Animal and Plant Health Inspection Service
Economic Development Administration
National Oceanic and Atmospheric Administration
Federal Energy Regulatory Commission
Food and Drug Administration
National Institutes of Health
Transportation Security Administration
U.S. Customs and Border Protection
Ocean Energy Management Bureau
Drug Enforcement Administration
Federal Aviation Administration
Federal Highway Administration
Foreign Assets Control Office
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription.
Federal Energy Regulatory Commission, Energy.
Final rule.
Pursuant to the authority delegated by the Commission's regulations, the Director of the Office of Energy Projects (OEP) computes and publishes the project cost and annual limits for natural gas pipelines blanket construction certificates for each calendar year.
This final rule is effective March 3, 2021 and establishes cost limits applicable from January 1, 2021 through December 31, 2021.
Richard W. Foley, Chief, Certificates Branch 1, Division of Pipeline Certificates, (202) 502-8955.
Section 157.208(d) of the Commission's Regulations provides for project cost limits applicable to construction, acquisition, operation and miscellaneous rearrangement of facilities (Table I) authorized under the blanket certificate procedure (Order No. 234, 19 FERC ¶ 61,216). Section 157.215(a) specifies the calendar year dollar limit which may be expended on underground storage testing and development (Table II) authorized under the blanket certificate. Section 157.208(d) requires that the “limits specified in Tables I and II shall be adjusted each calendar year to reflect the 'GDP implicit price deflator' published by the Department of Commerce for the previous calendar year.”
Pursuant to § 375.308(x)(1) of the Commission's Regulations, the authority for the publication of such cost limits, as adjusted for inflation, is delegated to the Director of the Office of Energy Projects. The cost limits for calendar year 2021, as published in Table I of § 157.208(d) and Table II of § 157.215(a), are hereby issued.
This final rule is effective March 3, 2021. The provisions of 5 U.S.C. 804 regarding Congressional review of final rules does not apply to the final rule because the rule concerns agency procedure and practice and will not substantially affect the rights or obligations of non-agency parties. The final rule merely updates amounts published in the Code of Federal Regulations to reflect the Department of Commerce's latest annual determination of the Gross Domestic Product (GDP) implicit price deflator, a mathematical updating required by the Commission's existing regulations.
Administrative practice and procedure, Natural gas, Reporting and recordkeeping requirements.
Accordingly, 18 CFR part 157 is amended as follows:
15 U.S.C. 717-717w, 3301-3432; 42 U.S.C. 7101-7352.
(d) * * *
(a) * * *
(5) * * *
Drug Enforcement Administration, Department of Justice.
Final rule.
This final rule adopts, without change, an interim final rule with request for comments published in the
The effective date of this final rulemaking is March 3, 2021.
Dr. Terrence L. Boos, Drug and Chemical Evaluation Section, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: 571-362-3249.
Under the Controlled Substances Act (CSA), as amended in 2015 by the Improving Regulatory Transparency for New Medical Therapies Act (Pub. L. 114-89), when the Drug Enforcement Administration (DEA) receives notification from the Department of Health and Human Services (HHS) that the Secretary has approved a certain new drug and HHS recommends control in the CSA schedule II-V, DEA is required to issue an interim final rule, with opportunity for public comment and to request a hearing, controlling the drug within a specified 90-day timeframe and to subsequently issue a final rule. 21 U.S.C. 811(j). When controlling a drug pursuant to subsection (j), DEA must apply the scheduling criteria of 21 U.S.C. 811 (b) through (d) and 812(b). 21 U.S.C. 811(j)(3).
On April 7, 2020, DEA published an interim final rule to make lemborexant (including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible) a schedule IV controlled substance. 85 FR 19387. The interim final rule provided an opportunity for interested persons to submit comments as well as file a request for hearing or waiver of hearing, on or before May 7, 2020. DEA did not receive any requests for hearing or waiver of hearing.
DEA received five comments in response to the interim final rule for the placement of lemborexant into schedule IV of the CSA. The submissions were from individual or anonymous commenters. Two commenters provided support for the interim final rule, one commenter opposed the rule, one commenter solely included a link to potential malware, and one commenter expressed views on a subject not related to the rule. As these final two comments were outside the scope of this rulemaking, DEA did not summarize or respond to them below.
A commenter supported controlling lemborexant as a schedule IV controlled substance, if such control helped to prevent abuse of, or the addiction to, this substance. Another commenter noted HHS, in its analysis, found that lemborexant had similar abuse potential to other schedule IV sedatives such as suvorexant and zolpidem, and therefore, agreed with HHS's recommendation of schedule IV control for lemborexant. In addition, this commenter referenced a study, conducted by Eisai, Inc. (the Sponsor of the new drug application for Dayvigo (lemborexant)), and recommended that DEA add this particular study analysis regarding abuse and dependency potential to DEA's final rule, under the “Determination to Schedule Lemborexant” section, to further support DEA's placing lemborexant in schedule IV.
A commenter claimed that DEA did not rely on the pharmacological data for lemborexant or follow any of the other factors required to be considered under 21 U.S.C. 811(c) to determine the placement of lemborexant in schedule IV. Instead, the commenter stated that DEA relied on a “small and unrepeated sample group” and its subjective responses, which matched responses to the schedule IV sedative suvorexant. The commenter also contended that there is a disparity in DEA's scheduling treatment for lemborexant (schedule IV) and Rozarem (non-controlled), as these both are sedatives—with the same Food and Drug Administration (FDA)-approved indication—that exert pharmacological activity by other means than binding to gamma-aminobutyric acid (GABA) receptors. As such, the commenter considered DEA's decision to schedule lemborexant “arbitrary and capricious.” This commenter further stated that the placement of lemborexant in schedule IV of the CSA would increase the regulatory restrictions on a drug intended to treat insomnia, thereby causing many to resort to more dangerous and addictive substances such as benzodiazepines and other drugs that bind to the GABA receptor. Lastly, the commenter stated lemborexant is a new molecular entity thus evidence of actual abuse or potential for abuse liability does not exist. Therefore, the commenter asserted that DEA should either not place lemborexant in the same schedule as drugs with proven abuse potential, such as Xanax and Ambien, or delay scheduling lemborexant until evidence of actual abuse data can be produced using the eight-factors stipulated in 21 U.S.C. 811(c).
Regarding the commenter's concerns that the control of lemborexant as a schedule IV drug would negatively impact treatment choices and increase addiction risks, DEA contends that there
Regarding the commenter's point that lemborexant is a new molecular entity with unknown actual or potential for abuse, and the commenter's request for DEA to either not place lemborexant in schedule IV or to postpone such scheduling until there is evidence showing the requisite abuse potential, DEA's determination of the abuse liability of lemborexant in the interim final rule, and again in this final rule, is in agreement with that of HHS. In a clinical HAP study investigating the abuse potential of lemborexant, HHS concluded that lemborexant produced subjective responses that were similar to those for the schedule IV sedative suvorexant. In the context of drug development, HAP studies are conducted as a component of the safety evaluation of a new molecular entity. These studies are utilized by HHS, FDA, and the scientific community. They are accepted as repeatable and follow rigorous scientific guidelines. In effect, the HAP studies are indeed evidence showing the requisite abuse potential of lemborexant; therefore, no additional studies are necessary to prove potential for abuse. Additionally, HHS' evaluation of a HAP study conducted by the Sponsor concluded that lemborexant produces positive subjective effects and has abuse potential similar to that of schedule IV sedatives, such as suvorexant and zolpidem, which were used as positive controls in the study. DEA asserts that when the evidence of actual abuse is not available, both HHS and DEA rely upon data from preclinical and clinical studies to inform determinations on potential for abuse of a given substance. Therefore, upon evaluation of the above-mentioned clinical studies and other preclinical data, DEA concurred with HHS' findings that the abuse liability of lemborexant is similar to other substances placed in schedule IV (
Finally, we address the commenter's claim that the control of lemborexant is improper because there is another substance, that is not controlled, which the commenter asserts has similar pharmacological properties to those of lemborexant. DEA contends that while both drugs are classified as sedatives with similar FDA-approved indications, they do not share the same pharmacological mechanism of action or abuse liability. Even assuming this assertion were correct, this is not a legal basis to decline to control a substance. The CSA does not require, as a condition of control under 21 U.S.C. 811, that every other substance with similar properties be simultaneously controlled.
Based on the rationale set forth in the interim final rule, DEA adopts the interim final rule without change.
As indicated above, lemborexant has been a schedule IV controlled substance by virtue of the interim final rule issued by DEA in April 2020. Thus, this final rule does not alter the regulatory requirements applicable to handlers of lemborexant that have been in place since that date. Nonetheless, for informational purposes, we re-state here those requirements. Lemborexant is subject to the CSA's schedule IV regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, dispensing, importing, exporting, research, and conduct of instructional activities and chemical analysis with, and possession involving schedule IV substances, including, but not limited to, the following:
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
This final rule, without change, affirms the amendment made by the interim final rule that is already in effect. Section 553 of the Administrative Procedure Act (APA) (5 U.S.C. 553) generally requires notice and comment for rulemakings. However, 21 U.S.C. 811(j) provides that in cases where a certain new drug is: (1) Approved by HHS and (2) HHS recommends control in CSA schedule II-V, DEA shall issue an interim final rule scheduling the drug within 90 days. Additionally, subsection (j) specifies that the rulemaking shall become immediately effective as an interim final rule without requiring DEA to demonstrate good cause. DEA issued an interim final rule on April 7, 2020, and solicited public comments on that rule. Subsection (j) further states that after giving interested persons the opportunity to comment and to request a hearing, the Attorney General, as delegated to the Administrator of DEA, shall issue a final rule in accordance with the scheduling criteria of 21 U.S.C. 811 (b) through (d) and 812(b). DEA is now responding to the comments submitted by the public and issuing the final rule in accordance with subsection (j).
In accordance with 21 U.S.C. 811(a) and (j), this scheduling action is subject to formal rulemaking procedures performed “on the record after opportunity for a hearing,” which are conducted pursuant to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth the procedures and criteria for scheduling a drug or other substance. Such actions are exempt from review by the Office of Management and Budget (OMB) pursuant to section 3(d)(1) of Executive Order (E.O.) 12866 and the principles reaffirmed in E.O. 13563.
This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.
This final rule does not have federalism implications warranting the application of E.O. 13132. The final rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
This final rule does not have tribal implications warranting the application of E.O. 13175. It does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to rules that are subject to notice and comment under section 553(b) of the APA. As noted in the above discussion regarding the applicability of the APA, DEA was not required to publish a general notice of proposed rulemaking. Consequently, the RFA does not apply.
In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 1501
This action does not impose a new collection of information requirement under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521. This action does not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
This final rule is not a major rule as defined by the Congressional Review Act (CRA), 5 U.S.C. 804. This rule will not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of the U.S.-based companies to compete with foreign-based companies in domestic and export markets. However, pursuant to the CRA, DEA has submitted a copy of this final rule to both Houses of Congress and to the Comptroller General.
Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements.
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) approves the Mashantucket Pequot Tribal Nation's (MPTN or the Tribe) Tribal Implementation Plan (TIP) under the Clean Air Act (CAA) to regulate air pollution within the exterior boundaries of the Tribe's reservation. The TIP is one of two CAA regulatory programs that comprise the Tribe's Clean Air Program (CAP). EPA approved the Tribe for treatment in the same manner as a State (Treatment as State or TAS) for purposes of administering New Source Review (NSR) and Title V operating permits under the CAA on July 10, 2008. In this action we act only on those portions of MPTN's CAP that constitute a TIP containing severable elements of
This rule is effective on April 2, 2021.
EPA has established a docket for this action under Docket Identification No. EPA-R01-OAR-2020-0374. All documents in the docket are listed on the
Patrick Bird, Air Permits, Toxics and Indoor Programs Branch, U.S. Environmental Protection Agency, Region 1, 5 Post Office Square, Mail Code: 05-2, Boston, MA 02109-0287. Telephone: 617-918-1287. Fax: 617-918-0287. Email:
Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.
On September 9, 2020 (85 FR 55628), EPA published a Notice of Proposed Rulemaking (NPRM) for a TIP submitted by the MPTN for approval under section 110 of the CAA. The TIP addresses attainment and maintenance of the National Ambient Air Quality Standards (NAAQS) by establishing a federally enforceable preconstruction permitting program within the exterior boundaries of the Tribe's reservation. It also allows for sources that otherwise would have the potential to emit hazardous air pollutants or regulated NSR pollutants in amounts at or above those for major sources to request federally enforceable permit limitations that restrict emissions to below those of a major source.
The MPTN is an Indian Tribe federally recognized in 1983 by Congressional legislation (Pub. L. 98-134, sec. 9, Oct. 1St, 1983 97 Stat 855, Title 25 U.S.C.A. 1751-1760). The Secretary of the Interior recognizes the “Mashantucket Pequot Tribe of Connecticut” (73 FR 18553, 18554, April 4, 2008). MPTN's CAP was established by Tribal Council Resolution in 2005 (TCR102600-01 of 02). On July 10, 2008, EPA determined that the Tribe is eligible for TAS for these purposes.
The MPTN formally submitted the applicable elements of its TIP to EPA Region 1 on December 7, 2018. Having found that the MPTN is eligible for TAS to implement these regulatory programs, EPA is now approving the Tribe's TIP. We intend to act on the Tribe's title V operating permit program in separate notice and comment processes, as appropriate.
The rationale for EPA's proposed approval of the MTPN TIP is explained in the NPRM and will not be restated here. No adverse public comments were received on the NPRM.
EPA received three comments during the comment period, all of which supported EPA's proposed action. As such, these comments do not require further response to finalize the action as proposed.
EPA is approving the MPTN's TIP under the Clean Air Act to regulate air pollution within the exterior boundaries of the Tribe's reservation. In this action we act only on those portions of MPTN's CAP that constitute a TIP containing severable elements of an implementation plan under CAA section 110(a). The TIP includes permitting requirements for major and minor sources of air pollution. Specifically, we are approving the following sections of the MPTN's air quality regulations. Title 12, Subtitle 12.1, § 2—Applicability (with effective date); Title 12, Subtitle 12.1, § 4—Definitions; and Title 12, Subtitle 12.2—New Source Review—MPTN TIP.
In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of the MPTN rules discussed in section I. and III. of this preamble. EPA has made, and will continue to make, these documents generally available through
Under the Clean Air Act, the Administrator is required to approve a TIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing TIP submissions, EPA's role is to approve tribal choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this final action merely approves tribal law as meeting Federal requirements and does not impose additional requirements beyond those imposed by tribal law. For that reason, this action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by May 3, 2021. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)
Environmental protection, Administrative practice and procedure, Air pollution control, Incorporation by reference, Indians, Intergovernmental relations, Reporting and recordkeeping requirements.
42 U.S.C. 7401
Part 49 of chapter I, title 40 of the Code of Federal Regulations is amended as follows:
42 U.S.C. 7401
(a)
(b)
(2) EPA Region 1 certifies that the rules/regulations provided by EPA in the TIP compilation at the addresses in paragraph (b)(3) of this section are an exact duplicate of the officially promulgated tribal rules/regulations which have been approved as part of the Tribal Implementation Plan as of January 6, 2021.
(3) Copies of the materials incorporated by reference may be inspected at the EPA Region 1 Office, 5 Post Office Square, Suite 100, Boston, MA 02109-3912 and at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email
(c)
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is taking final action to approve a state implementation plan (SIP) revision submitted by the State of California to address Clean Air Act (CAA or “Act”) requirements for the 2012 annual fine particulate matter (PM
This rule is effective on April 2, 2021.
The EPA has established a docket for this action under Docket ID No. EPA-R09-OAR-2020-0534. All documents in the docket are listed on the
John Ungvarsky, Air Planning Office (AIR-2), EPA Region IX, 75 Hawthorne Street, San Francisco, CA 94105, (415) 972-3963 or
Throughout this document, “we,” “us,” and “our” refer to the EPA.
On January 15, 2013, the EPA strengthened the primary annual NAAQS for particulate matter with a diameter of 2.5 microns or less by lowering the level from 15.0 micrograms per cubic meter (μg/m
Epidemiological studies have shown statistically significant correlations between elevated levels of PM
Following promulgation of a new or revised NAAQS, the EPA is required by CAA section 107(d) to designate areas throughout the nation as attaining or not attaining the NAAQS. The EPA designated and classified the Portola nonattainment area as “Moderate” nonattainment for the 2012 annual PM
The Portola nonattainment area includes the City of Portola (“Portola”), which has a population of approximately 2,100 and is located at an elevation of 4,890 feet in an intermountain basin isolated by rugged mountains. For a precise description of the geographic boundaries of the Portola nonattainment area, see 40 CFR 81.305.
The local air district with primary responsibility for developing a plan to attain the 2012 annual PM
On February 28, 2017, California submitted the “Portola Fine Particulate Matter (PM
On October 28, 2020, CARB submitted “Ordinance No. 359: An Ordinance of the City of Portola, County of Plumas Amending Chapter 15.10 of the City of Portola Municipal Code Providing for Regulation of Wood Stoves and Fireplaces and the Prohibition of the Open Burning of Yard Waste” (“City Ordinance No. 359”), together with a document entitled “Proposed Portola PM
On December 3, 2020, the EPA proposed to approve the Proposed PM
On November 19, 2020, CARB adopted the Proposed PM
The EPA's proposed action provided a 30-day public comment period that ended on January 4, 2021. During this period, the EPA received one anonymous comment that does not articulate any issue.
For the reasons discussed in detail in the proposed rule and summarized herein, under CAA section 110(k)(3), the EPA is taking final action to approve the PM
Finally, the EPA is approving new provisions in City Ordinance No. 359 concerning open burning of yard wastes and other debris, including related definitions and exemptions. These provisions strengthen the SIP and are consistent with CAA requirements regarding enforceability and SIP revisions. At the State's and District's request, we are not acting on paragraph 15.10.060 B., section 15.10.100, or section 15.10.110 of City Ordinance No. 359.
In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the City of Portola ordinance described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these documents available through
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves, or conditionally approves, state plans as meeting federal
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practical and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by May 3, 2021. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2)).
Environmental protection, Air pollution control, Ammonia, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Particulate matter, Reporting and recordkeeping requirements, Sulfur dioxide, Volatile organic compounds.
42 U.S.C. 7401
Chapter I, title 40 of the Code of Federal Regulations is amended as follows:
42 U.S.C. 7401
(c) * * *
(497) * * *
(i) * * *
(C) * * *
(
(
(500) * * *
(ii) * * *
(A) * * *
(
(553) The following additional materials were submitted on December 29, 2020, by the Governor's designee as an attachment to a letter dated December 28, 2020.
(i)
(
(
(
(B) [Reserved]
(ii)
(
(
(B) Northern Sierra Air Quality Management District.
(
(
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is approving a state implementation plan (SIP) revision submitted by the West Virginia Department of Environmental Protection (WVDEP) on behalf of the State of West Virginia (WV). This revision pertains to West Virginia's plan for maintaining the 1997 8-hour ozone national ambient air quality standard (NAAQS) for the West Virginia portion of the Huntington-Ashland, WV-KY area (Huntington Area), comprising Cabell and Wayne Counties. The EPA is approving these revisions to the West Virginia SIP in accordance with the requirements of the Clean Air Act (CAA).
This final rule is effective on April 2, 2021.
EPA has established a docket for this action under Docket ID Number EPA-R03-OAR-2020-0196. All documents in the docket are listed on the
Keila M. Pagán-Incle, Planning & Implementation Branch (3AD30), Air & Radiation Division, U.S. Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103. The telephone number is (215) 814-2926. Ms. Pagán-Incle can also be reached via electronic mail at
On June 29, 2020 (85 FR 38825), EPA published a notice of proposed rulemaking (NPRM) for the State of West Virginia. In the NPRM, EPA proposed approval of West Virginia's plan for maintaining the 1997 8-hour ozone NAAQS through October 16, 2026, in accordance with CAA section 175A. The formal SIP revision was submitted by WVDEP on December 10, 2019.
On September 15, 2006 (71 FR 54421, effective October 16, 2006), EPA approved a redesignation request (and maintenance plan) from WVDEP for the Huntington Area. Per CAA section 175A(b), at the end of the eighth year after the effective date of the redesignation, the state must also submit a second maintenance plan to ensure ongoing maintenance of the standard for an additional 10 years, and in
As discussed in the June 29, 2020 NPRM, consistent with longstanding EPA's guidance,
Other specific requirements of WVDEP's December 10, 2019 submittal and the rationale for EPA's proposed action are explained in the NPRM and will not be restated here.
EPA received four sets of relevant comments on the June 29, 2020 NPRM. Comments 2 and 3 raised concerns about EPA's reliance on the Air Quality Modeling Technical Support Document (TSD) and are summarized and addressed together under Comment 2. All comments received are in the docket for this rulemaking action. A summary of the comments and EPA's responses are provided herein.
The commenter further asserts that: (1) The plan did not provide information about prevention and reduction of future impacts of “oil and gas development activity;” (2) the plan did not take into consideration future installation of oil and gas pipelines in the area; and (3) the plan failed to consider “potential emissions from oil and gas pipeline.” We do not agree with the commenter that a demonstration of maintenance under CAA section 175A is required to “prevent” potential future emissions activities in the area, or to consider potential future emissions from sources that do not yet exist. As noted above and in the proposal, under the LMP option, states may demonstrate that areas will maintain the NAAQS by showing that design values in the area in question are stably and significantly below the level of the NAAQS. In this case, the Huntington Area's most recent design value
Moreover,
The commenter also contends that the LMP does not present “adequate funding to cover the costs” and fails to “comply with other provisions of state policy,” but provides no further details or explanation. Similar to the comment regarding the alleged failure of West Virginia to use “the best available science,” the commenter has made an allegation without providing any support. The commenter provides no basis for EPA to be able to evaluate whether or not a funding issue exists. With respect to an alleged failure to comply with state policy, no specific policies that “make it impossible for it to meet the EPA standards” are cited by the commenter. Even had the commenter cited specific policies, “[C]omments consisting of little more than assertions that in the opinions of the commenters the agency got it wrong,” when submitted with no accompanying data do not provide sufficient ground for EPA to change its evaluation of a plan that on its face comports with EPA's governing law and with the Agency's consistent and long-standing policies for LMPs. See
One of the commenters alleged that the TSD does not consider newer EPA policies (
Both commenters contend that: (1) The TSD shows maintenance of the area for three years and not 10 years; (2) the modeling was performed for transport purposes across state lines and not to show maintenance of the NAAQS; (3) the modeling was performed for the 2008 and 2015 ozone NAAQS and not the 1997 ozone NAAQS; and (4) the TSD has been “highly contested” by environmental groups, “incorrectly uses assumptions disputed by multiple non-governmental and governmental organizations” and “other states contend EPA's modeling as flawed.”
Further, one commenter contends that the TSD does not address a recent court decision that “threw out” EPA's modeling “because it modeled to the wrong attainment year. . . .” Both commenters assert that the TSD is not being used for its intended purpose and EPA should disapprove the LMP due to EPA's reliance on the TSD in the NPRM.
EPA disagrees that it must disapprove the LMP because the Air Quality Modeling TSD does not consider newer EPA policies like “repealing the MATS (Mercury and Air Toxics Standards) rule, or California's ability to regulate cars, or even the repeal of the Clean Power Plan and replacement with the ACE (Affordable Clean Energy) rule.” First, MATS was not repealed. All emission reductions required under MATS remain. See 85 FR 31286, 31312 (May 22, 2020). Second, the 2023 Air Quality Modeling TSD cited by West Virginia in their second maintenance plan submission does not include emission reductions associated with the Clean Power Plan.
The modeling cited by the commenters was referenced in West Virginia's submission and as part of EPA's proposed approval as supplementary supporting information, and we do not agree that the commenters' concerns about relying on that modeling are warranted. The commenters contend that the modeling only goes out three years (to 2023) and it needs to go out to 10 years, and therefore may not be relied upon. However, the Air Quality Modeling TSD was only relied upon by EPA to provide additional support to indicate that the area is expected to continue to attain the NAAQS during the relevant period. As noted above, West Virginia primarily met the requirement to demonstrate maintenance of the NAAQS by showing that they met the criteria for an LMP, rather than by modeling or projecting emissions inventories out to a future year. We also do not agree that the State is required to demonstrate maintenance for 10 years; CAA section 175A requires the State to demonstrate maintenance through the 20th year after the area is redesignated, which in this case is 2026.
We also disagree with the commenters' contention that because the Air Quality Modeling TSD was performed to analyze the transport of pollution across state lines with respect to other ozone NAAQS, it cannot be relied upon in this action. We acknowledge that the Air Quality Modeling TSD at issue was performed as part of EPA's efforts to address interstate transport pollution under CAA section 110(a)(2)(D)(i)(I). However, the purpose of the Air Quality Modeling TSD is fully in keeping with the question of whether the Huntington Area is expected to maintain the NAAQS. The Air Quality Modeling TSD projected ozone concentrations at every air quality monitor in the contiguous United States in 2023 in order to identify which monitors might have problems attaining or maintaining the 2008 and 2015 NAAQS for ozone in 2023. Because the Air Quality Modeling TSD results simply provide projected ozone concentration design values, which are expressed as three-year averages of the annual fourth high 8-hour daily maximum ozone concentrations, the modeling results are useful for analyzing attainment and maintenance of any of the ozone NAAQS that are measured using this averaging time; in this case, the 1997, 2008 and 2015 ozone NAAQS. The only difference between the three standards is stringency. Taking the Huntington Area's most recent certified design value as part of the proposal (
The commenters' assert that many groups have criticized EPA's transport modeling, alleging that the agency used improper emissions inventories, incorrect contribution thresholds, wrong modeling years, or that EPA has not accounted for local situations or reductions that occurred after the inventories were established. The commenters' also allege that EPA should not rely on its modeling because it “have now been outlawed by multiple courts” and “fails to stand up to the recent court decisions,” citing the
EPA is approving the 1997 8-hour ozone NAAQS limited maintenance plan for the Huntington Area, comprising Cabell and Wayne Counties as a revision to the West Virginia SIP.
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because it is not a significant regulatory action under Executive Order 12866;
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, this rule does not have tribal implications as specified by
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by May 3, 2021. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action pertaining to West Virginia's limited maintenance plan for the Huntington Area, comprising Cabell and Wayne Counties may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)
Environmental protection, Air pollution control, Incorporation by reference, Nitrogen dioxide, Ozone, Volatile organic compounds.
For the reasons stated in the preamble, the EPA amends 40 CFR part 52 as follows:
42 U.S.C. 7401
(e) * * *
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is approving, under the Clean Air Act (CAA), a revision to the State Implementation Plan (SIP) submitted by the Ohio Environmental Protection Agency on July 24, 2020. The CAA establishes emission inventory requirements for all ozone nonattainment areas. The revision addresses the emission inventory requirements for the Cleveland, Ohio (OH) ozone nonattainment area and the Ohio portion of the Cincinnati, Ohio-Kentucky (Cincinnati) ozone nonattainment area, as designated under the 2015 ozone National Ambient Air Quality Standard (NAAQS or standard). EPA is also confirming that Ohio's stationary annual emissions statement regulation, which has been previously approved by EPA under a prior ozone standard, satisfies the CAA emissions statement rule requirement for the Cleveland and Cincinnati nonattainment areas under the 2015 ozone NAAQS.
This final rule is effective on April 2, 2021.
EPA has established a docket for this action under Docket ID No. EPA-R05-OAR-2020-0388. All documents in the docket are listed on the
Charles Hatten, Environmental Engineer, Control Strategies Section, Air Programs Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312) 886-6031,
Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.
This rule approves Ohio's July 24, 2020 submission to address the ozone-related emissions inventory requirements and emissions statement requirements for the Cleveland and Cincinnati ozone nonattainment areas for the 2015 ozone NAAQS. An explanation of the CAA requirements, a detailed analysis of the revisions, and EPA's reasons for proposing approval were provided in EPA's notice of proposed rulemaking (NPRM), dated November 5, 2020 (85 FR 70554), and will not be restated here.
In the NPRM, EPA provided a 30-day review and comment period for the proposed rule. The comment period ended on December 7, 2020. We received no comments on the proposed rule.
EPA is approving Ohio's July 24, 2020 SIP revision as addressing the ozone-related emission inventory requirements for the Cleveland and Cincinnati ozone nonattainment areas for the 2015 ozone NAAQS. We are approving the emission inventories for these areas because they contain comprehensive, accurate, and current inventories of actual emissions of oxides of nitrogen (NO
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by May 3, 2021. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)
Environmental protection, Air pollution control, Incorporation by reference, Nitrogen dioxide, Ozone, Volatile organic compounds.
For the reasons stated in the preamble, EPA amends title 40 CFR part 52 as follows:
42 U.S.C. 7401
(e) * * *
Environmental Protection Agency (EPA).
Regulatory determinations.
The U.S. Environmental Protection Agency (EPA or Agency) is announcing final regulatory determinations for eight of the 109 contaminants listed on the Fourth Contaminant Candidate List. Specifically, the Agency is making final determinations to regulate perfluorooctanesulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) and to not regulate 1,1-dichloroethane, acetochlor, methyl bromide (bromomethane), metolachlor, nitrobenzene, and RDX. The Safe Drinking Water Act (SDWA), as amended in 1996, requires EPA to make regulatory determinations every five years on at least five unregulated contaminants. A regulatory determination is a decision about whether or not to begin the process to propose and promulgate a national primary drinking water regulation for an unregulated contaminant.
For purposes of judicial review, the determinations not to regulate in this document are issued as of March 3, 2021.
Richard Weisman, Standards and Risk Management Division, Office of Ground Water and Drinking Water, Office of Water (Mail Code 4607M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 564-2822; email address:
These final regulatory determinations will not impose any requirements on anyone. Instead, this action notifies interested parties of EPA's final regulatory determinations for eight unregulated contaminants and provides a summary of the major comments received on the March 10, 2020, preliminary determinations (USEPA, 2020a).
The purpose of this action is to present a summary of EPA's final regulatory determinations for eight contaminants listed on the Fourth Contaminant Candidate List (CCL 4) (USEPA, 2016a). The eight contaminants are: Perfluorooctanesulfonic acid (PFOS), perfluorooctanoic acid (PFOA), 1,1-dichloroethane, acetochlor, methyl bromide (bromomethane), metolachlor, nitrobenzene, and Royal Demolition eXplosive (RDX). The Agency is making final determinations to regulate two contaminants (PFOS and PFOA) and to not regulate the remaining six contaminants (1,1-dichloroethane, acetochlor, methyl bromide (bromomethane), metolachlor, nitrobenzene, and RDX). The Agency is not making any determination at this time on any other CCL contaminants, including strontium, 1,4-dioxane, and 1,2,3-trichloropropane. This action summarizes the statutory requirements for targeting drinking water contaminants for regulatory determination, provides an overview of the contaminants that the Agency considered for regulation, and describes the approach used to make the final regulatory determinations. In addition, this action summarizes the public comments received on the Agency's preliminary determinations announcement and the Agency's responses to those comments.
Section 1412(b)(1)(B)(i) of SDWA requires EPA to publish the CCL every five years after public notice and an opportunity to comment. The CCL is a list of contaminants which are not subject to any proposed or promulgated National Primary Drinking Water Regulations (NPDWRs) but are known or anticipated to occur in public water systems (PWSs) and may require regulation under SDWA. SDWA section 1412(b)(1)(B)(ii) directs EPA to determine, after public notice and an opportunity to comment, whether to regulate at least five contaminants from the CCL every five years.
Under Section 1412(b)(1)(A) of SDWA, EPA makes a determination to regulate a contaminant in drinking water if the Administrator determines that:
(a) The contaminant may have an adverse effect on the health of persons;
(b) The contaminant is known to occur or there is a substantial likelihood that the contaminant will occur in public water systems with a frequency and at levels of public health concern; and
(c) In the sole judgment of the Administrator, regulation of such contaminant presents a meaningful opportunity for health risk reduction for persons served by public water systems.
If after considering public comment on a preliminary determination, the Agency makes a determination to regulate a contaminant, EPA will initiate the process to propose and promulgate an NPDWR. In that case, the statutory time frame provides for Agency proposal of a regulation within 24 months and action on a final regulation within 18 months of proposal. When proposing and promulgating drinking water regulations, the Agency must conduct a number of analyses.
On March 10, 2020, EPA published preliminary regulatory determinations for eight contaminants on the fourth Contaminant Candidate List (CCL 4) (85 FR 14098) (USEPA, 2020a). The eight contaminants are PFOS, PFOA, 1,1-dichloroethane, acetochlor, methyl bromide, metolachlor, nitrobenzene, and RDX. The Agency is making final regulatory determinations to regulate two contaminants (
Information on the eight contaminants with regulatory determinations can be found in the
This section summarizes the process the Agency followed to identify and evaluate contaminants for the Fourth Regulatory Determination. For more detailed information on the process and the analyses performed, please refer to the “Protocol for the Regulatory Determination 4” found in Appendix E of the
The CCL 4 identified 109 contaminants that are currently not subject to any proposed or promulgated national drinking water regulation, are known or anticipated to occur in public water systems, and may require regulation under SDWA (USEPA, 2016a). Since some of the CCL 4 contaminants do not have adequate health and/or occurrence data to evaluate against the three statutory criteria (see section II.B of this document), as when EPA evaluated the previous CCLs, the Agency used a three-phase process to identify which of the contaminants are candidates for regulatory determinations. Priority was given to identifying contaminants known to occur or with substantial likelihood to occur at frequencies and levels of public health concern.
Because the regulatory determination process includes consideration of human health effects, the Agency's Policy on Evaluating Health Risks to Children (USEPA, 1995a) reaffirmed by Administrator Wheeler in a memorandum dated October 11, 2018 to Agency staff (USEPA, 2018a), applies to this document. The policy requires EPA to consistently and comprehensively address children's unique vulnerabilities. We have explicitly considered children's health in the RD 4 process by reviewing all the available
The three phases of the Fourth Regulatory Determination process are (1) the
The purpose of the first phase, the
During the second phase, the Agency evaluates the contaminants on the short list in greater depth and detail to identify those that have sufficient data (or are expected to have sufficient data within the timeframe allotted for the second phase) for EPA to assess the three statutory criteria. As part of the second phase, the Agency specifically focuses its efforts on identifying those contaminants or contaminant groups that are occurring or have substantial likelihood to occur at levels and frequencies of public health concern, based on the best available peer reviewed data. If, during the first or second phase, the Agency finds that sufficient data are not available or not likely to be available to evaluate the three statutory criteria, then the contaminant is not considered a candidate for making a regulatory determination.
If sufficient data are available for a contaminant to characterize the potential health effects and known or likely occurrence in drinking water, the contaminant is evaluated against the three statutory criteria in the
Of the 10 CCL4 contaminants that were evaluated in Phase 3, the Agency did not make preliminary regulatory determinations for two contaminants (1,4-dioxane and 1,2,3-trichloropropane); see Section IV of this document for discussion about these contaminants. Additionally, in Section IV of this document, EPA discusses continuing with its previous 2016 decision to defer a final determination for strontium (a CCL3 contaminant for which the Agency made a preliminary positive determination in the third
Of the eight remaining CCL 4 contaminants (PFOS, PFOA, 1,1-dichloroethane, acetochlor, methyl bromide, metolachlor, nitrobenzene, and RDX) evaluated in Phase 3 against the three statutory criteria, including an evaluation of level and frequency of occurrence in drinking water, the size of the population exposed to concentrations of health concern, and information on sensitive populations and lifestages
EPA received comments from approximately 11,600 organizations and individuals on the March 10, 2020,
After considering the public comments, EPA is making final regulatory determinations to regulate PFOS and PFOA and to not regulate 1,1-dichloroethane, acetochlor, methyl bromide, metolachlor, nitrobenzene, and RDX.
This document provides a brief description of the Agency findings on these contaminants. Details on the background, health and occurrence information, and analyses used to evaluate and make final determinations for these contaminants can be found in the
For each contaminant, the Agency reviewed the available human and toxicological data, derived a health reference level (HRL),
Per- and polyfluoroalkyl substances (PFAS) are a class of synthetic chemicals that have been manufactured and in use since the 1940s (AAAS, 2020; USEPA, 2018b). PFAS are most commonly used to make products resistant to water, heat, and stains and are consequently found in industrial and consumer products like clothing, food packaging, cookware, cosmetics, carpeting, and fire-fighting foam (AAAS, 2020). PFAS manufacturing and processing facilities, facilities using PFAS in production of other products, airports, and military installations have been associated with PFAS releases into the air, soil, and water (USEPA 2016b; USEPA 2016c). People may potentially be exposed to PFAS through the use of certain consumer products, through occupational exposure, and/or through consuming contaminated food or contaminated drinking water (Domingo and Nadal, 2019; Fromme et al. 2009).
Perfluorooctane sulfonate (PFOS) and perfluorooctanoic acid (PFOA) are part of a subset of PFAS referred to as perfluorinated alkyl acids (PFAA) and are two of the most widely studied and longest-used PFAS. Due to their widespread use and persistence in the environment, most people have been exposed to PFAS, including PFOA and PFOS (USEPA 2016b; USEPA 2016c). PFOA and PFOS have been detected in up to 98% of serum samples taken in biomonitoring studies that are representative of the U.S. general population (CDC, 2019). Following the voluntary phase-out of PFOA by eight major chemical manufacturers and processors in the United States under EPA's 2010/2015 PFOA Stewardship Program and reduced manufacturing of PFOS (last reported in 2002 under Chemical Data Reporting), serum concentrations have been declining. The National Health and Nutrition Examination Survey (NHANES) data exhibited that 95th-percentile serum PFOS concentrations have decreased over 75%, from 75.7 μg/L in the 1999-2000 cycle to 18.3 μg/L in the 2015-2016 cycle (CDC, 2019; Jain, 2018; Calafat et al., 2007; Calafat et al., 2019).
The Agency is making a determination to regulate PFOA and PFOS with a NPDWR. EPA has determined that PFOA and PFOS may have adverse health effects; that PFOA and PFOS occur in public water systems with a frequency and at levels of public health concern; and that, in the sole judgment of the Administrator, regulation of PFOA and PFOS presents a meaningful opportunity for health risk reduction for persons served by public water systems.
The Agency finds that PFOA and PFOS may have adverse effects on the health of persons. In 2016, EPA published health assessments (Health Effects Support Documents or HESDs) for PFOA and PFOS based on the Agency's evaluation of the peer reviewed science available at that time. The lifetime Health Advisory (HA) of 0.07 μg/L is used as the HRL for Regulatory Determination 4 and reflect concentrations of PFOA and PFOS in drinking water at which adverse health effects are not anticipated to occur over a lifetime. Studies indicate that exposure to PFOA and/or PFOS above certain exposure levels may result in adverse health effects, including developmental effects to fetuses during pregnancy or to breast-fed infants (
EPA has determined that PFOA and PFOS occur with a frequency and at levels of public health concern at PWSs based on the Agency's evaluation of available occurrence information. In accordance with SDWA 1412(b)(1)(B)(ii)(II), EPA has determined monitoring data from the third Unregulated Contaminant Monitoring Rule (UCMR 3) are the best available occurrence information for PFOA and PFOS regulatory determinations. UCMR 3 monitoring occurred between 2013 and 2015 and are currently the only nationally representative finished water dataset for PFOA and PFOS. Under UCMR 3, 36,972 samples from 4,920 PWSs were analyzed for PFOA and PFOS. The minimum reporting level (MRL) for PFOA was 0.02 μg/L and the MRL for PFOS was 0.04 μg/L. A total of 1.37% of samples had reported detections (greater than or equal to the MRL) of at least one of the two compounds. To examine the occurrence of PFOS and PFOA in aggregate, EPA summed the concentrations detected in the same sample to calculate a total PFOS/PFOA concentration. EPA notes that the reference doses (RfDs) for both PFOA and PFOS are based on similar developmental effects and are numerically identical; when these two chemicals co-occur at the same time and location in drinking water sources, EPA has recommended considering the sum of the concentrations (USEPA, 2016d; USEPA, 2016e) and has done so for this regulatory determination. The maximum summed concentration of PFOA and PFOS was 7.22 μg/L and the median summed value was 0.05 μg/L. Summed PFOA and PFOS concentrations exceeded one-half the HRL (0.035 μg/L) at a minimum of 2.4% of PWSs (115 PWSs) and exceeded the HRL (0.07 μg/L) at a minimum of 1.3% of PWSs (63 PWSs
Consistent with the Agency's commitment in the PFAS Action Plan (the Agency's first multi-media, multi-program, national research, management, and risk communication plan to address a challenge like PFAS) to present information about additional sampling efforts for PFAS in water systems, the Agency has supplemented its Unregulated Contaminant Monitoring Regulation (UCMR) data
Considering the population exposed to PFOA and PFOS including sensitive populations and lifestages, the potential adverse human health impacts of these contaminants, the environmental persistence of these substances, the persistence in the human body and potential for bioaccumulation of these substances, the availability of validated methods to measure and treatment technologies to remove PFOA and PFOS, the detections that exceeded the HRL and
PFOA and PFOS are both generated as degradation products of other perfluorinated compounds (
Adverse effects observed following exposures to PFOA and PFOS include effects in humans on serum lipids, birth weight, and serum antibodies. Some of the animal studies show common effects on the liver, neonate development, and responses to immunological challenges. Both compounds were also associated with tumors in long-term animal studies (USEPA, 2016d; USEPA, 2016e). In determining that regulation of PFOA and PFOS presents a meaningful opportunity for health risk reduction for sensitive populations, EPA noted that both PFOA and PFOS are associated with developmental toxicity in animals, with reduced birth weight in humans, and have been shown to be transmitted to the fetus via the placenta and to the newborn, infant, and child via breast milk (USEPA, 2016b; USEPA, 2016c).
Drinking water analytical methods are available to measure PFOA, PFOS, and other PFAS in drinking water. EPA has published validated drinking water laboratory methods for detecting a total of 29 unique PFAS in drinking water, including EPA Method 537.1 (18 PFAS) and EPA Method 533 (25 PFAS).
Available treatment technologies for removing PFAS from drinking water have been evaluated and reported in the literature (
EPA received many comments on the Agency's evaluation of the first statutory criterion under section 1412(b)(1)(A) of SDWA. Most commenters agreed with EPA's finding that PFOA and PFOS may have adverse effects on the health of persons. Most commenters also state that there is “strong evidence” and “substantial scientific evidence” for EPA's finding of adverse health effects of PFOA and PFOS. One commenter disagreed with EPA's evaluation of the first statutory criterion, arguing that the body of scientific evidence does not show adverse effects from PFAS in humans. EPA also received numerous comments relating to the Agency's 2016 Lifetime Health Advisory for PFOA and PFOS, the corresponding HESD and the HRL used to support the preliminary regulatory determination. Numerous commenters encouraged EPA to update and “improve its health reference level” and “revise the PFOA and PFOS hazard assessments” prior to making a final regulatory determination.
