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Food and Drug Administration, Health and Human Services (HHS).
Final rule.
The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule to require electronic submission of certain postmarketing safety reports for approved new animal drugs. The final rule also provides a procedure for requesting a temporary waiver of the electronic submission requirement.
This rule is effective August 28, 2020. For the applicable compliance date, please see section V, “Effective and Compliance Dates” in
For access to the docket to read background documents or comments received, go to
The purpose of this rulemaking is to require electronic submission of certain postmarketing safety reports for approved new animal drugs and to provide a procedure for requesting a temporary waiver of the requirement.
We require applicants to submit to us postmarketing safety reports of adverse drug experiences and product/manufacturing defects for approved new animal drugs (see § 514.80 (21 CFR 514.80)). An applicant is defined as a person or entity who owns or holds on behalf of the owner the approval for a new animal drug application (NADA) or an abbreviated new animal drug application (ANADA) and is responsible for compliance with applicable provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and regulations (see § 514.3 (21 CFR 514.3)). In addition, a nonapplicant, defined in § 514.3 as any person other than the applicant whose name appears on the label and who is engaged in manufacturing, packing, distribution, or labeling of the product, may elect to submit adverse drug experience reports directly to us (§ 514.80(b)(3)).
The continuous monitoring of new animal drugs affords the primary means by which we obtain information regarding problems with the safety and efficacy of marketed approved new animal drugs, as well as product/manufacturing problems. Postapproval marketing surveillance is important to ensure the continued safety and effectiveness of new animal drugs. Drug effects can change over time and other effects may not manifest until years after the approval.
Finalizing this rule will improve our systems for collecting and analyzing postmarketing safety reports. The change will help us to more rapidly review postmarketing safety reports, identify emerging safety problems, and disseminate safety information in support of our public health mission. In addition, the amendments will facilitate international harmonization and exchange of safety information. This rule also provides a procedure for requesting a temporary waiver of the electronic submission requirement.
The rule amends the records and reports regulation in part 514 (21 CFR part 514) to include the following:
• Procedures relating to the electronic submission of certain postmarketing safety reports for approved new animal drugs; and
• Procedures for requesting a temporary waiver of the electronic submission requirement.
The final rule requires electronic submission for the following reports for approved new animal drugs: (1) 3-day alert reports that applicants elect to submit as a courtesy copy directly to FDA's Center for Veterinary Medicine (CVM) in addition to the requirement they have to submit these reports on paper Form FDA 1932 to the appropriate FDA District Office or local FDA resident post; (2) 15-day alert reports and followup reports; product/manufacturing defect and adverse drug experience reports submitted by nonapplicants who elect to report adverse drug experiences directly to CVM in addition to providing these reports to the applicant; and (3) product/manufacturing defect and adverse drug experience reports (including reports of previously not reported adverse drug experiences that occur in postapproval studies) required
Our legal authority to require electronic submission of postmarketing safety reports for approved new animal drugs derives from sections 201, 301, 501, 502, 512, and 701 of the FD&C Act (21 U.S.C. 321, 331, 351, 352, 360b, and 371).
The quantifiable benefit of this rule is annual cost savings of $7,908 from reduced data entry time for CVM. The other benefits of this final rule would be to animal health and are not quantifiable. The main cost of this rule is a one-time upfront cost to industry of $73,500 for changing standard operating procedures (SOPs) and training employees to electronically submit postmarketing safety reports in accordance with the new SOPs. Recurring costs to the Agency would be $161 per year, for processing the waivers to the electronic reporting requirement. Annualizing these costs over a 15-year time horizon (from 2018 to 2033), we estimate total annualized costs to be $6,139 at a 3 percent discount rate, and total annualized costs of $7,703 at a 7 percent discount rate. The annualized net benefit of this rule is −$880 at a 3 percent discount rate and −$2,444 at a 7 percent discount rate. The present value of the net benefits is −$10,504 at a 3 percent discount rate and −$22,262 at a 7 percent discount rate over a 15-year time horizon.
When a new animal drug is approved and enters the market, the product is introduced to a larger population in settings different from the controlled studies required by the approval process. New information generated during the postmarketing period offers further insight into the benefits and/or risks of the product, and evaluation of this information is important to ensure the safe and effective use of these products.
CVM receives information regarding adverse drug experiences for approved new animal drugs from postmarketing safety reports. For over 25 years, we have received these safety reports on paper. However, the majority of submitters have chosen, voluntarily, to utilize electronic submission as electronic means became available.
In the
Electronic submission of postmarketing safety reports:
• Expedites our access to safety information and provides us data in a format that will support more efficient and comprehensive reviews;
• Enhances our ability to rapidly communicate information about suspected problems to animal owners, veterinarians, consumers, and industry within the United States and internationally in support of our public health mission; and
• Eliminates or reduces the time and costs to industry associated with submitting paper reports, and the time, costs, errors, and physical storage needs of the Agency associated with manually entering data from paper reports into the electronic system for review and analysis.
Electronic submission of postmarketing safety reports allows us to be more responsive to rapidly occurring changes in the technological environment. Consistent with our current practice for voluntarily provided electronic submissions, the final rule requires that data in electronic submissions conform to the data elements in Form FDA 1932 and our technical documents on how to provide electronic submissions (
The final rule is also an important step in our continuing efforts to harmonize our postmarketing safety reporting regulations with international standards for submitting safety information. Currently, the technical specifications referenced in our guidance documents supporting the voluntary electronic submission processes rely upon and adopt certain safety reporting and transmission standards recommended by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). VICH was formed to facilitate the harmonization of technical requirements for the marketing authorization or “registration” of veterinary medicinal products among three regions: the European Union, Japan, and the United States. Our electronic submission specifications allow applicants or nonapplicants to submit postmarketing safety reports using the Health Level 7 (HL7) Individual Case Safety Report (ICSR) standard that has been adopted worldwide by VICH. In this final rule, we reaffirm our intention to continue to rely on these VICH-recommended standards. We believe the continued use of VICH standards will promote harmonization of safety reporting among regulatory agencies and facilitate the international exchange of postmarketing safety information. Accordingly, this final rule is consistent with our ongoing initiatives to encourage the widest possible use of electronic submission and to promote international harmonization of safety reporting for animal drug products through reliance
We received two comment letters on the proposed rule by the close of the comment period, each containing one or more comments on one or more issues. We received comments from industry and an individual. Some comments support our rulemaking and our ongoing efforts to improve our systems for collecting and analyzing postmarketing safety reports. Some comments offer suggestions for specific changes for us to consider making to the subject regulations.
This final rule amends our animal drug records and reports regulation at part 514 to require electronic submission of certain postmarketing safety reports for approved new animal drugs. In addition, the rule provides a procedure for requesting a temporary waiver of the requirement. In this rulemaking, we finalize the provisions in the proposed rule.
Our legal authority for issuing this final rule is provided by section 512(
This section summarizes comments we received in response to the proposed rule and our response to those comments. Both commenters support our rulemaking and our ongoing efforts to improve our systems for collecting and analyzing postmarketing safety reports. Some of the comments offer suggestions for additional changes to the subject regulations. We considered the comments we received in response to the proposed rule in preparing this final rule. After considering these comments, we are not making any changes to the codified language that was included in the proposed rule.
In sections IV.B. through IV.C., we describe the comments received on the proposed rule and provide our responses. To make it easier to identify the comments and our responses, the word “Comment,” in parentheses, appears before the comment's description, and the word “Response,” in parentheses, appears before our response. We have numbered each comment to help distinguish between different comments. We have grouped similar comments together under the same number, and, in some cases, we have separated different issues discussed in the same comment and designated them as distinct comments for purposes of our responses. The number assigned to each comment or comment topic is purely for organizational purposes and does not signify the comment's value or importance or the order in which comments were received.
Two comments make general remarks supporting the proposed rule without focusing on a particular proposed provision.
(Comment 1) Comments generally support our efforts to require electronic submission of certain postmarketing safety reports for approved new animal drugs. One comment recognizes that the requirement of electronic submission would greatly benefit the Agency and animal health by supporting quicker access to postmarketing safety information. Another comment applauds our efforts to improve our systems for collecting and analyzing postmarketing safety reports and to facilitate international harmonization and exchange of safety information.
(Response 1) We appreciate the general support that the comments express. As noted in section II.A., we expect this rule to expedite our access to safety information and provide us data in a format that will support more efficient and comprehensive reviews. This will enhance our ability to rapidly communicate information about suspected problems to animal owners, veterinarians, consumers, and industry within the United States and internationally in support of our public health mission.
Several comments make specific remarks regarding particular proposed provisions. In this section, we discuss and respond to such comments.
(Comment 2) One comment states that, although in favor of electronically reporting 3-day alerts to CVM in addition to reporting to the appropriate FDA District Office or local resident post, until such time that this can be accomplished via a single mechanism (
(Response 2) We currently require 3-day alert reports to be submitted to the appropriate FDA District Office or local FDA resident post on paper (see § 514.80(b)(1)). However, if in addition to that report an applicant elects to submit a 3-day field alert report directly to CVM (
(Comment 3) One comment notes that, since the implementation of electronic reporting capability, postmarketing safety reports may be submitted to us via Extensible Markup Language (XML), which is designed to store and transport data and be both human-readable and machine-readable. Therefore, there is no official Form FDA 1932 version of these reports to provide to an inspector during manufacturing site FDA inspections. In addition, the comment continues, inspectors are not well versed in reading the XML formats created from electronically submitted reports. The comment suggests that we provide training to inspectors to help them better understand how to read the XML format for case data or that we provide industry with guidance for an alternative form that could be generated from the database that satisfies the inspectors' needs during site inspections.
(Response 3) We recognize the comment's concerns with regard to utility of the XML format information during inspections. We appreciate the commenter's interest in either preparing more easily readable versions of electronically submitted reports for inspectors or providing training to inspectors in reading the XML format of electronically submitted reports. We intend to consider these suggestions so that inspectors are better able to access the information they need during an inspection. However, the comment did not request any changes to the language in proposed § 514.80(b)(1), nor do we see a reason to make any changes based on the concerns and suggestions included in the comment.
(Comment 4) One comment notes that, while the proposed rule provides a procedure for requesting a temporary waiver of the electronic submission requirement for “good cause” (
(Response 4) We disagree that the Agency should automatically grant a temporary waiver from the electronic submission requirement for the amount of time that the Agency's Electronic Submission Gateway or Safety Reporting Portal is down. As stated in the proposed rule, electronic submission improves our ability to process and archive postmarketing safety reports in a timely manner, and to make postmarketing reports more readily available for analysis (83 FR 6480 at 6482). We also stated in the proposed rule that an applicant or nonapplicant experiencing technical difficulty that temporarily prevents use of the Electronic Submission Gateway could, as a backup, electronically submit reports using the Safety Reporting Portal. An applicant or nonapplicant that relies on the Safety Reporting Portal but experiences a short-term, temporary interruption of internet services could, as a backup, electronically submit reports from any other computer with access to a working internet connection (83 FR 6480 at 6485). It is highly unlikely that both the Agency's Electronic Submission Gateway or Safety Reporting Portal would be down at the same time. In the unlikely event that the Agency experiences a prolonged system outage or other major technical problem (which would include the highly unlikely situation where both the Agency's Electronic Submission Gateway or Safety Reporting Portal are down), the Agency does not intend to enforce the requirement to submit reports electronically so long as an applicant or nonapplicant submits reports in an alternate format (most likely on paper using Form FDA 1932).
We are not waiving the required content, frequency, or timeline for submission of the postmarketing safety reports to the Agency, and are finalizing proposed § 514.80(d) without change. The rule requires applicants and nonapplicants to submit a waiver request to us in writing. The initial request for a waiver may be by telephone or email to CVM's Division of Veterinary Product Safety, with prompt written followup submitted as a letter to the application(s). Applicants and nonapplicants should be prepared to comply with an Agency request for submission in an alternate format by maintaining the capability to submit paper reports using Form FDA 1932, if needed.
In addition to the comments specific to this rulemaking that we addressed previously in this preamble, we received general comments expressing views about matters that are not related to this rulemaking. Therefore, these general comments do not require a response.
This rule is effective August 28, 2020. Applicants and nonapplicants must comply with the electronic submission requirement in the final rule when submitting their reports beginning on July 29, 2021.
We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, Executive Order 13771, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Executive Order 13771 requires that the costs associated with significant new regulations “shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least two prior regulations.” This final rule is not an economically significant regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the costs of the rule are minimal in both absolute value and in comparison to average yearly sales of small firms in this industry, we certify that the final rule will not have a significant economic impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $156 million, using the most current (2019) Implicit Price Deflator for the Gross Domestic Product. This final rule would not result in an expenditure in any year that meets or exceeds this amount.
Currently, most submitters have chosen, voluntarily, to use electronic submission for the reports that would be affected by this final rule. As of 2016, 99.7 percent of postmarketing safety reports eligible for electronic submission were electronically submitted. Thus, this final rule would affect a small proportion of these reports.
The quantifiable benefit of this rule is annual cost savings of $5,259 from reduced data entry time for CVM. The other benefits of this final rule would be to animal health and are not quantifiable. The main cost to this rule is a one-time upfront cost to industry of $73,500 for changing SOPs and training employees to electronically submit postmarketing safety reports in accordance with the new SOPs. Recurring costs to the Agency would be $161 per year, for processing the waivers to the electronic reporting requirement. Annualizing these costs over a 15-year time horizon (from 2018 to 2033), we estimate total annualized costs to be $6,139 at a 3 percent discount rate, and total annualized costs of $7,703 at a 7 percent discount rate. The annualized net benefit of this rule is −$880 at a 3 percent discount rate and −$2,444 at a 7 percent discount rate. The present value of the net benefits is −$10,504 at a 3 percent discount rate and −$22,262 at a 7 percent discount rate over a 15-year time horizon.
In line with Executive Order 13771, in table 2 we estimate present and annualized values of costs and cost savings over an infinite time horizon. Based on these cost-savings this final rule would be considered a deregulatory action under Executive Order 13771. Our primary estimate for the present value of the net costs over an infinite time horizon is −$3,837 (or a cost savings of $3,837) at a 7 percent discount rate and −$96,287 at a 3 percent discount rate in 2016 dollars.
We have developed a comprehensive Economic Analysis of Impacts that assesses the impacts of the final rule. The full analysis of economic impacts is available in the docket for this final rule (Ref. 1) and at
We have determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This final rule contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The title, description, and respondent description of the information collection provisions are shown in the following paragraphs with an estimate of the one-time and recurring reporting and recordkeeping burdens. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.
The final rule revises these requirements to require electronic submission of the following postmarketing safety reports for approved new animal drugs:
• Three-day alert reports that applicants elect to submit directly to CVM as a “courtesy copy” in addition to the requirement that they have to submit these reports on paper Form FDA 1932 to the appropriate FDA District Office or local FDA resident post (§ 514.80(b)(1);
• Fifteen-day alert reports (§ 514.80(b)(2)(i)) and followup reports (§ 514.80(b)(2)(ii));
• Product/manufacturing defects and adverse drug experience reports submitted by nonapplicants who elect to report adverse drug experiences directly to FDA under § 514.80(b)(3) in addition to providing these reports to the applicant; and
• Product/manufacturing defects and adverse drug experience reports (including reports of previously not reported adverse drug experiences that occur in postapproval studies) required to be submitted as part of the periodic drug experience report (§ 514.80(b)(4)(iv)(A) and (C)).
We currently require 3-day alert reports to be submitted to the appropriate FDA District Office or local FDA resident post on paper (see § 514.80(b)(1)). As noted previously, the regulation does not require electronic submission of 3-day field alert reports (§ 514.80(b)(1)). These reports will continue to be submitted on paper Form FDA 1932 directly to the appropriate FDA District Office or local resident post. However, as noted, if an applicant elects to submit a 3-day field alert report directly to CVM as a “courtesy copy,” the applicant will be required to submit the report electronically. This will not alleviate the applicant's responsibility to submit this report to the FDA District Field Office or local FDA resident post on paper Form FDA 1932.
The final rule also revises these requirements to allow applicants or nonapplicants to request a temporary waiver from the electronic submission requirement for “good cause” shown. We anticipate that temporary waivers will only be needed in rare circumstances that impact an applicant's or nonapplicant's ability to report electronically, such as natural disasters, pandemics, and terrorism.
In the February 14, 2018, proposed rule, we included an analysis of the information collection provisions of the proposal under the PRA and requested comments on four topics relevant to that analysis (83 FR 6480 at 6487 through 6488). We have summarized and responded to these comments in sections IV.B. through IV.C., but have made no changes to the burden estimate in our proposed rule.
We estimate the reporting burden of this collection of information as follows:
Table 3 shows the estimated recurring reporting burden associated with the final rule. In section II.F. of the Final Regulatory Impact Analysis (FRIA), we estimated that 15 firms submitted a paper Form FDA 1932 report from 2011 to 2015 and thus will be affected by the rule's requirement to submit electronically. As stated in the FRIA, we estimate that in 2016 CVM received 270 of the affected postmarketing safety reports on paper. We calculate the number of responses per respondent as the total annual responses divided by the number of respondents. We estimate that, on average, it will take 1 hour to submit electronic postmarketing safety reports for approved new animal drugs, for a total of 270 hours. We base our estimate of 1 hour per report on our experience with electronic postmarketing safety reporting. In the FRIA, we also estimated the burdens associated with submission of waiver requests. We expect very few waiver requests (see section II.F.2. of the FRIA), estimating that one firm will request a waiver annually under § 514.80(d)(2). We assume a waiver request takes 1 hour to prepare and submit to us. Together, this results in a total of 271 hours and 271 responses. We are also adding 1 hour to the paper reporting collection to reflect the new waiver request process under § 514.80(d)(2).
We estimate the recordkeeping burden of this collection of information as follows:
Table 4 shows the estimated one-time recordkeeping burden associated with the final rule. This burden includes both the one-time burden of creating new SOPs to submit the reports electronically and the one-time cost of training employees to electronically submit postmarketing safety reports to CVM in accordance with the new SOPs. In section II.F. of the FRIA, we estimated that approximately 15 firms will be affected by this rule. We assume it will take an average of 20 hours per firm to create new SOPs for electronic submission of postmarketing safety reports and approximately 20 hours per firm to complete the training of employees to electronically submit postmarketing safety reports in accordance with the new SOPs. Together, this results in a total of 600 hours and 30 records. We assume that there are no capital costs associated with firms implementing this rule (
The information collection provisions in this final rule have been submitted to OMB for review as required by section 3507(d) of the Paperwork Reduction Act of 1995. Before the effective date of this final rule, FDA will publish a notice in the
We have analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that 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. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.
We have analyzed this rule in accordance with the principles set forth in Executive Order 13175. We have determined that the rule does not contain policies that 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. Accordingly, we conclude that the rule does not contain policies that have tribal implications as defined in the Executive order and, consequently, a
1. Economic Analysis of Impacts; also available at:
Administrative practice and procedure, Animal drugs, Confidential business information, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 514 is amended as follows:
21 U.S.C. 321, 331, 351, 352, 354, 356a, 360b, 360ccc, 371, 379e, 381.
The addition and revisions read as follows:
(b) * * *
(1) * * * If the applicant elects to also report directly to the FDA's Center for Veterinary Medicine (CVM), the applicant must submit the report to CVM in electronic format as described in paragraph (d)(1) of this section, unless the applicant obtains a waiver under paragraph (d)(2) of this section or FDA requests the report in an alternate format.
(2) * * *
(i) * * * The report must be submitted to FDA in electronic format as described in paragraph (d)(1) of this section, unless the applicant obtains a waiver under paragraph (d)(2) of this section or FDA requests the report in an alternate format.
(ii) * * * A followup report must be submitted to FDA in electronic format as described in paragraph (d)(1) of this section, unless the applicant obtains a waiver under paragraph (d)(2) of this section or FDA requests the report in an alternate format. * * *
(3) * * * If the nonapplicant elects to also report directly to FDA, the nonapplicant must submit the report to FDA in electronic format as described in paragraph (d)(1) of this section, unless the nonapplicant obtains a waiver under paragraph (d)(2) of this section or FDA requests the report in an alternate format.
(4) * * *
(iv) * * *
(A) Product/manufacturing defects and adverse drug experiences not previously reported under paragraphs (b)(1) and (2) of this section must be reported individually to FDA in electronic format as described in paragraph (d)(1) of this section, unless the applicant obtains a waiver under paragraph (d)(2) of this section or FDA requests the report in an alternate format.
(C) Reports of previously not reported adverse drug experiences that occur in postapproval studies must be reported individually to FDA in electronic format as described in paragraph (d)(1) of this section, unless the applicant obtains a waiver under paragraph (d)(2) of this section or FDA requests the report in an alternate format.
(v) * * * The summaries must state the time period on which the increased frequency is based, time period comparisons in determining increased frequency, references to any reports previously submitted under paragraphs (b)(1), (2), and (3) and (b)(4)(iv)(A) and (C) of this section, the method of analysis, and the interpretation of the results. * * *
(d)
(2)
(3)
(g)
Department of State.
Extension of temporary suspensions, modifications, and exceptions.
The Department of State is issuing this document to inform the public of an extension to certain temporary suspensions, modifications, and exceptions for the durations described herein to certain provisions of the International Traffic in Arms Regulations (ITAR) in order to provide for continued telework operations during the current SARS-COV2 public health emergency. These actions are taken in order to ensure continuity of operations within the Directorate of Defense Trade Controls (DDTC) and among members of the regulated community.
This document is issued July 29, 2020.
Sarah Heidema, Office of Defense Trade Controls Policy, U.S. Department of State, telephone (202) 663-1282, or email
On May 1, 2020, the Directorate of Defense Trade Controls (DDTC) published in the
Subsequently, on June 10, 2020 (85 FR 35376), DDTC published in the
The majority of the commenters requested that the telework provisions (numbers 3 and 4) be extended and DDTC agrees. Based upon continued public health recommendations and as informed by responses to request for public comment, it is apparent to DDTC that regulated entities will continue to engage in social distancing measures for the foreseeable future. In order to accommodate teleworking and decentralized workplaces, several commenters recommended extending these temporary modifications through at least the end of October or this calendar year. DDTC is extending the temporary modifications through the end of the calendar year in order to provide regulated entities with staffing flexibilities in the immediate term. DDTC will use this period to fully investigate the possibility and ramifications of making this modification, or a variation thereof, a permanent revision to the ITAR. If necessary, this extension will provide an opportunity to utilize notice and comment rulemaking and to address potential revisions through the interagency process. An extension of
The temporary suspension, modification, and exception to the requirement in ITAR parts 122 and 129 to renew registration as a manufacturer, exporter, and/or broker and pay a fee on an annual basis described at number 1 of 85 FR 25287, is not being extended to subsequent registrations. DDTC did not receive any request from industry for additional extensions to registrations that terminate after June 30. To the contrary, several commenters expressed their appreciation for the original action, but noted that any extension would be unnecessary. DDTC's experience since the original temporary suspension, modification, and exception is that registrants are able to use DDTC's DECCS online system for the purpose of registration in the normal course of business.
The temporary suspension, modification, and exception to the limitations on the duration of ITAR licenses and agreements described at number 2 of 85 FR 25287, is not extended. Although several commenters expressed appreciation for the original action, one commenter indicated a preference that it not be extended. Although three commenters did request extension for various reasons, DDTC is not accepting those requests. DDTC notes that the majority of commenters did not make such a request, and that of those that did, some of the reasons related to internal DDTC operations and coordination with other areas of the government. DDTC believes that progress is being made on those matters and that continued extensions to all existing authorizations is an overbroad response to the current situation. DDTC, its interagency partners, and the regulated entities have had several months to adjust to the current situation and DDTC believes it is prepared to handle authorizations in accordance with its statutory requirements.
DDTC further notes that several commenters requested additional measures be taken by DDTC. DDTC is not adopting any of those measures at this time. Although DDTC is not providing individual responses to those requests, DDTC notes generally that several of the requests would involve major infrastructure revisions to DDTC automated systems and are therefore not feasible as temporary suspensions, modifications, or exceptions; others were outside the scope of the request; and others involved matters of internal policy and practice and not regulatory matters. For all regulatory matters recommended, DDTC will continue to consider those that may merit future possibility of action.
Therefore, pursuant to ITAR §§ 126.2 and 126.3, in the interest of the security and foreign policy of the United States and as warranted by the exceptional and undue hardships and risks to safety caused by the public health emergency related to the SARS-COV2 pandemic, notice is provided that the following temporary suspensions, modifications, and exceptions are being extended as follows:
1. As of March 13, 2020, a temporary suspension, modification, and exception to the requirement that a regular employee, for purposes of ITAR § 120.39(a)(2), work at the company's facilities, to allow the individual to work at a remote work location, so long as the individual is not located in Russia or a country listed in ITAR § 126.1. This suspension, modification, and exception shall terminate on December 31, 2020, unless otherwise extended in writing.
2. As of March 13, 2020, a temporary suspension, modification, and exception to authorize regular employees of licensed entities who are working remotely in a country not currently authorized by a technical assistance agreement, manufacturing license agreement, or exemption to send, receive, or access any technical data authorized for export, reexport, or retransfer to their employer via a technical assistance agreement, manufacturing license agreement, or exemption so long as the regular employee is not located in Russia or a country listed in ITAR § 126.1. This suspension, modification, and exception shall terminate on December 31, 2020, unless otherwise extended in writing.
This notice makes no other revision to the notice published at 85 FR 25287, nor does it make any other temporary suspension, modification, or exception to the requirements of the ITAR.
22 CFR 126.2 and 126.3.
Internal Revenue Service (IRS), Treasury.
Temporary regulations.
This document amends the regulations under sections 3111 and 3221 of the Internal Revenue Code with the addition of temporary regulations issued under the regulatory authority granted by the Families First Coronavirus Response Act and the Coronavirus Aid, Relief, and Economic Security Act to prescribe such regulations as may be necessary for reconciling advance payments of refundable employment tax credits provided under these acts and recapturing the benefit of the credits when necessary. Consistent with this authority, these temporary regulations authorize the assessment of any erroneous refund of the credits paid under sections 7001 and 7003 of the Families First Coronavirus Response Act, including any increases in such credits under section 7005 thereof, and section 2301 of the Coronavirus Aid, Relief, and Economic Security Act. The text of these temporary regulations also serves as the text of the proposed regulations (REG-111879-20) set forth in the notice of proposed rulemaking on this subject in the Proposed Rules section of this issue of the
Concerning these temporary regulations, NaLee Park at 202-317-6798.
The Families First Coronavirus Response Act (Families First Act), Public Law 116-127, 134 Stat. 178 (2020), enacted on March 18, 2020, and the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), Public Law 116-136, 134 Stat. 281 (2020), enacted on March 27, 2020, provide relief to taxpayers from economic hardships resulting from the Coronavirus Disease 2019 (COVID-19).
The Families First Act, through the enactment of the Emergency Paid Sick Leave Act and the Emergency Family and Medical Leave Expansion Act, generally requires employers with fewer than 500 employees to provide paid leave due to certain circumstances related to COVID-19.
Division E of the Families First Act, the Emergency Paid Sick Leave Act (EPSLA), requires certain employers to provide employees with up to 80 hours of paid sick leave if the employee is unable to work or telework because the employee:
(1) Is subject to a Federal, State, or local quarantine or isolation order related to COVID-19;
(2) has been advised by a health care provider to self-quarantine due to concerns related to COVID-19;
(3) is experiencing symptoms of COVID-19 and seeking a medical diagnosis;
(4) is caring for an individual who is subject to a Federal, State, or local quarantine or isolation order related to COVID-19, or has been advised by a health care provider to self-quarantine due to concerns related to COVID-19;
(5) is caring for a son or daughter of such employee if the school or place of care of the son or daughter has been closed, or the child care provider of such son or daughter is unavailable, due to COVID-19 precautions; or
(6) is experiencing any other substantially similar condition specified by the Secretary of Health and Human Services in consultation with the Secretaries of the Treasury and Labor.
An employee who is unable to work or telework for reasons related to COVID-19 described in (1), (2), or (3) above is entitled to paid sick leave at the employee's regular rate of pay or, if higher, the Federal minimum wage or any applicable State or local minimum wage, up to $511 per day and $5,110 in the aggregate. An employee who is unable to work or telework for reasons related to COVID-19 described in (4), (5), or (6) above is entitled to paid sick leave at two-thirds the employee's regular rate of pay or, if higher, the Federal minimum wage or any applicable State or local minimum wage, up to $200 per day and $2,000 in the aggregate.
Division C of the Families First Act, the Emergency Family and Medical Leave Expansion Act (EFMLEA), amends the Family and Medical Leave Act of 1993 to require certain employers to provide expanded paid family and medical leave to employees who are unable to work or telework for reasons related to COVID-19. An employee can receive up to 10 weeks of paid family and medical leave at two-thirds the employee's regular rate of pay, up to $200 per day and $10,000 in the aggregate if the employee is unable to work or telework because the employee is caring for a son or daughter whose school or place of care is closed or whose child care provider is unavailable for reasons related to COVID-19.
Sections 7001 and 7003 of the Families First Act generally provide that employers subject to the paid leave requirements under EPSLA and EFMLEA (“eligible employers”) are entitled to fully refundable tax credits to cover the cost of the leave required to be paid for those periods of time during which employees are unable to work or telework for reasons related to COVID-19.
Eligible employers are entitled to receive a refundable credit equal to the amount of the qualified sick leave wages and qualified family leave wages (collectively “qualified leave wages”), plus allocable qualified health plan expenses. Under the respective provisions, qualified leave wages are defined to mean wages (as defined in section 3121(a) of the Internal Revenue Code (Code)) and compensation (as defined in section 3231(e) of the Code) paid by an employer which are required to be paid under the EPSLA and EFMLEA. See section 7001(c) and 7003(c). The credit is allowed against the taxes imposed on employers by section 3111(a) of the Code (the Old-Age, Survivors, and Disability Insurance tax (social security tax)), first reduced by any credits claimed under sections 3111(e) and (f) of the Code, and section 3221(a) of the Code (the Railroad Retirement Tax Act Tier 1 tax), on all wages and compensation paid to all employees. Under section 7005 of the Families First Act, the qualified leave wages are not subject to the taxes imposed on employers by sections 3111(a) and 3221(a) of the Code. In addition, section 7005 provides that the credits under sections 7001 and 7003 of the Families First Act are increased by the amount of the tax imposed by section 3111(b) of the Code (employer's share of Medicare tax) on qualified leave wages.
The CARES Act provides an additional credit for employers experiencing economic hardship related to COVID-19. Under section 2301 of the CARES Act, certain employers who pay qualified wages to their employees are eligible for an employee retention credit. Employers eligible for the employee retention credit are employers that carry on a trade or business during calendar year 2020 and tax-exempt organizations that either have a full or partial suspension of operations during any calendar quarter in 2020 due to an order from an appropriate governmental authority limiting commerce, travel, or group meetings (for commercial, social, religious, or other purposes) due to COVID-19, or experience a significant decline in gross receipts during the calendar quarter.
Qualified wages are wages (as defined in section 3121(a) of the Code) and compensation (as defined in section 3231(e) of the Code) paid by an employer to some or all employees after March 12, 2020, and before January 1, 2021, and include the employer's qualified health plan expenses that are properly allocable to such wages or compensation. For employers that averaged more than 100 full-time employees during 2019, qualified wages are wages and compensation (including allocable qualified health plan expenses), up to $10,000 per employee, paid to employees that are not providing services because operations were fully or partially suspended due to orders from an appropriate governmental authority or due to a decline in gross receipts. For employers who averaged 100 full-time employees or fewer during 2019, qualified wages are wages and compensation (including allocable qualified health plan expenses), up to $10,000 per employee, paid to any employee during the period operations were suspended due to orders from an
The employee retention credit is a fully refundable tax credit for employers equal to 50 percent of qualified wages. Because the maximum amount of qualified wages taken into account with respect to each employee is $10,000, the maximum employee retention credit for an eligible employer for qualified wages paid to any employee is $5,000. The credit is allowed against the taxes imposed on employers by section 3111(a) of the Code, first reduced by any credits allowed under sections 3111(e) and (f) of the Code and sections 7001 and 7003 of the Families First Act, and the taxes imposed under section 3221(a) of the Code that are attributable to the rate in effect under section 3111(a) of the Code, first reduced by any credits allowed under sections 7001 and 7003 of the Families First Act, on all wages and compensation paid to all employees. The same wages or compensation cannot be counted for both the Families First Act leave credits and the CARES Act employee retention credit.
Sections 7001(b)(4) and 7003(b)(3) of the Families First Act provide that if the amount of the paid sick and family leave credits under these sections exceeds the taxes imposed by section 3111(a) or 3221(a) of the Code for any calendar quarter, such excess shall be treated as an overpayment that shall be refunded under sections 6402(a) and 6413(b) of the Code. Section 2301(b)(3) of the CARES Act provides that if the amount of the employee retention credit exceeds the taxes imposed by section 3111(a) or 3221(a) (limited to the portion attributable to the rate in effect under section 3111(a)) of the Code for any calendar quarter, such excess shall be treated as an overpayment that shall be refunded under sections 6402(a) and 6413(b) of the Code.
Section 6402(a) of the Code provides that, within the applicable period of limitations, overpayments may be credited against any liability in respect of an internal revenue tax on the part of the person who made the overpayment and any remaining balance refunded to such person. Section 6413(b) provides that if more than the correct amount of employment tax imposed by sections 3101, 3111, 3201, 3221, or 3402 is paid or deducted and the overpayment cannot be adjusted under section 6413(a),
The IRS has revised Form 941,
Section 3606 of the CARES Act amends sections 7001(b)(4) and 7003(b)(3) of the Families First Act to provide that, in anticipation of the paid sick and family leave credits under these sections, including any refundable portions (which would include any increases in the credits under section 7005), these credits may be advanced, according to forms and instructions provided by the Secretary, up to the total allowable amount and subject to applicable limits for the calendar quarter. Section 2301(l)(1) of the CARES Act provides that the Secretary shall issue such forms, instructions, regulations, and guidance as are necessary to allow the advance payment of the employee retention credit under section 2301, subject to the limitations provided in section 2301 and based on such information as the Secretary shall require.
To implement the advance payment provisions of the Families First Act and the CARES Act, the IRS has created Form 7200,
Section 6201, in general, authorizes the Secretary to determine and assess tax liabilities including interest, additional amounts, additions to the tax, and assessable penalties. However, the general authority to assess tax liabilities under section 6201(a) does not allow the assessment of any non-rebate
Sections 7001 and 7003 of the Families First Act and section 2301 of the CARES Act grant authority to the Department of the Treasury (Treasury Department) and the IRS to issue regulations or other guidance to recapture an erroneous refund of the credits. Specifically, sections 7001(f)
Accordingly, this document amends the Employment Tax Regulations (26 CFR part 31) by adding temporary regulations under sections 3111 and 3221 of the Code. Concurrent with the publication of this Treasury decision, the Treasury Department and the IRS are publishing in the Proposed Rules section of this issue of the
Sections 7001 and 7003 of the Families First Act and section 2301 of the CARES Act provide that the credits described in these sections are taken against the taxes imposed on employers under sections 3111(a) or 3221(a) of the Code (for the employee retention credit, only the taxes imposed under section 3221(a) that are attributable to the rate in effect under section 3111(a) of the Code). Additionally, if the amount of the credit exceeds the taxes imposed under sections 3111(a) or 3221(a) of the Code (for the employee retention credit, only the taxes imposed under section 3221(a) that are attributable to the rate in effect under section 3111(a) of the Code) for any calendar quarter, such excess shall be treated as an overpayment to be refunded or credited under sections 6402(a) and 6413(b) of the Code. Any credits claimed that exceed the amount to which the employer is entitled and that are actually credited or paid by the IRS are considered to be erroneous refunds of the credits. These temporary regulations provide that erroneous refunds of these credits are treated as underpayments of the taxes imposed under sections 3111(a) or 3221(a) of the Code and authorize the IRS to assess any portion of the credits erroneously credited, paid, or refunded in excess of the amount allowed as if those amounts were tax liabilities under sections 3111(a) and 3221(a) subject to assessment and administrative collection procedures. This allows the IRS to efficiently recover the amounts, while also preserving administrative protections afforded to taxpayers with respect to contesting their tax liabilities under the Code and avoiding unnecessary costs and burdens associated with litigation. These assessment and administrative collection procedures will apply in the normal course in processing employment tax returns that report advances in excess of claimed credits and in examining returns for excess claimed credits.
Specifically, these temporary regulations provide that any amount of the credits for qualified leave wages under sections 7001 and 7003 of the Families First Act, plus any amount of credits for qualified health plan expenses under sections 7001 and 7003, and including any increases in these credits under section 7005, and any amount of the employee retention credit for qualified wages under section 2301 of the CARES Act that are erroneously refunded or credited to an employer shall be treated as underpayments of the taxes imposed by section 3111(a) or section 3221(a), as applicable, by the employer and may be administratively assessed and collected in the same manner as the taxes. These temporary regulations provide that the determination of any amount of credits erroneously refunded must take into account any credit amounts advanced to an employer under the process established by the IRS in accordance with sections 7001(b)(4)(A)(ii) and 7003(b)(3)(B) of the Families First Act and section 2301(l)(1) of the CARES Act.
Because in certain situations third party payors claim credits on behalf of their common law employer clients, these temporary regulations also provide that employers against whom an erroneous refund of credits can be assessed as an underpayment include persons treated as the employer under sections 3401(d), 3504, and 3511 of the Code, consistent with their liability for the section 3111(a) and section 3221(a) taxes against which the credit applied.
Finally, these temporary regulations apply to all credit refunds under section 7001 and 7003 of the Families First Act advanced or paid on or after April 1, 2020 and all credit refunds under section 2301 of the CARES Act advanced or paid on or after March 13, 2020. These applicability dates correspond to the effective dates of the statutory sections that provide for these credits and that authorize guidance to allow for the administrative reconciliation and recapture of erroneous refunds of these credits.
Sections 7001(g) and 7003(g) of the Families First Act provide that sections 7001 and 7003 apply to wages paid with respect to the period beginning on a date selected by the Secretary of the Treasury which is during the 15-day period beginning on the date of the enactment of the Families First Act (March 18, 2020). In Notice 2020-21, 2020-16 I.R.B. 660, the IRS provided that the tax credits for qualified sick leave wages and qualified family leave wages under sections 7001 and 7003 of the Families First Act apply to wages paid for the period beginning on April 1, 2020, and ending on December 31, 2020. Section 2301(m) of the CARES Act provides that section 2301 applies to wages paid on or after March 13, 2020, and before January 1, 2021.
Pursuant to section 7805(b)(2) of the Code, these temporary regulations are permitted to apply before the dates provided under section 7805(b)(1), including the date on which these temporary regulations are filed with the
The Office of Management and Budget's Office of Information and Regulatory Analysis has determined that these temporary regulations are not significant and not subject to review under section 6(b) of Executive Order 12866.
Pursuant to the Regulatory Flexibility Act (5 U.S.C. chapter 6), the Secretary certifies that these temporary regulations will not have a significant economic impact on a substantial number of small entities because these temporary regulations impose no compliance burden on any business entities, including small entities. Although these temporary regulations will apply to all employers eligible for the credits under the Families First Act and the CARES Act, including small businesses and tax-exempt organizations with fewer than 500 employees, and will therefore be likely to affect a substantial number of small entities, the economic impact will not be significant. These temporary regulations do not affect the employer's employment tax reporting or the necessary information to substantiate entitlement to the credits. Rather, these temporary regulations merely implement the statutory authority granted under sections 7001(f) and 7003(f) of the Families First Act and section 2301(l) of the CARES Act that authorize the IRS to assess, reconcile, and recapture any portion of the credits erroneously credited, paid, or refunded in excess of the actual amount allowed as if the amounts were tax liabilities under sections 3111(a) and 3221(a) subject to assessment and administrative collection procedures. Notwithstanding this certification, the Treasury Department and the IRS invite comments on any impact these temporary regulations would have on small entities.
Pursuant to section 7805(f), these temporary regulations have been submitted to the Chief Counsel of the Office of Advocacy of the Small Business Administration for comment on its impact on small business.
The Treasury Department and the IRS have determined that good cause exists under section 553(b)(B) of the Administrative Procedure Act (APA) (5 U.S.C. 551
IRS notices and other guidance cited in this preamble are published in the Internal Revenue Bulletin (or Cumulative Bulletin) and are available from the Superintendent of Documents, U.S. Government Publishing Office, Washington, DC 20402, or by visiting the IRS website at
The principal author of these temporary regulations is NaLee Park, Office of the Associate Chief Counsel (Employee Benefits, Exempt Organizations, and Employment Taxes). However, other personnel from the Treasury Department and the IRS participated in the development of these temporary regulations.
Employment taxes, Income taxes, Penalties, Pensions, Railroad retirement, Reporting and recordkeeping requirements, Social security, Unemployment compensation.
Accordingly, 26 CFR part 31 is amended as follows:
26 U.S.C. 7805.
Section 31.3111-6T also issued under sec. 7001 and sec. 7003 of the Families First Coronavirus Response Act of 2020 and sec. 2301 of the Coronavirus Aid, Relief, and Economic Security Act of 2020.
Section 31.3221-5T also issued under sec. 7001 and sec. 7003 of the Families First Coronavirus Response Act of 2020 and sec. 2301 of the Coronavirus Aid, Relief, and Economic Security Act of 2020.
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(e)
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Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a safety zone for emergency purposes for all waters of the Lower Mississippi River (LMR), extending from mile 660.0 to mile 663.0. This emergency safety zone is needed to protect persons, property, and infrastructure from the potential safety hazards associated with the diving and salvage effort of a sunken barge at Mississippi River Mile Marker (MM) 661.0, in the vicinity of the Helena Highway Bridge, Helena, Arkansas. Deviation from the safety zone is prohibited unless specifically authorized by the Captain of the Port Lower Mississippi River or a designated representative.
This rule is effective without actual notice from July 29, 2020 through August 30, 2020, or until all diving and salvage work is complete, whichever occurs earlier. For the purposes of enforcement, actual notice will be used from July 13, 2020 through July 29, 2020.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email LT Adam J. Paz, U.S. Coast Guard; telephone 901-521-4825, email
The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because salvage efforts for a sunken barge mid-river will impede the safe navigation of vessel traffic and immediate action is needed to protect persons and property. Completing the full NPRM process is impracticable because we must establish this safety zone immediately.
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The Captain of the Port (COTP) Lower Mississippi River has determined that potential hazards associated with the salvage of a sunken barge will be a safety concern for anyone within a one-mile radius of the salvage operation. This rule is needed to protect persons, property, and infrastructure from the potential safety hazards associated with the diving and salvage effort of a sunken barge at Mississippi River Mile Marker (MM) 661.0, in the vicinity of the Helena Highway Bridge from July 13, 2020 through August 30, 2020, or until all diving and salvage work is complete, whichever occurs earlier.
This rule establishes a temporary safety zone from July 13, 2020 through August 30, 2020, or until all diving and salvage work is complete, whichever occurs earlier. The safety zone will cover all navigable waters of the Mississippi River from MM 660.0 to MM 663.0, extending the entire width of the river. The safety zone will only be activated when salvage work precludes safe navigation of the established channel. The duration of the zone is intended to protect persons, property, and infrastructure in these navigable waters while the salvage work is being conducted. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
This regulatory action determination is based on the size, location, and duration of the safety zone. This emergency safety zone will temporarily restrict navigation on the Mississippi River from MM 660.0 through MM 663.0 in the vicinity of Helena, Arkansas, from July 13, 2020 through August 30, 2020, or until all diving and salvage work is complete, whichever occurs earlier. The Coast Guard will issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 informing the public that the zone will be activated, and the rule would allow vessels to seek permission to enter the zone on a case-by-case basis.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has 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. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect 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 Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves an emergency safety zone on the Mississippi River from MM 660.0 through MM 663.0, that will prohibit entry into this zone unless permission has been granted by the COTP Lower Mississippi River or a designated representative. The safety zone will only be enforced during short durations while salvage work precludes the safe navigation of the established channel. It is categorically excluded from further review under paragraph L60(d) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1.
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to call or email the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
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(2) To seek permission to enter, contact the COTP or the COTP's representative by telephone or email. Those in the safety zone must comply with all lawful orders or directions given to them by the COTP or the COTP's designated representative.
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Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary security zone encompassing certain waters of the North Atlantic Ocean. The security zone is necessary to prevent waterside threats before, during, and after National Geospatial-Intelligence Agency equipment testing conducted offshore near Ocean City, MD. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Maryland-National Capital Region or his designated representative.
This rule is effective without actual notice from July 29, 2020 through 9:30 p.m. on August 28, 2020. For the purposes of enforcement, actual notice will be used from 9 a.m. on July 27, 2020, through July 29, 2020.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email Mr. Ron Houck, Sector Maryland-National Capital Region Waterways Management Division, U.S. Coast Guard; telephone 410-576-2674,
The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The COTP Maryland-National Capital Region has determined that a security zone is needed for waterborne protection of the public, mitigation of potential terrorist acts, and the enhancing of public and maritime safety and security in order to safeguard life, property, and the environment on or near the navigable waters near Ocean City, MD.
This rule establishes a security zone from 9 a.m. on July 27, 2020, through 9:30 p.m. on August 28, 2020. The security zone will be enforced from 9 a.m. to 9:30 p.m. on July 27, 2020, and those same hours on July 28, 2020, July 29, 2020, July 30, 2020, July 31, 2020, August 24, 2020, August 25, 2020, August 26, 2020, August 27, 2020, and August 28, 2020. The security zone will cover all waters of the North Atlantic Ocean, from surface to bottom, encompassed by a line connecting the following points beginning at 38°23′56″ N, 074°48′06″ W, thence south to 38°21′40″ N, 074°48′33″ W, thence south to 38°17′54″ N, 074°49′57″ W, thence southwest to 38°15′04″ N, 074°51′44″ W, thence northwest to 38°18′52″ N, 074°54′24″ W, thence north to 38°22′55″ N, 074°52′44″ W, and northeast back to the beginning point. The zone is approximately 9.3 nautical miles yards in length and 3.6 nautical miles yards in width. If a person or vessel has been granted permission to enter the zone, while they are operating in the zone that they must not enter waters within 1,000 yards of the on scene Coast Guard vessel or test equipment being used by Coast Guard personnel.
The duration of the rule and enforcement of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters while the Coast Guard vessel and test equipment are being used. All vessels and persons must obtain permission from the COTP Maryland-National Capital Region or his designated representative before entering the security zone. Equipment testing operations may occur anywhere within the security zone during the enforcement periods. Vessels and persons will not be permitted to enter the security zone within 1,000 yards of the Coast Guard vessel or test equipment. While this 1,00- yards area lies within the security zone, its exact location within the security zone may change.
