Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics To Treat Pain and Addiction; Public Hearing; Correction, 43737-43738 [2019-18090]

Download as PDF 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). VerDate Sep<11>2014 16:22 Aug 21, 2019 Jkt 247001 • 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 E:\FR\FM\22AUP1.SGM 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: VerDate Sep<11>2014 16:22 Aug 21, 2019 Jkt 247001 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.

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[[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

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