EPA acknowledges commenters' suggestions to consider and evaluate newer studies; however, EPA disagrees with recommendations to establish new HRLs prior to a final regulatory determination. Consistent with SDWA section 1412(b)(3)(A)(i), EPA is using the 2016 PFOA and PFOS Lifetime Health Advisory as the basis in deriving an HRL which the Agency has concluded represent the best available peer reviewed scientific assessment at this time. Based upon the 2016 EPA HESDs for PFOA and PFOS, and other supporting studies cited in the record, EPA finds that PFOA and PFOS may have an adverse effect on the health of persons. Consistent with commenters' recommendations, EPA has initiated the first steps of a systematic literature review of peer-reviewed scientific literature for PFOA and PFOS published since 2013 with the goal of identifying any new studies that may be relevant to human health assessment. An annotated bibliography of the identified relevant studies as well as the protocol used to identify the relevant publications can be found in Appendix D of the Final Regulatory Determination 4 Support Document (USEPA, 2021a), available in the docket for this document. Additional analyses of these new
EPA also received comments on the Agency's evaluation of the second statutory criterion under section 1412(b)(1)(A) of SDWA. Many commenters supported EPA's preliminary determination that PFOA and PFOS meet the second statutory occurrence criterion under SDWA. Several commenters stated that while they are supportive of using UCMR 3 data as the basis of nationwide drinking water occurrence for PFOA and PFOS, solely relying on these monitoring data may be an inaccurate reflection of PFOA and PFOS exposure. The Agency also received comments and information on actions taken by a number of states to monitor PFOA, PFOS, and other PFAS in PWSs, particularly in locations that were not previously required to conduct UCMR monitoring. Some commenters suggested that PFOA and PFOS UCMR 3 occurrence information used by EPA in making the Preliminary Determination for PFOA and PFOS is not reflective of the actual occurrence of PFOS and PFOS within public water systems. These commenters stated that UCMR 3 monitoring excludes small public water systems and was conducted with high minimum reporting levels. Three commenters did not support EPA's preliminary determination that PFOA and PFOS meet the second statutory criterion under SDWA. These commenters expressed concern that the data EPA relied upon are outdated, are skewed, and overestimate current PFOA and PFOS occurrence. These commenters suggest that EPA should revise its occurrence analysis with more recent data prior to making a final determination.
EPA disagrees with those commenters who assert that UCMR 3 are not the best available occurrence data. EPA also disagrees that the UCMR 3 excludes small water systems and disagrees that the minimum reporting levels were too high. The UCMR 3 assured a nationally representative sample of 800 small drinking water systems and established minimum reporting levels based upon laboratory performance data that are lower than the HRLs for PFOA and PFOS. The UCMR 3 data are the best available information to assess the frequency and level of occurrence of PFOA and PFOS in the nation's public water systems. After considering the public comments and additional occurrence data provided by commenters, EPA continues to find that PFOA and PFOS meet the second statutory criterion for regulatory determinations under Section 1412(b)(1)(A) of SDWA that “the contaminant is known to occur or there is a substantial likelihood that the contaminant will occur in public water systems with a frequency and at levels of public health concern.” Nonetheless, EPA agrees with commenters who recommend that the Agency consider other existing available occurrence data to inform its final regulatory determination and PFOA and PFOS rulemaking. As discussed previously, the Final Regulatory Determination 4 Support Document presents a detailed discussion of state PFOA and PFOS occurrence information that were analyzed and used to further support the Agency's finding that PFOA and PFOS occur in public water systems with a frequency and at levels of public health concern (USEPA, 2021a).
EPA also received many comments on the Agency's evaluation of the third statutory criterion under section 14121412(b)(1)(A) of SDWA. Many commenters, including multiple state regulators and organizations representing states, agree with EPA's evaluation that regulation of PFOA and PFOS presents a meaningful opportunity for health risk reduction for persons served by PWSs. These commenters highlight the extensive amount of work associated with developing their own drinking water standards for several PFAS compounds. These commenters also noted the need for a consistent national standard for use in states where a state-specific standard has not yet been developed. Many commenters have also noted that although some states have developed or are in the process of developing their own state-level PFAS drinking water standards, regulatory standards currently vary across states. These commenters expressed concern that absence of a national drinking water standard has resulted in risk communication challenges with the public and disparities with PFAS exposure. Some commenters noted there are populations particularly sensitive or vulnerable to the health effects of PFAS, including newborns, infants and children. One commenter did not support EPA's evaluation of the third statutory criterion, noting that in their opinion, the toxicity assessment for PFOA and PFOS and existing occurrence data do not suggest that establishing drinking water standards presents a meaningful opportunity for health risk reduction.
EPA acknowledges commenter concerns regarding sensitive and vulnerable subpopulations and notes that the Agency has been particularly mindful that PFOA and PFOS are known to be transmitted to the fetus via cord blood and to the newborn, infant and child via breast milk. EPA agrees with commenters that there is a need for protective drinking water regulations across the United States and that moving forward with a national-level regulation for PFOA and PFOS would provide improved national consistency in protecting public health and may reduce regulatory uncertainty for stakeholders across the country. The Agency disagrees with the commenter's assertion that PFOA and PFOS health and occurrence information are insufficient to justify a drinking water standard, and the Agency finds that there is a meaningful opportunity for health risk reduction potential based upon consideration the population exposed to PFOA and PFOS including sensitive populations and lifestages, such as newborns, infants and children.
As EPA begins the process to promulgate the NPDWR for PFOA and PFOS, the Agency recognizes that there is additional information to consider regarding a broader range of PFAS, including new monitoring and occurrence data, and ongoing work developing toxicity assessments by EPA, other federal agencies, state governments, international organizations, industry groups, and other stakeholders. While the Agency is not making regulatory determinations for additional PFAS at this time, the Agency remains committed to filling information gaps, including those identified in the PFAS Action Plan, by completing peer reviewed toxicity assessments and collecting nationally representative occurrence data for additional PFAS to support future regulatory determinations as part of the UCMR monitoring program (see discussion below).
EPA committed in the PFAS Action Plan to characterize potential health impacts and develop more drinking water occurrence data for a broader set of PFAS (USEPA, 2019b). EPA has followed through on its commitments and as a result expects to have peer-reviewed health assessments and national occurrence data for more PFAS becoming available over the next few years. EPA notes that although SDWA does not require the Agency to complete regulatory determinations for the contaminants from the fifth CCL until 2026, because of the significant progress related to developing new high-quality PFAS information, combined with the Agency's commitment in the PFAS
EPA is currently developing scientifically rigorous toxicity assessments for seven PFAS chemicals. The chemicals currently undergoing assessment include PFBS, PFBA, PFHxS, PFHxA, PFNA, PFDA, and HFPO-DA (GenX chemicals), all of which are currently scheduled to be completed by 2023. These assessments all include public comment periods, independent scientific external peer review, and a robust interagency review process. Furthermore, these toxicity assessments will provide critical health information for PFAS with varying chain lengths and functional groups. When complete, these assessments will summarize available scientific information regarding the anticipated human dose-response relationship for these chemicals, which is a key information need for informing a variety of Agency decisions.
To inform EPA's understanding of PFAS occurrence in drinking water as discussed in EPA's PFAS Action Plan (USEPA, 2019b), the Agency is also leading efforts to gather additional monitoring data for 29 PFAS contaminants in finished drinking water. EPA recently announced its proposal for nationwide drinking water monitoring for PFAS under the next UCMR monitoring cycle (UCMR 5) utilizing Methods 537.1 and 533 to detect more PFAS chemicals and at lower reporting limits than previously possible.
EPA is also is generating new PFAS toxicology data for a much larger set of less-studied PFAS through new approach methods (NAMs)
EPA requested comment on potential regulatory constructs the Agency may consider for PFAS chemicals including PFOA and PFOS. EPA specifically requested input on a regulatory approach to evaluate PFAS by different grouping approaches.
EPA received multiple comments on how the Agency could consider additional PFAS for potential future rulemaking. Many commenters support a class-based approach for regulating PFAS based on one or more characteristics such as chain length, functional group, treatment processes, health effects, toxicity, common analytical methods, and/or shared occurrence with other contaminants within a group. Additionally, many commenters also urge EPA to make additional regulatory determinations for PFAS that have a proposed or final drinking water standard in at least one state; PFAS that have been measured in water systems through monitoring programs such as UCMR; and/or PFAS for which EPA or the Agency for Toxic Substances and Disease Registry (ATSDR) has established a toxicity value. Some commenters suggest that EPA should make positive regulatory determinations for PFHxS and PFNA as well as in combination with PFOA, PFOS, and other PFAS such as PFBS. Many commenters recommend EPA consider various grouping and treatment technique approaches for PFAS beyond PFOA and PFOS that may not have sufficient health and occurrence data. Some of these commenters recommend approaches that consider acute and chronic health effects, long-term compared to short-term exposures, exposures during sensitive lifestages, and type of water systems and vulnerable populations such as vulnerable workers. Many commenters stated that the data may not be robust enough for each PFAS and therefore support a class-based approach for regulating PFAS in drinking water. In contrast, two commenters did not support a class-based approach for regulating PFAS. In summary, these commenters suggest that regulation without assessing each chemical's individual traits “would be contrary to the intent of SDWA” and that the Agency should address outstanding data and knowledge gaps regarding PFAS of concern prior to determining a regulatory grouping approach.
With respect to comments received on regulatory determinations for additional PFAS compounds other than PFOA and PFOS, EPA remains committed to filling information gaps by completing peer reviewed health assessments where appropriate and collecting nationally representative occurrence data. As discussed above, in response to public comments advocating timely regulation of additional PFAS in drinking water, where sufficient information is available, EPA intends to make regulatory determinations for additional PFAS prior to the fifth Regulatory Determination's statutory deadline (2026).
The Agency acknowledges many commenters' support for a class-based approach for regulating PFAS and appreciates commenter recommendations regarding potential regulatory constructs. EPA acknowledges commenters' recommendations to evaluate whether PFAS can be regulated as groups, and the Agency is developing the science necessary to consider whether such regulation is necessary and appropriate for PFAS. Regarding commenters' assertions that regulation without assessing each chemical's individual traits “would be contrary to the intent of SDWA,” the Agency notes that the Safe Drinking Water Act establishes a robust scientific and public participation process that guide EPA's development of regulations for unregulated contaminants that may present a risk to public health. Regulation by groups is a regulatory strategy that is already used for certain regulated contaminants like disinfection byproducts, polychlorinated biphenyls, and radionuclides. EPA will continue to use best available science and available
As part of the proposed preliminary regulatory determination for PFOA and PFOS, EPA solicited comment on potential monitoring approaches if the Agency were to finalize a positive regulatory determination for these contaminants. EPA presented two monitoring approaches in the Agency's preliminary Regulatory Determination for CCL 4 contaminants. Under the Standardized Monitoring Framework (SMF) for synthetic organic chemicals, monitoring schedules are based around the detection levels of the regulated contaminants, and state primacy agencies can also issue waivers for monitoring. The Agency also presented an alternative monitoring approach to allow state primacy agencies to require monitoring at PWSs where information indicates potential PFAS contamination, such as proximity to facilities with historical or on-going uses of PFAS.
Many commenters supported the Agency's goal of reducing potential monitoring burden for PWSs without compromising public health protection. While there were differing views among commenters regarding which monitoring approach is best for PFAS, many urged EPA to keep evaluating different approaches as the Agency promulgates the NPDWR for PFOA and PFOS.
The Agency appreciates commenter recommendations on monitoring approaches. As the Agency promulgates the regulatory standard for PFOA and PFOS, EPA will continue to work to establish monitoring requirements in the rule that minimize burden while ensuring public health protection.
1,1-Dichloroethane is a halogenated alkane. It is an industrial chemical and is used as a solvent and a chemical intermediate. 1,1-Dichloroethane is expected to have moderate to high persistence in water (USEPA, 2021a).
The Agency is making a determination not to regulate 1,1-dichloroethane with an NPDWR. It does not occur with a frequency and at levels of public health concern. As a result, the Agency finds that an NPDWR does not present a meaningful opportunity for health risk reduction.
The Agency finds that 1,1-dichloroethane may have adverse effects on the health of persons. Based on a 13-week gavage study in rats (Muralidhara et al., 2001), the kidney was identified as a sensitive target for 1,1-dichloroethane, and no-observed-adverse-effect level (NOAEL) and lowest-observed-adverse-effect level (LOAEL) values of 1,000 and 2,000 mg/kg/day, respectively, were identified based on increased urinary enzyme markers for renal damage and central nervous system (CNS) depression (USEPA, 2006a).
The only available reproductive or developmental study with 1,1-dichloroethane is an inhalation study where pregnant rats were exposed on days 6 through 15 of gestation (Schwetz et al., 1974). No effects on the fetuses were noted at 3,800 ppm. Delayed ossification of the sternum without accompanying malformations was reported at a concentration of 6,000 ppm.
A cancer assessment for 1,1-dichloroethane is available on IRIS (USEPA, 1990a). That assessment classifies the chemical, according to EPA's 1986 Guidelines for Carcinogenic Risk Assessment (USEPA, 1986), as Group C, a possible human carcinogen. This classification is based on no human data and limited evidence of carcinogenicity in two animal species (rats and mice), as shown by increased incidences of hemangiosarcomas and mammary gland adenocarcinomas in female rats and hepatocellular carcinomas and benign uterine polyps in mice (NCI, 1978). The data were considered inadequate to support quantitative assessment. The close structural relationship between 1,1-dichloroethane and 1,2-dichloroethane, which is classified as a B2 probable human carcinogen and produces tumors at many of the same sites where marginal tumor increases were observed for 1,1-dichloroethane, supports the suggestion that the 1,1-isomer could possibly be carcinogenic to humans. Mixed results in initiation/promotion studies and genotoxicity assays are consistent with this classification. On the other hand, the animals from the 1,1-dichloroethane National Cancer Institute (NCI, 1978) study were housed with animals being exposed to 1,2-dichloroethane providing opportunities for possible co-exposure impacting the 1,1-dichloroethane results. The following groups of individuals may have an increased risk from exposure to 1,1-dichloroethane (NIOSH, 1978; ATSDR, 2015):
• Those with chronic respiratory disease,
• Those with liver diseases that impact hepatic microsomal cytochrome P-450 functions,
• Individuals with impaired renal function and vulnerable to kidney stones
• Individuals with skin disorders vulnerable to irritation by solvents like 1,1-dichloroethane,
• Those who consume alcohol or use pharmaceuticals (
A provisional chronic RfD was derived from the 13-week gavage study in rats based on a NOAEL of 1,000 mg/kg/day administered for five days/week and adjusted to 714.3 mg/kg/day for continuous exposure (an increase in urinary enzymes was the adverse impact on the kidney). The chronic oral RfD of 0.2 mg/kg/day was derived by dividing the normalized NOAEL of 714.3 mg/kg/day in male Sprague-Dawley rats by a combined UF of 3,000. The combined UF includes factors of 10 for interspecies extrapolation, 10 for extrapolation from a subchronic study, 10 for human variability, and 3 for database deficiencies (including lack of reproductive and developmental toxicity tests by the oral route). This assessment noted several limitations in the critical study and database as a whole. Specifically, that the reporting of the results in the critical study were marginally adequate and that the database lacks information on reproductive and developmental and nervous system toxicity.
EPA calculated an HRL for 1,1-dichloroethane of 1,000 μg/L, based on EPA oral RfD of 0.2 mg/kg/day, using 2.5 L/day drinking water ingestion, 80 kg body weight and a 20% relative source contribution (RSC) factor.
EPA has determined that 1,1-dichloroethane does not occur with a frequency and at levels of public health concern at PWSs based on the Agency's evaluation of available occurrence information. The primary occurrence data for 1,1-dichloroethane are the 2013-2015 nationally representative drinking water monitoring data generated through EPA's UCMR 3. 1,1-Dichloroethane was not detected in any of the 36,848 UCMR 3 samples collected by 4,916 PWSs (serving ~ 241 million people) at levels greater than
Other supplementary sources of finished water occurrence data from UCM Rounds 1 and 2 indicate that the occurrence of 1,1-dichloroethane in PWSs is likely to be low to non-existent (USEPA, 2021a). 1,1-Dichloroethane occurrence data for ambient water from NAWQA and NWIS are consistent with those for finished water (USEPA, 2021a).
The Agency has determined that regulation of 1,1-dichloroethane does not present a meaningful opportunity for health risk reduction for persons served by PWSs based on the estimated exposed populations, including sensitive populations. UCMR 3 findings indicate that the estimated population exposed to 1,1-dichloroethane at levels of public health concern is 0%, based on lack of detections at levels greater than
EPA received several comments on the Agency's evaluation of 1,1-dichloroethane under section 1412(b)(1)(A) of SDWA, all of which were in support of its preliminary determination not to regulate 1,1-dichloroethane. EPA agrees with the comments that are in support of the negative regulatory determination.
Acetochlor is a chloroacetanilide pesticide that is used as an herbicide for pre-emergence control of weeds. It is registered for use on corn crops (field corn and popcorn) and has been approved for use on cotton as a rotational crop. Synonyms for acetochlor include 2-chloro-2′-methyl-6-ethyl-N-ethoxymethylacetanilide (USEPA, 2021a). Acetochlor is expected to have low to moderate persistence in water due to its biodegradation half-life, as well as susceptibility to photolysis (USEPA, 2021a).
The Agency is making a determination not to regulate acetochlor with an NPDWR. Acetochlor does not occur with a frequency and at levels of public health concern. As a result, the Agency finds that an NPDWR does not present a meaningful opportunity for health risk reduction.
The Agency finds that acetochlor may have adverse effects on the health of persons. Subchronic and chronic oral studies have demonstrated adverse effects on the liver, thyroid (secondary to the liver effects), nervous system, kidney, lung, testes, and erythrocytes in rats and mice (USEPA, 2006b; USEPA, 2018c). There was evidence of carcinogenicity in studies conducted with acetochlor in rats and mice and a non-mutagenic mode of action was demonstrated for nasal and thyroid tumors in rats (USEPA, 2006b). Cancer effects include nasal tumors and thyroid tumors in rats, lung tumors and histiocytic sarcomas in mice, and liver tumors in both rats and mice (Ahmed and Seely, 1983; Ahmed et al., 1983; Amyes, 1989; Hardisty, 1997a; Hardisty, 1997b; Hardisty, 1997c; Naylor and Ribelin, 1986; Ribelin, 1987; USEPA, 2004b; USEPA, 2006b; and Virgo and Broadmeadow, 1988). No biologically sensitive human subpopulations have been identified for acetochlor. Developmental and reproductive toxicity studies do not indicate increased susceptibility to acetochlor exposure at early life stages in test animals (USEPA, 2006b).
The study used to derive the oral RfD is a 1-year oral chronic feeding study conducted in beagle dogs. This study describes a NOAEL of 2 mg/kg/day, and a LOAEL of 10 mg/kg/day, based on the critical effects of increased salivation; increased levels of alanine aminotransferase (ALT) and ornithine carbamoyl transferase (OTC); increased triglyceride levels; decreased blood glucose levels; and alterations in the histopathology of the testes, kidneys, and liver of male beagle dogs (USEPA, 2018c; ICI, Inc., 1988). The UF applied was 100 (10 for intraspecies variation and 10 for interspecies extrapolation). The EPA OPP RfD for acetochlor of 0.02 mg/kg/day, based on the NOAEL of 2 mg/kg/day from the 1-year oral chronic feeding study in beagle dogs, is expected to be protective of both noncancer and cancer effects.
EPA calculated an HRL of 100 μg/L based on the EPA OPP RfD for non-cancer effects for acetochlor of 0.02 mg/kg/day (USEPA, 2018c) using 2.5 L/day drinking water ingestion, 80 kg body weight, and a 20% RSC factor.
EPA has determined that acetochlor does not occur with a frequency and at levels of public health concern at PWSs based on the Agency's evaluation of available occurrence information. The primary occurrence data for acetochlor are from the first Unregulated Contaminant Monitoring Regulation (UCMR 1) assessment monitoring (AM) (2001-2003) and the second Unregulated Contaminant Monitoring Regulation (UCMR 2) screening survey (SS) (2008-2010). Acetochlor was not detected at levels greater than
Findings from the available ambient water data for acetochlor are consistent with the results in finished water. Ambient water data in NAWQA show that acetochlor was detected in between 13% and 23% of samples from between 3% and 10% of sites. While maximum values in NAWQA Cycle 2 (2002-2012) and Cycle 3 (2013-2017) monitoring exceeded the HRL (215 μg/L in 2004 and 137 μg/L in 2013) (only one sample in each of those two cycles exceeded the HRL), 90th percentile levels of acetochlor remained below 1 μg/L. More than 10,000 samples were collected in each cycle. Non-NAWQA NWIS data (1991-2016), which included limited finished water data in addition to the ambient water data, show no detected concentrations greater than the HRL (USEPA, 2021a).
The Agency has determined that regulation of acetochlor does not present a meaningful opportunity for health risk reduction for persons served by PWSs based on the estimated exposed populations, including sensitive populations. The estimated population exposed to acetochlor at levels of public health concern is 0% based on UCMR 1 finished water data gathered from 2001 to 2003 and UCMR 2 finished water data gathered from 2008 to 2010. As a result, the Agency finds that an NPDWR for acetochlor does not present a meaningful opportunity for health risk reduction.
EPA received several comments on the Agency's evaluation of acetochlor under section 1412(b)(1)(A) of SDWA, all of which were in support of its preliminary determination not to regulate acetochlor. EPA agrees with the comments that are in support of the negative regulatory determination.
Methyl bromide is a halogenated alkane and occurs as a gas. Methyl bromide has been used as a fumigant fungicide applied to soil before planting, to crops after harvest, to vehicles and buildings, and for other specialized purposes. Use of the chemical in the United States was phased out in 2005, except for specific critical use exemptions and quarantine and pre-shipment exemptions in accordance with the Montreal Protocol. Critical use exemptions have included strawberry cultivation and production of dry cured pork. Synonyms for methyl bromide include bromomethane, monobromomethane, curafume, Meth-O-Gas, and Brom-O-Sol. Methyl bromide is expected to have moderate persistence in water due to its susceptibility to hydrolysis (USEPA, 2021a).
The Agency is making a determination not to regulate methyl bromide with an NPDWR. Methyl bromide does not occur with a frequency and at levels of public health concern. As a result, the Agency finds that an NPDWR does not present a meaningful opportunity for health risk reduction.
The Agency finds that methyl bromide may have adverse effects on the health of persons. The limited number of studies investigating the oral toxicity of methyl bromide indicate that the route of administration influences the toxic effects observed (USEPA, 2006c). The forestomach of rats (forestomachs are not present in humans) appears to be the most sensitive target of methyl bromide when it is administered orally by gavage (ATSDR, 1992). Acute and subchronic oral gavage studies in rats identified stomach lesions (Kaneda et al., 1998), hyperemia (excess blood) (Danse et al., 1984), and ulceration (Boorman et al., 1986; Danse et al., 1984) of the forestomach. However, forestomach effects were not observed in rats and stomach effects were not observed in dogs that were chronically exposed to methyl bromide in the diet, potentially because methyl bromide degrades to other bromide compounds in the food (Mertens, 1997). Decreases in food consumption, body weight, and body weight gain were noted in the chronic rat study when methyl bromide was administered in capsules (Mertens, 1997).
In a subchronic (13-week) rat study (Danse et al., 1984), a NOAEL of 1.4 mg/kg/day (a time weighted average,
EPA selected an OPP Human Health Risk Assessment from 2006 as the basis for developing the HRL for methyl bromide (USEPA, 2006c). As described in the OPP document, the study was of chronic duration (two years) with four groups of male rats and four groups of female rats treated orally via encapsulated methyl bromide. In the OPP assessment (USEPA, 2006c), Mertens (1997) was identified as the critical study and decreased body weight, decreased rate of body weight gain, and decreased food consumption were the critical effects in rats orally exposed to methyl bromide (USEPA, 2006c). The NOAEL was 2.2 mg/kg/day and the LOAEL was 11.1 mg/kg/day. The RfD derived in the 2006 OPP Human Health Assessment is 0.022 mg/kg/day, based on the point of departure (POD) of 2.2 mg/kg/day (the NOAEL) and a combined uncertainty factor (UF) of 100 for interspecies variability (10) and intraspecies variability (10). No benchmark dose modeling was performed.
Neurological effects reported after inhalation exposures have not been reported after oral exposures, indicating that route of exposure may influence the most sensitive adverse health endpoint (USEPA, 1988).
Limited data are available regarding the developmental or reproductive toxicity of methyl bromide, especially via the oral route of exposure. ATSDR (1992) found no information on developmental effects in humans with methyl bromide exposure. An oral developmental toxicity study of methyl bromide in rats (doses of 3, 10, or 30 mg/kg/day) and rabbits (doses of 1, 3, or 10 mg/kg/day) found that there were no treatment-related adverse effects in fetuses of the treated groups of either species (Kaneda et al., 1998). ATSDR's 1992 Toxicological Profile also did not identify any LOAELs for rats or rabbits in this study. In rats exposed to 30 mg/kg/day, there was an increase in fetuses having 25 presacral vertebrae; however, ATSDR notes that there were no significant differences in the number of litters with this variation and the effect was not exposure-related (ATSDR, 1992). No significant alterations in resorptions or fetal deaths, number of live fetuses, sex ratio, or fetal body weights were observed in rats and no alterations in the occurrence of external, visceral, or skeletal malformations or variations were observed in the rabbits. Some inhalation studies reported no effects on development or reproduction, but other inhalation studies show adverse developmental effects. For example, Hardin et al. (1981) and Sikov et al. (1980) conducted studies in rats and rabbits and found no developmental effects, even when maternal toxicity was severe (ATSDR, 1992). However, another inhalation study of rabbits found increased incidence of gallbladder agenesis, fused vertebrae, and decreased fetal body weights in offspring (Breslin et al., 1990). Decreased pup weights were noted in a multigeneration study in rats exposed to 30 ppm (Enloe et al., 1986). Reproductive effects were noted in intermediate-duration inhalation studies in rats and mice (Eustis et al., 1988; Kato et al., 1986), which indicated that the testes may undergo degeneration and atrophy at high exposure levels.
In the OPP HHRA for methyl bromide (USEPA, 2006c), methyl bromide is classified as “not likely to be carcinogenic to humans”. In 2007, EPA published a PPRTV report which stated that there is “inadequate information to assess the carcinogenic potential” of methyl bromide in humans (USEPA, 2007a). The PPRTV assessment agrees with earlier National Toxicology Program (NTP) conclusions that the available data indicate that methyl bromide can cause genotoxic and/or mutagenic changes. The PPRTV assessment states that the results in studies by Vogel and Nivard (1994) and Gansewendt et al. (1991) clearly indicate methyl bromide is distributed throughout the body and is capable of methylating DNA in vivo. However, the
According to ATSDR (1992) and the EPA OPP assessment (USEPA, 2006c), no studies suggest that a specific subpopulation may be more susceptible to methyl bromide, though there is little information about susceptible lifestages or subpopulations when exposed via the oral route. Because the critical effects of decreased body weight, decreased rate of body weight gain, and decreased food consumption in this study are not specific to a sensitive subpopulation or life stage, the target population of the general adult population was selected in deriving the HRL for regulatory determination. EPA's OPP assessment conducted additional exposure assessments for lifestages that may increase exposure to methyl bromide and concluded that no lifestages have expected exposure greater than 10% of the chronic population-adjusted dose (cPAD), including children.
EPA calculated an HRL of 100 μg/L (rounded from 140.8 μg/L) based on an EPA OPP assessment cPAD of 0.022 mg/kg/day and using 2.5 L/day drinking water ingestion, 80 kg body weight, and a 20% RSC factor (USEPA, 2006d; USEPA, 2011, Table 8-1 and 3-33).
EPA has determined that methyl bromide does not occur with a frequency and at levels of public health concern at PWSs based on the Agency's evaluation of available occurrence information. The primary data occurrence data for methyl bromide are the 2013-2015 nationally representative drinking water monitoring data generated through EPA's UCMR 3. Methyl bromide was not detected in any of the 36,848 UCMR 3 samples collected by 4,916 PWSs (serving ~ 241 million people) at levels greater than
Findings from the available ambient water data for methyl bromide are consistent with the results in finished water. Ambient water data in NAWQA show that methyl bromide was detected in fewer than 1% of samples from fewer than 2% of sites. No detections were greater than the HRL in any of the three cycles. The median concentration among detections were 0.5 μg/L and 0.8 μg/L in Cycle 1 and Cycle 3, respectively. There were no detections in Cycle 2. The results of the NWIS analysis show that methyl bromide was detected in approximately 0.1% of samples at approximately 0.1% of sites. The median concentration among detections was 0.6 μg/L.
The Agency has determined that regulation of methyl bromide does not present a meaningful opportunity for health risk reduction for persons served by PWSs based on the estimated exposed populations, including sensitive populations. UCMR 3 findings indicate that the estimated population exposed to methyl bromide at levels of public health concern is 0%. As a result, the Agency finds that an NPDWR for methyl bromide does not present a meaningful opportunity for health risk reduction.
EPA received several comments on the Agency's evaluation of methyl bromide under section 1412(b)(1)(A) of SDWA, including several comments in support of its preliminary determination not to regulate methyl bromide. Three anonymous members of the public opposed the negative determination of methyl bromide because of their perceptions about its production and use. Specifically, commenters appear to be seeking to prohibit the production and use of methyl bromide.
EPA agrees with the comments that are in support of the negative regulatory determination. Regarding comments that oppose the negative determination because of methyl bromide's production and use; the production, importation, use, and disposal of specific chemicals are not regulated by SDWA and therefore are not relevant to this determination. As discussed above, methyl bromide was not found above
Metolachlor is a chloroacetanilide pesticide that is used as an herbicide for weed control. Initially registered in 1976 for use on turf, metolachlor has more recently been used on corn, cotton, peanuts, pod crops, potatoes, safflower, sorghum, soybeans, stone fruits, tree nuts, non-bearing citrus, non-bearing grapes, cabbage, certain peppers, buffalograss, guymon bermudagrass for seed production, nurseries, hedgerows/fencerows, and landscape plantings. Synonyms for metolachlor include dual and bicep (USEPA, 2021a). Metolachlor is expected to have moderate to high persistence in water due to its biodegradation half-life (USEPA, 2021a).
The Agency is making a determination not to regulate metolachlor with an NPDWR. Metolachlor does not occur with a frequency and at levels of public health concern. As a result, the Agency finds that an NPDWR does not present a meaningful opportunity for health risk reduction.
The Agency finds that metolachlor may have adverse effects on the health of persons. The existing toxicological database includes studies evaluating both metolachlor and S-metolachlor. When combined with the toxicology database for metolachlor, the toxicology database for S-metolachlor is considered complete for risk assessment purposes (USEPA, 2018d). In subchronic (metolachlor and S-metolachlor) (USEPA, 1995b; USEPA, 2018d) and chronic (metolachlor) (Hazelette, 1989; Tisdel, 1983; Page, 1981; USEPA, 2018d) toxicity studies in dogs and rats, decreased body weight was the most commonly observed effect. Chronic exposure to metolachlor in rats also resulted in increased liver weight and microscopic liver lesions in both sexes (USEPA, 2018d). No systemic toxicity was observed in rabbits when metolachlor was administered dermally, though dermal irritation was observed at lower doses (USEPA, 2018d). Portal of entry effects (
While some prenatal developmental studies in the rat and rabbit with both metolachlor and S-metolachlor revealed no evidence of a qualitative or quantitative susceptibility in fetal animals, decreased pup body weight was observed in a two-generation study (Page, 1981, USEPA, 2018d). Though there was no evidence of maternal toxicity, decreased pup body weight in the F1 and F2 litters was observed, indicating developmental toxicity (Page, 1981; USEPA, 1990b). Therefore, sensitive lifestages to consider include infants, as well as pregnant women and their fetus, and lactating women.
Although treatment with metolachlor did not result in an increase in treatment-related tumors in male rats or in mice (both sexes), metolachlor caused an increase in liver tumors in female rats (USEPA, 2018d). There was no evidence of mutagenic or cytogenetic effects in vivo or in vitro (USEPA, 2018d). In 1994 (USEPA, 1995b), EPA classified metolachlor as a Group C possible human carcinogen, in accordance with the 1986 Guidelines for Carcinogen Risk Assessment (USEPA, 1986). In 2017 (USEPA, 2018d), EPA re-assessed the cancer classification for metolachlor in accordance with EPA's final Guidelines for Carcinogen Risk Assessment (USEPA, 2005), and reclassified metolachlor/S-metolachlor as “Not Likely to be Carcinogenic to Humans” at doses that do not induce cellular proliferation in the liver. This classification was based on convincing evidence of a constitutive androstane receptor (CAR)-mediated mitogenic MOA for liver tumors in female rats that supports a nonlinear approach when deriving a guideline that is protective for the tumor endpoint (USEPA, 2018d).
A recent OPP HHRA identified a two-generation reproduction study in rats as the critical study (USEPA, 2018d). OPP proposed an RfD for metolachlor of 0.26 mg/kg/day, derived from a NOAEL of 26 mg/kg/day for decreased pup body weight in the F1 and F2 litters. A combined UF of 100 was used based on interspecies extrapolation (10), intraspecies variation (10), and an FQPA Safety Factor of 1. This RfD is considered protective of carcinogenic effects as well as effects observed in chronic toxicity studies (USEPA, 2018d). The decreased F1 and F2 litter pup body weights in the absence of maternal toxicity were considered indicative of increased susceptibility to the pups. Therefore, a rate of 0.15 L/kg/day was selected from the Exposure Factors Handbook (USEPA, 2011) to represent the consumers-only estimate of DWI based on the combined direct and indirect community water ingestion at the 90th percentile for bottle fed infants. This estimate is more protective than the estimate for pregnant women (0.033 L/kg/day) or lactating women (0.054 L/kg/day). DWI and BW parameters are further outlined in the Exposure Factors Handbook (USEPA, 2011).
EPA OW calculated an HRL for metolachlor of 300 μg/L (rounded from 0.347 mg/L). The HRL was derived from the oral RfD of 0.26 mg/kg/day for bottle fed infants ingesting 0.15 L/kg/day water, with the application of a 20% RSC.
EPA has determined that metolachlor does not occur with a frequency and at levels of public health concern at PWSs based on the Agency's evaluation of available occurrence information. The primary occurrence data for metolachlor are from the UCMR 2 screening survey. A total of 11,192 metolachlor samples were collected from 1,198 systems. Of these systems, three (0.25%) had metolachlor detections (1 μg/L) and none of the detections were greater than
Supplementary sources of finished water occurrence data from UCM Round 2 indicate that the occurrence of metolachlor in PWSs is likely to be low to non-existent (USEPA, 2021a). Metolachlor occurrence data for ambient water from NAWQA and NWIS are consistent with those for finished water (USEPA, 2021a).
The Agency has determined that regulation of metolachlor does not present a meaningful opportunity for health risk reduction for persons served by PWSs based on the estimated exposed populations, including sensitive populations. UCMR 2 findings indicate that the estimated population exposed to metolachlor at levels of public health concern is 0%. As a result, the Agency finds that an NPDWR for metolachlor does not present a meaningful opportunity for health risk reduction.
EPA received several comments on the Agency's evaluation of metolachlor under section 1412(b)(1)(A) of SDWA, all of which were in support of its preliminary determination not to regulate metolachlor. EPA agrees with the comments that are in support of the negative regulatory determination.
Nitrobenzene is a synthetic aromatic nitro compound and occurs as an oily, flammable liquid. It is commonly used as a chemical intermediate in the production of aniline and drugs such as acetaminophen. Nitrobenzene is also used in the manufacturing of paints, shoe polishes, floor polishes, metal polishes, aniline dyes, and pesticides. Nitrobenzene is expected to have a moderate to high likelihood of partitioning to water and moderate persistence in water (USEPA, 2021a).
The Agency is making a determination not to regulate nitrobenzene with an NPDWR. Nitrobenzene does not occur with a frequency and at levels of public health concern. As a result, the Agency finds that an NPDWR does not present a meaningful opportunity for health risk reduction.
The Agency finds that nitrobenzene may have adverse effects on the health of persons. NTP (1983) conducted a 90-day oral gavage study of nitrobenzene in F344 rats and B6C3F1 mice. The rats were more sensitive to the effects of nitrobenzene exposure than the mice, and changes in absolute and relative organ weights, hematologic parameters, splenic congestion, and histopathologic lesions in the spleen, testis, and brain were reported. Based on statistically significant changes in absolute and relative organ weights, splenic congestion, and increases in reticulocyte count and methemoglobin (metHb) concentration, a LOAEL of 9.38 mg/kg/day was identified for the subchronic oral effects of nitrobenzene in F344 male rats (USEPA, 2009). This was the lowest dose studied, so a NOAEL was not identified. The mice were treated with higher doses and were generally more resistant to nitrobenzene toxicity, the toxic endpoints were similar in both species.
The testis, epididymis, and seminiferous tubules of the male reproductive system are targets of nitrobenzene toxicity in rodents. In male rats (F344/N and CD) and mice (B6C3F1), nitrobenzene exposure via the oral and inhalation routes results in histopathologic lesions of the testis and
Under the Guidelines for Carcinogen Risk Assessment (USEPA, 2005), nitrobenzene is classified as “likely to be carcinogenic to humans” by any route of exposure (USEPA, 2009). A two-year inhalation cancer bioassay in rats and mice (Cattley et al., 1994; CIIT, 1993) reported an increase in several tumor types in both species. However, the lack of available data, including a physiologically based biokinetic or model that might predict the impact of the intestinal metabolism on serum levels of nitrobenzene and its metabolites following oral exposures, precluded EPA's IRIS program from deriving an oral CSF (USEPA, 2009). Additionally, a metabolite of nitrobenzene, aniline, is classified as a probable human carcinogen (B2) (USEPA, 1988).
Nitrobenzene has been shown to be non-genotoxic in most studies and was classified as, at most, weakly genotoxic in the 2009 USEPA IRIS assessment (ATSDR, 1990; USEPA, 2009).
Of the available animal studies with oral exposure to nitrobenzene, the 90-day gavage study conducted by NTP (1983) is the most relevant study for deriving an RfD for nitrobenzene. This study used the longest exposure duration and multiple dose levels. Benchmark dose software (BMDS) (version 1.4.1c; USEPA, 2007b) was applied to estimate candidate PODs for deriving an RfD for nitrobenzene. Data for splenic congestion and increases in reticulocyte count and metHb concentration were modeled. The POD derived from the male rat increased metHb data with a benchmark response (BMR) of 1 standard deviation (SD) was selected as the basis of the RfD (see USEPA, 2009 for additional detail). Therefore, the benchmark dose level (BMDL) used as the POD is a BMDL1SD of 1.8 mg/kg/day.
In deriving the RfD, EPA's IRIS program applied a composite UF of 1,000 to account for interspecies extrapolation (10), intraspecies variation (10), subchronic-to-chronic study extrapolation (3), and database deficiency (3) (USEPA, 2009). Thus, the RfD calculated in the 2009 IRIS assessment is 0.002 mg/kg/day. The overall confidence in the RfD was medium because the critical effect is supported by the overall database and is thought to be protective of reproductive and immunological effects observed at higher doses; however, there are no chronic or multigenerational reproductive/developmental oral studies available for nitrobenzene. Because the critical effect in this study (increased metHb in the adult rat) is not specific to a sensitive subpopulation or lifestage, the general adult population was selected in deriving the HRL for regulatory determination.
EPA calculated an HRL for the noncancer effects of nitrobenzene of 10 μg/L (rounded from 12.8 μg/L), based on the RfD of 0.002 mg/kg/day, using 2.5 L/day drinking water ingestion, 80 kg body weight, and a 20% RSC factor.
EPA has determined that nitrobenzene does not occur with a frequency and at levels of public health concern at PWSs based on the Agency's evaluation of available occurrence information. The primary occurrence data for nitrobenzene are nationally representative finished water monitoring data generated through EPA's UCMR 1 a.m. (2001-2003). UCMR 1 collected 33,576 finished water samples from 3,861 PWSs (serving ~226 million people) for nitrobenzene and it was detected in only a small number of those samples (0.01%) above the HRL (10 μg/L), which is the same as the MRL (10 μg/L).
Findings from the available ambient water data for nitrobenzene are consistent with the results in finished water. Ambient water data in NAWQA show that nitrobenzene was not detected in any of the samples collected under any of the three monitoring cycles, while NWIS data show that nitrobenzene was detected in approximately 1% of samples.
The Agency has determined that regulation of nitrobenzene does not present a meaningful opportunity for health risk reduction for persons served by PWSs based on the estimated exposed populations, including sensitive populations. UCMR 1 data indicate that the estimated population exposed to nitrobenzene above the HRL is 0.1%. The Agency finds that an NPDWR for nitrobenzene does not present a meaningful opportunity for health risk reduction.
EPA received several comments on the Agency's evaluation of nitrobenzene under section 1412(b)(1)(A) of SDWA, all of which were in support of its preliminary determination not to regulate nitrobenzene. EPA agrees with the comments that are in support of the negative regulatory determination.
RDX is a nitrated triazine and is an explosive. The name RDX is an abbreviation of “Royal Demolition eXplosive.” The formal chemical name is hexahydro-1,3,5-trinitro-1,3,5-triazine. RDX is expected to have a moderate to high likelihood of partitioning to water and low to moderate persistence in water (USEPA, 2021a).
The Agency is making a determination not to regulate RDX with an NPDWR. RDX does not occur with a frequency and at levels of public health concern. As a result, the Agency finds that an NPDWR does not present a meaningful opportunity for health risk reduction.
