in the Federal Register of June 21, 2019. The
document was published with incorrect presenter registration and slide
deck submission deadlines. This document corrects those deadlines.
FOR FURTHER INFORMATION CONTACT: Nicole Zelenak, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6429, Silver Spring, MD 20993-0002, 301-
796-9030.
SUPPLEMENTARY INFORMATION: In the Federal Register of Friday, June 21,
2019 (84 FR 29112), in FR Doc. 2019-13219, on page 29114, the following
correction is made:
On page 29114, in the first column, in the ``Presenter'' bulleted
paragraph, the fourth and fifth sentences ``Presenters must register no
later than August 9, 2019. Slide decks are due to [email protected] in PDF or PowerPoint format no later than
August 23, 2019.'' are corrected to read ``Presenters must register no
later than September 6, 2019. Slide decks are due to [email protected] in PDF or PowerPoint format no later than
September 6, 2019.''
Dated: August 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-18090 Filed 8-21-19; 8:45 am]
BILLING CODE 4164-01-P