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
This regulatory action determination is based on the location and duration of the security zone. This security zone will be enforced 125 hours over the course of a one month period. Vessels will be able to safely transit around the security zone, which impacts a small area of the North Atlantic Ocean, where vessel traffic is normally low. Additionally, the Coast Guard will make notifications to the maritime community via marine information broadcasts. The Coast Guard will update such notifications as necessary to keep the maritime community informed of the status of the security zone.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the
A rule has implications for federalism under Executive Order 13132, Federalism, if it has 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. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect 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 Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a security zone lasting only 125 total enforcement hours that will prohibit entry within a small portion of the North Atlantic Ocean. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to call or email the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
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(b)
(c)
(2) To seek permission to enter the security zone described in paragraph (a) of this section, contact the COTP or the COTP's representative by telephone at 410-576-2693 or on Marine Band Radio VHF-FM channel 16 (156.8 MHz). The Coast Guard vessel enforcing this section can be contacted on Marine Band Radio VHF-FM channel 16 (156.8 MHz). Those in the security zone must comply with all lawful orders or directions given to them by the COTP or the COTP's designated representative.
(3) A person or vessel operating in the security zone described in paragraph (a)(1) of this section must not enter waters within 1,000 yards of the on scene Coast Guard vessel or test equipment being used by Coast Guard personnel.
(d)
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone for navigable waters of the Fox River in Green Bay, WI. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards from a fireworks display. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port (COTP) Lake Michigan.
This rule is effective from 8 p.m. through 10 p.m. on August 1, 2020.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email Chief Petty Officer Kyle Weitzell, Sector Lake Michigan Waterways Management Division, U.S. Coast Guard; telephone 414-747-7148, email
The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a Notice of Proposed Rulemaking (NPRM) with respect to this rule because it is impracticable to do so. Notice of this event was submitted to the Coast Guard on July 6, 2020 and publishing a NPRM would delay the creation of this safety zone in time for the scheduled fireworks display on August 1, 2020.
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The COTP Lake Michigan has determined that potential hazards associated with fireworks over the Fox River on August 1, 2020 will be a safety concern for anyone within a 500-foot radius of the launch site. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the fireworks are being launched.
This rule establishes a safety zone from 8 p.m. through 10 p.m. on August 1, 2020. The safety zone will cover all navigable waters of the Fox River within a 500-foot radius of coordinates 44°31.15′ N, 088°00.86′ W. The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters while the fireworks are being launched. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP Lake Michigan or a designated representative.
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
This regulatory action determination is based on the size, location, and duration of this proposed safety zone. This regulation will be in effect on the Fox River within 500 feet of a fireworks display on August 1, 2020 for no more than two hours. Additionally, the COTP Lake Michigan may consider the movement of persons and vessels through or within the safety zone, if it is safe to do so.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has 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. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting only two hours that will prohibit entry within 500 feet of a fireworks display the Fox River. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to call or email the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(2) This safety zone is closed to all vessel traffic, except as may be permitted by the COTP Lake Michigan or a designated on-scene representative.
(3) The “on-scene representative” of the COTP Lake Michigan is any Coast Guard commissioned, warrant or petty officer who has been designated by the COTP Lake Michigan to act on his or her behalf.
(4) Vessel operators desiring to enter or operate within the safety zone must contact the COTP Lake Michigan or an on-scene representative to obtain permission to do so. The COTP Lake Michigan or an on-scene representative may be contacted via VHF Channel 16. Vessel operators given permission to enter or operate in the safety zone must comply with all directions given to them by the COTP Lake Michigan or an on-scene representative.
Office of Special Education and Rehabilitative Services (OSERS), Department of Education.
Final priority and definitions.
The Department of Education (Department) announces a priority and definitions under the State Personnel Development Grants program, Catalog of Federal Domestic Assistance (CFDA) number 84.323A. The Department may use this priority and definitions for competitions in fiscal year (FY) 2020 and later years. We take this action to focus attention on an identified national need to provide teachers and other personnel who serve children with disabilities the option to select professional development activities that will best meet their needs. This priority will support States in developing pilots or other innovative means of providing choice in professional development.
Jennifer Coffey, U.S. Department of Education, 400 Maryland Avenue SW, Room 5161, Potomac Center Plaza, Washington, DC 20202-5076. Telephone: (202) 245-6673. 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.
We published a notice of proposed priority and definitions (NPP) for this program in the
There are minor differences between the NPP and this notice of final priority and definitions (NFP) as discussed in
In response to concerns related to implementation science, the SPDG Government Performance Results Modernization Act of 2010 (GPRA) measures require projects to assess their use of implementation science principles when developing a professional development system. Specifically, an evidence-based professional development rubric is used to measure projects' use of implementation science strategies in their professional development activities. Additionally, projects use intervention fidelity measures to demonstrate changes in personnel practice as a result of participation in professional development. Finally, the effort provided for coaching or mentoring supports is reported by projects. The Department intends to use these GPRA measures for funded projects that respond to the Choice in Professional Development priority.
Also, the Department agrees that the teams supporting children with disabilities should take a coordinated approach in their efforts. The individuals on that team, however, may have varying professional development needs. The structure of the team provides an opportunity to bring the diverse skills and knowledge of the team members together in a way that best serves the needs of the child. Accordingly, the Department does not believe changes to the priority are necessary.
The purpose of this priority is to fund SPDG grants to SEAs that empower teachers and other personnel to select professional development activities that meet their individual needs to improve results for children with disabilities. States will meet the priority if they describe in their application how they will develop personalized professional development projects to carry out their State plan under section 653 of IDEA and implement professional development activities that are consistent with the use of funds provisions in section 654 of IDEA. This would be accomplished by using funds under the SPDG program for stipends or other mechanisms to provide personnel with choice in selecting professional development options that will count toward State or local professional development requirements, as appropriate, such as the number of hours personnel must fill or the competencies they must acquire to obtain or retain certification, and that are designed to meet their individual needs and thus improve results for children with disabilities.
Applicants must—
(a) Demonstrate, in the narrative section of the application under “Significance,” how the proposed project will develop personalized professional development activities using stipends or other mechanisms that provide personnel choice in professional development options designed to meet their individual needs and count toward State or local professional development requirements and thus improve results for children with disabilities;
(b) Describe how the State will select the individual(s) or groups of personnel that will be provided with professional development options, including the extent to which applicants will prioritize selecting individuals or groups of personnel serving rural children with disabilities or disadvantaged children with disabilities, such as children from low-income families. If applicable, applicants should specify how they will prioritize personnel if demand for professional development among the individuals or groups of personnel that the applicant proposes to serve exceeds what available funds can support;
(c) Describe how the State will create a list of approved professional development options that meet the requirements of the SPDG program. This description should include how the applicant will engage with a range of stakeholders, including school administrators, personnel serving students with disabilities, families of students with disabilities and individuals with disabilities, and other State or local agencies serving individuals with disabilities, such as juvenile justice agencies, to determine which professional development options it will offer. Specifically, professional development options must—
(1) Use evidence-based (as defined in this notice) professional development methods that will increase implementation of evidence-based practices and result in improved outcomes for children with disabilities;
(2) Include ongoing assistance that supports the implementation of evidence-based practices with fidelity (as defined in this notice); and
(3) Use technology to more efficiently and effectively provide ongoing professional development to personnel, including to personnel in rural areas and in urban or high-need local educational agencies (LEAs) (as defined in this notice);
(d) If applicable, describe the steps that personnel would need to take to request professional development options not already on a list of approved professional development options, the justification that personnel would need to provide to demonstrate how the selected options would improve results for children with disabilities, and how personnel would be notified if their request was approved or disapproved in writing and within 14 days; and
(e) Describe—
(1) The extent to which the proposed project will use professional development practices supported by evidence to support the attainment of identified competencies;
(2) How improvement in implementation of SPDG-supported practices over time will be demonstrated by participants in SPDG professional development activities;
(3) The extent to which the proposed project will use SPDG professional development funds to provide activities designed to sustain the use of SPDG-supported practices;
(4) How the proposed project will determine whether special education teachers who meet the qualifications described in section 612(a)(14)(C) of IDEA, as amended by the ESSA, that have participated in SPDG-supported special education teacher retention activities remain as special education teachers two years after their initial participation in these activities; and
(5) How the proposed project will assess whether and to what extent the project improves outcomes for children with disabilities.
When inviting applications for a competition using one or more priorities, we designate the type of each priority as absolute, competitive preference, or invitational through a notice in the
The Department establishes the following definitions for use with this priority and requirements, and with the SPDG program. We establish these definitions to ensure that applicants have a clear understanding of how we are using these terms. We use definitions the Department has adopted elsewhere and provide the source of existing definitions in parentheses.
(i) A randomized controlled trial employs random assignment of, for example, students, teachers, classrooms, or schools to receive the project component being evaluated (the treatment group) or not to receive the project component (the control group).
(ii) A regression discontinuity design study assigns the project component being evaluated using a measured variable (
(iii) A single-case design study uses observations of a single case (
(a) That serves not fewer than 10,000 children from families with incomes below the poverty line (as that term is defined in section 8101(41) of the ESEA), or for which not less than 20 percent of the children served by the LEA are from families with incomes below the poverty line; and
(b) For which there is (1) a high percentage of teachers not teaching in the academic subjects or grade levels that the teachers were trained to teach, or (2) a high percentage of teachers with emergency, provisional, or temporary certification or licensing.
(i) A practice guide prepared by WWC reporting a “strong evidence base” or “moderate evidence base” for the corresponding practice guide recommendation;
(ii) An intervention report prepared by the WWC reporting a “positive effect” or “potentially positive effect” on a relevant outcome with no reporting of a “negative effect” or “potentially negative effect” on a relevant outcome; or
(iii) A single study assessed by the Department, as appropriate, that—
(A) Is an experimental study, a quasi-experimental design study, or a well-designed and well-implemented correlational study with statistical controls for selection bias (
(B) Includes at least one statistically significant and positive (
(i) A practice guide prepared by the WWC using version 2.1 or 3.0 of the WWC Handbook reporting a “strong evidence base” for the corresponding practice guide recommendation;
(ii) An intervention report prepared by the WWC using version 2.1 or 3.0 of the WWC Handbook reporting a “positive effect” on a relevant outcome based on a “medium to large” extent of evidence, with no reporting of a “negative effect” or “potentially negative effect” on a relevant outcome; or
(iii) A single experimental study reviewed and reported by the WWC using version 2.1 or 3.0 of the WWC Handbook, or otherwise assessed by the Department using version 3.0 of the WWC Handbook, as appropriate, and that—
(A) Meets WWC standards without reservations;
(B) Includes at least one statistically significant and positive (
(C) Includes no overriding statistically significant and negative effects on relevant outcomes reported in the study or in a corresponding WWC intervention report prepared under version 2.1 or 3.0 of the WWC Handbook; and
(D) Is based on a sample from more than one site (
The What Works Clearinghouse Procedures and Standards Handbook (Version 3.0), as well as the more recent What Works Clearinghouse Handbooks released in October 2017 (Version 4.0) and January 2020 (Version 4.1), are available at
This document does not preclude the Department from proposing additional priorities, requirements, definitions, or selection criteria, subject to meeting applicable rulemaking requirements.
This document does
Under Executive Order 12866, the Office of Management and Budget (OMB) determines whether this regulatory action is “significant” and, therefore, subject to the requirements of the Executive order and subject to review by OMB. Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action likely to result in a rule that may—
(1) Have an annual effect on the economy of $100 million or more, or adversely affect a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or Tribal governments or communities in a material way (also referred to as an “economically significant” rule);
(2) Create serious inconsistency or otherwise interfere with an action taken or planned by another agency;
(3) Materially alter the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or
(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles stated in the Executive order.
This final regulatory action is not a significant regulatory action subject to review by OMB under section 3(f) of Executive Order 12866. Pursuant to the Congressional Review Act (5 U.S.C. 801
Under Executive Order 13771, for each new rule that the Department proposes for notice and comment or otherwise promulgates that is a significant regulatory action under Executive Order 12866, and that imposes total costs greater than zero, it must identify two deregulatory actions. For FY 2020, any new incremental costs associated with a new regulation must be fully offset by the elimination of existing costs through deregulatory actions. Because this regulatory action is not significant, the requirements of Executive Order 13771 do not apply.
We have also reviewed this final regulatory action under Executive Order 13563, which supplements and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, Executive Order 13563 requires that an agency—
(1) Propose or adopt regulations only upon a reasoned determination that their benefits justify their costs (recognizing that some benefits and costs are difficult to quantify);
(2) Tailor its regulations to impose the least burden on society, consistent with obtaining regulatory objectives and taking into account—among other things and to the extent practicable—the costs of cumulative regulations;
(3) In choosing among alternative regulatory approaches, select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity);
(4) To the extent feasible, specify performance objectives, rather than the behavior or manner of compliance a regulated entity must adopt; and
(5) Identify and assess available alternatives to direct regulation, including economic incentives—such as user fees or marketable permits—to encourage the desired behavior, or provide information that enables the public to make choices.
Executive Order 13563 also requires an agency “to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.” The Office of Information and Regulatory Affairs of OMB has emphasized that these techniques may include “identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes.”
We are issuing this final priority and definitions only on a reasoned determination that their benefits justify their costs. In choosing among alternative regulatory approaches, we selected those approaches that maximize net benefits. Based on the analysis that follows, the Department believes that this regulatory action is consistent with the principles in Executive Order 13563.
We also have determined that this regulatory action does not unduly interfere with State, local, and Tribal governments in the exercise of their governmental functions.
In accordance with these Executive orders, the Department has assessed the potential costs and benefits, both quantitative and qualitative, of this regulatory action. The potential costs are those resulting from statutory requirements and those we have determined as necessary for administering the Department's programs and activities.
The Department believes that the costs associated with this final priority and definitions will be minimal, while the benefits are significant. The Department believes that this regulatory action does not impose significant costs on eligible entities. Participation in this program is voluntary, and the costs imposed on applicants by this regulatory action will be limited to paperwork burden related to preparing an application. The benefits of implementing the program—to assist SEAs in reforming and improving their systems for personnel preparation and professional development in early intervention, educational, and transition services in order to improve results for children with disabilities—will outweigh the costs incurred by applicants, and the costs of carrying out activities associated with the application will be paid for with program funds. For these reasons, we have determined that the costs of implementation will not be burdensome for eligible applicants, including small entities.
The final priority and definitions contain information collection requirements that are approved by OMB under OMB control number 1820-0028; the final priority and definitions do not affect the currently approved data collection.
The small entities that this final regulatory action will affect are SEAs of the 50 States, the District of Columbia, or the Commonwealth of Puerto Rico or an outlying area (United States Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands). We believe that the costs imposed on an applicant by the final priority and definitions will be limited to paperwork burden related to preparing an application and that the benefits of this final priority and these final definitions will outweigh any costs incurred by the applicant.
Participation in the SPDG program is voluntary. For this reason, the final priority and definitions will impose no burden on small entities unless they apply for funding under the program. We expect that in determining whether to apply for SPDG program funds, an eligible entity will evaluate the requirements of preparing an application and any associated costs, and weigh them against the benefits likely to be achieved by receiving an SPDG program grant. An eligible entity will probably apply only if it determines that the likely benefits exceed the costs of preparing an application.
We believe that the final priority and definitions will not impose any additional burden on a small entity applying for a grant than the entity would face in the absence of the final action. That is, the length of the applications those entities would submit in the absence of the final regulatory action and the time needed to prepare an application will likely be the same.
This final regulatory action will not have a significant economic impact on a small entity once it receives a grant because it would be able to meet the costs of compliance using the funds provided under this program.
This document provides early notification of our specific plans and actions for this program.
You may also access documents of the Department published in the
Department of Veterans Affairs.
Final rule.
The Department of Veterans Affairs (VA) is amending its regulations that govern scholarship programs to certain health care professionals. This rulemaking implements the mandates of the VA MISSION Act of 2018 by establishing a Specialty Education Loan Repayment Program, which will assist VA in meeting the staffing needs of VA physicians in medical specialties for which VA has determined that recruitment or retention of qualified personnel is difficult.
This rule is effective August 28, 2020.
Teresa Culpepper, Manager, Education Loan Repayment Services, 810 Vermont Avenue NW, Washington, DC 20420, (501) 687-4064. (This is not a toll-free number.)
On December 26, 2019, VA published a proposed rule in the
On June 6, 2018, section 303 of Public Law 115-182, the John S. McCain III, Daniel K. Akaka, and Samuel R. Johnson VA Maintaining Internal Systems and Strengthening Integrated Outside Networks Act of 2018, or the VA MISSION Act of 2018, amended title 38 of the United States Code (U.S.C.) by establishing new sections 7691 through 7697 and created the SELRP. The SELRP serves as an incentive for physicians starting or currently in residency programs in medical specialties, for which VA has determined that recruitment and retention of qualified personnel is difficult, to work at VA facilities that need more physicians within that medical specialty after the individual completes their residency program. VA will determine the anticipated needs for medical specialties during a period of two to six years in the future. In taking this proactive approach, VA will commence recruitment for physicians in these specialties before the projected need to help ensure adequate health care coverage for VA beneficiaries. This final rule will establish the requirements for the SELRP in new 38 CFR 17.525 through 17.531.
One commenter requested that VA expand the individuals who qualify for the SELRP to include certified registered nurse anesthetists (CRNAs). The commenter stated that they understand there is underutilization and staffing shortages of other types of providers, including certified registered nurse anesthetists (CRNAs), and the commenter asked that this loan
We agree with the commenters in that VA's shortage of health care professionals is not limited to physicians. However, 38 U.S.C. 7693 establishes the eligibility criteria for individuals who wish to participate in the SELRP. This criteria states that eligible individuals must be recently graduated from an accredited medical or osteopathic school and matched to an accredited residency program in a medical specialty described in section 7692 of this title; or a physician in training in a medical specialty described in section 7692 of this title with more than 2 years remaining in such training. As such, VA cannot extend the eligibility criteria to include individuals who are not otherwise listed in section 7692. We are not making any changes based on these comments.
A commenter requested that CRNAs be granted the ability to practice to the full scope of their education, training, licensure, and certification in VA medical facilities to allow veterans to receive access to safe and timely anesthesia services. The commenter stated that this step would make an anesthesia position within the VA more attractive in its own right to prior active duty and civilian CRNAs. The commenter's request that VA grant CRNAs full practice authority is beyond the scope of the proposed rule. We are not making any changes based on this comment.
Another commenter recommended expanding the Doctors Across New York, or DANY, program that, as one of its features, forgives up to $150,000 of student loan debt for young physicians who commit to practicing medicine in certain parts of the state for at least five years. The commenter stated that medical school graduates from the class of 2012 left school with an average student loan debt of $166,750, according to the Association of American Medical Colleges. The commenter added that in the most recent round of the DANY program, 26 young doctors in 2013 received the full, five-year awards. The SELRP is not a loan forgiveness program. Section 7494(c)(1) of 38 U.S.C. states that the amount of payments made for a participant under the SELRP may not exceed $160,000 over a total of four years of participation in the Program, of which not more than $40,000 of such payments may be made in each year of participation in the Program. If an individual participates in the SELRP for four years, the total amount of repayment of the individual's educational loan would be more than the $150,000 that the commenter stated that is repaid under the DANY. Also, VA does not have the statutory authority to adopt any provision of the DANY and any such adoption is beyond the scope of the proposed rule. We are not making any changes based on this comment.
Several comments proposed opening new physician or medical schools, with some comments offering a specific number of schools to be opened, and some comments offering specific reasons why such schools should be opened or current failings to open such schools. The opening of new physician or medical schools is beyond the scope of the proposed rule and is not within VA's authority to do under section 303 of Public Law 115-182. We are not making any changes based on these comments.
A commenter referred to a HANYS survey and stated that they agree with this survey in that the survey recommends greater use of telemedicine to allow certain specialists to remotely provide a consultation or other medical service to patients in underserved areas of the state. The commenter did not provide more details on the source of the survey or the date of the study, so we are not clear what this survey might refer or relate to. Although the provision of telehealth services is beyond the scope of the proposed rule, we generally respond that VA has regulations in place that grant VA health care professionals the ability to provide telehealth services, within their scope of practice, functional statement, and/or in accordance with privileges granted to them by VA, irrespective of the State or location within a State where the health care provider or the beneficiary is physically located.
A commenter stated that incentives for medical students to pursue a career in primary care by helping with student loans is not enough to change what the commenter stated was a trend in which less than 10 percent of medical students are going into primary care. The commenter added that Medicare needs to restructure the reimbursement system now so current family practitioners, internists and pediatricians will have higher pay. The restructuring of Medicare's reimbursement system is beyond the scope of the proposed rulemaking. We are not making any changes based on this comment.
Another commenter indicated that they have long advocated for better recruitment of psychiatrists in the VA through the Clay Hunt Suicide Prevention for American Veterans Act, which included a pilot project encouraging more psychiatrists to choose a career with the VA by offering medical school loan repayments on par with those offered by other government agencies and private practices. The commenter added that the program was never implemented, but they are encouraged by the release of the SELRP and its potential to incentivize more psychiatrists to pursue careers with the VA. VA established into regulations the Program for the Repayment of Educational Loans for Certain VA Psychiatrists (PREL), which was established by Public Law 114-2, section 4, the Clay Hunt Suicide Prevention for American Veterans Act (Clay Hunt SAV Act).
A commenter recommended that the SELRP be portable to sites where specialty is needed instead of the recipient being placed in one location. We believe the commenter intended to recommend that the SELRP be portable to VA facilities where a resident's specialty is needed, to enable rotations or other multiple assignments of such residents. As previously stated in this rulemaking, the SELRP serves as an
A commenter stated that special protections or a continuation of eligibility should also be included for parental leave to encourage women to participate. The commenter added that given that this is early career, such protections are necessary to support applicants. The commenter also stated that Federal guidelines on parental leave should be followed as a minimum. VA agrees with the commenter. Because the participants of the SELRP are appointed VA employees, all Federal rules regarding parental leave apply. We are not making any changes based on this comment.
A commenter recommended that VA ensure that they coordinate with local VAs to announce and connect potential loan repayment recipients with local vacancies. The proposed rule stated in § 17.527(a)(1) that in determining staffing needs, VA will consider the anticipated needs of VA for a period of two to six years in the future. VA will publish these vacancies in a notice in the
A commenter also recommended that VA develop a process to comprehensively evaluate and track the application and placement process for accountable and equitable disbursement among the applicants, to ensure that psychiatrists are receiving equivalent consideration for this program among the specialties. The commenter added that this process could also include a mechanism to ensure the application process is not too burdensome for prospective candidates, thus streamlining the process overall. VA is leveraging existing programs and technologies to meet the lengthy application requirements while minimizing redundant requests for information. For example, VA will utilize approved VA forms to collect personnel and job application information instead of creating new program forms. We are not making any changes based on this comment.
We are making technical edits to § 17.529(c)(2)(i) for clarity. Proposed § 17.528(c)(2)(i) stated that a summary of the applicant's educational debt, which includes the total debt amount and when the debt was acquired, would be one piece of information that must be provided to VA. Proposed § 17.528(c)(2)(i) further stated that the health professional debt covered the loan must be specific to education that was required, used, and qualified the applicant for appointment as a physician. We have amended this paragraph to now state a summary of the applicant's educational loan, which includes the total loan amount and when the loan was acquired. The educational loan must be specific to the education that was required and used to qualify the applicant for appointment as a physician. VA always intended the meaning of the educational loan in this paragraph to clearly state that the eligible loan would only be that which was required and used to qualify an applicant for the SELRP. This change does not result in any substantive change in meaning and is only intended to be a technical change.
Based on the rationale set forth in the Supplementary Information to the proposed rule and in this final rule, VA is adopting the proposed rule with the edits discussed in this rule.
The Paperwork Reduction Act of 1995 (at 44 U.S.C. 3507) requires that VA consider the impact of paperwork and other information collection burdens imposed on the public. According to the 1995 amendments to the Paperwork Reduction Act (5 CFR 1320.8(b)(2)(vi)), an agency may not collect or sponsor the collection of information, nor may it impose an information collection requirement unless it displays a currently valid Office of Management and Budget (OMB) control number. This rule includes provisions constituting new collections of information under the Paperwork Reduction Act of 1995 that require approval by the OMB. Accordingly, under 44 U.S.C. 3507(d), VA has submitted a copy of this rulemaking action to OMB for review.
38 CFR 17.528 contains collections of information under the Paperwork Reduction Act of 1995. If OMB does not approve the collections of information as requested, VA will immediately remove the provisions containing a collection of information or take such other action as is directed by the OMB.
The collections of information contained in 38 CFR 17.528 are described immediately following this paragraph.
The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. The provisions associated with this rulemaking are not processed by any other entities outside of VA. Therefore, pursuant to 5 U.S.C.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. The Office of Information and Regulatory Affairs has determined that this rule is not a significant regulatory action under Executive Order 12866.
VA's impact analysis can be found as a supporting document at
This final rule is not expected to be an E.O. 13771 regulatory action because this final rule is not significant under E.O. 12866.
The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. This final rule will have no such effect on State, local, and tribal governments, or on the private sector.
Pursuant to the Congressional Review Act (5 U.S.C. 801
There are no Catalog of Federal Domestic Assistance numbers and titles for this rule.
Administrative practice and procedure, Health care, Health facilities, Health professions, Health records, Medical and dental schools, Scholarships and fellowships, Veterans.
The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Brooks D. Tucker, Acting Chief of Staff, Department of Veterans Affairs, approved this document on July 13, 2020, for publication.
For the reasons stated in the preamble, the Department of Veterans Affairs amends 38 CFR part 17 as follows:
38 U.S.C. 501, and as noted in specific sections.
Sections 17.525 through 17.531 are also issued under 38 U.S.C. 7691 through 7697.
The purpose of §§ 17.525 through 17.531 is to establish the Specialty Education Loan Repayment Program (SELRP). The SELRP is an incentive program for certain individuals to meet VA's need for physicians in medical specialties for which VA determines that recruitment and retention of qualified personnel is difficult. Assistance under the SELRP may be in addition to other assistance available to individuals under the Educational Assistance Program under 38 U.S.C. 7601.
The following definitions apply to §§ 17.525 through 17.530:
(1) Loans obtained from family members, relatives, or friends;
(2) Loans made prior to, or after, the individual's qualifying education;
(3) Any portion of a consolidated loan that is not specifically identified with the education and purposes for which the SELRP may be authorized, such as home or auto loans merged with educational loans;
(4) Loans for which an individual incurred a service obligation for repayment or agreed to service for future cancellation;
(5) Credit card debt;
(6) Parent Plus Loans;
(7) Loans that have been paid in full;
(8) Loans that are in default, delinquent, not in a current payment status, or have been assumed by a collection agency;
(9) Loans not obtained from a bank, credit union, savings and loan association, not-for-profit organization, insurance company, school, and other financial or credit institution which is subject to examination and supervision in its capacity as a lending institution by an agency of the United States or of the state in which the lender has its principal place of business;
(10) Loans for which supporting documentation is not available;
(11) Loans that have been consolidated with loans of other individuals, such as spouses, children, friends, or other family member; or
(12) Home equity loans or other noneducational loans.
(a)
(1) Will be eligible for appointment under 38 U.S.C. 7401 to work as a physician in a medical specialty for which VA determines that recruitment or retention of qualified personnel is difficult. In determining staffing needs, VA will consider the anticipated needs of VA for a period of two to six years in the future. VA will publish these vacancies in a notice in the
(2) Owes any amount of principal or interest for an educational loan where the proceeds were used by or on behalf of the individual to pay costs relating to a course of medical education or training that leads to employment as a physician and;
(3) Is:
(i) Recently graduated from an accredited medical or osteopathic school and matched to an accredited residency program in a medical specialty designated by VA; or
(ii) A physician in training with more than 2 years remaining in such training.
(b)
(1) The applicant is matched with the residency; and
(2) VA has published the residency in a Notice in the
(c)
(1) Are, or will be, participating in residency programs in health care facilities that are:
(i) Located in rural areas;
(ii) Operated by Indian tribes, tribal organizations, or the Indian Health Services; or
(iii) Are affiliated with underserved health care facilities of VA; or
(2) Veterans.
(a)
(b)
(1) One letter of reference from the Program Director of the core program in which the applicant is training, which indicates that the applicant is in good to excellent standing, or, for individuals who have yet to initiate training, a letter of reference from a faculty member or dean;
(2) One or more letters of reference from faculty members under which the applicant trained; and
(3) One letter of reference from a peer colleague who is familiar with the practice and character of the applicant.
(c)
(1) A cover letter that provides the following information:
(i) Why the applicant is interested in VA employment;
(ii) The applicant's interest in working at a particular medical specialty and underserved area;
(iii) Likely career goals, including career goals in VA; and
(iv) A brief summary of past employment or training and accomplishments, including any particular clinical areas of interest (
(2) The following information must be provided on a VA form or online collection system and is subject to VA verification:
(i) A summary of the applicant's educational loan, which includes the total loan amount and when the loan was acquired. The educational loan must be specific to the education that was required and used to qualify the applicant for appointment as a physician.
(ii) The name of the lending agency that provided the educational loan.
(3) A full curriculum vitae.
(a)
(2) An educational loan repayment may not exceed the actual amount of principal and interest on an educational loan or loans.
(b)
(c)
(a)
(1) Obtain a license to practice medicine in a State;
(2) Successfully complete postgraduate training leading to eligibility for board certification in a medical specialty;
(3) Serve as a full-time clinical practice employee of VA for 12 months for every $40,000.00 that the participant receives payment through the SELRP, however, the participant must serve for a period of no fewer than 24 months; and
(4) Except as provided in paragraph (b) of this section, begin obligated service as a full-time VA employee no later than 60 days after completing residency in the medical specialty described in § 17.527(a)(1).
(b)
(2)
(c)
A participant of the SELRP who fails to satisfy the period of obligated service will owe the United States government an amount determined by the formula A = B × ((T−S) ÷ T)), where:
(a) “A” is the amount the participant owes the United States government.
(b) “B” is the sum of all payments to or for the participant under the SELRP.
(c) “T” is the number of months in the period of obligated service of the participant.
(d) “S” is the number of whole months of such period of obligated service served by the participant.
Environmental Protection Agency (EPA).
Correcting amendment.
On June 2, 2020, the Environmental Protection Agency (EPA) issued a final rule entitled “Clean Air Plans; 2008 8-Hour Ozone Nonattainment Area Requirements; Phoenix-Mesa, Arizona.” That publication inadvertently omitted from the regulatory text the disapproval of the portion of the “MAG 2017 Eight-Hour Ozone Moderate Area Plan for the Maricopa Nonattainment Area (December 2016)” (“MAG 2017 Ozone Plan”) that addresses the requirements for contingency measures for failure to attain or to make reasonable further progress (RFP). This document corrects this error in the regulatory text.
This rule is effective on July 29, 2020.
The EPA has established a docket for this action under Docket ID No. EPA-R09-OAR-2019-0541. All documents in the docket are listed on the
Nancy Levin, EPA Region IX, 75 Hawthorne Street, San Francisco, CA 94105. Phone: (415) 972-3848 or by email at
On June 2, 2020, the Environmental Protection Agency (EPA) issued a final rule entitled “Clean Air Plans; 2008 8-Hour Ozone Nonattainment Area Requirements; Phoenix-Mesa, Arizona.” That publication inadvertently omitted from the regulatory text the disapproval of the portion of the MAG 2017 Ozone Plan that addresses the requirements for contingency measures for failure to attain or to make RFP. This action corrects the omission in Section 52.120 table 1.
The EPA has determined that this action falls under the “good cause” exemption in section 553(b)(3)(B) of the Administrative Procedure Act (APA) which, upon finding “good cause,” authorizes agencies to dispense with public participation where public notice and comment procedures are impracticable, unnecessary, or contrary to the public interest. Public notice and comment for this action is unnecessary because the underlying rule for which this correcting amendment has been prepared was already subject to a 30-day comment period, and this action is merely correcting a minor typographical error in the rule text. Further, this action is consistent with the purpose and rationale of the final rule, which is corrected herein. Because this action does not change the EPA's analyses or overall actions, no purpose would be served by additional public notice and comment. Consequently, additional public notice and comment are unnecessary.
The EPA also finds that there is good cause under APA section 553(d)(3) for this correction to become effective on the date of publication of this action. Section 553(d)(3) of the APA allows an effective date of less than 30 days after publication “as otherwise provided by the agency for good cause found and published with the rule.” 5 U.S.C. 553(d)(3). The purpose of the 30-day waiting period prescribed in APA section 553(d)(3) is to give affected parties a reasonable time to adjust their behavior and prepare before the final rule takes effect. This rule does not create any new regulatory requirements such that affected parties would need time to prepare before the rule takes effect. This action merely corrects a typographical error in a previous rulemaking. For these reasons, the EPA finds good cause under APA section 553(d)(3) for this correction to become effective on the date of publication of this action.
Under Executive Order (E.O.) 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and is therefore not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to E.O. 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action is not an E.O. 13771 (82 FR 9339, February 2, 2017) regulatory action because this action is not significant under E.O. 12866. Because the agency has made a “good cause” finding that this action is not subject to notice-and-comment requirements under the Administrative Procedures Act or any other statute as indicated in the Supplementary Information section above, it is not subject to the regulatory flexibility provisions of the Regulatory Flexibility Act (5 U.S.C. 601
The Congressional Review Act (5 U.S.C. 801
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
42 U.S.C. 7401
For the reasons stated in the preamble, EPA corrects Part 52, Chapter I, Title 40 of the Code of Federal Regulations by making the following correcting amendments:
42 U.S.C. 7401
(e) * * *
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is taking final action to approve portions of a State Implementation Plan (SIP) revision submitted by the State of Florida, through the Florida Department of Environmental Protection (FDEP), on February 27, 2013. These portions change the State's public notice and comment rule for air permitting by modifying the length of the public comment period for minor source operating permitting and by making non-substantive edits.
This rule is effective August 28, 2020.
EPA has established a docket for this action under Docket Identification No. EPA-R04-OAR-2017-0105. All documents in the docket are listed on the
D. Brad Akers, 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. Mr. Akers can be reached via telephone at (404) 562-9089 or via electronic mail at
EPA is approving changes to the Florida SIP that were provided to EPA through FDEP via a letter dated February 27, 2013.
Comments on the NPRM were due on or before June 4, 2020, and EPA received one comment. EPA has summarized this comment and is providing a response in the following section. The complete comment is available in the docket for this rulemaking.
Nonetheless, all SIP submittals, including those that contain permit conditions for incorporation into the SIP, must undergo a 30-day public comment period at the state level pursuant to CAA Section 110(a), 40 CFR 51.102, and Appendix V to 40 CFR part 51,
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 Rule 62-210.350, F.A.C.,
EPA is approving changes to the Florida SIP included in a February 27, 2013, submittal. Specifically, EPA is approving changes to the public comment period regarding FESOPs, as well as non-substantive edits, in Rule 62-210.350, F.A.C.,
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations.
• 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 SIP approvals are exempted 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).
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 as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.
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 September 28, 2020. 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.
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Reporting and recordkeeping requirements.
Therefore, for the reasons stated in the preamble, the EPA amends 40 CFR part 52 as follows:
42 U.S.C. 7401
(c) * * *
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is approving State Implementation Plan (SIP) revisions submitted by the State of South Carolina through letters dated April 12, 2019, and July 11, 2019, to establish a SIP-approved state control program to comply with the Nitrogen Oxides (NO
This rule is effective August 28, 2020.
EPA has established a docket for this action under Docket Identification No. EPA-R04-OAR-2019-0612. All documents in the docket are listed on the
Gobeail McKinley, 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) 562-9230. Ms. McKinley can also be reached via electronic mail at
Under Clean Air Act (CAA or Act) section 110(a)(2)(D)(i)(I), which EPA has traditionally termed 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 eastern states, including South Carolina, to submit SIPs that prohibited
On October 9, 2007, EPA approved an “abbreviated SIP” for South Carolina, consisting of regulations governing allocation of NO
On October 16, 2009, EPA approved a “full SIP” for South Carolina, through which various CAIR implementation provisions became governed by State rules rather than Federal rules.
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 on the D.C. Circuit's remand of CAIR, EPA promulgated the Cross-State Air Pollution Rule (CSAPR) to replace CAIR and address the good neighbor provisions for the 1997 ozone NAAQS, the 1997 PM
After litigation that reached the Supreme Court, the D.C. Circuit generally upheld CSAPR but remanded several state budgets to EPA for reconsideration, including the Phase 2 ozone season NO
Under 40 CFR 51.121(i)(4) of the NO
On April 12, 2019, and July 11, 2019,
See EPA's May 5, 2020 (85 FR 26635), NPRM for further detail on these changes and EPA's rationale for approving them. EPA did not receive public comments on the May 5, 2020, NPRM.
In this rule, the 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 South Carolina Regulation 61-62.96 titled, “Nitrogen Oxides (NO
EPA is approving South Carolina's SIP April 12, 2019, and July 11, 2019, SIP revisions and incorporating Regulation 61-62.96 entitled, “Nitrogen Oxides (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, these actions merely approve state law as meeting Federal requirements and do not impose additional requirements beyond those imposed by state law. For that reason, these actions:
• 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);
• Are not Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory actions because SIP approvals are exempted under Executive Order 12866;
• 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).
Because these actions merely approve state law as meeting Federal requirements and do not impose additional requirements beyond those imposed by state law, this action for the State of South Carolina does not have Tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). Therefore, this action will not impose substantial direct costs on Tribal governments or preempt Tribal law. The Catawba Indian Nation (CIN) Reservation is located within the boundary of York County, South Carolina. Pursuant to the Catawba Indian Claims Settlement Act, S.C. Code Ann. 27-16-120 (Settlement Act), “all state and local environmental laws and regulations apply to the [Catawba Indian Nation] and Reservation and are fully enforceable by all relevant state and local agencies and authorities.” The CIN also retains authority to impose regulations applying higher environmental standards to the Reservation than those imposed by state law or local governing bodies, in accordance with the Settlement Act.
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 September 28, 2020. 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.
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides.
Accordingly, 40 CFR part 52 is amended as follows:
42 U.S.C. 7401
(c) * * *
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to adopt a new airworthiness directive (AD) for certain Textron Aviation Inc. (Textron) (type certificate previously held by Beechcraft Corporation) Models F90, 65-90, 65-A90, B90, C90, H90 (T-44A), E90, 65-A90-1 (JU-21A, U-21A, RU-21A, RU-21D, U-21G, RU-21H), 65-A90-2 (RU-21B), 65-A90-3 (RU-21C), 65-A90-4 (RU-21E, RU-21H), 99, 99A, 99A (FACH), A99, A99A, B99, C99, 100, A100 (U-21F), and B100 airplanes. This proposed AD was prompted by reports of fatigue cracks in the lower forward wing fitting. This proposed AD would require a one-time inspection for the presence of washer part number (P/N) 90-380058-1 on the left-hand (LH) and right-hand (RH) lower forward wing bolt and, if applicable, removing washer P/N 90-380058-1, inspecting the wing fitting, bolt, and nut, replacing the wing fitting if it is cracked, and replacing the washer with washer P/N 90-380019-1. The FAA is proposing this AD to address the unsafe condition on these products.
The FAA must receive comments on this proposed AD by September 14, 2020.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this NPRM, contact Textron Aviation Inc., P.O. Box 7706, Wichita, KS 67277: phone: 316-517-5800; internet:
You may examine the AD docket on the internet at
Brian C. Adamson, Aerospace Engineer, Wichita ACO Branch, AIR-7K3, FAA, 1801 Airport Rd, Wichita, KS 67209; phone: 316-946-4193; fax: 316-946-4107; email:
The FAA invites you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
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 we receive, without change, to
Confidential Business Information (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 Brian C. Adamson, Aerospace Engineer, Wichita ACO Branch, AIR-7K3, FAA, 1801 Airport Rd, Wichita, KS 67209; phone: 316-946-4193; fax: 316-946-4107; email:
Textron has received reports of fatigue cracks in the lower forward wing fitting on two airplanes. Investigation revealed that installing washer P/N 90-380058-1 on the wing bolt will cause a premature torque indication. This washer may have been installed as part of kit 101-4024-3 on Models F90, 65-90, 65-A90, B90, C90, H90 (T-44A), E90, 65-A90-1 (JU-21A, U-21A, RU-21A, RU-21D, U-21G, RU-21H), 65-A90-2 (RU-21B), 65-A90-3 (RU-21C), 65-A90-4 (RU-21E, RU-21H), 99, 99A, 99A (FACH), A99, A99A, B99, C99, 100, A100 (U-21F), and B100 airplanes, or as part of kit 90-4077-1 on Models 65-90, 65-A90, 65-A90-1 (JU-21A, U-21A, RU-21A, RU-21D, U-21G, RU-21H),
This condition, if not addressed, could result in fatigue cracks that lead to failure of the forward lower wing fitting, wing separation, and loss of airplane control.
The FAA reviewed Beechcraft Mandatory Service Letter MTL-57-01, Revision 1, dated September 19, 2018. The service information contains procedures for a one-time inspection for the presence of washer P/N 90-380058-1 on the LH and RH lower forward wing bolt and, if applicable, removing washer P/N 90-380058-1; inspecting the wing fitting, bolt, and nut; replacing the wing fitting if it is cracked; and replacing the washer with washer P/N 90-380019-1. 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
The FAA is proposing this AD because it evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of this same type design.
This proposed AD would require accomplishing the actions specified in the service information described previously.
The service information specifies inspecting within 200 flight hours or 12 months, whichever occurs earlier. This proposed AD would require inspecting within the next 200 flight hours or 12 months, whichever occurs later.
The service information applies to Models A100A and A100C airplanes, and to Model F90 with S/N LA-1. This proposed AD would not apply to these airplanes because they do not have an FAA type certificate.
This proposed AD would apply to military models T-44A, JU-21A, RU-21A, RU-21B, RU-21C, RU-21D, RU-21E, RU-21H, U-21A, U-21F, U-21G, and FACH airplanes, because these models have a civil counterpart that is subject to the unsafe condition. The service information does not apply to all of these military models.
The FAA estimates that this proposed AD would affect 1,319 airplanes of U.S. registry.
The FAA estimates the following costs to comply with this proposed AD:
The FAA estimates the following costs to do any necessary replacements that would be required based on the results of the proposed inspection. The FAA has no way of determining the number of airplanes that might need these replacements:
According to the manufacturer, some or all of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected individuals. The FAA does not control warranty coverage for affected individuals. As a result, the FAA has included all costs in this cost estimate.
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
For the reasons discussed above, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Will not affect intrastate aviation in Alaska, and
(3) Will 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 by September 14, 2020.
None.
This AD applies to the Textron Aviation Inc. (type certificate previously held by Beechcraft Corporation) airplanes, certificated in any category, identified in table 1 to paragraph (c) of this AD:
Joint Aircraft System Component (JASC): 5700, Wings.
This AD was prompted by information provided by Textron Aviation Inc. that a washer assembly may provide premature torque indication that could lead to cracking of the wing fitting. The FAA is issuing this AD to prevent such fatigue cracks. The unsafe condition, if not addressed, could result in failure of the forward lower wing fitting, which could lead to wing separation and loss of airplane control.
Comply with this AD within the compliance times specified below, unless already done.
(1) Within the next 200 flight hours after the effective date of this AD or within 12 months after the effective date of this AD, whichever occurs later, inspect each washer assembly attached to the left and right lower forward wing bolts and remove all part number 90-380058-1 washers in accordance with the Accomplishment Instructions, paragraphs 3 through 5, of Beechcraft Mandatory Service Letter MTL-57-01, Revision 1, dated September 19, 2018 (MTL-57-01). In all locations where a washer part number 90-380058-1 was removed, do the following:
(i) Inspect the bolt, nut, and fitting in accordance with the Accomplishment Instructions, paragraph 6, of MTL-57-01. If there is a crack in the fitting, replace the fitting before further flight.
(ii) Install a part number 90-380019-1 washer in accordance with the Accomplishment Instructions, paragraph 7, of MTL-57-01.
(2) As of the effective date of this AD, do not install washer part number 90-380058-1 on any airplane listed in table 1 to paragraph (c) of this AD.
(1) The Manager, Wichita ACO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Brian C. Adamson, Aerospace Engineer, Wichita ACO Branch, AIR-7K3, FAA, 1801 Airport Rd, Wichita, KS 67209; phone: 316-946-4193; fax: 316-946-4107; email:
(1) For more information about this AD, contact Brian C. Adamson, Aerospace Engineer, Wichita ACO Branch, AIR-7K3, FAA, 1801 Airport Rd, Wichita, KS 67209; phone: 316-946-4193; fax: 316-946-4107; email:
(2) For service information identified in this AD, contact Textron Aviation Inc., PO Box 7706, Wichita, KS 67277: phone: 316-517-5800: internet:
Drug Enforcement Administration, Department of Justice.
Notice of proposed rulemaking.
This proposed rule would amend Drug Enforcement Administration (DEA) regulations regarding DEA Form 106, used by DEA registrants to report thefts or significant losses of controlled substances, to clarify that all such forms must be submitted electronically. In addition, the proposed rule would add new requirements for the form to be submitted accurately and within a 15-day time period. This proposed rule will
Comments must be submitted electronically or postmarked on or before September 28, 2020. Commenters should be aware that the electronic Federal Docket Management System will not accept any comments after 11:59 p.m. Eastern Time on the last day of the comment period.
All comments concerning collection of information under the Paperwork Reduction Act must be submitted to the Office of Management and Budget (OMB) on or before September 28, 2020.
To ensure proper handling of comments, please reference “Docket No. DEA-574” on all electronic and written correspondence, including any attachments.
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Scott A. Brinks, Regulatory Drafting and Policy Support Section (DPW), Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (571) 362-3261.
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 the confidential business information to be redacted within the comment.
Comments containing personal identifying information or confidential business information identified as directed above will be made publicly available in redacted form. If a comment has so much confidential business 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 proposed rule is available at
The Controlled Substances Act (CSA) authorizes the Administrator of DEA (by delegation from the Attorney General) to promulgate rules and regulations relating to the registration and control of the manufacture, distribution, and dispensing of controlled substances; maintenance and submission of records and reports; and for the efficient execution of his statutory functions. 21 U.S.C. 821, 827, 871(b). Currently, 21 CFR 1301.74(c) requires a non-practitioner registrant to notify DEA's Field Division Office in his or her area, in writing, of any theft or significant loss of any controlled substances within one business day upon discovery of such theft or loss. The provision stipulates this same notification requirement and one-day time period regarding in-transit losses of controlled substances for suppliers, importers, and exporters with certain exceptions. In addition to the requirement to notify DEA within one business day of the discovery of a theft or loss, this provision requires a non-practitioner registrant to complete and submit to the same field division office a DEA Form 106 regarding the theft or loss. This provision is silent as to the actual submission method of the DEA Form 106 (
Similarly, 21 CFR 1301.76(b) currently requires practitioner registrants to notify DEA's Field Division Office in his area, in writing, of the theft or significant loss of any controlled substances within one business day upon discovery of the theft or loss; and to complete and submit DEA Form 106 to the same Field Division Office. Again, this provision is silent as to the actual submission method of DEA Form 106 and the due date for this report.
This proposed rule will not change the requirement under 21 CFR 1301.74(c) and 1301.76(b), respectively, that non-practitioner and practitioner registrants notify DEA's Field Division Office in their area, in writing, of the theft or significant loss of any controlled substances within one business day of discovery of such loss or theft.