The Agency finds that RDX may have adverse effects on the health of persons. Available health effects assessments include an IRIS toxicological review (USEPA, 2018e), and older assessments including an ATSDR toxicological profile (ATSDR, 2012) and an OW assessment published in the 1992 Drinking Water Health Advisory: Munitions (USEPA, 1992). The EPA IRIS assessment (2018e) presents an RfD of 0.004 mg/kg/day based on convulsions as the critical effect observed in a subchronic study in F-344 rats by Crouse et al. (2006). The POD for the derivation was a BMDL
Additionally, the EPA IRIS assessment (USEPA, 2018e) classified data from the Lish et al. (1984) chronic study in B6C3F1 as providing suggestive evidence of carcinogenic potential following EPA (USEPA, 2005) guidelines. The slope factor was derived from the lung and liver tumors' dose-response in the Lish et al. (1984) study. The POD for the slope factor was the BMDL
In mice fed doses of 0 to 35 mg/kg/day for 24 months in the Lish et al. (1984) study, there were dose-dependent increases in adenomas or carcinomas of the lungs and liver in males and females (USEPA, 2018e). The formulation used contained 3 to 10% HMX, another munition ingredient. EPA assessed the toxicity of HMX (USEPA, 1988). No chronic-duration studies were available to evaluate the carcinogenicity of HMX (USEPA, 1988). HMX is classified as Group D, or not classifiable as to human carcinogenicity (USEPA, 1992; USEPA, 1988). In the Levine et al. (1983) RDX dietary exposure study with Fischer 344 rats, a statistically significant increase in the incidence of hepatocellular carcinomas was observed in males but not in females (USEPA, 2018e). Although evidence of carcinogenicity included dose-dependent increases in two experimental animal species, two sexes, and two systems (liver and lungs), evidence supporting carcinogenicity in addition to the B6C3F1 mouse study was not robust; this factor contributed to the suggestive evidence of carcinogenic potential classification. EPA considered both the Lish et al. (1984) and Levine et al. (1983) studies to be suitable for dose-response analysis because they were well conducted, using similar study designs with large numbers of animals at multiple dose levels (USEPA, 2018e). EPA (2018e) concluded that insufficient information was available to evaluate male reproductive toxicity from experimental animals exposed to RDX. In addition, EPA (2018e) concluded that inadequate information was available to assess developmental effects from experimental animals exposed to RDX. EPA selected the 2018 EPA IRIS assessment to derive two HRLs for RDX: The RfD-derived HRL (based on Crouse et al., 2006) and the oral cancer slope factor-derived HRL (based on Lish et al., 1984). EPA has generally derived HRLs for “possible” or Group C carcinogens using the RfD approach in past Regulatory Determinations. However, for RDX, EPA decided to show both an RfD-derived and oral-cancer-slope-factor-derived HRL since the mode of action for liver tumors is unknown and the 1 × 10
The RfD-derived HRL for RDX was calculated using the RfD of 0.004 mg/kg/day based on a subchronic study in F-344 rats by Crouse et al. (2006) with convulsions as the critical effect (USEPA, 2018e). The point of departure for the RfD calculation was a human equivalent BMDL
The oral-cancer-slope-factor-derived HRL for RDX was also based on values presented in the 2018 EPA IRIS assessment. The slope factor is derived from the dose-response for lung and liver tumors in the Lish et al. (1984) study, with elimination of the data for the high dose group due to high mortality. The point of departure for the slope factor of 0.08 (mg/kg/day)-1 was the BMDL
EPA's (USEPA, 2018e) derivation of an oral slope factor for cancer is in accordance with the Guidelines for Carcinogen Risk Assessment (USEPA, 2005) while RDX is classified as having “suggestive evidence of carcinogenic potential.” Specifically, the guidelines state “when the evidence includes a well-conducted study, quantitative analyses may be useful for some purposes, for example, providing a sense of the magnitude and uncertainty of potential risks, ranking potential hazards, or setting research priorities” (USEPA, 2005). The EPA IRIS assessment concluded that the database for RDX contains well-conducted carcinogenicity studies (Lish et al., 1984; Levine et al., 1983) suitable for dose response and that the quantitative analysis may be useful for providing a sense of the magnitude and uncertainty of potential carcinogenic risk (USEPA, 2018e). Therefore, EPA felt it was important to evaluate the occurrence information against both the RfD-derived HRL and the oral cancer slope factor-derived HRL.
EPA has determined that RDX does not occur with a frequency and at levels of public health concern at PWSs based on the Agency's evaluation of available occurrence information. The primary data for RDX are nationally representative drinking water monitoring data generated through EPA's UCMR 2 AM (2008-2010). UCMR 2 collected 32,150 finished water samples from 4,139 PWSs (serving ~229 million people) for RDX and it was detected in only a small number of those samples (0.01%) at or above the MRL. The detections occurred in three large surface water systems; the maximum detected concentration of RDX was 1.1 μg/L. The MRL is 1 μg/L, which is about 2.5 times higher than the oral cancer slope factor-derived HRL (0.4 μg/L). The RfD-derived HRL (30 μg/L) is 30 times higher than the MRL and 75 times higher than the cancer slope factor-derived HRL.
Findings from the available ambient water data for RDX in ambient water, available from NWIS, show that RDX was detected in approximately 46% of samples and at approximately 29% of sites; RDX data are not available from the NAWQA program.
The Agency has determined that regulation of RDX does not present a meaningful opportunity for health risk reduction for persons served by PWSs based on the estimated exposed populations, including sensitive populations. UCMR 2 findings indicate that the estimated population exposed to RDX at or above the MRL is 0.04%. There were no detections greater than the non-cancer HRL (30 μg/L) or the one-half the non-cancer HRL (15 μg/L). Because the MRL of 1 μg/L is higher than the cancer HRL of 0.4 μg/L, the population exposed relative to the cancer HRL and
EPA received several comments on the Agency's evaluation of RDX under section 1412(b)(1)(A) of SDWA, all of which were in support of its preliminary determination not to regulate RDX. EPA agrees with the comments that are in support of the negative regulatory determination.
Strontium is an alkaline earth metal. On October 20, 2014 the Agency published its preliminary regulatory determination to regulate strontium and requested public comment on the determination and supporting technical information (USEPA, 2014). Informed by the public comments received, rather than making a final determination for strontium in 2016, EPA delayed the final determination to consider additional data, and to decide whether there is a meaningful opportunity for health risk reduction by regulating strontium in drinking water (USEPA, 2016f). Specifically, the publication on the delayed final determination mentioned that EPA would evaluate additional studies on strontium exposure and health studies related to strontium exposure. Since 2016, EPA has worked to identify and evaluate published studies on health effects associated with strontium exposure, sources of exposure to strontium, and treatment technologies to remove strontium from drinking water. In its March 10, 2020 document (USEPA, 2020a), EPA clarified that it is continuing with its previous 2016 decision (USEPA, 2016f) to delay a final determination for strontium in order to further consider additional studies related to strontium exposure.
The Agency received several comments in support of a continued evaluation of strontium and not making a final determination for strontium in this action. One commenter requested that EPA complete its evaluation of strontium in a more timely manner. EPA agrees with the comments that are in support of the continued evaluation prior to making a final regulatory determination for strontium. Regarding making a regulatory determination for strontium in this rulemaking, EPA notes that there continues to be a need for additional information and analyses before a regulatory determination can be made for strontium. While EPA determined in 2014 that strontium may have adverse effects on the health of persons including children, the Agency continues to consider additional data, consult existing assessments (such as Health Canada's Drinking Water Guideline from 2018), and evaluate whether there is a meaningful opportunity for health risk reduction by regulating strontium in drinking water. Additionally, EPA understands that strontium may co-occur with beneficial calcium in some drinking water systems and treatment technologies that remove strontium may also remove calcium. The Agency is evaluating the effectiveness of treatment technologies under different water conditions, including calcium concentrations. EPA intends to make a determination after these data needs have been resolved as part of its regulatory determination process.
1,4-Dioxane is used as a solvent in cellulose formulations, resins, oils, waxes, and other organic substances; also used in wood pulping, textile processing, degreasing; in lacquers, paints, varnishes, and stains; and in paint and varnish removers.
While the health effects data suggest that 1,4-dioxane may have an adverse effect on human health and the occurrence data indicate that 1,4-dioxane is occurring in finished drinking water above the current HRL in some systems, EPA has not made a preliminary determination for 1,4-dioxane, as the Agency has not determined whether 1,4-dioxane occurs in public water systems with a frequency and at levels of public health concern and whether there is a meaningful opportunity for public health risk reduction by establishing an NPDWR for 1,4-dioxane (USEPA, 2020a). The
The Agency received several comments in support of a continued evaluation and not making a 1,4-dioxane determination at this time. One commenter provided information summarizing their belief that 1,4 dioxane has a non-linear mode of action. Another commenter requested that EPA complete its evaluation of 1,4-dioxane in a more-timely manner. EPA agrees with the comments that are in support of the continued evaluation. Regarding making a regulatory determination for 1,4-dioxane today, EPA notes that there is a need for additional information and analyses before a regulatory determination can be made for 1,4-dioxane. Based on UCMR 3 data, EPA derived a national estimate of less than two baseline cancer cases per year attributable to 1,4-dioxane in drinking water (USEPA, 2021a). However, while the number of baseline cancer cases is relatively low, other adverse health effects following exposure to 1,4-dioxane may also contribute to potential risk to public health, and these analyses under SDWA have not yet been completed. The Agency recently completed its new TSCA risk evaluation for 1,4-dioxane by the Office of Chemical Safety and Pollution Prevention (OCSPP) (USEPA, 2020c) and intends to consider it and the Canadian guideline technical document, once finalized, (Health Canada, 2018) and other relevant new science relevant to drinking water contamination prior to making a regulatory determination. This evaluation may provide clarity as to whether a new HRL is appropriate for evaluating the occurrence of 1,4-dioxane and whether there is a meaningful opportunity for an NPDWR to reduce public health risk.
1,2,3-Trichloropropane is a man-made chemical used as an industrial solvent, cleaning and degreasing agent, and synthesis intermediate.
While the UCMR 3 data indicated 1,2,3-trichloropropane occurrence was relatively low at concentrations above the MRL, the MRL (0.03 μg/L) is more than 75 times the HRL (0.0004 μg/L) for 1,2,3-trichloropropane. This discrepancy allows for a broad range of potential contaminant concentrations that could be in exceedance of the HRL but below the MRL. EPA did not make a preliminary determination for 1,2,3-trichloropropane due to these analytical method-based limitations. The Agency noted that it needs additional lower-level occurrence information prior to making a preliminary regulatory determination for 1,2,3-trichloropropane. The
The Agency received several comments in support of a continued evaluation and not making a 1,2,3-trichloropropane determination at this time. In addition, EPA notes that several comments requested that EPA find solutions to the analytical method limitations and collect additional monitoring data with an MRL adequate to support decision-making. EPA agrees with the comments that are in support of the continued evaluation. EPA also agrees that further evaluation of 1,2,3-tricholoropropane is warranted when new methods or other tools are available to do so.
As required by SDWA, EPA will initiate the process to propose a NPDWR for PFOA and PFOS within 24 months of the publication of this document in the
This document of the Environmental Protection Agency was signed on January 15, 2021, by Andrew Wheeler, Administrator, pursuant to the statutory requirements of the Safe Drinking Water Act, Section 1412(b). That document with the original signature and date is maintained by EPA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned EPA Official re-signs the document for publication, as an official document of the Environmental Protection Agency. This administrative process in no way alters the legal effect of this document upon publication in the
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure of the General category January fishery for 2021.
NMFS closes the Atlantic bluefin tuna (BFT) General category fishery for the January subquota period. The intent of this closure is to prevent overharvest of the adjusted January subquota.
Effective 11:30 p.m., local time, February 27, 2021, through May 31, 2021.
Sarah McLaughlin,
Regulations implemented under the authority of the Atlantic Tunas Convention Act (ATCA; 16 U.S.C. 971
Under § 635.28(a)(1), NMFS files a closure notice with the Office of the Federal Register for publication when a BFT quota (or subquota) is reached or is projected to be reached. Retaining, possessing, or landing BFT under that quota category is prohibited on and after the effective date and time of a closure notice for that category, for the remainder of the fishing year, until the opening of the subsequent quota period or until such date as specified.
The base quota for the General category is 555.7 mt. See § 635.27(a). Each of the General category time periods (January, June through August, September, October through November, and December) is allocated a subquota or portion of the annual General category quota. Although it is called the “January” subquota, the regulations allow the General category fishery under this quota to continue until the subquota is reached or March 31, whichever comes first. The baseline subquotas for each time period are as follows: 29.5 mt for January; 277.9 mt for June through August; 147.3 mt for September; 72.2 mt for October through November; and 28.9 mt for December. Any unused General category quota rolls forward from one time period to the next and is available for use in subsequent time periods within the fishing year. Effective January 1, 2021, NMFS transferred 19.5 mt of the 28.9-mt General category quota allocated for the December 2021 period to the January 2021 period, resulting in an adjusted subquota of 49 mt for the January period and a subquota of 9.4 mt for the December 2021 period (85 FR 83832, December 23, 2020). Effective February 8, 2021, NMFS transferred an additional 26 mt from the Reserve category to the General category, in the same notice as NMFS made the annual reallocation of Purse Seine category quota to the Reserve category, resulting in an adjusted subquota of 75 mt for the General category 2021 January subquota period and 168 mt for the Reserve category (86 FR 8717, February 9, 2021).
Based on the best available General category BFT Landings information (
Fishermen may catch and release (or tag and release) BFT of all sizes, subject to the requirements of the catch-and-release and tag-and-release programs at § 635.26. All BFT that are released must be handled in a manner that will maximize their survival, and without removing the fish from the water, consistent with requirements at § 635.21(a)(1). For additional information on safe handling, see the “Careful Catch and Release” brochure available at
NMFS will continue to monitor the BFT fisheries closely. Dealers are required to submit landings reports within 24 hours of a dealer receiving BFT. Late reporting by dealers compromises NMFS' ability to timely implement actions such as quota and retention limit adjustment, as well as closures, and may result in enforcement actions. Additionally, and separate from the dealer reporting requirement, General and HMS Charter/Headboat category vessel owners are required to report the catch of all BFT retained or discarded dead within 24 hours of the landing(s) or end of each trip, by accessing
Depending on the level of fishing effort and catch rates of BFT, NMFS may determine that additional adjustments are necessary to ensure available subquotas are not exceeded or to enhance scientific data collection from, and fishing opportunities in, all geographic areas. If needed, subsequent adjustments will be published in the
NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act. This action is consistent with regulations at 50 CFR part 635, which were issued pursuant to section 304(c) of the Magnuson-Stevens Act and the Atlantic Tunas Convention Act, and is exempt from review under Executive Order 12866.
The Assistant Administrator for NMFS finds that pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice of, and an opportunity for public comment on, for the following reasons: The regulations implementing the 2006 Consolidated HMS FMP and amendments provide for inseason retention limit adjustments and fishery closures to respond to the unpredictable nature of BFT availability on the fishing grounds, the migratory nature of this species, and the regional variations in the BFT fishery. This fishery is currently underway and delaying this action would be contrary to the public interest as it could result in BFT landings exceeding the January 2021 subquota, which could result in the need to reduce quota for the General category later in the year and thus could affect later fishing opportunities. For all of the above reasons, there is good cause under 5 U.S.C. 553(d) to waive the 30-day delay in effectiveness.
16 U.S.C. 971
Animal and Plant Health Inspection Service, USDA.
Proposed rule.
We are proposing to eliminate the Animal and Plant Health Inspection Service (APHIS) Voluntary Trichinae Certification Program and remove the regulations associated with the program. This action would also notify the public that APHIS will no longer maintain any activity associated with the program, such as training for qualified accredited veterinarians, on-farm audits, or any other administrative process associated with program maintenance and support. We are proposing to eliminate the program because it generates little producer participation. This action would allow APHIS to direct APHIS resources to areas of greater need.
We will consider all comments that we receive on or before May 3, 2021.
You may submit comments by either of the following methods:
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Supporting documents and any comments we receive on this docket may be viewed at
Dr. María Celia Antognoli, Swine Health Senior Staff Officer, Aquaculture, Swine, Equine and Poultry Health Center, Strategy and Policy, VS, APHIS, 2150 Centre Ave., Bldg. B, Fort Collins, CO 80526-8117; (970) 494-7304;
Trichinella are parasitic nematodes (roundworms) that are found in many warm-blooded carnivores and omnivores, including swine. There are eight known species of
In a final rule
Producer participation in this voluntary program has decreased since the program began. Only two producers re-enrolled in the past 3 years. The lack of producer interest and involvement has become problematic for a number of reasons. Maintaining the program places demands on limited Animal and Plant Health Inspection Service (APHIS) funding and human resources that could be better directed elsewhere. In addition, the existence of a program that producers have little interest in has had trade implications. Trading partners have questioned our ability to certify freedom of trichinae in exported products, given that the vast majority of the products are not produced under the auspices of the Trichinae Certification Program.
We are therefore proposing to eliminate the program by removing part 149 from the regulations. Eliminating this program should benefit the swine industry by reducing possible confusion about the trichinae-free status of exported products. APHIS would also no longer incur the costs associated with program administration and payments to auditors.
This proposed rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.
In accordance with the Regulatory Flexibility Act, we have analyzed the potential economic effects of this action on small entities. The analysis is summarized below. Copies of the full analysis are available by contacting the person listed under
APHIS is proposing to eliminate the Voluntary Trichinae Certification Program and remove its associated regulations from title 9 of the Code of Federal Regulations.
Producer participation in the Voluntary Trichinae Certification program has decreased significantly since this voluntary program began in 2007. Only two producers with 23 audit sites re-enrolled in the past 3 years. Continuation of the voluntary program, given the lack of producer participation, is difficult to justify. Furthermore, a voluntary certification program that does not attract producer participation could negatively affect APHIS' and the pork industry's credibility, especially
Preserving APHIS' credibility is crucial in supporting the U.S. pork industry and its exports, which have increased substantially in recent years. Since 2007, U.S. pork exports have more than doubled in value (110 percent increase) and in quantity (109 percent increase).
The Small Business Administration (SBA) small business size standard for hog and pig farming is annual revenue of not more than $1 million. According to the 2017 Agricultural Census, 64,871 hog and pig farms sold over 235 million hogs and pigs with total sales of $26.3 billion in 2017. Average annual sales per farm was 3,267 head valued at $404,907, well below the SBA small-entity standard.
When the census data are divided into two categories—the largest producers, with 5,000 or more hogs and pigs sold, and the remaining farms—the prevalence of small-scale producers becomes clear. Farms with fewer than 5,000 hogs and pigs sold accounted for 57,084 farms (88 percent of the total). However, the number and value of hogs and pigs sold by these farms, 15,157,702 head valued at $2.4 billion, represent only 6 percent and 9 percent, respectively, of total sales. The average number and value of hogs and pigs sold per farm in 2017 by these smaller farms was 266 head valued at $42,078. Clearly, hog and pig farms are predominantly small.
Because the Voluntary Trichinae Certification Program did not progress beyond the pilot stage, the participating producers have not borne program costs.
Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action would not have a significant economic impact on a substantial number of small entities.
This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 2 CFR chapter IV.)
This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. If this proposed rule is adopted: (1) State and local laws and regulations will not be preempted; (2) no retroactive effect will be given to this rule; and (3) administrative proceedings will not be required before parties may file suit in court challenging this rule.
This proposed rule contains no new information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Animal diseases, Laboratories, Meat and meat products, Meat inspection, Reporting and recordkeeping requirements, Swine.
Accordingly, for the reasons stated in the preamble, and under the authority of 7 U.S.C. 8301
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to adopt a new airworthiness directive (AD) for Airbus Helicopters Deutschland GmbH (AHD) Model MBB-BK 117 D-2 helicopters. This proposed AD was prompted by a report of a broken Titanium (Ti) bolt. This proposed AD would require removing certain Ti-bolts from service and prohibit installing these Ti-bolts in a critical area. The FAA is proposing this AD to address the unsafe condition on these products.
The FAA must receive comments on this proposed AD by April 19, 2021.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
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For service information identified in this NPRM, contact Airbus Helicopters, 2701 N Forum Drive, Grand Prairie, TX 75052; telephone (972) 641-0000 or (800) 232-0323; fax (972) 641-3775; or at
You may examine the AD docket at
Matt Fuller, AD Program Manager, General Aviation & Rotorcraft Unit, Airworthiness Products Section, Operational Safety Branch, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone (817) 222-5110; email
The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under
Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to
CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Matt Fuller, AD Program Manager, General Aviation & Rotorcraft Unit, Airworthiness Products Section, Operational Safety Branch, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone (817) 222-5110; email
EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD No. 2019-0258, dated October 18, 2019, to correct an unsafe condition for Airbus Helicopters Deutschland GmbH (AHD), formerly Eurocopter Deutschland GmbH, Model MBB-BK117 D-2 helicopters. EASA advises of a report of a broken Ti-bolt. Subsequent investigation revealed that an improper heat treatment process was accomplished on a batch of Ti-bolts, which can lead to hydrogen embrittlement. Hydrogen embrittlement can make high-strength bolts susceptible to stress corrosion, pitting, and failure.
EASA states that this condition, if not detected and corrected, could lead to failure of an affected Ti-bolt installed in a critical location, possibly resulting in reduced control of the helicopter. Accordingly, the EASA AD requires a one-time inspection for Ti-bolt part number (P/N) EN3740-060022F marked with manufacturer monogram “D” or with an illegible manufacturer monogram installed on the aft connection of the tail rotor ball bearing control (ball bearing control) and, depending on findings, contacting AHD for corrective action. The EASA AD also prohibits the (re)installation of these Ti-bolts.
These helicopters have been approved by EASA and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with the European Union, EASA has notified the FAA about the unsafe condition described in its AD. The FAA is proposing this AD after evaluating all known relevant information and determining that an unsafe condition is likely to exist or develop on other helicopters of the same type design.
The FAA reviewed Airbus Helicopters Alert Service Bulletin (ASB) No. ASB MBB-BK117 D-2-00A-001, Revision 1, dated October 16, 2019 (ASB MBB-BK117 D-2-00A-001 Rev 1), which specifies replacing each Ti-bolt P/N EN3740-060022F that is marked with manufacturer monogram “D” or if the manufacturer monogram cannot be identified with an airworthy Ti-bolt in both locations of the aft connection of ball bearing control and both HF antenna bracket locations.
This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
This proposed AD would require removing any Ti-bolt P/N EN3740-060022F marked with manufacturer monogram “D” or with an illegible manufacturer monogram installed on the aft connection of the ball bearing control from service. This proposed AD would also prohibit installing an affected Ti-bolt on the aft connection of the ball bearing control of any helicopter.
The EASA AD applies to Model MBB-BK117 D-2 helicopters and requires inspecting for Ti-bolt P/N EN3740-060022F marked with manufacturer monogram “D” or with an illegible manufacturer monogram installed on the aft connection of the ball bearing control. This proposed AD applies to Model MBB-BK 117 D-2 helicopters with a Ti-bolt P/N EN3740-060022F marked with manufacturer monogram “D” or with an illegible manufacturer monogram installed on the aft connection of the ball bearing control instead. The EASA AD requires contacting AHD for approved instructions if an affected Ti-bolt is found, whereas this proposed AD would require removing an affected Ti-bolt from service instead.
The FAA estimates that this AD if adopted as proposed, would affect 29 helicopters of U.S. Registry. Labor rates are estimated at $85 per work-hour. Based on these numbers, the FAA estimates that operators may incur the following costs in order to comply with this proposed AD.
Replacing a Ti-bolt would take about 2 work-hours and parts would cost about $100 for an estimated cost of $270 per Ti-bolt.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Would not affect intrastate aviation in Alaska, and
(3) Would not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
The FAA must receive comments on this airworthiness directive (AD) by April 19, 2021.
None.
This airworthiness directive (AD) applies to Airbus Helicopters Deutschland GmbH (AHD) Model MBB-BK 117 D-2 helicopters, certificated in any category, with a Titanium (Ti) bolt part number EN3740-060022F marked with manufacturer monogram “D” or with an illegible manufacturer monogram, installed on the aft connection of the tail rotor ball bearing control.
Joint Aircraft System Component (JASC) Codes: 1430, Fasteners; and 6720, Tail Rotor Control System.
This AD defines the unsafe condition as a Ti-bolt with hydrogen embrittlement. This condition could result in failure of the tail rotor ball bearing control Ti-bolt and subsequent loss of tail rotor control.
Comply with this AD within the compliance times specified, unless already done.
(1) Within 50 hours time-in-service or 3 months, whichever occurs first, remove any Ti-bolt identified in paragraph (c) of this AD, located on the aft connection of the tail rotor ball bearing rod end (item 5) and at the input lever (item 2) as shown in Figure 1 to Airbus Helicopters Alert Service Bulletin (ASB) No. ASB MBB-BK117 D-2-00A-001, Revision 1, dated October 16, 2019, from service.
(2) As of the effective date of this AD, do not install a Ti-bolt identified in paragraph (c) of this AD on the aft connection of the tail rotor ball bearing control of any helicopter.
(1) The Manager, Strategic Policy Rotorcraft Section, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in paragraph (i)(1) of this AD. Information may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(1) For more information about this AD, contact Matt Fuller, AD Program Manager, General Aviation & Rotorcraft Unit, Airworthiness Products Section, Operational Safety Branch, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone (817) 222-5110; email
(2) For service information identified in this AD, contact Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052; telephone (972) 641-0000 or (800) 232-0323; fax (972) 641-3775; or at
(3) The subject of this AD is addressed in European Union Aviation Safety Agency (EASA) AD No. 2019-0258, dated October 18, 2019. You may view the EASA AD on the internet at
Drug Enforcement Administration, Department of Justice.
Notice of proposed rulemaking.
The Drug Enforcement Administration proposes placing
Comments must be submitted electronically or postmarked on or before April 2, 2021.
Requests for hearing and waivers of an opportunity for a hearing or to participate in a hearing must be received on or before April 2, 2021.
To ensure proper handling of comments, please reference “Docket No. DEA-476” on all electronic and written correspondence, including any attachments.
•
•
•
Terrence L. Boos, Drug and Chemical Evaluation Section, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (571) 362-3249
Please note that all comments received in response to this docket are considered part of the public record. They will, unless reasonable cause is given, be made available by the Drug Enforcement Administration (DEA) for public inspection online at
If you want to submit confidential business information as part of your comment, but do not want it to be made publicly available, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment.
Comments containing personal identifying information and confidential business information identified as directed above will be made publicly available in redacted form. If a comment has so much confidential business information or personal identifying information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments posted to
An electronic copy of this document and supplemental information to this proposed rule are available at
Pursuant to 21 U.S.C. 811(a), this action is a formal rulemaking “on the record after opportunity for a hearing.” Such proceedings are conducted pursuant to the provisions of the Administrative Procedure Act, 5 U.S.C. 551-559. 21 CFR 1308.41-1308.45; 21 CFR part 1316, subpart D. Interested persons may file requests for hearing or notices of intent to participate in a hearing in conformity with the requirements of 21 CFR 1308.44(a) or (b), and include a statement of interest in the proceeding and the objections or issues, if any, concerning which the person desires to be heard. Any interested person may file a waiver of an opportunity for a hearing or to participate in a hearing together with a written statement regarding the interested person's position on the matters of fact and law involved in any hearing as set forth in 21 CFR 1308.44(c).
All requests for a hearing and waivers of participation must be sent to DEA using the address information provided above.
The Controlled Substances Act (CSA) provides that proceedings for the issuance, amendment, or repeal of the scheduling of any drug or other substance may be initiated by the Attorney General (delegated to the Administrator of DEA pursuant to 28 CFR 0.100) on his own motion. 21 U.S.C. 811(a). This proposed action is supported by a recommendation from the Assistant Secretary for Health of U.S. Department of Health and Human Services (HHS) (Assistant Secretary) and an evaluation of all other relevant data by DEA. If finalized, this action would make permanent the existing temporary regulatory controls and administrative, civil, and criminal sanctions of schedule I controlled substances on any person who handles or proposes to handle 2′-fluoro
On February 6, 2018, pursuant to 21 U.S.C. 811(h)(1), the then-Acting Administrator of DEA published an order in the
That temporary order was effective upon the date of publication. Pursuant to 21 U.S.C. 811(h)(2), the temporary control of fentanyl-related substances, a class of substances as defined in the order, as well as the 10 specific substances already covered by that order, was set to expire on February 6, 2020. However, as explained in DEA's April 10, 2020, correcting amendment (85 FR 20155), Congress overrode and extended that expiration date until May 6, 2021, by enacting on February 6, 2020 the Temporary Reauthorization and Study of the Emergency Scheduling of Fentanyl Analogues Act (Pub. L. 116-114, sec. 2, 134 Stat. 103). By operation of law, the temporary control of fentanyl-related substances, which includes these 10 covered substances, will remain in effect until May 6, 2021, unless DEA permanently places them in schedule I prior to May 6, 2021. As discussed in the above Legal Authority section, proceedings under 21 U.S.C. 811(a) may be initiated by the Administrator of DEA on his own motion.
The Acting Administrator, on his own motion, is initiating proceedings to permanently schedule the following 10 fentanyl-related substances: 2′-fluoro
Upon evaluating the scientific and medical evidence, on July 2, 2020, the Assistant Secretary submitted to the Acting Administrator, HHS's scientific and medical evaluation and scheduling recommendation for 11 of the 16 fentanyl-related substances, including the 10 named substances in this proposed rule as well as crotonyl fentanyl.
As discussed in the background section, the Acting Administrator is initiating proceedings to permanently add 2′-fluoro
1.
The abuse potential of 2′-fluoro
These 10 substances have no approved medical use in the United States and have been encountered on the illicit drug market. The use of some fentanyl-related substances has been associated with adverse health outcomes, including death. The appearance of several substances structurally related to fentanyl in the illicit drug market has resulted in a significant increase in drug overdose deaths in the United States. According to the Centers for Disease Control and Prevention (CDC) overdose death data for 2018, there continues to be an increase in the number of deaths related to synthetic opioids. Opioids were involved in about 70 percent of all drug-involved overdose deaths in 2018. Further, CDC reports demonstrate that the increase in synthetic opioid overdose deaths are largely attributed to an increase in the supply of illicitly manufactured fentanyl and substances structurally related to fentanyl. Because 2′-fluoro
There are no legitimate drug channels for 2′-fluoro
2.
3.
(A) Replacement of the phenyl portion of the phenethyl group by any monocycle, whether or not further substituted in or on the monocycle;
(B) substitution in or on the phenethyl group with alkyl, alkenyl, alkoxyl, hydroxyl, halo, haloalkyl, amino or nitro groups;
(C) substitution in or on the piperidine ring with alkyl, alkenyl, alkoxyl, ester, ether, hydroxyl, halo, haloalkyl, amino or nitro groups;
(D) replacement of the aniline ring with any aromatic monocycle whether or not further substituted in or on the aromatic monocycle; and/or
(E) replacement of the
According to the February 6, 2018, temporary scheduling order, the existence of a substance with any one, or any combination, of above-mentioned modifications (see Figure 1) would meet the structural requirements of the definition of fentanyl-related substances. The present 10 substances fall within the definition of fentanyl-related substances by the following modifications:
1. 2′-Fluoro
2. 4′-methyl acetyl fentanyl: Substitution on the phenethyl group with an alkyl group and replacement of the
3. β-methyl fentanyl: Substitution on the phenethyl group with an alkyl group (meets definition for modification B);
4. β′-phenyl fentanyl: Replacement of the
5.
6.
7.
8.
9. phenyl fentanyl: Replacement of the
10. thiofuranyl fentanyl: Replacement of the
No study has been undertaken to evaluate the efficacy, toxicology, and safety of the 10 substances in humans. It can be inferred from data obtained from animal studies that these 10 substances have sufficient distribution to the brain to produce depressant effects similar to that of other mu-opioid receptor agonists such as fentanyl. Data from
There are no FDA-approved marketing applications for a drug product containing 2′-fluoro
4.
5.
6.
According to a CDC report, from 2013 to 2017, opioid-related overdose deaths in the United States increased 90 percent from 25,052 to 47,600. The increase in the number of opioid-related deaths was primarily driven by illicitly manufactured fentanyl.
7.
8.
The CSA establishes five schedules of controlled substances known as schedules I, II, III, IV, and V. The CSA also outlines the findings required to place a drug or other substance in any particular schedule. 21 U.S.C. 812(b). After consideration of the analysis and recommendation of the Assistant Secretary for Health of HHS and review of all other available data, the Acting Administrator of DEA, pursuant to 21 U.S.C. 811(a) and 21 U.S.C. 812(b)(1), finds that:
According to HHS, 2′-fluoro
According to HHS, there are no FDA-approved new drug applications for 2′-fluoro
i. The drug's chemistry must be known and reproducible;
ii. there must be adequate safety studies;
iii. there must be adequate and well-controlled studies proving efficacy;
iv. the drug must be accepted by qualified experts; and
v. the scientific evidence must be widely available.
57 FR 10499 (1992),
Because 2′-fluoro
Based on these findings, the Acting Administrator of DEA concludes that 2′-fluoro
If this rule is finalized as proposed, 2′-fluoro
1.
2.
3.
4.
5.
After the initial inventory, every DEA registrant must take a new inventory of all stocks of controlled substances (including 2′-fluoro
6.
In accordance with 21 U.S.C. 811(a), this proposed scheduling action is subject to formal rulemaking procedures done “on the record after opportunity for a hearing,” which are conducted pursuant to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth the criteria for scheduling a drug or other substance. Such actions are exempt from review by the Office of Management and Budget (OMB) pursuant to section 3(d)(1) of Executive Order (E.O.) 12866 and the principles reaffirmed in E.O. 13563.
This proposed regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.
This proposed rulemaking does not have federalism implications warranting the application of E.O. 13132. The proposed rule does not have substantial direct effects on the States, on the relationship between the National Government and the States, or the distribution of power and responsibilities among the various levels of government.
This proposed rule does not have tribal implications warranting the application of E.O. 13175. It does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
The Acting Administrator, in accordance with the Regulatory Flexibility Act, 5 U.S.C. 601-602, has reviewed this proposed rule and by approving it, certifies that it will not have a significant economic impact on a substantial number of small entities. On February 6, 2018, DEA published an order to temporarily place fentanyl-related substances, as defined in the order, in schedule I of the CSA pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). DEA estimates that all entities handling or planning to handle 2′-fluoro
There are currently 57 registrations authorized to handle the fentanyl-related substances as a class, which include 2′-fluoro
A review of the 57 registrations indicates that all entities that currently handle fentanyl-related substances, including 2′-fluoro
In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 1501
This action does not impose a new collection of information under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521. This action would not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements.
For the reasons set out above, DEA proposes to amend 21 CFR part 1308 as follows:
21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise noted.
The additions to read as follows:
(b) * * *
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve a State Implementation Plan (SIP) revision submitted by the State of Alabama through a letter dated February 27, 2020, to add regulations maintaining compliance with the State's Nitrogen Oxide (NO
Comments must be received on or before April 2, 2021.
Submit your comments, identified by Docket ID No. EPA-R04-OAR-2020-0129 at
Steven Scofield, Air Regulatory Management Section, Air Planning and Implementation Branch, Air and Radiation Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia 30303-8960. The telephone number is (404) 562-9034. Mr. Scofield can also be reached via electronic mail at
Under Clean Air Act (CAA or Act) section 110(a)(2)(D)(i)(I), also called the good neighbor provision, states are required to address the interstate transport of air pollution. Specifically, the good neighbor provision requires that each state's implementation plan contain adequate provisions to prohibit air pollutant emissions from within the state that will significantly contribute to nonattainment of the national ambient air quality standards (NAAQS), or that will interfere with maintenance of the NAAQS, in any other state.
In October 1998 (63 FR 57356), EPA finalized the “Finding of Significant Contribution and Rulemaking for Certain States in the Ozone Transport Assessment Group Region for Purposes of Reducing Regional Transport of Ozone” (NO
To comply with the NO
In 2005, EPA published CAIR, which required several eastern states, including Alabama, to submit SIPs that prohibited emissions consistent with revised ozone season (and annual) NO
On October 1, 2007 (72 FR 55659), EPA approved revisions to Alabama's SIP that incorporated requirements for CAIR. Consistent with CAIR's
The United States Court of Appeals for the District of Columbia Circuit (D.C. Circuit) initially vacated CAIR in 2008, but ultimately remanded the rule to EPA without vacatur to preserve the environmental benefits provided by CAIR.
Following the D.C. Circuit's remand of CAIR, EPA promulgated the Cross-State Air Pollution Rule (CSAPR) to replace CAIR and address good neighbor obligations for the 1997 ozone NAAQS, the 1997 PM
To comply with CSAPR, Alabama adopted SO
After litigation that reached the Supreme Court, the D.C. Circuit generally upheld CSAPR but remanded several state budgets to EPA for reconsideration.
The CSAPR Update trading program replaced the original CSAPR trading program for ozone season NO
Under 40 CFR 51.121(f)(2) of the NO
After evaluating the various options available following EPA's March 8, 2019, revision to the NO
ADEM's February 27, 2020, letter
As discussed above, ADEM has revised its regulations to require non-EGUs to maintain compliance with NO
ADEM added Rule 335-3-8-.71, “NO
ADEM Rule 335-3-8-.71(4) and (5) contain the rule's applicability provisions, generally covering all existing and new non-EGUs (including cogeneration units) that would have been subject to the NOx Budget Trading Program and that are not subject to the CSAPR Update trading program. ADEM Rule 335-3-8-.71(6)(a) defines the budget for the State at 2,328 tons per ozone season, which is the portion of the State's trading budget under the NOx Budget Trading Program assigned to non-EGUs, and restricts the collective emissions from the State's affected large non-EGUs from exceeding the budget during each control period. ADEM Rule 335-3-8-.71(6)(a) also states that Alabama will conduct an annual review of the actual NOx emissions to ensure that the state budget has not been exceeded. Further, in the event of an exceedance, Alabama will submit a revised SIP to EPA which compensates for any potential budget shortfall and ensures the state program budget is met in all future years. ADEM Rule 335-3-8-.71(6)(b) requires monitoring and reporting of NOx emissions from covered units according to the methods specified in ADEM Rule 335-3-8-.72. Other provisions of ADEM Rule 335-3-8-.71 address definitions, recordkeeping requirements, and liability.
ADEM Rule 335-3-8-.72, “NOx Budget Program Monitoring and Reporting,” requires all owners and operators of covered NOx budget units to implement a monitoring and reporting system necessary to attribute ozone season NOx mass emissions to each individual NOx budget unit at the source and provide a compliance certification report following each ozone season. ADEM Rule 335-3-8-.72(1) requires units to monitor and report ozone season NOx mass emissions determined under one of the following alternatives: (1) 40 CFR part 75; (2) NOx CEMS, with a requirement to convert the NOx concentration or NOx emission rate derived from the CEMS to mass emissions; or (3) the use of approved emissions factors, with a requirement to
As discussed above, in order to address the requirements of the NOx SIP Call for sources that are not covered under a CSAPR trading program for ozone season NOx emissions, SIP revisions must provide for enforceable emissions limitations and require emissions monitoring consistent with the NOx SIP Call's general enforceability and monitoring requirements.
Further, EPA is proposing to find that ADEM Rule 335-3-8-.72 meets the State's ongoing obligations under the NOx SIP Call with respect to monitoring to ensure compliance with required limitations, with the following exception. While ADEM Rule 335-3-8-.72 generally addresses the State's ongoing obligations under the NOx SIP Call with respect to monitoring, EPA identified one issue impacting monitoring under ADEM's rule. Accordingly, on September 15, 2020, ADEM sent a letter
EPA proposes to approve the removal from the SIP of the State's repealed NO
CAA section 110(l) provides that EPA cannot approve a SIP revision if the revision would interfere with any applicable requirement concerning attainment or reasonable further progress (RFP), or any other applicable requirement of the CAA. EPA generally considers whether the SIP revision would worsen, preserve, or improve the status quo in air quality.
ADEM's February 27, 2020 submission seeks to remove the SIP-approved portions of the state trading program rules adopted to comply with annual CAIR programs from Alabama's SIP because the CAIR annual programs have been replaced by the CSAPR annual programs. In addition, ADEM's February 27, 2020 submission seeks to remove the SIP-approved portions of the State's trading program rules adopted to comply with ozone season CAIR programs from Alabama's SIP because the CAIR program has been replaced by CSAPR for EGUs, and, if approved, Alabama's state control program would address the outstanding NO
In this notice, EPA is proposing to approve the removal of the CAIR-related provisions from Alabama's SIP because removal of these provisions is appropriate and consistent with all applicable requirements, including 40 CFR 51.121 and CAA section 110(l). As explained above, the D.C. Circuit remanded CAIR to EPA in 2008; however, the court left CAIR in place while EPA worked to develop a new interstate transport rule. CSAPR was promulgated to respond to the Court's concerns and to replace CAIR. The implementation of CSAPR was delayed for several years beyond its originally expected implementation timeframe of 2012, and therefore, the sunsetting of CAIR was also deferred. CAIR was implemented through the 2014 compliance periods and was replaced by CSAPR on January 1, 2015. EPA promulgated regulations to sunset the CAIR trading programs and is no longer
ADEM further provided an analysis to demonstrate that the monitoring flexibilities comply with CAA section 110(l). Given that several of the original large non-EGU sources are no longer subject to the NO
EPA also proposes to approve into the SIP ADEM's non-substantive renumbering of the existing regulation titled, “New Combustion Sources” from Rule 335-3-8-.14 to Rule 335-3-8-.05.
In this document, EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is proposing to incorporate by reference Alabama Administrative Code Rule 335-3-8-.71, “NO
EPA is proposing to approve Alabama's February 27, 2020 SIP revision to Rule 335-3-8-.71, “NO
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations.
• Are not significant regulatory actions subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Do not impose information collection burdens under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Are certified as not having significant economic impacts on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Do not contain any unfunded mandates or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Do not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Are not economically significant regulatory actions based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Are not significant regulatory actions subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Are not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Do not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, these proposed actions do not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides.
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve revisions to the Arizona State Implementation Plan (SIP). These revisions concern emissions of sulfur dioxide (SO
Comments must be received on or before April 2, 2021.
Submit your comments, identified by Docket ID No. EPA-R09-OAR-2020-0735 at
Kevin Gong, EPA Region IX, 75 Hawthorne St., San Francisco, CA 94105. By phone: (415) 972-3073 or by email at
Throughout this document, “we,” “us” and “our” refer to the EPA.
Table 1 lists the rule provisions addressed by this proposal with the dates that they were adopted, submitted, and approved. On March 10, 2020, ADEQ submitted a formal request to the EPA requesting that the EPA rescind these provisions from the SIP.
On September 10, 2020 the submittal for the rescission of A.A.C. R18-2-715(F)(2) and (H) was deemed by operation of law to meet the completeness criteria in 40 CFR part 51 appendix V, which must be met before formal EPA review.
ADEQ adopted A.A.C. R18-2-715(F)(2) and (H) in order to establish source-specific SO
In 2010, the EPA promulgated a new 1-hour SO
The EPA approved A.A.C. R18-2-C1302 into the Arizona SIP on November 14, 2018,
ADEQ is requesting that EPA rescind R18-2-715(F)(2) and (H) from the Arizona SIP in order to remove the emissions limits and associated requirements that were established to meet the now-revoked 1971 SO
Once a rule has been approved as part of a SIP, the rescission of that rule from the SIP constitutes a SIP revision. To approve such a revision, the EPA must determine whether the revision meets relevant CAA criteria for stringency, and complies with restrictions on relaxation of SIP measures under CAA section 110(l), and the General Savings Clause in CAA section 193 for SIP-approved control requirements in effect before November 15, 1990.
The EPA previously determined that R18-2-C1302 and the Miami SO
We also note that while ADEQ is not requesting rescission of the compliance and monitoring requirements in R18-2-715.01, the removal of R18-2-715(F)(2) and (H) from the SIP would effectively render the provisions of R18-2-715.01 inapplicable to the Miami smelter.