Currently, 99.5 percent of all DEA Form 106 submissions are completed electronically via DEA's secure website. The remaining 0.5 percent of form submissions are completed by paper. See Regulatory Analyses section for additional information.
This proposed rule would set a 15-day calendar period for submitting a complete and accurate DEA Form 106 and clarify the form submission process, requiring all forms be submitted electronically. This would match the submission process for DEA Form 107, a form used by regulated persons
These proposed changes would make clear to registrants that all DEA Form 106 submissions must go through the secure online database, and physical copies will no longer be accepted. Through the secure online database, forms will be more easily submitted and organized.
This proposed rule was developed in accordance with the principles of Executive Orders (E.O.s) 12866, 13563, and 13771. E.O. 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health, and safety effects; distributive impacts; and equity). E.O. 13563 is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review as established in E.O. 12866. E.O. 12866 classifies a “significant regulatory action,” requiring review by the Office of Management and Budget (OMB), as any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the E.O. DEA has determined that this proposed rule is not a “significant regulatory action” under E.O. 12866, section 3(f).
DEA has examined the benefits and costs of this proposed rule. Currently, 99.5 percent of all DEA Form 106 reports are reported electronically via DEA's secure website. This proposed rule will impact the remaining 0.5 percent of responses that are reported by paper representing 181 of a total of 37,047 responses. Benefits include costs savings, as discussed in the following paragraphs, and increased simplicity in reporting theft and loss on controlled substances and clarity in the regulations. This proposed rule will add clarity to the submission method by matching the submission process and requirements for “Reports of Loss or Disappearance of Listed Chemicals”—DEA Form 107. Additionally, electronic submissions will allow all report submissions to be received more quickly and stored in a central database, as well as allow for analysis.
There is no new cost associated with this proposed rule. The labor burden to submit DEA Form 106 is estimated to be the same for electronic and paper submissions. However, DEA anticipates there will be cost savings associated with electronic submissions. Some cost savings are described qualitatively and some are quantified. From submissions received in 2018, DEA estimates approximately 181 paper submissions per year. Many of these paper forms contain illegible or erroneous information, requiring DEA to call respondents to correct or clarify the information in the paper form, consuming both DEA's and the respondent's time and resources. Electronic submissions are expected to virtually eliminate the requirement for DEA to call back the respondent for clarifications of form data. As DEA has not tracked the number of call backs or the average duration of calls, DEA does not have a strong basis to quantify the cost savings.
This proposed rule would eliminate the need to print paper forms and transmit by mail or courier service. DEA estimates there will be a cost savings of $0.63, $0.55 for postage plus $0.08 for an envelope, or a total of $114 per year for an estimated 181 responses per year. DEA assumes the cost savings associated with not having to print is negligible.
In summary, DEA estimates the economic impact of this proposed rule is
E.O. 13771 was issued on January 30, 2017, and published in the
This proposed regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of E.O. 12988 Civil Justice Reform 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. This proposed rule 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.
In accordance with the Regulatory Flexibility Act (RFA), DEA has reviewed the economic impact of this proposed rule on small entities. DEA's economic impact evaluation indicates that the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities.
The RFA requires agencies to analyze options for regulatory relief of small entities unless it can certify that the rule will not have a significant impact on a substantial number of small entities. For the purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. DEA has analyzed the economic impact of each provision of this proposed rule and estimates that the proposed rule will have minimal economic impact on affected entities, including small entities.
This proposed rule would amend regulations regarding DEA Form 106 to clarify that all submissions of the form must be submitted online. Based on actual submissions in 2018, DEA estimates there are 181 paper submissions per year, submitted by six entities: One distributor, two pharmacies, one researcher, one veterinarian service entity, and one hospital.
DEA estimates the affected entities are in the following North American Industry Classification System (NAICS) industries:
• 424210—Drugs and Druggists' Sundries Merchant Wholesalers
• 446110—Pharmacies and Drug Stores
• 541712—Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
• 541940—Veterinary Services
• 622110—General Medical and Surgical Hospitals
The U.S. Census Bureau's Statistics of U.S. Businesses (SUSB) is an annual series that provides economic data by enterprise size and industry. SUSB data contains the number of firms for various employment or revenue size ranges for each industry. Comparing the size ranges to the U.S. Small Business Administration (SBA) size standards, DEA estimated the number of entities in each affected industry, number of small entities in each affected industry, and number of affected small entities. The table below summarizes the results.
There is no new cost associated with this proposed rule. The labor burden to submit DEA Form 106 is estimated to be the same for electronic and paper submissions. However, DEA anticipates there will be cost savings associated with electronic submissions. Some cost savings are described qualitatively and some are quantified. From submissions received in 2018, DEA estimates the one affected small entity submits one paper submission per year. Many of these paper forms contain illegible or erroneous information, requiring DEA to call respondents to correct or clarify the information in the paper form, consuming DEA's and the respondent's time and resources. Electronic submissions are expected to virtually eliminate the requirement for DEA to call back the respondent for clarifications of form data. As DEA has not tracked the number of call backs or the average duration of calls, DEA does not have a strong basis to quantify the cost savings.
DEA estimates there will be a cost saving associated with eliminating the need to print paper forms and transmit by mail or courier service. The estimated cost savings is $0.63, $0.55 for postage plus $0.08 for an envelope, per paper submission.
In summary, DEA estimates this rule will affect six entities who submit 181 paper DEA Forms 106. Of the affected six entities, one entity (veterinary services entity) is a small entity, submitting one paper form per year. The estimated cost savings for the affected small entity is minimal ($0.63 per year). Therefore, this proposed rule, if promulgated, will not have a significant economic impact on a substantial number of small entities.
On the basis of information contained in the “Regulatory Flexibility Act” section above, DEA has determined and certifies pursuant to the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1501
Pursuant to the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521), DEA has identified the following collection of information related to this proposed rule. This action would modify existing collection 1117-0001 and DEA will be submitting the revision to OMB for approval. A person is not required to respond to a collection of information unless it displays a valid OMB control number. Copies of existing information collections approved by OMB may be obtained at
DEA is proposing to amend its regulations for reporting thefts or significant losses of controlled substances to implement the requirement of electronic submissions for reporting the thefts or significant losses of controlled substances to clarify that all such reports must be submitted electronically within 15 days of discovery of the circumstances requiring the report. This amendment would clarify the submission process by aligning it with the current requirements of reporting losses of disappearance of listed chemicals on DEA Form 107 and no longer accepting physical copies. Form 107 (OMB Control Number 1117-0024) is also only submitted electronically, within 15 days of discovery of the circumstances requiring the report.
Currently, 99.5 percent of all DEA Form 106 reports are reported electronically via DEA's secure website. This proposed rule will impact the remaining 0.5 percent of responses that are reported by paper. Electronic submissions are expected to virtually eliminate the requirement for DEA to call back the respondent for clarifications of form data. Furthermore, this proposed rule would eliminate the need for respondents to print paper forms and transmit by mail or courier service, resulting in cost savings for the 0.5 percent of responses per year transitioning from paper to electronic forms.
The electronic submission would be filed with DEA through the DEA Diversion Control Diversion secure network application (available on the DEA Diversion Control Division website). The submissions of forms will be more easily submitted and organized through the secure database.
The DEA estimates the following number of respondents and burden associated with this collection of information:
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Written comments and suggestions from the public and affected entities concerning the proposed revision of this collection of information are encouraged. Under the PRA, DEA is required to provide a notice regarding the proposed collections of information in the
• Whether the proposed collection of information is necessary for the proper performance of the functions of DEA, including whether the information will have practical utility.
• The accuracy of DEA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used.
• Recommendations to enhance the quality, utility, and clarity of the information to be collected.
• Recommendations to minimize the burden of the collection of information on those who are to respond, including through the use of automated collection techniques or other forms of information technology.
Please send written comments to the Office of Information and Regulatory Affairs, OMB, Attention: Desk Officer for DOJ, 725 17th Street NW, Washington, DC 20503. Please state that your comments refer to RIN 1117-AB57/Docket No. DEA-574. All comments must be submitted to OMB on or before September 28, 2020. The final rule will respond to any OMB or public comments on the information collection requirements contained in this proposed rule.
If you need a copy of the proposed information collection instrument(s) with instructions or additional information, please contact the Regulatory Drafting and Policy Support Section (DPW), Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152-2639; Telephone: (571) 362-3261.
Administrative practice and procedure, Drug traffic control, Security measures.
For the reasons set out above, the DEA proposes to amend 21 CFR part 1301 as follows:
21 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877, 886a, 951, 952, 956, 957, 958, 965 unless otherwise noted.
(c) * * * The registrant must also file a complete and accurate DEA Form 106 with the Administration through the DEA Diversion Control Division secure network application within 15 calendar days after discovery of the theft or loss. * * *
(b) * * * The registrant must also file a complete and accurate DEA Form 106 with the Administration through the DEA Diversion Control Division secure network application within 15 calendar days after the discovery of theft or loss. * * *
Internal Revenue Service (IRS), Treasury.
Notice of Proposed Rulemaking by cross-reference to temporary regulations.
In the Rules and Regulations section of this issue of the
Written or electronic comments and requests for a public hearing must be received by September 28, 2020. Requests for a public hearing must be submitted as prescribed in the “Comments and Requests for a Public Hearing” section.
Commenters are strongly encouraged to submit public comments electronically. Submit electronic submissions via the Federal eRulemaking Portal at
Concerning the proposed regulations, NaLee Park at (202) 317-6879; concerning submissions of comments and/or requests for a public hearing, Regina Johnson, (202) 317-5177 (not toll-free numbers).
Temporary regulations in the Rules and Regulations section of this issue of the
The Office of Management and Budget's Office of Information and Regulatory Analysis has determined that these regulations are not significant and not subject to review under section 6(b) of Executive Order 12866.
Pursuant to the Regulatory Flexibility Act (5 U.S.C. chapter 6), the Secretary certifies that these proposed regulations will not have a significant economic impact on a substantial number of small entities because these proposed regulations impose no compliance burden on any business entities, including small entities. Although these proposed regulations will apply to all employers eligible for the credits under the Families First Act and the CARES Act, including small businesses and tax-exempt organizations with fewer than 500 employees, and will therefore be likely to affect a substantial number of small entities, the economic impact will not be significant. These proposed regulations do not affect the employer's employment tax reporting or the necessary information to substantiate entitlement to the credits. Rather, these proposed regulations merely implement the statutory authority granted under sections 7001(f) and 7003(f) of the Families First Act and section 2301(l) of the CARES Act that authorize the Service to assess, reconcile, and recapture any portion of the credits erroneously paid or refunded in excess of the actual amount allowed as if such amounts were tax liabilities under sections 3111(a) and 3221(a) subject to assessment and administrative collection procedures. Notwithstanding this certification, the Treasury Department and the IRS invite comments on any impact these regulations would have on small entities.
Pursuant to section 7805(f), this notice of proposed rulemaking has been submitted to the Chief Counsel of the Office of Advocacy of the Small Business Administration for comment on its impact on small business.
Before these proposed regulations are adopted as final regulations, consideration will be given to any comments that are timely submitted to the IRS as prescribed in the preamble under the
A public hearing will be scheduled if requested in writing by any person who timely submits electronic or written comments. Requests for a hearing are strongly encouraged to be submitted electronically. If a public hearing is scheduled, notice of the date and time for the public hearing will be published in the
IRS notices and other guidance cited in this preamble are published in the Internal Revenue Bulletin (or Cumulative Bulletin) and are available from the Superintendent of Documents, U.S. Government Publishing Office, Washington, DC 20402, or by visiting the IRS website at
The principal author of these regulations is NaLee Park, Office of the Associate Chief Counsel (Employee Benefits, Exempt Organizations, and Employment Taxes). However, other personnel from the Treasury Department and the IRS participated in the development of these regulations.
Employment taxes, Income taxes, Penalties, Pensions, Railroad retirement, Reporting and recordkeeping requirements, Social security, Unemployment compensation.
Accordingly, 26 CFR part 31 is proposed to be amended as follows:
26 U.S.C. 7805.
Section 31.3111-6T also issued under sec. 7001 and sec. 7003 of the Families First Coronavirus Response Act of 2020 and sec. 2301 of the Coronavirus Aid, Relief, and Economic Security Act of 2020
Section 31.3221-5T also issued under sec. 7001 and sec. 7003 of the Families First Coronavirus Response Act of 2020 and sec. 2301 of the Coronavirus Aid, Relief, and Economic Security Act of 2020
[The text of proposed § 31.3111-6 is the same as the text of § 31.3111-6T published elsewhere in this issue of the
[The text of proposed § 31.3221-5 is the same as the text of § 31.3221-5T published elsewhere in this issue of the
National Labor Relations Board.
Notice of proposed rulemaking; request for comments.
As part of its ongoing efforts to more effectively administer the National Labor Relations Act (the Act) and to further the purposes of the Act, the National Labor Relations Board (the Board) proposes to amend its rules and regulations to eliminate the requirement that employers must, as part of the Board's voter list requirement, provide available personal email addresses and available home and personal cellular telephone numbers of all eligible voters. The Board believes, subject to comments, that elimination of this requirement will better balance employee privacy interests against those supporting disclosure of this information. The Board also proposes an amendment providing for absentee mail ballots for employees who are on military leave. The Board believes, subject to comments, that it should seek to accommodate such voters in light of congressional policies facilitating their participation in federal elections and protecting their employment rights. The Board further believes, subject to comments, that a procedure for providing such voters with absentee ballots can be instituted without impeding the expeditious resolution of questions of representation.
Comments regarding this proposed rule must be received by the Board on or before September 28, 2020. Comments replying to comments submitted during the initial comment period must be received by the Board on or before October 13, 2020. Reply comments should be limited to replying to comments previously filed by other parties. No late comments will be accepted.
You may submit comments on this proposed rule only by the following methods:
Internet—Federal eRulemaking Portal. Electronic comments may be submitted through
Delivery—Comments may be sent by mail to: Roxanne L. Rothschild, Executive Secretary, National Labor Relations Board, 1015 Half Street SE, Washington, DC 20570-0001. Because of security precautions, the Board continues to experience delays in U.S. mail delivery. You should take this into consideration when preparing to meet the deadline for submitting comments. It is not necessary to mail comments if they have been filed electronically with
Only comments submitted through
The Board will post, as soon as practicable, all comments received on
Roxanne L. Rothschild, Executive Secretary, National Labor Relations Board, 1015 Half Street SE, Washington, DC 20570-0001, (202) 273-1940 (this is not a toll-free number), 1-866-315-6572 (TTY/TDD).
The National Labor Relations Board is proposing two amendments to its current rules and regulations governing the conduct of elections held pursuant to the Act. The first amendment would modify the Board's voter list provisions—set forth in §§ 102.62(d) and 102.67(l) of the Board's Rules and Regulations—to eliminate the requirement that the employer provide “available personal email addresses” and “available home and personal cellular (`cell') telephone numbers” of all eligible voters (including individuals permitted to vote subject to challenge) to the Regional Director and the other parties. The second amendment would modify the Board's general policy of not providing absentee ballots—not currently set forth in the rules and regulations—by establishing a procedure to provide absentee ballots to employees who would otherwise be unable to vote in the election because they are on military leave.
The Board believes, subject to comments, that the current voter list requirement affords insufficient weight to employee privacy interests, and that eliminating the required disclosure of personal email addresses and personal telephone numbers will redress this imbalance. The Board also believes, subject to comments, that it should, consistent with the policies and principles underlying other statutes, seek to maximize the opportunity for otherwise-eligible voters on military leave to participate in Board-conducted elections, and that a practical procedure providing absentee mail ballots for such voters can be implemented without impeding the expeditious resolution of questions of representation.
The National Labor Relations Board administers the National Labor Relations Act, which, among other things, governs the formation of collective-bargaining relationships between employers and groups of employees in the private sector. Section 7 of the Act, 29 U.S.C. 157, gives employees, among other rights, the right to bargain collectively through representatives of their own choosing and to refrain from such activity.
When employees and their employer are unable to agree whether employees should be represented for purposes of collective bargaining, Section 9 of the Act, 29 U.S.C. 159, gives the Board the authority to resolve the question of representation. The Supreme Court has recognized that “Congress has entrusted the Board with a wide degree of discretion in establishing the procedure and safeguards necessary to insure the fair and free choice of bargaining representatives by employees.”
Representation case procedures are set forth in the statute, in Board regulations, and in Board caselaw.
Within this general framework, “the Board must adopt policies and promulgate rules and regulations in order that employees' votes may be recorded accurately, efficiently and speedily.”
In
Aside from subsequent clarification that the list must disclose
More specifically, the 2014 amendments justified the disclosure of personal email addresses in light of the dramatically increased role electronic communications now play in workplace communication. They also noted that, in the Board's experience, employers were making increasingly frequent use of email to communicate with employees during election campaigns. 79 FR 74336-74338.
As for personal phone numbers, the 2014 amendments acknowledged that—in contrast to email—telephonic communication existed and was already in widespread use in 1966, and also acknowledged that
The Board's initial proposal to expand the contact information required on the voter list
Dissenting Board Members Miscimarra and Johnson criticized the 2014 amendments for failing to adequately address the privacy concerns raised by the comments, particularly the majority's failure to provide adequate protection of those concerns in the face of the expanded disclosure requirement. More specifically, the dissent contended that the 2014 amendments did not and could not provide specific appropriate restrictions on use, and remedies for misuse, of the information. Citing the prevalence of hacking, identity theft, phishing scams, and related ills, the dissent emphasized that employees who have provided personal email addresses and phone numbers to their employer may have good reasons for not wanting to share them with nonemployer parties they do not know and trust. The dissent expressed doubt that such privacy concerns would be assuaged by the majority's reliance on the ostensibly limited nature of the disclosures, observing that the disclosed information does not disappear after election day and that the limitation on use of the information (for the “representation proceeding, Board proceedings arising from it, and related matters”) was troublingly vague and specified no remedy for violations. Finally, the dissent took issue with the majority's emphasis on the absence of abuses under the original
In litigation that followed the 2014 amendments, several trade and employer advocacy associations contended that the expanded disclosure requirements were unlawful, and among other arguments specifically contended that employee privacy rights “should outweigh the desire of unions to use the latest technology to facilitate their organizing efforts.”
The mandatory disclosure of available personal email addresses and telephone numbers has continued to garner criticism. In
As noted above, the Act contains a single provision regarding voter eligibility that pertains only to certain economic strikers, and thus neither provides for nor prohibits absentee balloting. Similarly, the Board's Rules and Regulations neither provide for nor prohibit absentee balloting. But as a general policy matter, the Board has long declined to provide absentee mail ballots. See,
The Board's general policy of not providing absentee mail ballots for employees on sick, vacation, or related types of leave on the day of election appears to have cohered relatively early in the Board's history.
In December 1941, however, the Board reversed course. In
Following
Shortly after the end of the Second World War, the Board softened its stance towards absentee mail balloting by employees in military service or training. In
Under the circumstances of this case, we are of the opinion that balloting by mail of the 15 or less employees of the Company now on military leave may be accomplished so that no undue delay in determining the election will result. It is also apparent that many of the administrative complexities necessarily involved in conducting a mail ballot of absent employees—problems arising out of overlapping bargaining units, the contraction of wartime operations, conflicting reemployment rights of servicemen—are not present here. There is evidence in this record to show that ballots can be returned within 20 days. We refer, moreover, to the relatively small size of the unit involved [124 employees], the presence of adequate and accurate data (with names and addresses of servicemen) in the original record, and the fact that no substantial reconversion question is present. This is not a war plant with a rapidly diminishing work force. Certain other cases may require other action.
The Board continued to permit absentee balloting pursuant to
Since
That said, the Board, on at least one occasion, has expressed willingness to revisit its approach to absentee balloting for employees on military leave. On January 8, 1992, the Board's Division of Operations-Management issued Memorandum OM 92-2, “Mail Ballot Elections and Absentee Mail Ballots,” informing Regional Directors that the Board “has decided to review the Agency's current practice and experience both with respect to mail ballot elections and with respect to the use of absentee mail ballots for employees on military leave.” The Memorandum asked Regional Directors to provide information including the number of elections in Fiscal Years 1990 and 1991 in which absentee ballots were requested for employees on military leave, the number of cases in which objections were filed based on a refusal to supply such ballots, and the number of elections in which such requested ballots might have been determinative had they been provided, returned, opened, and counted. By internal memorandum dated March 17, 1992, the General Counsel transmitted the survey results to the Board,
More recently, individual Board members have suggested that the Board should reconsider its policy in this area. In
Although the Board majority in both
Section 6 of the Act, 29 U.S.C. 156, provides that “[t]he Board shall have authority from time to time to make, amend, and rescind, in the manner prescribed by subchapter II of chapter 5 of Title 5 [the Administrative Procedure Act], such rules and regulations as may be necessary to carry out the provisions of this Act.” The Board interprets Section 6 as authorizing the proposed rules and invites comments on these issues. Although the Board historically has made most substantive policy determinations through case adjudication, the Board has, with Supreme Court approval, engaged in substantive rulemaking.
The Board finds that informal notice-and-comment rulemaking with respect to the policies at issue here is desirable for several important reasons. First, rulemaking presents the opportunity to solicit broad public comment on, and to address in a single proceeding, two related issues that would not necessarily arise in the adjudication of a single case. By engaging in rulemaking after receiving public comment on the issues presented, the Board will be better able to make informed judgments as to (1) whether the current voter list disclosures sufficiently account for employee privacy concerns, and (2) whether it should provide absentee ballots for employees on military leave. Second, the proposed amendments will be rules of general application in representation cases, and thus the types of rules for which the Act's rulemaking provisions “were designed to assure fairness and mature consideration.”
The Board is inclined to believe, subject to comments, that the required provision of available personal email addresses and home and cellular telephone numbers should be eliminated in light of technological developments since 2014 and ongoing privacy concerns.
The 2014 amendments in effect concluded that disclosure of this contact information was required because, due to changes in communications technology since 1966, supplying nonemployer parties with such information would better serve the twin purposes underlying the original
The Board acknowledges that the
To begin, the Board is inclined to believe that the 2014 amendments overemphasized the degree to which disclosure of personal email addresses and telephone numbers advanced the twin purposes of the
Turning to the countervailing privacy interests, the Board is of the view that the 2014 amendments imprecisely identified the privacy interest at stake. To be sure, one dimension of the privacy interest in telephone numbers and email addresses—or, indeed, any type of contact information—is the right of the individual to be left alone. In upholding the
But the Board is inclined to find that the privacy interest at stake is not solely limited to the interest in being left alone. As the 2014 amendments recognized, the privacy interest is also implicated by the fact of disclosure itself because “some employees will consider disclosure of the additional contact information * * * to invade their privacy, even if they are never contacted.” 79 FR 74343. Put differently, an individual has a privacy interest “in controlling the dissemination of information regarding personal matters.”
Mindful that the fact of disclosure itself, not just undesired contact that may follow from it, is part of the privacy interest at stake here, the Board is inclined to find that the privacy interest in nondisclosure of personal telephone numbers and email addresses is entitled to substantially greater weight than it was given by the 2014 amendments. First, concerns about the protection of privacy interests have grown exponentially in conjunction with the accompanying rapid development of communications technology and the novel problems that have come with it. Just as the Board in 1966 could not possibly have imagined the proliferation of mobile smartphones, the Board could not have envisioned the rampancy of data and identity theft in today's information- and data-based society. Personal telephone numbers present special concerns in this regard: As explained in a recent
Second, the lack of an opt-out procedure entitles the privacy interest in personal telephone numbers and email addresses to greater weight. For the purposes of this proceeding, the Board assumes that the 2014 amendments were correct that crafting an opt-out provision would be difficult
Third, the Board is inclined to agree with the view, expressed by dissenting Members Miscimarra and Johnson in 2014, that employees have a greater privacy interest in personal phone numbers and email addresses than they do in home addresses. As the dissenting members stated, a home is a fixed point that can be visited independent of disclosure of the address, whereas a personal email address is entirely the creation of the employee and typically is not identifiable at all without the employee's consent. A personal phone number is also created in part by the employee, who can determine whether it is publicly listed. Further, the Board is inclined to find that the emergence of smartphones as a “universal point of contact,” as well as the general proliferation of cellular telephones, also heightens the privacy interest in telephone numbers. As cellular telephone ownership has increased, and as more households have abandoned landlines,
Taking these considerations together, the Board believes, subject to comments, that employees clearly have a heightened privacy interest in their personal email addresses and telephone numbers.
In sum, the Board is inclined to find that eliminating the mandatory disclosure of employees' personal telephone numbers and email addresses strikes a better balance between the purposes underlying the voter list requirement and employee privacy concerns.
The Board is inclined, subject to comments, to adopt a procedure that will provide absentee mail ballots for employees on military leave.
To begin, the Board has, from its earliest days, zealously protected the eligibility of employees on military leave. From
In addition, the Board is also inclined to find, subject to comments, that the types of administrative difficulties cited in
Further, telecommunications have evolved markedly since 1950, as a result of which the Board anticipates it will be much easier to determine the locations and addresses of any employees on military leave. The Board is inclined to believe that most employees on military leave will have provided their employer with their contact information, and so determining such employees' mailing addresses may often be as simple as sending an employee an email to ask for it. Even where this is not possible, the Board is inclined to believe that employers will possess sufficient information to permit the parties to use the military personnel locator services provided by the U.S. Navy,
Perhaps more importantly, the Board is inclined to agree with former Member Johnson's suggestion that provision of absentee mail ballots to individuals on military leave would be more consistent with other laws and public policies than the Board's current refusal to provide absentee ballots. In this regard, the Board is inclined, subject to comments, to conclude that Congress has manifested an approach or general policy of providing special protections to service members, especially with respect to matters of employment and voting. In 1940, before
The Board does not suggest that any of these statutes apply to Board-conducted elections or require the provision of absentee ballots to employees on military leave. But taken together, they do indicate a national policy that favors taking measures to ensure that servicemembers' employment and electoral rights are preserved. Indeed, this policy has informed the Act itself: Section 10(b) (as amended in 1947), 29 U.S.C. 160(b), provides that no complaint shall issue based on any unfair labor practice occurring more than six months prior to the filing of the charge “unless the person aggrieved thereby was prevented from filing such charge by reason of service in the armed forces in which event the six-month period shall be computed” from the date of discharge. Given that the Act itself reflects this policy, that Board-conducted elections implicate the employment-related rights of those on military leave, and that Congress has exhorted administrators who conduct political elections to facilitate the right of servicemembers to vote, the Board is inclined to find, subject to comments, that it too should provide for absentee balloting by employees on military leave.
The Board recognizes that adopting a policy of providing for absentee mail ballots presents a number of logistical challenges. The Board believes,
• Whether there should be a time limit on when an absentee ballot may be requested;
• who should be permitted and/or required to request absentee ballots on behalf of employees on military leave;
• whether the Board should require documentary proof that the individual will in fact be on military leave at the time of the election;
• how the Board should approach securing the addresses of employees on military leave, including whether the parties should be responsible for doing so;
• whether time limits on returning absentee ballots should be set and, if so, what those time limits should be;
• whether other procedures or provisions are necessary or desirable to help avoid challenges to or objections over absentee ballots.
Subject to any such comments that may be received, the Board's preliminary inclination is to adopt a new procedure, rather than reinstate the standard applied under
With respect to notification and the timeliness thereof, the Board's initial inclination is, as just set forth, to provide that absentee ballots will be provided upon notice “from any party or person.” As a threshold matter, the Board is of the view that it would indeed be impracticable to require regional directors to investigate and identify employees on military leave in each case; such an approach would almost certainly overburden regional personnel. The Board also believes that it would be unfair to adopt a rule requiring those employees on military leave to secure their own absentee ballots. The Board is generally of the view that the parties will be in the best position to know if there are employees in the unit that are (or will be) on military leave, and that they are also best positioned to inform the Board that absentee ballots will be required. The Board has considered whether the burden of identifying personnel on military leave should be allocated to a specific party, but is inclined, subject to comments, not to impose any such burden. Although the employer is probably best positioned to know if there are (or will be) any employees on military leave, there may be situations where an incumbent or petitioning union, or individual decertification petitioner, has earlier notice of the situation. Further, the Board's goal in adopting this amendment is to ensure that employees on military leave have maximum opportunity to participate in the election; accordingly, who informs the Board of the existence of such employees is immaterial. The Board is inclined to find that so long as timely notice is received from
On a closely related count, the Board recognizes that there may be situations in which a party is aware that an eligible employee is on military leave but does not so inform the Board, whether due to neglect, indifference, or gamesmanship. In such situations, the Board believes, subject to comments, that the party should be estopped from filing an objection based on the failure to provide the eligible employee with an absentee ballot. This is consistent with the Board's voter list requirement, which prevents an employer from filing an objection based on its own failure to comply with the requirement, as well as with the broader principle that a party cannot profit from its own misconduct. See,
As for “timely” notice, the Board is of the view that there must be a point after which absentee ballots will no longer be provided. Such a cutoff point is necessary to ensure that the absentee ballot procedure does not come at the expense of promptly conducting and resolving elections. The Board's preliminary view, subject to comments, is that the cutoff point should be linked to the issuance of the decision and direction of election or the approval of the stipulated election agreement. In stipulated cases, the agreement contains the election details, at which point the parties (or other persons) will be able to determine with certainty whether there are indeed employees on military leave who will be unable to vote unless they are provided with an absentee ballot. In directed elections, regional directors have the discretion to include the election details in the decision and direction of election, though they retain the discretion to subsequently issue the election details. The 2019 amendments made the regional directors' discretion in this regard clear (the prior rules having stated that regional directors will “ordinarily” include the election details in the decision and direction of election), but the supplementary information to the 2019 amendments also made clear that the Board expected
With respect to securing the mailing addresses of employees on military leave, the Board is inclined, subject to comments, to provide that in order to be timely, a request for an absentee ballot must not only be received within 5 business days of the direction of election or approval of an election agreement, but must also be “accompanied by the mailing address at which the person can be reached while on leave.” As discussed above, the Board believes that the parties—most often the employer—will already have such employees' contact information or will have a way of readily obtaining it, and in such situations the parties should simply provide it in the course of notifying the Board that absentee ballots will be needed for those employees.
Finally, the Board is also of the view that there must be a provision setting forth a time after which absentee ballots will not be counted. Such a cutoff point is, like the cutoff point for notifying the Board of employees on military leave, necessary to prevent the absentee ballot procedure from unduly delaying the finality of election results. The Board is of the preliminary view that the cutoff point for counting absentee mail ballots should be tied to the date on which they are mailed to the employees, and that 30 calendar days should, in most circumstances, provide enough time for the absentee ballot to be delivered to the employee, filled out, and returned to the region. The Board recognizes, however, that this will often create situations when the election has been conducted but the period for receiving absentee ballots has not yet passed. The Board is of the view that where absentee ballots remain outstanding when the ballots would otherwise be counted (usually at the end of manual polling periods), the region should conduct the count as usual, but the tally of ballots should include a tabulation for outstanding absentee ballots. In the event the outstanding absentee ballots could not be determinative, the tally of ballots will be considered final; if the absentee ballots could be determinative, the region will wait until the 30-day period has elapsed, after which the region will determine whether the absentee ballots received (if any) since the initial tally of ballots are sufficient in number to affect the result. If so, the Regional Director will open and count such ballots and issue a revised tally of ballots; if not, the initial tally of ballots will be deemed final.
The Board believes that by adopting these or similar procedures, absentee ballots for military personnel can be provided without sacrificing the prompt conduct and conclusion of elections. Under the proposed amendment, the election itself will not be delayed, nor will the ballot count; the likely worst-case scenario is that the final tally of ballots will be delayed by several days in order to wait for and count outstanding determinative absentee ballots. The Board also believes that these or similar procedures will minimize or avoid the types of considerations that may otherwise favor prohibiting absentee balloting, such as those identified by the Third Circuit in
The Regulatory Flexibility Act of 1980 (“RFA”), 5 U.S.C. 601
As discussed below, the Board is uncertain whether its proposed rule will have a significant economic impact on a substantial number of small entities. The Board assumes for purposes of this analysis that a substantial number of small employers and small entity labor unions will be impacted by this rule because at a minimum, they will need to review and understand the effect of
For these reasons, the Board has elected to prepare an IRFA to provide the public the fullest opportunity to comment on the proposed rule.
Detailed descriptions of this proposed rule, its purpose, objectives, and the legal basis are contained earlier in the
To evaluate the impact of the proposed rule, the Board first identified the universe of small entities that could be impacted by the changes to the voter list requirement and by the introduction of absentee balloting by employees on military leave.
Both changes will apply to all entities covered by the National Labor Relations Act (“NLRA” or “the Act”). According to the United States Census Bureau, there were 5,954,684 businesses with employees in 2016.
The following employers are excluded from the NLRB's jurisdiction by statute:
—Federal, state and local governments, including public schools, libraries, and parks, Federal Reserve banks, and wholly-owned government corporations. 29 U.S.C. 152(2).
—employers that employ only agricultural laborers, those engaged in farming operations that cultivate or harvest agricultural commodities or prepare commodities for delivery. 29 U.S.C. 152(3).
—employers subject to the Railway Labor Act, such as interstate railroads and airlines. 29 U.S.C. 152(2).
These two changes will also impact all labor unions, as organizations representing or seeking to represent employees. Labor unions, as defined by the NLRA, are entities “in which employees participate and which exist for the purpose . . . of dealing with employers concerning grievances, labor disputes, wages, rates of pay, hours of employment, or conditions of work.”
The proposed change to the voter list requirement will only be applied as a matter of law under certain circumstances in Board proceedings, namely, when a petition has been filed pursuant Section 9(c) of the Act and the Regional Director, based on that petition, has either approved an election agreement or directed an election. Therefore, the frequency with which the issue arises is indicative of the number of small entities most directly impacted by the proposed rule. For example, in Fiscal Year 2019, 1,179 petitions were filed and proceeded to an election.
Similarly, the number of small entities expected to be impacted by the provision of absentee ballots for military personnel is also low. Although in theory each party to an election could be affected by this proposed change, it is unlikely that every Board-conducted election will require absentee ballots for military personnel. But even if every election were to require such ballots, the number of parties involved is once again only a de minimis amount of all small entities under the Board's jurisdiction.
The RFA requires agencies to consider the direct burden that compliance with a new regulation will likely impose on
The Board concludes that the proposed rule imposes no capital costs for equipment needed to meet the regulatory requirements; no lost sales and profits resulting from the proposed rule; no changes in market competition as a result of the proposed rule and its impact on small entities or specific submarkets of small entities; and no costs of hiring employees dedicated to compliance with regulatory requirements.
Small entities may incur some costs from reviewing the rule in order to understand the substantive changes. To become generally familiar with the revised voter list requirements and the military absentee ballot procedure, the Board estimates that a human resources specialist at a small employer or labor union may take at most ninety minutes to read the rule. It is also possible that a small employer or labor union may wish to consult with an attorney, which the Board estimates will require one hour. Using the Bureau of Labor Statistics' estimated wage and benefit costs, the Board has assessed these labor costs to be $147.12.
The Board does not foresee any additional compliance costs related to eliminating the required disclosure of available personal email addresses and telephone numbers of employees and other individuals included on the voter list. For small employers, existing compliance costs are limited to gathering the required information (including available email addresses and telephone numbers), placing it in the proper format, and serving it on the Regional Director and the other parties within the required timeframe. The Board believes that removing the required disclosure of email addresses and telephone numbers will reduce existing compliance costs for small employers. There are no existing compliance costs for small unions with respect to the voter list requirement; they are merely obligated to refrain from misusing the list or the information contained therein. Removing email addresses and phone numbers from the list may result in some additional costs to small unions, who will now need to gather such information themselves or, failing that, resort to other methods of contacting eligible voters, but such costs do not involve compliance with the proposed change itself. Should a commenter provide data demonstrating the cost of eliminating provision of personal email addresses and telephone numbers, the Board will consider that information.
The Board also believes that any additional compliance costs related to the provision of absentee ballots to employees on military leave will be de minimis. As proposed, all a party need do to comply with the change is timely inform the Board when it is aware of such voters; parties are not required to affirmatively ascertain whether such voters exist. A party's failure to comply may in some circumstances give rise to objections, related litigation, and potentially a second election, but the cost of compliance itself is merely the de minimis cost of telling the Board what the party knows with regard to employees on military leave when the party knows it. The proposed change may result in some situations where a final tally of ballots is delayed due to outstanding dispositive absentee ballots, but the Board does not think that such delay will result in additional costs because once the final tally of ballots issues, parties will have the usual allotted time to file objections. It is possible that the absentee balloting procedure may itself give rise to additional litigation surrounding whether absentee ballots were timely requested and/or provided to the absentee voter, improperly denied or provided, or whether late-arriving absentee ballots should have been counted. But the Board's proposed procedure addresses these contingencies and should accordingly minimize this type of litigation and the costs associated with it. Should a commenter provide data demonstrating the cost of instituting an absentee ballot procedure for employees on military leave, the Board will consider that information.
The Board does not find the estimated, quantifiable cost of reviewing and understanding the rule—$147.12 for small employers and unions—to be significant within the meaning of the RFA.
In making this finding, one important indicator is the cost of compliance in relation to the revenue of the entity or the percentage of profits affected.
—Whether the rule will cause long-term insolvency,
—Whether the cost of the proposed regulation will (a) eliminate more than 10 percent of the businesses' profits; (b) exceed one percent of the gross revenues of the entities in a particular sector; or (c) exceed five percent of the labor costs of the entities in the sector.
The minimal cost to read and understand the rule will not generate any such significant economic impacts.
Since the only quantifiable impact that the Board has identified is the $147.12 that may be incurred in reviewing and understanding the rule, the Board does not believe there will be a significant economic impact on a substantial number of small entities associated with this proposed rule. The Board welcomes input from the public regarding additional costs of compliance not identified by the Board or costs of compliance the Board identified but lacks the means to accurately estimate.
Agencies are required to include in an IRFA “all relevant Federal rules which may duplicate, overlap or conflict with the proposed rule.”
Pursuant to 5 U.S.C. 603(c), agencies are directed to look at “any significant alternatives to the proposed rule which accomplish the stated objectives of applicable statutes and which minimize any significant impact of the proposed rule on small entities.” Specifically, agencies must consider establishing different compliance or reporting requirements or timetable for small entities, simplifying compliance and reporting for small entities, using performance rather than design
First, the Board considered taking no action. Inaction would leave in place the current voter list requirements and would not provide absentee ballots for employees on military leave. However, for the reasons stated in Section I through III, the Board finds it desirable to revisit these policies and to do so through the rulemaking process. Consequently, the Board rejects maintaining the status quo.
Second, the Board considered creating exemptions for certain small entities. This was rejected as impractical, considering that exemptions for small entities would substantially undermine the purposes of the proposed rule because such a large percentage of employers and unions would be exempt under the SBA definitions. Specifically, to exempt small entities from the decision to eliminate the required disclosure of available personal email addresses and telephone numbers from the voter list would leave the employees of most small entities with inadequate protection of their privacy interests and would in fact penalize small employers by requiring them to disclose more contact information than would be required of other employers. And to exempt small entities from the provision of absentee ballots to employees on military leave would be contrary to the purposes of the rule: To maximize the opportunity such employees have to participate in Board-conducted elections.
Moreover, given the very small quantifiable cost of compliance, it is possible that the burden on a small business of determining whether it fell within an exempt category might exceed the burden of compliance. Congress gave the Board very broad jurisdiction, with no suggestion that it wanted to limit the coverage of any part of the Act to only larger employers. As the Supreme Court has noted, “[t]he [NLRA] is federal legislation, administered by a national agency, intended to solve a national problem on a national scale.”
Because no alternatives considered will accomplish the objectives of this proposed rule while minimizing costs for small businesses, the Board believes that proceeding with this rulemaking is the best regulatory course of action. The Board welcomes public comment on any facet of this IRFA, including alternatives that it has failed to consider.
The NLRB is an agency within the meaning of the Paperwork Reduction Act (“PRA”). 44 U.S.C. 3502(1) and (5). The PRA creates rules for agencies for the “collection of information,” 44 U.S.C. 3507, which is defined as “the obtaining, causing to be obtained, soliciting, or requiring the disclosure to third parties or the public, of facts or opinions by or for an agency, regardless of form or format.” 44 U.S.C. 3502(3)(A). Collections of information that occur “during the conduct of an administrative action or investigation involving an agency against specific individuals or entities” are exempt from the PRA. 44 U.S.C. 3518(c)(1)(B)(ii); 5 CFR 1320.4(a)(2).
As a preliminary matter, the elimination of the required provision of available personal telephone numbers and email addresses in the voter list does not require any collection of information—indeed, it reduces the information collected—so the PRA does not apply.
Aside from that circumstance, the changes contained in this proposed rule are exempt from the PRA because any potential collection of information would take place in the context of a representation proceeding, which is an administrative action within the meaning of the PRA. As the Board noted in its 2014 rulemaking, the Senate Report on the PRA makes it clear that the exemption in “Section 3518(c)(1)(B) is not limited to agency proceedings of a prosecutorial nature but also include[s] any agency proceeding involving specific adversary parties.” 79 FR 74468 (quoting S. Rep. No. 96-930, at 56 (1980)). See also 5 CFR 1320.4(c) (OMB regulation interpreting the PRA, providing that exemption applies “after a case file or equivalent is opened with respect to a particular party”). As the Board explained in its 2014 rulemaking, “[a] representation proceeding is . . . `against specific individuals or entities' within the meaning of section 3518(c)(1)(B)(ii),” and the outcome is binding on and thereby alters the legal rights of those parties. See 79 FR 74469. The proposed changes will apply within representation proceedings, and thus are administrative actions involving specific parties and fall within the PRA exemption.
Accordingly, the proposed rules do not contain information collection requirements that require approval of the Office of Management and Budget under the PRA.
Administrative practice and procedure, Claims, Equal access to justice, Freedom of information, Income taxes, Labor management relations, Lawyers, Privacy, Reporting and recordkeeping requirements, Sunshine Act.
For the reasons discussed in the preamble, the Board proposes to amend 29 CFR part 102 as follows:
Sections 1, 6, National Labor Relations Act (29 U.S.C. 151, 156). Section 102.117 also issued under section 552(a)(4)(A) of the Freedom of Information Act, as amended (5 U.S.C. 552(a)(4)(A)), and Section 102.117a also issued under section 552a(j) and (k) of the Privacy Act of 1974 (5 U.S.C. 552a(j) and (k)). Sections 102.143 through 102.155 also issued under section 504(c)(1) of the Equal Access to Justice Act, as amended (5 U.S.C. 504(c)(1)).
(d)
(l)
(a)
(2) All elections shall be by secret ballot. The Regional Director shall provide absentee mail ballots for eligible voters or individuals permitted to vote subject to challenge who are on military leave upon timely notice from any party or person that such voters or individuals will otherwise be unable to vote in the election. Absent extraordinary circumstances, such notification will be timely if received by the Regional Director within 5 business days of the direction of election or approval of election agreement, and if accompanied by the mailing address at which the person can be reached while on leave. This paragraph (a)(2) does not in any way modify the requirement that the employer provide the voter list information required in § 102.62(d) or § 102.67(l). A party that was aware of a person on military leave but did not timely notify the Regional Director shall be estopped from objecting to the failure to provide such person with an absentee ballot. Absentee ballots must be returned to and received at the regional office within 30 calendar days from the date they are mailed to the employees by the Regional Director.
(7) Upon conclusion of the election the ballots will be counted and a tally of ballots prepared and immediately made available to the parties. If the Regional Director has provided absentee ballots to employees on military leave, the time for returning such ballots remains open at the conclusion of the election, and absentee ballots remain outstanding, the tally of ballots shall include the number of absentee ballots that remain outstanding. If the outstanding absentee ballots are potentially dispositive, after the time for returning absentee ballots has passed the Regional Director shall determine whether the number of outstanding absentee ballots received since the initial tally of ballots is dispositive; if so, the Regional Director shall open and count any absentee ballots received since the election, and shall issue a revised tally of ballots. If the number of outstanding absentee ballots received since the initial tally of ballots is not dispositive, the initial tally of ballots shall be deemed final.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing approval of a State Implementation Plan (SIP) revision submitted by the State of Missouri on January 15, 2019, and supplemented by letter on July 11, 2019. Missouri requests that the EPA remove a rule related to the control of emissions from polyethylene bag sealing operations in the St. Louis, Missouri area from its SIP. This removal does not have an adverse effect on air quality. The EPA's proposed approval of this rule revision is in accordance with the requirements of the Clean Air Act (CAA).
Comments must be received on or before August 28, 2020.
You may send comments, identified by Docket ID No. EPA-R07-OAR-2020-0356 to
David Peter, Environmental Protection Agency, Region 7 Office, Air Permitting and Standards Branch, 11201 Renner Boulevard, Lenexa, Kansas 66219; telephone number: (913) 551-7397; email address:
Throughout this document “we,” “us,” and “our” refer to the EPA.
Submit your comments, identified by Docket ID No. EPA-R07-OAR-2020-0356 at
The EPA is proposing to approve the removal of 10 Code of State Regulations (CSR) 10-5.360,
According to the July 11, 2019 letter from the Missouri Department of Natural Resources, available in the docket for this proposed action, Missouri rescinded the rule because, of the only two facilities that were initially subject to the rule, neither facility is currently subject to the rule. One facility shutdown and the other facility no longer meets the applicability of the rule, specifically the facility no longer has a potential-to-emit (PTE) of volatile organic compounds (VOC) greater than 100 tons per year (tpy). Therefore, the rule is no longer necessary for attainment and maintenance of the 1979, 1997, 2008, or 2015 National Ambient Air Quality Standards (NAAQS) for Ozone.
The EPA established a 1-hour ozone NAAQS in 1971. 36 FR 8186 (April 30, 1971). On March 3, 1978, the entire St. Louis Air Quality Control Region (AQCR) (070) was identified as being in nonattainment of the 1971 1-hour ozone NAAQS, as required by the CAA Amendments of 1977. 43 FR 8962 (March 3, 1978). On the Missouri side, the St. Louis nonattainment area included the city of St. Louis and Jefferson, St. Charles, Franklin and St. Louis Counties (hereinafter referred to in this document as the “St. Louis Area”). On February 8, 1979, the EPA revised the 1-hour ozone NAAQS, referred to as the 1979 ozone NAAQS. 44 FR 8202 (February 8, 1979). On May 26, 1988, the EPA notified Missouri that the SIP was substantially inadequate (hereinafter referred to as the “SIP Call”) to attain the 1-hour ozone NAAQS in the St. Louis Area.
The EPA redesignated the St. Louis Area to attainment of the 1979 1-hour ozone standard on May 12, 2003. 68 FR 25418. Pursuant to section 175A of the CAA, the first 10-year maintenance period for the 1-hour ozone standard began on May 12, 2003, the effective date of the redesignation approval. On April 30, 2004, the EPA published a final rule in the
As noted above, 10 CSR 10-5.360,
By letter dated January 15, 2019, Missouri requested that the EPA remove 10 CSR 10-5.360 from the SIP. Section 110(l) of the CAA prohibits EPA from approving a SIP revision that interferes with any applicable requirement concerning attainment and reasonable further progress (RFP), or any other applicable requirement of the CAA. The State supplemented its SIP revision with a July 11, 2019 letter in order to address the requirements of section 110(l) of the CAA.
In its July 11, 2019 letter, Missouri states that it intended its RACT rules, such as 10 CSR 10-5.360, to solely apply to existing sources in accordance with section 172(c)(1) of the CAA.
Missouri, in its July 11, 2019 letter, indicated that Bemis is no longer in operation. The EPA confirmed that Bemis is no longer in operation
As stated above, Missouri contends that 10 CSR 10-5.360 may be removed from the SIP because section 172(c)(1) of the CAA requires RACT for existing sources, and because 10 CSR 10-5.360 was applicable to only two sources
Missouri's July 11, 2019 letter states that any new sources or major modifications of existing sources are subject to new source review (NSR) permitting. Under NSR, a new major source or major modification of an existing source with a PTE of 250 tpy
Missouri has demonstrated that removal of 10 CSR 10-5.360 will not interfere with attainment of the NAAQS, RFP
The State submission has met the public notice requirements for SIP submissions in accordance with 40 CFR 51.102. The submission also satisfied the completeness criteria of 40 CFR part 51, appendix V. The State provided public notice on this SIP revision from May 15, 2018, to August 2, 2018, and received eleven comments from the EPA that related to Missouri's lack of an adequate demonstration that the rule could be removed from the SIP in accordance with section 110(l) of the CAA, whether the rule applied to new sources and other implications related to rescinding the rule. Missouri's July 11, 2019 letter and December 3, 2018 response to comments on the state rescission rulemaking addressed the EPA's comments. In addition, the revision meets the substantive SIP requirements of the CAA, including section 110 and implementing regulations.
The EPA is proposing to approve Missouri's request to rescind 10 CSR 10-5.360 from the SIP because the rule applied to two facilities that are no longer subject and because the rule is not applicable to any other source. Therefore, the rule no longer serves to reduce emissions in the St. Louis Area. Furthermore, any new sources or major modifications of existing sources in the St. Louis Area are subject to NSR permitting.
In this document, the EPA is proposing to amend regulatory text that includes incorporation by reference. As described in the proposed amendments to 40 CFR part 52 set forth below, the EPA is proposing to remove provisions of the EPA-Approved Missouri Regulation from the Missouri 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, 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
• 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 SIP approvals are exempted 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 the National Technology Transfer and Advancement Act (NTTA) because this rulemaking does not involve technical standards; 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 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).
Environmental protection, Air pollution control, Incorporation by reference, Reporting and recordkeeping requirements, Volatile organic compounds.
For the reasons stated in the preamble, the EPA proposes to amend 40 CFR part 52 as set forth below:
42 U.S.C. 7401
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of Availability of proposed fishery management plan amendment; request for comments.
The Mid-Atlantic Fishery Management Council has submitted Amendment 21 to the Summer Flounder, Scup, and Black Sea Bass Fishery Management Plan to NMFS. Amendment 21 proposes revisions to the summer flounder commercial state quota allocation percentages and the fishery management plan goals and objectives. Amendment 21 is intended to increase equity in state allocations when annual coastwide commercial quotas are at or above historical averages, while recognizing the economic reliance coastal communities have on the state allocation percentages currently in place.
Public comments must be received on or before September 28, 2020.
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Copies of Amendment 21, including the Environmental Impact Statement, the Regulatory Impact Review, and the Initial Regulatory Flexibility Analysis (EIS/RIR/IRFA) prepared in support of this action are available from Dr. Christopher M. Moore, Executive Director, Mid-Atlantic Fishery Management Council, Suite 201, 800 North State Street, Dover, DE 19901. The supporting documents are also accessible via the internet at:
Emily Keiley, Fishery Policy Analyst, (978) 281-9116, or email:
The summer flounder fishery is managed cooperatively under the provisions of the Summer Flounder, Scup, and Black Sea Bass Fishery Management Plan (FMP) developed by the Mid-Atlantic Fishery Management Council and the Atlantic States Marine Fisheries Commission, in consultation with the New England Fishery Management Council. The management unit specified in the FMP includes summer flounder (
On September 16, 2014 (79 FR 55432), the Council published a notice of intent (NOI) to prepare an EIS for Amendment 21 to consider, in coordination with the Commission: (1) Performing a comprehensive review of all aspects of the FMP related to summer flounder; (2) updating the FMP goals and objectives for summer flounder management; and (3) modifying management strategies and measures as necessary to achieve those goals and objectives. The Council and Commission held scoping meetings during September and October of 2014 to solicit comments from the public regarding the range of commercial and recreational summer flounder management issues should be considered in the amendment.
On March 29, 2018 (83 FR 13478), the Council published a supplemental NOI announcing that the scope of the amendment would be narrowed to include only commercial summer flounder management considerations. Due to ongoing revisions to the recreational data by the Marine Recreational Information Program, the Council and Commission chose to delay development of any issues that would rely heavily on recreational data. This includes quota allocation between the commercial and recreational sectors as well as recreational management measures and strategies. The supplemental NOI identified that the commercial fishery-focused amendment would consider revisions to:
• Current qualification criteria for Federal moratorium permit holders;
• Current state-by-state allocation of commercial quota;
• List of frameworkable items in the FMP; and
• FMP goals and objectives for summer flounder.
On August 17, 2018 (83 FR 41072), the Environmental Protection Agency announced the public comment period for the Amendment 21 draft environmental impact statement (DEIS). The public comment period extended until October 12, 2018. During that time, the Council and Commission held public hearings on the DEIS in Old Lyme, Connecticut; Washington, North Carolina; Dover, Delaware; Newport News, Virginia; Buzzards Bay, Massachusetts; Narragansett, Rhode Island; Toms River, New Jersey; Berlin, Maryland; Stony Brook, New York; and via webinar.
The Council adopted Amendment 21 on March 6, 2019, and submitted the amendment to us for review on March 17, 2020.
Amendment 21 would modify the state-by-state commercial quota allocations when the coastwide quota exceeds 9.55 million lb (4,332 mt). When the coastwide quota is 9.55 million lb (4,332 mt) or less the quota would be distributed according to the current allocations. In years when the coastwide quota exceeds 9.55 million lb (4,332 mt) any additional quota, beyond this trigger, would be distributed in equal shares to all states except Maine, Delaware, and New Hampshire, which would split 1 percent of the additional quota.
The original FMP objectives were adopted via Amendment 2 to the Summer Flounder FMP in 1993 and have remained unchanged since that time. Amendment 21 revises the FMP goals and objectives. While the current FMP contains only management objectives, the proposed revisions contain three overarching goals linked to more specific objectives. The revised goals include: (1) Ensuring sustainability, of both the summer flounder stock and fishery; (2) increasing the effectiveness of management measures, through partnerships, enforcement, and data collection; and, (3) optimization of the social and economic benefits from the summer flounder stock. Additional information on these changes can be found in the FEIS.
The Magnuson-Stevens Fishery Conservation and Management Act allows us to approve, partially approve, or disapprove measures recommended by the Council in an amendment based on whether the measures are consistent with the fishery management plan, plan amendment, the Magnuson-Stevens Act and its National Standards, and other applicable law. The Council develops policy for its fisheries and we defer to the Council on policy decisions unless those policies are inconsistent with the Magnuson-Steven Act or other applicable law. As such, we are seeking comment on whether measures in
A proposed rule to implement the amendment, including draft regulatory text, will also be published in the
16 U.S.C. 1801
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding; whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; ways to enhance the quality, utility and clarity of the information to be collected; and ways to 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.
Comments regarding this information collection received by August 28, 2020 will be considered. Written comments and recommendations for the proposed information collection should be submitted within 30 days of the publication of this notice on the following website
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding (1) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden 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 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.
Comments regarding this information collection received by August 28, 2020 will be considered. Written comments and recommendations for the proposed information collection should be submitted within 30 days of the publication of this notice on the
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
U.S. Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Kentucky Advisory Committee (Committee) will hold two virtual briefings hearings to hear testimony from advocates and others on bail reform in Kentucky.
The hearings will take place on:
Barbara Delaviez, DFO, at
Members of the public can listen to the discussion. These meetings are free and open to the public through the above listed toll-free number. Members of the public may join through the above listed toll-free number. An open comment period will be provided to allow members of the public to make a statement as time allows. The conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with the conference call number and conference ID number.
Members of the public are also entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be emailed to Carolyn Allen at
Records generated from this meeting may be inspected and reproduced at the Regional Programs Unit Office, as they become available, both before and after the meeting. Records of the meeting will be available via
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.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Applicable July 29, 2020.
Allison Hollander at (202) 482-2805 (Bahrain); Shanah Lee at (202) 482-6386 (Brazil); Irene Gorelik at (202) 482-6905 (Croatia); Magd Zalok at (202) 482-4162 (Egypt); Jonathan Hill at (202) 482-3518 (Germany); Samantha Kinney at (202) 482-2285 (Greece); Jasun Moy at (202) 482-8194 (India); John Drury at (202) 482-0195 and Glenn Bass at (202) 482-8338 (Indonesia); Kathryn Wallace at (202) 482-6251 (Italy); Matthew Renkey at (202) 482-2312 (Republic of Korea (Korea)); Chelsey Simonovich at (202) 482-1979 (Oman); Krisha Hill at (202) 482-4037 (Romania); Jaron Moore at (202) 482-3640 (Serbia); Faris Montgomery at (202) 482-1537 (Slovenia); Laurel LaCivita at (202) 482-4243 (South Africa); Rachel Greenberg at (202) 482-0652 (Spain); Kathryn Turlo at (202) 482-3870 (Taiwan); and Sean Carey at (202) 482-3964 (Republic of Turkey (Turkey)), AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230.
On March 30, 2020, the Department of Commerce (Commerce) initiated less-than-fair-value (LTFV) investigations of imports of common alloy aluminum sheet (aluminum sheet) from Bahrain, Brazil, Croatia, Egypt, Germany, Greece, India, Indonesia, Italy, Korea, Oman, Romania, Serbia, Slovenia, South Africa, Spain, Taiwan, and Turkey.
Section 733(b)(1)(A) of the Tariff Act of 1930, as amended (the Act), requires Commerce to issue the preliminary determination in an LTFV investigation within 140 days after the date on which Commerce initiated the investigation. However, section 733(c)(1) of the Act permits Commerce to postpone the preliminary determination until no later than 190 days after the date on which Commerce initiated the investigation if: (A) The petitioner makes a timely request for a postponement; or (B) Commerce concludes that the parties concerned are cooperating, that the investigation is extraordinarily complicated, and that additional time is necessary to make a preliminary determination. Under 19 CFR 351.205(e), the petitioner must submit a request for postponement 25 days or more before the scheduled date of the preliminary determination and must state the reasons for the request. Commerce will grant the request unless it finds compelling reasons to deny the request.
On July 16, 2020, the petitioners
For the reasons stated above, and because there are no compelling reasons to deny the request, Commerce, in accordance with section 733(c)(1)(A) of the Act, is postponing the deadline for the preliminary determinations by 50 days (
This notice is issued and published pursuant to section 733(c)(2) of the Act and 19 CFR 351.205(f)(1).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
As a result of this sunset review, the Department of Commerce (Commerce) finds that revocation of the antidumping duty (AD) order on certain oil country tubular goods (OCTG) from the People's Republic of China (China) would be likely to lead to continuation or recurrence of dumping at the levels indicated in the “Final Results of Sunset Review” section of this notice.
Applicable July 29, 2020.
Moses Song or Natasia Harrison, AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Street and Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-7885 or (202) 482-1240, respectively.
On April 1, 2020, Commerce published a notice of initiation of the second sunset review of the AD order on OCTG from China, pursuant to section 751(c)(2) of the Tariff Act of 1930, as amended (the Act).
On May 1, 2020, Commerce received a complete substantive response from the domestic interested parties within the 30-day deadline specified in 19 CFR 351.218(d)(3)(i).
This AD order covers OCTG. The Issues and Decision Memorandum, which is hereby adopted by this notice, provides a full description of the scope of the order.
The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at
In the Issues and Decision Memorandum, we have addressed all issues that parties raised in this review. The issues include the likelihood of continuation or recurrence of dumping in the event of revocation and the magnitude of the dumping margins likely to prevail if Commerce revoked the AD order.
Pursuant to sections 751(c)(1) and 752(c)(3) of the Act, we determine that revocation of the AD order on OCTG from China would be likely to lead to continuation or recurrence of dumping, and that the magnitude of the margins of dumping likely to prevail would be up to 99.14 percent.
This notice serves as the only reminder to parties subject to an administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305. Timely notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction. We are issuing and publishing these results and notice in accordance with sections 751(c), 752(c), and 777(i)(1) of the Act and 19 CFR 351.218.
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 Mayflower Wind Energy LLC (Mayflower) to incidentally harass, by Level B harassment only, marine mammals during site characterization surveys off the coast of Massachusetts in the area of the Commercial Lease of Submerged Lands for Renewable Energy Development on the Outer Continental Shelf (OCS-A 0521) and along a potential submarine cable route to landfall at Falmouth, Massachusetts.
This authorization is effective from July 23, 2020 to July 22, 2021.
Amy Fowler, 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.
On January 17, 2020, NMFS received a request from Mayflower for an IHA to take marine mammals incidental to site characterization surveys in the area of the Commercial Lease of Submerged Lands for Renewable Energy Development on the Outer Continental Shelf (OCS-A 0521; Lease Area) and a submarine export cable route connecting the Lease Area to landfall in Falmouth, Massachusetts. A revised application was received on April 9, 2020. NMFS deemed that request to be adequate and complete. Mayflower's request is for take of a small number of 14 species of marine mammals by Level B harassment only. Neither Mayflower nor NMFS expects serious injury or mortality to result from this activity and, therefore, an IHA is appropriate.
Mayflower plans to conduct marine site characterization surveys, including high-resolution geophysical (HRG) and geotechnical surveys, in the area of Commercial Lease of Submerged Lands for Renewable Energy Development on the Outer Continental Shelf #OCS-A 0521 (Lease Area), located approximately 60 kilometers (km) south of Martha's Vineyard, Massachusetts, and along a potential submarine cable route to landfall at Falmouth, Massachusetts.
The purpose of the planned surveys is to acquire geotechnical and HRG data on the bathymetry, seafloor morphology, subsurface geology, environmental/biological sites, seafloor obstructions, soil conditions, and locations of any man-made, historical, or archaeological resources within the Lease Area and export cable route to support development of offshore wind energy facilities. Up to three survey vessels may operate concurrently as part of the surveys, but the three vessels will spend no more than a combined total of 215 days at sea. Surveys are expected to occur over a three-month period, beginning upon issuance of the IHA. Underwater sound resulting from Mayflower's site characterization surveys has the potential to result in incidental take of marine mammals in the form of behavioral harassment.
The HRG survey activities planned by Mayflower are described in detail in the notice of proposed IHA (85 FR 31856; May 27, 2020). The HRG equipment planned for use is shown in Table 1.
As described above, a detailed description of the planned HRG surveys is provided in the
A notice of NMFS's proposal to issue an IHA to Mayflower was published in the
NMFS is concerned about the status of the North Atlantic right whale population given that an unusual mortality event (UME) has been in effect for this species since June of 2017 and that there have been a number of recent mortalities. While the ensonified areas contemplated for any single HRG vessel are comparatively small and the anticipated resulting effects of exposure relatively lower-level, the potential impacts of multiple HRG vessels (up to three vessels are planned for use by Mayflower) operating simultaneously in areas of higher right whale density are not well-documented and warrant caution. However, Mayflower does not plan to conduct HRG survey operations during the timeframe suggested by the ENGOs, and their BOEM-approved survey plan requires surveys to end in September 2020. If Mayflower requests future authorizations that include HRG survey operations between January 1 and April 30, NMFS will consider the possibility of including seasonal restrictions.
We also note that the effects to North Atlantic right whales, and all marine mammals, from the types of surveys authorized in this IHA are expected to be limited to low level behavioral harassment even in the absence of mitigation; no injury is expected or authorized. In consideration of the limited additional benefit anticipated by adding this detection method (especially for right whales and other low frequency cetaceans, species for which PAM has limited efficacy) and the cost and impracticability of implementing a full-time PAM program, we have determined the current requirements for visual monitoring are sufficient to ensure the least practicable adverse impact on the affected species or stocks and their habitat. However, we note that Mayflower will voluntarily implement PAM during night operations as an added precautionary measure even though this is not a NMFS requirement.
While there will be additional documents submitted with a Renewal request, for a qualifying Renewal these will be limited to documentation that NMFS will make available and use to verify that the activities are identical to those in the initial IHA, are nearly identical such that the changes would have either no effect on impacts to marine mammals or decrease those impacts, or are a subset of activities already analyzed and authorized but not completed under the initial IHA. NMFS will also confirm, among other things, that the activities will occur in the same location; involve the same species and stocks; provide for continuation of the same mitigation, monitoring, and reporting requirements; and that no new information has been received that would alter the prior analysis. The Renewal request will also contain a preliminary monitoring report, but that is to verify that effects from the activities do not indicate impacts of a scale or nature not previously analyzed. The additional 15-day public comment period provides the public an opportunity to review these few documents, provide any additional pertinent information and comment on whether they think the criteria for a Renewal have been met. Between the initial 30-day comment period on these same activities and the additional 15 days, the total comment period for a Renewal is 45 days.
In addition to the IHA Renewal process being consistent with all requirements under section 101(a)(5)(D), it is also consistent with Congress' intent for issuance of IHAs to the extent reflected in statements in the legislative history of the MMPA. Through the provision for Renewals in the regulations, description of the process and express invitation to comment on specific potential Renewals in the Request for Public Comments section of each proposed IHA, the description of the process on NMFS' website, further elaboration on the process through responses to comments such as these, posting of substantive documents on the agency's website, and provision of 30 or 45 days for public review and comment on all proposed initial IHAs and Renewals respectively, NMFS has ensured that the public “is invited and encouraged to participate fully in the agency decision-making process.”
The estimated take in the proposed IHA was based on monthly density
In the proposed IHA, NMFS included an exclusion zone of 100-m for all marine mammal species other than North Atlantic right whales, which required a 500-m exclusion zone, and certain genera of dolphins (
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 ESA and potential biological removal (PBR), where known. For taxonomy, we follow Committee on Taxonomy (2019). 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. Atlantic SARs. All values presented in Table 2 are the most recent available at the time of publication and are available in the 2018 Atlantic and Gulf of Mexico Marine Mammal Stock Assessments (Hayes
As indicated above, all 14 species (with 14 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 have authorized it. All species that could potentially occur in the planned survey areas are included in Table 4 of the IHA application. However, the temporal and/or spatial occurrence of several species listed in Table 4 in the IHA application is such that take of these species is not expected to occur. The blue whale (
A detailed description of the species for which take has been authorized,
The effects of underwater noise from Mayflower's survey activities have the potential to result in take of marine mammals by harassment in the vicinity of the survey area. The
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 be by Level B harassment only in the form of disruption of behavioral patterns for individual marine mammals resulting from exposure to HRG sources. Based on the nature of the activity and the anticipated effectiveness of the mitigation measures (
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 (
Using the best available science, NMFS has developed 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 permanent threshold shift (PTS) of some degree (equated to Level A harassment).
Level B Harassment for non-explosive sources—Though significantly driven by received level, the onset of behavioral disturbance from anthropogenic noise exposure is also informed to varying degrees by other factors related to the source (
Level A harassment for non-explosive sources—NMFS' Technical Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammal Hearing (Version 2.0) (Technical Guidance, 2018) identifies dual criteria to assess auditory injury (Level A harassment) to five different marine mammal groups (based on hearing sensitivity) as a result of exposure to noise from two different types of sources (impulsive or non-impulsive). The components of Mayflower's planned activity includes the use of impulsive sources.
Predicted distances to Level A harassment isopleths, which vary based on marine mammal functional hearing groups were calculated. The updated acoustic thresholds for impulsive sounds (such as HRG survey equipment) contained in the Technical Guidance (NMFS, 2018) were presented as dual metric acoustic thresholds using both cumulative sound exposure level (SEL
These thresholds are provided in Table 3 below. 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 planned survey entails the use of HRG equipment. The distance to the isopleth corresponding to the threshold for Level B harassment was calculated for all HRG equipment with the potential to result in harassment of marine mammals. NMFS has developed methodology for determining the rms sound pressure level (SPL
NMFS considers the data provided by Crocker and Fratantonio (2016) to represent the best available information on source levels associated with HRG equipment and therefore recommends that source levels provided by Crocker and Fratantonio (2016) be incorporated in the method described above to estimate isopleth distances to the Level B harassment threshold. In cases when the source level for a specific type of HRG equipment is not provided in Crocker and Fratantonio (2016), NMFS recommends that either the source levels provided by the manufacturer be used, or, in instances where source levels provided by the manufacturer are unavailable or unreliable, a proxy from Crocker and Fratantonio (2016) be used instead. Table 1 shows the HRG equipment types that may be used during the planned surveys and the sound levels associated with those HRG equipment types. Tables 2 and 4 of Appendix B in the IHA application shows the literature sources for the sound source levels that are shown in Table 1 and that were incorporated into the modeling of Level B isopleth distances to the Level B harassment threshold.
Results of modeling using the methodology described above indicated that, of the HRG survey equipment planned for use by Mayflower that has the potential to result in harassment of marine mammals, sound produced by the Geomarine Geo-Spark 400 tip sparker would propagate furthest to the Level B harassment threshold (Table 4); therefore, for the purposes of the exposure analysis, it was assumed the Geomarine Geo-Spark 400 tip sparker would be active during the entire duration of the surveys. Thus the distance to the isopleth corresponding to the threshold for Level B harassment for the Geomarine Geo-Spark 400 tip sparker (estimated at 141 m; Table 4) was used as the basis of the take calculation for all marine mammals. Note that this results in a conservative estimate of the total ensonified area resulting from the planned activities as Mayflower may not operate the Geomarine Geo-Spark 400 tip sparker during the entire planned survey, and for any survey segments in which it is not ultimately operated, the distance to the Level B harassment threshold would be less than 141 m (Table 4). However, as Mayflower cannot predict the precise number of survey days that will require the use of the Geomarine Geo-Spark 400 tip sparker, it was assumed that it would be operated during the entire duration of the planned surveys.
Predicted distances to Level A harassment isopleths, which vary based on marine mammal functional hearing groups (Table 3), were also calculated. The updated acoustic thresholds for impulsive sounds (such as HRG survey equipment) contained in the Technical Guidance (NMFS, 2018) were presented as dual metric acoustic thresholds using both cumulative sound exposure level (SEL
Modeling of distances to isopleths corresponding to the Level A harassment threshold was performed for all types of HRG equipment planned for use with the potential to result in harassment of marine mammals. Mayflower used a new model developed by JASCO to calculate distances to Level A harassment isopleths based on both the peak SPL and the SEL
1. Weighted broadband source levels were calculated by assuming a flat spectrum between the source minimum and maximum frequency, weighted the spectrum according to the marine mammal hearing group weighting function (NMFS 2018), and summed across frequency;
2. Propagation loss was modeled as a function of oblique range;
3. Per-pulse SEL was modeled for a stationary receiver at a fixed distance off a straight survey line, using a vessel transit speed of 3.5 knots and source-specific pulse length and repetition rate. The off-line distance is referred to as the closest point of approach (CPA) and was performed for CPA distances between 1 m and 10 km. The survey line length was modeled as 10 km long (analysis showed longer survey lines increased SEL by a negligible amount). SEL is calculated as
4. The SEL for each survey line was calculated to produce curves of weighted SEL as a function of CPA distance; and
5. The curves from Step 4 above were used to estimate the CPA distance to the impact criteria.
We note that in the modeling methods described above and in Appendix A of the IHA application, sources that operate with a repetition rate greater than 10 Hz were assessed with the non-impulsive (intermittent) source criteria while sources with a repetition rate equal to or less than 10 Hz were assessed with the impulsive source criteria. NMFS does not necessarily agree with this step in the modeling assessment, which results in nearly all HRG sources being classified as impulsive; however, we note that the classification of the majority of HRG sources as impulsive results in more conservative modeling results. Thus, we have assessed the potential for Level A harassment to result from the planned activities based on the modeled Level A zones with the acknowledgement that these zones are likely conservative.
Modeled isopleth distances to Level A harassment thresholds for all types of HRG equipment and all marine mammal functional hearing groups are shown in Table 4. The dual criteria (peak SPL and SEL
Modeled distances to isopleths corresponding to the Level A harassment threshold are very small (<1 m) for three of the four marine mammal functional hearing groups that may be impacted by the planned activities (
In this section we provide the information about the presence, density, or group dynamics of marine mammals that will inform the take calculations.
The habitat-based density models produced by the Duke University Marine Geospatial Ecology Laboratory (Roberts
For the exposure analysis, density data from Roberts
Roberts
Here we describe how the information provided above is brought together to produce a quantitative take estimate.
In order to estimate the number of marine mammals predicted to be exposed to sound levels that would result in harassment, radial distances to predicted isopleths corresponding to harassment thresholds are calculated, as described above. Those distances are then used to calculate the area(s) around the HRG survey equipment predicted to be ensonified to sound levels that exceed harassment thresholds. The area estimated to be ensonified to relevant thresholds in a single day is then calculated, based on areas predicted to be ensonified around the HRG survey equipment and the estimated trackline distance traveled per day by the survey vessel. Mayflower estimates that the survey vessel in the Lease Area and deep-water sections of the cable route will achieve a maximum daily trackline of 110 km per day and the survey vessels in the shallow-water section of the cable route will achieve a maximum of 55 km per day during planned HRG surveys. This distance accounts for survey vessels traveling at roughly 3 knots and accounts for non-active survey periods.
Based on the maximum estimated distance to the Level B harassment threshold of 141 m (Table 4) and the maximum estimated daily track line distance of 110 km, an area of 31.1 km
Similarly, based on the maximum estimated distance to the Level B harassment threshold of 141 m (Table 4) and the maximum estimated daily track line distance of 55 km, an area of 15.6 km
As described above, this is a conservative estimate as it assumes the HRG sources that result in the greatest isopleth distances to the Level B harassment threshold would be operated at all times during all 215 vessel days.
The estimated numbers of marine mammals that may be taken by Level B harassment were calculated by multiplying the monthly density for each species in each survey area (Tables 5 and 6) by the respective monthly ensonified area within each survey section. The results were then summed to determine the total estimated take (Table 7).
Using the take methodology approach described above, the take estimates for Risso's dolphin, sei whale, North Atlantic right whale, and sperm whale were less than the average group sizes estimated for these species (Table 7). However, information on the social structures of these species indicates these species are likely to be encountered in groups. Therefore it is reasonable to conservatively assume that one group of each of these species will be taken during the planned survey. We have therefore authorized the take of the average group size for these species to account for the possibility that the planned survey encounters a group of either of these species (Table 7).
As described above, NMFS has determined that the likelihood of take of any marine mammals in the form of Level A harassment occurring as a result of the planned surveys is so low as to be discountable; therefore, we have not authorized take of any marine mammals by Level A harassment.
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 (latter not applicable for this action). 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. 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 may consider such things as cost, impact on operations, and, in the case of a military readiness activity, personnel safety, practicality of implementation, and impact on the effectiveness of the military readiness activity.
NMFS has required the following mitigation measures be implemented during Mayflower's planned marine site characterization surveys.
Marine mammal exclusion zones (EZ) must be established around the HRG survey equipment and monitored by protected species observers (PSO) during HRG surveys as follows:
• A 500-m EZ is required for North Atlantic right whales; and
• A 100-m EZ is required for all other marine mammals (with the exception of certain small dolphin species and pinnipeds specified below).
If a marine mammal is detected approaching or entering the EZs during the planned survey, the vessel operator must adhere to the shutdown procedures described below. In addition to the EZs described above, PSOs must visually monitor a 200 m Buffer Zone. During use of acoustic sources with the potential to result in marine mammal harassment (
A minimum of one NMFS-approved PSO must be on duty and conducting visual observations at all times during daylight hours (
Prior to initiating HRG survey activities, Mayflower must implement a 30-minute pre-clearance period. During pre-clearance monitoring (
If a marine mammal were observed within the relevant EZs or Buffer Zone during the pre-clearance period, initiation of HRG survey equipment must not begin until the animal(s) has been observed exiting the respective EZ or Buffer Zone, or, until an additional time period has elapsed with no further sighting (
When technically feasible, a ramp-up procedure must be used for geophysical survey equipment capable of adjusting energy levels at the start or re-start of survey activities. The ramp-up procedure must be used at the beginning of HRG survey activities in order to provide additional protection to marine mammals near the Project Area by allowing them to detect the presence of the survey and vacate the area prior to the commencement of survey equipment operation at full power. Ramp-up of the survey equipment must not begin until the relevant EZs and Buffer Zone has been cleared by the PSOs, as described above. HRG equipment must be initiated at their lowest power output and must be incrementally increased to full power. If any marine mammals are detected within the EZs or Buffer Zone prior to or during ramp-up, the HRG equipment must be shut down (as described below).
If an HRG source is active and a marine mammal is observed within or entering a relevant EZ (as described above) an immediate shutdown of the HRG survey equipment is required. When shutdown is called for by a PSO, the acoustic source must be immediately deactivated and any dispute resolved only following deactivation. Any PSO on duty has the authority to delay the start of survey operations or to call for shutdown of the acoustic source if a marine mammal is detected within the applicable EZ. The vessel operator must establish and maintain clear lines of communication directly between PSOs on duty and crew controlling the HRG source(s) to ensure that shutdown commands are conveyed swiftly while allowing PSOs to maintain watch. Subsequent restart of the HRG equipment must only occur after the marine mammal has either been observed exiting the relevant EZ, or, until an additional time period has elapsed with no further sighting of the animal within the relevant EZ (
Upon implementation of shutdown, the HRG source may be reactivated after the marine mammal that triggered the shutdown has been observed exiting the applicable EZ (
The shutdown requirement is waived for certain genera of small delphinids (
If a species for which authorization has not been granted, or, a species for which authorization has been granted but the authorized number of takes have been met, approaches or is observed within the area encompassing the Level B harassment isopleth (141 m), shutdown must occur.
Vessel strike avoidance measures include, but are not limited to, the following, except under circumstances when complying with these requirements would put the safety of the vessel or crew at risk:
• All vessel operators and crew will maintain vigilant watch for cetaceans and pinnipeds, and slow down or stop their vessel to avoid striking these protected species;
• All survey vessels, regardless of size, must observe a 10-knot speed
• All vessel operators will reduce vessel speed to 10 knots (18.5 km/hr) or less when any large whale, any mother/calf pairs, large assemblages of non-delphinoid cetaceans are observed near (within 100 m (330 ft)) an underway vessel;
• All vessels will maintain a separation distance of 500 m (1,640 ft) or greater from any sighted North Atlantic right whale;
• If underway, vessels must steer a course away from any sighted North Atlantic right whale at 10 knots (18.5 km/hr) or less until the 500-m (1,640 ft) minimum separation distance has been established. If a North Atlantic right whale is sighted in a vessel's path, or within 100 m (330 ft) to an underway vessel, the underway vessel must reduce speed and shift the engine to neutral. Engines will not be engaged until the North Atlantic right whale has moved outside of the vessel's path and beyond 100 m. If stationary, the vessel must not engage engines until the North Atlantic right whale has moved beyond 100 m;
• All vessels will maintain a separation distance of 100 m (330 ft) or greater from any sighted non-delphinoid cetacean. If sighted, the vessel underway must reduce speed and shift the engine to neutral, and must not engage the engines until the non-delphinoid cetacean has moved outside of the vessel's path and beyond 100 m. If a survey vessel is stationary, the vessel will not engage engines until the non-delphinoid cetacean has moved out of the vessel's path and beyond 100 m;
• All vessels will maintain a separation distance of 50 m (164 ft) or greater from any sighted delphinoid cetacean. Any vessel underway remain parallel to a sighted delphinoid cetacean's course whenever possible, and avoid excessive speed or abrupt changes in direction. Any vessel underway reduces vessel speed to 10 knots (18.5 km/hr) or less when pods (including mother/calf pairs) or large assemblages of delphinoid cetaceans are observed. Vessels may not adjust course and speed until the delphinoid cetaceans have moved beyond 50 m and/or the abeam of the underway vessel;
• All vessels will maintain a separation distance of 50 m (164 ft) or greater from any sighted pinniped; and
• All vessels underway will not divert or alter course in order to approach any whale, delphinoid cetacean, or pinniped. Any vessel underway will avoid excessive speed or abrupt changes in direction to avoid injury to the sighted cetacean or pinniped.
Project-specific training will be conducted for all vessel crew prior to the start of survey activities. Confirmation of the training and understanding of the requirements will be documented on a training course log sheet. Signing the log sheet will certify that the crew members understand and will comply with the necessary requirements throughout the survey activities.
Mayflower will also employ passive acoustic monitoring (PAM) to support monitoring during night time operations to provide for acquisition of species detections at night. While PAM is not typically required by NMFS for HRG surveys, it may a provide additional benefit as a mitigation and monitoring measure to further limit potential exposure to underwater sound at levels that could result in injury or behavioral harassment.
Based on our evaluation of the applicant's planned measures, as well as other measures considered by NMFS, NMFS has determined that the required mitigation 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.
As described above, visual monitoring must be performed by qualified and NMFS-approved PSOs. Mayflower must use independent, dedicated, trained PSOs, meaning that the PSOs must be employed by a third-party observer provider, must have no tasks other than to conduct observational effort, collect data, and communicate with and instruct relevant vessel crew with regard to the presence of marine mammals and mitigation requirements (including brief alerts regarding maritime hazards), and must have successfully completed an approved PSO training course appropriate for their designated task. Mayflower must provide resumes of all proposed PSOs (including alternates) to NMFS for review and approval prior to the start of survey operations.
During survey operations (
PSOs must be equipped with binoculars and have the ability to estimate distances to marine mammals located in proximity to the vessel and/or exclusion zone using range finders. Reticulated binoculars will also be available to PSOs for use as appropriate based on conditions and visibility to support the monitoring of marine mammals. Position data must be recorded using hand-held or vessel GPS units for each sighting. Observations must take place from the highest available vantage point on the survey vessel. General 360-degree scanning must occur during the monitoring periods, and target scanning by the PSO must occur when alerted of a marine mammal presence.
During good conditions (
Data on all PSO observations must be recorded based on standard PSO collection requirements. This includes dates, times, and locations of survey operations; dates and times of observations, location and weather; details of marine mammal sightings (
Within 90 days after completion of survey activities, a final technical report must be provided to NMFS that fully documents the methods and monitoring protocols, summarizes the data recorded during monitoring, summarizes the number of marine mammals estimated to have been taken during survey activities (by species, when known), summarizes the mitigation actions taken during surveys (including what type of mitigation and the species and number of animals that prompted the mitigation action, when known), and provides an interpretation of the results and effectiveness of all mitigation and monitoring. Any recommendations made by NMFS must be addressed in the final report prior to acceptance by NMFS.
In addition to the final technical report, Mayflower must provide the reports described below as necessary during survey activities. In the unanticipated event that Mayflower's activities lead to an injury (Level A harassment) of a marine mammal, Mayflower must immediately cease the specified activities and report the incident to the NMFS Office of Protected Resources Permits and Conservation Division and the NMFS Northeast Regional Stranding Coordinator. The report must include the following information:
• Time, date, and location (latitude/longitude) of the incident;
• Name and type of vessel involved;
• Vessel's speed during and leading up to the incident;
• Description of the incident;
• Status of all sound source use in the 24 hours preceding the incident;
• Water depth;
• Environmental conditions (
• Description of all marine mammal observations in the 24 hours preceding the incident;
• Species identification or description of the animal(s) involved;
• Fate of the animal(s); and
• Photographs or video footage of the animal(s) (if equipment is available).
Activities must not resume until NMFS is able to review the circumstances of the event. NMFS will work with Mayflower to minimize reoccurrence of such an event in the future. Mayflower must not resume activities until notified by NMFS.
In the event that Mayflower personnel discover an injured or dead marine mammal, Mayflower must report the incident to the OPR Permits and Conservation Division and the NMFS Northeast Regional Stranding Coordinator as soon as feasible. 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.
In the unanticipated event of a ship strike of a marine mammal by any vessel involved in the activities covered by the IHA, Mayflower must report the incident to the NMFS OPR Permits and Conservation Division and the NMFS Northeast Regional Stranding Coordinator as soon as feasible. The report must include the following information:
• Time, date, and location (latitude/longitude) of the incident;
• Species identification (if known) or description of the animal(s) involved;
• Vessel's speed during and leading up to the incident;
• Vessel's course/heading and what operations were being conducted (if applicable);
• Status of all sound sources in use;
• Description of avoidance measures/requirements that were in place at the time of the strike and what additional measures were taken, if any, to avoid strike;
• Environmental conditions (
• Estimated size and length of animal that was struck;
• Description of the behavior of the marine mammal immediately preceding and following the strike;
• If available, description of the presence and behavior of any other marine mammals immediately preceding the strike;
• Estimated fate of the animal (
• To the extent practicable, photographs or video footage of the animal(s).
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
To avoid repetition, our analysis applies to all the species listed in Table 7, given that NMFS expects the anticipated effects of the planned survey to be similar in nature. NMFS does not anticipate that serious injury or mortality would result from HRG surveys, even in the absence of mitigation, and no serious injury or mortality is authorized. As discussed in the
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). Most likely, individuals will simply move away from the sound source and temporarily avoid the area where the survey is occurring. We expect that any avoidance of the survey area by marine mammals would be temporary in nature and that any marine mammals that avoid the survey area during the survey activities would not be permanently displaced. Even repeated Level B harassment of some small subset of an overall stock is unlikely to result in any significant realized decrease in viability for the affected individuals, and thus would not result in any adverse impact to the stock as a whole.
Regarding impacts to marine mammal habitat, prey species are mobile, and are broadly distributed throughout the Project Area and the footprint of the activity is small; therefore, marine mammals that may be temporarily displaced during survey activities are expected to be able to resume foraging once they have moved away from areas with disturbing levels of underwater noise. Because of the availability of similar habitat and resources in the surrounding area the impacts to marine mammals and the food sources that they utilize are not expected to cause significant or long-term consequences for individual marine mammals or their populations. The HRG survey equipment itself will not result in physical habitat disturbance. Avoidance of the area around the HRG survey activities by marine mammal prey species is possible. However, any avoidance by prey species would be expected to be short term and temporary.
ESA-listed species for which takes are authorized are North Atlantic right, fin, sei, and sperm whales, and these effects are anticipated to be limited to lower level behavioral effects. The planned survey is not anticipated to affect the fitness or reproductive success of individual animals. Since impacts to individual survivorship and fecundity are unlikely, the planned survey is not expected to result in population-level effects for any ESA-listed species or alter current population trends of any ESA-listed species.
The status of the North Atlantic right whale population is of heightened concern and, therefore, merits additional analysis. NMFS has rigorously assessed potential impacts to right whales from this survey. We have established a 500-m shutdown zone for right whales which is precautionary considering the Level B harassment isopleth for the largest source utilized (
The Project Area encompasses or is in close proximity to feeding biologically important areas (BIAs) for right whales (February-April), humpback whales (March-December), fin whales (March-October), and sei whales (May-November) as well as a migratory BIA for right whales (March-April and November-December). Most of these feeding BIAs are extensive and sufficiently large (705 km
A migratory BIA for North Atlantic right whales (effective March-April and November-December) extends from Massachusetts to Florida (LaBrecque,
There are several active unusual mortality events (UMEs) occurring in the vicinity of Mayflower's planned surveys. Elevated humpback whale mortalities have occurred along the Atlantic coast from Maine through Florida since January 2016. Of the cases examined, approximately half had evidence of human interaction (ship
Direct physical interactions (ship strikes and entanglements) appear to be responsible for many of the UME humpback and right whale mortalities recorded. The planned HRG survey will require ship strike avoidance measures which would minimize the risk of ship strikes while fishing gear and in-water lines will not be employed as part of the survey. Furthermore, the planned activities are not expected to promote the transmission of infectious disease among marine mammals. The survey is not expected to result in the deaths of any marine mammals or combine with the effects of the ongoing UMEs to result in any additional impacts not analyzed here. Accordingly, Mayflower did not request, and NMFS has not authorized, take of marine mammals by serious injury, or mortality.
The required mitigation measures are expected to reduce the number and/or severity of takes by giving animals the opportunity to move away from the sound source before HRG survey equipment reaches full energy and preventing animals from being exposed to sound levels that have the potential to cause injury (Level A harassment) and more severe Level B harassment during HRG survey activities, even in the biologically important areas described above. No Level A harassment is anticipated or authorized.
NMFS expects that takes would be in the form of short-term Level B behavioral harassment in the form of brief startling reaction and/or temporary vacating of the area, or decreased foraging (if such activity were occurring)—reactions that (at the scale and intensity anticipated here) are considered to be of low severity and with no lasting biological consequences. Since both the source and the marine mammals are mobile, only a smaller area would be ensonified by sound levels that could result in take for only a short period. Additionally, required mitigation measures would reduce exposure to sound that could result in more severe behavioral harassment.
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 or serious injury is anticipated or authorized;
• No Level A harassment (PTS) is anticipated;
• Any foraging interruptions are expected to be short term and unlikely to be cause significantly impacts;
• Impacts on marine mammal habitat and species that serve as prey species for marine mammals are expected to be minimal and the alternate areas of similar habitat value for marine mammals are readily available;
• Take is anticipated to be primarily Level B behavioral harassment consisting of brief startling reactions and/or temporary avoidance of the Project Area;
• Survey activities would occur in such a comparatively small portion of the biologically important area for north Atlantic right whale migration, that any avoidance of the Project Area due to activities would not affect migration. In addition, mitigation measures to shut down at 500 m to minimize potential for Level B behavioral harassment would limit both the number and severity of take of the species;
• Similarly, due to the relatively small footprint of the survey activities in relation to the size of a biologically important areas for right, humpback, fin, and sei whales foraging, the survey activities would not affect foraging success of this species; and
• Required mitigation measures, including visual monitoring and shutdowns, are expected to minimize the intensity of potential impacts to marine mammals.
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 Mayflower's planned HRG surveys 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. Additionally, other qualitative factors may be considered in the analysis, such as the temporal or spatial scale of the activities.
The numbers of marine mammals that we authorize to be taken, for all species and stocks, would be considered small relative to the relevant stocks or populations (less than one third of the best available population abundance for all species and stocks) (see Table 7). In fact, the total amount of taking authorized for all species is 1 percent or less for all affected stocks.
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.
There are no relevant subsistence uses of the affected marine mammal stocks or species implicated by this action. Therefore, NMFS has determined that the total taking of affected species or
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 (16 U.S.C. 1531
The NMFS Office of Protected Resources is authorizing the incidental take of four species of marine mammals which are listed under the ESA: Fin, sei, sperm, and North Atlantic right whales. We requested initiation of consultation under section 7 of the ESA with NMFS GARFO on May 6, 2020, for the issuance of this IHA. On July 22, 2020, NMFS GARFO determined our issuance of the IHA to Mayflower was not likely to adversely affect the North Atlantic right, fin, sei, and sperm whale or the critical habitat of any ESA-listed species or result in the take of any marine mammals in violation of the ESA.
NMFS has issued an IHA to Mayflower for the potential harassment of small numbers of 14 marine mammal species incidental to the conducting marine site characterization surveys offshore of Massachusetts in the area of the Commercial Lease of Submerged Lands for Renewable Energy Development on the Outer Continental Shelf (OCS-A 0521) and along a potential submarine cable route to landfall at Falmouth, Massachusetts, provided the previously mentioned mitigation, monitoring and reporting requirements are followed.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public workshops.
Additional free Atlantic Shark Identification Workshops and Safe Handling, Release, and Identification Workshops will be held in August and September of 2020. Certain fishermen and shark dealers are required to attend a workshop to meet regulatory requirements and to maintain valid permits. Specifically, the Atlantic Shark Identification Workshop is mandatory for all federally permitted Atlantic shark dealers. The Safe Handling, Release, and Identification Workshop is mandatory for vessel owners and operators who use bottom longline, pelagic longline, or gillnet gear, and who have also been issued shark or swordfish limited access permits. More free workshops will be conducted during 2020 and will be announced in a future notice.
The additional Atlantic Shark Identification Workshops will be held on August 20, 2020, August 28, 2020, and September 3, 2020. The additional Safe Handling, Release, and Identification Workshops will be held on August 25, August 28, September 11, September 23, 2020, and September25, 2020. See
The Atlantic Shark Identification Workshops will be held in Philadelphia, PA; Titusville, FL; and Boston, MA. The Safe Handling, Release, and Identification Workshops will be held in Philadelphia, PA; Gulfport, MS; Palm Coast, FL; and Charleston, SC. See
Rick Pearson by email at
The workshop schedules, registration information, and a list of frequently asked questions regarding the Atlantic Shark Identification and Safe Handling, Release, and Identification workshops are posted on the internet at:
Since January 1, 2008, Atlantic shark dealers have been prohibited from receiving, purchasing, trading, or bartering for Atlantic sharks unless a valid Atlantic Shark Identification Workshop certificate is on the premises of each business listed under the shark dealer permit that first receives Atlantic sharks (71 FR 58057; October 2, 2006). Dealers who attend and successfully complete a workshop are issued a certificate for each place of business that is permitted to receive sharks. These certificate(s) are valid for 3 years. Thus, certificates that were initially issued in 2017 will be expiring in 2020. Approximately 170 free Atlantic Shark Identification Workshops have been conducted since July 2008.
Currently, permitted dealers may send a proxy to an Atlantic Shark Identification Workshop. However, if a dealer opts to send a proxy, the dealer must designate a proxy for each place of business covered by the dealer's permit that first receives Atlantic sharks. Only one certificate will be issued to each
1. August 20, 2020, 12 p.m.-4 p.m., Hampton Inn, 8600 Bartram Avenue, Philadelphia, PA 19153.
2. August 28, 2020, 12 p.m.-4 p.m., Hampton Inn, 4760 Helen Hauser Boulevard, Titusville, FL 32780.
3. September 3, 2020, 12 p.m.-4 p.m., Embassy Suites, 207 Porter Street, Boston, MA 02128.
To register for a scheduled Atlantic Shark Identification Workshop, please contact Eric Sander at
To ensure that workshop certificates are linked to the correct permits, participants will need to bring the following specific items to the workshop:
• Atlantic shark dealer permit holders must bring proof that the attendee is an owner or agent of the business (such as articles of incorporation), a copy of the applicable permit, and proof of identification.
• Atlantic shark dealer proxies must bring documentation from the permitted dealer acknowledging that the proxy is attending the workshop on behalf of the permitted Atlantic shark dealer for a specific business location, a copy of the appropriate valid permit, and proof of identification.
The Atlantic Shark Identification Workshops are designed to reduce the number of unknown and improperly identified sharks reported in the dealer reporting form and increase the accuracy of species-specific dealer-reported information. Reducing the number of unknown and improperly identified sharks will improve quota monitoring and the data used in stock assessments. These workshops will train shark dealer permit holders or their proxies to properly identify Atlantic shark carcasses.