For the foregoing reasons, we propose to find that the rescission of R18-2-715(F)(2) and (H) from the Arizona SIP would not interfere with any CAA requirements and would therefore comply with CAA section 110(l). We also propose to find that our prior approval of R18-2-C1302 ensures equivalent or greater emission reductions of SO
As authorized in section 110(k)(3) of the Act, the EPA proposes to approve the rescission of R18-2-715(F)(2) and (H) from the Arizona SIP because these provisions are no longer needed to meet any CAA requirement and rescission would comply with CAA sections 110(l) and 193. We will accept comments from the public on this proposal until April 2, 2021. If we take final action to approve the rule rescission, our final action will rescind these provisions from the federally enforceable SIP.
In this document, the EPA is proposing to amend regulatory text that includes incorporation by reference. The EPA is proposing to remove R18-2-715(F)(2) and (H) as described in Table 1 of this preamble from the Arizona State Implementation Plan, which is incorporated by reference in accordance with the requirements of 1 CFR part 51.
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this proposed action merely proposes to approve state law as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and
• Does not provide the EPA with the discretionary authority to address disproportionate human health or environmental effects with practical, appropriate, and legally permissible methods under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Reporting and recordkeeping requirements, Sulfur dioxide.
42 U.S.C. 7401
Federal Communications Commission.
Proposed rules.
In this document, the International Bureau seeks comment on a set of standardized national security and law enforcement questions (Standard Questions) that proponents of certain applications and petitions involving reportable foreign ownership will be required to answer as part of the application review process and whose application and petition will be referred to the Executive Branch.
Comments are due April 2, 2021. Reply comments are due April 19, 2021.
You may submit comments, identified by IB Docket No. 16-155, by any of the following methods:
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•
Filings can be sent by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail. All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.
• Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9050 Junction Drive, Annapolis Junction, MD 20701.
• U.S. Postal Service first-class, Express, and Priority mail must be addressed to 45 L Street NE, Washington, DC 20554.
• Effective March 19, 2020, and until further notice, the Commission no longer accepts any hand or messenger delivered filings. This is a temporary measure taken to help protect the health and safety of individuals, and to mitigate the transmission of COVID-19.
In addition, filers should provide one copy of each filing to each of the following:
(1) Arthur Lechtman, Attorney, Telecommunications and Analysis Division, International Bureau, at
(2) David Krech, Associate Division Chief, Telecommunications and Analysis Division, International Bureau, at
Arthur Lechtman, International Bureau, Telecommunications and Analysis Division, at (202) 418-1465. For information regarding the Paperwork Reduction Act (PRA) information collection requirements contained in the PRA, contact Cathy Williams, Office of Managing Director, at (202) 418-2918 or
This is a summary of the Public Notice, DA 20-
As required by the Regulatory Flexibility Act of 1980, as amended (RFA), the International Bureau has prepared a Supplemental Initial Regulatory Flexibility Analysis (Supplemental IRFA) of the possible significant economic impact on small entities of the proposals addressed in this Public Notice to supplement the Federal Communications Commission's (Commission) Final Regulatory Flexibility Analyses completed in the
By this Public Notice, the International Bureau (Bureau) seeks comment on a set of standardized national security and law enforcement questions (Standard Questions) that proponents of certain applications and petitions involving reportable foreign ownership will be required to answer as part of the review process. In the
To expedite the Executive Branch agencies' review of such applications and petitions, applicants and petitioners will provide responses to the Standard Questions directly to the Committee for the Assessment of Foreign Participation in the United States Telecommunications Services Sector (Committee) prior to or at the same time that they file applications or petitions with the Commission. The Commission adopted five categories of information to be provided by an applicant or petitioner: (1) Corporate structure and shareholder information; (2) relationships with foreign entities; (3) financial condition and circumstances; (4) compliance with applicable laws and regulations; and (5) business and operational information, including services to be provided and network infrastructure. The Commission directed the International Bureau (Bureau) to develop, solicit comment on, and make available on a publicly available website the Standard Questions that will elicit the information needed by the Committee within those categories of information. The Bureau will also maintain and update the Standard Questions, as needed.
We seek comment on the Standard Questions set out in each of the following Appendices, which are identified by the type of application or petition. The Standard Questions are based upon current questionnaires used by the Committee to obtain information from applicants and petitioners.
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•
•
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•
•
We seek comment on the questions in each of the Appendices. If needed, to help clarify the questions for applicants and petitioners, we ask that commenting parties provide specific suggested changes to the language of the questions. We seek comment on whether there are questions that are not necessary or if there are any questions that we should include to help expedite the review process. We ask parties for comment on the definitions of key terms that are used in the Appendices, such as “corporate officers” and “senior-level” officers as well as “remote access” and “managed services.” We seek comment on how often, and under what circumstances, the Bureau should reevaluate the Standard Questions. Finally, we seek comment on how long it would take applicants to fill out each questionnaire.
After we review and consider the comments received on the Standard Questions, we will issue an Order addressing the comments and will seek approval for the Standard Questions under the Paperwork Reduction Act. We will issue a Public Notice informing the public of the effective date of the Standard Questions. Following Public Notice of the effective date, the Standard Questions will be made available on the Commission's website and all parties filing applications or petitions subject to Executive Branch referral will be required to submit answers to the Standard Questions to the Committee prior to or at the same time that they file the application or petition with the Commission. Until that time, the Committee will continue to send its own questions to the applicant or petitioner upon the Commission's referral of the application or petition.
Pursuant to the Regulatory Flexibility Act of 1980, as amended (RFA),
This Public Notice sets forth the specific proposed “Standard Questions” for applications and petitions prescribed by the
A copy of this Public Notice, including the Supplemental Initial Regulatory Flexibility Analysis, shall be sent to the Chief Counsel for Advocacy of the Small Business Administration.
This proceeding shall be treated as a “permit-but-disclose” proceeding in accordance with the Commission's
The following appendices will not appear in the Code of Federal Regulations.
Federal Communications Commission.
Proposed rule.
In this document, the Federal Communications Commission (the FCC or Commission) proposes rules to implement the Don't Break Up the T-Band Act of 2020, which is Section 902 of the Consolidated Appropriations Act, 2021, Division FF, Title IX (Section 902). Section 902 directs the Commission to issue final rules, not later than 180 days after the date of enactment of Section 902, designating the uses of 911 fees by states and taxing jurisdictions that constitute 911 fee diversion for purposes of certain sections of the United States Code, as amended by Section 902. The intended effect of this notice of proposed rulemaking (NPRM) is to propose rules that implement Section 902 and help to identify those uses of 911 fees by states and other jurisdictions that support the provision of 911 services.
Comments are due on or before March 23, 2021, and reply comments are due on or before April 2, 2021.
You may submit comments, identified by PS Docket Nos. 20-291 and 09-14, by any of the following methods:
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•
• Effective March 19, 2020, and until further notice, the Commission no longer accepts any hand or messenger delivered filings. This is a temporary measure taken to help protect the health and safety of individuals, and to mitigate the transmission of COVID-19.
Brenda Boykin, Attorney Advisor, Policy and Licensing Division, Public Safety and Homeland Security Bureau, (202) 418-2062,
This is a summary of the Commission's notice of proposed rulemaking (NPRM), FCC 21-25, in PS Docket Nos. 20-291 and 09-14, adopted and released on February 17, 2021. The full text of this document is available at
This notice of proposed rulemaking may contain new or modified information collection(s) subject to the Paperwork Reduction Act of 1995 (PRA). If the Commission adopts any new or modified information collection requirements, they will be submitted to the Office of Management and Budget (OMB) for review under section 3507(d) of the PRA. OMB, the general public, and other Federal agencies will be invited to comment on the new or modified information collection requirements contained in this proceeding. In addition, pursuant to the Small Business Paperwork Relief Act of 2002, we seek specific comment on how we might further reduce the information collection burden for small business concerns with fewer than 25 employees.
Pursuant to §§ 1.415 and 1.419 of the Commission's rules, 47 CFR 1.415, 1.419, interested parties may file comments and reply comments on or before the dates indicated in the
The Commission will treat this proceeding as a “permit-but-disclose” proceeding in accordance with the Commission's
Congress has had a longstanding concern about the practice by some states and local jurisdictions of diverting 911 fees for non-911 purposes. In the ENHANCE 911 Act of 2004, Congress required states and local jurisdictions receiving Federal 911 grants to certify that they were not diverting 911 funds.
The NET 911 Act also required the Commission to begin reporting annually on the status in each state of the collection and distribution of fees for the support or implementation of 911 or E911 services, including findings on the amount of revenues obligated or expended by each state “for any purpose other than the purpose for which any such fees or charges are specified.”
In October 2020, the Commission released a Notice of Inquiry seeking comment on the effects of fee diversion and the most effective ways to dissuade states and jurisdictions from continuing or instituting the diversion of 911/E911 fees.
On December 27, 2020, the President signed the Don't Break Up the T-Band Act of 2020 as part of the Consolidated Appropriations Act, 2021.
Section 902 also amends section 615a-1(f)(1) to provide that the rules adopted by the Commission for these purposes will apply to states and taxing jurisdictions that impose 911 fees or charges. Whereas the prior version of section 615a-1(f)(1) referred to fees or charges “obligated or expended only in support of 9-1-1 and enhanced 9-1-1 services, or enhancements of such services, as specified in the provision of State or local law adopting the fee or charge,” the amended version provides that nothing in the Act, the Communications Act of 1934 (47 U.S.C. 151
In addition, Section 902(c) establishes a process for states and taxing jurisdictions to seek a determination that a proposed use of 911 fees should be treated as having such an acceptable purpose or function even if it is for a purpose or function that has not been designated as such in the Commission's
8. Section 902(d) requires the Commission to create an “interagency strike force” to study “how the Federal Government can most expeditiously end diversion” by states and taxing jurisdictions and to report to Congress on its findings within 270 days of the statute's enactment.
Finally, Section 902(d)(4) prohibits any state or taxing jurisdiction identified as a fee diverter in the Commission's annual report from participating or sending a representative to serve on any committee, panel, or council established to advise the First Responder Network Authority (FirstNet) under 47 U.S.C. 1425(a) or any advisory committee established by the Commission.
Section 902 does not impose any requirement on states or taxing jurisdictions to impose any fee in connection with the provision of 911 service. As revised, the proviso to section 615a-1 states that nothing in the Act or the Commission's rules “shall prevent the imposition and collection of a fee or charge applicable to commercial mobile services or IP-enabled voice services” specifically designated by the taxing jurisdiction “for the support or implementation of 9-1-1 or enhanced 9-1-1 services, provided that the fee or charge is obligated or expended only in support of 9-1-1 and enhanced 9-1-1 services, or enhancements of such services, consistent with the purposes and functions designated in [the Commission's forthcoming rules] as purposes and functions for which the obligation or expenditure of such a fee or charge is acceptable.”
In this notice of proposed rulemaking, we propose measures to implement Section 902. We seek comment on these measures, which are designed to identify those uses of 911 fees by states and other jurisdictions that support the provision of 911 services.
As a preliminary matter, we note that Section 902 defines certain terms relating to 911 fees and fee diversion. To promote consistency, we propose to codify these definitions in our rules with certain modifications, as described below. We seek comment on these proposed definitions.
To promote regulatory parity and avoid gaps that could inadvertently frustrate the rapid deployment of effective 911 services, including advanced Next Generation 911 (NG911) services, we propose to define “911 fee or charge” in our rules to include fees or charges applicable to “other emergency communications services” as defined in section 201(b) of the NET 911 Act. Under the NET 911 Act, the term “other emergency communications service” means “the provision of emergency information to a public safety answering point via wire or radio communications, and may include 9-1-1 and enhanced 9-1-1 service.”
We tentatively conclude that adoption of this proposed expanded definition of “911 fee or charge” is reasonably ancillary to the Commission's effective performance of its statutorily mandated responsibilities under Section 902 and other Federal 911-related statutes that, taken together, establish an overarching Federal interest in ensuring the effectiveness of the 911 system. The Commission's general jurisdictional grant includes the responsibility to set up and maintain a comprehensive and effective 911 system, encompassing a variety of communication services in addition to CMRS and IP-enabled voice services. Section 251(e)(3) of the Communications Act of 1934, which directs the Commission to designate 911 as the universal emergency telephone number, states that the designation of 911 “shall apply to both wireline and wireless telephone service,” which evidences Congress's intent to grant the Commission broad authority over different types of communications services in the 911 context.
Based on the foregoing, we tentatively conclude that including “other emergency communications services” within the scope of the definition of 911 fees we propose is also reasonably ancillary to the Commission's effective performance of its statutorily mandated responsibilities for ensuring that the 911 system, including 911, E911, and NG911 calls and texts from any type of service, is available, that these 911 services function effectively, and that 911 fee diversion by states and other jurisdictions does not detract from these critical, statutorily recognized purposes. Diverting fees collected for 911 service of any type, whether it be wireline, wireless, IP based, or text, undermines the purpose of these Federal statutes by depriving the 911 system of the funds it needs to function effectively and to modernize 911 operations.
In addition, we seek comment on extending the definition of “911 fee or charge” to include fees or charges designated for the support of “public safety,” “emergency services,” or similar purposes if the purposes or allowable uses of such fees or charges include the support or implementation of 911 services.
We propose that for purposes of implementing Section 902, our definition of “911 fee or charge” should similarly extend to fees or charges that are expressly identified by the state or taxing jurisdiction as supporting 911, even if the fee is not labelled as a 911 fee. We tentatively conclude that this is consistent with the purpose of Section 902 with respect to diversion of 911 fees and charges. We seek comment on this proposal. Does the proposed definition of 911 fees or charges capture the universe of 911 fees or charges that can be diverted? Is the definition overinclusive or underinclusive? Are there other modifications to the definition that would help to prevent 911 fee diversion?
We propose to codify this definition, with minor changes to streamline it. Specifically, we propose to define diversion as “[t]he obligation or expenditure of a 911 fee or charge for a purpose or function other than the purposes and functions designated by the Commission as acceptable pursuant to [the applicable rule section in subpart I].” In addition, we propose to clarify that diversion also includes distribution of 911 fees to a political subdivision that obligates or expends such fees for a purpose or function other than those designated by the Commission. We believe this provision will clarify that states and taxing jurisdictions are also responsible for diversion of 911 fees by political subdivisions, such as counties, that may receive 911 fees. We seek comment on these proposals.
Regarding the scope of proposed subpart I, we propose that the rules apply to states or taxing jurisdictions that collect 911 fees or charges (as defined in that subpart) from commercial mobile services, IP-enabled voice services, and other emergency communications services. And as the proposed definitions make clear, such fees or charges would include fees or charges designated for the support of public safety, emergency services, or similar purposes if the purposes or allowable uses of such fees or charges include the support or implementation of 911 services. We seek comment on these proposals.
Section 902 requires the Commission to issue rules “designating purposes and functions for which the obligation or expenditure of 9-1-1 fees or charges, by any State or taxing jurisdiction authorized to impose such a fee or charge, is acceptable” for purposes of the statute. In addition, Section 902 provides that the purposes and functions designated as acceptable for such purposes “shall be limited to the support and implementation of 9-1-1 services provided by or in the State or taxing jurisdiction imposing the fee or charge and operational expenses of public safety answering points within such State or taxing jurisdiction.”
We propose to codify the statutory standard for acceptable purposes and functions for the obligation or expenditure of 911 fees or charges by providing that acceptable purposes and functions for purposes of the statute are limited to (1) support and implementation of 911 services provided by or in the state or taxing jurisdiction imposing the fee or charge, and (2) operational expenses of PSAPs within such state or taxing jurisdiction. This proposed language tracks the language in Section 902. In addition, we propose to specify in the rules that examples of such acceptable purposes and functions include, but are not limited to, the following, provided that the state or taxing jurisdiction can adequately document that it has obligated or spent the fees or charges in question for these purposes and functions:
(1) PSAP operating costs, including lease, purchase, maintenance, and upgrade of customer premises equipment (CPE) (hardware and software), computer aided dispatch (CAD) equipment (hardware and software), and the PSAP building/facility;
(2) PSAP personnel costs, including telecommunicators' salaries and training;
(3) PSAP administration, including costs for administration of 911 services and travel expenses associated with the provision of 911 services;
(4) Integrating public safety/first responder dispatch and 911 systems, including lease, purchase, maintenance, and upgrade of CAD hardware and software to support integrated 911 and public safety dispatch operations; and
(5) Providing for the interoperability of 911 systems with one another and with public safety/first responder radio systems.
We believe these purposes and functions are consistent with the general standard for designating acceptable uses of 911 fees and charges set out in Section 902. They also are consistent with the Commission's past analysis of 911 fee diversion in its annual fee reports, and, as required under Section 902, they reflect the Commission's consideration of the purposes and functions that states have specified for their 911 fees and charges. In particular, the Commission has stated in its annual fee reports that the requisite nexus to 911 includes expenditures that (1) support PSAP functions or operations, (2) have a reasonable nexus to PSAPs' ability to receive 911 calls and/or dispatch emergency responders, or (3) relate to communications infrastructure that connects PSAPs (or otherwise ensures the reliable reception and processing of emergency calls and their dispatch to first responders).
We also seek comment on specifying certain examples of purposes and
(1) Transfer of 911 fees into a state or other jurisdiction's general fund or other fund for non-911 purposes;
(2) Equipment or infrastructure for constructing or expanding non-public safety communications networks (
(3) Equipment or infrastructure for law enforcement, firefighters, and other public safety/first responder entities, including public safety radio equipment and infrastructure, that does not have a direct impact on the ability of a PSAP to receive or respond to 911 calls or to dispatch emergency responders.
Identifying these examples as unacceptable expenditures for purposes of the statute is consistent with the manner in which such expenditures were analyzed in our annual 911 fee reports. For example, the fee reports have repeatedly found that transferring 911 fees to the state's general fund or using 911 fees for the expansion of commercial cellular networks constitutes fee diversion.
Our proposed designation of acceptable purposes and functions for purposes of the statute is also consistent with the legislative history of the NET 911 Act. In its report on H.R. 3403 (the bill that was enacted as the NET 911 Act), the House Committee on Energy and Commerce noted that several states were known to be using 911 fees for “purposes other than 911 or emergency communications services.”
We seek comment on our proposed designation of acceptable purposes and functions under the statute. Are the proposed purposes and functions that would be deemed acceptable overinclusive or underinclusive? If the proposed purposes are overinclusive, commenters should explain how and why. What purposes and functions have states and taxing jurisdictions specified as the intended functions for 911 fees and charges, and how should we take these specifications into account as we designate acceptable purposes and functions under Section 902? CTIA contends that allowable 911 expenditures should include the nonrecurring costs of establishing a 911 system, the costs of emergency telephone and dispatch equipment, and costs for training for maintenance and operation of the 911 system but should exclude costs for leasing real estate, cosmetic remodeling of facilities, salaries or benefits, or emergency vehicles.
We also propose to define acceptable purposes and functions under Section 902 for states and taxing jurisdictions that impose multi-purpose fees or charges intended to support 911 services as well as other public safety purposes. In such instances, we believe states and taxing jurisdictions should have the flexibility to apportion the collected funds between 911 related and non-911 related programs, but that safeguards are needed to ensure that such apportionment is not subject to manipulation that would constitute fee diversion. We therefore propose to adopt a safe harbor in our rules providing that the obligation or expenditure of such fees or charges will not constitute diversion so long as the state or taxing jurisdiction: (1) Specifies the amount or percentage of such fees or charges that is dedicated to 911 services; (2) ensures that the 911 portion of such fees or charges is segregated and not commingled with any other funds; and (3) obligates or expends the 911 portion of such fees or charges for acceptable purposes and functions as defined under this section. This provision would provide transparency in the use of 911 fees when a state or taxing jurisdiction collects a fee for both 911 and non-911 purposes. It would also enable the Commission to verify through the annual fee report data collection that the 911 portion of such fees or charges is not being diverted.
We seek comment on our proposal for determining whether there is diversion of a fee or charge collected for both 911 and non-911 purposes. Are the measures we propose sufficient to provide transparency with respect to diversion in the use of such fees? Are there other measures that would help ensure that 911 fees or charges are fully traceable in states or taxing jurisdictions with such funding mechanisms? In addition, some state laws and regulations provide that any excess 911 funds left over after all 911 expenditures have been covered can be used for non-911 related purposes.
Section 902(c)(1)(C) provides that a state or taxing jurisdiction may petition the Commission for a determination that “an obligation or expenditure of a 9-1-1 fee or charge . . . by such State or taxing jurisdiction for a purpose or function other than a purpose or function designated under paragraph (3)(A) [support for 911 services/PSAP expenditures] should be treated as such a purpose or function.”
We propose to codify these provisions in new subpart I of the rules. We believe Congress intended this petition process to serve as a safety valve allowing states to seek further refinement of the definition of obligations and expenditures that are considered 911 related. At the same time, the proposed rule would set clear standards for what states must demonstrate to support a favorable ruling, including the requirement to provide sufficient documentation. To promote efficiency in reviewing such petitions, we also propose that states or taxing jurisdictions seeking such a determination must do so by filing a petition for declaratory ruling under § 1.2 of the Commission's rules.
Pursuant to Section 902(d)(4), any state or taxing jurisdiction identified by the Commission in the annual 911 fee report as engaging in diversion of 911 fees or charges “shall be ineligible to participate or send a representative to serve on any committee, panel, or council established under section 6205(a) of the Middle Class Tax Relief and Job Creation Act of 2012 . . . or any advisory committee established by the Commission.”
Section 902(c)(1)(C) also provides that if a state or taxing jurisdiction receives a grant under section 158 of the National Telecommunications and Information Administration Organization Act (47 U.S.C. 942) after the date of enactment of Section 902, “such State or taxing jurisdiction shall, as a condition of receiving such grant, provide the information requested by the Commission to prepare [the annual report to Congress on 911 fees].”
Finally, Section 902(d)(2) provides that, beginning with the first annual fee report “that is required to be submitted after the date that is 1 year after the date of the enactment of this Act,” the Commission shall include in each report “all evidence that suggests the diversion by a State or taxing jurisdiction of 9-1-1 fees or charges, including any information regarding the impact of any underfunding of 9-1-1 services in the State or taxing jurisdiction.” Given that the Commission is similarly required to provide the interagency strike force with any information regarding underfunding of 911 services,
As required by the Regulatory Flexibility Act of 1980, as amended (RFA), the Commission has prepared this Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on a substantial number of small entities by the policies and rules proposed in the notice of proposed rulemaking (NPRM). Written public comments are requested on this IRFA. Comments must be identified as responses to the IRFA and must be filed by the deadlines for comments provided on the first page of the NPRM. The Commission will send a copy of the NPRM, including this IRFA, to the Chief Counsel for Advocacy of the Small Business Administration (SBA). In addition, the NPRM and IRFA (or summaries thereof) will be published in the
The NPRM proposes and seeks comment on ways to implement Section 902 of the Consolidated Appropriations Act of 2021. On December 27, 2020, the President signed the Don't Break Up the T-Band Act of 2020, which is Division FF, Title IX, Section 902 of the Consolidated Appropriations Act, 2021 (Pub. L. 116-260). Section 902 directs the Commission to issue final rules 180 days after enactment on December 27, 2020 designating acceptable purposes and functions for the obligation or expenditure of 911 fees by states and taxing jurisdictions. Section 902 also provides that the use of 911 fees for any
To implement Section 902 of the Act, the NPRM seeks comment on the Commission's proposals to amend part 9 of the rules to establish a new subpart I regarding “911 Fees.” Section 902 defines several terms, and the NPRM proposes to codify these definitions in the new subpart I of the rules. In addition, Section 902 directs the Commission to issue final rules designating purposes and functions for which the obligation or expenditure of 911 fees is acceptable. It also provides that the purposes and functions identified by the Commission as acceptable “shall be limited to the support and implementation of 9-1-1 services provided by or in the State or taxing jurisdiction imposing the fee or charge and operational expenses of public safety answering points within such State or taxing jurisdiction.” The NPRM seeks comments on proposals to develop an illustrative, non-exhaustive list of permissible and non-permissible uses for purposes of Section 902.
Section 902 provides that a state or taxing jurisdiction may petition the FCC for a determination that an obligation or expenditure of a 911 fee for a purpose or function other than those deemed acceptable by the Commission should be treated as an acceptable expenditure. Per Section 902, the petition must demonstrate that the expenditure: (1) Supports public safety answering point (PSAP) functions or operations, or (2) has a direct impact on the ability of a PSAP to receive or respond to 911 calls or to dispatch emergency responders. If the Commission finds that a state or taxing jurisdiction has provided sufficient documentation to make this demonstration, the statute provides that it shall grant the petition. In addition, the Commission seeks comment on amending the rules to require that if a state or taxing jurisdiction receives a grant under section 158 of the National Telecommunications and Information Administration Organization Act (47 U.S.C. 942) after December 27, 2020, such state or taxing jurisdiction shall provide the information requested by the Commission to prepare the annual report to Congress required by the NET 911 Act. The NPRM seeks comment on proposals to codify these provisions in subpart I of part 9 of the rules.
This action was taken pursuant to Sections 1, 4(i), 4(j), 4(o), 201(b), 251(e), 301, 303(b), and 303(r) of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154(i), 154(j), 154(o), 201(b), 251(e), 301, 303(b), and 303(r), the Don't Break Up The T-Band Act of 2020, Section 902 of Title IX, Division FF of the Consolidated Appropriations Act, 2021, Public Law 116-260, Section 101 of the New and Emerging Technologies 911 Improvement Act of 2008, Public Law 110-283, 47 U.S.C. 615a-1, and the Wireless Communications and Public Safety Act of 1999, Public Law 106-81, 47 U.S.C. 615 note, 615, 615a, and 615b.
The RFA directs agencies to provide a description of and, where feasible, an estimate of the number of small entities that may be affected by the proposed rules, if adopted. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small-business concern” under the Small Business Act. A “small-business concern” is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the SBA.
Next, the type of small entity described as a “small organization” is generally “any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.” The Internal Revenue Service (IRS) uses a revenue benchmark of $50,000 or less to delineate its annual electronic filing requirements for small exempt organizations. Nationwide, for tax year 2018, there were approximately 571,709 small exempt organizations in the U.S. reporting revenues of $50,000 or less according to the registration and tax data for exempt organizations available from the IRS.
Finally, the small entity described as a “small governmental jurisdiction” is defined generally as “governments of cities, counties, towns, townships, villages, school districts, or special districts, with a population of less than fifty thousand.” U.S. Census Bureau data from the 2017 Census of Governments indicate that there were 90,075 local governmental jurisdictions consisting of general purpose governments and special purpose governments in the United States. Of this number there were 36,931 general purpose governments (county, municipal and town or township) with populations of less than 50,000 and 12,040 special purpose governments—independent school districts with enrollment populations of less than 50,000. Accordingly, based on the 2017 U.S. Census of Governments data, we estimate that at least 48,971 entities fall into the category of “small governmental jurisdictions.”
As indicated in Section A above, the NPRM seeks comment on proposed rules to implement Section 902. The NPRM generally does not propose specific reporting or recordkeeping requirements. The NPRM does, however, propose and seek comment on codifying the requirement that states or taxing jurisdictions seeking a Commission determination on 911 fee diversion satisfy certain criteria established in Section 902. In such cases, a state or taxing jurisdiction would have to show that a proposed expenditure: (1) Supports PSAP functions or operations, or (2) has a direct impact on the ability of a PSAP to receive or respond to 911 calls or to dispatch emergency responders. If the Commission finds that a state or taxing jurisdiction has provided sufficient documentation to make this demonstration, the statute provides that it shall grant the petition. The information and documentation that a state or taxing jurisdiction will have to provide the Commission to make the requisite showing will impact the reporting and recordkeeping requirements for small entities and others subject to the requirements. The Commission proposes to apply the existing declaratory ruling procedures and obligations under § 1.2 of the Commission's rules, which small entities may already be familiar with, to petitions for determination.
In addition, the NPRM seeks comment on amending the rules to require that if a state or taxing jurisdiction receives a grant under section 158 of the National Telecommunications and Information Administration Organization Act (47 U.S.C. 942) after December 27, 2020, such state or taxing jurisdiction shall provide the information requested by the Commission to prepare the report required under section 6(f)(2) of the Wireless Communications and Public Safety Act of 1999 (47 U.S.C. 615a-1(f)(2)). This proposed requirement is consistent with the requirements of Section 902. Under OMB Control No. 3060-1122, the Office of Management and Budget previously approved and renewed the information collection requirements associated with filing annual 911 fee reports as mandated by the NET 911 Act.
The RFA requires an agency to describe any significant specifically small business alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): (1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities; (3) the use of performance, rather than design, standards; and (4) an exemption from coverage of the rule, or any part thereof, for small entities.
In the NPRM, the Commission seeks to implement the provisions of Section 902 that require Commission action by proposing changes to part 9 of our rules that would achieve the stated objectives of Congress's mandated rules in a cost-effective manner that is not unduly burdensome to providers of emergency telecommunication services or to states and taxing jurisdictions. Using this approach, we inherently take steps to minimize any significant economic impact or burden for small entities. Specifically, we propose to adopt and codify the definitions in Section 902 for certain terms relating to 911 fees and fee diversion in part 9 of our rules. For a few terms, we make limited modifications to the definition to avoid gaps and promote the apparent intent of the new statute. In addition to promoting consistency, we believe our proposals will help small entities and others who will be subject to Section 902 and our rules avoid additional expenses for compliance which may have resulted if the Commission in the alternative proposed and adopted different definitions for certain terms in Section 902 relating to 911 fees and fee diversion.
Similarly, to fulfill the Commission obligations associated with issuing rules designating acceptable purposes and functions, for consistency we propose to use language from Section 902 codifying the statutory standard for which the obligation or expenditure of 911 fees or charges by any state or taxing jurisdiction is considered acceptable. We also propose to specify in the rules examples of both acceptable and unacceptable purposes and functions for the obligation or expenditure of 911 fees or charges. If adopted, identifying and including these examples in the Commission's rules should enable small entities to avoid unacceptable expenditures in violation of our rules, which could impact eligibility for Federal grants and participation in Federal advisory committees.
Finally, the Commission expects to more fully consider the economic impact on small entities, as identified in comments filed in response to the NPRM and this IRFA, in reaching its final conclusions and taking action in this proceeding.
None.
Accordingly,
Communications common carriers, Communications equipment, Radio, Federal Communications Commission.
For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR part 9 as follows:
47 U.S.C. 151-154, 152(a), 155(c), 157, 160, 201, 202, 208, 210, 214, 218, 219, 222, 225, 251(e), 255, 301, 302, 303, 307, 308, 309, 310, 316, 319, 332, 403, 405, 605, 610, 615, 615 note, 615a, 615b, 615c, 615a-1, 616, 620, 621, 623, 623 note, 721, and 1471, and Section 902 of Title IX, Division FF, Pub. L. 116-260, 134 Stat. 1182, unless otherwise noted.
The rules in this subpart apply to States or taxing jurisdictions that collect 911 fees or charges (as defined in this subpart) from commercial mobile services, IP-enabled voice services, and other emergency communications services.
For purposes of this subpart, the terms in this section have the following meaning:
(a) Acceptable purposes and functions for the obligation or expenditure of 911 fees or charges are limited to:
(1) Support and implementation of 911 services provided by or in the State or taxing jurisdiction imposing the fee or charge; and
(2) Operational expenses of public safety answering points within such State or taxing jurisdiction.
(b) Examples of acceptable purposes and functions include, but are not limited to, the following, provided that the State or taxing jurisdiction can adequately document that it has obligated or spent the fees or charges in question for these purposes and functions:
(1) PSAP operating costs, including lease, purchase, maintenance, and upgrade of customer premises equipment (CPE) (hardware and software), computer aided dispatch (CAD) equipment (hardware and software), and the PSAP building/facility;
(2) PSAP personnel costs, including telecommunicators' salaries and training;
(3) PSAP administration, including costs for administration of 911 services and travel expenses associated with the provision of 911 services;
(4) Integrating public safety/first responder dispatch and 911 systems, including lease, purchase, maintenance, and upgrade of CAD hardware and software to support integrated 911 and public safety dispatch operations; and
(5) Providing for the interoperability of 911 systems with one another and with public safety/first responder radio systems.
(c) Examples of purposes and functions that are not acceptable for the obligation or expenditure of 911 fees or charges include, but are not limited to, the following:
(1) Transfer of 911 fees into a State or other jurisdiction's general fund or other fund for non-911 purposes;
(2) Equipment or infrastructure for constructing or expanding non-public safety communications networks (
(3) Equipment or infrastructure for law enforcement, firefighters, and other public safety/first responder entities, including public safety radio equipment and infrastructure, that does not have a direct impact on the ability of a PSAP to receive or respond to 911 calls or to dispatch emergency responders.
(d) If a State or taxing jurisdiction collects fees or charges designated for “public safety,” “emergency services,” or similar purposes that include the support or implementation of 911 services, the obligation or expenditure of such fees or charges shall not constitute diversion provided that the State or taxing jurisdiction:
(1) Specifies the amount or percentage of such fees or charges that is dedicated to 911 services;
(2) Ensures that the 911 portion of such fees or charges is segregated and not commingled with any other funds; and
(3) Obligates or expends the 911 portion of such fees or charges for acceptable purposes and functions as defined under this section.
(a) A State or taxing jurisdiction may petition the Commission for a determination that an obligation or expenditure of 911 fees or charges for a purpose or function other than the purposes or functions designated as acceptable in § 9.23 should be treated as an acceptable purpose or function. Such a petition must meet the requirements applicable to a petition for declaratory ruling under § 1.2 of this chapter.
(b) The Commission shall grant the petition if the State or taxing jurisdiction provides sufficient documentation to demonstrate that the purpose or function:
(1) Supports public safety answering point functions or operations; or
(2) Has a direct impact on the ability of a public safety answering point to:
(i) Receive or respond to 911 calls; or
(ii) Dispatch emergency responders.
If a State or taxing jurisdiction receives a grant under section 158 of the National Telecommunications and Information Administration Organization Act (47 U.S.C. 942) after December 27, 2020, such State or taxing jurisdiction shall provide the information requested by the Commission to prepare the report required under section 6(f)(2) of the Wireless Communications and Public Safety Act of 1999 (47 U.S.C. 615a-1(f)(2)).
Notwithstanding any other provision of law, any State or taxing jurisdiction identified by the Commission in the report required under section 6(f)(2) of the Wireless Communications and Public Safety Act of 1999 (47 U.S.C. 615a-1(f)(2)) as engaging in diversion of 911 fees or charges shall be ineligible to participate or send a representative to serve on any advisory committee established by the Commission.
Economic Development Administration, U.S. Department of Commerce.
Notice and opportunity for public comment.
The Economic Development Administration (EDA) has received petitions for certification of eligibility to apply for Trade Adjustment Assistance from the firms listed below. Accordingly, EDA has initiated investigations to determine whether increased imports into the United States of articles like or directly competitive with those produced by each of the firms contributed importantly to the total or partial separation of the firms' workers, or threat thereof, and to a decrease in sales or production of each petitioning firm.
Any party having a substantial interest in these proceedings may request a public hearing on the matter. A written request for a hearing must be submitted to the Trade Adjustment Assistance Division, Room 71030, Economic Development Administration, U.S. Department of Commerce, Washington, DC 20230, no later than ten (10) calendar days following publication of this notice. These petitions are received pursuant to section 251 of the Trade Act of 1974, as amended.
Please follow the requirements set forth in EDA's regulations at 13 CFR 315.9 for procedures to request a public hearing. The Catalog of Federal Domestic Assistance official number and title for the program under which these petitions are submitted is 11.313, Trade Adjustment Assistance for Firms.
National Marine Fisheries Service (NMFS), National Ocean Service (NOS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce.
Notice; request for information.
On January 27, 2021, the White House issued an Executive Order on Tackling the Climate Crisis at Home and Abroad. As part of this effort, NOAA is collecting recommendations on how to make fisheries and protected resources more resilient to climate change, including changes in management and conservation measures, and improvements in science, monitoring, and cooperative research. NOAA requests written input from interested parties on how best to achieve these objectives described in the Executive Order.
Responses must be received by April 2, 2021.
Responses should be submitted via email to
Heather Sagar,
On January 27, 2021, the President signed a new Executive Order on Tackling the Climate Crisis at Home and Abroad. Section 216(c) of the Executive Order requires the Secretary of Commerce, through the Administrator of the National Oceanic and Atmospheric Administration, to collect input from fishermen, regional ocean councils, fishery management councils, scientists, and other stakeholders on how to make fisheries and protected resources more resilient to climate change, including changes in management and conservation measures, and improvements in science, monitoring, and cooperative research.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; issuance of an incidental harassment authorization.
In accordance with the regulations implementing the Marine Mammal Protection Act (MMPA) as amended, notification is hereby given that NMFS has issued an incidental harassment authorization (IHA) to the City of Ketchikan, Alaska (COK) to incidentally harass, by Level A and B harassment, marine mammals during construction activities associated with the Berth III New Mooring Dolphins Project in Ketchikan, AK.
This Authorization is effective for a period of one year, from October 1, 2021 through September 30, 2022.
Robert Pauline, Office of Protected Resources, NMFS, (301) 427-8401. Electronic copies of the application and supporting documents, as well as a list of the references cited in this document, may be obtained online at:
The MMPA prohibits the “take” of marine mammals, with certain exceptions, sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361
Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s) and will not have an unmitigable adverse impact on the availability of the species or stock(s) for taking for subsistence uses (where relevant). Further, NMFS must prescribe the permissible methods of taking and other “means of effecting the least practicable adverse impact” on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of the species or stocks for taking for certain subsistence uses (referred to in shorthand as “mitigation”); and requirements pertaining to the mitigation, monitoring and reporting of the takings are set forth.
The definitions of all applicable MMPA statutory terms cited above are included in the relevant sections below.
On May 14, 2020, NMFS received a request from COK for an IHA to take marine mammals incidental to construction activities associated with the Berth III Mooring Dolphin Project in Ketchikan, Alaska. After several revisions, the application was deemed adequate and complete on September 22, 2021. COK's request is for take of nine species of marine mammals by harassment, including Level A harassment of three of these species. Neither COK nor NMFS expects serious injury or mortality to result from this activity and, therefore, an IHA is appropriate.
COK plans to make improvements to Berth III, in order to accommodate a new fleet of large cruise ships (
The proposed project would install three new mooring dolphins (MD) with one at the north end of Berth III (MD#2) and two at the south end (MD#3 & MD#4) as shown in Figure 2 in COK's IHA application (available online at:
A detailed description of the planned Berth III New Mooring Dolphins Project is provided in the
Mitigation, monitoring, and reporting measures are described in detail later in this document (please see Mitigation and Monitoring and Reporting sections).
A notice of NMFS's proposal to issue an IHA to COK was published in the
NMFS increased authorized take of harbor porpoise from 40 to 80 and authorized take of minke whale from 2 to 8 based on informal comments from the Commission. Authorized take of humpback whales was also increased from 68 to 119 due to the daily occurrence of a single humpback whale in Tongass Narrows after the notice of proposed IHA (85 FR 71612; November 12, 2020) had published in the
Sections 3 and 4 of the application summarize available information regarding status and trends, distribution and habitat preferences, and behavior and life history, of the potentially affected species. Additional information regarding population trends and threats may be found in NMFS's Stock Assessment Reports (SARs;
Table 2 lists all species or stocks for which take is expected and authorized for this action, and summarizes information related to the population or stock, including regulatory status under the MMPA and Endangered Species Act (ESA) and potential biological removal (PBR), where known. For taxonomy, we follow Committee on Taxonomy (2020). PBR is defined by the MMPA as the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its optimum sustainable population (as described in NMFS's SARs). While no mortality is anticipated or authorized here, PBR and annual serious injury and mortality from anthropogenic sources are included here as gross indicators of the status of the species and other threats.
Marine mammal abundance estimates presented in this document represent the total number of individuals that make up a given stock or the total number estimated within a particular study or survey area. NMFS's stock abundance estimates for most species represent the total estimate of individuals within the geographic area, if known, that comprises that stock. For some species, this geographic area may extend beyond U.S. waters. All managed stocks in this region are assessed in NMFS's U.S. Alaska SARs (Muto
As indicated above, all nine species (with 12 managed stocks) in Table 2 temporally and spatially co-occur with the activity to the degree that take is reasonably likely to occur, and we are authorizing it.
A detailed description of the of the species likely to be affected by the project, including brief introductions to the species and relevant stocks as well as available information regarding population trends and threats, and information regarding local occurrence, were provided in the
Hearing is the most important sensory modality for marine mammals underwater, and exposure to anthropogenic sound can have deleterious effects. To appropriately assess the potential effects of exposure to sound, it is necessary to understand the frequency ranges marine mammals
The pinniped functional hearing group was modified from Southall
For more detail concerning these groups and associated frequency ranges, please see NMFS (2018) for a review of available information. Nine mammal species (seven cetacean and two pinniped (one otariid and one phocid) species) have the reasonable potential to co-occur with the planned survey activities. Of the cetacean species that may be present, three are classified as low-frequency cetaceans (
The effects of underwater noise from pile removal activities have the potential to result in behavioral harassment of marine mammals in the vicinity of the survey area. The notice of proposed IHA (85 FR 71602; November 10, 2020) included a discussion of the effects of anthropogenic noise on marine mammals and the potential effects of underwater noise from WSDOT's vibratory pile removal on marine mammals and their habitat. That information and analysis is incorporated by reference into this final IHA determination and is not repeated here; please refer to the notice of proposed IHA (85 FR 71602; November 10, 2020).
This section provides an estimate of the number of incidental takes authorized through this IHA, which will inform both NMFS' consideration of “small numbers” and the negligible impact determination.
Harassment is the only type of take expected to result from these activities. Except with respect to certain activities not pertinent here, section 3(18) of the MMPA defines “harassment” as any act of pursuit, torment, or annoyance, which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).
Authorized takes would primarily be by Level B harassment, as use of the acoustic sources (
As described previously, no mortality is anticipated or authorized for this activity. Below we describe how the take is estimated.
Generally speaking, we estimate take by considering: (1) Acoustic thresholds above which NMFS believes the best available science indicates marine mammals will be behaviorally harassed or incur some degree of permanent hearing impairment; (2) the area or volume of water that will be ensonified above these levels in a day; (3) the density or occurrence of marine mammals within these ensonified areas; and, (4) and the number of days of activities. We note that while these basic factors can contribute to a basic calculation to provide an initial prediction of takes, additional information that can qualitatively inform take estimates is also sometimes available (
NMFS recommends the use of acoustic thresholds that identify the received level of underwater sound above which exposed marine mammals would be reasonably expected to be behaviorally harassed (equated to Level B harassment) or to incur PTS of some degree (equated to Level A harassment).
COK's planned activity includes the use of continuous (vibratory pile driving, DTH pile installation) and impulsive (impact pile driving), sources, and therefore the 120 and 160 dB re 1 μPa (rms) criteria are applicable.