Since January 1, 2007, shark limited-access and swordfish limited-access permit holders who fish with longline or gillnet gear have been required to submit a copy of their Safe Handling, Release, and Identification Workshop certificate in order to renew either permit (71 FR 58057; October 2, 2006). These certificate(s) are valid for 3 years. Certificates issued in 2017 will be expiring in 2020. As such, vessel owners who have not already attended a workshop and received a NMFS certificate, or vessel owners whose certificate(s) will expire prior to the next permit renewal, must attend a workshop to fish with, or renew, their swordfish and shark limited-access permits. Additionally, new shark and swordfish limited-access permit applicants who intend to fish with longline or gillnet gear must attend a Safe Handling, Release, and Identification Workshop and submit a copy of their workshop certificate before either of the permits will be issued. Approximately 350 free Safe Handling, Release, and Identification Workshops have been conducted since 2006.
In addition to certifying vessel owners, at least one operator on board vessels issued a limited-access swordfish or shark permit that uses longline or gillnet gear is required to attend a Safe Handling, Release, and Identification Workshop and receive a certificate. Vessels that have been issued a limited-access swordfish or shark permit and that use longline or gillnet gear may not fish unless both the vessel owner and operator have valid workshop certificates onboard at all times. Vessel operators who have not already attended a workshop and received a NMFS certificate, or vessel operators whose certificate(s) will expire prior to their next fishing trip, must attend a workshop to operate a vessel with swordfish and shark limited-access permits that uses longline or gillnet gear.
1. August 25, 2020, 9 a.m.-5 p.m., Embassy Suites, 9000 Bartram Avenue, Philadelphia, PA 19153.
2. August 28, 2020, 9 a.m.-5 p.m., Holiday Inn, 9515 Highway 49, Gulfport, MS 39503.
3. September 11, 2020, 9 a.m.-5 p.m., Hilton Garden Inn, 55 Town Center Boulevard, Palm Coast, FL 32164.
4. September 23, 2020, 9 a.m.-5 p.m., Hampton Inn, 678 Citadel Haven Drive, Charleston, SC 29414.
5. September 25, 2020, 9 a.m.-5 p.m., Holiday Inn, 300 Woodbury Avenue, Portsmouth, NH 03801.
To register for a scheduled Safe Handling, Release, and Identification Workshop, please contact Angler Conservation Education at (386) 682-0158. Pre-registration is highly recommended, but not required.
To ensure that workshop certificates are linked to the correct permits, participants will need to bring the following specific items with them to the workshop:
• Individual vessel owners must bring a copy of the appropriate swordfish and/or shark permit(s), a copy of the vessel registration or documentation, and proof of identification.
• Representatives of a business-owned or co-owned vessel must bring proof that the individual is an agent of the business (such as articles of incorporation), a copy of the applicable swordfish and/or shark permit(s), and proof of identification.
• Vessel operators must bring proof of identification.
The Safe Handling, Release, and Identification Workshops are designed to teach longline and gillnet fishermen the required techniques for the safe handling and release of entangled and/or hooked protected species, such as sea turtles, marine mammals, smalltooth sawfish, Atlantic sturgeon, and prohibited sharks. In an effort to improve reporting, the proper identification of protected species and prohibited sharks will also be taught at these workshops. Additionally, individuals attending these workshops will gain a better understanding of the requirements for participating in these fisheries. The overall goal of these workshops is to provide participants with the skills needed to reduce the mortality of protected species and prohibited sharks, which may prevent additional regulations on these fisheries in the future.
16 U.S.C. 1801
United States Patent and Trademark Office, Department of Commerce.
Notice of information collection; request for comment.
The United States Patent and Trademark Office (USPTO), in accordance with the Paperwork Reduction Act of 1995, invites comments on the extension and revision of an existing information collection: 0651-0050 (Responses to Office Action and Voluntary Amendment Forms). The purpose of this notice is to allow 60 days for public comment preceding submission of the information collection to OMB.
To ensure consideration, comments regarding this information collection must be received on or before September 28, 2020.
Interested persons are invited to submit written comments by any of the following methods. Do not submit Confidential Business Information or otherwise sensitive or protected information.
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Requests for additional information should be directed to Catherine Cain, Attorney Advisor, Office of the Commissioner for Trademarks, United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450, by telephone at 571-272-8946, or by email at
This collection of information is required by the Trademark Act (Act), 15 U.S.C. 1051
In some cases, the USPTO issues Office Actions to applicants who have applied to register a mark, requesting information that was not provided with the initial submission, but is required before the issuance of a registration. Also, the USPTO may determine that a mark is not entitled to registration, pursuant to one or more provisions of the Trademark Act. In such cases, the USPTO will issue an Office Action advising the applicant of the refusal to register the mark. Applicants reply to these Office Actions by providing the required information and/or by putting forth legal arguments as to why the refusal of registration should be withdrawn.
Applicants may also supplement their applications and provide further information by filing a Voluntary Amendment Not in Response to USPTO Office Action/Letter, a Request for Reconsideration after Final Office Action, a Post-Approval/Publication/Post-Notice of Allowance (NOA) Amendment, a Petition to Amend Basis Post-Publication, or a Response to Suspension Inquiry or Letter of Suspension. In rare instances, an applicant may also submit a Substitute Trademark/Servicemark, Substitute Certification Mark, Substitute Collective Membership Mark, or Substitute Collective Trademark/Servicemark application.
Items in this information collection may be submitted via online electronic submissions. In limited circumstances, applicants may be permitted to submit the information in paper form by mail, fax, or hand delivery.
The USPTO is soliciting public comments to:
(a) 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;
(b) 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; (c) Enhance the quality, utility, and clarity of the information to be collected; and
(d) 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,
All comments submitted in response to this notice are a matter of public record. USPTO will include or summarize each comment in the request to OMB to approve this information collection. Before including an address, phone number, email address, or other personal identifying information in a comment, be aware that the entire comment— including personal identifying information—may be made publicly available at any time. While you may ask in your comment to withhold personal identifying information from public view, USPTO cannot guarantee that it will be able to do so.
Office of Special Education and Rehabilitative Services (OSERS), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.
Interested persons are invited to submit comments on or before September 28, 2020.
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 August Martin, 202-245-7410.
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.
The proposed changes to the existing form will improve user friendliness, clarity of data element questions, and accuracy of data reported. These revisions are not significantly different from the original collection, but are proposed to provide clarity, consistency, and usability. In order to improve the user friendliness of the form, some sections were reorganized to enhance the natural flow of data collection. Data element questions were revised to improve clarity of the requests, which will result in accuracy of data being reported. On additional data element was inserted in order to ensure grantees remain compliant with regulatory requirements, but the additional data element is offset by the elimination and consolidation of other sections in this ICR. Additionally, ED had revised how it will collect survey data regarding the Training and Technical Needs of AIVRS projects and the entire section of the report is deleted to further reduces burden. The Training and Technical Needs assessment survey will not be conducted independent of the ICR.
Office of Elementary and Secondary Education (OESE), 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 September 28, 2020.
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 Gabriella Tanner, 202-453-6129, or email
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.
The First Annual Report is due on January 29, 2021 and applies to the reporting period from March 13, 2020 through September 30, 2020. The Second Annual Report is due on January 31, 2022 and applies to the reporting period from October 1, 2020 through September 30, 2021. The Third Annual Report is due on March 1, 2023 and applies to the reporting period from October 1, 2021 through December 31, 2022.
(1) What data in this form will be difficult to collect or report and why? Are there changes that could be made to improve the quality of the data or reduce the burden? What are the overall challenges to reporting these data on an annual basis?
(2) The Department is interested in reducing the burden of data collection and making use of existing data when at all possible. For example, are the proposed data on LEAs available in State data systems? If data are not available in the State data system, is it feasible for States to collect these data from LEAs that received ESSER funding?
(3) Are the proposed data on student participation and engagement during remote learning currently being tracked by LEAs or SEAs? Are the proposed methods to document student participation and engagement during remote learning reliable? Are there additional methods used by LEAs to document student participation and engagement during remote learning?
(4) Are SEAs and LEAs able determine to what proportion of students within the LEA had internet access (school or family provided internet access) at home?
(5) Will the proposed method for collecting the number of FTE positions created or retained as a result of ESSER funds awarded to the SEA yield accurate data? Is there an alternative methodology that would improve the accuracy of the data?
(6) What changes should be made to the form to accommodate data collection from the Outlying Areas of the United States, specifically: The US Virgin Islands (VI), Guam (GU), the Commonwealth of the Northern Mariana Islands (CNMI), and American Samoa (AS)?
Office of Elementary and Secondary Education, Department of Education.
Notice.
The Department of Education (Department) is issuing a notice inviting applications for fiscal year (FY) 2020 for the EIR program—Early-phase Grants, Catalog of Federal Domestic Assistance (CFDA) number 84.411C (Early-phase Grants). This notice relates to the approved information collection under OMB control number 1855-0021.
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
Ashley Brizzo, U.S. Department of Education, 400 Maryland Avenue SW, Room 3E325, Washington, DC 20202-5900. Telephone: (202) 453-7122. 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.
The central design element of the EIR program is its multi-tier structure that links the amount of funding an applicant may receive to the quality of the evidence supporting the efficacy of the proposed project, with the expectation that projects that build this evidence will advance through EIR's grant tiers: “Early-phase,” “Mid-phase,” and “Expansion.” Applicants proposing innovative practices that are supported by limited evidence can receive relatively small grants to support the development, implementation, and initial evaluation of the practices; applicants proposing practices supported by evidence from rigorous evaluations, such as an experimental study (as defined in this notice), can receive larger grant awards to support expansion across the country. This structure provides incentives for applicants to—(1) explore new ways of addressing persistent challenges that other educators can build on and learn from; (2) build evidence of effectiveness of their practices; and (3) replicate and scale successful practices in new schools, districts, and States while addressing the barriers to scale, such as cost structures and implementation fidelity.
All EIR projects are expected to generate information regarding their effectiveness in order to inform EIR grantees' efforts to learn about and improve upon their efforts, and to help similar, non-EIR efforts across the country benefit from EIR grantees' knowledge. By requiring that all grantees conduct independent evaluations of their EIR projects, EIR ensures that its funded projects make a significant contribution to improving the quality and quantity of information available to practitioners and policymakers about which practices improve student achievement and attainment, for which types of students, and in what contexts.
In prior years, the Department has awarded three types of grants under this program: “Early-phase” grants, “Mid-phase” grants, and “Expansion” grants. For FY 2020, the Department will award two types of grants: “Early-phase” grants and “Mid-phase” grants. These grants differ in terms of the level of prior evidence of effectiveness required for consideration for funding, the expectations regarding the kind of evidence and information funded projects should produce, the level of scale funded projects should reach, and, consequently, the amount of funding available to support each type of project.
The Department expects that Early-phase grants provide funding to support the development, implementation, and feasibility testing of a program, which prior research suggests has promise, for the purpose of determining whether the program can successfully improve student achievement and attainment for high need students. Early-phase grants must demonstrate a rationale. These Early-phase grants are not intended simply to implement established practices in additional locations or address needs that are unique to one particular context. The goal is to determine whether and in what ways relatively newer practices can improve student achievement and attainment for high need students.
The notice inviting applications for Mid-phase grants was published in the
The premise of the EIR program is that new and innovative programs and practices can help to solve the persistent problems in education that prevent students, particularly high-need students, from succeeding. These innovations need to be evaluated, and, if sufficient evidence of effectiveness can be demonstrated, the intent is for these innovations to be replicated and tested in new populations and settings. EIR is not intended to provide support for practices that are already commonly implemented by educators, unless significant adaptations of such practices warrant testing to determine if they can accelerate achievement, or greatly increase the efficiency and likelihood that they can be widely implemented in a variety of new populations and settings effectively.
As an EIR project is implemented, grantees are encouraged to learn more about how the practices improve student achievement and attainment; and to develop increasingly rigorous evidence of effectiveness and new strategies to efficiently and cost-effectively scale to new school districts, regions, and States. Applicants must develop a logic model (as defined in this notice) that includes the goals, objectives, proposed outcomes, and key project components (as defined in this notice) of the project.
Disseminating evaluation findings is a critical element of every project, even if a rigorous evaluation does not demonstrate positive results. Such results can influence the next stage of education practice and promote follow-up studies that build upon the results. The EIR program considers all high-quality evaluations to be a valuable contribution to the field of education research and encourages the documentation and sharing of lessons learned.
For those innovations that have positive results and have the potential for continued development and implementation, the Department is interested in learning more about continued efforts regarding cost-effectiveness and feasibility when scaled to additional populations and settings. EIR projects at the Mid-phase level are encouraged to test new strategies for recruiting and supporting new project adoption, seek efficiencies where project implementation has been too costly or cumbersome to operate at scale, and test new ways of overcoming any other barriers in practice or policy that might inhibit project growth. Early-phase grantees that are not yet ready to scale are still encouraged to think about how their innovations might translate to other populations or settings in the long term and to select their partners and implementation sites accordingly.
All EIR applicants and grantees should also consider how they need to develop their organizational capacity, project financing, or business plans to sustain their projects and continue implementation and adaptation after Federal funding ends. The Department intends to provide grantees with technical assistance in their dissemination, scaling, and sustainability efforts.
EIR is designed to offer opportunities for States, districts, schools, and educators to develop innovations and scale effective practices that address their most pressing challenges. Early-phase grantees are encouraged to make continuous improvements in project design and implementation before conducting a full-scale evaluation of effectiveness. Grantees should consider how easily others could implement the proposed practice, and how its implementation could potentially be improved. Additionally, grantees should consider using data from early indicators to gauge initial impact and to consider possible changes in implementation that could increase student achievement and attainment.
By focusing on continuous improvement and iterative development, Early-phase grantees can make adaptations that are necessary to increase their practice's potential to be effective and ensure that the EIR-funded evaluation assesses the impact of a thoroughly conceived practice.
Early-phase applicants should develop, implement, and test the feasibility of their projects. The evaluation of an Early-phase project should be an experimental or quasi-experimental design study (as defined in this notice) that can determine whether the program can successfully improve student achievement and attainment for high-need students. Early-phase grantees' evaluation designs are encouraged to have the potential to demonstrate a statistically significant effect on improving student outcomes or other relevant outcomes based on moderate evidence (as defined in this notice) from at least one well-designed and well-implemented experimental study. The Department intends to provide grantees and their independent evaluators with evaluation technical assistance. This evaluation technical assistance could include grantees and their independent evaluators providing to the Department or its contractor updated comprehensive evaluation plans in a format as requested by the technical assistance provider and using such tools as the Department may request. Grantees will be encouraged to update this evaluation plan at least annually to reflect any changes to the evaluation, with updates consistent with the scope and objectives of the approved application.
The FY 2020 Early-phase competition includes three absolute priorities and
Absolute Priority 1—Demonstrates a Rationale, establishes the evidence requirement for this tier of grants. All Early-phase applicants must submit prior evidence of effectiveness that meets the demonstrates a rationale (as defined in this notice) evidence standard.
Absolute Priority 2—Field-Initiated Innovations—STEM, is intended to highlight the Administration's efforts to ensure our Nation's economic competitiveness by improving and expanding STEM learning and engagement, including computer science (as defined in this notice).
In Absolute Priority 2, the Department recognizes the importance of funding Pre-Kindergarten (Pre-K) through grade 12 STEM education and anticipates that projects would expand opportunities for high-need students. Within this absolute priority, the Department includes Competitive Preference Priority 1, which specifically focuses on expanding opportunities in computer science for underserved populations such as minorities, girls, and youth from rural communities and low-income families, to help reduce achievement and attainment gaps in a manner consistent with nondiscrimination requirements contained in the U.S. Constitution and Federal civil rights laws.
Absolute Priority 3—Teacher-Directed Professional Learning—is intended to support efforts to develop, implement, and evaluate teacher-directed professional learning projects designed to enhance instructional practice and improve achievement and attainment for high-need students. The Department believes that teacher-directed professional development provided through such projects may be more effective in improving instructional practice and student outcomes than the one-size-fits-all professional development activities often funded by school systems in response to districtwide improvement goals.
In Absolute Priority 3, the Department identifies a need for innovative projects that develop and test approaches providing teachers with professional learning stipends. With the autonomy to identify instructionally relevant professional learning, teachers can improve their craft to better support student achievement and attainment for high-need students. Within this absolute priority, the Department includes Competitive Preference Priority 2, which encourages partnerships between an eligibly entity and a State educational agency (SEA).
Through these priorities, the Department intends to advance innovation, build evidence, and address the learning and achievement of high-need students beginning in Pre-K through grade 12.
In the Early-phase grant competition, Absolute Priorities 2 and 3 constitute their own funding categories. The Secretary intends to award grants under both of these absolute priorities provided that applications of sufficient quality are submitted. To ensure that applicants are considered for the correct type of grant, applicants must clearly identify the specific absolute priority that the proposed project addresses. If an entity is interested in proposing two separate projects (one that addresses Absolute Priority 2 and another that addresses Absolute Priority 3), separate applications must be submitted.
These priorities are:
Under this priority, an applicant proposes a project that demonstrates a rationale (as defined in 34 CFR 77.1).
Under the priority, we provide funding to projects that are designed to—
(1) Create, develop, implement, replicate, or take to scale entrepreneurial, evidence-based (as defined in this notice), field-initiated innovations to improve student achievement and attainment for high-need students; and
(2) Improve student achievement or other educational outcomes in one or more of the following areas: Science, technology, engineering, math, or computer science.
Under this priority, an applicant must propose a project in which classroom teachers receive stipends to select professional learning alternatives that are instructionally relevant and meet their individual needs related to instructional practices for high-need students. Additionally, teachers receiving stipends must be allowed the flexibility to replace a significant portion (no less than 20 percent) of existing mandatory professional development with such teacher-directed learning, which must also be allowed to fully count toward any mandatory teacher professional development goals (
These priorities are:
Projects designed to improve student achievement or other educational outcomes in computer science (as defined in this notice). These projects must address the following priority area: Expanding access to and participation in rigorous computer science coursework for traditionally underrepresented students such as racial or ethnic minorities, women, students in communities served by rural local educational agencies (as defined in this notice), children or students with disabilities (as defined in this notice), or low-income individuals (as defined under section 312(g) of the Higher Education Act of 1965, as amended).
Under this priority, an applicant must demonstrate it has established a partnership between an eligible entity and an SEA (with either member of the partnership serving as the applicant) to support the proposed project.
An applicant must—
(a) Describe the pool of teachers eligible to request a stipend, including whether the applicant intends to prioritize eligibility based on content areas, strategic staffing initiatives, or other factors (and including a rationale for how such a determination addresses the needs of high-need students, as defined by the applicant);
(b) Describe the anticipated level of teacher participation, including—
(1) Current information on teacher satisfaction with existing professional learning;
(2) Details on the planned outreach strategy to communicate the stipend opportunity to eligible teachers;
(3) A summary of the ways in which teachers were involved in developing the proposed project; and
(4) A plan for how to include teachers in key decisions about the stipend system.
(c) Describe the proposed stipend structure, including—
(1) Estimated dollar amount per stipend, including associated expenses related to the professional learning (
(2) A rationale for how the estimated dollar amount per stipend is sufficient to ensure access to professional learning activities that are, at minimum, comparable in quality, frequency, and duration to the professional development other non-participating teachers will receive in a given year;
(3) Mechanisms to protect against fraud, waste, and abuse (
(4) Plans for how the applicant will select participants if there is more interest than available stipends (
(d) Describe details about the stipend system, including—
(1) How the applicant will update its policies to offer stipends to teachers such that a significant portion (no less than 20 percent) of existing mandatory professional development is replaced by teacher-directed professional learning, including—
(i) The professional development days or activities from which participating teachers will be released in order to enable teacher-directed learning opportunities and to ensure that teacher-directed learning replaces a significant portion of existing mandatory professional development; or
(ii) Other methods in which participating teachers will be given the flexibility to participate in teacher-directed learning (
(2) How the applicant will ensure that teacher-directed learning will fully substitute for mandatory professional development in meeting mandatory professional development goals or activities (
(3) How the applicant will provide information to teachers about professional learning options not previously available to teachers (
(4) In addition to any list of professional learning options or providers identified by the applicant, mechanisms for teachers to independently select different high-quality, instructionally relevant professional learning activities connected to the achievement and attainment of high-need students (based on teacher-identified needs such as self-assessment surveys, student assessment data, and professional growth plans);
(e) Describe strategies for supporting teachers' implementation of changes in instructional practice as a result of their professional learning;
(f) Describe the process for managing the stipend system, including—
(1) For professional learning options that are among a list of options identified by the applicant: The processes for teachers to submit their requests to participate in those options in place of a previously required training and the processes for direct vendor payment using the stipend; and
(2) For professional learning options selected by a teacher that are not on the applicant's list of options: How the applicant will determine that the activity meets the definition of “professional learning” and is reasonable, and what processes the applicant will implement to ensure payment or timely reimbursement to teachers;
(g) Describe the proposed strategy to expand the use of professional learning stipends (pending the results of the evaluation), including—
(1) Plans for continuously improving the stipend system in order to, over time, offer more teachers the opportunity to engage in teacher-directed professional learning and, for participating teachers, ensure a higher percentage of all mandatory professional learning is teacher-directed; and
(2) Mechanisms for incorporating effective practices discovered through teacher-directed professional learning into the professional development curriculum for all teachers; and
(h) Provide an assurance that—
(1) At a minimum, the SEA or local educational agency (LEA) involved in the project (as an applicant, partner, or implementation site) will maintain its current fiscal and administrative levels of effort in teacher professional development and allow the professional learning activities funded through the stipends to supplement the level of effort that is typically supported by the applicant;
(2) Project funds will only be used for instructionally relevant professional learning activities and not solely for obtaining advanced degrees, taking or preparing for licensure exams, or for pursuing personal enrichment activities; and
(3) Projects will allow for a variety professional learning options for teachers and not limit use of the stipend to an overly restrictive set of choices (for example, professional learning provided only by the applicant or partners,
Computer science often includes computer programming or coding as a tool to create software, including applications, games, websites, and tools to manage or manipulate data; or development and management of computer hardware and the other electronics related to sharing, securing, and using digital information.
In addition to coding, the expanding field of computer science emphasizes computational thinking and interdisciplinary problem-solving to equip students with the skills and abilities necessary to apply computation in our digital world.
Computer science does not include using a computer for everyday activities, such as browsing the internet; use of tools like word processing, spreadsheets, or presentation software; or using computers in the study and exploration of unrelated subjects.
(i) A randomized controlled trial employs random assignment of, for example, students, teachers, classrooms, or schools to receive the project component being evaluated (the treatment group) or not to receive the project component (the control group).
(ii) A regression discontinuity design study assigns the project component being evaluated using a measured variable (
(iii) A single-case design study uses observations of a single case (
(a) In General. A public board of education or other public authority legally constituted within a State for either administrative control or direction of, or to perform a service function for, public elementary schools or secondary schools in a city, county, township, school district, or other political subdivision of a State, or of or for a combination of school districts or counties that is recognized in a State as an administrative agency for its public elementary schools or secondary schools.
(b) Administrative Control and Direction. The term includes any other public institution or agency having administrative control and direction of a public elementary school or secondary school.
(c) Bureau of Indian Education Schools. The term includes an elementary school or secondary school funded by the Bureau of Indian Education but only to the extent that including the school makes the school eligible for programs for which specific eligibility is not provided to the school in another provision of law and the school does not have a student population that is smaller than the student population of the local educational agency receiving assistance under the ESEA with the smallest student population, except that the school shall not be subject to the jurisdiction of any SEA (as defined in this notice) other than the Bureau of Indian Education.
(d) Educational Service Agencies. The term includes educational service agencies and consortia of those agencies.
(e) State Educational Agency. The term includes the SEA in a State in which the SEA is the sole educational agency for all public schools.
(i) A practice guide prepared by the WWC using version 2.1 or 3.0 of the WWC Handbook reporting a “strong evidence base” or “moderate evidence base” for the corresponding practice guide recommendation;
(ii) An intervention report prepared by the WWC using version 2.1 or 3.0 of the WWC Handbook reporting a “positive effect” or “potentially positive effect” on a relevant outcome based on
(iii) A single experimental study or quasi-experimental design study reviewed and reported by the WWC using version 2.1 or 3.0 of the WWC Handbook, or otherwise assessed by the Department using version 3.0 of the WWC Handbook, as appropriate, and that—
(A) Meets WWC standards with or without reservations;
(B) Includes at least one statistically significant and positive (
(C) Includes no overriding statistically significant and negative effects on relevant outcomes reported in the study or in a corresponding WWC intervention report prepared under version 2.1, or 3.0 of the WWC Handbook; and
(D) Is based on a sample from more than one site (
(1) Content knowledge;
(2) Understanding of instructional strategies and intervention techniques for high-need students, including how best to analyze and use data to inform such strategies and techniques; and
(3) Classroom management skills to better support high-need students.
Professional learning must be job-embedded or classroom-focused, collaborative, data-driven, part of a sustained and intensive program, and related to the achievement and attainment of high-need students. Professional learning may include innovative activities such as peer shadowing opportunities, virtual mentoring, online modules, professional learning communities, communities of practice, action research, micro-credentials, and coaching support.
The What Works Clearinghouse Procedures and Standards Handbook (Version 3.0), as well as the more recent What Works Clearinghouse Handbooks released in October 2017 (Version 4.0) and January 2020 (Version 4.1), are available at
Section 4611 of the ESEA, 20 U.S.C. 7261.
The regulations in 34 CFR part 86 apply to institutions of higher education (IHEs) only.
These estimated available funds are the total available for both Early-phase and Mid-phase grants. 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.
The Department is not bound by any estimates in this notice.
Contingent upon the availability of funds and each grantee's substantial progress towards accomplishing the goals and objectives of the project as described in its approved application, we may make continuation awards to grantees for the remainder of the project period.
Applicants must propose a budget that covers the entire project period of up to 60 months.
Under section 4611(c) of the ESEA, the Department must use at least 25 percent of EIR funds for a fiscal year to make awards to applicants serving rural areas, contingent on receipt of a sufficient number of applications of sufficient quality. For purposes of this competition, we will consider an applicant as rural if the applicant meets the qualifications for rural applicants as described in the
In implementing this statutory provision and program requirement, the Department may fund high-quality applications from rural applicants and applications submitted under Absolute Priorities 2 and 3 out of rank order in the Early-phase competition.
In addition, for FY 2020 Early-phase competition, the Department intends to award an estimated $34 million in funds for STEM projects, contingent on receipt of a sufficient number of applications of sufficient quality.
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(a) An LEA;
(b) An SEA;
(c) The Bureau of Indian Education (BIE);
(d) A consortium of SEAs or LEAs;
(e) A nonprofit organization; and
(f) An LEA, an SEA, the BIE, or a consortium described in clause (d), in partnership with—
(1) A nonprofit organization;
(2) A business;
(3) An educational service agency; or
(4) An IHE.
To qualify as a rural applicant under the EIR program, an applicant must meet both of the following requirements:
(a) The applicant is—
(1) An LEA with an urban-centric district locale code of 32, 33, 41, 42, or 43, as determined by the Secretary;
(2) A consortium of such LEAs;
(3) An educational service agency or a nonprofit organization in partnership with such an LEA; or
(4) A grantee described in clause (1) or (2) in partnership with an SEA; and
(b) A majority of the schools to be served by the program are designated with a locale code of 32, 33, 41, 42, or 43, or a combination of such codes, as determined by the Secretary.
Applicants are encouraged to retrieve locale codes from the National Center for Education Statistics School District search tool (
If you are a nonprofit organization, under 34 CFR 75.51, you may demonstrate your nonprofit status by providing: (1) Proof that the Internal Revenue Service currently recognizes the applicant as an organization to which contributions are tax deductible under section 501(c)(3) of the Internal Revenue Code, (2) a statement from a State taxing body or the State attorney general certifying that the organization is a nonprofit organization operating within the State and that no part of its net earnings may lawfully benefit any private shareholder or individual, (3) a certified copy of the applicant's certificate of incorporation or similar document if it clearly establishes the nonprofit status of the applicant, or (4) any item described above if that item applies to a State or national parent organization, together with a statement by the State or parent organization that the applicant is a local nonprofit affiliate. In addition, any IHE is eligible to be a partner in an application where an LEA, SEA, BIE, consortium of SEAs or LEAs, or a nonprofit organization is the lead applicant that submits the application. A nonprofit organization, such as a development foundation, that is affiliated with a public IHE can apply for a grant. A public IHE that has 501(c)(3) status would also qualify as a nonprofit organization and could be a lead applicant for an EIR grant. A public IHE without 501(c)(3) status, or that could not provide any other documentation described in 34 CFR 75.51(b), however, would not qualify as a nonprofit organization, and therefore could not apply for and receive an EIR grant.
2.
(a) The difficulty of raising matching funds for a program to serve a rural area;
(b) The difficulty of raising matching funds in areas with a concentration of LEAs or schools with a high percentage of students aged 5 through 17—
(1) Who are in poverty, as counted in the most recent census data approved by the Secretary;
(2) Who are eligible for a free or reduced price lunch under the Richard B. Russell National School Lunch Act (42 U.S.C. 1751
(3) Whose families receive assistance under the State program funded under part A of title IV of the Social Security Act (42 U.S.C. 601
(4) Who are eligible to receive medical assistance under the Medicaid program; and
(c) The difficulty of raising funds on Tribal land.
Applicants that wish to apply for a waiver must include a request in their application that describes why the matching requirement would cause serious hardship or an inability to carry out project activities. Further information about applying for waivers can be found in the application package. However, given the importance of matching funds to the long-term success of the project, the Secretary expects eligible entities to identify appropriate matching funds.
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4.
Each application will be reviewed under the competition it was submitted under in the
b.
c.
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2.
Because we plan to make successful applications available to the public, you may wish to request confidentiality of business information.
Consistent with Executive Order 12600, please designate in your application any information that you believe is exempt from disclosure under Exemption 4. In the appropriate Appendix section of your application, under “Other Attachments Form,” please list the page number or numbers on which we can find this information. For additional information please see 34 CFR 5.11(c).
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4.
5.
• A “page” is 8.5″ x 11″, on one side only, with 1″ margins at the top, bottom, and both sides.
• Double space (no more than three lines per vertical inch) all text in the application narrative, including titles, headings, footnotes, quotations, references, and captions.
• Use a font that is either 12 point or larger or no smaller than 10 pitch (characters per inch).
• Use one of the following fonts: Times New Roman, Courier, Courier New, or Arial.
The recommended page limit does not apply to Part I, the cover sheet; Part II, the budget section, including the narrative budget justification; Part IV, the assurances and certifications; or the one-page abstract, the resumes, the bibliography, or the letters of support. However, the recommended page limit does apply to all of the application narrative.
6.
1.
In evaluating an application for Absolute Priority 2, the Secretary considers the following criteria:
A.
The Secretary considers the quality of the design of the proposed project. In determining the quality of the design of the proposed project, the Secretary considers the following factors:
(1) The extent to which the goals, objectives, and outcomes to be achieved by the proposed project are clearly specified and measurable. (10 points)
(2) The extent to which the design of the proposed project is appropriate to, and will successfully address, the needs of the target population or other identified needs. (10 points)
(3) The extent to which the design of the proposed project reflects up-to-date knowledge from research and effective practice. (10 points)
(4) The potential contribution of the proposed project to increased knowledge or understanding of educational problems, issues, or effective strategies. (10 points)
B.
The Secretary considers the adequacy of resources and the quality of the management plan for the proposed project. In determining the adequacy of resources and quality of the management plan for the proposed project, the Secretary considers the following factors:
(1) 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. (10 points)
(2) The extent to which the costs are reasonable in relation to the objectives, design, and potential significance of the proposed project. (5 points)
(3) The qualifications, including relevant training and experience, of key project personnel. (5 points)
(4) The adequacy of procedures for ensuring feedback and continuous improvement in the operation of the proposed project. (10 points)
(5) The extent to which the results of the proposed project are to be disseminated in ways that will enable others to use the information or strategies. (5 points)
C.
The Secretary considers the quality of the evaluation to be conducted of the proposed project. In determining the quality of the evaluation, the Secretary considers the following factors:
(1) The extent to which the methods of evaluation will, if well implemented, produce evidence about the project's effectiveness that would meet the What Works Clearinghouse standards with or
(2) The extent to which the evaluation plan clearly articulates the key project components, mediators, and outcomes, as well as a measurable threshold for acceptable implementation. (5 points)
(3) The extent to which the methods of evaluation will provide valid and reliable performance data on relevant outcomes. (5 points)
In evaluating an application for Absolute Priority 3, the Secretary considers the following criteria:
A.
The Secretary considers the quality of the design of the proposed project. In determining the quality of the design of the proposed project, the Secretary considers the following factors:
(1) The extent to which professional learning funded through the stipend will replace existing mandatory professional development for participating teachers at the following levels:
(i) Replacing less than 20 percent of required professional learning. (0 points)
(ii) Replacing 20 percent of required professional learning. (5 points)
(iii) Replacing 40 percent of required professional learning. (10 points)
(iv) Replacing 60 percent of required professional learning. (15 points)
(v) Replacing 80 percent of required professional learning. (20 points)
(vi) Replacing 100 percent of required professional learning. (25 points)
(2) The adequacy of plans to ensure that stipends are appropriately used for high-quality professional learning. (5 points)
(3) The extent to which the proposed project will offer teachers flexibility and autonomy regarding the extent of the choice teachers have in selecting their professional learning. (5 points)
(4) The likelihood that the procedures and resources for teachers result in a simple process to select or request professional learning based on their professional learning needs and those identified needs of high-need students. (5 points)
(5) The extent to which the goals, objectives, and outcomes to be achieved by the proposed project are clearly specified and measurable. (5 points)
B.
The Secretary considers the adequacy of resources and the quality of the management plan for the proposed project. In determining the adequacy of resources and quality of the management plan for the proposed project, the Secretary considers the following factors:
(1) The sufficiency of the stipend amount to enable professional learning funded through the stipend to replace a significant portion of existing mandatory professional development for participating teachers. (5 points)
(2) The extent to which the costs are reasonable in relation to the objectives, design, and potential significance of the proposed project. (5 points)
(3) The extent to which the proposed payment structure will enable teachers to have an opportunity to apply for and use the stipend with minimal burden. (5 points)
(4) The qualifications, including relevant training and experience, of key project personnel. (5 points)
(5) 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. (5 points)
(6) The adequacy of procedures for leveraging the stipend program to inform continuous improvement and systematic changes to professional learning. (5 points)
C.
The Secretary considers the quality of the evaluation to be conducted of the proposed project. In determining the quality of the evaluation, the Secretary considers the following factors:
(1) The extent to which the methods of evaluation will, if well implemented, produce evidence about the project's effectiveness that would meet the What Works Clearinghouse standards with or without reservations as described in the What Works Clearinghouse Handbook (as defined in 34 CFR 77.1(c)). (15 points)
(2) The extent to which the evaluation plan clearly articulates the key project components, mediators, and outcomes, as well as a measurable threshold for acceptable implementation. (5 points)
(3) The extent to which the methods of evaluation will provide performance feedback and permit periodic assessment of progress toward achieving intended outcomes. (5 points)
Applicants may wish to review the following technical assistance resources on evaluation: (1) WWC Procedures and Standards Handbooks:
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).
Before making awards, we will screen applications submitted in accordance with the requirements in this notice to determine whether applications have met eligibility and other requirements. This screening process may occur at various stages of the process; applicants that are determined to be ineligible will not receive a grant, regardless of peer reviewer scores or comments.
Peer reviewers will read, prepare a written evaluation of, and score the assigned applications, using the selection criteria provided in this notice.
3.
4.
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.
1.
If your application is not evaluated or not selected for funding, we notify you.
2.
We reference the regulations outlining the terms and conditions of an award in the
3.
The evaluation report is a specific deliverable under an Early-phase grant that grantees must make available to the public. Additionally, EIR grantees are encouraged to submit final studies resulting from research supported in whole or in part by EIR to the Educational Resources Information Center (
4.
(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.
5.
(1) Performance measures. How each proposed performance measure would accurately measure the performance of the project and how the proposed performance measure would be consistent with the performance measures established for the program funding the competition.
(2) Baseline (as defined in this notice) data. (i) Why each proposed baseline is valid; or (ii) if the applicant has determined that there are no established baseline data for a particular performance measure, an explanation of why there is no established baseline and of how and when, during the project period, the applicant would establish a valid baseline for the performance measure.
(3) Performance targets. Why each proposed performance target is ambitious yet achievable compared to
(4) Data collection and reporting. (i) The data collection and reporting methods the applicant would use and why those methods are likely to yield reliable, valid, and meaningful performance data; and (ii) the applicant's capacity to collect and report reliable, valid, and meaningful performance data, as evidenced by high-quality data collection, analysis, and reporting in other projects or research.
All grantees must submit an annual performance report with information that is responsive to these performance measures.
6.
In making a continuation award, 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 Elementary and Secondary Education (OESE), 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 September 28, 2020.
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 Gabriella Tanner, 202-453-6129, or email
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.
The First Annual Report is due on January 29, 2021 and applies to the reporting period from March 13, 2020 through September 30, 2020. The Second Annual Report is due on January 31, 2022 and applies to the reporting period from October 1, 2020 through September 30, 2021. The Third Annual Report is due on March 1, 2023 and applies to the reporting period from October 1, 2021 through December 31, 2022.
(1) What data in this form will be difficult to collect or report and why? Are there changes that could be made to improve the quality of the data or reduce the burden?
(2) The Department is interested in reducing the burden of data collection and making use of existing data when at all possible. For example, are the proposed data on LEAs and IHEs available in State data systems? If data are not available in the State data system, is it feasible for States to collect these data from LEAs and IHEs that received GEER funding?
(3) Will the proposed method for collecting the number of FTE positions created or retained as a result of GEER funds awarded to the State yield accurate data? Is there an alternative methodology that would improve the accuracy of the data?
(4) What changes should be made to the form to accommodate data collection from the Outlying Areas of the United States, specifically: The U.S. Virgin Islands (VI), Guam (GU), the Commonwealth of the Northern Mariana Islands (CNMI), and American Samoa (AS)?
Office of Special Education and Rehabilitative Services, Department of Education.
Notice.
The Department of Education (Department) is issuing a notice inviting applications (NIA) for fiscal year (FY) 2020 for the State Personnel Development Grants (SPDG) program, Catalog of Federal Domestic Assistance (CFDA) number 84.323A. This notice relates to the approved information collection under OMB control number 1820-0028.
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
Jennifer Coffey, U.S. Department of Education, 400 Maryland Avenue SW, Room 5161, Potomac Center Plaza, Washington, DC 20202-5076. Telephone: (202) 245-6673. 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.
Under this competition, Absolute Priority 3 constitutes its own funding category, and the Department intends to award one-third of the SPDG grants under this competition to grants under Absolute Priority 3 provided applications of sufficient quality are submitted. Applications will be rank ordered separately for Absolute Priority 3. Therefore, applicants must clearly identify if the proposed project addresses Absolute Priority 3.
These priorities are:
The Department establishes a priority to assist SEAs in reforming and
In order to meet this priority, an applicant must demonstrate in the SPDG State Plan it submits, as part of its application under section 653(a)(2) of IDEA, that its proposed project will—
(1) Use evidence-based professional development practices that will increase implementation of evidence-based practices and result in improved outcomes for children with disabilities;
(2) Provide ongoing assistance to personnel receiving SPDG-supported professional development that supports the implementation of evidence-based practices with fidelity (as defined in this notice); and
(3) Use technology to more efficiently and effectively provide ongoing professional development to personnel, including to personnel in rural areas and to other populations, such as personnel in urban or high-need local educational agencies (LEAs) (as defined in this notice).
Statutory Requirements. To meet this priority, an applicant must meet the following statutory requirements:
1. State Personnel Development Plan.
An applicant must submit a State Personnel Development Plan that identifies and addresses the State and local needs for the personnel preparation and professional development of personnel, as well as individuals who provide direct supplementary aids and services to children with disabilities, and that—
(a) Is designed to enable the State to meet the requirements of section 612(a)(14) of IDEA, as amended by the ESSA and section 635(a)(8) and (9) of IDEA;
(b) Is based on an assessment of State and local needs that identifies critical aspects and areas in need of improvement related to the preparation, ongoing training, and professional development of personnel who serve infants, toddlers, preschoolers, and children with disabilities within the State, including—
(1) Current and anticipated personnel vacancies and shortages; and
(2) The number of preservice and inservice programs;
(c) Is integrated and aligned, to the maximum extent possible, with State plans and activities under the Elementary and Secondary Education Act of 1965, as amended (ESEA); the Rehabilitation Act of 1973, as amended; and the Higher Education Act of 1965, as amended (HEA);
(d) Describes a partnership agreement that is in effect for the period of the grant, which agreement must specify—
(1) The nature and extent of the partnership described in accordance with section 652(b) of IDEA and the respective roles of each member of the partnership, including, if applicable, an individual, entity, or agency other than the SEA that has the responsibility under State law for teacher preparation and certification; and
(2) How the SEA will work with other persons and organizations involved in, and concerned with, the education of children with disabilities, including the respective roles of each of the persons and organizations;
(e) Describes how the strategies and activities the SEA uses to address identified professional development and personnel needs will be coordinated with activities supported with other public resources (including funds provided under Part B and Part C of IDEA and retained for use at the State level for personnel and professional development purposes) and private resources;
(f) Describes how the SEA will align its personnel development plan with the plan and application submitted under sections 1111 and 2101(d), respectively, of the ESEA;
(g) Describes strategies the SEA will use to address the identified professional development and personnel needs and how such strategies will be implemented, including—
(1) A description of the programs and activities that will provide personnel with the knowledge and skills to meet the needs of, and improve the performance and achievement of, infants, toddlers, preschoolers, and children with disabilities; and
(2) How such strategies will be integrated, to the maximum extent possible, with other activities supported by grants funded under section 662 of IDEA, as amended by the ESSA;
(h) Provides an assurance that the SEA will provide technical assistance to LEAs to improve the quality of professional development available to meet the needs of personnel who serve children with disabilities;
(i) Provides an assurance that the SEA will provide technical assistance to entities that provide services to infants and toddlers with disabilities to improve the quality of professional development available to meet the needs of personnel serving those children;
(j) Describes how the SEA will recruit and retain teachers who meet the qualifications described in section 612(a)(14)(C) of IDEA, as amended by the ESSA, and other qualified personnel in geographic areas of greatest need;
(k) Describes the steps the SEA will take to ensure that economically disadvantaged and minority children are not taught at higher rates by teachers who do not meet the qualifications described in section 612(a)(14)(C) of IDEA, as amended by the ESSA; and
(l) Describes how the SEA will assess, on a regular basis, the extent to which the strategies implemented have been effective in meeting the performance goals described in section 612(a)(15) of IDEA, as amended by the ESSA.
2. Partnerships.
(a) Required Partners.
Applicants must establish a partnership with LEAs and other State agencies involved in, or concerned with, the education of children with disabilities, including—
(1) Not less than one institution of higher education (IHE); and
(2) The State agencies responsible for administering Part C of IDEA, early education, child care, and vocational rehabilitation programs.
(b) Other Partners.
An SEA must work in partnership with other persons and organizations involved in, and concerned with, the education of children with disabilities, which may include—
(1) The Governor;
(2) Parents of children with disabilities ages birth through 26;
(3) Parents of nondisabled children ages birth through 26;
(4) Individuals with disabilities;
(5) Parent training and information centers or community parent resource centers funded under sections 671 and 672 of IDEA, respectively;
(6) Community-based and other nonprofit organizations involved in the education and employment of individuals with disabilities;
(7) Personnel as defined in section 651(b) of IDEA;
(8) The State advisory panel established under Part B of IDEA;
(9) The State interagency coordinating council established under Part C of IDEA;
(10) Individuals knowledgeable about vocational education;
(11) The State agency for higher education;
(12) Public agencies with jurisdiction in the areas of health, mental health, social services, and juvenile justice;
(13) Other providers of professional development who work with infants, toddlers, preschoolers, and children with disabilities;
(14) Other individuals; and
(15) An individual, entity, or agency as a partner in accordance with section 652(b)(3) of IDEA, if State law assigns responsibility for teacher preparation and certification to an individual, entity, or agency other than the SEA.
3. Use of Funds.
(a) Professional Development Activities—Each SEA that receives a grant under this program must use the grant funds to support activities in accordance with the State's Personnel Development Plan, including one or more of the following:
(1) Carrying out programs that provide support to both special education and regular education teachers of children with disabilities and principals, such as programs that—
(i) Provide teacher mentoring, team teaching, reduced class schedules and caseloads, and intensive professional development;
(ii) Use standards or assessments for guiding beginning teachers that are consistent with challenging State academic achievement standards and with the requirements for professional development, as defined in section 8101 of the ESEA; and
(iii) Encourage collaborative and consultative models of providing early intervention, special education, and related services.
(2) Encouraging and supporting the training of special education and regular education teachers and administrators to effectively use and integrate technology—
(i) Into curricula and instruction, including training to improve the ability to collect, manage, and analyze data to improve teaching, decision making, school improvement efforts, and accountability;
(ii) To enhance learning by children with disabilities; and
(iii) To effectively communicate with parents.
(3) Providing professional development activities
that—
(i) Improve the knowledge of special education and regular education teachers concerning—
(A) The academic and developmental or functional needs of students with disabilities; or
(B) Effective instructional strategies, methods, and skills, and the use of State academic content standards and student academic achievement standards, and State assessments, to improve teaching practices and student academic achievement;
(ii) Improve the knowledge of special education and regular education teachers and principals and, in appropriate cases, paraprofessionals, concerning effective instructional practices, and that—
(A) Provide training in how to teach and address the needs of children with different learning styles and children who are English learners;
(B) Involve collaborative groups of teachers, administrators, and, in appropriate cases, related services personnel;
(C) Provide training in methods of—
(I) Positive behavioral interventions and supports to improve student behavior in the classroom;
(II) Scientifically based reading instruction, including early literacy instruction;
(III) Early and appropriate interventions to identify and help children with disabilities;
(IV) Effective instruction for children with low-incidence disabilities;
(V) Successful transitioning to postsecondary opportunities; and
(VI) Classroom-based techniques to assist children prior to referral for special education;
(D) Provide training to enable personnel to work with and involve parents in their child's education, including parents of low income and children with disabilities who are English learners;
(E) Provide training for special education personnel and regular education personnel in planning, developing, and implementing effective and appropriate individualized education programs (IEPs); and
(F) Provide training to meet the needs of students with significant health, mobility, or behavioral needs prior to serving those students;
(iii) Train administrators, principals, and other relevant school personnel in conducting effective IEP meetings; and
(iv) Train early intervention, preschool, and related services providers, and other relevant school personnel in conducting effective individualized family service plan (IFSP) meetings.