These thresholds are provided in Table 4. The references, analysis, and methodology used in the development of the thresholds are described in NMFS 2018 Technical Guidance, which may be accessed at
Here, we describe operational and environmental parameters of the activity that will feed into identifying the area ensonified above the acoustic thresholds, which include source levels and transmission loss coefficient.
The sound field in the project area is the existing background noise plus additional construction noise from the planned project. Marine mammals are expected to be affected via sound generated by the primary components of the project (
Vibratory hammers produce constant sound when operating, and produce vibrations that liquefy the sediment surrounding the pile, allowing it to penetrate to the required seating depth. An impact hammer would then generally be used to place the pile at its intended depth through rock or harder substrates. An impact hammer is a steel device that works like a piston, producing a series of independent strikes to drive the pile. Impact hammering typically generates the loudest noise associated with pile installation. The actual durations of each installation method vary depending on the type of pile, size of the pile, and substrate characteristics (
In order to calculate distances to the Level A harassment and Level B harassment sound thresholds for piles of various sizes being used in this project, NMFS used acoustic monitoring data from other locations to inform selection of representative source levels (see Table 5).
Sound source levels for vibratory installation of 30-inch steel piles were obtained by Denes
Sound levels for impact installation of 30-inch steel piles were taken from Denes
DTH pile installation includes drilling (non-impulsive sound) and hammering (impulsive sound) to penetrate rocky substrates (Denes
The source level employed to derive Level B harassment isopleths for DTH pile installation (socketing) of all pile sizes was derived from the Denes
For DTH anchoring of 12-inch holes, COK used a sound source level from 18-inch piles from Guan and Miner (2020) as a proxy (146 dB SEL) for Level A harassment calculations. For DTH installation of 30 and 36-inch sockets, source levels from 42-inch holes from Reyff & Heyvaert (2019), Reyff (2020), and Denes
When the NMFS Technical Guidance (2016) was published, in recognition of the fact that ensonified area/volume could be more technically challenging to predict because of the duration component in the new thresholds, we developed a User Spreadsheet that includes tools to help predict a simple isopleth that can be used in conjunction with marine mammal density or occurrence to help predict takes. We note that because of some of the assumptions included in the methods used for these tools, we anticipate that isopleths produced are typically going to be overestimates of some degree, which may result in some degree of overestimate of Level A harassment take. However, these tools offer the best way to predict appropriate isopleths when more sophisticated 3D modeling methods are not available, and NMFS continues to develop ways to quantitatively refine these tools, and will qualitatively address the output where appropriate. For stationary sources such as impact driving, vibratory driving and DTH pile installation example from project, NMFS User Spreadsheet predicts the distance at which, if a marine mammal remained at that distance the whole duration of the activity, it would incur PTS.
Inputs used in the User Spreadsheet (Table 6) and the resulting isopleths are reported below (Table 7). Level A harassment thresholds for impulsive sound sources (impact pile driving, DTH pile installation) are defined for both SELcum and Peak SPL, with the threshold that results in the largest modeled isopleth for each marine mammal hearing group used to establish the effective Level A harassment isopleth. Note that the peak SPL for DTH installation of 48-inch piles is unknown as no sound source verification testing has been conducted
Transmission loss (TL) is the decrease in acoustic intensity as an acoustic pressure wave propagates out from a source. TL parameters vary with frequency, temperature, sea conditions, current, source and receiver depth, water depth, water chemistry, and bottom composition and topography. The general formula for underwater TL is:
The recommended TL coefficient for most nearshore environments is the, practical spreading value of 15. This value results in an expected propagation environment that would lie between spherical and cylindrical spreading loss conditions, which is the most appropriate assumption for COK's planned activity.
Using the practical spreading model, COK determined underwater noise would fall below the behavioral effects threshold of 120 dB rms for marine mammals at a maximum radial distance of 16,343 m for vibratory pile driving of 36 and 48-inch diameter piles. Other activities, including rock anchoring and impact pile driving, have smaller Level B harassment zones. All Level B harassment isopleths are reported in Table 8 below. It should be noted that based on the geography of Tongass Narrows and the surrounding islands, sound will not reach the full distance of the Level B harassment isopleth. The largest Level B Harassment isopleth will be truncated by land masses at approximately 12,500 m to the southeast and approximately 3,590 m northwest of the project area. Constraining land masses include Revillagigedo Island, Gravina Island, Pennock Island and Spire Island.
In this section we provide the information about the presence, density, or group dynamics of marine mammals that will inform the take calculations. Note that there is no density data for any of the species near the Berth III mooring dolphin project area, therefore the take estimate is informed by qualitative data.
The number of marine mammals that may be exposed to harassment thresholds is calculated by estimating the likelihood of a marine mammal being present within a harassment zone during the associated activities. Estimated marine mammal abundance is determined by reviewing local and regional reports, surveys, permits and observations of abundance and frequency near the planned project action. For example, for species that are common with the potential to occur daily, the take calculations are based on the group size multiplied by the projected number of days of underwater noise activities. For species that are less common, take estimates are based on group size multiplied by the frequency (
Authorization of Level A harassment takes was requested by COK for harbor seal, harbor porpoise, and Dall's porpoise. Harbor seals are habituated to fishing vessels and may follow vessels that enter the marina. Dall's and harbor porpoises' small size and speed make it possible that these animals could occur within the Level A harassment zones and potentially incur injury prior to detection.
Humpback whales occur frequently in Tongass Narrows and the adjacent Clarence Strait during summer and fall months to feed, but are less common during winter and spring. The average group size during the fall surveys was two whales according to Dalheim
In the notice of proposed IHA (85 FR 71612; November 12, 2020) NMFS estimated that up to 2 individuals could be exposed to underwater noise twice a week during the 17 weeks of the project's in-water work, for a total of 68 incidents of take from the Central North Pacific stock. Wade et al. (2016) determined that 6.1 percent of all humpback whales in Southeast Alaska and northern British Columbia were members of the Mexico DPS, while all others are assumed to be members of the Hawaii DPS. Therefore, NMFS had proposed to authorize 68 incidents of take by Level B harassment from the Central North Pacific Stock with 64
Therefore:
As described above, an estimated 6.1 percent of humpback whales in Southeast Alaska are from the Mexico DPS (Wade
Take by Level A harassment is not expected for humpback whales because of the expected effectiveness of the monitoring and mitigation measures. While calculated Level A harassment zones are up to 2,800 m, multiple protected species observers (PSOs) will monitoring Tongass Narrows which is < less than 600 m in width and represents a much smaller effective Level A harassment zone. Humpbacks are usually readily visible, therefore, shutdown measures can be implemented prior to any humpback whales incurring PTS within Level A harassment zones.
Steller sea lion abundance in the Tongass Narrows area is not well known and no systematic studies of Steller sea lions have been conducted in or near the Tongass Narrows area. However, sea lions are known to occur in the Tongass Narrows area throughout the year with peak numbers March through September (ADOT 2019). Sea lions may be present during salmon and herring runs and are known to visit hatcheries and fish processing facilities in the vicinity.
Group sizes are generally 6 to 10 individuals (Freitag 2017) but have been reported to reach 80 animals (Freitag 2017). COK assumed one large group of 10 individuals could be present each day in the project vicinity based on HDR (2019) and Freitag (2017) (as cited in 83 FR 22009; May 11, 2018). NMFS agrees that this daily estimate is appropriate and therefore has authorized up to 1,200 takes by Level B harassment.
Take by Level A harassment is not expected for Steller sea lions because of the relatively small Level A harassment zones for otariids (Table 7) and the expected effectiveness of the monitoring and mitigation measures discussed below.
Harbor seal densities in the Tongass Narrows area are not well known. No systematic studies of harbor seals have been conducted in or near Tongass Narrows. Seals are known to occur year-round with little seasonal variation in abundance (Freitag 2017) and local experts estimate that there are about 1 to 3 harbor seals in Tongass Narrows every day, in addition to those that congregate near the seafood processing plants and fish hatcheries. COK conducted pinnacle rock blasting in December 2019 and January 2020 near the vicinity of the planned project and recorded a total of 21 harbor seal sightings of 24 individuals over 76.2 hours of pre- and post-blast monitoring (Sitkiewicz 2020). Harbor seals were observed in groups ranging from 1-3 animals throughout the 0.70-mile (1.12-kilometer) observation zone. Based on this knowledge, COK assumed an average group size in Tongass Narrows of three individuals. They anticipated that three groups of three harbor seals per group could be exposed to project-related underwater noise each day for 120 days of in-water work. Given that harbor seals are known to follow fishing vessels into the marina and may be difficult to detect, COK assumed that one group of three seals could be taken by Level A harassment daily, resulting in 360 Level A harassment takes. NMFS agreed with these assumptions and, therefore, has authorized 720 takes by Level B harassment and 360 takes by Level A harassment.
The mean group size of Dall's porpoise in Southeast Alaska is estimated at approximately three individuals (Dahlheim
COK assumed that a maximum group size of 20 Dall's porpoise could occur in the project area each month. NMFS concurs with this assessment and has authorized 80 takes of Dall's porpoise over the anticipated four-month project duration.
Given the large size of the Level A harassment zone associated with impact pile driving for high-frequency cetaceans, it is possible Dall's porpoises may enter the Level A harassment zone undetected. Therefore, NMFS has authorized a total of 60 takes of Dall's porpoise by Level B harassment and 20 takes by Level A harassment over the course of the project.
Harbor porpoises are non-migratory; therefore, occurrence estimates are not dependent on season. Freitag (2017 as cited in 83 FR 37473; August 1, 2018) observed harbor porpoises in Tongass Narrows zero to one time per month. Harbor porpoises observed in the project vicinity typically occur in groups of one to five animals with an estimated maximum group size of eight animals (83 FR 37473, August 1, 2018, Solstice 2018). Based on this previous information from the Ketchikan Berth IV Expansion project and the AKDOT Tongass Narrows project, COK estimated that two groups of five harbor porpoise may enter the Tongass Narrows twice per month. NMFS agrees with this estimate and, therefore, has authorized 80 takes of harbor porpoise during the duration of the project.
Given that harbor porpoises are stealthy, having no visible blow and a low profile in the water making the species difficult for monitors to detect (Dahlheim
Typical pod sizes observed within the project vicinity range from 1 to 10 animals. COK assumed that the frequency of killer whales passing through the action area is estimated to be once per month and also conservatively assumed a pod size of 10.
Therefore, NMFS has authorized 40 takes of killer whales by Level B harassment.
Take by Level A harassment is not expected for killer whales because of the small Level A harassment zones for mid-frequency cetaceans and the expected effectiveness of the monitoring and mitigation measures discussed below.
Gray whales have not been reported within the Tongass Narrows; however, their presence cannot be entirely discounted. Since the largest Level B harassment zone extends beyond Tongass Narrows, COK assumed that up to two gray whales may be taken per month. Therefore, NMFS has authorized up to 8 takes of gray whale by Level B harassment.
Due to the unlikely occurrence of gray whales and the ability to shut down pile driving activities prior to a whale entering the Level A harassment zone, no Level A harassment takes of gray whales were requested or are authorized.
There are no known occurrences of minke whales within the project area although they may be present in Tongass Narrows and Clarence Strait year-round. Their abundance throughout Southeast Alaska is low. However, minke whales are distributed throughout a wide variety of habitats and could occur near the project area. Minke whales are generally sighted as individuals (Dahlheim
NMFS had proposed to authorize two minke whale takes by Level B harassment in the proposed IHA. However, based on an informal comment from the Commission, NMFS has increased to eight the authorized take of minke whales (two takes per month) since they are at least if not more likely to occur in Tongass Narrows compared to gray whales, which have never been observed in Tongass Narrows. No Level A harassment takes of minke whales are anticipated due to the very limited occurrence of minke whales and the ability to shut down pile driving activities prior to a whale entering the Level A harassment zone.
Pacific white-sided dolphins have not been reported within the Tongass Narrows; however, the dolphin is within its range and thus its presence cannot be discounted. Pacific white-sided dolphin group sizes generally range from between 20 and 164 animals. For the purposes of this assessment, COK assumed one group of 30 dolphins may be present within the Level B harassment zone every tenth day, or about every other week, similar to what was estimated for a prior IHA (84 FR 36891; July 30, 2019). Therefore, NMFS has authorized 360 takes of Pacific white-sided dolphin by Level B harassment.
No Level A takes are expected due to the relatively small size of Level A harassment zone for mid-frequency cetaceans which can be readily monitored.
Table 9 below summarizes the authorized take for all the species described above as a percentage of stock abundance.
In order to issue an IHA under section 101(a)(5)(D) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to the activity, and other means of effecting the least practicable impact on the species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of the species or stock for taking for certain subsistence uses. NMFS regulations require applicants for incidental take authorizations to include information about the availability and feasibility (economic and technological) of equipment, methods, and manner of conducting the activity or other means of effecting the least practicable adverse impact upon the affected species or stocks and their habitat (50 CFR 216.104(a)(11)).
In evaluating how mitigation may or may not be appropriate to ensure the least practicable adverse impact on species or stocks and their habitat, as well as subsistence uses where applicable, we carefully consider two primary factors:
(1) The manner in which, and the degree to which, the successful implementation of the measure(s) is expected to reduce impacts to marine mammals, marine mammal species or stocks, and their habitat, as well as subsistence uses. This considers the nature of the potential adverse impact being mitigated (likelihood, scope, range). It further considers the likelihood that the measure will be effective if implemented (probability of accomplishing the mitigating result if implemented as planned), the likelihood of effective implementation (probability implemented as planned), and;
(2) The practicability of the measures for applicant implementation, which
The following mitigation measures are required for this IHA:
• For in-water heavy machinery work other than pile driving, if a marine mammal comes within 10 m, operations shall cease and vessels shall reduce speed to the minimum level required to maintain steerage and safe working conditions. This type of work could include the following activities: (1) Movement of the barge to the pile location; or (2) positioning of the pile on the substrate via a crane (
• Briefings must be conducted between construction supervisors and crews and the marine mammal monitoring team prior to the start of all pile driving activity and when new personnel join the work, to explain responsibilities, communication procedures, marine mammal monitoring protocol, and operational procedures;
• For those marine mammals for which take has not been authorized, in-water pile installation and removal will shut down immediately if such species are observed within or entering the Level A or Level B harassment zone; and
• If take reaches the authorized limit for an authorized species, pile installation and removal will be stopped as these species approach the Level A or Level B harassment zone to avoid additional take.
• COK is required to implement all mitigation measures described in the biological opinion (issued on DATE).
The following mitigation measures would apply to COK's in-water construction activities.
•
• If a marine mammal is entering or is observed within an established shutdown zone, pile driving must be halted or delayed. Pile driving may not commence or resume until either the animal has voluntarily left and been visually confirmed beyond the shutdown zone or 15 minutes have passed without subsequent detections of small cetaceans and pinnipeds; or 30 minutes have passed without subsequent detections of large cetaceans.
• The placement of PSOs during all pile driving and removal activities (described in detail in the
•
•
•
•
To minimize impacts to marine mammals and their prey vibratory installation will be used as the primary methods of pile installation. Impact driving will be minimized and used only as needed to seat the pile in its final position or to penetrate material that is too dense for a vibratory hammer.
Based on our evaluation of the applicant's planned measures, as well as other measures considered by NMFS, we have determined that the required measures provide the means effecting the least practicable impact on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.
In order to issue an IHA for an activity, section 101(a)(5)(D) of the MMPA states that NMFS must set forth requirements pertaining to the monitoring and reporting of such taking. The MMPA implementing regulations at 50 CFR 216.104(a)(13) indicate that requests for authorizations must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present in the planned action area. Effective reporting is critical both to compliance as well as ensuring that the most value is obtained from the required monitoring.
Monitoring and reporting requirements prescribed by NMFS should contribute to improved understanding of one or more of the following:
• Occurrence of marine mammal species or stocks in the area in which take is anticipated (
• Nature, scope, or context of likely marine mammal exposure to potential stressors/impacts (individual or cumulative, acute or chronic), through better understanding of: (1) Action or environment (
• Individual marine mammal responses (behavioral or physiological) to acoustic stressors (acute, chronic, or cumulative), other stressors, or cumulative impacts from multiple stressors;
• How anticipated responses to stressors impact either: (1) Long-term fitness and survival of individual marine mammals; or (2) populations, species, or stocks;
• Effects on marine mammal habitat (
• Mitigation and monitoring effectiveness.
Monitoring must be conducted 30 minutes before, during, and 30 minutes after pile driving and removal activities. In addition, observers shall record all incidents of marine mammal occurrence, regardless of distance from activity, and shall document any behavioral reactions in concert with distance from piles being driven or removed. Marine mammal monitoring during pile driving and removal must be conducted by NMFS-approved PSOs in a manner consistent with the following:
• Independent PSOs (
• At least one PSO must have prior experience performing the duties of a PSO during construction activity pursuant to a NMFS-issued incidental take authorization;
• Other PSOs may substitute education (degree in biological science or related field) or training for experience;
• Where a team of two or more PSOs are required, a lead observer or monitoring coordinator must be designated. The lead observer must have prior experience working as a marine mammal observer during construction;
• COK must submit PSO Curriculum Vitae for approval by NMFS prior to the onset of pile driving;
• PSOs must work in rotating shifts of 4 hours and individual PSOs must not perform duties for more than 12 hours in a 24-hour period; and
• PSOs must use elevated platforms at observation points to the extent practicable.
PSOs should have the following additional qualifications:
• Ability to conduct field observations and collect data according to assigned protocols;
• Experience or training in the field identification of marine mammals, including the identification of behaviors;
• Sufficient training, orientation, or experience with the construction operation to provide for personal safety during observations;
• Writing skills sufficient to prepare a report of observations including but not limited to the number and species of marine mammals observed; dates and times when in-water construction activities were conducted; dates, times, and reason for implementation of mitigation (or why mitigation was not implemented when required); and marine mammal behavior; and
• Ability to communicate orally, by radio or in person, with project personnel to provide real-time information on marine mammals observed in the area as necessary.
A minimum of three onshore observers will be stationed along Tongass Narrows at locations that provide optimal visual coverage for shutdown and monitoring zones. To maximize the visual coverage of shutdown and monitoring zones, observers will use elevated platforms at observation points to the extent practicable. Observers will be in contact with each other via two-way radio and with a cellular phone used as back-up communications. The primary purpose of this observer is to implement the shutdown zones and monitor the Level B harassment zones. PSOs must be positioned in order to focus on monitoring these zones. PSOs would scan the waters using binoculars, and/or spotting scopes, and would use a handheld global positioning system (GPS) or range-finder device to verify the distance to each sighting from the project site.
Monitoring will be conducted 30 minutes before, during, and 30 minutes after pile driving/removal activities. In addition, observers shall record all incidents of marine mammal occurrence, regardless of distance from activity, and shall document any behavioral reactions in concert with distance from piles being driven or removed. Pile driving activities include the time to install or remove a single pile or series of piles, as long as the time elapsed between uses of the pile driving equipment is no more than 30 minutes.
A draft marine mammal monitoring report would be submitted to NMFS within 90 days after the completion of pile driving and removal activities, or 60 days prior to a requested date of issuance of any future IHAs for projects at the same location, whichever comes first. It will include an overall description of work completed, a narrative regarding marine mammal sightings, and associated marine mammal observation data sheets. Specifically, the report must include:
• Dates and times (begin and end) of all marine mammal monitoring;
• Construction activities occurring during each daily observation period, including how many and what type of piles were driven or removed and by what method (
• Weather parameters and water conditions during each monitoring period (
• The number of marine mammals observed, by species, relative to the pile location and if pile driving or removal was occurring at time of sighting;
• Age and sex class, if possible, of all marine mammals observed;
• PSO locations during marine mammal monitoring;
• Distances and bearings of each marine mammal observed to the pile being driven or removed for each sighting (if pile driving or removal was occurring at time of sighting);
• Description of any marine mammal behavior patterns during observation, including direction of travel and estimated time spent within the Level A and Level B harassment zones while the source was active;
• Number of individuals of each species (differentiated by month as appropriate) detected within the harassment zones,;
• Detailed information about any implementation of any mitigation triggered (
• Description of attempts to distinguish between the number of individual animals taken and the number of incidences of take, such as ability to track groups or individuals; and
• Submit all PSO datasheets and/or raw sighting data (in a separate file from the Final Report referenced immediately above).
If no comments are received from NMFS within 30 days, the draft final report will constitute the final report. If comments are received, a final report addressing NMFS comments must be submitted within 30 days after receipt of comments.
In the event that personnel involved in the construction activities discover an injured or dead marine mammal, the IHA-holder shall report the incident to the Office of Protected Resources (OPR) (301-427-8401), NMFS and to the Alaska regional stranding coordinator (907-586-7209) as soon as feasible. If the death or injury was clearly caused by the specified activity, the IHA-holder must immediately cease the specified activities until NMFS is able to review the circumstances of the incident and determine what, if any, additional measures are appropriate to ensure compliance with the terms of the IHA. The IHA-holder must not resume their activities until notified by NMFS.
The report must include the following information:
• Time, date, and location (latitude/longitude) of the first discovery (and updated location information if known and applicable);
• Species identification (if known) or description of the animal(s) involved;
• Condition of the animal(s) (including carcass condition if the animal is dead);
• Observed behaviors of the animal(s), if alive;
• If available, photographs or video footage of the animal(s); and
• General circumstances under which the animal was discovered.
NMFS has defined negligible impact as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival (50 CFR 216.103). A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (
Vibratory pile removal, vibratory pile driving, impact pile driving, and DTH pile installation have the potential to disturb or displace marine mammals. Specifically, these planned project activities may result in take, in the form of Level A harassment and Level B harassment. Potential takes could occur if individuals are present in the ensonified zone when these activities are underway. No mortality is anticipated given the nature of the activity and measures designed to minimize the possibility of injury to marine mammals.
The Level A harassment zones identified in Table 7 are based upon an animal exposed to vibratory pile driving, impact pile driving, and DTH pile installation for periods of time ranging from 30 minutes for impact driving, up to 8 hours for vibratory driving, up to 6 hours for DTH socketing and 8 hours for DTH anchoring. Exposures of this length are unlikely for vibratory driving/removal and DTH pile installation scenarios given marine mammal movement throughout the area. Even during impact driving scenarios, an animal exposed to the accumulated sound energy would likely experience only limited PTS at the lower frequencies where pile driving energy is concentrated.
Behavioral responses of marine mammals to pile driving at the project site, if any, are expected to be mild and temporary. Given that the installation of 12 permanent piles and eight temporary piles would occur over 4 months, any harassment would be temporary and intermittent. Effects on individuals that are taken by Level B harassment, on the basis of reports in the literature as well as monitoring from other similar activities, will likely be limited to reactions such as increased swimming speeds, increased surfacing time, or decreased foraging (if such activity were occurring) (Southall
The potential for harassment is minimized through the implementation of the required mitigation measures. During all impact driving, implementation of soft start procedures and monitoring of established shutdown zones shall be required, significantly reducing any possibility of injury. Given sufficient notice through use of soft start (for impact driving), marine mammals are expected to move away from an irritating sound source prior to it becoming potentially injurious. To reduce the severity of in-water noise, vibratory pile driving will be the primary installation method for the project and impact hammers will only be used to seat pile tips into fractured bedrock ahead of the hammering operations or if material is encountered that is too dense to penetrate with a vibratory hammer.
The planned project is located within an active marine commercial and industrial area with no known pinniped haulouts or rookeries near the project area. While construction of mooring dolphins at Berth III would have some permanent removal of habitat available to marine mammals, the area lost is relatively small and not of particular importance to any marine mammals.
Any impacts on prey that would occur during in-water construction would have at most short-terms effects on foraging of individual marine mammals, and likely no effect on the populations of marine mammals as a whole. Therefore, effects on marine mammal prey during the construction are expected to be minimal and, therefore, are unlikely to cause substantial effects on marine mammals at the individual or population level.
In addition, it is unlikely that minor noise effects in a small, localized area of habitat would have any effect on the stocks' ability to recover. In combination, we believe that these factors, as well as the available body of evidence from other similar activities, demonstrate that the potential effects of the specified activities will have only minor, short-term effects on individuals. The specified activities are not expected to impact rates of recruitment or survival and will therefore not result in population-level impacts.
For all species except humpback whales, there are no known BIAs near the project zone that would be impacted by COK's planned activities. For humpback whales, the whole of Southeast Alaska is a seasonal BIA from spring through late fall (Ferguson
In summary and as described above, the following factors primarily support our determination that the impacts resulting from this activity are not expected to adversely affect the species or stock through effects on annual rates of recruitment or survival:
• No mortality is anticipated or authorized;
• Authorized Level A harassment would be limited and of low degree;
• Mitigation measures such as employing vibratory driving to the maximum extent practicable, soft-starts, and shut downs will be implemented;
• Impacts to marine mammal habitat are anticipated to be minimal;
• The project area is located in an industrialized and commercial marina;
• The project area does not include any rookeries, or known areas or features of special significance for foraging or reproduction; and
• The anticipated incidents of Level B harassment consist of, at worst, temporary modifications in behavior.
Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the required monitoring and mitigation measures, NMFS finds that the total marine mammal take from the planned activity will have a negligible impact on all affected marine mammal species or stocks.
As noted above, only small numbers of incidental take may be authorized under sections 101(a)(5)(A) and (D) of the MMPA for specified activities other than military readiness activities. The MMPA does not define small numbers and so, in practice, where estimated numbers are available, NMFS compares the number of individuals taken to the most appropriate estimation of abundance of the relevant species or stock in our determination of whether an authorization is limited to small numbers of marine mammals. When the predicted number of individuals to be
The number of instances of take for each species or stock authorized to be taken as a result of this project is included in Table 9. Our analysis shows that less than one-third of the best available population abundance estimate of each species or stock could be taken by harassment. The number of animals authorized to be taken for each authorized stock would be considered small relative to the relevant stock's abundances even if each estimated taking occurred to a new individual, which is an unlikely scenario.
The west coast transient stock of killer whales represents the highest percentage of a single stock (<17 percent) that is authorized take. This take percentage also assumes that all authorized killer whale takes would be from this stock, which is highly unlikely given the expansive range of the stock.
A lack of an accepted stock abundance value for the Alaska stock of minke whale did not allow for the calculation of an expected percentage of the population that would be affected. The most relevant estimate of partial stock abundance is 1,232 minke whales in coastal waters of the Alaska Peninsula and Aleutian Islands (Zerbini
Based on the analysis contained herein of the planned activity (including the required mitigation and monitoring measures) and the anticipated take of marine mammals, NMFS finds that small numbers of marine mammals will be taken relative to the population size of the affected species or stocks.
In order to issue an IHA, NMFS must find that the specified activity will not have an “unmitigable adverse impact” on the subsistence uses of the affected marine mammal species or stocks by Alaskan Natives. NMFS has defined “unmitigable adverse impact” in 50 CFR 216.103 as an impact resulting from the specified activity: (1) That is likely to reduce the availability of the species to a level insufficient for a harvest to meet subsistence needs by: (i) Causing the marine mammals to abandon or avoid hunting areas; (ii) Directly displacing subsistence users; or (iii) Placing physical barriers between the marine mammals and the subsistence hunters; and (2) That cannot be sufficiently mitigated by other measures to increase the availability of marine mammals to allow subsistence needs to be met.
Alaska Native hunters in the Ketchikan vicinity do not traditionally harvest cetaceans (Muto
Based on the description of the specified activity, the measures described to minimize adverse effects on the availability of marine mammals for subsistence purposes, and the required mitigation and monitoring measures, NMFS has determined that there will not be an unmitigable adverse impact on subsistence uses from COK's planned activities.
To comply with the National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321
This action is consistent with categories of activities identified in Categorical Exclusion B4 (incidental harassment authorizations with no anticipated serious injury or mortality) of the Companion Manual for NOAA Administrative Order 216-6A, which do not individually or cumulatively have the potential for significant impacts on the quality of the human environment and for which we have not identified any extraordinary circumstances that would preclude this categorical exclusion. Accordingly, NMFS has determined that the issuance of the IHA qualifies to be categorically excluded from further NEPA review.
Section 7(a)(2) of the Endangered Species Act of 1973 (ESA: 16 U.S.C. 1531
There is one marine mammal species (Mexico DPS humpback whale) with confirmed occurrence in the project area that is listed as endangered under the ESA. The NMFS Alaska Regional Office Protected Resources Division issued a Biological Opinion under section 7 of the ESA, on the issuance of an IHA to the City of Ketchikan under section 101(a)(5)(D) of the MMPA by the NMFS Permits and Conservation Division. The Biological Opinion concluded that the issuance of an IHA to COK is not likely to jeopardize the continued existence of Mexico DPS humpback whales or adversely modify critical habitat because none exists in the area.
NMFS has issued an IHA to the City of Ketchikan for in-water construction activities associated with the Berth III Expansion Project in Ketchikan, Alaska between October 1, 2021 and September 30, 2022, provided the previously mentioned mitigation, monitoring, and reporting requirements are incorporated.
Office of Postsecondary Education, Department of Education.
Notice.
The U.S. Department of Education (Department) is issuing a notice inviting applications for new awards for fiscal year (FY) 2021 for the Child Care Access Means Parents in School (CCAMPIS) Program, Assistance Listing Number 84.335A. This notice relates to the approved information collection under OMB control number 1840-0737.
For the addresses for obtaining and submitting an application, please refer to our Common Instructions for Applicants to Department of Education Discretionary Grant Programs, published in the
Tanisha Hamblin-Johnson, Ed.D., U.S. Department of Education, 400 Maryland Avenue SW, Room 2C145, Washington, DC 20202-4260. Telephone: (202) 453-6090. Email:
If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.
These priorities are:
The IWPR research also finds that supports, such as free child care, financial assistance, and social skills training, would allow more student parents to graduate. According to the IWPR, offering free child care to a single mother pursuing a bachelor's degree improves success rates for community college students. Free child care may allow many student parents to finish school much quicker, meaning they would require fewer years of support and likely spend more years earning higher wages. Studies show that students who utilize a campus child care center had more than triple the rate of on-time completion than that of parents who did not use the center.
Projects that propose to serve children of student-parents residing in a single parent home. An applicant should describe in its application how it will provide resources with institutional funds, in addition to child care assistance provided by CCAMPIS funds, that will enhance the student-parents' educational, personal, and financial growth.
Students list the Novel Coronavirus as being the main reason for cancelling their college enrollment plans. The numbers of college enrollment cancellations are largest in those demographic groups that have been impacted by the virus the hardest: Black and Latinx students and low-income households.
Another finding suggests that income security is a major contributing factor to who cancels their community college plans. Studies show that low-income households, specifically those led by a single parent, exit community college at a higher rate.
The Center for American Progress defines “child care deserts” as areas with little or no access to quality child care or a ZIP code with more than three children for every licensed child care center slot.
Projects that propose to increase the number of licensed, quality child care centers in areas most impacted by the Novel Coronavirus where under-resourced community colleges are located, by, for example, utilizing unused classrooms on campus, working with community partners to create space in neighboring buildings, and hiring and training child care staff.
Projects that propose to develop high-impact community engagement strategies and partner with community organizations in order to leverage institutional and community resources to provide wrap-around services (such as public benefits and additional financial aid to cover textbook costs, transportation costs, mental health services, faculty mentoring, tutoring, peer support groups, and emergency grants) that meet the whole need of low-income parents in postsecondary education.
(a) An institution of higher education desiring a grant under this competition must submit an application that—
(1) Demonstrates that the institution is an eligible institution;
(2) Specifies the amount of funds requested;
(3) Demonstrates the need of low-income students (as defined in this notice) at the institution for campus-based child care services by including in the application—
(i) Information regarding student demographics;
(ii) An assessment of child care capacity on or near campus;
(iii) Information regarding the existence of waiting lists for existing child care;
(iv) Information regarding additional needs created by concentrations of poverty or by geographic isolation; and
(v) Other relevant data;
(4) Contains a description of the activities to be assisted, including whether the grant funds will support an existing child care program or a new child care program;
(5) Identifies the resources, including technical expertise and financial support, the institution will draw upon to support the child care program and the participation of low-income students in the program, such as accessing social services funding, using student activity fees to help pay the costs of child care, using resources obtained by meeting the needs of parents who are not low-income students, and accessing foundation, corporate, or other institutional support, and demonstrate that the use of the resources will not result in increases in student tuition;
(6) Contains an assurance that the institution will meet the child care needs of low-income students through the provision of services, or through a contract for the provision of services;
(7) Describes the extent to which the child care program will coordinate with the institution's early childhood education curriculum, to the extent the curriculum is available, to meet the needs of the students in the early childhood education program at the institution, and the needs of the parents and children participating in the child care program assisted under the applicant's project;
(8) In the case of an institution seeking assistance for a new child care program—
(i) Provides a timeline, covering the period from receipt of the grant through the provision of the child care services, delineating the specific steps the institution will take to achieve the goal of providing low-income students with child care services;
(ii) Specifies any measures the institution will take to assist low-income students with child care during the period before the institution provides child care services; and
(iii) Includes a plan for identifying resources needed for the child care services, including space in which to provide child care services, and technical assistance, if necessary;
(9) Contains an assurance that any child care facility assisted under this section will meet the applicable State or local government licensing,
(10) Contains a plan for any child care facility assisted under this program to become accredited within three years of the date the institution first receives assistance under this program.
(1) A Head Start program or an Early Head Start program carried out under the Head Start Act (42 U.S.C. 9831
(2) A State licensed or regulated child care program; or
(3) A program that—
(i) Serves children from birth through age six that addresses the children's cognitive (including language, early literacy, and early mathematics), social, emotional, and physical development; and
(ii) Is—
(I) A State prekindergarten program;
(II) A program authorized under section 619 (20 U.S.C. 1419) or part C of the Individuals with Disabilities Education Act (20 U.S.C. 1431
(III) A program operated by a local educational agency.
(1) Who is eligible to receive a Federal Pell Grant for the award year for which the determination is made; or
(2) Who would otherwise be eligible to receive a Federal Pell Grant for the award year for which the determination is made, except that the student fails to meet the requirements of—
(i) 20 U.S.C. 1070a(c)(1) because the student is enrolled in a graduate or first professional course of study; or
(ii) 20 U.S.C. 1091(a)(5) because the student is in the United States for a temporary purpose.
Contingent upon the availability of funds and the quality of applications, we may make additional awards in subsequent years from the list of unfunded applications from this competition.
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• A “page” is 8.5” × 11”, on one side only, with 1” margins.
• Double space all text in the application narrative, and single-space titles, headings, footnotes, quotations, references, and captions, as well as all text in charts, tables, figures, and graphs.
• Use a 12-point font.
• Use an easily readable font such as Times New Roman, Courier, Courier New, or Arial.
The recommended 50-page limit does not apply to the Application for Federal Assistance cover sheet (SF 424); the Budget Information Summary form (ED Form 524); the CCAMPIS Program Profile form and the one-page Project Abstract form; or the assurances and certifications. The recommended page limit also does not apply to a table of contents, which you should include in the application narrative. You must include your complete response to the
We recommend that any application addressing the invitational priorities include no more than three additional pages for each priority.
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We will award up to 100 points to an application under the selection criteria. The maximum number of points available for each criterion is indicated in parentheses.
(a)
In determining the need for the proposed project, the Secretary considers the extent to which the applicant demonstrates, in its application, the need for campus-based child care services for low-income students, by including the following (see section 419N(c)(3) of the HEA):
(i) Information regarding student demographics.
(ii) An assessment of child care capacity on or near campus, including information regarding the existence of waiting lists for existing child care.
(iii) Information regarding additional needs created by concentrations of poverty or by geographic isolation.
(iv) Other relevant data.
(b)
In determining the quality of the design of the proposed project, the Secretary considers the following:
(i) The extent to which the applicant describes in its application the activities to be assisted, including whether the grant funds will support an existing child care program or a new child care program (see section 419N(c)(4) of the HEA).
(ii) The extent to which the services to be provided by the proposed project are focused on those with greatest needs (see 34 CFR 75.210(d)(3)(xi)).
(iii) The likely impact of the services to be provided by the proposed project on the intended recipients of those services (see 34 CFR 75.210(d)(3)(iv)).
(iv) The extent to which the application includes an assurance that the institution will meet the child care needs of low-income students through the provision of services, or through a contract for the provision of services (see section 419N(c)(6) of the HEA).
(v) The extent to which the child care program will coordinate with the institution's early childhood education curriculum, to the extent the curriculum is available, to meet the needs of the students in the early childhood education program at the institution, and the needs of the parents and children participating in the child care program assisted under this section (see section 419N(c)(7) of the HEA).
(vi) The extent to which the proposed project encourages parental involvement (see 34 CFR 75.210(c)(2)(xix)).
(vii) If the applicant is seeking assistance for a new child care program (see section 419N(c)(8) of the HEA).
(1) The extent to which the applicant's timeline, covering the period from receipt of the grant through the provision of the child care services, delineates the specific steps the institution will take to achieve the goal of providing low-income students with child care services;
(2) The extent to which the applicant specifies any measures the institution will take to assist low-income students with child care during the period before the institution provides child care services; and
(3) The extent to which the application includes a plan for identifying resources needed for the child care services, including space in which to provide child care services and technical assistance if necessary.
(c)
In determining the quality of the management plan for the proposed project, the Secretary considers the following:
(i) The extent to which the application identifies the resources, including technical expertise and financial support, the institution will draw upon to support the child care program and the participation of low-income students in the program, such as accessing social services funding, using student activity fees to help pay the costs of child care, using resources obtained by meeting the needs of parents who are not low-income students, and accessing foundation, corporate or other institutional support, and demonstrates that the use of the resources will not result in increases in student tuition (see section 419N(c)(5) of the HEA).
(ii) The qualifications, including relevant training and experience, of key project personnel (see 34 CFR 75.210(e)(3)(ii)).
(iii) The adequacy of the management plan to achieve the objectives of the proposed project on time and within budget, including clearly defined responsibilities, timelines, and milestones for accomplishing project tasks (see 34 CFR 75.210(g)(2)(i)).
(d)
In determining the quality of the project evaluation, the Secretary considers the following:
(i) The extent to which the methods of evaluation are thorough, feasible, and appropriate to the goals, objectives, and outcomes of the proposed project (see 34 CFR 75.210(h)(2)(i)).
(ii) The extent to which the methods of evaluation include the use of objective performance measures that are clearly related to the intended outcomes of the project and will produce quantitative and qualitative data to the extent possible (see 34 CFR 75.210(h)(2)(iv)).
(iii) The extent to which the methods of evaluation will provide performance feedback and permit periodic assessment of progress toward achieving intended outcomes (see 34 CFR 75.210(h)(2)(vi)).
(e)
In determining the adequacy of resources for the proposed project, the Secretary considers the following:
(i) The extent to which the budget is adequate to support the proposed project (see 34 CFR 75.210(f)(2)(iii)).
(ii) The extent to which the costs are reasonable in relation to the number of persons to be served and to the anticipated results and benefits (see 34 CFR 75.210(f)(2)(v)).
2.
In addition, in making a competitive grant award, the Secretary requires various assurances, including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).
For this competition, a panel of non-Federal readers will review each application in accordance with the selection criteria. The individual scores of the reviewers will be added and the sum divided by the number of reviewers to determine the peer review score received in the review process.
If there are insufficient funds for all applications with the same total scores, the Secretary will choose among the tied applications so as to serve geographical areas that have been underserved by the CCAMPIS Program.
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Please note that, if the total value of your currently active grants, cooperative agreements, and procurement contracts from the Federal Government exceeds $10,000,000, the reporting requirements in 2 CFR part 200, Appendix XII, require you to report certain integrity information to FAPIIS semiannually. Please review the requirements in 2 CFR part 200, Appendix XII, if this grant plus all the other Federal funds you receive exceed $10,000,000.
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(a) Selecting recipients most likely to be successful in delivering results based on the program objectives through an objective process of evaluating Federal award applications (2 CFR 200.205);
(b) Prohibiting the purchase of certain telecommunication and video surveillance services or equipment in alignment with section 889 of the National Defense Authorization Act of 2019 (Pub. L. 115—232) (2 CFR 200.216);
(c) Providing a preference, to the extent permitted by law, to maximize use of goods, products, and materials produced in the United States (2 CFR 200.322); and
(d) Terminating agreements in whole or in part to the greatest extent authorized by law if an award no longer effectuates the program goals or agency priorities (2 CFR 200.340).
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If your application is not evaluated or not selected for funding, we will notify you.
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We reference the regulations outlining the terms and conditions of an award in the
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(b) At the end of your project period, you must submit a final performance report, including financial information, as directed by the Secretary. If you receive a multiyear award, you must submit an annual performance report that provides the most current performance and financial expenditure information as directed by the Secretary under 34 CFR 75.118. The Secretary may also require more frequent performance reports under 34 CFR 75.720(c). For specific requirements on reporting, please go to
(c) Under 34 CFR 75.250(b), the Secretary may provide a grantee with additional funding for data collection analysis and reporting. In this case the Secretary establishes a data collection period.
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In making a continuation grant, the Secretary also considers whether the grantee is operating in compliance with the assurances in its approved application, including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).
You may also access documents of the Department published in the
Office of Postsecondary Education (OPE), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing an extension without change of a currently approved collection.
Interested persons are invited to submit comments on or before May 3, 2021.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Sophia McArdle, 202-453-6318.
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Institute of Educational Sciences, Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a new information collection.
Interested persons are invited to submit comments on or before April 2, 2021.
Written comments and recommendations for proposed information collection requests should be sent within 30 days of publication of this notice to
For specific questions related to collection activities, please contact Meredith Bachman, 202-245-7494.
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Office of Energy Efficiency and Renewable Energy, Department of Energy.
Notification of petition for waiver and grant of an interim waiver; request for comments.
This document announces receipt of and publishes a petition for waiver and interim waiver from KeepRite Refrigeration (“KeepRite”), which seeks a waiver for specified carbon dioxide (“CO
The Interim Waiver Order is effective on March 3, 2021. Written comments and information will be accepted on or before April 2, 2021.
Interested persons are encouraged to submit comments using the Federal eRulemaking Portal at
No telefacsimilies (“faxes”) will be accepted. For detailed instructions on submitting comments and additional information on this process, see the
The docket web page can be found at
Ms. Lucy deButts, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies Office, Mail Stop EE-5B, 1000 Independence Avenue SW, Washington, DC 20585-0121. Email:
Mr. Michael Kido, U.S. Department of Energy, Office of the General Counsel, Mail Stop GC-33, Forrestal Building, 1000 Independence Avenue SW, Washington, DC 20585-0103. Telephone: (202) 586-8145. Email:
DOE is publishing KeepRite's petition for waiver in its entirety in appendix 1 to this document, pursuant to 10 CFR 431.401(b)(1)(iv).
However, your contact information will be publicly viewable if you include it in the comment or in any documents attached to your comment. Any information that you do not want to be publicly viewable should not be included in your comment, nor in any document attached to your comment. If this instruction is followed, persons viewing comments will see only first and last names, organization names, correspondence containing comments, and any documents submitted with the comments.