(4) Developing and implementing initiatives to promote the recruitment and retention of special education teachers who meet the qualifications described in section 612(a)(14)(C) of IDEA, as amended by the ESSA, particularly initiatives that have proven effective in recruiting and retaining teachers who meet those qualifications, described in section 612(a)(14)(C) of IDEA, as amended by the ESSA, including programs that provide—
(i) Teacher mentoring from exemplary special education teachers, principals, or superintendents;
(ii) Induction and support for special education teachers during their first three years of employment as teachers; or
(iii) Incentives, including financial incentives, to retain special education teachers who have a record of success in helping students with disabilities.
(5) Carrying out programs and activities that are designed to improve the quality of personnel who serve children with disabilities, such as—
(i) Innovative professional development programs (which may be provided through partnerships with IHEs), including programs that train teachers and principals to integrate technology into curricula and instruction to improve teaching, learning, and technology literacy and that are consistent with the definition of professional development in section 8101 of the ESEA; and
(ii) The development and use of proven, cost effective strategies for the implementation of professional development activities, such as through the use of technology and distance learning.
(6) Carrying out programs and activities that are designed to improve the quality of early intervention personnel, including paraprofessionals and primary referral sources, such as—
(i) Professional development programs to improve the delivery of early intervention services;
(ii) Initiatives to promote the recruitment and retention of early intervention personnel; and
(iii) Interagency activities to ensure that early intervention personnel are adequately prepared and trained.
(b) Other Activities—Each SEA that receives a grant under this program must use the grant funds to support activities in accordance with the State's Personnel Development Plan, including one or more of the following:
(1) Reforming special education and regular education teacher certification (including re-certification) or licensing requirements to ensure that—
(i) Special education and regular education teachers have—
(A) The training and information necessary to address the full range of needs of children with disabilities across disability categories; and
(B) The necessary subject matter knowledge and teaching skills in the academic subjects that the teachers teach;
(ii) Special education and regular education teacher certification (including re-certification) or licensing requirements are aligned with challenging State academic content standards; and
(iii) Special education and regular education teachers have the subject
(2) Programs that establish, expand, or improve alternative routes for State certification of special education teachers for individuals with a baccalaureate or master's degree who meet the qualifications described in section 612(a)(14)(C)of IDEA, as amended by the ESSA, including mid-career professionals from other occupations, paraprofessionals, and recent college or university graduates with records of academic distinction who demonstrate the potential to become highly effective special education teachers.
(3) Teacher advancement initiatives for special education teachers that promote professional growth and emphasize multiple career paths (such as paths to becoming a career teacher, mentor teacher, or exemplary teacher) and pay differentiation.
(4) Developing and implementing mechanisms to assist LEAs and schools in effectively recruiting and retaining special education teachers who meet the qualifications described in section 612(a)(14)(C) of IDEA, as amended by the ESSA.
(5) Reforming tenure systems, implementing teacher testing for subject matter knowledge, and implementing teacher testing for State certification or licensure, consistent with title II of the HEA (20 U.S.C. 1021
(6) Funding projects to promote reciprocity of teacher certification or licensing between or among States for special education teachers, except that no reciprocity agreement developed under this absolute priority may lead to the weakening of any State teacher certification or licensing requirement.
(7) Assisting LEAs to serve children with disabilities through the development and use of proven, innovative strategies to deliver intensive professional development programs that are both cost effective and easily accessible, such as strategies that involve delivery through the use of technology, peer networks, and distance learning.
(8) Developing, or assisting LEAs in developing, merit-based performance systems and strategies that provide differential and bonus pay for special education teachers.
(9) Supporting activities that ensure that teachers are able to use challenging State academic content standards and student academic achievement standards, and State assessments for all children with disabilities, to improve instructional practices and improve the academic achievement of children with disabilities.
(10) When applicable, coordinating with, and expanding centers established under section 2113(c)(18) of the ESEA, as amended by the No Child Left Behind Act of 2002, to benefit special education teachers.
(c) Contracts and Subgrants—An SEA that receives a grant under this program—
(1) Must award contracts or subgrants to LEAs, IHEs, parent training and information centers, or community parent resource centers, as appropriate, to carry out the State Personnel Development Plan; and
(2) May award contracts and subgrants to other public and private entities, including the lead agency under Part C of IDEA, to carry out the State plan.
(d) Use of Funds for Professional Development—An SEA that receives a grant under this program must use—
(1) Not less than 90 percent of the funds the SEA receives under the grant for any fiscal year for the Professional Development Activities described in paragraph (a); and
(2) Not more than 10 percent of the funds the SEA receives under the grant for any fiscal year for the Other Activities described in paragraph (b).
The purpose of this priority is to fund SPDG grants to SEAs that empower teachers and other personnel to select professional development activities that meet their individual needs to improve results for children with disabilities. States will meet the priority if they describe in their application how they will develop personalized professional development projects to carry out their State plan under section 653 of IDEA and implement professional development activities that are consistent with the use of funds provisions in section 654 of IDEA. This would be accomplished by using funds under the SPDG program for stipends or other mechanisms to provide personnel with choice in selecting professional development options that will count toward State or local professional development requirements, as appropriate, such as the number of hours personnel must fill or the competencies they must acquire to obtain or retain certification, and that are designed to meet their individual needs and thus improve results for children with disabilities.
Applicants must—
(a) Demonstrate, in the narrative section of the application under “Significance,” how the proposed project will develop personalized professional development activities using stipends or other mechanisms that provide personnel choice in professional development options designed to meet their individual needs and count toward State or local professional development requirements and thus improve results for children with disabilities;
(b) Describe how the State will select the individual(s) or groups of personnel that will be provided with professional development options, including the extent to which applicants will prioritize selecting individuals or groups of personnel serving rural children with disabilities or disadvantaged children with disabilities, such as children from low-income families. If applicable, applicants should specify how they will prioritize personnel if demand for professional development among the individuals or groups of personnel that the applicant proposes to serve exceeds what available funds can support;
(c) Describe how the State will create a list of approved professional development options that meet the requirements of the SPDG program. This description should include how the applicant will engage with a range of stakeholders, including school administrators, personnel serving students with disabilities, families of students with disabilities and individuals with disabilities, and other State or local agencies serving individuals with disabilities, such as juvenile justice agencies, to determine which professional development options it will offer. Specifically, professional development options must—
(1) Use evidence-based (as defined in this notice) professional development methods that will increase implementation of evidence-based practices and result in improved outcomes for children with disabilities;
(2) Include ongoing assistance that supports the implementation of evidence-based practices with fidelity (as defined in this notice); and
(3) Use technology to more efficiently and effectively provide ongoing professional development to personnel, including to personnel in rural areas and in urban or high-need local
(d) If applicable, describe the steps that personnel would need to take to request professional development options not already on a list of approved professional development options, the justification that personnel would need to provide to demonstrate how the selected options would improve results for children with disabilities, and how personnel would be notified if their request was approved or disapproved in writing and within 14 days; and
(e) Describe—
(1) The extent to which the proposed project will use professional development practices supported by evidence to support the attainment of identified competencies;
(2) How improvement in implementation of SPDG-supported practices over time will be demonstrated by participants in SPDG professional development activities;
(3) The extent to which the proposed project will use SPDG professional development funds to provide activities designed to sustain the use of SPDG-supported practices;
(4) How the proposed project will determine whether special education teachers who meet the qualifications described in section 612(a)(14)(C) of IDEA, as amended by the ESSA, that have participated in SPDG-supported special education teacher retention activities remain as special education teachers two years after their initial participation in these activities; and
(5) How the proposed project will assess whether and to what extent the project improves outcomes for children with disabilities.
Projects funded under this program must—
(a) Budget for a three-day project directors' meeting in Washington, DC, during each year of the project;
(b) Budget $4,000 annually for support of the SPDG Program website currently administered by the University of Oregon (
(c) If a project receiving assistance under this program authority maintains a website, include relevant information and documents in a form that meets a government or industry-recognized standard for accessibility.
The following definitions apply to this competition. We provide the source of the definitions in parentheses.
(i) A randomized controlled trial employs random assignment of, for example, students, teachers, classrooms, or schools to receive the project component being evaluated (the treatment group) or not to receive the project component (the control group).
(ii) A regression discontinuity design study assigns the project component being evaluated using a measured variable (
(iii) A single-case design study uses observations of a single case (
(a) That serves not fewer than 10,000 children from families with incomes below the poverty line (as that term is defined in section 8101(41) of the ESEA), or for which not less than 20 percent of the children served by the LEA are from families with incomes below the poverty line; and
(b) For which there is (1) a high percentage of teachers not teaching in the academic subjects or grade levels that the teachers were trained to teach, or (2) a high percentage of teachers with emergency, provisional, or temporary certification or licensing.
(i) A practice guide prepared by WWC reporting a “strong evidence base” or “moderate evidence base” for the corresponding practice guide recommendation;
(ii) An intervention report prepared by the WWC reporting a “positive effect” or “potentially positive effect” on a relevant outcome with no reporting of a “negative effect” or “potentially negative effect” on a relevant outcome; or
(iii) A single study assessed by the Department, as appropriate, that—
(A) Is an experimental study, a quasi-experimental design study, or a well-designed and well-implemented correlational study with statistical controls for selection bias (
(B) Includes at least one statistically significant and positive (
(i) A practice guide prepared by the WWC using version 2.1 or 3.0 of the WWC Handbook reporting a “strong evidence base” for the corresponding practice guide recommendation;
(ii) An intervention report prepared by the WWC using version 2.1 or 3.0 of the WWC Handbook reporting a “positive effect” on a relevant outcome based on a “medium to large” extent of evidence, with no reporting of a “negative effect” or “potentially negative effect” on a relevant outcome; or
(iii) A single experimental study reviewed and reported by the WWC using version 2.1 or 3.0 of the WWC Handbook, or otherwise assessed by the Department using version 3.0 of the WWC Handbook, as appropriate, and that—
(A) Meets WWC standards without reservations;
(B) Includes at least one statistically significant and positive (
(C) Includes no overriding statistically significant and negative effects on relevant outcomes reported in the study or in a corresponding WWC intervention report prepared under version 2.1 or 3.0 of the WWC Handbook; and
(D) Is based on a sample from more than one site (
The What Works Clearinghouse Procedures and Standards Handbook (Version 3.0), as well as the more recent What Works Clearinghouse Handbooks released in October 2017 (Version 4.0) and January 2020 (Version 4.1), are available at
20 U.S.C. 1451-1455.
The regulations in 34 CFR part 86 apply to IHEs only.
Projects must be awarded and operated in a manner consistent with the nondiscrimination requirements contained in the U.S. Constitution and the Federal civil rights laws.
Contingent upon the availability of funds and the quality of applications, we may make additional awards in FY 2021 from the list of unfunded applications from this competition.
We will set the amount of each award after considering—
(1) The amount of funds available for making the grants;
(2) The relative population of the State or outlying area;
(3) The types of activities proposed by the State or outlying area;
(4) The alignment of proposed activities with section 612(a)(14) of IDEA, as amended by the ESSA;
(5) The alignment of proposed activities with State plans and applications submitted under sections 1111 and 2101(d), respectively, of the ESEA; and
(6) The use, as appropriate, of research and instruction supported by evidence.
The Department is not bound by any estimates in this notice.
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Public Law 95-134, which permits the consolidation of grants to the outlying areas, does not apply to funds received under this competition.
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(a) Recipients of funding under this competition must make positive efforts to employ and advance in employment qualified individuals with disabilities (see section 606 of IDEA).
(b) Applicants for, and recipients of, funding must, with respect to the aspects of their proposed project relating to Absolute Priorities 2 and 3, involve individuals with disabilities, or parents of individuals with disabilities ages birth through 26, in planning, implementing, and evaluating the project (see section 682(a)(1)(A) of IDEA).
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• A “page” is 8.5″ x 11″, on one side only, with 1″ margins at the top, bottom, and both sides.
• Double space (no more than three lines per vertical inch) all text in the application narrative, including titles, headings, footnotes, quotations, reference citations, and captions, as well as all text in charts, tables, figures, graphs, and screen shots.
• Use a font that is 12 point or larger.
• Use one of the following fonts: Times New Roman, Courier, Courier New, or Arial.
The recommended page limit does not apply to Part I, the cover sheet; Part II, the budget section, including the narrative budget justification; Part IV, the assurances and certifications; or the abstract (follow the guidance provided in the application package for completing the abstract), the table of contents, the list of priority requirements, the resumes, the reference list, the letters of support, or the appendices. However, the recommended page limit does apply to all of the application narrative, including all text in charts, tables, figures, graphs, and screen shots.
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(a)
(1) The Secretary considers the significance of the proposed project.
(2) In determining the significance of the proposed project, the Secretary considers the following factors:
(i) The extent to which the proposed project is part of a comprehensive effort to improve teaching and learning and support rigorous academic standards for students.
(ii) The extent to which specific gaps or weaknesses in services, infrastructure, or opportunities have been identified and will be addressed by the proposed project, including the nature and magnitude of those gaps or weaknesses.
(iii) The extent to which the training or professional development services to be provided by the proposed project are of sufficient quality, intensity, and duration to lead to improvements in practice among the recipients of those services.
(iv) The likelihood that the proposed project will result in system change or improvement.
(b)
(1) The Secretary considers the quality of the design of the proposed project.
(2) In determining the quality of the design of the proposed project, the Secretary considers the following factors:
(i) The extent to which the goals, objectives, and outcomes to be achieved by the proposed project are clearly specified and measurable.
(ii) The extent to which the design of the proposed project is appropriate to, and will successfully address, the needs of the target population or other identified needs.
(iii) The extent to which the services to be provided by the proposed project involve the collaboration of appropriate partners for maximizing the effectiveness of project services.
(iv) The extent to which the design of the proposed project reflects up-to-date knowledge from research and effective practice.
(v) The extent to which the proposed project will establish linkages with other appropriate agencies and organizations providing services to the target population.
(c)
(1) The Secretary considers the quality of the personnel who will carry out the proposed project.
(2) In determining the quality of project personnel, the Secretary considers the extent to which the applicant encourages applications for employment from persons who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability.
(3) In addition, the Secretary considers the following factors:
(i) The qualifications, including relevant training and experience, of the project director or principal investigator.
(ii) The qualifications, including relevant training and experience, of key project personnel.
(d)
(1) The Secretary considers the adequacy of resources and management plan for the proposed project.
(2) In determining the adequacy of resources for the proposed project, the Secretary considers the following factors:
(i) The relevance and demonstrated commitment of each partner in the proposed project to the implementation and success of the project.
(ii) The extent to which the budget is adequate to support the proposed project.
(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.
(iv) How the applicant will ensure that a diversity of perspectives are brought to bear in the operation of the proposed project, including those of parents, teachers, the business community, a variety of disciplinary and professional fields, recipients or beneficiaries of services, or others, as appropriate.
(v) The potential for continued support of the project after Federal funding ends, including, as appropriate, the demonstrated commitment of appropriate entities to such support.
(e)
(1) The Secretary considers the quality of the evaluation to be conducted of the proposed project.
(2) In determining the quality of the evaluation, the Secretary considers the following factors:
(i) The extent to which the methods of evaluation are thorough, feasible, and appropriate to the goals, objectives, and outcomes of the proposed project.
(ii) The extent to which the methods of evaluation are appropriate to the context within which the project operates.
(iii) The extent to which the methods of evaluation provide for examining the effectiveness of project implementation strategies.
(iv) The extent to which the methods of evaluation include the use of
(v) The extent to which the evaluation will provide guidance about effective strategies suitable for replication or testing in other settings.
(vi) The extent to which the methods of evaluation will provide performance feedback and permit periodic assessment of progress toward achieving intended outcomes.
(vii) The extent to which the evaluation plan clearly articulates the key project components, mediators, and outcomes, as well as a measurable threshold for acceptable implementation.
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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).
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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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If your application is not evaluated or not selected for funding, we 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
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• Projects use professional development practices supported by evidence to support the attainment of identified competencies;
• Participants in SPDG professional development demonstrate improvement in implementation of SPDG-supported practices over time;
• Projects use SPDG professional development funds to provide activities designed to sustain the use of SPDG-supported practices;
• Special education teachers who meet the qualifications described in section 612(a)(14)(C) of IDEA, as amended by the ESSA, and who have participated in SPDG-supported special education teacher retention activities remain as special education teachers two years after their initial participation in these activities; and
• Projects improve outcomes for children with disabilities.
Each grantee funded under this competition must collect and annually report data related to its performance on these measures in the project's annual and final performance report to the Department in accordance with section 653(d) of IDEA and 34 CFR 75.590. Applicants should discuss in the application narrative how they propose to collect performance data for these measures.
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In making a continuation award, 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 Elementary and Secondary Education, Department of Education.
Final priorities, requirements, definition, and selection criteria.
The Assistant Secretary for Elementary and Secondary Education announces priorities, requirements, definition, and selection criteria under the Education Innovation and Research (EIR) program, Catalog of Federal Domestic Assistance (CFDA) numbers 84.411A/B/C. The Assistant Secretary may use these priorities, requirements, definition, and selection criteria for a competition in fiscal year (FY) 2020 and in later years. The Department intends these priorities, requirements, definition, and selection criteria to support competitions under the EIR program for the purpose of developing, implementing, and evaluating teacher-directed professional learning projects designed to enhance instructional practice and improve achievement and attainment for high-need students.
These priorities, requirements, definition, and selection criteria are effective August 28, 2020.
Ashley Brizzo. U.S. Department of Education, 400 Maryland Avenue SW, Room 3E325, Washington, DC 20202. Telephone: (202) 453-7122. 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.
Section 4611 of the ESEA, 20 U.S.C. 7261.
We published a notice of proposed priorities, requirements, definition, and selection criteria for this program in the
Regarding comments about narrowing the focus of EIR, the Department annually examines the needs of the field and the existing projects in the EIR portfolio to determine the priorities in that year's competitions. Although commenters raised concerns that such a priority could undermine title II, part A, the Department notes that title II, part A was funded by Congress in FY 2020 and is a separate funding stream with separate statutory requirements. These final priorities provide the Department an opportunity to complement those investments and contribute ideas for ways that teacher voice can be better included in how professional learning is delivered. The Department also includes an assurance that grantees will maintain current fiscal and administrative levels of effort in teacher professional development to help ensure that this program offers an added value to professional learning.
The Department agrees that there is value in collaborative learning, and these priorities allow for teacher-driven decisions to use stipends in such ways including coaching, job shadows, and other peer learning opportunities. Applicants also have the discretion to continue implementing effective collaborative professional learning that already exists.
Although concerns were raised about not all teachers having access to the stipend, the Department believes the applicant is best situated to propose the pool of teachers their proposed program focuses on (
The Department understands that there are a few existing cases of some degree of teacher choice in professional learning. However, it is not a broadly adopted policy or practice in education and is in need of further evaluation. The use of these priorities in EIR is intended to support field-initiated innovations that either build on existing efforts for, or initiate systemic changes that increase, teacher agency. Entities that believe they already have robust systems of teacher-selected professional learning are not required to apply for a grant.
Principals continue to have an important role in supporting teachers and this program is intended to provide an additional set of resources that reinforce principals' efforts to recruit and retain a talented pool of professionals. Given that teachers also can have a vital role in professional learning decisions, this program focuses on enhancing the ways in which teachers are involved in identifying professional learning opportunities.
In response to comments about the ability of teachers to be reflective and self-aware enough to know their needs, the Department highly respects the teaching profession and teachers as professionals. As such, we believe that the teachers who request a stipend are likely to be individuals who are reflective practitioners eager to continue to hone their craft in a way that best supports the students they teach. The Department has structured this priority in a way that would encourage teachers to use data such as student achievement trends, evaluation or observation results, and other feedback about their performance to determine what types of
The Department is required to award grants to eligible entities in a manner consistent with its authorizing statute and thus cannot award funds, such as stipends, directly to teachers.
Thirty-six commenters opposed the requirement to replace no less than a majority of required professional development. One primary reason for
Many of the Department's established priorities entail activities that many eligible applicants lack the authority or capacity to do. We recognize that professional development is uniquely tied to rules set by States that most of our eligible applicants will not, if those rules are a barrier, be able to alter. However, the Department has established this priority with the express purpose of altering the way in which teachers engage in professional learning. Each eligible applicant must assess, based on their own unique needs and capabilities, whether to respond to this particular funding opportunity. We note that the EIR NIAs have to date always offered more than two absolute priorities, so applicants that do not feel they are in a position to respond to this priority could consider applying under other priorities.
This notice contains three final priorities.
Under this priority, an applicant must propose a project in which classroom teachers receive stipends to select professional learning alternatives that are instructionally relevant and meet their individual needs related to instructional practices for high-need students. Additionally, teachers receiving stipends must be allowed the flexibility to replace a significant portion (no less than 20 percent) of existing mandatory professional development with such teacher-directed learning, which must also be allowed to fully count toward any mandatory teacher professional development goals (
Under this priority, an applicant must demonstrate it has established a partnership between an eligible entity and an SEA (with either member of the partnership serving as the applicant) to support the proposed project.
Under this priority, an applicant must demonstrate it has established a partnership between an eligible entity and an LEA (with either member of the partnership serving as the applicant) to support the proposed project.
When inviting applications for a competition using one or more priorities, we designate the type of each priority as absolute, competitive preference, or invitational through a notice in the
This document does not preclude us from proposing additional priorities, requirements, definitions, or selection criteria, subject to meeting applicable rulemaking requirements.
This document does
This notice contains eight requirements. We may apply one or more of these requirements in any year in which this program is in effect.
An applicant must—
(a) Describe the pool of teachers eligible to request a stipend, including whether the applicant intends to prioritize eligibility based on content areas, strategic staffing initiatives, or other factors (and including a rationale for how such a determination addresses the needs of high-need students, as defined by the applicant);
(b) Describe the anticipated level of teacher participation, including—
(1) Current information on teacher satisfaction with existing professional learning;
(2) Details on the planned outreach strategy to communicate the stipend opportunity to eligible teachers;
(3) A summary of the ways in which teachers were involved in developing the proposed project; and
(4) A plan for how to include teachers in key decisions about the stipend system;
(c) Describe the proposed stipend structure, including—
(1) Estimated dollar amount per stipend, including associated expenses related to the professional learning (
(2) A rationale for how the estimated dollar amount per stipend is sufficient to ensure access to professional learning activities that are, at minimum, comparable in quality, frequency, and duration to the professional development other non-participating teachers will receive in a given year;
(3) Mechanisms to protect against fraud, waste, and abuse (
(4) Plans for how the applicant will select participants if there is more interest than available stipends (
(d) Describe details about the stipend system, including—
(1) How the applicant will update its policies to offer stipends to teachers such that a significant portion (no less than 20 percent) of existing mandatory professional development is replaced by teacher-directed professional learning, including—
(i) The professional development days or activities from which participating teachers will be released in order to enable teacher-directed learning opportunities and to ensure that teacher-directed learning replaces a significant portion of existing mandatory professional development; or
(ii) Other methods in which participating teachers will be given the flexibility to participate in teacher-directed learning (
(2) How the applicant will ensure that teacher-directed learning will fully substitute for mandatory professional development in meeting mandatory professional development goals or activities (
(3) How the applicant will provide information to teachers about professional learning options not previously available to teachers (
(4) In addition to any list of professional learning options or providers identified by the applicant, mechanisms for teachers to independently select different high-quality, instructionally relevant professional learning activities connected to the achievement and attainment of high-need students (based on teacher-identified needs such as self-assessment surveys, student assessment data, and professional growth plans);
(e) Describe strategies for supporting teachers' implementation of changes in instructional practice as a result of their professional learning;
(f) Describe the process for managing the stipend system, including—
(1) For professional learning options that are among a list of options identified by the applicant: The processes for teachers to submit their requests to participate in those options in place of a previously required training and the processes for direct vendor payment using the stipend; and
(2) For professional learning options selected by a teacher that are not on the applicant's list of options: How the applicant will determine that the activity meets the definition of “professional learning” and is reasonable, and what processes the applicant will implement to ensure payment or timely reimbursement to teachers;
(g) Describe the proposed strategy to expand the use of professional learning stipends (pending the results of the evaluation), including—
(1) Plans for continuously improving the stipend system in order to, over time, offer more teachers the opportunity to engage in teacher-directed professional learning and, for participating teachers, ensure a higher percentage of all mandatory professional learning is teacher-directed; and
(2) Mechanisms for incorporating effective practices discovered through teacher-directed professional learning into the professional development curriculum for all teachers; and
(h) Provide an assurance that—
(1) At a minimum, the SEA or LEA involved in the project (as an applicant, partner, or implementation site) will maintain its current fiscal and administrative levels of effort in teacher professional development and allow the professional learning activities funded through the stipends to supplement the level of effort that is typically supported by the applicant;
(2) Project funds will only be used for instructionally relevant professional learning activities and not solely for obtaining advanced degrees, taking or preparing for licensure exams, or for pursuing personal enrichment activities; and
(3) Projects will allow for a variety professional learning options for teachers and not limit use of the stipend to an overly restrictive set of choices (for example, professional learning provided only by the applicant or partners, specific pedagogical or philosophical viewpoints, or organizations with specific methodological stances). The applicant and any application partners will not be the primary financial beneficiaries of the professional learning stipends, and there is no conflict between the applicant, any application partner, and the purpose of providing teachers the autonomy to select their own professional learning opportunities.
This notice includes one final definition. We may apply this definition in any year in which this program is in effect.
(1) Content knowledge;
(2) Understanding of instructional strategies and intervention techniques for high-need students, including how best to analyze and use data to inform such strategies and techniques; and
(3) Classroom management skills to better support high-need students.
Professional learning must be job-embedded or classroom-focused, collaborative, data-driven, part of a sustained and intensive program, and related to the achievement and attainment of high-need students. Professional learning may include innovative activities such as peer shadowing opportunities, virtual mentoring, online modules, professional learning communities, communities of practice, action research, micro-credentials, and coaching support.
This notice contains eight selection criteria for evaluating an application under this program. We may apply one or more of these selection criteria in any year in which this program is in effect.
(a) The sufficiency of the stipend amount to enable professional learning funded through the stipend to replace a significant portion of existing mandatory professional development for participating teachers.
(b) The adequacy of plans to ensure that stipends are appropriately used for high-quality professional learning.
(c) The extent to which the proposed project will offer teachers flexibility and autonomy regarding the extent of the choice teachers have in selecting their professional learning.
(d) The likelihood that the procedures and resources for teachers result in a simple process to select or request professional learning based on their professional learning needs and those identified needs of high-need students.
(e) The likelihood that the professional learning supported through the stipends will result in sustained positive changes in teachers' instructional practices.
(f) The likelihood that the professional learning supported through the stipends will result in improved student outcomes.
(g) The extent to which the proposed payment structure will enable teachers to have an opportunity to apply for and use the stipend with minimal burden.
(h) The adequacy of procedures for leveraging the stipend program to inform continuous improvement and systematic changes to professional learning.
(i) The extent to which professional learning funded through the stipend will replace existing mandatory professional development for participating teachers.
Under Executive Order 12866, it must be determined whether this regulatory action is “significant” and, therefore, subject to the requirements of the Executive order and subject to review by the Office of Management and Budget (OMB). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action likely to result in a rule that may—
(1) Have an annual effect on the economy of $100 million or more, or adversely affect a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or Tribal governments or communities in a material way (also referred to as an “economically significant” rule);
(2) Create serious inconsistency or otherwise interfere with an action taken or planned by another agency;
(3) Materially alter the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or
(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles stated in the Executive order.
This final regulatory action is not a significant regulatory action subject to review by OMB under section 3(f) of Executive Order 12866. Pursuant to the Congressional Review Act (5 U.S.C. 801
Under Executive Order 13771, for each new rule that the Department proposes for notice and comment or otherwise promulgates that is a significant regulatory action under Executive Order 12866, and that imposes total costs greater than zero, it must identify two deregulatory actions. For Fiscal Year 2020, any new incremental costs associated with a new regulation must be fully offset by the elimination of existing costs through deregulatory actions. Because the regulatory action is not significant, the requirements of Executive Order 13771 do not apply.
We have also reviewed this final regulatory action under Executive Order 13563, which supplements and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, Executive Order 13563 requires that an agency—
(1) Propose or adopt regulations only upon a reasoned determination that their benefits justify their costs (recognizing that some benefits and costs are difficult to quantify);
(2) Tailor its regulations to impose the least burden on society, consistent with obtaining regulatory objectives and taking into account—among other things and to the extent practicable—the costs of cumulative regulations;
(3) In choosing among alternative regulatory approaches, select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity);
(4) To the extent feasible, specify performance objectives, rather than the behavior or manner of compliance a regulated entity must adopt; and
(5) Identify and assess available alternatives to direct regulation, including economic incentives—such as user fees or marketable permits—to encourage the desired behavior, or provide information that enables the public to make choices.
Executive Order 13563 also requires an agency “to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.” The Office of Information and Regulatory Affairs of OMB has emphasized that these techniques may include “identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes.”
We are issuing these final priorities, requirements, definition, and selection criteria only on a reasoned determination that their benefits justify their costs. In choosing among alternative regulatory approaches, we selected those approaches that maximize net benefits. Based on the analysis that follows, the Department believes that this regulatory action is consistent with the principles in Executive Order 13563.
We also have determined that this regulatory action does not unduly interfere with State, local, and Tribal governments in the exercise of their governmental functions.
In accordance with these Executive orders, the Department has assessed the potential costs and benefits, both quantitative and qualitative, of this regulatory action. The potential costs are those resulting from statutory requirements and those we have determined as necessary for administering the Department's programs and activities.
The potential costs are those resulting from statutory requirements and those we have determined as necessary for administering the Department's programs and activities. Entities selected for awards under section 4611 of the ESEA will be able to pay the costs associated with implementing projects related to teacher-directed professional learning experiences with grant funds. Thus, the costs of these final priorities, requirements, definition, and selection criteria will not be a significant burden for any eligible applicant.
Priority 1 gives the Department the opportunity to elevate the teaching profession by increasing the available funds for professional learning while requiring that applicants maintain current levels of investment. Additionally, by acknowledging teachers' ability to identify their professional learning needs and empowering them to select professional learning opportunities to meet those needs, we believe that this priority could result in a number of changes including reducing personal costs that teachers incur when they must pay for professional learning that they want through their own means if their school, district, or State will not pay for the professional learning. We also believe that teachers are more likely to have a committed investment in professional learning that they select, thereby enhancing the benefits of professional learning, including, but not limited to, increased knowledge and skills. Such changes have the potential to change instructional practices in ways that will improve student outcomes.
Priorities 2 and 3 may have the result of shifting at least some of the Department's grants among eligible entities by giving the Department the opportunity to prioritize partnerships that might be well suited to achieve the purposes of Priority 1. By prioritizing projects that are supported by an SEA or LEA—entities that establish professional development requirements—the Department is increasing the likelihood that such teacher-driven approaches can be implemented more widely, should they be determined as more effective. Because these final priorities would neither expand nor restrict the universe of eligible entities for any Department grant program, and since application submission and participation in our discretionary grant programs is voluntary, there are not costs associated with this priority.
The small entities that this regulatory action would affect are public or private nonprofit agencies and organizations, including institutions of higher education, that may apply. We believe that the costs imposed on an applicant by the final priorities, requirements, definition, and selection criteria will be limited to paperwork burden related to preparing an application and that the benefits of implementing these final priorities will outweigh any costs incurred by the applicant.
Of the impacts we estimate accruing to grantees or eligible entities, all are voluntary and related mostly to an increase in the availability of teacher-selected professional learning. Therefore, we do not believe that the final priorities, requirements, definition, and selection criteria will significantly impact entities beyond the potential for receiving additional support should the entity receive a competitive grant from the Department.
As part of its continuing effort to reduce paperwork and respondent burden, the Department provides the general public and Federal agencies with an opportunity to comment on proposed and continuing collections of information, in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)). This helps ensure that: The public understands the Department's collection instructions, respondents can provide the requested data in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the Department can properly assess the impact of collection requirements on respondents.
The final program priorities, requirements, definition, and selection criteria contain information collection requirements (ICR) for the program application package. As a result of the revisions to these sections, we are submitting the grant application package with OMB control number 1855-0021 for a reinstatement with change. In Table 1 below, we assume 50 applicants each spend 30 hours preparing their applications.
This document provides early notification of our specific plans and actions for this program.
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 a new information collection.
Interested persons are invited to submit comments on or before September 28, 2020.
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 Beatriz Ceja, 202-377-3711, or email
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)6239 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.
The First Annual Report is due on January 29, 2021 and applies to the reporting period from March 13, 2020 through June 30, 2020. The Second Annual Report is due on September 30, 2021 and applies to the reporting period from July 1, 2020 through June 30, 2021. The Third Annual Report is due on September 20, 2022 and applies to the reporting period from July 1, 2021 through June 30, 2022.
(1) What data in this form will be difficult to collect or report and why? Are there changes that could be made to improve the quality of the data or reduce the burden?
(2) The Department believes the data requested under this collection will be valuable for multiple purposes, such as measuring program performance and informing future program design. The Department is interested in learning the extent to which others, particularly stakeholders at the State and local level, agree that this data is valuable for their own purposes and whether there is additional data that would be valuable for the Department to collect from its grantees?
(3) The Department is interested in reducing the burden of data collection and making use of existing data when at all possible. For example, are there
(4) Will the proposed method for collecting the number of FTE positions created or retained as a result of HEER funds awarded to IHEs yield accurate data? Is there an alternative methodology that would improve the accuracy of the data?
Take notice that on July 20, 2020, ANR Pipeline Company (ANR), 700 Louisiana Street, Suite 700, Houston, Texas, 77002-2700, filed in Docket No. CP20-1-001 an application for an amendment, pursuant to Section 7(c) of the Natural Gas Act (NGA) and Part 157 of the Commission's regulations, to the certificate of public convenience and necessity issued on March 19, 2020 in this proceeding, relative to the interim lease by ANR of base gas owned by Mid Michigan Gas Storage Company (Mid Michigan) in the Austin, Goodwell, Lincoln-Freeman, Loreed, and Reed City storage fields.
Specifically, ANR seeks authorization to amend the Lease of Base Gas Agreement (Lease Agreement) between ANR and Mid Michigan to reflect changes to certain provisions of Exhibit 1 of the Lease Agreement pertaining to the open season procedures applicable to ANR's base gas purchases, all as more fully described in their application which is on file with the Commission and open to public inspection.
In addition to publishing the full text of this document in the
Any questions concerning this application may be directed to Sorana Linder, Director, Modernization & Certificates, ANR Pipeline Company, 700 Louisiana Street, Suite 700, Houston, Texas, by telephone at (832) 320-5209, or by email at
Pursuant to section 157.9 of the Commission's rules (18 CFR 157.9), within 90 days of this Notice, the Commission staff will issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the environmental assessment (EA) for this proposal. The issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's EA.
There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, on or before the comment date stated below file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by all other parties. A party must submit seven copies of filings made in the proceeding with the Commission and must mail a copy to the applicant and to every other party. Only parties to the proceeding can ask for court review of Commission orders in the proceeding.
However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest.
Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commenters will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commenters will not be required to serve copies of filed documents on all other parties. However, the non-party commenters will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.
As of the February 27, 2018 date of the Commission's order in Docket No. CP16-4-001, the Commission will apply its revised practice concerning out-of-time motions to intervene in any new NGA section 3 or section 7 proceeding.
The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the “eFile” link at
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 a new license for the Upper Mechanicville Hydroelectric Project, located on the Hudson River, in Saratoga and Rensselaer Counties, New York, and has prepared an Environmental Assessment (EA) for the project.
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 45 days from the date of this notice.
The Commission strongly encourages electronic filings. Please file comments using the Commission's eFiling system at
For further information, contact Jody Callihan at (202) 502-8278 or by email at
This is a supplemental notice in the above-referenced proceeding of Rancho Seco Solar II 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 August 12, 2020.
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 corporate filings:
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following electric securities filings:
Take notice that the Commission received the following qualifying facility 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 on July 22, 2020, pursuant to Rule 207(a)(2) of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.207(a)(2) (2019), American Electric Power Service Corporation (AEP or Petitioner) on behalf of its affiliate, Kentucky Power Company (KPCo, and with other affiliates discussed herein, AEP), hereby submits a petition for declaratory order (Petition) seeking confirmation that the Middle Creek energy storage project, a transmission asset that has undergone full review through the PJM Interconnection, L.L.C. stakeholder process, is eligible for cost-of-service recovery through AEP's Commission-approved transmission formula rates, and specifically through the transmission accounts designated for such projects in Order No. 784,
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Petitioner.
In addition to publishing the full text of this document in the
The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the “eFiling” link at
On June 17, 2020, the Commission issued a notice in the above-captioned proceeding and provided self-nomination instructions for those wishing to participate as panelists. However, due to unforeseen circumstances, the self-nomination form is not accepting submissions. Therefore, in this supplemental notice,
The subject line of your email should specify, “Speaker nomination for Offshore Wind Integration Technical Conference.” Please include the following information in your nomination:
For more information, please contact Ben Foster, 202-502-6149,
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.
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j. Deadline for filing motions to intervene and protests: 60 days from the issuance date of this notice.
The Commission strongly encourages electronic filing. Please file motions to intervene and protests using the Commission's eFiling system at
The Commission's Rules of Practice require all intervenors filing documents with the Commission to serve a copy of that document on each person on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.
k. This application has been accepted but is not ready for environmental analysis at this time.
l. The Normanskill Project consists of the following existing facilities: (1) A 380-foot-long reinforced concrete Ambursen-type dam with a 306-foot-long overflow section having a crest elevation of 259 feet National Geodetic Vertical Datum of 1929 (NGVD29) surmounted by 3-foot-high flashboards; (2) a 380-acre reservoir with a gross volume of 3,600 acre-feet at the normal maximum pool elevation of 262 feet NGVD29; (3) an intake structure and sluiceway; (4) a 700-foot-long, 6-foot-diameter, concrete-encased steel, buried penstock; (5) a reinforced concrete underground powerhouse containing a single 1,250-kilowatt tube-type generating unit; (6) a 600-foot-long, 2.4-kilovolt (kV) transmission line; (7) a 2.4/13.2-kV transformer bank; and (8) appurtenant facilities.
The Normanskill Project is operated in a run-of-river mode with an average annual generation of 2,863 megawatt-hours between 2010 and 2019.
m. In addition to publishing the full text of this document in the
You may also register online at
n. Anyone may submit a protest or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, and .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any protests or motions to intervene must be received on or before the specified comment date for the particular application.
All filings must: (1) Bear in all capital letters the title “PROTEST” or “MOTION TO INTERVENE;” (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person protesting or intervening; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. Agencies may obtain copies of the application directly from the applicant. A copy of any protest or motion to intervene must be served upon each representative of the applicant specified in the particular application.
o. Procedural schedule and final amendments: The application will be processed according to the following preliminary schedule. Revisions to the schedule will be made as appropriate.
p. Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of the notice of ready for environmental analysis.
Federal Deposit Insurance Corporation (FDIC).
Notice and request for comment.
The FDIC, as part of its obligations under the Paperwork Reduction Act of 1995 (PRA), invites the general public and other Federal agencies to take this opportunity to comment on the renewal of the existing information collection described below (OMB Control No. 3064-0092).
Comments must be submitted on or before September 28, 2020.
Interested parties are invited to submit written comments to the FDIC by any of the following methods:
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All comments should refer to the relevant OMB control number. A copy of the comments may also be submitted to the OMB desk officer for the FDIC: Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Washington, DC 20503.
Manny Cabeza, Regulatory Counsel, 202-898-3767,
Proposal to renew the following currently approved collections of information:
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There is no change in the method or substance of the collection. The overall decrease in burden hours is a result of the decrease in the estimated number of respondents.
Appraisal Subcommittee of the Federal Financial Institutions Examination Council.
Notice of special meeting.
Status:
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The public portions of the applications listed below, as well as other related filings required by the Board, if any, are available for immediate inspection at the Federal Reserve Bank(s) indicated below and at the offices of the Board of Governors. This information may also be obtained on an expedited basis, upon request, by contacting the appropriate Federal Reserve Bank and from the Board's Freedom of Information Office at
Comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors, Ann E. Misback, Secretary of the Board, 20th Street and Constitution Avenue NW, Washington, DC 20551-0001, not later than August 28, 2020.
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The notificants listed below have applied under the Change in Bank Control Act (Act) (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the applications are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The public portions of the applications listed below, as well as other related filings required by the Board, if any, are available for immediate inspection at the Federal Reserve Bank(s) indicated below and at the offices of the Board of Governors. This information may also be obtained on an expedited basis, upon request, by contacting the appropriate Federal Reserve Bank and from the Board's Freedom of Information Office at
Comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors, Ann E. Misback, Secretary of the Board, 20th Street and Constitution Avenue NW, Washington DC 20551-0001, not later than August 13, 2020.
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Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).
Notice and request for comments.
In accordance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, and the Office of Management and Budget (OMB) regulations, DoD, GSA, and NASA invite the public to comment on a revision and renewal concerning rights in data and copyrights. DoD, GSA, and NASA invite comments on: Whether the proposed collection of information is necessary for the proper performance of the functions of Federal Government acquisitions, including whether the information will have practical utility; the accuracy of the estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including the use of automated collection techniques or other forms of information technology. OMB has approved this information collection for use through October 31, 2020. DoD, GSA, and NASA propose that OMB extend its approval for use for three additional years beyond the current expiration date.
DoD, GSA, and NASA will consider all comments received by September 28, 2020.
DoD, GSA, and NASA invite interested persons to submit comments on this collection through
Zenaida Delgado, Procurement Analyst, at telephone 202-969-7207, or
9000-0090, Rights in Data and Copyrights.
Contracts must contain terms that delineate the appropriate rights and obligations of the Government and the contractor regarding the use, reproduction and disclosure of data. This clearance covers the information that offerors and contractors must submit to comply with the following Federal Acquisition Regulation (FAR) requirements:
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Requesters may obtain a copy of the information collection documents from the GSA Regulatory Secretariat Division by calling 202-501-4755 or emailing
Office of Government Ethics.
Notice of new guidance portal.
The U.S. Office of Government Ethics (OGE) is publishing this notice to announce a new guidance portal on its website for guidance documents, as required by Executive Order 13891 “Promoting the Rule of Law Through Improved Agency Guidance Documents.”
The guidance portal is accessible by the public on the date of publication of this notice: July 29, 2020.
Patrick J. Lightfoot, Assistant Counsel, U.S. Office of Government Ethics, Telephone: 202-482-9300.
Executive Order 13891 “Promoting the Rule of Law Through Improved Agency Guidance Documents” requires each agency to establish or maintain on its website a guidance portal that contains or links to all guidance documents in effect issued by that agency. Guidance documents are defined by the Executive Order, subject to certain exclusions, as agency statements of general applicability, intended to have future effect on the behavior of regulated parties, that set forth a policy on a statutory, regulatory, or technical issue, or an interpretation of a statute or regulation.
The Office of Management and Budget (OMB) issued Memorandum M-20-02, “Guidance Implementing Executive Order 13891, Titled `Promoting the Rule of Law Through Improved Agency Guidance Documents' ” on October 31, 2019. OMB's memorandum directed agencies to establish a guidance portal and publish a notice in the
The guidance portal notes that guidance documents do not have the force and effect of law, except as authorized by law or as incorporated into a contract. However, to the extent that a guidance document provides an interpretation of the government ethics laws and regulations or concerns aspects of ethics program management, guidance documents are controlling within the executive branch. Guidance documents not included in the guidance portal will not be cited to, used, or relied on by OGE, except to establish historical facts.
Centers for Medicare & Medicaid Services (CMS), HHS.
Final notice.
This final notice announces our decision to approve DNV GL Healthcare USA Inc. (DNV GL) for initial recognition as a national accrediting organization for psychiatric hospitals that wish to participate in the Medicare or Medicaid programs.
The decision announced in this final notice is effective July 30, 2020 through July 30, 2024.
Joann Fitzell, (410) 786-4280. Lillian Williams, (410) 786-8636.
Under the Medicare program, eligible beneficiaries may receive covered services from a psychiatric hospital provided certain requirements established by the Secretary of the Department of Health and Human Services (the Secretary) are met. Section 1861(f) of the Social Security Act (the Act) establishes distinct criteria for facilities seeking designation as a psychiatric hospital under Medicare. Regulations concerning provider agreements and supplier approval are at 42 CFR part 489 and those pertaining to activities relating to the survey and certification of facilities are at 42 CFR part 488. The regulations at 42 CFR part 482 subparts A, B, C and E specify the minimum conditions that a psychiatric hospital must meet to participate in the Medicare program, the scope of covered services and the conditions for Medicare payment for psychiatric hospitals.
Generally, to enter into a provider agreement with the Medicare program, a psychiatric hospital must first be certified by a state survey agency as complying with the conditions or requirements set forth in part 482 subpart A, B, C and E of Centers for Medicare & Medicaid Services (CMS) regulations. Thereafter, the psychiatric hospital is subject to regular surveys by a state survey agency to determine whether it continues to meet the Medicare requirements.
However, there is an alternative to surveys by state agencies. Section 1865(a)(1) of the Act states, if a provider entity demonstrates through accreditation by an approved national accrediting organization (AO) that all applicable Medicare conditions are met or exceeded, we may treat the provider entity as having met those conditions, that is, we may deem the provider entity as having met the requirements. Accreditation by an AO is voluntary and is not required for Medicare participation.
If an AO is recognized by CMS as having standards for accreditation that meet or exceed Medicare requirements, any provider entity accredited by the national accrediting body's approved program may be deemed to meet the Medicare conditions. A national AO applying for approval of its accreditation program under part 488, subpart A, must provide CMS with reasonable assurance that the AO requires the accredited provider entities to meet requirements that are at least as stringent as the Medicare conditions. Our regulations concerning the approval of AOs are set forth at § 488.5. The regulations at § 488.5(e)(2)(i) require the AO to reapply for continued approval of its accreditation program every 6 years or sooner as determined by CMS.
Section 1865(a)(2) of the Act and our regulations at § 488.5 require that findings concerning review and approval of an AO's requirements consider, among other factors, the applying AO's requirements for accreditation; survey procedures; resources for conducting required surveys; capacity to furnish information for use in enforcement activities; monitoring procedures for provider entities that were found not in compliance with the conditions or requirements; and ability to provide CMS with the necessary data for validation.
Section 1865(a)(3)(A) of the Act provides a statutory timetable to ensure that our review of applications for CMS-approval of an accreditation program is conducted in a timely manner. The Act provides CMS 210 days after the date of receipt of a complete application, with any documentation necessary to make the determination, to complete our survey activities and application process. Within 60 days after receiving a complete application, CMS must publish a notice in the
On March 2, 2020
• An onsite administrative review of DNV GL's: (1) Corporate policies; (2) financial and human resources available to accomplish the proposed surveys; (3) procedures for training, monitoring, and evaluation of its psychiatric hospital surveyors; (4) ability to investigate and respond appropriately to complaints against accredited psychiatric hospitals; and, (5) survey review and decision-making process for accreditation.
• The comparison of DNV GL's Medicare psychiatric hospital accreditation program standards to our current Medicare hospitals Conditions of Participation (CoPs) and psychiatric hospital special CoPs.