Do not submit to
DOE processes submissions made through
Include contact information each time you submit comments, data, documents, and other information to DOE. If you submit via postal mail or hand delivery/courier, please provide all items on a CD, if feasible, in which case it is not necessary to submit printed copies. Faxes will not be accepted.
Comments, data, and other information submitted to DOE electronically should be provided in PDF (preferred), Microsoft Word or Excel, WordPerfect, or text (ASCII) file format. Provide documents that are not secured, written in English and free of any defects or viruses. Documents should not contain special characters or any form of encryption and, if possible, they should carry the electronic signature of the author.
It is DOE's policy that all comments may be included in the public docket, without change and as received, including any personal information provided in the comments (except information deemed to be exempt from public disclosure).
The Energy Policy and Conservation Act, as amended (“EPCA”),
The energy conservation program under EPCA consists essentially of four parts: (1) Testing, (2) labeling, (3) Federal energy conservation standards, and (4) certification and enforcement procedures. Relevant provisions of EPCA include definitions (42 U.S.C. 6311), energy conservation standards (42 U.S.C. 6313), test procedures (42 U.S.C. 6314), labeling provisions (42 U.S.C. 6315), and the authority to require information and reports from manufacturers (42 U.S.C. 6316).
The Federal testing requirements consist of test procedures that manufacturers of covered equipment must use as the basis for: (1) Certifying to DOE that their equipment complies with the applicable energy conservation standards adopted pursuant to EPCA (42 U.S.C. 6316(a); 42 U.S.C. 6295(s)), and (2) making representations about the efficiency of that equipment (42 U.S.C. 6314(d)). Similarly, DOE must use these test procedures to determine whether the covered equipment complies with relevant standards promulgated under EPCA. (42 U.S.C. 6316(a); 42 U.S.C. 6295(s))
Under 42 U.S.C. 6314, EPCA sets forth the criteria and procedures DOE is required to follow when prescribing or amending test procedures for covered equipment. EPCA requires that any test procedures prescribed or amended under this section must be reasonably designed to produce test results which reflect the energy efficiency, energy use or estimated annual operating cost of covered equipment during a representative average use cycle and requires that test procedures not be unduly burdensome to conduct (42 U.S.C. 6314(a)(2)). The test procedure for walk-in refrigeration systems is contained in the Code of Federal Regulations (“CFR”) at 10 CFR part 431, subpart R, appendix C,
Under 10 CFR 431.401, any interested person may submit a petition for waiver from DOE's test procedure requirements. DOE will grant a waiver from the test procedure requirements if DOE determines either that the basic model for which the waiver was requested contains a design characteristic that prevents testing of the basic model according to the prescribed test procedures, or that the prescribed test procedures evaluate the basic model in a manner so unrepresentative of its true energy consumption characteristics as to provide materially inaccurate comparative data. 10 CFR 431.401(f)(2). A petitioner must include in its petition any alternate test procedures known to the petitioner to evaluate the performance of the equipment type in a manner representative of the energy consumption characteristics of the basic model. 10 CFR 431.401(b)(1)(iii). DOE may grant the waiver subject to conditions, including adherence to alternate test procedures specified by DOE. 10 CFR 431.401(f)(2).
As soon as practicable after the granting of any waiver, DOE will publish in the
The waiver process also provides that DOE may grant an interim waiver if it appears likely that the underlying petition for waiver will be granted and/or if DOE determines that it would be desirable for public policy reasons to grant immediate relief pending a determination on the underlying petition for waiver. 10 CFR 431.401(e)(2). Within one year of issuance of an interim waiver, DOE will either: (i) Publish in the
When DOE amends the test procedure to address the issues presented in a waiver, the waiver will automatically terminate on the date on which use of that test procedure is required to demonstrate compliance. 10 CFR 431.401(h)(2).
DOE received a petition from KeepRite for waiver and interim waiver docketed on August 11, 2020 from the test procedure for walk-in refrigeration systems set forth at 10 CFR part 431, subpart R, appendix C (KeepRite, No. 1 at p. 1
The statements made by KeepRite reference the difference in thermodynamic properties between CO
All refrigerants have a “critical pressure” and an associated “critical temperature” above which liquid and vapor phases cannot coexist. Above this critical point, the refrigerant will be a gas and its temperature will increase or decrease as heat is added or removed. For all conventional refrigerants, the critical pressure is so high that it is never exceeded in typical refrigeration cycles. For example, R404A is a common refrigerant used in refrigeration systems that has a critical pressure of 540.8 psia
The transcritical nature of CO
KeepRite also requests an interim waiver from the existing DOE test procedure. DOE will grant an interim waiver if it appears likely that the petition for waiver will be granted, and/or if DOE determines that it would be desirable for public policy reasons to grant immediate relief pending a determination of the petition for waiver.
Based on the assertions in the petition, absent an interim waiver, the prescribed test procedure is not appropriate for KeepRite's CO
EPCA requires that manufacturers use the applicable DOE test procedures when making representations about the energy consumption and energy consumption costs of covered equipment (42 U.S.C. 6314(d)). Consistency is important when making representations about the energy efficiency of equipment, including when demonstrating compliance with applicable DOE energy conservation standards. Pursuant to 10 CFR 431.401, and after consideration of public comments on the petition, DOE may establish in a subsequent Decision and Order an alternate test procedure for the basic models addressed by the Interim Waiver Order.
KeepRite seeks to test and rate specific CO
DOE has reviewed KeepRite's application, its suggested testing approach, industry materials regarding CO
For the reasons stated, it is
(1) KeepRite must test and rate the following CO
(2) The KeepRite basic models identified in paragraph (1) of this Interim Waiver Order shall be tested according to the test procedure for walk-in cooler and walk-in freezer refrigeration systems prescribed by DOE at 10 CFR part 431, subpart R, appendix C (“Appendix C”), except that the liquid inlet saturation temperature test condition and liquid inlet subcooling temperature test condition shall be modified to 38 °F and 5 °F, respectively, for both walk-in refrigerator unit coolers and walk-in freezer unit coolers, as detailed below. All other requirements of Appendix C and DOE's regulations remain applicable.
In Appendix C, under section 3.1.
(3) Representations. KeepRite may not make representations about the energy efficiency of a basic model listed in paragraph (1) of this Interim Waiver Order for compliance, marketing, or other purposes unless the basic model has been tested in accordance with the provisions set forth in this alternate test procedure and such representations fairly disclose the results of such testing.
(4) This Interim Waiver Order shall remain in effect according to the provisions of 10 CFR 431.401.
(5) This Interim Waiver Order is issued on the condition that the statements and representations provided by KeepRite are valid. If KeepRite makes any modifications to the controls or configurations of a basic model subject to this Interim Waiver Order, such modifications will render the waiver invalid with respect to that basic model, and KeepRite will either be required to use the current Federal test method or submit a new application for a test procedure waiver. DOE may rescind or modify this waiver at any time if it determines the factual basis underlying the petition for the Interim Waiver Order is incorrect, or the results from the alternate test procedure are unrepresentative of the basic model's true energy consumption characteristics. 10 CFR 431.401(k)(1). Likewise, KeepRite may request that DOE rescind or modify the Interim Waiver Order if KeepRite discovers an error in the information provided to DOE as part of its petition, determines that the interim waiver is no longer needed, or for other appropriate reasons. 10 CFR 431.401(k)(2).
(6) Issuance of this Interim Waiver Order does not release KeepRite from the applicable requirements set forth at 10 CFR part 429.
DOE makes decisions on waivers and interim waivers for only those basic models specifically set out in the petition, not future models that may be manufactured by the petitioner. KeepRite may submit a new or amended petition for waiver and request for grant of interim waiver, as appropriate, for additional basic models of CO
This document of the Department of Energy was signed on February 24, 2021, by Kelly Speakes-Backman, Principal Deputy Assistant Secretary and Acting Assistant Secretary for Energy Efficiency and Renewable Energy, pursuant to delegated authority from the Acting Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the
Request for Waiver and Interim Waiver from a DOE test procedure pursuant to provisions described in 10 CFR 431.401 for the following product on the grounds that “the basic model contains one or more design characteristics that prevent testing of the basic model according to the prescribed test procedures.”
The design characteristics constituting the grounds for the Waiver and Interim Waiver Application:
• Appendix C to Subpart R of Part 431—Uniform Test Method for the Measurement of Net Capacity and AWEF of Walk-in Cooler and Walk-in Freezer Refrigeration Systems specifies that unit coolers tested alone use the test procedures described in AHRI 1250-2009. Table 15 and Table 16 of AHRI 1250-2009 are as follows:
• CO
• The test condition values need to be more in line with typical operating conditions for a CO2 refrigeration application.
Utilize the test procedure as outlined in Appendix C to Subpart R of Part 431—Uniform Test Method for the Measurement of Net Capacity and AWEF of Walk-in Cooler and Walk-in Freezer Refrigeration Systems with reference to AHRI 1250-2009 with the exception of modifying the test conditions in Table 15 and 16 for liquid inlet saturation temperature and liquid inlet subcooling temperature as noted below. In addition, per Appendix C to Subpart R of 431 use the calculations in AHRI 1250 section 7.9 to determine AWEF and net capacity for unit coolers matched to parallel rack systems. Use AHRI 1250 Table 17, EER for Remote Commercial Refrigerated Display Merchandisers and Storage Cabinets to determine the power consumption of the system.
What economic hardship and/or competitive disadvantage is likely to result absent a favorable determination on the Application for Interim Waiver—Economic hardship will be loss of sales due to not meeting the DOE requirements set forth.
In accordance with the National Environmental Policy Act of 1969 and the Federal Energy Regulatory Commission's (Commission) regulations, 18 CFR part 380, the Office of Energy Projects has reviewed the application for an original license for the Evelyn Hydroelectric Project No. 14799, and has prepared an Environmental Assessment (EA) for the project. The proposed project would be located on the Kentucky River in Lee County, Kentucky, at the existing Kentucky River Lock and Dam No. 13, which is owned by the Commonwealth of Kentucky and operated by the Kentucky River Authority. No federal land would be occupied by project works or located within the project boundary.
The EA contains staff's analysis of the potential environmental impacts of the project and concludes that licensing the project, with appropriate environmental protective measures, would not constitute a major federal action that would significantly affect the quality of the human environment.
The Commission provides all interested persons with an opportunity to view and/or print the EA via the internet through the Commission's Home Page (
You may also register online at
Any comments should be filed within 30 days from the date of this notice.
The Commission strongly encourages electronic filing. Please file comments using the Commission's eFiling system at
For further information, contact Sarah Salazar at (202) 502-6863, or by email at
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system (
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that Federal Energy Regulatory Commission (Commission) staff will convene a technical workshop to discuss the functionality and features of the relational database through which the Commission will begin collecting certain market-based rate (MBR) information in accordance with Order No. 860 (MBR Database).
The technical workshop will be held on Thursday, March 25, 2021, from approximately 10:00 a.m. to 3:00 p.m. Eastern Time. The technical workshop will be held electronically. A supplemental notice will be issued prior to the technical workshop with further details regarding the agenda and if there are changes to the date or time of the technical workshop.
Individuals who are interested in registering for the conference can do so here:
Commission conferences are accessible under section 508 of the Rehabilitation Act of 1973. For accessibility accommodations, please send an email to
For more information about this technical workshop, please contact Ryan Stertz, 202-502-6473,
This is a supplemental notice in the above-referenced proceeding of Pay Less Energy LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is March 17, 2021.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically may mail similar pleadings to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. Hand delivered submissions in docketed proceedings should be delivered to Health and Human Services, 12225 Wilkins Avenue, Rockville, Maryland 20852.
In addition to publishing the full text of this document in the
This is a supplemental notice in the above-referenced proceeding of All Choice Energy MidAmerica LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is March 17, 2021.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically may mail similar pleadings to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. Hand delivered submissions in docketed proceedings should be delivered to Health and Human Services, 12225 Wilkins Avenue, Rockville, Maryland 20852.
In addition to publishing the full text of this document in the
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system (
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Environmental Protection Agency (EPA).
Notice of meeting.
Pursuant to the Federal Advisory Committee Act (FACA), the Environmental Protection Agency (EPA) is announcing a public meeting of the Clean Air Act Advisory Committee (CAAAC) to be conducted via remote/virtual participation only. Due to unforeseen administrative circumstances, EPA is announcing this meeting with less than 15 calendar days' notice. The EPA renewed the CAAAC charter on November 19, 2020 to provide independent advice and counsel to EPA on policy issues associated with implementation of the Clean Air Act of 1990. The Committee advises EPA on economic, environmental, technical, scientific and enforcement policy issues.
The CAAAC will hold its next public meeting remote/virtually on Monday, March 15, 2021 from 2:00 p.m. to 3:00 p.m. (EST) to introduce current members to incoming Office of Air and Radiation senior leadership. Members of the public may register to listen to the meeting or provide comments, by emailing
Shanika Whitehurst, Designated Federal Official, Clean Air Act Advisory Committee (6103A), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: 202-564-8235; email address:
Pursuant to 5 U.S.C. App. 2 section 10(a)(2), notice is hereby given that the Clean Air Act Advisory Committee will hold its next public meeting remote/virtually on Monday, March 15, 2021 from 2:00 p.m. to 3:00 p.m. (EST) to introduce current members to incoming Office of Air and Radiation senior leadership.
The committee agenda and any documents prepared for the meeting will be publicly available on the CAAAC website at
For information on access or services for individuals with disabilities, please contact Lorraine Reddick at
Equal Employment Opportunity Commission.
Notice and request for comments.
This notice announces that the U.S. Equal Employment Opportunity Commission (EEOC or Commission) is submitting a request for a three-year approval, under the Paperwork Reduction Act of 1995 (PRA), of a revision to the current Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery that the Office of Management and Budget (OMB) previously approved. This collection is part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery.
Written comments on this notice must be submitted on or before April 2, 2021.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
For EEOC Office of Field Programs: Michelle Crew,
For EEOC Office of Federal Operations: Patricia St. Clair,
The solicitation of feedback will target areas such as: Timeliness, appropriateness, accuracy of information, course materials, course instructor, courtesy, efficiency of service delivery, and resolution of issues with service delivery. Responses will be assessed to plan and inform efforts to improve or maintain the quality of service offered to the public. If this information is not collected, vital feedback from customers and stakeholders on the Agency's services will be unavailable.
The Agency will only submit a collection for approval under this generic clearance if it meets the following conditions:
• The collections are voluntary;
• The collections are low-burden for respondents (based on considerations of total burden hours, total number of respondents, or burden-hours per respondent) and are low-cost for both the respondents and the Federal Government;
• The collections are the only way to collect information; there are no alternative existing sources.
• The collections are noncontroversial and do not raise issues of concern to other Federal agencies;
• Any collection is targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program;
• Personally identifiable information (PII) is collected only to the extent necessary and is not retained;
• Information gathered will be used only internally for general service improvement and program management purposes and is not intended for release outside of the agency;
• Information gathered will not be used for the purpose of substantially informing influential policy decisions; and
• Information gathered will yield qualitative information; the collections will not be designed or expected to yield statistically reliable results or used as though the results are generalizable to the population of study.
Feedback collected under this generic clearance provides useful information, but it does not yield data that can be generalized to the overall population. This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance. Such data uses require more rigorous designs that address: The target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential nonresponse bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior to fielding the study. Depending on the degree of influence the results are likely to have, such collections may still be eligible for submission for other generic mechanisms that are designed to yield quantitative results.
As a general matter, information collections will not result in any new system of records containing privacy information and will not ask questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private.
Pursuant to the PRA and OMB regulation 5 CFR 1320.8(d)(1), the EEOC has solicited public comment on its intent to seek a three-year approval of this revised collection: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the EEOC's functions, including whether the information will have practical utility; (2) Evaluate the accuracy of the EEOC's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
One comment was received from the public in response to the 60-day notice published in the
In addition to clearance hours for the previously approved customer feedback forms, the EEOC requested an additional 39,716 clearance hours. Most of these requested hours-39,116-are for a randomly-generated, pop-up form that will solicit feedback from a sample of visitors to the EEOC website on the contents and performance of the web pages. The 39,116 hours burden estimate is based on the number of web page views in a year. The remaining 600 hours represent a reserve to cover any additional feedback forms that may be developed over the next three years for new trainings offered by the EEOC. The EEOC anticipates any new potential feedback forms will be similar in length and content to existing feedback forms. The EEOC is seeking clearance for the additional hours so the EEOC can use the existing clearance number if the need arises for additional training and feedback forms.
For the Commission.
Farm Credit Administration Board, Farm Credit Administration.
Notice, regular meeting.
Notice is hereby given, pursuant to the Government in the Sunshine Act, of the forthcoming regular meeting of the Farm Credit Administration Board.
The regular meeting of the Board will be held March 11, 2021, from 9:00 a.m. until such time as the Board may conclude its business.
To observe the virtual meeting, go to
Dale Aultman, Secretary to the Farm Credit Administration Board (703) 883-4009. TTY is (703) 883-4056.
This meeting of the Board will be open to the public. If you wish to observe, follow the instructions above in the
Federal Communications Commission.
Notice of a new matching program.
In accordance with the Privacy Act of 1974, as amended (“Privacy Act”), this document announces the establishment of a computer matching program the Federal Communications Commission (“FCC” or “Commission” or “Agency”) and the Universal Service Administrative Company (USAC) will conduct with the Pennsylvania's Department of Human Services (PDHS); (“Agency”). The purpose of this matching program is to verify the eligibility of applicants to and subscribers of the Emergency Broadband Benefit Program, which is administered by USAC under the direction of the FCC. More information about this program is provided in the
Written comments are due on or before April 2, 2021. This computer matching program will commence on April 2, 2021, and will conclude 18 months after becoming effective.
Send comments to Margaret Drake, FCC, 45 L Street NE, Washington, DC 20554, or to
Margaret Drake at 202-418-1707 or
The Emergency Broadband Benefit Program (EBBP) was established by Congress in the Consolidated Appropriations Act of 2021, Public Law 116-260, 134 Stat. 1182. EBBP is a program that will help low-income Americans obtain discounted broadband service and one-time co-pay for a connected device (laptop, desktop computer or tablet). This program was created specifically to assist American families' access to broadband, which has proven to be essential for work, school, and healthcare during the public health emergency that exists as a result of COVID-19. A household may qualify for the EBBP benefit under various criteria, including an individual qualifying for the FCC's Lifeline program.
In a Report and Order adopted on March 31, 2016 (81 FR 33026, May 24, 2016), the Commission ordered USAC to create a National Lifeline Eligibility Verifier (“National Verifier”), including the National Lifeline Eligibility Database (LED), that would match data about Lifeline applicants and subscribers with other data sources to verify the eligibility of an applicant or subscriber. The Commission found that the National Verifier would reduce compliance costs for Lifeline service providers, improve service for Lifeline subscribers, and reduce waste, fraud, and abuse in the program. The
Pennsylvania Department of Human Services (PDHS).
Consolidated Appropriations Act of 2021, Public Law 116-260, 134 Stat. 1182; 47 CFR part 54.
In the 2016 Lifeline Modernization Order (81 FR 33026, May 24, 2016), the FCC required USAC to develop and operate the National Verifier to improve efficiency and reduce waste, fraud, and abuse in the Lifeline program. The stated purpose of the National Verifier is “to increase the integrity and improve the performance of the Lifeline program for the benefit of a variety of Lifeline participants, including Lifeline providers, subscribers, states, community-based organizations, USAC, and the Commission.” 31 FCC Rcd 3962, 4006, para. 126. To help determine whether Lifeline applicants and subscribers are eligible for Lifeline benefits, the Order contemplates that the USAC-operated LED will communicate with information systems and databases operated by other Federal and State agencies. Id. at 4011-2, paras. 135-7.
The Consolidated Appropriations Act of 2021 directs the FCC to leverage the National Verifier to verify applicants' eligibility for EBBP. The purpose of this matching program is to verify the eligibility of EBBP applicants and subscribers by determining whether they receive Medicaid or SNAP benefits administered by the Pennsylvania Department of Human Services. Under FCC rules, consumers receiving these benefits qualify for Lifeline discounts and also for EBBP benefits.
The categories of individuals whose information is involved in the matching program include, but are not limited to, those individuals who have applied for EBBP benefits; are currently receiving benefits; are individuals who enable another individual in their household to qualify for EBBP benefits; are minors whose status qualifies a parent or guardian for EBBP benefits; or are individuals who have received EBBP benefits.
The categories of records involved in the matching program include, but are not limited to, the last four digits of the applicant's Social Security Number, date of birth, and first name or last name. The National Verifier will transfer these data elements to the Pennsylvania DHS which will respond either “yes” or “no” that the individual is enrolled in a EBBP-qualifying assistance program: State of Pennsylvania's SNAP or Medicaid.
The USAC records shared as part of this matching program reside in the EBBP system of records, FCC/WCB-3, Emergency Broadband Benefit Program, which can be found on the FCC website at
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal Agencies to take this opportunity to comment on the following information collection. Pursuant to the Small Business Paperwork Relief Act of 2002, the FCC seeks specific comment on how it can further reduce the information collection burden for small business concerns with fewer than 25 employees.
Written comments and recommendations for the proposed information collection should be submitted on or before April 2, 2021.
Comments should be sent to
For additional information or copies of the information collection, contact Cathy Williams at (202) 418-2918. To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the web page
The Commission may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
As part of its continuing effort to reduce paperwork burdens, as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the FCC invited the general public and other Federal Agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's
Recordkeeping, reporting, and third-party disclosure requirements associated with the FCC items listed in item 1 of the supporting statement will be used by incumbent licensees and new entrants to negotiate relocation agreements and to coordinate operations to avoid interference. The information also will be used by licensees to determine reimbursement obligations of other licensees pursuant to the Commission's rules, and notify to notify such licensees of their reimbursement obligations. Additionally, the information will be used to facilitate dispute resolution and for FCC oversight of the cost-sharing plan.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal Agencies to take this opportunity to comment on the following information collection. Pursuant to the Small Business Paperwork Relief Act of 2002, the FCC seeks specific comment on how it might “further reduce the information collection burden for small business concerns with fewer than 25 employees.” The Commission may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written comments and recommendations for the proposed information collection should be submitted on or before April 2, 2021.
Comments should be sent to
For additional information or copies of the information collection, contact Nicole Ongele at (202) 418-2991. To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the web page
As part of its continuing effort to reduce paperwork burdens, as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the FCC invited the general public and other Federal Agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimates; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology. Pursuant to the Small Business
Federal Housing Finance Agency.
Federal Home Loan Bank Director—60-day notice of submission of information collection for approval from Office of Management and Budget.
In accordance with the requirements of the Paperwork Reduction Act of 1995 (PRA), the Federal Housing Finance Agency (FHFA or the Agency) is seeking public comments concerning an information collection known as “Federal Home Loan Bank Directors,” which has been assigned control number 2590-0006 by the Office of Management and Budget (OMB). FHFA intends to submit the information collection to OMB for review and approval of a three-year extension of the control number, which is due to expire on February 28, 2021.
Interested persons may submit comments on or before May 3, 2021.
Submit comments to FHFA, identified by “Proposed Collection; Comment Request: `Federal Home Loan Bank Directors, (No. 2021-N-3)'” by any of the following methods:
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We will post all public comments we receive without change, including any personal information you provide, such as your name and address, email address, and telephone number, on the FHFA website at
Vickie Olafson, Assistant General Counsel,
Section 7 of the Federal Home Loan Bank Act (Bank Act) vests the management of each Federal Home Loan Bank (Bank) in its board of directors.
Part 1261 of the regulations requires that each Bank administer its own annual director election process. As part of this process, a Bank must require each nominee for both types of directorship, including any incumbent that may be a candidate for re-election, to complete and return to the Bank a form that solicits information about the candidate's statutory eligibility to serve and, in the case of independent director candidates, about his or her professional qualifications for the directorship being sought.
The Banks use the information collection contained in the
The OMB control number for this information collection is 2590-0006. The current clearance for the information collection expired on February 28, 2021. The likely respondents are individuals who are prospective and incumbent Bank directors.
In advance of the 2021 Bank director election cycle, FHFA is revising each of the three Bank Director Application and Certification forms, all of which have existed in substantially their current form since the current statutory requirements for Bank directors were adopted in 2008.
The
The
The
The revised questions, including preset answer selections, and instructions for each of the Bank director forms appear at the end of this notice. The final formatting of the revised forms has yet to be determined.
FHFA estimates the total annual hour burden imposed upon respondents by the three Bank director forms comprising this information collection to be 119 hours (39 hours + 50 hours + 30 hours = 119 hours, as detailed below).
The Agency estimates the total annual hour burden on all member director candidates and incumbent member directors associated with review and completion of the
The Agency estimates the total annual hour burden on all independent director candidates associated with review and completion of the
The Agency estimates the total annual hour burden on all incumbent independent directors associated with review and completion of the
FHFA requests written comments on the following: (1) Whether the collection of information is necessary for the proper performance of FHFA functions, including whether the information has practical utility; (2) the accuracy of FHFA's estimates of the burdens of the collection of information; (3) ways to enhance the quality, utility, and clarity of the information collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Federal Maritime Commission.
Notice.
The Federal Maritime Commission (Commission) is giving public notice that the agency has submitted to the Office of Management and Budget (OMB) for approval the continuing information collections described in this notice. The public is invited to comment on the proposed information collections pursuant to the Paperwork Reduction Act of 1995.
Written comments must be submitted at the addresses below on or before April 2, 2021.
Comments should be addressed to:
Office of the Managing Director,
Federal Maritime Commission,
Copies of the submission(s) may be obtained by contacting Donna Lee at
Pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104-13), the Commission invites the general public and other Federal agencies to comment on proposed information collections. On October 13, 2020, the Commission published a notice and request for comments in the
In response to this notice, comments and suggestions should address one or more of the following points: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
I.
II.
The Commission hereby gives notice of the filing of the following agreement under the Shipping Act of 1984. Interested parties may submit comments, relevant information, or
Board of Governors of the Federal Reserve System.
Temporary approval of information collection, request for comment.
The Board of Governors of the Federal Reserve System (Board) has temporarily revised the Reporting and Disclosure Requirements Associated with Emergency Lending, pursuant to the authority delegated to the Board by the Office of Management and Budget (OMB).
Comments must be submitted on or before May 3, 2021.
You may submit comments, identified by
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All public comments are available from the Board's website at
Additionally, commenters may send a copy of their comments to the Office of Management and Budget (OMB) Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW, Washington, DC 20503, or by fax to (202) 395-6974.
Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551, (202) 452-3829.
On June 15, 1984, OMB delegated to the Board authority under the PRA to approve and assign OMB control numbers to collections of information conducted or sponsored by the Board. In exercising this delegated authority, the Board is directed to take every reasonable step to solicit comment. In determining whether to approve a collection of information, the Board will consider all comments received from the public and other agencies. Pursuant to its delegated authority, the Board may temporarily approve a revision to a collection of information, without providing opportunity for public comment, if the Board determines that a change in an existing collection must be instituted quickly and that public participation in the approval process would defeat the purpose of the collection or substantially interfere with the Board's ability to perform its statutory obligation.
As discussed below, the Board has made certain temporary revisions to the FR A information collection. The Board's delegated authority requires that the Board, after temporarily approving a collection, publish a notice soliciting public comment. Therefore, the Board is also inviting comment on a proposal to extend the FR A information collection for three years, with these revisions.
A copy of the Paperwork Reduction Act (PRA) OMB submission, including the reporting form and instructions, supporting statement, and other documentation will be available at
The Board invites public comment on the following information collection, which is being reviewed under authority delegated by the OMB under the PRA. Comments are invited on the following:
a. Whether the proposed collection of information is necessary for the proper performance of the Board's functions, including whether the information has practical utility;
b. The accuracy of the Board's estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;
c. Ways to enhance the quality, utility, and clarity of the information to be collected;
d. Ways to minimize the burden of information collection on respondents, including through the use of automated collection techniques or other forms of information technology; and
e. Estimates of capital or startup costs and costs of operation, maintenance, and purchase of services to provide information.
At the end of the comment period, the comments and recommendations received will be analyzed to determine the extent to which the Board should modify the proposal.
In addition to these certifications, the Board may establish additional certification requirements for an individual emergency lending facility. The second part of the FR A information collection, the FR A-2, pertains to reporting requirements associated with individual facilities that are related to requirements of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). The third part of FR A, designated as the FR A-3, pertains to reporting requirements specific to the Main Street Expanded Loan Facility, the Main Street New Loan Facility, the Main Street Priority Loan Facility, the Nonprofit Organization Expanded Loan Facility, and the Nonprofit Organization New Loan Facility (collectively, the “Main Street Lending Program”). The fourth part of FR A, designated as the FR A-4, pertains to a disclosure requirement for Paycheck Protection Program (PPP) borrowers seeking to reduce the calculation of existing outstanding and undrawn available debt to participate in the Main Street Lending Program.
The information collected under the FR A may be kept confidential under exemption 4 of the Freedom of Information Act, which protects commercial or financial information obtained from a person that is privileged or confidential.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the
Submit either electronic or written comments on the collection of information by May 3, 2021.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before May 3, 2021. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733,
Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
Current Good Manufacturing Practice for Finished Pharmaceuticals, Including Medical Gases, and Active Pharmaceutical Ingredients—21 CFR parts 210 and 211 and 21 U.S.C 351(a)(2)(B).
This information collection supports FDA regulations that govern the manufacture, processing, packing, or holding of finished pharmaceuticals, including medical gases, and APIs. Under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C 351(a)(2)(B)), a drug is adulterated if the methods used in, or the facilities or controls used for its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with CGMP regulations. FDA is responsible for enforcing the FD&C Act as well as related statutes, including the Public Health Service Act. Congress enacted these laws to ensure that covered products meet applicable requirements regarding the safety, identity and strength, and the quality and purity characteristics they purport or are represented to possess, and are labeled with adequate warnings and instructions for use.
The pharmaceutical or drug quality-related regulations appear in several parts of Title 21 Code of Federal Regulations (CFR) (Food and Drugs), including sections in parts 1 through 99, 200 through 299, 300 through 499, 600 through 799, and 800 through 1299. The
These regulations set forth information collection requirements that allow FDA to meet its public health protection responsibilities. Products that fail to comply with CGMP requirements may be rendered adulterated under section 501(a)(2)(B) of the FD&C Act. To demonstrate that their products comply with the requirements of section 501(a)(2)(B), API manufacturers must maintain CGMP records; therefore, we have counted them among respondents who incur burden for the information collection. In the table below, we have included an additional 1,260 respondents to reflect API manufacturers not included in our previous submission for renewal.
To assist respondents with the information collection requirements for medical gases, we developed a draft guidance for industry entitled “Current Good Manufacturing Practice for Medical Gases.” This guidance, when finalized will discuss our recommendations regarding compliance with applicable requirements found in the regulations as they apply to these products. The guidance is available for download from our internet site at
We estimate the burden of the information collection as follows:
Our estimated burden for the information collection reflects an overall decrease of 29,073 hours and 1,762 records annually for CGMP for finished pharmaceutical manufacturers, excluding those manufacturers of medical gases. Our estimated burden for the information collection also reflects an overall decrease of 486 hours and 1,574 records annually for medical gas manufacturers. Our inclusion of API manufacturers in this collection represents an addition of 264,499 hours and 322,560 records prepared.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the
Submit either electronic or written comments on the collection of information by May 3, 2021.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before May 3, 2021. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
ENDS, also called electronic cigarettes, e-cigarettes, and vaporizers, are deemed tobacco products and fall under FDA's regulatory scope. FDA has the authority under the Family Smoking Prevention and Tobacco Control Act (Pub. L. 111-31, H.R. 1256) to regulate and restrict the marketing of tobacco products. However, given the recency of ENDS products to the market, limited research exists to inform the regulation of certain aspects of their marketing. Research to understand “marketing influences on youth experimentation, initiation, use and cessation of tobacco products” is a regulatory priority for the FDA Center for Tobacco Products (CTP).
Flavors are a unique and important aspect of ENDS. ENDS use a liquid (“e-liquid” or “e-juice”) that can span a diverse range of flavors, from tobacco flavor, menthol, mint, fruit flavors, non-fruit sweet flavors (
This study of “How Consumers Make Inferences about ENDS” is voluntary research. The primary goal of the study is to understand whether flavor-related imagery, descriptors, and flavor name modifiers affect product appeal, curiosity about the product, interest in
The study will collect data from two groups of consumers: 2,500 youth (aged 13 to 17 years old) and 2,500 young adults (aged 18 to 24 years old). The sample will be stratified by ENDS and cigarette use, so that 625 participants in each age group will be (a) non-cigarette and non-ENDS users (N=625), (b) cigarette users only (N=625), (c) ENDS users only (N=625), and (d) dual ENDS and cigarette users (N=625). Participants will participate in a repeated measure experiment in which they will be asked to view five ads and report their liking of the ad, curiosity about using the product (an important precursor to use), and interest in using the product. Participants will also report additional perceptions of product qualities. Findings from this study will inform FDA rulemaking regarding the marketing and presence of flavor features in ENDS and be used to guide other public health agencies' policies and messaging regarding the role of flavors in ENDS.
Participants who meet the inclusion criteria will be randomized to view five ads across five conditions to report their liking of the ad, curiosity about using the product (an important precursor to use), and interest in using the product. The order of ad presentation will be randomized. These procedures will minimize order effects as well as the likelihood of a demand characteristic in which a participant guesses the purpose of the experiment and intentionally or unintentionally alters their response.
Study outcomes include comparisons to assess the extent to which presence or absence of a flavor-representing image, name modifier, or descriptor will be associated with increased or decreased (a) product appeal, (b) curiosity about the product, (c) interest in using the product, and (d) increased positive product perceptions compared to a control condition ad (without or with flavor features).
FDA estimates the burden of this collection of information as follows:
FDA's burden estimate is based on prior experience with research that is similar to this proposed study (OMB control number 0910-0848). Applying assumptions from previous experience in conducting similar studies, approximately 250,000 respondents from an internet panel will be recruited via an email invitation, which is estimated to take 1 minute to read and respond. An estimated 7,500 (3,750 youth and 3,750 young adults) respondents will provide assent and consent and be screened to yield the desired sample size of 5,000 total (2,500 youth and 2,500 young adults) participants. The consent/screening process is estimated to take an average of 7 minutes per respondent. Participants that qualify for the study will be automatically directed to begin the online survey, which is estimated to take an average of 20 minutes per respondent.
The total estimated burden for the data collection is 6,712 hours.
Food and Drug Administration, HHS.
Notice.
The Director of the Center for Drug Evaluation and Research (Center Director) of the Food and Drug Administration (FDA or Agency) is proposing to refuse to approve a new drug application (NDA) submitted by Lexicon Pharmaceuticals, Inc. (Lexicon) for sotagliflozin oral tablets, 200 milligrams (mg) and 400 mg, in its present form. This notice summarizes the grounds for the Center Director's proposal and offers Lexicon an opportunity to request a hearing on the matter.
Submit either electronic or written requests for a hearing by April 2, 2021; submit data, information, and analyses in support of the hearing and any other comments by May 3, 2021.
You may submit hearing requests, documents in support of the hearing, and any other comments as follows. Please note that late, untimely filed requests and documents will not be considered. Electronic requests for a hearing must be submitted on or before April 2, 2021; electronic documents in support of the hearing and any other comments must be submitted on or before May 3, 2021. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Kevin Fain, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6419, Silver Spring, MD 20993, 301-796-5842,
Sanofi-aventis U.S. LLC (Sanofi), Lexicon's predecessor-in-interest, submitted NDA 210934 for sotagliflozin oral tablets in 200 and 400 mg strengths on March 22, 2018, pursuant to section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(b)(1)). Sanofi proposed that sotagliflozin tablets be indicated as an adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus (T1DM).
On March 22, 2019, the Office of Drug Evaluation II (ODE II) in the Office of New Drugs (OND) in FDA's Center for Drug Evaluation and Research (CDER) issued a complete response letter to Sanofi under § 314.110(a) (21 CFR 314.110(a)) stating that NDA 210934 could not be approved in its present form, describing the specific deficiencies, and, where possible, recommending ways that Sanofi might remedy these deficiencies. The application in its present form is not approvable because the data submitted
(1) The data demonstrated that the addition of sotagliflozin to insulin is associated with an increased risk of diabetic ketoacidosis (DKA), a serious and often life-threatening consequence of insulin insufficiency.
a. In particular, the submitted clinical trial data showed a nearly 8-fold excess risk of DKA associated with sotagliflozin. Based on an FDA analysis of all three trials, an overall estimated hazard ratio (95 percent confidence interval) for DKA associated with sotagliflozin was 7.9 (3.2, 19.9).
b. The majority of these cases required hospitalization and treatment in the intensive care unit, which underscores the seriousness of this risk.
c. Although DKA is an inherent risk in T1DM, the magnitude of excess risk, severity of the cases, and characteristics of DKA (
d. Time-to-event analyses of the clinical trial data showed earlier development of DKA in sotagliflozin-treated patients than in patients assigned to placebo, without evidence that the risk stopped increasing over time.
e. The clinical trial data did not identify a patient group at lower risk of DKA, but instead showed the DKA risk was associated with sotagliflozin regardless of sex, age, duration of diabetes, method of insulin delivery, or body mass index.
f. Overall, risk mitigation strategies used in the clinical trials were not sufficient to address the excess DKA risk observed in the clinical trials, as evidenced by the nearly 8-fold excess risk.
g. Data analyses assessing the impact of risk mitigation strategies implemented during the course of the trials were inadequate to provide reassurance that these strategies would be successful in reducing DKA risk post-approval.
(2) The data demonstrated the significant DKA risk resulting from the addition of sotagliflozin to insulin was not justified by the drug's modest clinical benefits.
a. The data showed that sotagliflozin reduced HbA1c, a validated surrogate endpoint for clinical benefits expected due to improved glycemic control in the treatment of diabetes mellitus, including T1DM. However, the effect on HbA1c in the sotagliflozin clinical trials was modest.
b. In the three pivotal trials, addition of sotagliflozin to insulin resulted in statistically significant reductions in HbA1c at Week 24. The treatment difference relative to placebo was approximately −0.3 percent with sotagliflozin 200 mg and −0.4 percent with sotagliflozin 400 mg.
c. In the extension of two pivotal trials to 52 weeks, the effect of sotagliflozin on HbA1c was smaller (−0.23 percent and −0.33 percent HbA1c reductions with the 200 mg and 400 mg doses, respectively), and there are no longer term data to evaluate persistence of effect. The decrease in treatment effect from Week 24 to Week 52 is clinically relevant, as the major benefits to consider with sotagliflozin treatment are related to improved long-term glycemic control reducing the risk of microvascular complications.
d. The improved HbA1c associated with sotagliflozin was not accompanied by an increased rate of hypoglycemia (defined as glucose ≤ 55 mg/dL) in the clinical trials, an adverse clinical effect that occurs with insulin therapy; however, this observation does not outweigh the increased rate of DKA. The data did not show sotagliflozin was associated with an overall decrease in the rate of severe hypoglycemia.
e. In addition to improved glycemic control, other clinical benefits associated with sotagliflozin, small reductions in body weight and blood pressure, were not sufficient to outweigh the serious risk of DKA.
f. The data did not show that sotagliflozin was associated with an effect on glycemic variability and time-in-range that provided benefits distinct from reduced HbA1c.
g. Patient reported outcome measures were not adequate in directly reflecting important aspects of the patient's experience with T1DM and how sotagliflozin treatment affected these important aspects.
The complete response letter stated that Sanofi is required either to resubmit the application, fully addressing all deficiencies listed in the letter, or take other actions available under § 314.110 (
Sanofi submitted a formal dispute resolution request (FDRR) on September 3, 2019, concerning the complete response letter issued by ODE II. Peter Stein, Director of CDER's OND, denied the FDRR by correspondence dated November 29, 2019, based on his determination that the drug's immediate, sustained, and substantial increase in DKA risk outweighed the modest benefit on glycemic control and any potential additional benefits (
On November 10, 2020, Lexicon submitted a request for an opportunity for a hearing under § 314.110(b)(3) on whether there are grounds under section 505(d) of the FD&C Act for denying approval of NDA 210934.
For the reasons stated above and as explained in further detail in the complete response letter and the November 29, 2019, and March 11, 2020, FDRR denials, notice is given to Lexicon and all other interested persons that the Center Director proposes to issue an order refusing to approve NDA 210934 on the grounds that the application fails to meet the criteria for approval under section 505(d)(2) of the FD&C Act because data submitted in the application do not show that the product would be safe under the proposed conditions of use.
Lexicon may request a hearing before the Commissioner of Food and Drugs
As stated in § 314.200(g), a request for a hearing may not rest upon allegations or denials, but must present specific facts showing that there is a genuine and substantial issue of fact that requires a hearing to resolve. We note in this regard that because CDER proposes to refuse to approve NDA 210934 based on the multiple deficiencies summarized above, any hearing request from Lexicon must address all of those deficiencies. Failure to request a hearing within the time provided and in the manner required by § 314.200 constitutes a waiver of the opportunity to request a hearing. If a hearing request is not properly submitted, FDA will issue a notice refusing to approve NDA 210934.
The Commissioner will grant a hearing if there exists a genuine and substantial issue of fact or if the Commissioner concludes that a hearing would otherwise be in the public interest (§ 314.200(g)(6)). If a hearing is granted, it will be conducted according to the procedures provided in 21 CFR parts 10 through 16 (21 CFR 314.201).
Paper submissions under this notice of opportunity for a hearing should be filed in one copy. Except for data and information prohibited from public disclosure under 21 U.S.C. 331(j) or 18 U.S.C. 1905, submissions may be seen in the Dockets Management Staff Office between 9 a.m. and 4 p.m., Monday through Friday, and on the internet at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Michael Gurry from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Gurry was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. Mr. Gurry was given notice of the proposed permanent debarment and an opportunity to request a hearing to show why he should not be debarred. As of October 22, 2020 (30 days after receipt of the notice), Mr. Gurry had not responded. Mr. Gurry's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this action.
This order is applicable March 8, 2021.