• A documentation review of DNV GL's psychiatric hospital survey process to do the following:
++ Determine the composition of the survey team, surveyor qualifications, and DNV GL's ability to provide continuing surveyor training.
++ Compare DNV GL's processes to those we require of state survey agencies, including periodic re-survey and the ability to investigate and respond appropriately to complaints against accredited psychiatric hospitals.
++ Evaluate DNV GL's procedures for monitoring psychiatric hospitals it has found to be out of compliance with DNV GL's program requirements. (This pertains only to monitoring procedures when DNV GL identifies as non-compliance. If noncompliance is identified by a state survey agency through a validation survey, the state survey agency monitors corrections as specified at § 488.9(c)(1)).
++ Assess DNV GL's ability to report deficiencies to the surveyed hospital and respond to the psychiatric hospital's plan of correction in a timely manner.
++ Establish DNV GL's ability to provide CMS with electronic data and reports necessary for effective validation
++ Determine the adequacy of DNV GL's staff and other resources.
++ Confirm DNV GL's ability to provide adequate funding for performing required surveys.
++ Confirm DNV GL's policies with respect to surveys being unannounced.
++ Confirm DNV GL's policies and procedures to avoid conflicts of interest, including the appearance of conflicts of interest, involving individuals who conduct surveys or participate in accreditation decisions.
++ Obtain DNV GL's agreement to provide CMS with a copy of the most current accreditation survey together with any other information related to the survey as we may require, including corrective action plans.
++ As authorized under § 488.8(h), CMS reserves the right to conduct onsite observations of accrediting organization's operations at any time as part of the ongoing review and continuing oversight of an AO's performance.
In accordance with section 1865(a)(3)(A) of the Act, the March 2, 2020 proposed notice also solicited public comments regarding whether DNV GL's requirements met or exceeded the Medicare CoPs for psychiatric hospitals. We received 4 comments in response to our proposed notice. We thank the commenters for their support. We agreed with the commenters that a new psychiatric hospital accreditation organization would provide hospitals further options in regards to accreditation. Based on our comprehensive review of their program, we have approved DNV GL as such a program.
We compared DNV GL's psychiatric hospital accreditation program requirements and survey process with the Medicare CoPs at 42 CFR part 482, and the survey and certification process requirements of parts 488 and 489. Our review and evaluation of DNV GL's psychiatric hospital application, which were conducted as described in section III of this final notice, yielded the following areas where, as of the date of this notice, DNV GL has revised its standards and certification processes in order to meet the requirements at:
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++ Complete and accurate tracking of complaints as well as a process for maintaining a documented record of contacts made (for example, phone, email and United States mail) with the complainant, and others, if applicable.
++ Defining the number of contact attempts required before closing out a complaint if the complainant does not respond.
++ Educating DNV GL complaint intake staff that when complaint allegations could potentially result in condition-level non-compliance affecting the health and safety of patients, a survey is to be considered regardless if the allegation also involves payment related allegations.
++ Investigating complaints onsite within an appropriate timeframe.
Based on our review and observations described in section III of this final notice, we have determined that DNV GL's psychiatric hospital accreditation program requirements meet or exceed our requirements, and its survey processes are also comparable. Therefore, we approve DNV GL as a national AO for psychiatric hospitals that request participation in the Medicare program, effective July 30, 2020 through July 30, 2024.
This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The Administrator of the Centers for Medicare & Medicaid Services (CMS), Seema Verma, having reviewed and approved this document, authorizes Lynette Wilson, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled “Multiple Function Device Products: Policy and Considerations; Guidance for Industry and Food and Drug Administration Staff.” This final guidance provides FDA's regulatory approach for device products with multiple functions including at least one device function and includes such device products that are part of combination products, in accordance with the 21st Century Cures Act (Cures Act).
The announcement of the guidance is published in the
You may submit either electronic or written comments on Agency guidances at any time as follows:
Submit electronic comments in the following way:
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• 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:
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• 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
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
An electronic copy of the guidance document is available for download from the internet. See the
Bakul Patel, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5458, Silver Spring, MD 20993-0002, 301-796-5528; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911; or Kristina Lauritsen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6162, Silver Spring, MD 20993-0002, 301-796-8936.
On December 13, 2016, the Cures Act (Pub. L. 114-255) was signed into law. Section 3060(a) of this legislation entitled “Clarifying Medical Software Regulation” amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to add section 520(o) (21 U.S.C. 360j(o)), which excludes certain software functions from the definition of device in section 201(h) of the FD&C Act (21 U.S.C. 321(h)). In addition, section 520(o)(2) of the FD&C Act describes the regulation and assessment of a product with multiple functions including at least one device function and at least one software function that is not a device. Although section 520(o)(2) of the FD&C Act applies to the regulation of software products containing at least one device function and at least one non-device software function, FDA believes that a similar approach should be used for the assessment of all multiple function device products that contain at least one device function and one “other function”, which may be a non-device software function; a function that meets the definition of a device, but is not subject to premarket review; or a function that meets the definition of device, but for which FDA has expressed its intention not to enforce compliance with applicable regulatory controls. This approach also applies to multiple function device products that are device constituent parts of combination products. FDA considered comments received on the draft guidance that appeared in the
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Multiple Function Device Products: Policy and Considerations; Guidance for Industry and Food and Drug Administration Staff.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at
This guidance refers to previously approved collections of information. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information have been approved by OMB as follows:
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
The meeting will take place virtually on September 8, 2020, from 8 a.m. to 6 p.m. Eastern Time and on September 9, 2020, from 8 a.m. to 1 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 held via webcast only. Answers to commonly asked questions about FDA advisory committee meetings may be accessed at:
Patricio Garcia, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5216, Silver Spring, MD 20993-0002,
On September 9, 2020, the committee will discuss and make recommendations regarding the classification of three devices, which are currently unclassified pre-amendment devices to class II (general and special controls). The committee, during session I, will discuss semi-constrained toe (metatarsophalangeal) joint prostheses; during session II, will discuss intracompartmental pressure monitors; and during session III, will discuss intra-abdominal pressure monitoring devices.
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
Select the link for the 2020 Meeting Materials. The meeting will include slide presentations with audio components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting.
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 of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products.” This guidance describes FDA's current recommendations about endotoxin limits in certain investigational oncology drugs and biological products. This guidance looks at a risk-based approach of weighing the potential risks of not evaluating endotoxin levels in all components of a multidrug regimen against the potential benefits to patients with serious and life-threatening diseases.
Submit either electronic or written comments on the draft guidance by September 28, 2020 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
You may submit comments on any guidance at any time as follows:
Submit electronic comments in the following way:
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• 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:
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• 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
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Patricia Keegan, Center for Drug Evaluation and Research, Food and Drug Administration, 10993 New Hampshire Ave., Bldg. 22, Rm. 2322, Silver Spring, MD 20993, 301-796-1387; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
FDA is announcing the availability of a draft guidance for industry entitled “Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products.” When finalized, this guidance will describe FDA's current recommendations about endotoxin limits in investigational oncology drugs and biological products. It looks at a risk-based approach of weighing the potential risks of not evaluating endotoxin levels in all components of a multidrug regimen against the potential benefits to patients with serious and life-threatening diseases. It is limited to anticancer drugs administered parenterally (except for intraocular administration) to treat serious and life-threatening cancers based on histology or stage of disease.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
This draft guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collection of information in 21 CFR part 312 have been approved under OMB control number 0910-0014.
Persons with access to the internet may obtain the draft guidance at
Office of the Assistant Secretary for Planning and Evaluation (ASPE), U.S. Department of Health and Human Services (HHS).
Request for information.
HHS issues this Request for Information (RFI) in order to seek information about programs that provide services to help young people, ages 16 to 24, advance on education and employment pathways. This project is focused on the population of young people who are out of work and/or out of school, particularly those from lower income families and communities, sometimes called disconnected or opportunity youth. The information gathered will result in a public compendium that profiles selected programs operating in this area, particularly innovative programs.
Submit written comments at the address provided below no later than September 28, 2020.
Written comments should be submitted to
Lisa Trivits on the Reconnecting Youth team at
In the fall of 2019, the Office of the Assistant Secretary for Planning and Evaluation (ASPE) within the U.S. Department of Health and Human Services, funded MDRC and its partner, Child Trends, to conduct a project examining practices and programs aimed at reconnecting youth to school and work. This RFI is intended to help identify programs for the first major task of the project, which is to conduct a scan of programs and practices, including innovative approaches, aimed at improving education and employment outcomes for disconnected young people from low-income families and communities. The information gathered through this RFI will result in a public compendium that profiles selected programs operating in this area, particularly innovative programs. To ensure this project reaches the full range of programs operating in the United States, including new and innovative programs, we are seeking recommendations on programs to be screened for inclusion in the compendium. Specifically, we are seeking information about programs that provide services to help youth ages 16 to 24 advance on education and employment pathways.
Through this RFI, HHS seeks to gather feedback from public stakeholders—state and local government agencies, local program operators, and the people that we serve—to identify programs that aim to improve education and employment outcomes for the population of young people who are out of work and out of school, particularly those from low income families or communities, sometimes called disconnected or opportunity youth. Please note that we will consider all recommended programs, but not all submissions will be included in the compendium.
We are looking for programs that fit the following criteria:
• Serves young people ages 16-24 (may also serve adults).
• Targets young people who are out of school, out of work, or have other risk factors (low income family, or community; parenting; justice involved; foster care; experiencing homelessness; has a disability).
• Provides services in support of education or employment goals.
• Currently operating in the United States.
Please use the questions below to tell us about programs that you think we should consider for this project.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Deafness and Other Communication Disorders Advisory Council.
The meeting will be open to the public as indicated below, with attendance limited to space availability. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the 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.
Information is also available on the Institute's/Center's home page:
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.
Pursuant to Public Law 92-463, notice is hereby given of a meeting of the Substance Abuse and Mental Health Services Administration's (SAMHSA) Advisory Committee for Women's Services (ACWS) on August 19, 2020.
The meeting will include discussions on assessing SAMHSA's current strategies, including the mental health and substance use needs of the women and girls population. Additionally, the ACWS will be addressing priorities regarding the impact of COVID-19 on the behavioral health needs of women and children, and the current ethnic/racial climate and related economic and health disparities on women, and directions around behavioral health services and access for women and children.
The meeting is open to the public and will be held virtually only. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.
Written submissions should be forwarded to the contact person by August 9, 2020. Oral presentations from the public will be scheduled at the conclusion of the meeting. Individuals interested in making oral presentations must notify the contact person on or before August 9, 2020. Up to five minutes will be allotted for each presentation, as time permits.
The meeting may be accessed via telephone or web meeting. To obtain the call-in number and access code, submit written or brief oral comments, or request special accommodations for persons with disabilities, please register on-line at
Substantive meeting information and a roster of ACWS members may be obtained either by accessing the SAMHSA Committees' Web
U.S. Customs and Border Protection, Department of Homeland Security.
General notice.
This document announces that U.S. Customs and Border Protection (CBP) is adjusting certain customs user fees and corresponding limitations established by the Consolidated Omnibus Budget Reconciliation Act (COBRA) for Fiscal Year 2021 in accordance with the Fixing America's Surface Transportation Act (FAST Act) as implemented by the CBP regulations.
The adjusted amounts of customs COBRA user fees and their corresponding limitations set forth in this notice for Fiscal Year 2021 are required as of October 1, 2020.
Tina Ghiladi, Senior Advisor, International Trade & Travel, Office of Finance, 202-344-3722,
On December 4, 2015, the Fixing America's Surface Transportation Act (FAST Act, Pub. L. 114-94) was signed into law. Section 32201 of the FAST Act amended section 13031 of the Consolidated Omnibus Budget Reconciliation Act (COBRA) of 1985 (19 U.S.C. 58c) by requiring the Secretary of the Treasury (Secretary) to adjust certain customs COBRA user fees and corresponding limitations to reflect certain increases in inflation.
Sections 24.22 and 24.23 of title 19 of the Code of Federal Regulations (19 CFR 24.22 and 24.23) describe the procedures that implement the requirements of the FAST Act. Specifically, paragraph (k) in section 24.22 (19 CFR 24.22(k)) sets forth the methodology to determine the change in
In accordance with 19 CFR 24.22, CBP must determine annually whether the fees and limitations must be adjusted to reflect inflation. For fiscal year 2021, CBP is making this determination by comparing the average of the Consumer Price Index—All Urban Consumers, U.S. All items, 1982-1984 (CPI-U) for the current year (June 2019-May 2020) with the average of the CPI-U for the comparison year (June 2018-May 2019) to determine the change in inflation, if any. If there is an increase in the CPI-U of greater than one (1) percent, CBP must adjust the customs COBRA user fees and corresponding limitations using the methodology set forth in 19 CFR 24.22(k). Following the steps provided in paragraph (k)(2) of section 24.22, CBP has determined that the increase in the CPI-U between the most recent June to May twelve-month period (June 2019-May 2020) and the comparison year (June 2018-May 2019) is 1.58
Using the methodology set forth in section 24.22(k)(2) of the CBP regulations (19 CFR 24.22(k)), CBP has determined that the factor by which the base fees and limitations will be adjusted is 8.933 percent (base fees and limitations can be found in Appendices A and B to part 24 of title 19). In reaching this determination, CBP calculated the values for each variable found in paragraph (k) of 19 CFR 24.22 as follows:
• The arithmetic average of the CPI-U for June 2019-May 2020, referred to as (A) in the CBP regulations, is 257.092;
• The arithmetic average of the CPI-U for Fiscal Year 2014, referred to as (B), is 236.009;
• The arithmetic average of the CPI-U for the comparison year (June 2018-May 2019), referred to as (C), is 252.922;
• The difference between the arithmetic averages of the CPI-U of the comparison year (June 2018-May 2019) and the current year (June 2019-May 2020), referred to as (D), is 4.170;
• This difference rounded to the nearest whole number, referred to as (E), is 4;
• The percentage change in the arithmetic averages of the CPI-U of the comparison year (June 2018-May 2019) and the current year (June 2019-May 2020), referred to as (F), is 1.58 percent;
• The difference in the arithmetic average of the CPI-U between the current year (June 2019-May 2020) and the base year (Fiscal Year 2014), referred to as (G), is 21.084; and
• Lastly, the percentage change in the CPI-U from the base year (Fiscal Year 2014) to the current year (June 2019-May 2020), referred to as (H), is 8.933 percent.
The adjusted amounts of customs COBRA user fees and their corresponding limitations for Fiscal Year 2021 as adjusted by 8.933 percent set forth below are required as of October 1, 2020. Table 1 provides the fees and limitations found in 19 CFR 24.22 as adjusted for Fiscal Year 2021, and Table 2 provides the fees and limitations found in 19 CFR 24.23 as adjusted for Fiscal Year 2021.
Tables 1 and 2,
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the territory of the U.S. Virgin Islands (FEMA-4513-DR), dated April 2, 2020, and related determinations.
This amendment was issued July 6, 2020.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the territory of the U.S. Virgin Islands is hereby amended to include Individual Assistance limited to the Crisis Counseling Program for those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of April 2, 2020.
Individual Assistance limited to the Crisis Counseling Program for all areas in the territory of the U.S. Virgin Islands (already designated for emergency protective measures [Category B] not authorized under other Federal statutes, including direct Federal assistance).
Federal Emergency Management Agency, DHS.
30-Day notice and request for comments.
The Federal Emergency Management Agency (FEMA) will submit the information collection abstracted below to the Office of Management and Budget for review and clearance in accordance with the requirements of the Paperwork Reduction Act of 1995. The submission will describe the nature of the information collection, the categories of respondents, the estimated burden (
Comments must be submitted on or before August 28, 2020.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Requests for additional information or copies of the information collection should be made to Director, Information Management Division, 500 C Street SW, Washington, DC 20472, email address
This proposed information collection previously published in the
Comments may be submitted as indicated in the
Office of Partnership and Engagement OPE), Department of Homeland Security (DHS).
Notice of partially closed Federal advisory committee meeting.
The Homeland Security Advisory Council (HSAC or Council) will meet in person on Tuesday, August 18, 2020. The meeting will be partially closed to the public and have both an open session and a closed session. Due to the National Emergency concerning the Novel Coronavirus Disease (COVID-19) pandemic members of the public will join the public session by teleconference.
The meeting will take place from 9:15 a.m. to 3:15 p.m. EDT on Tuesday, August 18, 2020. The meeting will be closed to the public from 9:10 a.m. to 1:40 p.m. EDT. The meeting will be open to the public from 1:45 p.m. to 3:15 p.m. EDT. Please note the meeting may end early if the Council has completed its business. If the times change due to the current National Emergency concerning the COVID-19 pandemic, those members of the public who have signed up for this notice will receive the new time schedule as soon as it becomes available.
The meeting will be held in the Town Hall at the Transportation Security Administration (TSA), 601 S
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Mike Miron at
Notice of this meeting is given under Section 10(a) of the Federal Advisory Committee Act (FACA), Public Law 92-463 (5 U.S.C. Appendix), which requires each FACA committee meeting to be open to the public.
The Council provides organizationally independent, strategic, timely, specific, actionable advice, and recommendations to the Secretary of Homeland Security on matters related to homeland security. The Council is comprised of leaders of local law enforcement, first responders, Federal, State, and Local governments, the private sector, and academia.
The Council will meet in an open session between 1:45 p.m. to 3:15 p.m. EDT. The Council will receive progress reports from the Economic Security, Biometrics, Information and Communication Technology Risk Reduction, and Youth Engagement subcommittees; and senior leadership will announce a new tasking and new Council membership. The HSAC will also review, deliberate, and vote on the final draft report of the Emerging Technology Subcommittee.
The Council will meet in a closed session from 9:10 a.m. to 1:40 p.m. EDT to receive sensitive operational information from senior officials on intelligence, border security, transportation security, cybersecurity and infrastructure.
The Council will receive closed session briefings containing For Official Use Only and Law Enforcement sensitive information from senior officials. The session is closed under 5 U.S.C. 552b(c)(7)(E) because disclosure of that information could reveal investigative techniques and procedures not generally available to the public, allowing terrorists and those with interests against the United States to circumvent the law and thwart the Department's strategic initiatives.
Specifically, there will be material presented during the briefings regarding the latest viable threats against the United States and how DHS and other Federal agencies plan to address those threats. The session is closed pursuant to 5 U.S.C. 552b(c)(9)(B) because disclosure of these techniques and procedures could frustrate the successful implementation of protective measures designed to keep our country safe.
Bureau of Indian Affairs, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the Bureau of Indian Affairs (BIA) are proposing to renew an information collection.
Interested persons are invited to submit comments on or before September 28, 2020.
Send your comments on this information collection request (ICR) by email to Mr. Jack Stevens, Office of Indian Energy and Economic Development, Office of the Assistant Secretary—Indian Affairs, at: 1849 C Street NW, MS-4152 MIB, Washington, DC 20240; or by email to
To request additional information about this ICR, contact Jack Stevens by email at
In accordance with the Paperwork Reduction Act of 1995, we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information
We are soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary to the proper functions of the BIA; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the BIA enhance the quality, utility, and clarity of the information to be collected; and (5) how might the BIA minimize the burden of this collection on the respondents, including through the use of information technology.
Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
This is an annual program whose primary objective is to create jobs and foster economic activity within Tribal communities. The DED will administer the program within IEED; and studies as described herein will be sole discretionary projects DED will consider or fund absent a competitive bidding process. When funding is available, DED will solicit proposals for studies. To receive these funds, Tribes may, if eligible, obtain adjustments to their funding from the Office of Self-Governance.
Interested applicants must submit a Tribal resolution requesting funding, a statement of work describing the project for which the study is requested, the identity of the academic institution, consultants, or other entity the applicant wishes to retain (if known) and a budget indicating the funding amount requested and how it will be spent. The DED expressly retains the authority to reduce or otherwise modify proposed budgets and funding amounts.
Applications for funding will be juried and evaluated primarily on the basis of a proposed project's potential to generate jobs and economic activity in a Tribal community.
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.
The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Bureau of Land Management, Interior.
Notice of availability.
In accordance with the National Environmental Policy Act of 1969, as amended (NEPA), and the Federal Land Policy and Management Act of 1976, as amended, the Bureau of Land Management (BLM) Humboldt River Field Office, Winnemucca, Nevada, as the lead agency, has prepared a Draft Environmental Impact Statement (EIS) to analyze the potential impacts of approving the Lithium Nevada Corp. (LNC), Thacker Pass Project Proposed Plans of Operations and Reclamation Plan Permit Applications (Project) in Humboldt County, Nevada. In accordance with the Bald and Golden Eagle Protection Act (Eagle Act), the Fish and Wildlife Service (FWS) is a cooperating agency with the BLM on the development of this Draft EIS to analyze the potential impacts of approving LNC's request for an incidental take permit for golden eagles. The FWS will evaluate LNC's Eagle Conservation Plan (ECP), which describes their request for incidental take of eagles and a 5-year incidental take permit for golden eagles under the Eagle Act. This notice announces the beginning of the public comment period to solicit public comments on the Draft EIS.
To ensure comments will be considered, BLM must receive written comments on the Draft EIS no later than 45 days after the Environmental Protection Agency publishes its notice of availability of the Thacker Pass Lithium Mine Project Draft Environmental Impact Statement DOI-BLM-NV-W010-2020-0012-EIS in the
You may submit comments related to the Project by any of the following methods:
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For questions about the proposed Project, contact Mr. Ken Loda, telephone: (775) 623-1500, address: 5100 E Winnemucca Blvd., Winnemucca, NV 89445. Contact Mr. Loda to have your name added to our mailing list. For questions concerning the Eagle Act permitting process, contact Mr. Thomas Leeman at (916) 978-6189. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Relay Service (FRS) at 1-800-877-8339 to contact the above individual during normal business hours. The FRS is available 24 hours a day, 7 days a week, to leave a message or question with the above individual. You will receive a reply during normal business hours.
The applicant LNC proposes to construct, operate, reclaim, and eventually close an open pit lithium mine, processing operation, and continued exploration activities on public lands in northern Humboldt County, Nevada. LNC currently has two approved Plans of Operations (PoOs), one for exploration and one for a specialty clay mine, approved within the area proposed for the new lithium mine. There are 75 acres of exploration disturbance approved under LNC's existing exploration PoO, and 140 acres of existing disturbance approved under their clay mine PoO. LNC has submitted two new PoOs to develop the Project and to provide a description of the proposed lithium mining, processing, and exploration operations. Each of these PoOs include a reclamation plan for the activities identified under the respective PoO. The operations proposed under the two new PoOs would involve a project area of about 18,000 acres, with an ultimate disturbance footprint of approximately 5,700 acres. The proposed lithium mine PoO boundary overlaps the existing PoO boundaries.
LNC proposes to develop the Project in two phases over the estimated 41-year mine life. Pending LNC receiving the required authorizations and permits for Phase 1 of the Project, pre-stripping would commence in early 2021 and construction in the first quarter of 2021, with mining production and ore processing estimated to commence in late 2022. LNC estimates that it would complete mining, processing and concurrent reclamation activities in 2061, after which, reclamation, site closure activities, and post-closure monitoring would occur for a minimum of five years.
The proposed activities and facilities associated with the Project include development of an open pit mine; construction and operation of lithium processing and production facilities, mine facilities to support mining operations, two waste rock storage facilities, a run-of-mine stockpile, a clay tailings filter stack, water supply facilities, two power transmission lines and substations, and various ancillary facilities. Pit dewatering is not expected to be required as part of the Project until 2055, and concurrent backfill of the open pit would occur after sufficient volume has been excavated to initiate direct placement of waste rock. Continued exploration would be conducted under both PoOs. Upon further review the BLM has determined than an amendment to the Winnemucca District Resource Management Plan is not necessary.
In addition, the Project would affect golden eagle nests and territories by planned blasting within a two-mile radius of golden eagle nests; therefore, LNC has requested authorization from the FWS to disturb eagle nests and a 5-year incidental take permit for golden eagles under the Eagle Act. LNC's Eagle Conservation Plan is the foundation of the permit application and contains commitments to avoid, minimize, and mitigate adverse effects on golden eagles resulting from the implementation of the Project. Issuance of an eagle take permit must comply with the Eagle Act and all related regulatory requirements (50 CFR 22.26).
The purpose of this comment period is for the public to comment on the Draft EIS. The Draft EIS, through scoping, has identified and analyzed impacts to the following resources: Air and atmospheric resources; cultural resources; noxious weeds, invasive species, and nonnative species; migratory birds; golden eagles; Native American religious concerns; wastes and materials (hazardous and solid); water quality (surface and ground); geology, minerals and energy; lands and realty; paleontology; rangeland management; recreation; social values and economics; soils; special status species (plants and wildlife); transportation and access; vegetation; visual resources; and wildlife. The Draft EIS describes and analyzes the proposed Project's direct, indirect, and cumulative impacts on all affected resources. In addition to the Proposed Action, Alternative A, the following alternatives are also analyzed in the document: Alternative B, which is a partial backfilling of the pit that would result in a small wet area; Alternative C which does not backfill the pit and would result in three small, and probably seasonal, pit lakes; and the No Action Alternative. Alternatives A, B and C request an eagle take permit for loss of productivity of three golden eagle breeding pairs. Additionally, Alternative C would require nest site enhancement as compensatory mitigation under the Bald and Golden Eagle Protection Act.
The BLM has consulted and continues to consult with Indian tribes on a government-to-government basis in accordance with Executive Order 13175 and other policies. Tribal concerns, including impacts to Indian trust assets and potential impacts to cultural resources have been analyzed in the Draft EIS. Federal, State, and local agencies, along with tribes and other stakeholders that may be interested in or affected by the proposed Project that the BLM and FWS are evaluating, are invited to participate in the comment process.
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you may request in your comment that your personal identifying information be withheld from public review, we cannot guarantee that we will be able to do so.
40 CFR 1501.7.
National Park Service, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the National Park Service (NPS) are proposing to renew an information collection.
Interested persons are invited to submit comments on or before August 28, 2020.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
To request additional information about this ICR contact Peggi Brooks, Interagency Pass Program Manager, National Park Service by email at
In accordance with the Paperwork Reduction Act of 1995 (PRA, 44 U.S.C. 3501
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As part of our continuing effort to reduce paperwork and respondent burdens, we are again soliciting comments from the public and other Federal agencies on the proposed ICR that is described below. We are especially interested in public comment addressing the following:
(1) Whether or not the collection of information is necessary for the proper performance of the functions of the NPS, including whether or not the information will have practical utility;
(2) The accuracy of our estimate of burden for this 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) how might the NPS minimize the burden of this collection 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,
Comments that you submit in response to this notice are a matter of public record. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
NPS Form 10-596, “Interagency Access Pass” is a free, lifetime pass issued to citizens or residents who are domiciled in the United States, regardless of age, who have a medical determination and documentation of permanent disability. Ordering an Access Pass requires a complete application, proof of residency, documentation that proves permanent disability, payment (Lifetime Senior Pass $80 or Annual Senior Pass $20) and the $10 processing fee. Passes can be obtained in person from a participating Federal recreation site or office, through the mail, or on-line via the U.S. Geological Survey (USGS) store at
If a person arrives at a recreation site and claims eligibility for the Interagency Access Pass, but cannot produce any documentation, that person must read, sign, and date NPS Form 10-597, “Statement of Disability” in the presence of the agency officer issuing the Interagency Access Pass. If the applicant cannot read and/or sign the form, someone else may read, date, and sign the statement on his/her behalf in the applicant's presence and in the presence of the agency officer issuing the Interagency Access Pass.
NPS Form 10-595, “Interagency Senior Pass” is a pass issued to U.S. citizens or permanent residents who are 62 years or older. Senior Passes may be issued on a lifetime or annual basis. Both types of the Senior Pass can be purchased at any federal recreation site, including national parks, that charges an entrance or standard amenity (day-use) fee; online or through the mail from USGS.
Agency websites provide information on the passes and acceptable documentation. All documentation submitted in person or through the mail is returned to the applicant after the form is processed.
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.
The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
National Park Service, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act (PRA) of 1995, we, the National Park Service (NPS) are proposing to renew an information collection with revisions.
Interested persons are invited to submit comments on or before August 28, 2020.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
To request additional information about this ICR by mail contact Bill Commins, Natural Resource Stewardship and Science by email at
In accordance with the PRA, 44 U.S.C. 3501
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. . . we request the following question be added to the application, under the section “Study Schedule.” •
To increase the utility and clarity of this application (as requested, we request it include a separate box (in item 3) under the section “
We examined the requests in the context that RPRS is a national system that applies equally to all parks that receive applications for Scientific Research and Collecting Permits. With respect to the first comment, the NPS recognizes that many parks, whether in Alaska, the conterminous states, the Caribbean, or Hawaii and the Pacific Islands, are subject to biological, weather, or other circumstances beyond the control of incoming field teams. We conclude that all parks issuing Scientific Research and Collecting Permits, including the parks in Alaska, are acutely aware of factors that can affect field schedules and as a consequence maintain appropriate flexibilities to work with permittees to modify field schedules as necessary. Because of this awareness, we conclude that park research coordinators do not require redundant notice, therefore we rejected this recommendation.
With respect to the second comment, there is already a section in the application titled: “
As part of our continuing effort to reduce paperwork and respondent burdens, we are again soliciting comments from the public and other Federal agencies on the proposed ICR that is described below. We are especially interested in public comment addressing the following:
(1) Whether or not the collection of information is necessary for the proper performance of the functions of the NPS, including whether or not the information will have practical utility;
(2) The accuracy of our estimate of the burden for this 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) How might the NPS 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,
Comments that you submit in response to this notice are a matter of public record. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal
As required by these regulations, a permitting system is managed for scientific research and collecting. NPS forms 10-741a, “Application for a Scientific Research and Collecting Permit” and 10-741b, “Application for a Science Education Permit,” are used to collect information from persons seeking a permit to conduct natural or social science research and collection activities in individual units of the National Park System. Individuals who receive a permit must report annually on the activities conducted under the permit using form 10-226, “Investigator's Annual Report.”
The information in this collection is used to manage the use and preservation of park resources, and to report on the status of permitted research and collecting activities. We encourage respondents to use RPRS to complete and submit applications and reports. Additional information about existing applications, reporting forms, guidance and explanatory material can be found on the RPRS website (
With this renewal we are requesting clearance for the use of a new form, the “Permittee Field Check-In/Field Check-Out Report.” Information requested will give parks real time knowledge of what activities are taking place and where, ensuring field work conducted conforms with the permitted activity. For form users on the RPRS, the majority of the new form will be prepopulated using responses from the permit application.
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.
The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Office of Surface Mining Reclamation and Enforcement, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995 (PRA, 44 U.S.C. 3501
Interested persons are invited to submit comments on or before August 28, 2020.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
To request additional information about this ICR, contact Mark Gehlhar by email at
In accordance with the PRA and 5 CFR 1320.8(d)(1), we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.
A
As part of our continuing effort to reduce paperwork and respondent burdens, we are again soliciting comments from the public and other Federal agencies on the proposed ICR that is described below. We are especially interested in public comment addressing the following:
(1) Whether or not the collection of information is necessary for the proper performance of the functions of the agency, including whether or not the information will have practical utility;
(2) The accuracy of our estimate of the burden for this 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) How might the agency 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
Comments that you submit in response to this notice are a matter of public record. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
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.
The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Bureau of Alcohol, Tobacco, Firearms and Explosives, Department of Justice.
30-Day notice.
The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), 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 an additional 30 days until August 28, 2020.
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)
(4)
(5)
(6)
(7)
Bureau of Alcohol, Tobacco, Firearms and Explosives, Department of Justice.
30-Day notice.
The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), 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 an additional 30 days until August 28, 2020.
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)
(4)
(5)
(6)
(7)
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.405A, Washington, DC 20530.
On April 2, 2018, the Drug Enforcement Administration (hereinafter, DEA or Government), issued an Order to Show Cause (hereinafter, OSC) to Salvatore Cavaliere, D.O. (hereinafter, Respondent). OSC, at 1. The OSC proposed the revocation of Respondent's Certificate of Registration No. FC2341876 pursuant to 21 U.S.C. 824(a)(4) “because [he had] committed acts which render [his] registration inconsistent with the public interest . . . .”
Specifically, the OSC alleged that Respondent sold to an acquaintance, approximately 32,000 dosage units of Lortab
The OSC notified Registrant of the right to either request a hearing on the allegations or submit a written statement in lieu of exercising the right to a hearing, the procedures for electing each option, and the consequences for failing to elect either option.
By letter dated May 1, 2018, Respondent timely submitted a designation of representative, which stated, “My client desires to waive any hearing in this cause.”
On March 22, 2019, the Government forwarded its RFAA, along with the evidentiary record in this matter, to my office. Attached to the RFAA were 383 pages of exhibits including, but not limited to, declarations from a DEA Diversion Investigator and a DEA Special Agent, 62 pages of prescriptions issued by Respondent, 33 pages of patient records, and 216 pages of text messages from Respondent's cell phone. RFAAX A-G. The RFAA asserted that “Respondent has waived his right to a hearing in this matter and did not file a written statement of position in lieu of a hearing request.” RFAA, at 1. Despite Respondent's waiver the Government certified that the RFAA and all of the exhibits thereto were served on Respondent's representative. RFAA, at 33.
Having considered the record in its entirety, I find that the record establishes, by substantial evidence, that Respondent committed acts rendering his continued registration inconsistent with the public interest. I further find that revocation is the appropriate sanction. Based on the representations of the Government in its RFAA, I make the following findings of fact.
Respondent is registered with DEA as a practitioner in schedules II through V under DEA Certificate of Registration No. FC2341876, at 525 East Big Beaver Road, Suite #100, Troy, MI 48083. RFAAX D (Controlled Substance Registration Certificate). This registration expired on August 31, 2019.
As discussed above, the Government alleged three factual bases for the revocation of Respondent's registration pursuant to 21 U.S.C. 824(a)(4) and 823(f). OSC, at 1. First, the Government alleged that Respondent dispensed and sold controlled substances (specifically hydrocodone bitartrate/acetaminophen) to an acquaintance outside of the ordinary course of professional practice.
Second, the Government alleged that Respondent was unable to provide to DEA various records that Respondent was required by law to maintain.
And third, the Government alleged that Respondent issued prescriptions outside of the usual course of professional practice and beneath the standard of care in the State of Michigan, and that he failed to maintain complete patient files for seven
The Government retained Dr. Chambers to review medical files obtained during the investigation for seven patients, and to evaluate the medical files for compliance with the standard of care and usual course of the professional practice in Michigan. Dr. Chambers is a practicing, board-certified addiction psychiatrist. RFAAX G, at 1; and G-1, at 1-2. He is also an Associate Professor of Psychiatry at the Indiana University School of Medicine, Department of Psychiatry, IU Neuroscience Center and the head of the Addiction Psychiatry Training Program “where [h]e train[s] psychiatrists and physicians on the diagnosis and treatment of mental illness and drug addiction.” RFAAX G, at 1. Although Dr. Chambers is licensed in Indiana, he has “reviewed various materials to familiarize [him]self with the standard of care for the prescribing of controlled substances in Michigan.”
Dr. Chambers credibly declared that, in Michigan, “any controlled substance must be prescribed for a legitimate or professionally recognized therapeutic purpose.” RFAAX G, at 4. To properly determine whether a prescription has a legitimate or professionally recognized therapeutic purpose, “a practitioner must take a complete medical history of the patient and conduct an adequate examination to determine if there is a legitimate medical basis for so prescribing.”
Dr. Chambers stated that when evaluating the use of controlled substance for pain control specifically, “a complete medical history and physical examination must be conducted and documented in the medical record. The medical record should document the nature and intensity of the pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of pain on physical and psychological function, and history of substance abuse.” RFAAX G, at 4. Dr. Chambers attested based on his knowledge and experience “that taking a complete medical history and documenting the patient's complaint, medical history, and history of substance abuse is required to meet the standard of care for the prescribing of any controlled substance, not just those prescriptions which relate to pain control.” RFAAX G, at 5.
Regarding recordkeeping, under Michigan law, a physician “shall keep and maintain a record for each patient for whom he or she has provided medical services, including a full and complete record of tests and examinations performed, observations made, and treatments provided.” Mich. Comp. Laws Ann. § 333.16213(1) (West 2020);
Having read and analyzed all of the record evidence and law, I find that Dr. Chambers' declaration concerning a Michigan physician's standard of care when prescribing controlled substances is supported by substantial evidence—in particular that it is consistent with the explicit text of Michigan law and Michigan Guidelines. As such, I apply the standard of care for the State of Michigan as described by Dr. Chambers and Michigan law.
Having read and analyzed all of the record evidence, I find that the Government has demonstrated by substantial evidence that Respondent unlawfully sold and dispensed controlled substances, namely hydrocodone bitartrate/acetaminophen,
DI “began an investigation into Respondent after receiving information that Respondent was providing an individual with the initials B.S. with entire bottles of hydrocodone bitartrate/acetaminophen products in exchange for cash.” RFAAX E, at 1. On September 28, 2016, DI participated in an interview of B.S.
More specifically, B.S. explained that at some point after she met Respondent, she went to dinner with him and “told Respondent that she took `Vicodin' and asked whether he knew anyone that would sell her pain medication.”
DI learned that B.S. and Respondent would communicate by text message. RFAAX E, at 4. “In the text message[s], B.S. would refer to the Vicodin as `books' and Valium as `magazines.' ”
• “You just owe 1000 since the other one never came in.” RFAAX E-4, at 198.
• “Sorry mags are 100 each[.]”
• “I do have an order for 4 books and 6 magazines. Total $4600[.]”
• “They sent me 20. So it's two months. $4k[.]”
DEA, pursuant to a search warrant and with Respondent's consent, had a forensic technician image Respondent's cell phone.
Further, the evidence demonstrates that Respondent and B.S. exchanged text messages regarding the purchase of `books' in close temporal proximity to Respondent placing orders for controlled substances.
Example 1:
• 6/13/2013, 1:35 p.m., from Respondent to B.S.: “Barb I need to put in the order for books. Do you want me to get you some magazines?” RFAAX E-4, at 140.
• 6/13/2013, 7:23 p.m., from B.S. to Respondent: “Hi Sal that would b great. Thank u[.]”
• 6/19/2013, transaction date for two bottles, for a total of 1,000 dosage units of Hydrocodone Bit.7.5MG/Acetamin tablets is reported by McKesson Corporation for Respondent. RFAAX E-1, at 2.
• 6/22/2013, 6:27 p.m., from B.S. to Respondent: “Hi Sal how r u? Can u let me know when the books come in? Thank you[.]” RFAAX E-4, at 135.
• 6/22/2013, 6:30 p.m., from Respondent to B.S.: “They're in. At funeral home call later[.]”
• 6/24/2013, 7:16 p.m., from B.S. to Respondent: “Hi Sal how r u? Can we meet up tomarrow [sic.] because I'm going out of town Wed. morning? Thank you[.]”
• 6/24/2013, 10:21 p.m., from Respondent to B.S.: “Ok. How's 9. I have a meeting til [sic.] 8:30 downtown Detroit[.]”
• 6/24/2013, 10:23 p.m., from B.S. to Respondent: “That would b great!”
• 6/25/2013, 8:04 a.m., from Respondent to B.S.: “C u then[.]”
During her interview, B.S. explained, “On occasion, B.S. would run out of Vicodin between shipments and Respondent would write her a prescription to `help her out.' ” RFAAX E, at 5. I find that the text messages between Respondent and B.S. and the record as a whole corroborates this statement. For example:
Example 2:
• 12/30/2013, 11:22 a.m., from Respondent to B.S.: “Barb. I'll be putting in an order for the books Thursday[.] I'll hold off on the magazines and order those next month. I'm trying to stay on top of things in case there are back orders or delays[.]” RFAAX E-4, at 105.
• 12/30/2013, 7:23 p.m., from B.S. to Respondent: “Sounds great . . . thank u[.]”
• 1/9/2014, 8:01 p.m., from B.S. to Respondent: “Hi Sal how r u? Can u let me know when the books come in? Thank u[.]”
• 1/13/2014, 3:02 p.m., from Respondent to B.S.: “Orders have been changed. The books come in bottles of 100 and not 500 as before. So an order will be placed on Friday [1/17/14] for 10 bottles of 100 same cost. I knew there was going to be a glitch. So they should be in next week. Ok?”
• 1/13/2014, 10:15 p.m., from B.S. to Respondent: “Hi I just got ur message. I only have a couple left and I'm really starting to worry. Thank u for trying.”
• 1/18/2014, 12:19 a.m. (in three parts), from B.S. to Respondent: “Hi Sal sorry to text u so late. I don't have any books left and I feel sooo terrible. I don't know what to do and I'm sorry to bother u with this but can . . . u PLEASE call in a script I am just really getting sick? If u can the number is [redacted] b-day [redacted] CVS. I am so sorry but I don't want to check [into] a treatment center. I'm sorry to bother u.”
• 1/18/2014, 12:13 p.m., from Respondent to B.S.: “Done. Ready in 1 hour.”
• 1/18/2014, 1:15 p.m., from B.S. to Respondent: “Thank u[.]”
• 1/18/2014, Prescription issued from Respondent to B.S. for Hydrocodone Bitartrate—Acetaminophen, 300 MG-7.5 MG, quantity 50. RFAAX, E-2 (MAPS Report Showing Prescriptions Issued to B.S.).
• 1/23/2014, 11:51 p.m., from B.S. to Respondent: “Hi Sal please call me when the books come in. Thank you[.]” RFAAX E-4, at 98.
• 1/24/2014, 5:39 a.m., from Respondent to B.S.: “I called them yesterday. They didn't call me back. I'm so irate. I told them its been three weeks. I'm calling again today[.]”
• 1/27/2014, 7:20 p.m., from B.S. to Respondent: “Hi Sal do u know when the books r coming in?”
• 1/28/2014, transaction date for ten bottles for a total of 1,000 dosage units of Hydrocodone Bitartrate/Aceta 7 tablets is reported by McKesson Corporation for Respondent. RFAAX E-1, at 2.
• 1/28/2014, 9:00 p.m., from B.S. to Respondent: “Hi Sal do u think they will b in tommarrow [sic.]?” RFAAX E-4, at 95.
• 1/28/2014, 10:32 p.m., from Respondent to B.S.: “I'll call. . . . As I said. I can give you some thurs to hold you by til they come in[.]”
• 1/28/2014, 10:36 p.m., from B.S. to Respondent: “O.k. Thank u. I have been getting really sick I've been in bed sick so please do that. I can buy them if u want I just REALLY need them.[ T]hank u[.]”
• 1/30/2014, 8:38 p.m., from B.S. to Respondent: “Hi Sal my brother came over because I have the flu. Can u PLEASE put them in the mailbox so he does not see. Please text me. Thank u[.]”
In addition to being supported by the text messages, B.S.'s statements to DI are supported by other evidence in the record. Specifically, DEA's ARCOS records show “that Respondent had purchased approximately 48,000 dosage units of hydrocodone/acetaminophen from McKesson Corporation between 2011 and 2015.” RFAAX E, at 1-2. Additional records show that, “between September 2012 and June 2014, Respondent purchased 22 100-count bottles of Diazepam [also called Valium] 10mg from McKesson Corporation.”
In short, I credit B.S.'s statements as reflected in DI's affidavit—B.S.'s statements are not only uncontradicted, but they are fully supported and corroborated by the relevant evidence in the record. Additionally, based on the entire body of evidence before me, I find that between March 2011 and August 2015, Respondent sold and dispensed controlled substances (hydrocodone bitartrate/acetaminophen) to B.S. approximately 45 times (a total of approximately 48,000 dosage units) without any evidence of a valid doctor-patient relationship.
Having read and analyzed all of the record evidence, I find that the Government has proven by substantial evidence that Respondent was unable to provide DEA with a dispensing log or inventory. RFAA, at 9. On July 13, 2016, DEA executed a federal search warrant at Respondent's registered address. RFAAX E, at 3. “During the execution of the search warrant, [DI] requested that Respondent provide [DI] with dispensing records for the controlled substances he had purchased from McKesson Corporation.”
The Government submitted a declaration from SA attesting that, “[o]n October 30, 2017, [SA] served an administrative subpoena . . . on Respondent requesting patients records for . . . individuals who had been prescribed testosterone by Respondent during 2017.” RFAAX F, at 1. On November 16, 2017, SA received copies of the requested patient records from Respondent along with a letter “explain[ing] that the provided materials represented `all the records [Respondent] ha[d] in reference to the patients delineated in attach[ment] to the Subpoena. . . .' ”
According to the subpoenaed pharmacy records, Respondent issued a prescription to D.K. for “testosterone cypionate”
Dr. Chambers pointed out that the earliest dated document in D.K.'s patient file was dated “more than three months after Respondent issued Patient D.K. a prescription for a controlled substance.”
Dr. Chambers, based on his review of the patient file for D.K., opined, and I agree, that Respondent “failed to document an adequate medical history; failed to document the patient's complaint; failed to document the patient's use of other controlled substances, and failed to properly maintain medical records as required under Michigan law.” RFAAX G, at 6. Dr. Chambers further concluded, and I agree, that “the prescription issued by Respondent to Patient D.K. dated November 6, 2014, was issued outside of the standard of care in the state of Michigan and outside the usual course of professional practice.”
According to the subpoenaed pharmacy records, Respondent issued a prescription to F.C. for “Cheratussin AC Syrup”
There is no mention of the Cheratussin AC prescription in the November 1, 2011, “Progress Note”—in fact, there is no mention of Cheratussin AC anywhere in the patient file, and Respondent issued additional prescriptions to F.C. for Cheratussin dated May 2, 2013, October 3, 2014, and May 24, 2015. RFAAX F-2, at 3; F-8, at 31-37; G at 8.
Dr. Chambers pointed out that “Respondent failed to document the Cheratussin AC prescriptions that were issued to Patient F.C. between August 2011 and May 2015, and failed to maintain any records relating to those prescription[s] or relating to any medical examinations performed or observations made prior to the issuance of those prescriptions.”
Dr. Chambers, based on his review of the patient file for F.C., opined, and I agree, that “Respondent failed to document the patient's complaint; failed to document the patient's use of other controlled substances; and failed to properly maintain medical records as required under Michigan law.” RFAAX G, at 8. Dr. Chambers further concluded, and I agree, that “four prescriptions issued by respondent to Patient F.C. dated August 28, 2011; May 2, 2013; October 3, 2014; and May 24, 2015, were issued outside of the standard of care in the state of Michigan and outside the usual course of professional practice.”
According to the subpoenaed pharmacy records, Respondent issued a prescription for “Vicodin”
Dr. Chambers opined that, “Respondent's patient file for Patient M.A. does not include
Dr. Chambers, based on his review of the patient file for M.A., opined, and I agree, that “Respondent failed to conduct or document an adequate physical exam; failed to document an adequate medical history; failed to document the patient's complaint; failed to document the patient's use of other controlled substances; and failed to properly maintain medical records as required under Michigan law.” RFAAX G, at 9. Dr. Chambers further concluded, and I agree, that “the prescription issued by Respondent to Patient M.A. dated June 6, 2011[,] was issued outside of the standard of care in the state of Michigan and outside the usual course of professional practice.”