Submit applications for termination of debarment to the Dockets Management Staff, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, or at
Jaime Espinosa (ELEM-4029) Division of Enforcement, Office of Strategic Planning and Operational Policy, Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Drive, Rockville, MD 20857, 240-402-8743,
Section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B)) requires debarment of an individual from providing services in any capacity to a person that has an approved or pending drug product application if FDA finds that the individual has been convicted of a felony under Federal law for conduct relating to the regulation of any drug product under the FD&C Act. On January 13, 2020, Mr. Gurry was convicted as defined in section 306(
The factual basis for this conviction is as follows: Mr. Gurry held executive management positions, to include Vice President of Managed Markets, of Insys Therapeutics Inc. (Insys), a Delaware Corporation, with headquarters in Chandler, Arizona. Insys developed and owned a drug called SUBSYS, a liquid formulation of fentanyl to be applied under the tongue. FDA approved SUBSYS for the management of breakthrough pain in adult cancer patients who are already receiving and are already tolerant to opioid therapy for their underlying persistent cancer pain. From early 2012 and continuing through 2015, Mr. Gurry participated in a conspiracy whereby employees of Insys bribed medical practitioners in various states to get those practitioners to increase prescribing SUBSYS to their patients, many of whom did not have cancer. Mr. Gurry, along with his coconspirators, measured the effect of these bribes on each practitioner's prescribing habits and on the revenue that each bribed practitioner generated for Insys. Mr. Gurry, along with his coconspirators, reduced or eliminated bribes paid to those practitioners who failed to meet the minimum prescription requirements or failed to generate enough revenue to justify additional bribes. To further this conspiracy, Mr. Gurry and his coconspirators misled and defrauded health insurance providers to ensure those providers approved payment for SUBSYS. Insys achieved this goal by establishing the “Insys Reimbursement Center”, which was designed to shift the burden of seeking prior authorization for SUBSYS from practitioners to Insys. This allowed Insys to determine what medical information was presented to insurers. Mr. Gurry and his coconspirators directed Insys employees to mislead insurers to obtain payment authorization.
As a result of this conviction, FDA sent Mr. Gurry, by United Parcel Service, on September 21, 2020, a notice proposing to permanently debar him from providing services in any capacity to a person that has an approved or pending drug product application. The proposal was based on a finding, under section 306(a)(2)(B) of the FD&C Act, that Mr. Gurry was convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. The proposal also offered Mr. Gurry an opportunity to request a hearing, providing him 30 days from the date of receipt of the letter in which to file the request, and advised him that failure to request a hearing constituted an election not to use the opportunity for a hearing and a waiver of any contentions concerning this
Therefore, the Assistant Commissioner, Office of Human and Animal Food Operations, under section 306(a)(2)(B) of the FD&C Act, under authority delegated to the Assistant Commissioner, finds that Mr. Gurry has been convicted of a felony under Federal law for conduct otherwise relating to the regulation of a drug product under the FD&C Act.
As a result of the foregoing finding, Mr. Gurry is permanently debarred from providing services in any capacity to a person with an approved or pending drug product application, effective (see
Any application by Mr. Gurry for special termination of debarment under section 306(d)(4) of the FD&C Act should be identified with Docket No. FDA-2020-N-1413 and sent to the Dockets Management Staff (see
Publicly available submissions will be placed in the docket and will be viewable at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of three new drug applications (NDAs) and is announcing an opportunity for the NDA holders to request a hearing on this proposal. The basis for the proposal is that the NDA holders have repeatedly failed to file required annual reports for those NDAs.
The NDA holders may submit a request for a hearing by April 2, 2021. Submit all data, information, and analyses upon which the request for a hearing relies by May 3, 2021. Submit electronic or written comments by May 3, 2021.
The request for a hearing may be submitted by the NDA holders by either of the following methods:
Submit electronic comments in the following way:
•
Submit written/paper submissions as follows:
•
• Because your request for a hearing will be made public, you are solely responsible for ensuring that your request does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. The request for a hearing must include the Docket No. FDA-2021-N-0104 for “PolyMedica Industries Inc. et al.; Proposal to Withdraw Approval of Three New Drug Applications; Opportunity for a Hearing.” The request for a hearing will be placed in the docket and publicly viewable at
The NDA holders may submit all data and analyses upon which the request for a hearing relies in the same manner as the request for a hearing except as follows:
• Confidential Submissions—To submit any data analyses with confidential information that you do not wish to be made publicly available, submit your data and analyses only as a written/paper submission. You should submit two copies total of all data and analyses. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of any decisions on this matter. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Kimberly Lehrfeld, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-796-3137,
The holder of an approved NDA to market a new drug for human use is required to submit annual reports to FDA concerning its approved NDA under §§ 314.81 and 314.98 (21 CFR 314.81 and 314.98). The holders of the approved NDAs listed in table 1 have repeatedly failed to submit the required annual reports and have not responded to the Agency's request for submission of the reports.
Therefore, notice is given to the holders of the approved NDAs listed in table 1 and to all other interested persons that the Director of CDER proposes to issue an order, under section 505(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)), withdrawing approval of the NDAs and all amendments and supplements thereto on the grounds that the NDA holders have failed to submit reports required under § 314.81.
In accordance with section 505 of the FD&C Act and 21 CFR part 314, the NDA holders are hereby provided an opportunity for a hearing to show why the approval of the NDAs listed previously should not be withdrawn and an opportunity to raise, for administrative determination, all issues relating to the legal status of the drug products covered by these NDAs.
An NDA holder who decides to seek a hearing must file the following: (1) A written notice of participation and request for a hearing (see
The failure of an NDA holder to file a timely written notice of participation and request for a hearing, as required by § 314.200, constitutes an election by that
A request for a hearing may not rest upon mere allegations or denials but must present specific facts showing that there is a genuine and substantial issue of fact that requires a hearing. If a request for a hearing is not complete or is not supported, the Commissioner of Food and Drugs will enter summary judgment against the person who requests the hearing, making findings and conclusions, and denying a hearing.
All paper submissions under this notice of opportunity for a hearing must be filed in two copies. Except for data and information prohibited from public disclosure under 21 U.S.C. 331(j) or 18 U.S.C. 1905, the submissions may be seen at the Dockets Management Staff (see
This notice is issued under section 505(e) of the FD&C Act and under authority delegated to the Director of CDER by the Commissioner of Food and Drugs.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled “Modifications to the List of Recognized Standards, Recognition List Number: 054” (Recognition List Number: 054), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Submit either electronic or written comments on the notice at any time. These modifications to the list of recognized standards are applicable March 3, 2021.
You may submit comments on the current list of FDA Recognized Consensus Standards at any time as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
An electronic copy of Recognition List Number: 054 is available on the internet at
Scott Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5606, Silver Spring, MD 20993, 301-796-6287,
Section 204 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions or other requirements.
In the
These notices describe the addition, withdrawal, and revision of certain standards recognized by FDA. The Agency maintains on its website hypertext markup language (HTML) and portable document format (PDF) versions of the list of FDA Recognized Consensus Standards, available at
FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the Agency is recognizing for use in premarket submissions and other requirements for devices. FDA is incorporating these modifications to the list of FDA Recognized Consensus Standards in the Agency's searchable database. FDA is using the term “Recognition List Number: 054” to identify the current modifications.
In table 1, FDA describes the following modifications: (1) The withdrawal of standards and their replacement by others, if applicable; (2) the correction of errors made by FDA in listing previously recognized standards; and (3) the changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of the standards.
In section III, FDA lists modifications the Agency is making that involve new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 054.
In Table 2, FDA provides the listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 054. These entries are of standards not previously recognized by FDA.
FDA maintains the current list of FDA Recognized Consensus Standards in a searchable database that may be accessed at
Any person may recommend consensus standards as candidates for recognition under section 514 of the FD&C Act by submitting such recommendations, with reasons for the recommendation, to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Lawrence B. Ryan from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Ryan was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. Mr. Ryan was given notice of the proposed permanent debarment and an opportunity to request a hearing to show why he should not be debarred. As of October 18, 2020 (30 days after receipt of the notice), Mr. Ryan had not responded. Mr. Ryan's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this action.
This order is applicable March 3, 2021.
Submit applications for termination of debarment to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers
Jaime Espinosa, (ELEM-4029) Division of Enforcement, 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
Section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B)) requires debarment of an individual from providing services in any capacity to a person that has an approved or pending drug product application if FDA finds that the individual has been convicted of a felony under Federal law for conduct relating to the regulation of any drug product under the FD&C Act. On June 18, 2020, Mr. Ryan was convicted as defined in section 306(l)(1) of the FD&C Act when judgment was entered against him in the U.S. District Court for the Eastern District of Virginia, Norfolk Division, after his plea of guilty to one count of conspiracy to defraud the United States in violation of 18 U.S.C. 371.
The factual basis for this conviction is as follows: As contained in the Statement of Facts in Mr. Ryan's case, filed on January 8, 2020, from October 2007, and continuing through September 2010, Mr. Ryan, a physician, authorized drug orders for RX Limited (also known as RX Partners), an internet pharmacy organization that facilitated the unlawful distribution of prescription drugs to consumers throughout the United States. RX Limited had a business model whereby it allowed consumers to fill out a brief medical questionnaire, select the type of drugs the consumer desired, the desired drug strength, and the desired drug quantity and pay by credit card. RX Limited then forwarded the order to a participating physician for “approval.” The drugs sold by RX Limited were dispensed without a valid prescription because there was no valid doctor-patient relationship established between the authorizing physicians and the customers. Customers had no face-to-face contact with the participating physician and were not subject to any mental or physical examinations.
The physicians authorizing the orders for prescription drugs sold by RX Limited did not take patient histories or perform any diagnostic or laboratory testing, did not check the accuracy of the information customers provided (including their identities, ages, and qualifying medical conditions), and did not monitor, or provide any means to monitor, medication response. After the participating physician authorized the prescription, RX Limited sent the order to a fulfillment pharmacy, which fulfilled the order and mailed the drugs to the customer.
As a participating physician, Mr. Ryan authorized more than 158,000 drug orders for well over 10 individual RX Limited customers. Prescription drugs distributed pursuant to these orders included, FIORICET (and its generic equivalents), Carisoprodol (SOMA), Tramadol (ULTRAM), VIAGRA, CIALIS, and XENICAL. RX Limited paid Mr. Ryan $2.00 per drug order he authorized. From October 2007 through September 2010, RX Limited paid Mr. Ryan at least $316,153 for the orders he authorized.
As a result of this conviction, FDA sent Mr. Ryan by certified mail on September 11, 2020, a notice proposing to permanently debar him from providing services in any capacity to a person that has an approved or pending drug product application. The proposal was based on a finding, under section 306(a)(2)(B) of the FD&C Act, that Mr. Ryan was convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. The proposal also offered Mr. Ryan an opportunity to request a hearing, providing him 30 days from the date of receipt of the letter in which to file the request, and advised him that failure to request a hearing constituted an election not to use the opportunity for a hearing and a waiver of any contentions concerning this action. Mr. Ryan received the proposal on September 18, 2020. Mr. Ryan did not request a hearing within the timeframe prescribed by regulation and has, therefore, waived his opportunity for a hearing and any contentions concerning his debarment (21 CFR part 12).
Therefore, the Assistant Commissioner, Office of Human and Animal Food Operations, under section 306(a)(2)(B) of the FD&C Act, under authority delegated to the Assistant Commissioner, finds that Mr. Ryan, has been convicted of a felony under Federal law for conduct otherwise relating to the regulation of a drug product under the FD&C Act.
As a result of the foregoing finding, Mr. Ryan, is permanently debarred from providing services in any capacity to a person with an approved or pending drug product application, effective (see
Any application by Mr. Ryan for special termination of debarment under section 306(d)(4) of the FD&C Act should be identified with Docket No. FDA-2020-N-1638 and sent to the Dockets Management Staff (see
Publicly available submissions will be placed in the docket and will be viewable at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) announces a
The meeting will take place virtually on April 6, 2021, from 9 a.m. Eastern Time to 6 p.m. Eastern Time.
Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at:
Aden Asefa, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5214, Silver Spring, MD 20993-0002,
OCS Heart is indicated for donor hearts with one or more of the following characteristics:
• Expected total cross-clamp time of ≥2 hours PLUS one of the following risk factors:
• Donor Age ≥55 years; or
• Donors with history of cardiac arrest and downtime ≥20 minutes; or
• Donor history of alcoholism; or
• Donor history of diabetes; or
• Donor Left Ventricular Ejection Fraction ≤50 percent but ≥40 percent; or
• Donor history of Left Ventricular Hypertrophy (septal or posterior wall thickness of >12 and ≤16 mm); or
• Donor angiogram with luminal irregularities but no significant coronary artery disease.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on FDA's website at the time of the advisory committee meeting, and the background material will be posted on FDA's website after the meeting. Background material and the link to the online teleconference meeting room will be available at
For press inquiries, please contact the Office of Media Affairs at
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Artair Mallet at
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is announcing that a proposed collection
Submit written comments (including recommendations) on the collection of information by April 2, 2021.
To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to
Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
FDA is seeking to conduct qualitative and quantitative research studies to better understand consumers', patients', caregivers', academic/scientific experts', and public health professionals' perceptions and behaviors regarding various issues and outcomes associated with disease prevention, treatment, and the safety and efficacy of all FDA-regulated products. These studies may consist of small groups, focus groups/town halls, individual indepth interviews, and surveys relating to the evaluation of disease prevention and treatment and the safety, efficacy, and usage of FDA-regulated products; the studies may also include communication messages and strategies, and other materials directed to consumers, patients, caregivers, and public health professionals (
Among the general provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA is charged with promoting the public health through regulatory oversight as well as clinical research. Specifically, section 1003(d)(2)(C) and (D) of the FD&C Act (21 U.S.C. 393(d)(2)(C) and (D)) provides that the Commissioner of Food and Drugs shall be responsible for research. Accordingly, FDA is seeking to conduct qualitative and quantitative research studies.
The information collection is intended to support research conducted by, or on behalf of, FDA. Understanding consumers', patients', caregivers', academic/scientific experts', and public health professionals' perceptions and behaviors plays an important role in improving FDA's decision-making processes and communications impacting various stakeholders. To better understand consumers', patients', caregivers', academic/scientific experts', and public health professionals' perceptions and behaviors regarding various issues and outcomes associated with disease prevention, treatment, and the safety, efficacy, and usage of products overseen by the Agency, FDA is requesting approval of this generic information collection request.
The qualitative and quantitative research anticipated by FDA aligns with Agency objectives. For example, among eight scientific priorities is the goal to support social and behavioral sciences. Such research helps the Agency meet this goal by:
• Identifying gaps in the target audiences' knowledge regarding FDA-regulated products, and outcomes associated the disease prevention and treatment;
• reaching diverse audiences;
• assessing target audiences' knowledge, perceptions, and behaviors about FDA-regulated products;
• evaluating the effectiveness of FDA's communications;
• exploring ways to incorporate patient input into decision making;
• leveraging real-world data;
• evaluating outcomes; and
• integrating the knowledge gained from the research into Agency communications, activities, interventions, and programs.
FDA will only submit a collection for approval under this generic clearance if it meets the following condition: Information provided by respondents will be kept private and anonymous, except as otherwise required by law. This will be communicated to respondents by means of introductory letters, explanatory texts on the cover pages of questionnaires, scripts read prior to focus groups or telephone interviews, and consent forms as appropriate. Respondents also will be advised of the following: (1) The nature of the activity; (2) the intended purpose and use of the data collected; (3) FDA sponsorship (when appropriate); and (4) the fact that participation is voluntary at all times. Because responses are voluntary, respondents will be assured that there will be no penalties if they decide not to respond, either to the information collection as a whole or to any individual questions.
Only Agency or Agency-sponsored personnel will have access to individual-level surveys, interviews, or focus group data. All project staff from a contractor or cooperative agreement grantee conducting the information collection must take required measures to ensure respondent privacy and confidentiality of data. Personally identifiable information (PII) shall be limited to data that may be required in the process of respondent enrollment. PII will be accessible to only those contractors or cooperative agreement grantees who need it and will not be linked to interview data. Neither FDA employees nor any Federal employee of any other Agency will have access to PII. All PII will be destroyed by contractors as soon as feasible following data collected during interviews.
All electronic and hard-copy data will be maintained securely throughout the information collection and data processing phases. While under review, electronic data will be stored in locked files on secured computers; hard-copy data will be maintained in secure building facilities in locked filing cabinets. As a further guarantee of privacy and anonymity, all data will be reported to FDA in aggregate form, with no links to individuals preserved. Reports generated by this information collection will be used only for research purposes and for the development of communication messages.
Social and behavioral testing efforts described in this proposal are typically considered exempt from the “Regulations for the Protection of Human Subjects” in accordance with 45 CFR 46.101(b)(3). Before data are collected, FDA researchers must obtain either an exemption or an expedited or full approval for all research from FDA's institutional review board (IRB).
When FDA's IRB determines that minors are capable of giving assent, the
FDA plans to use the data collected under the generic clearance to inform the following information for education, interventions, outcomes, regulatory science programs, materials and resources, and disease prevention and treatment. FDA expects the data to guide the formulation of the Agency's educational and public health objectives on FDA-regulated products and support development of subsequent research efforts. The data will not be used to make policy or regulatory decisions. Rather, these data will: (1) Inform FDA's public education campaigns and other educational/interventional materials directed to informing consumers, patients, caregivers, and public health professionals about human and animal health issues; and (2) provide information on the safety, efficacy, and usage of FDA-regulated products.
If these conditions are not met, FDA will submit an information collection request to OMB for approval through the normal PRA process.
To obtain approval for a collection that meets the conditions of this generic clearance, an abbreviated supporting statement will be submitted to OMB, along with supporting documentation (
FDA will submit individual qualitative and quantitative collections under this generic clearance to the OMB. Individual collections will also undergo review by FDA's IRB, senior leadership for the primary investigator's respective offices, and PRA specialists.
In the
FDA estimates the burden of this collection of information as follows:
This is a new collection of information whose total estimated annual reporting burden is 9,198 hours. The number of participants to be included in each individual generic submission under this collection of information will vary, depending on the nature of the compliance efforts and the target audience.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Board of Scientific Counselors, NIAMS.
The meeting will be closed to the public as indicated below in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Notice is hereby given of a change in the meeting of the National Institute on Deafness and Other Communication Disorders Special Emphasis Panel, which was published in the
This meeting is being amended to change the SRO to Eliane Lazar-Wesley. The meeting is closed to the public.
U.S. Customs and Border Protection, Department of Homeland Security.
Notice of final determination.
This document provides notice that U.S. Customs and Border Protection (CBP) has issued a final determination concerning the country of origin of a transceiver, identified as the Barrett 4050 HF SDR Transceiver. Based upon the facts presented, CBP has concluded in the final determination that the transceiver, which is assembled in the United States of various imported components, including three Australian-origin printed circuit board assemblies, is not a product of a foreign country or instrumentality designated for purposes of U.S. Government procurement.
The final determination was issued on February 25, 2021. A copy of the final determination is attached. Any party-at-interest, as defined in 19 CFR 177.22(d), may seek judicial review of this final determination within April 2, 2021.
Cynthia Reese, Valuation and Special Programs Branch, Regulations and Rulings, Office of Trade (202-325-0046).
Notice is hereby given that on February 25, 2021, CBP issued a final determination concerning the country of origin of the Barrett 4050 HF SDR Transceiver for purposes of Title III of the Trade Agreements Act of 1979. This final determination, HQ H314982, was issued at the request of Barrett Communications USA Corporation, under procedures set forth at 19 CFR part 177, subpart B, which implements Title III of the Trade Agreements Act of 1979, as amended (19 U.S.C. 2511-18). In the final determination, CBP has concluded that, based upon the facts presented, as a result of the assembly of various imported components, including three Australian-origin
Section 177.29, CBP Regulations (19 CFR 177.29), provides that notice of final determinations shall be published in the
This is in response to your request of October 22, 2020, on behalf of your client, Barrett Communications USA Corporation, for a final determination concerning the country of origin of a device referred to as a Barrett 4050 HF SDR Transceiver pursuant to Title III of the Trade Agreements Act of 1979 (TAA), as amended (19 U.S.C. 2511
The item at issue, the Barrett 4050 HF SDR Transceiver (hereinafter, “transceiver”), is a software-defined based, single-sideband (“SSB”) transceiver with a frequency range of 1.6 to 30 MHz (transmit) and 250 kHz to 30 MHz (receive). You describe the transceiver as “a commercial product that supports features such as Selective Call (Selcall), direct dial telephone connection to base stations fitted with telephone interconnect systems (Telcall), GPS location, 2G and 3G ALE (Automatic Link Establishment), frequency hopping, digital voice, data transmission and remote diagnostics.” You indicate that the transceiver provides “a comprehensive data modem interface port, high speed transmit-to-receive switching, a high stability frequency standard and an efficient cooling system option.”
You indicate that the transceiver's control head “features a GUI [graphical user interface] on a high definition 24-bit LCD color touchscreen.” You state that “[t]he [c]ontrol [h]ead can be detached from the main body of the [t]ransceiver for remote control. The [t]ransceiver can also be controlled remotely from most mobile and desktop platforms, including iOS, Android, and Windows devices.”
You specify that there are three main assemblies for each transceiver—(1) the control head assembly; (2) the power amplifier (PA) assembly and chassis; and, (3) the microprocessor board and interface board assembly and chassis. Within these three main assemblies are five printed circuit board assemblies (PCBAs). The five PCBAs and the countries in which each PCBA is produced are as follows: the control head board (United States); the interface board (United States); the micro board (Australia); the PA board (Australia); and the volume control board (Australia). You indicate that prior to export to the United States, the only software installed on the boards produced in Australia is for the limited purpose of testing and diagnostics. The Australian produced boards are non-functional at the time of importation into the United States.
In addition to the PCBAs described above, “each transceiver includes, a radio chassis, a speaker, an LCD screen, looms, various molded plastic parts including dials and buttons, and various seals and fasteners.”
The transceiver is assembled in the United States from imported and domestically produced components. You state the transceiver is assembled as a “clamshell.” You state:
The Micro and Interface Boards are mounted on one half of the “clamshell;” the PA Board is on the other half of the “clamshell.” When the “clamshell” is assembled there are cables between the two (2) halves to allow signaling and RF to pass between them. An HD15 pin connector interface on one half of the “clamshell” provides signaling to the Control Head. The Control Head has a color, touch screen display, volume knob, and buttons.
The Control Head Board is mounted to the chassis of the Control Head, using screws and a loom. The loom takes the signaling from the screen and buttons to the Control Head Board, while another loom takes the signaling from the Control Head Board out to the interfacing HD connector. The Volume Control Board fits directly to the Control Head Board, as a daughter board.
With regard to the functions of the boards, you state that the transceiver cannot function without the control head board. In addition, the interface board “allows the [t]ransceiver to connect to antennae and auxiliaries such as modems and audio devices.” Further, you indicate that the interface board enables the micro board to function. You state that the interface board allows the micro board “to interface with all external items.”
With regard to the control head, an integrated circuit (IC) and firmware programming process must be performed prior to assembly. After the IC is provided with its base programming, the control head is partially assembled and the control head board is loaded with base firmware programming. Once the programming is completed, the assembly of the control head (which entails cleaning and inspecting parts, installing the LCD screen and control head board, and assembling the remaining twenty-two control head components) is completed and the control head board is modified to function as part of the main assembly.
After the transceiver is fully assembled, base operating firmware and software, which will control and enable functionality, is installed on the interface board and micro board. This software is developed by a combination of efforts. Source code is written for the transceiver by software developers in Australia. Technicians in the United States convert the source code into executable object code, load it onto the interface board and micro board and test the downloaded object code. Software for optional features, which is obtained from a foreign third-party, may also be installed if required according to a customer's purchase order specifications. Personnel in the U.S. “install the software and firmware, which takes approximately forty-five (45) minutes, including programming the 2G ALE modem and the [t]ransceiver.”
After the transceivers are assembled and programmed, they are tested. The software and the transceiver operation are tested. The testing occurs at the U.S. facility where the transceivers are assembled and programmed. Testing may also occur at customer sites within and outside the United States. After assembling, programming and testing, the transceivers are packed and shipped to customers located in the United States and throughout the Americas.
Whether the transceivers at issue, which are assembled and programmed in the United States of domestic and foreign inputs, are eligible under Title III of the TAA, as amended (19 U.S.C. 2511-2518), as products of a foreign country or instrumentality designated pursuant to section 2511(b).
U.S. Customs and Border Protection (CBP) issues country of origin advisory rulings and final determinations as to whether an article is or would be a product of a designated country or instrumentality for the purpose of granting waivers of certain “Buy American” restrictions in U.S. law or practice for products offered for sale to the U.S. Government, pursuant to subpart B of Part 177, 19 CFR 177.21
The rule of origin set forth in 19 U.S.C. 2518(4)(B) states:
An article is a product of a country or instrumentality only if (i) it is wholly the growth, product, or manufacture of that country or instrumentality, or (ii) in the case of an article which consists in whole or in part of materials from another country or instrumentality, it has been substantially transformed into a new and different article of commerce with a name, character, or use distinct from that of the article or articles from which it was so transformed.
In rendering advisory rulings and final determinations for purposes of U.S.
The regulations define a “designated country end product” as:
WTO GPA [World Trade Organization Government Procurement Agreement] country end product, an FTA [Free Trade Agreement] country end product, a least developed country end product, or a Caribbean Basin country end product.
A “Free Trade Agreement country end product” means an article that—
(1) Is wholly the growth, product, or manufacture of a Free Trade Agreement (FTA) country; or
(2) In the case of an article that consists in whole or in part of materials from another country, has been substantially transformed in an FTA country into a new and different article of commerce with a name, character, or use distinct from that of the article or articles from which it was transformed. The term refers to a product offered for purchase under a supply contract, but for purposes of calculating the value of the end product, includes services (except transportation services) incidental to the article, provided that the value of those incidental services does not exceed that of the article itself.
CBP's authority to issue advisory rulings and final determinations is set forth in 19 U.S.C. 2515(b)(1), which states:
For the purposes of this subchapter, the Secretary of the Treasury shall provide for the prompt issuance of advisory rulings and final determinations on whether, under section 2518(4)(B) of this title,
In this case, the transceiver contains five separate PCBAs. We are told that three of these are produced by the assembly of the various components onto the PCB in Australia, and two are similarly produced in the United States. CBP has consistently held that the assembly of various components onto a blank printed circuit board to produce a PCBA is a substantial transformation.
We note the production includes the assembly in the United States of the dominant PBCAs related to the transceiver's function, along with the assembly of all the remaining components of the transceiver to produce the finished good. While CBP does not recognize downloading of firmware or software to constitute a substantial transformation, we note that the conversion of the Australian software into executable code, which occurs in the United States, and programming of the transceiver boards is additional work to be considered in assessing the proper origin of the finished transceiver.
Noting that CBP is limited by the language of 19 U.S.C. 2515(b)(1) to a determination of whether a good is a product of a foreign country or instrumentality designated pursuant to section 2511(b) of this title, based upon the information presented, the transceiver is not a product of Australia or any other foreign country or instrumentality designated pursuant to section 2511(b) of Title 19. As to whether the transceiver which is assembled in the United States qualifies as a “U.S.-made end product,” we encourage you to review the recent court decision in
The transceiver at issue, the Barrett 4050 HF SDR Transceiver, is not a product of Australia or any other foreign country or instrumentality designated pursuant to section 2511(b) of Title 19.
You should consult with the relevant government procuring agency to determine whether the transceiver qualifies as a “U.S.-made end product” for purposes of the Federal Acquisition Regulations implementing the TAA.
Notice of this final determination will be given in the
Department of Homeland Security (DHS).
30-Day notice and request for comments; extension without change of a currently approved Collection, DHS-2021-0004.
The Department of Homeland Security, will submit the following Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. DHS previously published this information collection request (ICR) in the
The comment period for the information collection request published on January 15, 2021 at 86 FR 4107 is extended. Comments are encouraged and will be accepted until April 2, 2021. This process is conducted in accordance with 5 CFR 1320.1
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
COVID-19 Contact Tracing information is necessary to support the President's
DHS is authorized to collect the information pursuant to Section 319 of the Public Health Service (PHS) Act (42 U.S.C. 274d); DHS Chief Medical Officer's authorities pursuant to 6 U.S.C. 350 and 6 U.S.C. 597; 6 U.S.C. 464; 21 U.S.C. 360bbb-3; 40 U.S.C. 1315; 42 U.S.C. 97; American with Disabilities Act, including 42 U.S.C. 12112(d)(3), 29 CFR 1630.2(r), 1630.14(b), (c) Workforce safety federal requirements, including the Occupational Safety and Health Act of 1970, Executive Order 12196, 5 U.S.C. 7902; 29 U.S.C. Chapter 15 (
This is a new collection for the agency. The contract tracing process is triggered when an employee voluntarily self-reports to their supervisor that they are COVID-19 positive. The supervisor will provide the employee's name and contact information to a DHS Supervisory Contact Tracer. The Supervisory Contact tracer will assign a Contact Tracer to contact and interview the COVID-19 positive employee and obtain a list of employees the COVID-19 positive employee was in close contact with, as well as locations in the DHS worksite that the COVID-19 positive employee visited for 15 minutes or more. The Contact Tracer will call the exposed employees to inform them that were exposed by a DHS COVID-19 positive employee so they can take appropriate precautions in minimizing exposure to other DHS personnel and speak with their supervisor to discuss their work status. The contact tracer will not disclose the name or any other personally identifiable information regarding the COVID-19 positive employee to the exposed employees. The contact tracer will inform the exposed employee to notify their supervisor, contracting company (contractors only), medical provider, and local public health authorities to get instructions. The purpose of contact tracing is to control the spread of COVID-19 in the workforce.
The following information will be collected from the respondent:
The collection of information will be automated using Service Now, the existing DHS Information Technology Help desk ticketing platform. Service Now will be modified to be used as the COVID-19 reporting tool. The COVID-19 positive employee will voluntarily inform their supervisor that they are COVID-19 positive. The COVID-19 positive employee or their supervisor will create a new ticket in the COVID-19 reporting tool and include locations in the office that they were in for 15 minutes or more (to initiate facility cleaning) and names of employees they were in close contact with for 15 minutes or more (to identify exposed individuals to notify). The COVID-19 reporting tool will create a ticket and route this to the employee's supervisor and the supervisory contract tracer. The supervisory contact tracer will assign the case (ticket) to the contact tracer. The contact tracer will call the COVID-19 positive employee to verify information submitted by the employee. The Contact Tracer will call the exposed employees to inform them that were exposed to a DHS COVID-19 positive employee so they can take appropriate precautions in minimizing exposure to other DHS personnel and speak with their supervisor to discuss their work status as detailed in response #2.
The basis of the decision for adopting Service Now as a contact tracing reporting/collection tool are: Service now is an existing operating system with an approved Authority to Operate and is in accordance with DHS IT policies, procedures, and controls. Using information technology helps to streamline the process, adds uniformity, and reduces the burden on the contact tracer. The system includes an active directory for all DHS personnel, and contains the data collection, routing, reporting, and tracking capability required to automate contact tracing reporting, case (ticket) assignment and disposition.
This information collection request will not impact small businesses or other small entities.
In response to the Coronavirus Pandemic, public health leaders are calling for communities around the country to ramp up capacity and implement a massive contact tracing effort to control spread of the Coronavirus. The response and recovery from the effect of COVID-19 will continue to present Federal agencies with unprecedented challenges, as well as opportunities for improvement, that require new processes and practices such as COVID-19 Contact Tracing to keep the workforce and the public safe. As DHS plans to reconstitute the workforce, it is essential to have an internal DHS Contact Tracing Program
As required by the COVID-19 Contact Tracing Script, the Contact Tracer is required to read the following statement at the beginning of the call with each respondent:
Pursuant to 5 U.S.C. 552a(e)(3), this Privacy Act Statement serves to inform you of why DHS is requesting the information that will be collected by this information system.
DHS is authorized to collect the information pursuant to Section 319 of the Public Health Service (PHS) Act (42 U.S.C. 274d); DHS Chief Medical Officer's authorities pursuant to 6 U.S.C. 350 and 6 U.S.C. 597; 6 U.S.C. 464; 21 U.S.C. 360bbb-3; 40 U.S.C. 1315; 42 U.S.C. 97; American with Disabilities Act, including 42 U.S.C. 12112(d)(3)(B), 29 CFR 602.14, 1630.2(r), 1630.14(b)(1), (c)(1), (d)(4); Medical Examinations for Fitness for Duty Requirements, including 5 CFR part 339; Genetic Information Nondiscrimination Act (GINA), including 42 U.S.C. Chapter 21f, 29 CFR part 1635; Workforce safety federal requirements, including the Occupational Safety and Health Act of 1970, Executive Order 12196, 5 U.S.C. 7902; 29 U.S.C. Chapter 15 (
DHS will be collecting the information for the purpose of maintaining and ensuring a healthy workforce and a safe DHS workspace. This information will help the Department to prevent the spread of infectious disease by notifying those individuals who may have been exposed so they can take appropriate precautions in minimizing exposure to other DHS personnel and DHS-affiliated personnel.
The information will not be shared externally or with any third parties. It will only be used by the DHS Component or Office who employs the individual about whom the information will be collected. Further, no personally identifiable information will be shared with anyone other than the individual's supervisor and the assigned contact tracer. A complete list of routine uses for the information this system will collect can be found in the system of records notice associated with the system “Office of Personnel Management/GOVT-10—Employee Medical File System Records.” The Department's full list of system of records notices can be found on the Department's website at
Providing information via this system is completely voluntary and no adverse action will be taken against individuals who refuse to participate. However, participation is requested because contact tracing is a key strategy in preventing further spread of infectious disease among the DHS workforce.
The Contact Tracer is required to sign a DHS non-Disclosure Agreement and take the following DHS Training—Privacy and Protecting Personal Information, IT Security Awareness and Rules of Behavior, Cybersecurity Awareness and one of the following Contact Tracer Trainings offered by the Michigan Department of Public Health Michigan Department of Public Health
The Supervisory Contact Tracer is required to review a minimum of 10% of interview calls with Contact Tracers to ensure comprehensive and high-quality interviews and compliance with privacy and confidentiality.
Explain the reasons for any program changes or adjustments reporting in Items 13 or 14 of the OMB Form 83-I.
The Office of Management and Budget is particularly interested in comments which:
1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to be collected; and
4. Minimize the burden of the collection of information on those who
Department of Homeland Security, (DHS)
30-Day notice and request for comments; extension without change of a currently approved collection, 1601-0024.
The Department of Homeland Security, will submit the following Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. DHS previously published this information collection request (ICR) in the
Comments are encouraged and will be accepted until April 2, 2021. This process is conducted in accordance with 5 CFR 1320.1.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
The Office of Management and Budget is particularly interested in comments which:
1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to be collected; and
4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Recipients of federal financial assistance from the Department of Homeland Security (DHS) are required to meet certain legal requirements relating to nondiscrimination and nondiscriminatory use of federal funds. Those requirements include ensuring that entities receiving Federal financial assistance from the Department of Homeland Security do not deny benefits or services, or otherwise discriminate on the basis of race, color, national origin, disability, age, sex, or religion, in accordance with the following authorities:
• Title VI of the Civil Rights Act of 1964 (Title VI) Public Law 88-352, 42 U.S.C. 2000d-1
• Section 504 of the Rehabilitation Act of 1973 (Section 504), Public Law 93-112, as amended by Public Law 93-516, 29 U.S.C. 794, which prohibits discrimination on the basis of disability by recipients of Federal financial assistance.
• Title IX of the Education Amendments of 1972 (Title IX), 20 U.S.C. 1681
• Age Discrimination Act of 1975, Public Law 94-135, 42 U.S.C. Section 6101
• U.S. Department of Homeland Security regulation 6 CFR part 19, which prohibits organizations that receive financial assistance from DHS for a social service program from discriminating against beneficiaries on the basis of religion or religious belief, a refusal to hold a religious belief, or a refusal to attend or participate in a religious practice.
The aforementioned civil rights authorities also prohibit retaliatory acts against individuals for participating or opposing discrimination in a complaint, investigation, or other proceeding related to prohibited discrimination.
DHS has an obligation to enforce nondiscrimination requirements to ensure that its federally assisted programs and activities are administered in a nondiscriminatory manner. In order to carry out its enforcement responsibilities, DHS must obtain a signed assurance of compliance and collect and review information from recipients to ascertain their compliance with applicable requirements. DHS implementing regulations and the Department of Justice (DOJ) regulation
DHS uses DHS Form 3095: DHS Civil Rights Evaluation Tool as the primary tool to implement this information collection. DHS is seeking an extension of the form for another three-year period. DHS is not proposing any changes to the information collected in the form but is proposing changes to Section 1 of the form on instructions to streamline the process for submitting the completed form.
DHS uses the form to collect civil rights related information from all recipients of federal financial assistance from the Department. Recipients are
Recipients are required to provide the information 30 days from acceptance of award. Recipient of multiple awards of DHS financial assistance only submit one completed form for their organization, not per award. Recipient are required to complete the form once every two years if they have an active award, not every time a grant is awarded. Entities whose award does not run a full two years are required to provide the information again if they receive a subsequent award more than two (2) years after the prior award. In responding to
The purpose of the information collection is to advise recipients of their civil rights obligations and collect pertinent civil rights information to ascertain if the recipient has in place adequate policies and procedures to achieve compliance, and to determine what, if any, further action may be needed (technical assistance, training, compliance review, etc.) to ensure the recipient is able to meet its civil rights requirements and will carry out its programs and activities in a nondiscriminatory manner.
Over the past three years, DHS has used the information collected via the DHS Civil Rights Evaluation Tool to identify gaps and deficiencies in recipient programs and directly help recipients address these gaps and deficiencies by providing technical assistance on developing or improving policies and procedures to prevent discrimination and ensure accessibility.
DHS requires recipients to submit their completed forms and supporting information electronically, via email, to the Department, in an effort to minimize administrative burden on the recipient and the Department. DHS anticipates that records or files that will be used to respond to the information collection are already maintained in electronic format by the recipient, so providing the information electronically further minimizes administrative burden. DHS allows recipients to scan and submit documents that are not already maintained electronically.
If the recipient is unable to submit their information electronically, alternative arrangements will be made to submit responses in hard copy.
DHS is pursuing further streamlining of the submission process through development of an online portal that would allow recipients to submit the data directly in a fully electronic form and eliminate the need for recipients to email the form and supporting documents as attachments.
The information collection will impact some small entities (
In accordance with the authorities identified in Question 1, the Department is required to obtain a signed assurance of compliance from recipients and to ensure that its federally assisted programs and activities are administered in a nondiscriminatory manner. If the information collection is not conducted or is conducted less frequently, the Department will not be able to fulfill its obligations to ascertain recipient compliance and enforce nondiscrimination in recipient programs. This could lead to the award of federal financial assistance to recipients that are not complying with federal civil rights law, and the perpetuation of discrimination in the provision of benefits and services to members of the public.
There are no confidentiality assurances associated with this collection. The only privacy-sensitive information the form collects are the names of Point of Contacts (POCs) from recipient organizations. Coverage for the collection of this information is provided under a Department Privacy Impact Assessment, DHS/ALL/PIA-006 General Contacts List.
DHS is seeking an extension of the form for another three-year period. DHS is not proposing any changes to the information collected in the form but is proposing changes to Section 1 of the form on instructions to streamline the process for submitting the completed form. The changes to Section 1 do not impact the burden analysis. The changes in costs in Item 14 reflect increased hourly rates for Federal staff as reported by Office of Personnel Management for 2020, as well as an increase in the number of staff participating in the review process. Despite these increases, because the number of recipients subject to the collection has decreased from the previous reporting period, the total costs reported in Item 13 and 14 have also decreased.
Transportation Security Administration, DHS.
30-day notice.
This notice announces that the Transportation Security Administration (TSA) has forwarded the Information Collection Request (ICR), Office of Management and Budget (OMB) control number 1652-0001, abstracted below to OMB for review and approval of an extension of the currently approved collection under the
Send your comments by April 2, 2021. A comment to OMB is most effective if OMB receives it within 30 days of publication.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Christina A. Walsh, TSA PRA Officer, Information Technology (IT), TSA-11, Transportation Security Administration, 6595 Springfield Center Drive, Springfield, VA 20598-6011; telephone (571) 227-2062; email
TSA published a
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
(1) Evaluate whether the proposed information requirement is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including using appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Bureau of Ocean Energy Management, Interior.
Notice to resume the preparation of a final environmental impact statement.
The Bureau of Ocean Energy Management (BOEM) is resuming the preparation of a final environmental impact statement (FEIS) for the Construction and Operations Plan (COP) submitted by Vineyard Wind LLC (Vineyard Wind) concerning the construction and operation of an 800-megawatt wind energy facility offshore Massachusetts (Vineyard Wind 1 Project or Project).
Preparation of the FEIS resumed after BOEM completed its independent review of information provided in Vineyard Wind's January 22, 2021, letter.
For further information, please contact: Michelle Morin, BOEM, Office of Renewable Energy Programs, 45600 Woodland Road, Sterling, Virginia 20166, (703) 787-1722 or
In December 2017, Vineyard Wind submitted a COP to BOEM for the Vineyard Wind 1 Project. On December 7, 2018, BOEM published a draft EIS for the proposed Project in accordance with the National Environmental Policy Act (NEPA), as amended (42 U.S.C. 4321
In response to Vineyard Wind's December 1, 2020, letter, BOEM published a
On January 22, 2021, Vineyard Wind notified BOEM via letter that it had completed its technical and logistical due diligence review and had concluded that inclusion of the Haliade-X turbines did not warrant any modifications to the COP. Vineyard Wind therefore informed BOEM that it was rescinding its temporary withdrawal and asked BOEM to resume its review of the COP. Because Vineyard Wind has indicated that its proposed COP is “a decision pending before BOEM,” BOEM is resuming its review of the COP under NEPA.
This notice was prepared under NEPA (42 U.S.C. 4321
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission (“Commission”) has determined to issue a limited exclusion order against defaulted respondent Ningbo Linhua Plastic Co., Ltd. (“Ningbo”), the last remaining respondent. The Commission has also determined to impose a bond equal to one hundred percent (100%) of the entered value of the infringing products imported during the period of Presidential review. The investigation is hereby terminated.
Amanda Fisherow, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-2737. Copies of non-confidential documents filed in connection with this investigation may be viewed on the Commission's electronic docket (EDIS) at
The Commission instituted this investigation on June 23, 2020, based on a complaint filed by Clearly Clean Products, LLC of South Windsor, Connecticut and Converter Manufacturing, LLC of Orwigsburg, Pennsylvania (“Complainants”). 85 FR 37689-90 (June 23, 2020). The complaint alleges a violation of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337 (“section 337”), by reason of infringement of certain claims of U.S. Patent Nos. 9,908,281 and 10,562,680. The notice of investigation named the following respondents: Eco Food Pak (USA), Inc. of Chino, California (“Eco”) and Ningbo Linhua Plastic Co., Ltd. of Fenghua, China (“Ningbo”). The Commission's Office of Unfair Import Investigations (“OUII”) also was named as a party.
Eco was terminated from the investigation on October 20, 2020, on the basis of a consent order and consent order stipulation. Comm'n Notice (Oct. 20, 2020).
Also on October 20, 2020, the Commission determined not to review an initial determination (“ID”) (Order No. 7) granting Complainants' unopposed motion to find respondent Ningbo in default. Order No. 7 (Oct. 6, 2020),
On November 3, 2020, Complainants and OUII filed responses to the Commission's request for briefing. Both parties also filed reply submissions on November 10, 2020. No other submissions were received.
Upon review of the record, and in the absence of any response from Ningbo or from other interested persons or government agencies, and having concluded that it would not be contrary to the public interest to do so, the Commission has determined to issue a limited exclusion order against Ningbo pursuant to Section 337(g)(1), 19 U.S.C. 1337(g)(1). However, the Commission declines to issue the requested cease and desist order against Ningbo because Complainants have not established that Ningbo maintains a commercially significant inventory in the U.S. or engages in significant commercial business operations in the United States, taking the allegations in the complaint as true, and as supported by the available circumstantial evidence.
Commissioner Karpel and Commissioner Schmidtlein would issue both an LEO and a CDO directed to defaulting respondent Ningbo pursuant to Section 337(g)(1) because all requirements of this provision are met. Ningbo was named in the complaint and was served with the complaint and notice of investigation.
The investigation is hereby terminated.
The Commission vote for this determination took place on February 25, 2021.
While temporary remote operating procedures are in place in response to COVID-19, the Office of the Secretary is not able to serve parties that have not retained counsel or otherwise provided a point of contact for electronic service. Accordingly, pursuant to Commission Rules 201.16(a) and 210.7(a)(1) (19 CFR 201.16(a), 210.7(a)(1)), the Commission orders that the Complainants complete service for any party/parties without a method of electronic service noted on the attached Certificate of Service and shall file proof of service on the Electronic Document Information System (EDIS).
The authority for the Commission's determination is contained in Section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in Part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
U.S. Marshals Service, Department of Justice.
60-Day notice.
The Department of Justice (DOJ), U.S. Marshals Service (USMS), will submit the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
Comments are encouraged and will be accepted for 60 days until May 3, 2021.
If you have additional comments, particularly with respect to the estimated public burden or associated response time, have suggestions, need a copy of the proposed information collection instrument with instructions, or desire any additional information, please contact Nicole Timmons either by mail at CG-3, 10th Floor, Washington, DC 20530-0001, by email at
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
1.
2.
3.
4.
5.
6.
Executive Office for Immigration Review, Department of Justice.
60-Day notice.
The Department of Justice (DOJ), Executive Office for Immigration Review (EOIR), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
Comments are encouraged and will be accepted for 60 days until May 3, 2021.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Lauren Alder Reid, Assistant Director, Office of Policy, Executive Office for Immigration Review, 5107 Leesburg Pike, Suite 2500, Falls Church, VA 22041, telephone: (703) 305-0289.
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
Overview of this information collection:
1.
2.
3.
4.
Primary: A party who appeals a decision of a DHS Officer to the Board of Immigration Appeals (Board).
Other: None.
Abstract: A party affected by a decision of a DHS Officer may appeal that decision to the Board, provided that the Board has jurisdiction pursuant to 8 CFR 1003.1(b). The party must complete the Form EOIR-29 and submit it to the DHS office having administrative control over the record of proceeding in order to exercise its regulatory right to appeal.
5.
6.
If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, 3E.405B, Washington, DC 20530.
Federal Bureau of Investigation, Department of Justice.
30-Day notice.
The Department of Justice, Federal Bureau of Investigation, Criminal Justice Information Services Division, will be submitting the following information collection request to the Office of Management and Budget for review and approval in accordance with the Paperwork Reduction Act of 1995.
Comments are encouraged and will be accepted for 30 days until April 2, 2021.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
1.
2.
3.
5.
6.
National Archives and Records Administration (NARA).
Notice of availability of proposed records schedules; request for comments.
The National Archives and Records Administration (NARA) publishes notice of certain Federal agency requests for records disposition authority (records schedules). We publish notice in the
NARA must receive comments by April 19, 2021.
You may submit comments by either of the following methods. You must cite the control number, which appears on the records schedule in parentheses after the name of the agency that submitted the schedule.
•
•
Kimberly Keravuori, Regulatory and External Policy Program Manager, by email at
We are publishing notice of records schedules in which agencies propose to dispose of records they no longer need to conduct agency business. We invite public comments on these records schedules, as required by 44 U.S.C. 3303a(a), and list the schedules at the end of this notice by agency and subdivision requesting disposition authority.
In addition, this notice lists the organizational unit(s) accumulating the records or states that the schedule has agency-wide applicability. It also provides the control number assigned to each schedule, which you will need if you submit comments on that schedule.
We have uploaded the records schedules and accompanying appraisal memoranda to the
We will post comments, including any personal information and attachments, to the public docket unchanged. Because comments are public, you are responsible for ensuring that you do not include any confidential or other information that you or a third party may not wish to be publicly posted. If you want to submit a comment with confidential information or cannot otherwise use the
We will consider all comments submitted by the posted deadline and consult as needed with the Federal agency seeking the disposition authority. After considering comments, we will post on
We will post schedules on our website in the Records Control Schedule (RCS) Repository, at
Each year, Federal agencies create billions of records. To control this accumulation, agency records managers prepare schedules proposing retention periods for records and submit these schedules for NARA's approval. Once approved by NARA, records schedules provide mandatory instructions on what happens to records when no longer needed for current Government business. The records schedules authorize agencies to preserve records of continuing value in the National Archives or to destroy, after a specified period, records lacking continuing administrative, legal, research, or other value. Some schedules are comprehensive and cover all the records of an agency or one of its major subdivisions. Most schedules, however, cover records of only one office or program or a few series of records. Many of these update previously approved schedules, and some include records proposed as permanent.
Agencies may not destroy Federal records without the approval of the Archivist of the United States. The Archivist grants this approval only after thorough consideration of the records' administrative use by the agency of origin, the rights of the Government and of private people directly affected by the
1. Department of Homeland Security, Immigration and Customs Enforcement, Non-Evidentiary Video Audio Records (DAA-0567-2021-0001).
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
Cboe Exchange, Inc. (the “Exchange” or “Cboe Options”) proposes to amend an Exchange Rule relating to Inactive Nominees. The text of the proposed rule change is provided below.
(additions are
(e) A TPH organization may designate one or more inactive nominees. An “inactive nominee” of a TPH organization is an individual who is eligible to become an effective nominee of that organization with respect to any Floor Broker Trading Permit or Market-Maker Floor Trading Permit which the organization holds. The following requirements shall apply to inactive nominees:
(1) To become an inactive nominee of a TPH organization, an individual must be approved to be a Trading Permit Holder and become an effective nominee of the TPH organization, with authorized trading functions, within 90 days of the approval to be a Trading Permit Holder;
(2) an individual may be an inactive nominee of only one TPH organization;
(3) an inactive nominee shall have no rights or privileges of a Trading Permit Holder and shall have no right of access to the trading floor of the Exchange to trade as a Trading Permit Holder, unless and until the inactive nominee becomes an effective Trading Permit Holder pursuant to Rule 3.11
(4) if at any time an individual remains an inactive nominee for 9 consecutive months, the individual's eligibility to be a Trading Permit Holder will be terminated and the individual must reapply to be a Trading Permit Holder in order to again become eligible for inactive nominee status.]
The text of the proposed rule change is also available on the Exchange's website (
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend a certain requirement related to inactive nominees. Specifically, the Exchange proposes to amend Cboe Options Rule 3.9 (Responsible Persons and Nominees) with respect to inactive nominee status. By way of background, an inactive nominee is an individual who is eligible to become an effective nominee of that organization with respect to any Floor Broker Trading Permit or Market-Maker Floor Trading Permit which the organization holds.
The Exchange proposes to eliminate Rule 3.9(e)(4) which provides that if an individual remains an inactive nominee for 9 consecutive months, the individual's eligibility to be a TPH will be terminated and the individual must reapply to be a TPH in order to again become eligible for inactive nominee status. Particularly, the Exchange doesn't believe the 9-month inactive status deadline adds any meaningful value, but rather is an arbitrary administrative requirement that the Exchange believes is unnecessary and no longer wishes to (nor does it believe is required to) maintain. For example, if a TPH organization wishes to add a new inactive nominee, such organization can merely request that the Exchange make that individual “effective” in the System and then request that the nominee be switched to the inactive status in the system just moments later to restart the clock. The Exchange does not believe such a deadline is necessary and therefore does not wish to maintain it.
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange
In particular, the Exchange believes the proposed rule change will remove impediments to and perfect the mechanism of a free and open market and a national market system by eliminating an arbitrary and administrative process that the Exchange believes is outdated and an administrative burden to both TPHs and the Exchange. As noted above, the Exchange also does not believe such requirement adds meaningful value. The Exchange also does not believe it's required to maintain the requirement and notes that other exchanges similarly do not include such requirement. The Exchange notes that it is not substantively changing any rights or obligations of nominees of floor Trading Permits.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. Particularly, the Exchange does not believe that the proposed rule change will impose any burden on intramarket competition that is not necessary or appropriate in furtherance of the purposes of the Act because the proposed change applies to all TPHs. The proposed rule change also does not address competitive issues, but rather, amends a requirement relating to nominees, particularly inactive nominees, to eliminate a practice that the Exchange no longer believes is necessary. The Exchange does not believe that the proposed rule change will impose any burden on intermarket competition that is not necessary or appropriate in furtherance of the purposes of the Act because the proposed change only affects TPHs of Cboe Options.
The Exchange neither solicited nor received comments on the proposed rule change.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given, pursuant to the provisions of the Government in the Sunshine Act, Public Law 94-409, that the Securities and Exchange Commission Investor Advisory Committee will hold a public meeting on Thursday, March 11, 2021. The meeting will begin at 10:00 a.m. (ET) and will be open to the public.
The meeting will be conducted by remote means and/or at the Commission's headquarters, 100 F St. NE, Washington, DC 20549. Members of the public may watch the webcast of the meeting on the Commission's website at
This Sunshine Act notice is being issued because a majority of the Commission may attend the meeting. On February 17, 2021, the Commission published notice of the Committee meeting (Release Nos. 33-10927, 34-91150), indicating that the meeting is open to the public and inviting the public to submit written comments to the Committee.
MATTER TO BE CONSIDERED: The agenda for the meeting includes: Welcome remarks; approval of previous meeting minutes; a follow-on panel discussion regarding self-directed individual retirement accounts (IRAs); a panel discussion regarding special purpose acquisition companies (SPACs); a discussion of a recommendation regarding minority and underserved inclusion; a discussion of a recommendation regarding credit rating agencies; subcommittee reports; and a non-public administrative session.
For further information and to ascertain what, if any, matters have been added, deleted or postponed; please contact Vanessa A. Countryman from the Office of the Secretary at (202) 551-5400.
Securities and Exchange Commission.
Notice of meeting.
Notice is being provided that the Securities and Exchange Commission Asset Management Advisory Committee (“AMAC”) will hold a public meeting on March 19, 2021, by remote means. The meeting will begin at 9 a.m. (ET) and will be open to the public via webcast on the Commission's website at
The public meeting will be held on March 19, 2021. Written statements should be received on or before March 15, 2021.
The meeting will be held by remote means and webcast on
• Use the Commission's internet submission form (
• Send an email message to
• Send paper statements to Vanessa Countryman, Federal Advisory Committee Management Officer, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
Statements also will be available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Room 1580, Washington, DC 20549, on official business days between the hours of 10 a.m. and 3 p.m. For up-to-date information on the availability of the Public Reference Room, please refer to
All statements received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from submissions. You should submit only information that you wish to make available publicly.
Christian Broadbent, Senior Special Counsel, or Jay Williamson, Branch Chief, at (202) 551-6720, Division of Investment Management, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-3628.
In accordance with Section 10(a) of the Federal Advisory Committee Act, 5 U.S.C.-App. 1, and the regulations thereunder, Sarah ten Siethoff, Designated Federal Officer of the Committee, has ordered publication of this notice.
Pursuant to Section 19(b)(1)
The Exchange proposes to update certain representations regarding the Alger 25 ETF (the “Fund”). The Securities and Exchange Commission (“Commission”) has approved listing and trading of shares of the Fund on the Exchange under NYSE Arca Rule 8.900-E (Managed Portfolio Shares).
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Commission has approved a proposed rule change relating to listing and trading on the Exchange of shares (“Shares”) of the Fund under NYSE Arca Rule 8.900-E,
The Exchange proposes to update two representations made in the Prior Filing and the Prior Order relating to the Fund. The Exchange proposes to (1) update the name of the Fund to the Alger 35 ETF and (2) update the number of holdings that the Fund will generally own to approximately 35, rather than approximately 25 as represented in the Prior Filing. The Prior Filing represented that the Fund's primary objective is to seek long-term capital appreciation and that the Fund will primarily invest in equity securities of growth companies of any market capitalization listed on U.S. exchanges, including common or preferred stocks, and these representations are unchanged with respect to the Alger 35 ETF. The Alger 35 ETF will differ from the Fund only in that it will generally own approximately 35 holdings, instead of approximately 25 holdings.
The basis under the Act for this proposed rule change is the requirement under Section 6(b)(5)
This proposed rule change merely updates the name of the Fund and the approximate number of holdings that the Fund will own, in accordance with the Registration Statement. Other than this proposed change, all statements in the Prior Filing remain unchanged, including that the Alger 35 ETF will have the same investment objectives as the Fund and will invest in the same types of securities as the Fund. Accordingly, the Exchange believes that this proposed rule change raises no novel regulatory issues.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purpose of the Act. The proposed change does not introduce a new product, but rather proposes to update representations regarding the Fund that would not impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act.
No written comments were solicited or received with respect to the proposed rule change.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to: Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On December 31, 2020, the Nasdaq Stock Market LLC filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
Section 19(b)(2) of the Act
The Commission finds that it is appropriate to designate a longer period within which to take action on the proposed rule change so that it has sufficient time to consider the proposed rule change. Accordingly, pursuant to Section 19(b)(2) of the Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”) ,
The Exchange proposes to amend Rule 4754 to introduce price protections for the Limit-Up Limit-Down (“LULD”) Closing Cross
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The purpose of the proposed rule change is to amend Rule 4754 to introduce price protections for the LULD Closing Cross that are similar to the protections currently employed by the standard Nasdaq Closing Cross, and to make other changes related to the LULD Closing Cross. With the proposed changes, the Exchange's LULD and standard Closing Cross processes will be more harmonized, which the Exchange believes will promote a more consistent experience for members and investors participating in the close and reduce any potential confusion regarding Nasdaq's closing processes.
The Nasdaq Closing Cross is a transparent auction process that determines a single price for the close. The price determined by the Closing Cross is also the Nasdaq Official Closing Price (“NOCP”) for securities that participate in the cross. Members can submit Limit on Close (“LOC”) Orders,
When the Closing Cross price is calculated as described in Rule 4754(b)(2), the Exchange applies a boundary within which the cross must execute to ensure that the closing price derived does not exceed a price reasonably tied to the prevailing market at the time. Specifically, the Exchange applies a threshold amount to a benchmark value that, when applied to an individual security, determines the threshold price range that a security may cross, outside of which the closing price of a security may not occur.
The threshold amounts and benchmarks are set by Nasdaq management in advance and communicated to market participants. Nasdaq may adjust the threshold amounts and benchmarks from time to time based on Nasdaq's experience with the Closing Cross. Nasdaq publishes this information publicly on its website, and sets the threshold amount so that repricing of a security is rare.
Today, in addition to the standard Nasdaq Closing Cross described above, the Exchange operates a LULD Closing Cross that provides an alternative process for executing closing trades on Nasdaq. The Exchange conducts this process (instead of the standard Closing Cross) for Nasdaq-listed securities when a Trading Pause pursuant to Rule 4120(a)(12) exists at or after 3:50 p.m.
The Exchange now proposes to introduce price protections to the LULD Closing Cross that will be similar to the protections used today for the standard Closing Cross, and will ensure that the LULD Closing Cross price is reasonably related to current market conditions.
The proposed price thresholds will be calculated by applying a threshold amount set by Nasdaq management in advance and communicated to market participants (“LULD Price Thresholds”). The LULD Price Thresholds, like the thresholds presently used for the standard Closing Cross, will be published on Nasdaq's public website. The LULD Price Thresholds will be applied to a benchmark associated with the LULD Band that triggered the Trading Pause to calculate the benchmark price range within which the LULD Closing Cross price must fall (“Benchmark Prices”). The Benchmark Prices will be published via the SIP and Exchange proprietary data feeds. Nasdaq will initially set the LULD Price Thresholds at the greater of $1.00 or 10% for securities with a reference price greater than $1.00 (or $0.50 for securities with a benchmark equal to or less than $1.00), which will be applied to the last disseminated LULD Auction Collar, or the LULD Band that triggered the Trading Pause in the direction of the trading that invoked the Trading Pause.
To effect these changes, the Exchange proposes in new paragraph (E) of Rule 4754(b)(6)
(i) Upper (or lower) Auction Collar that was last updated for any security that enters a Trading Pause that was extended prior to 3:50 p.m. ET, rounded to the nearest minimum price increment;
(ii) Upper Auction Collar for a Limit Up triggered pause (or lower Auction Collar for a Limit Down triggered pause) for any security that entered a Trading Pause that was not extended prior to 3:50 p.m. ET, rounded to the nearest minimum price increment; or
(ii) [sic] Upper Band for a Limit Up triggered pause (or Lower Band for a Limit Down triggered pause) for any security that entered a Trading Pause at or after 3:50 p.m. ET, rounded to the nearest minimum price increment.
Nasdaq management shall set and modify such thresholds from time to time upon prior notice to market participants.
As applied, for securities that entered a Trading Pause prior to 3:50 p.m. ET and for which the Trading Pause was subsequently extended, the Exchange will calculate the lower and upper Benchmark Prices as follows:
• If the lower Auction Collar was the collar that was last widened for the security subject to the Trading Pause, the lower Benchmark Price will be calculated by subtracting 10% of the last updated lower Auction Collar price (or $1.00 (or $0.50 if the lower Auction Collar price is equal to or below $1.00), whichever is greater) from the last updated lower Auction Collar price (rounded to the nearest minimum price increment). The upper Benchmark Price will be equal to the last updated upper Auction Collar price that was updated with the lower Auction Collar price used to calculate the lower Benchmark Price.
• If the upper Auction Collar was the collar that was last widened for the security subject to the Trading Pause, the upper Benchmark Price will be calculated by adding 10% of the last updated upper Auction Collar price (or $1.00 (or $0.50 if the upper Auction Collar price is equal to or below $1.00), whichever is greater) to the last updated upper Auction Collar price (rounded to the nearest minimum price increment). The lower Benchmark Price will be equal to the last updated lower Auction Collar price that was updated with the upper Auction Collar price used to calculate the upper Benchmark Price.
For securities that entered a Trading Pause that was not extended prior to 3:50 p.m. ET,
• For a Limit Down triggered pause, the lower Benchmark Price will be calculated by subtracting 10% of the lower Auction Collar price (or $1.00 (or $0.50 if the lower Auction Collar price is equal to or below $1.00), whichever is greater) from the lower Auction Collar price (rounded to the nearest minimum price increment). The upper Benchmark Price will be equal to the upper Auction Collar price that was disseminated with the lower Auction Collar price used to calculate the lower Benchmark Price.
• For a Limit Up triggered pause, the upper Benchmark Price will be calculated by adding 10% of the upper Auction Collar price (or $1.00 (or $0.50 if the upper Auction Collar price is equal to or below $1.00), whichever is greater) to the upper Auction Collar price (rounded to the nearest minimum price increment). The lower Benchmark Price will be equal to the lower Auction Collar price that was disseminated with the upper Auction Collar price used to calculate the upper Benchmark Price.
For securities that entered a Trading Pause at or after 3:50 p.m. ET, the Exchange will calculate the lower and upper Benchmark Prices as follows:
• For a Limit Down triggered pause, the lower Benchmark Price will be calculated by subtracting 10% of the Lower LULD Band (or $1.00 (or $0.50 if the Lower LULD Band is equal to or below $1.00), whichever is greater) from the Lower LULD Band (rounded to the nearest minimum price increment). The upper Benchmark Price will be equal to Upper LULD Band in place at the time the Trading Pause was triggered.
• For a Limit Up triggered pause, the upper Benchmark Price will be calculated by adding 10% of the Upper LULD Band (or $1.00 (or $0.50 if the Upper LULD Band is equal to or below $1.00), whichever is greater) to the Upper LULD Band (rounded to the nearest minimum price increment). The lower Benchmark Price will be equal to Lower LULD Band in place at the time the Trading Pause was triggered.
At 4:00 p.m. ET, Nasdaq will conduct the LULD Closing Cross, and if the cross price would fall outside of the Benchmark Prices as calculated above, the LULD Closing Cross will execute all
The following illustrate how the proposed Benchmark Prices will be calculated:
In connection with the changes proposed above to introduce price protections for the LULD Closing Cross, the Exchange proposes to amend the methodology for determining the LULD cross price. Specifically, the Exchange proposes the following in new paragraph (D) of Rule 4754(b)(6):
(D)(i) The LULD Closing Cross will occur at the price within the benchmark prices established pursuant to paragraph (E) below (“Benchmark Prices”) that maximizes the number of shares of Eligible Interest in the Nasdaq Market Center to be executed.
(ii) If more than one price exists under subparagraph (i), the LULD Closing Cross shall occur at the price within the Benchmark Prices that minimizes any Imbalance.
(iii) If more than one price exists under subparagraph (ii), the LULD Closing Cross shall occur at the entered price within the Benchmark Prices at which shares will remain unexecuted in the cross.
(iv) If there is no price within the Benchmark Prices that satisfies the above conditions, then the LULD Closing Cross shall occur at:
(a) If an Imbalance exists, a price equal to the upper (lower) Benchmark Price for a buy (sell) Imbalance; or
(b) if no Imbalance exists, a price that minimizes the distance from the last published Upper Band (Lower Band) for a Limit Up (Limit Down) Trading Pause.
Today, the LULD Closing Cross price is determined by the same execution algorithm as currently used by the standard Closing Cross.
The first tiebreaker in new paragraph (D)(i) will be substantially similar to the existing tiebreaker in Rule 4754(b)(2)(A),
The second tiebreaker in new paragraph (D)(ii) will be based on the same principle as the existing tiebreaker in Rule 4754(b)(2)(B) (
The third tiebreaker in new paragraph (D)(iii) will be substantially similar to the existing tiebreaker in Rule 4754(b)(2)(C),
The fourth and final tiebreaker in new paragraph (D)(iv) will be used if there is no price within the proposed Benchmark Prices that satisfies the conditions described above in (D)(i)-(iii), and speaks to two possible outcomes. The first outcome is reached when an Imbalance exists, in which case the LULD cross price would be the upper (lower) Benchmark Price for a buy (sell) Imbalance. The Exchange believes that this outcome is the appropriate result in the presence of an Imbalance as it best reflects current market forces while also making it clear to market participants that the imbalance exists. The second outcome is reached when there is no Imbalance, in which case the LULD Closing Cross would occur at a price that minimizes the distance from the last published Upper Band (Lower Band) for a Limit Up (Limit Down) Trading Pause. This tiebreaker is similar to the existing tiebreaker in Rule 4754(b)(2)(D)
The Exchange also proposes to amend the LULD Closing Cross Rule to remove all provisions relating to extending the cross past 4:00 p.m. ET as this language will no longer be necessary with the changes proposed herein. In particular, the Exchange proposes to delete Rule 4754(b)(6)(A)(iii) as this provision relates to how the Exchange would extend the time of the LULD Closing Cross. Further, the Exchange proposes to amend current Rule 4754(b)(6)(C)(iii) (renumbered to Rule 4754(b)(6)(D)(iii) [sic] under this proposal) to delete the last two sentences, which provide how certain new orders may be entered or modified after 4:00 p.m. ET.
The Exchange also proposes other aligning changes to the LULD Closing Cross that would more closely harmonize this process with the current standard Closing Cross. In Rule 4754(b)(6)(C)(iii) (renumbered to Rule 4754(b)(6)(D)(iii) [sic]), the Exchange proposes to remove the parenthetical that excludes MOC and LOC orders from being entered, modified, and cancelled in the LULD Closing Cross. The Exchange proposes to allow MOC and LOC orders to participate in the LULD Closing Cross in order to align with the regular Closing Cross where such orders may participate pursuant to Rules 4702(b)(11) and 4702(b)(12). The Exchange similarly proposes to allow IO orders to participate in the LULD Closing Cross in the same manner as in the regular Closing Cross (
The Exchange proposes to amend Rule 4754(b)(6)(B), which governs the Net Order Imbalance Indicator (“NOII”) message for the LULD Closing Cross and disseminates information about MOC, LOC, IO, and Close Eligible Interest and the price at which those orders would execute at the time of dissemination. The Rule currently provides that Nasdaq shall continue disseminating the NOII every second until After Hours Trading begins. The Exchange notes, however, that it recently updated its Closing Cross to allow for the dissemination of abbreviated NOII data (
The Rule also indicates that the NOII message displays the Near Price, Far Price, and Reference Prices, which all currently represent the price at which the LULD Closing Cross would execute should the cross conclude at that time. With the proposed changes to implement the new Benchmark Prices, the Near Price and Reference Price will both represent the price at which the LULD Closing Cross would execute, bounded by the Benchmark Prices, at
The Exchange proposes a corrective change in Rule 4754(b)(6)(A)(i), which currently contains language relating to Trading Pauses “triggered” at or after 3:50 and before 4:00 p.m. The Exchange previously amended paragraph (b)(6) of Rule 4754 in 2017 to provide that the cross is employed when a Trading Pause
Lastly, the Exchange proposes to update obsolete cross-cites to Rule 4751 within Rules 4756(c)(3)(B) and 4763(b). Rule 4751 was previously relocated as part of a prior rule filing, so the proposed changes will update the obsolete references to their current locations in the Rulebook.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange believes that its proposal will promote just and equitable principles of trade because it will implement price protections for the LULD Closing Cross that are similar to the protections used today for the standard Closing Cross. As explained above, the Exchange currently calculates and applies a price threshold range within which the standard Closing Cross must execute. The Exchange believes that this mechanism has been effective in facilitating a fair and orderly price discovery process at the close, and ensuring that the cross price derived does not exceed a price reasonably tied to the prevailing market at the time. The Exchange has therefore determined to apply similar protections for the LULD Closing Cross. The Exchange believes that its proposal will benefit members and investors by facilitating price discovery. Additionally, introducing price protections to the LULD Closing Cross in the manner discussed above will further harmonize the Exchange's LULD and standard Closing Cross processes, thereby promoting a more consistent experience for members and investors, and reducing any potential confusion regarding Nasdaq's closing processes. The Exchange believes that calculating price thresholds associated with the LULD band that triggered the Trading Pause as discussed above will ensure that the LULD Closing Cross executes at a reasonable level relative to the last disseminated LULD Auction Collar, or the LULD band itself, thereby mitigating price dislocations in the cross. The Exchange also believes that allowing members to enter, modify and cancel new MOC, LOC and IO orders pursuant to Rules 4702(b)(11), 4702(b)(12), and 4702(b)(13) in the LULD Closing Cross will keep these close order type functionality consistent with the standard close behavior, and will facilitate a more efficient closing auction by allowing additional interest to participate in the close.
The Exchange believes that the amended execution algorithm for the LULD Closing Cross is consistent with the Act because it is substantially similar to the execution logic that is used for the cross today, with certain intended differences. The proposed tiebreakers in new paragraphs (D)(i)-(iii) of Rule 4754(b)(6) are designed to preserve to the extent possible the current tiebreakers in paragraphs (B)(2)(A)-(C) of Rule 4754(b)(2) while accommodating the proposed Benchmark Prices. The proposed changes to add the definitions of Eligible Interest and Imbalance as used in the proposed first and second tiebreakers are consistent with the protection of investors and the public interest because these changes will more accurately describe how the LULD Closing Cross price will be determined pursuant to the tiebreakers in proposed Rule 4754(b)(6)(A) and (B). As it relates to the fourth tiebreaker proposed in new paragraph (D)(iv) of Rule 4754(b)(6), the Exchange believes that using the Benchmark Price in the presence of an Imbalance is appropriate and best reflects current market forces while also making it clear to market participants that the Imbalance exists. The Exchange also believes that using the price that minimizes the distance from the last published LULD Band more accurately reflects current market conditions as opposed to using the existing tiebreaker based on the System bid-ask midpoint as there is no continuous market just prior to the execution of the LULD Closing Cross.
With respect to not extending a LULD Closing Cross past 4:00 p.m. ET, the Exchange believes that the clarity that comes from requiring that the LULD Closing Cross occur at 4:00 p.m. ET will help reduce uncertainty for members participating in the cross. While the Exchange recognizes the reasons for extending the LULD Closing Cross may exist where there are unmatched market orders or dramatic price movements during the cross, the Exchange believes based on its experience with the cross that these concerns are outweighed by the importance of providing members and the investing public with a definitive market close and a NOCP at 4:00 p.m. ET. Taken together with the proposed price thresholds, the Exchange believes that the LULD Closing Cross process, as amended, will reduce unnecessary confusion by providing certainty that the LULD Closing Cross will occur at a specified time, and will occur at a price that is reasonably based on current market conditions.
The Exchange also believes that it is appropriate to amend Rule 4754(b)(6)(B) to specify the contents of the NOII message for LULD Closing Cross. The proposed changes will bring greater transparency around what information is disseminated for the LULD Closing Cross, and is therefore consistent with the public interest and the protection of investors.
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. Today, the standard Nasdaq Closing Cross provides a transparent auction process for executing member interest at the close. The proposed rule change is designed to further align the Exchange's LULD Closing Cross with the standard Closing Cross to promote a more consistent
No written comments were either solicited or received.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove the proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for the State of Oklahoma (FEMA-4587-DR), dated 02/24/2021.
Issued on 02/24/2021.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given that as a result of the President's major disaster declaration on 02/24/2021, applications for disaster loans may be filed at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 16882 7 and for economic injury is 16883 0.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of Louisiana (FEMA-4577-DR), dated 02/25/2021.
Issued on 02/25/2021.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given that as a result of the President's major disaster declaration on 02/25/2021, Private Non-Profit organizations that provide essential services of a governmental nature may file disaster loan applications at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 16884 8 and for economic injury is 16885 0.
U.S. Small Business Administration.
Amendment 2.
This is an amendment of the Presidential declaration of a major disaster for the State of Texas (FEMA-4586-DR), dated 02/19/2021.
Issued on 02/25/2021.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
The notice of the President's major disaster declaration for the State of TEXAS, dated 02/19/2021, is hereby amended to include the following areas as adversely affected by the disaster:
All other information in the original declaration remains unchanged.
Small Business Administration.
30-Day notice.
The Small Business Administration (SBA) is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act and OMB procedures, SBA is publishing this notice to allow all interested members of the public an additional 30 days to provide comments on the proposed collection of information.
Submit comments on or before April 2, 2021.
Written comments and recommendations for this information collection request should be sent within 30 days of publication of this notice to
You may obtain a copy of the information collection and supporting documents from the Agency Clearance Office at
Applicants for SBA-guaranteed leverage commitments must complete these forms as part of the application process. SBA uses the information to make informed and proper credit decisions and to establish the SBIC's eligibility for leverage and need for funds.
Comments may be submitted on (a) whether the collection of information is necessary for the agency to properly perform its functions; (b) whether the burden estimates are accurate; (c) whether there are ways to minimize the burden, including through the use of automated techniques or other forms of information technology; and (d) whether there are ways to enhance the quality, utility, and clarity of the information.
By virtue of the authority vested in me as Secretary of State by the laws of the United States, including 22 U.S.C. 2651a, I hereby delegate to the Assistant Secretary for Political-Military Affairs, to the extent authorized by law, the authority to concur on behalf of the Department on future requests from the Department of Defense to enter into public-private partnerships with foreign governments or foreign entities under 10 U.S.C. 1501a.
Exercise of this authority is subject to clearance by the relevant regional bureau(s) and the Office of the Legal Adviser. Any act, regulation, or procedure subject to, or affected by, this delegation shall be deemed to be such act, regulation, or procedure as amended from time to time.
The Secretary, Deputy Secretary, Deputy Secretary for Management and Resources, and the Under Secretary for Arms Control and International Security may exercise any function or authority delegated by this delegation.
This memorandum shall be published in the
The Surface Transportation Board has received a request from the East Central Wisconsin Regional Planning Commission (WB21-16—2/16/21) for permission to use select data from the Board's 2018-2019 masked Carload Waybill Sample. A copy of this request may be obtained from the Board's website under docket no. WB21-16.
The waybill sample contains confidential railroad and shipper data; therefore, if any parties object to these requests, they should file their objections with the Director of the Board's Office of Economics within 14 calendar days of the date of this notice. The rules for release of waybill data are codified at 49 CFR 1244.9.
Federal Aviation Administration (FAA), DOT.
Notice of Aviation Rulemaking Advisory Committee (ARAC) meeting.
This notice announces a meeting of the ARAC.
The meeting will be held on Thursday, March 18, 2021, from 1:00 p.m. to 4:00 p.m. Eastern Standard Time.
Requests to attend the meeting must be received by Monday, February 22, 2021.
Requests for accommodations to a disability must be received by Monday, March 1, 2021.
Requests to submit written materials to be reviewed during the meeting must be received no later than Monday, February 22, 2021.
The meeting will be held virtually. Members of the public who wish to observe the meeting must RSVP by emailing
Lakisha Pearson, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591, telephone (202) 267-4191; email
The ARAC was created under the Federal Advisory Committee Act (FACA), in accordance with Title 5 of the United States Code (5 U.S.C. App. 2) to provide advice and recommendations to the FAA concerning rulemaking activities, such as aircraft operations, airman and air agency certification, airworthiness standards and certification, airports, maintenance, noise, and training.
At the meeting, the agenda will cover the following topics:
Detailed agenda information will be posted on the FAA Committee website address listed in the
The meeting will be open to the public on a first-come, first-served basis, as space is limited. Please confirm your attendance with the person listed in the
For persons participating by telephone, please contact the person listed in the
The U.S. Department of Transportation is committed to providing equal access to this meeting for all participants. If you need alternative formats or services because of a disability, such as sign language, interpretation, or other ancillary aids, please contact the person listed in the
The FAA is not accepting oral presentations at this meeting due to time constraints. Any member of the public may present a written statement to the committee at any time. The public may present written statements to the Aviation Rulemaking Advisory Committee by providing a copy to the Designated Federal Officer via the email listed in the
Federal Highway Administration (FHWA), Department of Transportation (DOT).
Notice to rescind a notice of intent to prepare an environmental impact statement.
The FHWA is issuing this notice to advise the public that an environmental impact statement (EIS) will not be prepared for the Eastern Bypass Study, a proposed highway within Peoria, Tazewell and Woodford Counties in Illinois. The termini for the bypass were proposed to be Interstate 74, east of the city of East Peoria, and Illinois Route 6, north of the City of Peoria. The FHWA is rescinding its notice of intent (NOI) to prepare a Tier I EIS which was published in the
For FHWA: Arlene K. Kocher, Division Administrator, Federal Highway Administration, 3250 Executive Park Drive, Springfield, Illinois 62703; telephone: (217) 492-4600; email address:
The FHWA, in cooperation with the Illinois Department of Transportation (IDOT), issued an NOI to prepare a Tier I EIS for the proposed Eastern Bypass Study on May 8, 2014 (79 FR 26497). The project was being considered in order to improve vehicular mobility and access across the Illinois River between Tazewell and Woodford Counties. The FHWA is rescinding the NOI because IDOT has no plans to continue the project study and no further activities will occur in its development.
Comments or questions concerning this notice should be directed to FHWA or the IDOT contacts provided in the
42 U.S.C. 4321
Office of Foreign Assets Control, Treasury.
Notice.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.
See
OFAC: Associate Director for Global Targeting, tel.: 202-622-2420; Assistant Director for Sanctions Compliance & Evaluation, tel.: 202-622-2490; Assistant Director for Licensing, tel.: 202-622-2480; or Assistant Director for Regulatory Affairs, tel.: 202-622-4855.
The Specially Designated Nationals and Blocked Persons List and additional information concerning OFAC sanctions programs are available on OFAC's website (
On February 22, 2021, OFAC determined that the property and interests in property subject to U.S. jurisdiction of the following persons are blocked under the relevant sanctions authority listed below.
1. KYAW, Maung Maung, Burma; DOB 23 Jul 1964; nationality Burma; Gender Male; National ID No. 12/BAHANA(N)010023 (Burma) (individual) [BURMA-EO14014].
Designated pursuant to section 1(a)(iii)(A) of Executive Order 14014 of February 10, 2021, “Blocking Property With Respect To The Situation In Burma” (“E.O. 14014”) for being a foreign person who is or has been a leader of the military or security forces of Burma or any successor entity to any of the foregoing.
2. TUN, Moe Myint, Burma; DOB 24 May 1968; nationality Burma; Gender Male; National ID No. 7/KATAKHA(N)007836 (Burma) (individual) [BURMA-EO14014].
Designated pursuant to section 1(a)(iii)(A) of E.O. 14014 for being a foreign person who is or has been a leader of the military or security forces of Burma or any successor entity to any of the foregoing.
Office of Foreign Assets Control, Treasury.
Notice.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in
See
OFAC: Associate Director for Global Targeting, tel.: 202-622-2420; Assistant Director for Sanctions Compliance & Evaluation, tel.: 202-622-2490; Assistant Director for Licensing, tel.: 202-622-2480; or Assistant Director for Regulatory Affairs, tel.: 202-622-4855.
The Specially Designated Nationals and Blocked Persons List and additional information concerning OFAC sanctions programs are available on OFAC's website (
On February 11, 2021, OFAC determined that the property and interests in property subject to U.S. jurisdiction of the following persons are blocked under the relevant sanctions authority listed below.
1. AUNG, Ye, Burma; DOB 08 Jun 1960; POB Chauk, Burma; Gender Male (individual) [BURMA-E.O.].
Designated pursuant to section 1(a)(iii)(A) of Executive Order of February 10, 2021, “Blocking Property With Respect To The Situation In Burma” (“the Order”) for being a foreign person who is or has been a leader of the military or security forces of Burma or any successor entity to any of the foregoing.
2. HLAING, Min Aung, Burma; DOB 03 Jul 1956; POB Dawei, Burma; Gender Male (individual) [GLOMAG] [BURMA-E.O.].
Designated pursuant to section 1(a)(iii)(A) of the Order for being a foreign person who is or has been a leader of the military or security forces of Burma or any successor entity to any of the foregoing.
3. HTUT, Soe, Burma; DOB 1960; Gender Male (individual) [BURMA-E.O.].
Designated pursuant to section 1(a)(iii)(A) of the Order for being a foreign person who is or has been a leader of the military or security forces of Burma or any successor entity to any of the foregoing.
4. SWE, Myint, Burma; DOB 24 May 1951; Gender Male (individual) [BURMA-E.O.].
Designated pursuant to section 1(a)(iii)(A) of the Order for being a foreign person who is or has been a leader of the military or security forces of Burma or any successor entity to any of the foregoing.
5. WIN, Soe, Burma; DOB 01 Mar 1960; Gender Male (individual) [GLOMAG] [BURMA-E.O.].
Designated pursuant to section 1(a)(iii)(A) of the Order for being a foreign person who is or has been a leader of the military or security forces of Burma or any successor entity to any of the foregoing.
6. WIN, Sein, Burma; DOB Jul 1956; POB Pyin Oo Lwin, Burma; Gender Male (individual) [BURMA-E.O.].
Designated pursuant to section 1(a)(iii)(A) of the Order for being a foreign person who is or has been a leader of the military or security forces of Burma or any successor entity to any of the foregoing.
7. DWE, Aung Lin (a.k.a. DWAY, Aung Lin), Burma; DOB 31 May 1962; Gender Male (individual) [BURMA-E.O.].
Designated pursuant to section 1(a)(iii)(A) of the Order for being a foreign person who is or has been a leader of the military or security forces of Burma or any successor entity to any of the foregoing.
8. OO, Mya Tun, Burma; DOB 04 May 1961; alt. DOB 05 May 1961; Gender Male (individual) [BURMA-E.O.].
Designated pursuant to section 1(a)(ii)(c)(i) of the Order for being a foreign person who is or has been a leader of the military or security forces of Burma or any successor entity to any of the foregoing.
9. OO, Ye Win, Burma; DOB 21 Feb 1966; Gender Male (individual) [BURMA-E.O.].
Designated pursuant to section 1(a)(iii)(A) of the Order for being a foreign person who is or has been a leader of the military or security forces of Burma or any successor entity to any of the foregoing.
10. SAN, Tin Aung, Burma; DOB 16 Oct 1960; Gender Male (individual) [BURMA-E.O.].
Designated pursuant to section 1(a)(iii)(A) of the Order for being a foreign person who is or has been a leader of the military or security forces of Burma or any successor entity to any of the foregoing.
1. CANCRI GEMS & JEWELLERY CO., LTD. (a.k.a. CANCRI GEMS & JEWELLERY COMPANY LIMITED; a.k.a. CANCRI GEMS AND JEWELLERY CO., LTD.; a.k.a. CANCRI GEMS AND JEWELLERY COMPANY LIMITED; a.k.a. PHU SHA STAR), Burma; Company Number 113099127 (Burma) issued 24 Jul 2012 [BURMA-E.O.].
Designated pursuant to section 1(a)(vii) of the Order for being a foreign person that is owned or controlled by, or has acted or purported to act for or on behalf of, directly or indirectly, the military or security forces of Burma or any person whose property and interests in property are blocked pursuant to the Order.
2. MYANMAR IMPERIAL JADE CO., LTD. (a.k.a. MYANMAR IMPERIAL JADE GEMS & JEWELLERY CO., LTD.; a.k.a. MYANMAR IMPERIAL JADE GEMS & JEWELLERY COMPANY LIMITED; a.k.a. MYANMAR IMPERIAL JADE GEMS AND JEWELLERY CO., LTD.; a.k.a. MYANMAR IMPERIAL JADE GEMS AND JEWELLERY COMPANY LIMITED), Burma; Company Number 176227869 (Burma) issued 13 Sep 1996 [BURMA-E.O.].
Designated pursuant to section 1(a)(vii) of the Order for being a foreign person that is owned or controlled by, or has acted or purported to act for or on behalf of, directly or indirectly, the military or security forces of Burma or any person whose property and interests in property are blocked pursuant to the Order.
3. MYANMAR RUBY ENTERPRISE (a.k.a. MYANMAR RUBY ENTERPRISE GEMS & JEWELLERY CO., LTD.; a.k.a. MYANMAR RUBY ENTERPRISE GEMS & JEWELLERY COMPANY LIMITED; a.k.a. MYANMAR RUBY ENTERPRISE GEMS AND JEWELLERY CO., LTD.; a.k.a. MYANMAR RUBY ENTERPRISE GEMS AND JEWELLERY COMPANY LIMITED), Burma; Company Number 100941821 (Burma) issued 14 Feb 1996 [BURMA-E.O.].
Designated pursuant to section 1(a)(vii) of the Order for being a foreign person who is owned or controlled by, or has acted or purported to act for or on behalf of, directly or indirectly, the military or security forces of Burma or any person whose property and interests in property are blocked pursuant to the Order.