According to the subpoenaed pharmacy records, Respondent issued a prescription for “Valium”
Dr. Chambers pointed out that the first patient record was dated “almost a year after Respondent issued Patient M.D. a prescription for a controlled substance.”
Dr. Chambers, based on his review of the patient file for M.D., opined, and I agree, that with regard to the Vicodin prescription, “Respondent failed to document an adequate medical history; failed to document the patient's complaint; failed to document the patient's use of other controlled substances; and failed to properly maintain medical records as required under Michigan law.” RFAAX G, at 10. Dr. Chambers further concluded, and I agree, that “the prescription issued by Respondent to Patient M.D. dated May 24, 2013[,] was issued outside of the standard of care in the state of Michigan and outside the usual course of professional practice.”
According to the subpoenaed pharmacy records, Respondent issued prescriptions for “Vicodin”
Dr. Chambers pointed out that “Respondent's patient file for Patient S.C. [does] not include
Dr. Chambers, based on his review of the patient file for S.C., opined, and I agree, that with regard to the Vicodin prescriptions, “Respondent failed to conduct or document an adequate physical exam; failed to document the patient's complaint; failed to document the patient's use of other controlled
Respondent maintained patient records for S.D. dating back to December 5, 2011.
According to the subpoenaed pharmacy records, Respondent issued prescriptions for “Valium”
Dr. Chambers, based on his review of the patient file for S.D., observed that “[t]he patient file does not include any records of examinations or visits related to the [benzodiazepine] prescriptions nor does it provide any basis to assess the reason for the issuance of a benzodiazepine prescription to Patient S.D.”
Based on these observations, Dr. Chambers found, and I agree, that “Respondent failed to document an adequate medical history; failed to document the patient's complaint; failed to document the patient's use of other controlled substances; and failed to properly maintain medical records as required under Michigan law.”
According to the subpoenaed pharmacy records, Respondent issued a prescription to S.H. for “Tussinex,” a controlled substance,
Dr. Chambers pointed out that “the prescriptions issued by Respondent [to S.H.] were dated between September 2011 and July 2014—years before the first entry in the medical records.”
Dr. Chambers, based on his review of the patient file for S.H., opined, and I agree, that “Respondent failed to document an adequate medical history; failed to document the patient's complaint; failed to document the patient's use of other controlled substances; and failed to properly maintain medical records as required under Michigan law.” RFAAX G, at 15. Dr. Chambers further concluded, and I agree, that “the four prescriptions issued by Respondent to Patient S.H. . . . were issued outside of the standard of care in the state of Michigan and outside the usual course of professional practice.”
To summarize my findings above, I agree with Dr. Chambers and find substantial evidence that Respondent issued a total of twenty-one prescriptions to seven different patients without maintaining adequate records in violation of §§ 333.7303a and 333.17745 of the Michigan Compiled Laws. I also agree with Dr. Chambers and find substantial evidence that Respondent issued these twenty-one prescriptions for controlled substances outside of the usual course of professional practice and beneath the standard of care in the State of Michigan. Further, I find that Respondent sold and dispensed controlled substances to B.S. approximately 45 times without any evidence of a valid doctor-patient relationship, and I find that Respondent failed to maintain dispensing or inventory logs.
Under the Controlled Substances Act (CSA), “[a] registration . . . to . . . distribute[ ] or dispense a controlled substance . . . may be suspended or revoked by the Attorney General upon
(1) The recommendation of the appropriate State licensing board or professional disciplinary authority.
(2) The applicant's experience in dispensing . . . controlled substances.
(3) The applicant's conviction record under Federal or State laws relating to the . . . distribution[ ] or dispensing of controlled substances.
(4) Compliance with applicable State, Federal, or local laws relating to controlled substances.
(5) Such other conduct which may threaten the public health and safety.
According to Agency decisions, I “may rely on any one or a combination of factors and may give each factor the weight [I] deem[ ] appropriate in determining whether” to revoke a registration.
Under DEA's regulation, “[a]t any hearing for the revocation . . . of a registration, the . . . [Government] shall have the burden of proving that the requirements for such revocation . . . pursuant to . . . 21 U.S.C. [§ ] 824(a) . . . are satisfied.” 21 CFR 1301.44(e).
In this matter, while I have considered all of the Factors, the Government's evidence in support of its
As to Factor Three, there is no evidence in the record that Respondent has a “conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.” 21 U.S.C. 823(f)(3). However, as Agency cases have noted, there are a number of reasons why a person who has engaged in criminal misconduct may never have been convicted of an offense under this factor, let alone prosecuted for one.
Under Factor Two, I evaluate the registrant's “experience in dispensing . . . with respect to controlled substances.” 21 U.S.C. 823(f)(2). There is no evidence in the record as to the Respondent's positive dispensing experience; however, the Government has clearly established the Registrant's significant history of unlawful and dangerous dispensing practices through the text messages and patient files contained in the record.
Factor Four is demonstrated by evidence that a registrant has not complied with laws related to controlled substances, including violations of the CSA, DEA regulations, or other state or local laws regulating the dispensing of controlled substances. It is well established that a physician who engages in illegal drug distribution violates the Controlled Substances Act.
According to the CSA's implementing regulations, a lawful prescription for controlled substances is one that is “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 CFR 1306.04(a). The Supreme Court has stated, in the context of the CSA's requirement that schedule II controlled substances may be dispensed only by written prescription, that “the prescription requirement . . . ensures patients use controlled substances under the supervision of a doctor so as to prevent addiction and recreational abuse . . . [and] also bars doctors from peddling to patients who crave the drugs for those prohibited uses.”
Under the CSA, it is fundamental that a practitioner must establish and maintain a legitimate doctor-patient relationship in order to act “in the usual course of . . . professional practice” and to issue a prescription for a “legitimate medical purpose.”
Respondent's actions with regard to B.S. demonstrate egregious dispensing experience. The definition of “dispense” under the CSA is “to deliver a controlled substance to an ultimate user . . . pursuant to the lawful order of, a practitioner. . . .”
Agency decisions have clearly demonstrated that in order for a physician to utilize his registration to dispense controlled substances, there must be a “valid physician-patient relationship” and that “[l]egally, there is absolutely no difference between the sale of an illicit drug on the street and the illicit dispensing of a licit drug by means of a physician's prescription.”
I agree with the Government that these actions appear to constitute “outright drug deals.” RFAA, at 26 (citing
As I found above, Respondent failed to produce either a dispensing log or an inventory. The DEA regulations require that “[a] registered individual practitioner is required to keep records . . . of controlled substances . . . which are dispensed, other than by prescribing or administering in the lawful course of professional practice.” 21 CFR 1304.03(b). Further, “[e]very registrant required to keep records pursuant to § 1304.03 shall maintain, on a current basis, a complete and accurate record of each substance . . . received, sold, delivered, exported, or otherwise disposed of by him/her. . . .”
The undisputed facts are that Respondent purchased hydrocodone bitartrate/acetaminophen from McKesson Corporation and dispensed it to B.S. RFAAX E, at 1-2, and
Regarding an inventory, federal regulations require that registrants maintain “a complete and accurate record of all controlled substances on hand. . . .” 21 CFR 1304.11(a). Registrants must “take a new inventory . . . at least every two years.” 21 CFR 1304.11(c). The inventory “must be kept by the registrant and be available, for at least 2 years from the date of such inventory . . . for inspection and copying by authorized employees of the Administration.” 21 CFR 1304.04(a).
On July 13, 2016, DI requested “that Respondent provide [her] with copies of any inventories of controlled substances.” RFAAX E, at 3. “[Respondent] did not provide them.”
In sum, I find that Respondent's failure to provide a dispensing log and an inventory is relevant to public interest Factors Two and Four. I find that the Government has established that Respondent was not in compliance with several state and federal laws—including 21 CFR 1304.03(b), 1304.11(c) and 1304.21(a), Mich. Comp. Laws Ann. § 333.17745, and Mich. Admin. Code r. §§ 338.3151-3153.
My full factual findings regarding the standard of care in Michigan (including the Michigan Laws reflecting the standard of care) are set forth above.
As set forth more fully in the factual findings section above, the Government established through a credible expert witness that Respondent violated §§ 333.16213 and 333.7303a of the Michigan Compiled Laws and issued prescriptions outside of the usual course of professional practice and beneath the standard of care for the State of Michigan as follows:
—He failed to maintain records regarding other controlled substances that patients were taking with regard to patients D.K., F.C., M.A., M.D., S.C., S.D., and S.H.
—He failed to take or document a complete medical history with regard to patients D.K., M.A., M.D., S.D., and S.H.
—He failed to document the patient's complaint with regard to patients D.K., F.C., M.A., M.D., S.C., S.D., and S.H.
—He issued prescriptions without first having any patient files or records of examinations performed with regard to patients D.K., F.C., M.A., M.D., S.C., and S.H.
—He issued prescriptions without having any record of an examination performed regarding or any medical history regarding the need for the specific prescriptions at issue with regard to patient S.D.
Based on my analysis of Factors Two and Four in considering these violations, I find that Respondent's continued registration would be inconsistent with the public interest.
Under Factor Five, the Administrator is authorized to consider “[s]uch other conduct which may threaten the public health and safety.” 5 U.S.C. 823(f)(5). Although Factor Five is broad, DEA decisions have qualified its breadth by limiting the considerations made under that factor to those where there is “a substantial relationship between the conduct and the CSA's purpose of preventing drug abuse and diversion.”
Here, Respondent continued to provide controlled substances to B.S. illegally despite indications of addiction and abuse.
“[A] DEA registrant is obligated at all times to act in the public interest.”
As found above, the Government's case establishes by substantial evidence that Registrant issued controlled substance prescriptions without a legitimate medical purpose and outside the usual course of professional practice and beneath the standard care in the State of Michigan. I conclude that Registrant engaged in egregious misconduct, which supports the revocation of his registration.
Where, as here, the Government has met its
The CSA authorizes the Attorney General to “promulgate and enforce any rules, regulations, and procedures which he may deem necessary and appropriate for the efficient execution of his functions under this subchapter.” 21 U.S.C. 871(b). This authority specifically relates “to `registration' and `control,' and `for the efficient execution of his functions' under the statute.”
In efficiently executing the revocation and suspension authority delegated to me under the CSA for the aforementioned purposes, I review the evidence and argument submitted to determine whether or not a respondent has presented “sufficient mitigating evidence to assure the Administrator that [he] can be trusted with the responsibility carried by such a registration.”
“The issue of trust is necessarily a fact-dependent determination based on the circumstances presented by the individual respondent; therefore, the Agency looks at factors, such as the acceptance of responsibility and the
Here the Respondent responded to the Government's Order to Show Cause by waiving his right to a hearing—no written brief or other explanation of his behavior accompanied the waiver of his right to a hearing. RFAAX B; RFAA, at 1. In other words, Respondent did not avail himself of the opportunity to refute the Government's
In sanction determinations, the Agency has historically considered its interest in deterring similar acts, both with respect to the respondent in a particular case and the community of registrants.
I agree with the former Assistant Administrator of the Diversion Control Division, that Respondent's proposed Corrective Action Plan provides no basis for me to discontinue or defer this proceeding. Its insufficiencies include Respondent's failure to accept responsibility, to institute adequate remedial measures, and to convince me to entrust him with a registration. 21 U.S.C. 824(c)(3).
I will therefore order that Respondent's registration be revoked and that any pending applications be denied as contained in the Order below.
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No. FC2341876 issued to Salvatore Cavaliere, D.O. Further, pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I hereby deny any pending application of Salvatore Cavaliere, D.O. to renew or modify this registration, as well as any other pending application of Salvatore Cavaliere, D.O. for registration in Michigan. This Order is effective August 28, 2020.
On April 12, 2018, a former Acting Administrator of the Drug Enforcement Administration (hereinafter, DEA or Government), issued an Order to Show Cause and Immediate Suspension Order (hereinafter collectively, OSC) to Kaniz F. Khan-Jaffery, M.D. (hereinafter, Respondent), of Absecon, New Jersey. Administrative Law Judge (hereinafter, ALJ) Exhibit (hereinafter, ALJX) 1, (OSC) at 1. The OSC informed Respondent of the immediate suspension of her DEA Certificate of Registration No. BK9710939 pursuant to 21 U.S.C. 824(d) “because . . . [her] continued registration constitute[d] an imminent danger to the public health and safety.”
Specifically, the OSC alleged that Respondent issued prescriptions for controlled substances to six individuals outside the usual course of the professional practice and beneath the standard of care for the State of New Jersey in violation of 21 CFR 1306.04(a) and N.J. Stat. §§ 24:21-15.2 and 45:9-22.19. OSC, at 2-5.
On April 12, 2018, based on his preliminary finding that Respondent issued multiple prescriptions to one individual without a legitimate medical purpose, and to five individuals, while ignoring inconsistent urine screens that indicated abuse or diversion of controlled substances, the former Acting Administrator concluded that Respondent's “continued registration . . . [was] inconsistent with the public interest.” OSC, at 5. Citing 21 U.S.C. § 824(d), he also made the preliminary finding that Respondent's continued registration during the pendency of proceedings “would constitute an imminent danger to the public health or safety because of the substantial likelihood that [Respondent] would continue to issue prescriptions for controlled substances, which would result in the abuse or diversion of controlled substances.”
Pursuant to 21 U.S.C. 824(d) and 21 CFR 1301.36(e), the former Acting Administrator immediately suspended Respondent's Certificate of Registration and authorized the DEA Special Agents and Diversion Investigators serving the OSC on Respondent to place under seal or to remove for safekeeping all controlled substances Respondent possessed pursuant to the immediately suspended registration.
The OSC notified Respondent of the right to request a hearing on the allegations or to submit a written statement, while waiving the right to a hearing, the procedures for electing each option, and the consequences for failing to elect either option.
By letter dated May 1, 2018, Respondent timely requested a hearing. ALJX 2 (Request for Hearing), at 1. The matter was placed on the docket of the
The hearing in this matter spanned five days.
Having considered this matter in the entirety, I find that Respondent issued twenty-three prescriptions beneath the applicable standard of care and outside of the usual course of the professional practice in New Jersey, in violation of federal law, and that Respondent also committed violations of state law.
I issue this Decision and Order based on the entire record before me. 21 CFR 1301.43(e). I make the following findings of fact.
Respondent is registered with the DEA as a practitioner in schedules II through V under DEA Certificate of Registration No. BK9710939, at the registered address of 1129 North New Road, Absecon, New Jersey, 08201. Government Exhibit (hereinafter, GX) 1 (Respondent's Certificate of Registration). This registration expires on December 31, 2020.
The Government's documentary evidence consisted primarily of medical records for six individuals treated by Respondent between January 30, 2015, and October 18, 2017, which included the records for one undercover Special Agent. The Government called three witnesses; a DEA Special Agent, who posed undercover as patient A.D. on six occasions (hereinafter, the UC); a DEA Diversion Investigator (hereinafter, DI), who participated in the investigation of Respondent; and an expert witness, Dr. Andrew Kaufman. RD, at 7-10.
The UC testified about her role in the investigation of Respondent and her role-related and investigatory experience. Tr. 36-38. On each of the six occasions in which the UC visited Respondent, she wore a recording device that provided audio and video recordings of each visit.
The Government presented the testimony of a DI assigned to the DEA Camden Resident Office, who participated in the administrative investigation of Respondent. Tr. 125-26. The DI testified that she first became aware of Respondent while investigating a pharmacy.
I agree with the ALJ that the DI's testimony was “sufficiently objective, detailed, plausible, and internally consistent.” RD, at 8. Although the ALJ ultimately concluded that D.I.'s testimony was unnecessary, I credit her testimony regarding the Agency's initiation of an investigation into Respondent's practice and the results of the subpoenas to the extent that they provide the foundations of this administrative matter.
The Government's expert witness, Professor Andrew Kaufman, M.D., is a professor of anesthesiology at Rutgers University, and testified that he has “extensive clinical responsibilities, seeing patients in two offices” in New Jersey. Tr. 155-57. He also teaches medical students and residents and serves as the Executive Director of the New Jersey Society of Interventional Pain Physicians.
The ALJ found, and I agree, that Dr. Kaufman's testimony was “presented in a professional, candid, and straightforward manner” and “was sufficiently objective, detailed, plausible, and internally consistent,” and therefore credible.
Respondent presented the testimony of four witnesses at the hearing, including her own. The first witness, Dr. Lawrence J. Epstein, M.D., has treated pain patients for thirty years and is an Associate Professor of Anesthesiology and Neurology at the Icahn School of Medicine, Mt. Sinai Hospital, and has held professorial appointments and staff positions at multiple hospitals in New York. RD, at 11;
Dr. Epstein holds a license to practice medicine in New Jersey since “somewhere between” 1986-88, but has never practiced there, and his license is inactive. Tr. 703; RD, at 11.
The ALJ admitted Dr. Epstein as an expert in pain management practice in “standard of care, on proper medical procedures with respect to pain management, and the appropriate use of controlled substances in medical practice.” RD, at 12 (citing tr. 702, 730). The Government objected on the ground that he lacked experience and knowledge of the standard of care in New Jersey. RD, at 12; tr. 716-17, 730. The ALJ found, and I agree, that Dr. Epstein's testimony regarding several aspects of the case was “concerning.” RD, at 14. In particular, the ALJ found that his testimony about Patient J.C.'s inconsistent urine screens did not withstand close scrutiny, because the patient records did not support his statements.
Respondent testified on her own behalf. Tr. 775-1120. She testified that she earned her medical degree in Pakistan and completed a neurology residency and a fellowship in pain management at Louisiana State University. RD, at 17; tr. 784-87. In 2008, Respondent began practicing pain management in New Jersey, and worked for two years at a neurosurgeon's office, then she worked with her husband's practice, as well as consulted in pain management at AtlantiCare Regional Medical Center. Tr. 788-89, 793-94. Respondent testified as to her standard pain management practice with respect to the patients in question, including her use of monthly urine screens, her practice of obtaining MRIs before prescribing controlled substances, her use of an electronic recordkeeping
The ALJ found, and I agree, that “there were several aspects of [Respondent's] testimony that were problematic.” RD, at 22. He found that her testimony regarding Patient L.M.'s urine screen showing Suboxone was not credible.
While the five concerns discussed above detract from [Respondent's] overall credibility, I find that most of her testimony was sufficiently objective, detailed, plausible, and internally consistent. I do not find that [Respondent] was engaged in intentional fabrication . . . . Therefore, I merit her testimony to be credible in all non-contested matters in this Recommended Decision.
Although I believe that the ALJ analyzed the Respondent's testimony thoroughly and honestly, and I defer to his determination of credibility as to Respondent's demeanor, I do not believe that there is practical value in meriting her testimony in non-contested matters for purposes of this proceeding, particularly because she did not offer much, if any, acceptance of responsibility, as further discussed in the sanctions section herein.
Respondent also presented the testimony of Dr. Thomas Gutheil as an expert in medical documentation and medical records. RD, at 24-28; tr. 1123-1325. Dr. Gutheil is a practicing psychiatrist and professor of psychiatry at Harvard Medical School and lectures on electronic medical recordkeeping, among other medical subjects. RD, at 24; tr. 1123-1124. He testified that as a hospital records committee chairperson reviewing medical records for quality assurance for many years, he developed his study of medical recordkeeping, and has published several peer review articles on medical documentation, and lectures on the subject worldwide. RD, at 24-25. He also provided a written report, which was submitted in Respondent's initial Prehearing statement. ALJX 5, Attachment 2. Dr. Gutheil testified that he is not licensed to practice medicine in New Jersey, but he follows the developments of medical documentation in New Jersey, and he reviewed some of the New Jersey regulations and laws about medical recordkeeping in preparation for the hearing. RD, at 28 (citing tr. 1135-36, 1136-38). He also testified that he was not familiar with Respondent's recordkeeping eClinical when he wrote his report, and that he did not know which version of eClinical Respondent used in her practice. RD, at 28; tr. 1155, 1281-82.
The ALJ accepted Dr. Gutheil as an expert in “medical documentation and medical records.” RD, at 28; tr. 1132. He also found Dr. Gutheil's testimony was presented in a professional, candid, straightforward manner, and it was “helpful in understanding the standards of medical documentation and electronic medical recordkeeping.” RD, at 28. He merited it as sufficiently objective, detailed, plausible and internally consistent to be fully credible.
Finally, Respondent offered the testimony of Patient J.C., who was one of the six patients whose records were at issue in this proceeding. Tr. 1327-69; RD, 28-31. J.C. testified that Respondent had been treating him since 2016 for neuropathy in his feet and pain in his lower back due to a pinched nerve and degenerative disc disease in his lower back. RD, at 28; tr. 1328-29, 1330. He testified generally about Respondent's care, including her counseling on his inconsistent urine screens. RD, at 29-30. The ALJ found several “discrepancies,” which “detract from J.C.'s overall credibility.”
The Government alleged that Respondent violated a New Jersey statute and two New Jersey regulations.
New Jersey Administrative Code § 13:35-7.1A requires in relevant part that practitioners shall not dispense drugs or issue prescriptions (not solely controlled substances) “without first having conducted an examination, which shall be appropriately documented in the patient record.” N.J. Admin. Code § 13:35-7.1A (West 2020) (effective September 15, 2003).
The ALJ noted that the first time that the Government cited to this section was in its Supplemental Prehearing Statement. RD, at 101 n.49, 102 n.50 (citing ALJX 22, at 4). He determined that this regulation was never mentioned during the hearing, and “[f]urthermore, the Government expert did not rely on N.J. Admin. Code § 13:35.71A in reaching his conclusion that the Respondent's prescriptions to A.D. were issued beneath the standard of care in New Jersey.” RD, at 101, n.49 (citing tr. 272, 674-77). He therefore concluded that Respondent “was not put on notice that any of her prescriptions violated” this provision.
The Government's Supplemental Prehearing Statement used bold type to emphasize changes to the testimony of Dr. Kaufman, stating, “Dr. Kaufman will also testify that the New Jersey standard of care is also governed by N.J. Stat. Section 13.35-7.1A and 13:35-7.6.” Govt Supp Prehearing, at 4, 5. On August 20, 2018, Respondent filed a motion objecting to the Government's Supplemental Prehearing Statement, and made a correction to the Government's citation of the regulation, stating, “Among other things, Dr. Kaufman's testimony has been changed to allege respondent's violation of New Jersey regulations—improperly identified as statutes—in the revised proposed testimony.” Respondent's Pre-Trial Motions, at 9.
During the hearing, the Government's attorney asked Dr. Kaufman if the requirement for a physical exam had recently changed in New Jersey and Dr. Kaufman said that it had not. Tr. 271-72. The Government's attorney then asked if, in 2015, someone would be required to do a physical exam to which the witness responded, “[W]ithout
Ultimately, the ALJ agreed with the Government's allegations regarding Respondent's failure to conduct a physical examination of the UC before prescribing controlled substances, because he found that Respondent's actions were beneath the applicable standard of care and outside the usual course of the professional practice in New Jersey. RD, at 38. Even though the ALJ recommended dismissing the allegations of a regulatory violation, he did not change his overall conclusion that the lack of a physical examination violated the applicable standard of care in New Jersey. I agree with the Government, and the Respondent, that the Government adequately noticed the regulatory and statutory violations, and at the very least, this regulation was clearly litigated by consent during the hearing, as exemplified by the Respondent's arguments during the hearing and in Respondent's Exceptions.
The Government also cited to New Jersey Administrative Code Section 13:35-7.6 in its Supplemental Prehearing Statement, which sets forth numerous requirements for practitioners prescribing controlled substances, including entering a pain management plan by the third visit and monitoring compliance. There are two affirmative obligations in this Section of the regulations that are applicable to this record—“[w]hen controlled dangerous substances are continuously prescribed for management of chronic pain”
The ALJ concluded that despite discussion of Respondent's pain agreements in the testimony,
Further, at the very least, this regulation fully supports the testimony of Dr. Kaufman and discredits the testimony of Dr. Epstein regarding whether the applicable standard of care in New Jersey requires documentation of inconsistent urine screens as further explained below in Section II(E)(1) and (3).
The OSC alleged that Respondent did not “comply with New Jersey Stat. [ ]§ 24:21-15.2
During cross examination, Respondent's attorney asked Dr. Kaufman about the statutes to which he was testifying and Dr. Kaufman replied that he didn't know them by number, but he knew them in substance. Tr. 297-298. He testified that the substance was:
Later, on cross examination, the ALJ overruled Government's objection when Respondent's attorney required Dr. Kaufman to read a statute,
The Government and Respondent both presented arguments about N.J. Stat. § 24:21-15.2 in prehearing and posthearing filings, and therefore, I find that it was adequately noticed and will consider it below for prescriptions issued after its effective date.
In accepting Dr. Epstein as an expert witness despite his lack of specific expertise in the New Jersey standard of care, the ALJ cited
I do not disagree with the ALJ's determination regarding Dr. Epstein's general credibility or his admission as an expert; however, it is important to emphasize that the OSC alleges that Respondent prescribed “outside the usual course of practice and beneath the standard of care in New Jersey.” OSC, at 2-5;
Dr. Epstein testified that New Jersey laws and regulations “can further limit the prescribing,” and agreed with the Government attorney that “Federal law
In this case, New Jersey has enacted laws and regulations, which, as Dr. Epstein predicted, have put in place “higher standards” than those upon which Dr. Epstein relies.
The ALJ found, and I agree, that, before prescribing a controlled substance, the applicable standard of care in New Jersey “requires a full medical history, a targeted physical examination based on the patient's complaint, review of relevant documents, and checking the PMP.” RD, at 38 (citing tr. 174, 180, 271, 1442). Dr. Kaufman credibly testified that the applicable New Jersey standard of care requires a physical examination
Dr. Epstein stated that the standard of care requires a diagnosis obtained by “a thorough history and then a physical that's directed, which can vary in scope
As further explained below, I find that the applicable standard of care in New Jersey requires a physical examination, including a directed physical examination of the area of complaint, and that observation without directed movement, is not adequate under the applicable standard of care.
Dr. Kaufman testified that a urine screen
Dr. Epstein testified at several points that a urine screen that comes back negative for the controlled substance that was prescribed has two possible answers: “the patient used the medication, finished the medication;” or that “they're diverting it, that they're not using it at all.”
Much of Dr. Epstein's testimony was aimed at justifying why addressing an inconsistent urine screen is not, in his view, critical in preventing the diversion of opioids, but the issue in this case is whether the applicable standard of care in the State of New Jersey requires a practitioner to address an inconsistent urine screen, including with counseling, and whether and to what extent the practitioner must document an inconsistent urine screen.
Support for the credibility of Dr. Kaufman's testimony is that, beginning on March 1, 2017, a New Jersey regulation required that a physician prescribing controlled substances for the treatment of chronic pain enter into a pain management agreement with the patient and monitor the patient's compliance with that agreement to include documentation of any breaches that indicated that the patient was not taking the medication as prescribed.
The Respondent dedicated substantial time in proffering that she always counseled her patients regarding negative urine screens through her own testimony and that of her patient J.C.
Respondent testified that when a urine test comes back clean, she would state, “Last month's urine was—didn't show any of your—any medication, why is that? And, when was the last time you took your medication? How often are you taking it? Are you taking it every—like I wrote it?”
In the case of patient records, it is impossible to know for certain one way or the other whether the counseling occurred if it was not documented. The evidence in the record shows that the UC was partially counseled once for her inconsistent urine screen, but the Government presented evidence that that counseling did not meet the applicable standard of care, nor was it documented. The ALJ found and I agree that the Respondent and her patient J.C. had dubious credibility, but the ALJ still deferred to them both that the counseling occurred. The windows through which we can clearly see what likely occurred are the recorded visits between Respondent and the UC, where the Government has demonstrated that the Respondent did not adequately counsel and that her recordkeeping was unreliable.
Establishing that the applicable standard of care in New Jersey requires a practitioner to address and document an inconsistent urine screen, the Government put forward evidence attempting to establish a timeframe for when the patient's negative urine screen would be considered inconsistent and thus the lack of documentation of counseling would implicate a violation of prescribing beneath the applicable standard of care. Dr. Kaufman testified that a negative urine screen would be consistent if the patient came back thirty-five days after being issued a thirty-day prescription for oxycodone, because the oxycodone would likely no longer be in the patient's system. Tr. 206-07; 494. Dr. Kaufman further testified that if a prescription for thirty days was filled within thirty-three days of the negative urine screen, it would be inconsistent.
The ALJ found that the Government “has the burden of proof to establish when a urine screen is inconsistent” and that “[t]he Government chose to meet its burden by offering evidence of an estimate of when the results of a urine screen would be inconsistent.” RD, at 122. I agree with the ALJ's statement, but I do not believe that the record supports his finding that the date that was established is “up to and including 32 days prior to providing a urine sample.”
The Respondent also posed arguments regarding the level of documentation that is required when there is an inconsistent screen. Respondent argued that the automatic counseling note that she included in combination with the maintenance of the results of the urine tests in the patient's record constitute adequate documentation of the counseling and the fact that the screen was addressed.
In this case, I find that Dr. Kaufman and Dr. Epstein were generally in agreement that the matter of what a practitioner is required to do when the urine screen is inconsistent is not “black or white,” and where the toxicology screen is negative, the issue is not necessarily whether the practitioner stops prescribing the controlled substance.
Dr. Kaufman credibly testified that when the patient tests positive for a non-prescribed controlled substance, the applicable standard of care in New Jersey requires the practitioner to address the urine test with the patient and “to document their conversation in the medical record.”
Although the Government originally alleged in the OSC that every prescription after the initial prescription demonstrating an inconsistent urine screen was outside the usual course of the professional practice and beneath the applicable standard of care, Dr. Kaufman contradicted that allegation, stating “[a]ny subsequent ones, if
Dr. Kaufman testified that in order to meet the applicable standard of care in New Jersey a practitioner who was confronted with a urine screen that was positive for alcohol metabolites would need to “discuss it with the patient and discuss the risks of alcohol with the use of opioids, of opiates, and to tell him to stop drinking” and would need to document that discussion in the record. Tr. 212. Dr. Epstein testified that mixing oxycodone and alcohol is a “very, very bad thing,” and a practitioner must counsel his patient, and “the standard of care is that, you know, if you're going to have a drink you shouldn't be doing it at the same time you're taking this pill.”
Additionally, Respondent testified that when alcohol appears in a drug screen, her usual practice is to counsel the patients and insert the alcohol entry for counseling in e-Clinical.
Finding that counseling and its documentation is required when a urine screen shows alcohol metabolites, I also agree with the ALJ's finding that Respondent's selection of alcohol specific counseling is adequate to document the counseling. RD, at 124 n.68. Dr. Kaufman agreed that the “counseling, alcohol and drugs . . . documented in the patient record . . . would [] be an appropriate way to deal with an alcohol screen.” Tr. 214. This is further supported by the language in the state regulation regarding alcohol counseling that requires that the record “note” that the discussion took place and not the substance or the plan after that discussion. N.J. Admin. Code 13:35-76(d). In sum, I find that when a urine screen tests positive for alcohol metabolites, the applicable standard of care in New Jersey requires that a practitioner counsel regarding the dangers of alcohol and opioid use and document that counseling, and further that noting that the alcohol-specific counseling occurred is adequate for purposes of this case.
Having read and analyzed all of the record evidence, I agree with the RD's conclusion and find that the substantial record evidence that Respondent prescribed controlled substances outside of the usual course of the professional practice and below the applicable standard of care in New Jersey. RD, at 139. The ALJ sustained the Government's allegations with regard to the five Vicodin prescriptions Respondent issued to the UC, and twelve of the twenty-one prescriptions that Respondent issued to patients A.P., J.C., L.M., M.W., and SW
The ALJ sustained the Government's allegations that Respondent issued five prescriptions for hydrocodone-acetaminophen (Vicodin), a Schedule II controlled substance, to the UC between November 23, 2016 and April 4, 2017, outside the usual course of the professional practice and beneath the applicable standard of care for the State of New Jersey in violation of 21 CFR 1306.04(a), because she failed to conduct a physical exam at each of the
During the hearing, Respondent admitted that she did not palpate the UC's shoulder or touch the UC. RD, at 122 (citing tr. 878-79).
Respondent argued that she had required the UC to obtain a new MRI before prescribing controlled substances, and she testified that when she reviewed the second MRI, she was able to make a diagnosis that the UC had arthritis.
After reviewing the record evidence, including the video and audio recordings of the UC's visits with Respondent, I agree with the ALJ's finding that, Respondent did not perform an adequate physical examination of the UC at any of the UC's appointments. RD, at 46.
Based on the fact that Respondent did not perform an adequate physical examination, as required by the applicable standard of care in New Jersey, the ALJ found, and I agree, that the prescription for Vicodin issued to the UC at her second appointment on November 23, 2016, was issued outside the usual course of the professional practice of medicine. RD, at 58 (citing Tr. 179-80, 878-79, 1442; GX 20). Additionally, I agree with the ALJ that the prescriptions Respondent issued to the UC for: Vicodin on December 22, 2016; Vicodin on January, 19, 2017;
The ALJ did not sustain the alleged violation of the applicable standard of care that Respondent recorded the results of a complete physical in the UC's medical record, even though the exam did not occur. RD, at 139. He reasoned that he could not find a recordkeeping violation “because it was not alleged as a separate violation in the OSC, and the Government did not detail in either of its prehearing statements how this false entry was a separate violation.”
The stipulated facts demonstrate that between and including June 6, 2016, and April 5, 2018, Respondent issued prescriptions for controlled substances to A.P. on twenty-three occasions.
The ALJ found, and I agree, that Patient A.P. tested negative for opioids
Dr. Kaufman testified that a January 8, 2018 urine screen that tested negative for opiates following a prescription that was issued on December 7, 2017, thirty-three days prior to the drug screen, was inconsistent, and therefore the prescription issued on February 8, 2018, following Respondent's knowledge of the results of that drug screen was issued outside the usual course of practice for the State of New Jersey. Tr. at 210. Dr. Kaufman reasoned that it was outside the usual course of the professional practice because “[t]hat urine screen was never addressed, it's almost as if it didn't happen.”
Dr. Kaufman testified that the urine screen on June 8, 2017, was inconsistent with the prescribed opioids; however, the ALJ found that the allegation regarding the prescription could not be sustained because it had been thirty-five days since A.P. had filled the prescription on May 5, 2017. RD, at 76. Due to the fact that the Government's expert testified that a negative urine screen would not be concerning thirty-three days after the prescription was filled, I agree with the ALJ that the Government has not proven that the prescription on July 6, 2017, after the results of the negative urine screen on June 8, 2017, was issued outside of the usual course of the professional practice and below the applicable standard of care in New Jersey, based on the negative urine screen.
Overall, with respect to Patient A.P, I find that the prescriptions issued on October 5, 2017; June 8, 2017; March 8, 2018 were issued below the applicable standard of care in the State of New Jersey, because there was no documented alcohol counseling, and the prescription on February 8, 2018, was issued below the applicable standard of care in the State of New Jersey, because there was no documented discussion related to the inconsistent urine screens.
The stipulated facts demonstrate that between and including August 22, 2016, and April 10, 2018, Respondent issued prescriptions for controlled substances to J.C. on twenty-one occasions.
The ALJ conducted a thorough evaluation of the PMP records to determine the number of days between the date that the PMP indicated that J.C. filled the prescription and the date that his urine tested negative for oxycodone. RD, at 78-79 (citing ALJX 45, at 2-3 (PMP)). The ALJ analyzed these dates in a chart with the amount of tablets in the prior prescription to determine whether it was reasonable for Respondent not to document the inconsistent urine screen.
Dr. Kaufman testified that a October 19, 2016, urine screen that tested negative for opiates following a prescription that was issued on September 21, 2016 (seventeen days prior to the drug screen) was inconsistent, and therefore the prescription issued on November 17, 2016 following Respondent's knowledge of the results of that drug screen was issued outside the usual course of the professional practice in the State of New Jersey. Tr. 223. J.C. testified that Respondent always counseled him on the negative test results and asked him why he was not taking his medication and J.C. further testified that he told Respondent that his pain was too intense, so he used all of the medication. RD, at 80 (citing tr. 853,
On June 20, 2017, J.C. tested negative for opiates despite the fact that he had been prescribed thirty days of Roxicodone thirty days prior to the urine test on May 11, 2017. Dr. Kaufman testified that the prescription issued to J.C. on July 25, 2017, was “not issued within the usual course of practice, because it `was issued after the negative urine screen, without counseling of the urine drug screen as to why it was negative . . .' for opiates.” RD, at 81 (citing tr. 227, GX 109, 110). Due to the Respondent's lack of documentation regarding the counseling that she asserts occurred, I agree with the ALJ that the prescription issued on July 25, 2017, was issued outside of the usual course of the professional practice and below the applicable standard of care in the State of New Jersey. RD, at 129.
On July 25, 2017, J.C. tested negative for opiates despite the fact that he had been prescribed thirty days of Roxicodone thirty-four days prior to the urine test on June 20, 2017. The ALJ applied the measuring unit of thirty-two days to determine when the applicable standard of care would require counseling and found that the subsequent prescription on August 22, 2017, was issued within the usual course of the professional practice. RD, at 129. Although I believe the appropriate test is 33 days, I agree with the ALJ that the Government has not proven by substantial evidence that this prescription was beneath the applicable standard of care in New Jersey. RD, at 129.
Overall, with respect to Patient J.C., I find that the prescriptions issued on November 17, 2016, and July 25, 2017, were issued below the applicable standard of care in the State of New Jersey, because there was no documented discussion related to the inconsistent urine screens.
The stipulated facts demonstrate that between and including September 28, 2015, and May 24, 2017, Respondent issued prescriptions for controlled substances to L.M. on twenty-three occasions.
Respondent testified that when L.M. tested positive for Suboxone, she had called the lab and the lab had said to recheck the urine “[a]nd I tested her again; she didn't come back positive the next time.” Tr. 857. This description of the events is undermined by the evidence on the record that shows that L.M. tested positive three times in a row for Suboxone and Respondent's own later testimony.
On January 31, 2017, L.M.'s urine sample tested positive for fentanyl, which was not prescribed by Respondent. GX 175, at 129. Respondent stated that she “called the primary care and [she] asked for their note” and they “told [her] over the phone that they ordered a
On April 26, 2017, Patient L.M.'s urine sample tested positive for 6-MAM, a heroin metabolite. RD, at 131; GX 175, at 126. On L.M.'s subsequent appointment with Respondent on May 24, 2017, L.M.'s patient records demonstrate that Respondent discharged the patient for heroin; however, she also issued L.M. a prescription for 90 Percocet 5/325 milligrams. RD, at 131;
Dr. Kaufman testified that Respondent did address the positive heroin test, because “she discharged [L.M.] from the practice.” Tr. 564;
Furthermore, when the Government followed up with Dr. Kaufman on this issue, he clarified that weaning a patient would require documentation in the record, and also would include directions “written on the prescription to give the patient the proper directions on how to do it”; therefore, the prescription was “not necessarily” a weaning prescription. Tr. 654-55. Dr. Kaurman also affirmed that the prescription was outside the applicable standard of care.
The stipulated facts demonstrate that between and including January 30, 2015, and August 25, 2017, Respondent issued prescriptions for controlled substances to M.W. on thirty-two occasions.
The stipulated facts demonstrate that between and including March 16, 2015, and April 6, 2018, Respondent issued prescriptions for controlled substances to S.W. on thirty-nine occasions.
Patient S.W.'s urine tested positive for alcohol metabolites on March 30, May 25, June 22, July 20, and August 23, 2016. RD, at 95-96 (citing GX 288, 293, 296, 299, 302; Stip. 13(a), 13(b), 13(c), 13(d), 13(e)). The patients' records for the prescriptions issued on the visit following the results of these urine screens did not document any specific counseling with regard alcohol.
On April 5, 2017, S.W.'s urine screen tested positive for fentanyl.
In sum, I find that the record evidence demonstrates that Respondent issued twenty-three prescriptions for controlled substances beneath the applicable standard of care and outside the usual course of the professional practice in New Jersey (five occasions to UC, four occasions to A.P., two occasions to J.C., three occasions to L.M., three occasions to M.W., and six occasions to S.W.). Additionally, I find that the Government has presented substantial evidence that Respondent: failed to conduct a physical examination of the UC in violation of N.J. Admin. Code 13:35-7.1A, and failed to document the discussion of the plan and assess the risk of abuse, addiction or diversion after inconsistent urine screens in violation of N.J. Admin. Code § 13:35-7.6(e) and (f), as further explained in
Under Section 304 of the CSA, “[a] registration . . . to . . . dispense a controlled substance . . . may be suspended or revoked by the Attorney General upon a finding that the registrant . . . has committed such acts as would render his registration under section 823 of this title inconsistent with the public interest as determined by such section.” 21 U.S.C. 824(a)(4). In the case of a “practitioner,” defined in 21 U.S.C. 802(21) to include a “physician,” Congress directed the Attorney General to consider the following factors in making the public interest determination:
(1) The recommendation of the appropriate State licensing board or professional disciplinary authority.
(2) The applicant's experience in dispensing . . . controlled substances.
(3) The applicant's conviction record under Federal or State laws relating to the . . . distribution[ ] or dispensing of controlled substances.
(4) Compliance with applicable State, Federal, or local laws relating to controlled substances.
(5) Such other conduct which may threaten the public health and safety.
According to Agency decisions, I “may rely on any one or a combination of factors and may give each factor the weight [I] deem[ ] appropriate in determining whether” to revoke a registration.
Under DEA's regulation, “[a]t any hearing for the revocation . . . of a registration, the . . . [Government] shall have the burden of proving that the
According to the CSA's implementing regulations, a lawful prescription for controlled substances is one that is “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 CFR 1306.04(a). The Supreme Court has stated, in the context of the CSA's requirement that schedule II controlled substances may be dispensed only by written prescription, that “the prescription requirement . . . ensures patients use controlled substances under the supervision of a doctor so as to prevent addiction and recreational abuse . . . [and] also bars doctors from peddling to patients who crave the drugs for those prohibited uses.”
Respondent engaged a skillful attorney to defend herself against the allegations. I read and analyzed every aspect of Respondent's defense including all of the evidence she put in the record. Respondent's arguments regarding the allegations are not persuasive.
I acknowledge the complexity of this case. The OSC/ISO contained errors, what appeared to be a very adversarial hearing led to confusion relating to testimony on both sides, and the ALJ's statements in the lengthy RD were at times inconsistent with each other.
Respondent contended that the OSC alleged over 150 unlawful prescriptions and the Government only presented evidence about twenty-six and highlights the ALJ's characterization of the OSC as “error-filled and overzealous.”
Respondent additionally contended that the number of alleged violations only represents a small subset of the 2,800 patient visits that DEA reviewed.
The Respondent asserted that no one “died or overdosed or diverted any medication.” Resp Posthearing, at 1. She does not, however, cite legal authority for the proposition that I must find death, an overdose or controlled substance diversion before I may suspend or revoke a registration. I agree with the ALJ that a decision of revocation does not need to be based on specific evidence of death or overdose.
Respondent further argued that the UC failed in obtaining opiates without
I found Respondent's credibility to be dubious and her counseling on the record to be insufficient, but the record was clear that, whether or not Respondent actually counseled patients with inconsistent urine screens or alcohol metabolites, she did not adequately document that counseling to demonstrate that she was actively resolving the issues. The ALJ cited to numerous DEA cases that demonstrate that “requiring patients to take a drug test serves little purpose, if any, if the registrant ignores the test results.” RD, at 112 (citing
Respondent paints herself as an “appropriate steward of her controlled-substance license.” Resp Posthearing, at 2. Further, she argued that “with her lack of venality and her cautious approach to her practice, it is submitted that [R]espondent is exactly the kind of practitioner who should be encouraged.”
I find that in issuing twenty-three prescriptions beneath the applicable standard of care and outside the usual course of the professional practice in New Jersey, Respondent violated 21 CFR 1306.04(a).
I also find that the Government has proven by substantial evidence that Respondent's failure to conduct an adequate physical examination of the UC constitutes a violation of N.J. Admin. Code § 13:35-7.1A (West 2020) (effective September 15, 2003) (practitioners shall not issue prescriptions “without first having conducted an examination, which shall be appropriately documented in the patient record” to include “an appropriate history and physical examination.”). Respondent characterizes the regulation to require an “appropriate physical examination,” but in fact, the regulation requires “an appropriate history” and “physical
Respondent further argued both that the patient's MRI gave her a diagnosis and that she had conducted enough of an examination by observing the patient “to derive a proper etiology of a patient's subjective pain complaints and come up with a plan. . . .”
I further find that Respondent violated N.J. Admin. Code § 13:35-7.6(f)(2) and (5) for five prescriptions issued after its effective date of March 1, 2017, where the patients' records demonstrate no documentation of the resolution or “plan” after breaches to the pain management agreement due to patients not taking controlled substances as prescribed and no documented assessment of their risk of dependence before issuing additional prescriptions.
Respondent argued that she complied with the requirement to document a “plan,” because of what she described as her “decision-tree analysis” based on Dr. Gutheil's testimony that the end result shows the judgment that goes before it. Resp Posthearing, at 20 (citing Tr. 1220). “For [Respondent], whenever there was an inconsistent urine reported, but a prescription was issued, it indicated to her that appropriate counseling was done and all safety concerns were resolved.”
The plain meaning of the term “plan” cannot be, as Respondent suggests, merely identifying the breach and documenting the end result after a discussion. Respondent's own testimony demonstrates why it cannot. With regard to Patient L.M., who tested positive three times in a row for un-prescribed Suboxone, Respondent could not remember why she had not cut L.M.'s dosage even though she testified that after the third positive test, she realized that the “counseling wasn't successful.” Tr. 1092-95. The unchanged prescriptions following these visits could not be adequate documentation of a plan to address counseling about a breach of her pain management agreement that Respondent herself knew at that point was not being successful, because Respondent cannot remember why she issued the full prescription or why she resolved the unsuccessful counseling in that manner.
Furthermore, in other sections of the regulation, the State of New Jersey used very different terminology. For example, Section (d) states, “The practitioner shall include a note in the patient record that the required discussion(s) took place.” N.J. Admin. Code 13:35-76(d). As discussed earlier, this provision requires that the practitioner note the fact that the discussions took place. The inclusion of the word “plan” in the Section at issue indicates that the regulations require more documentation than only a conclusory assertion.
In interpreting the meaning of a regulation, “agencies normally address problems in a detailed manner and can speak through a variety of means, including regulations, preambles, interpretive statements, and responses to comments. . . .”
There are two affirmative obligations in the regulation that are applicable to this record—“[w]hen controlled dangerous substances are continuously prescribed for management of chronic pain”
The Preamble is very clear that the State of New Jersey's purpose in enacting emergency controls on prescribing controlled dangerous substances for chronic pain is to ensure not only vigilance and involvement but that these “active pain management procedures” are also reflected in the patient record. Additionally, reading the two paragraphs together, it is apparent that the practitioner must assess the risks before every prescription and where there is a breach to the pain management agreement that demonstrates a potential risk of dependence, the plan and the assessment must be documented. Therefore, I find that five prescriptions with unresolved inconsistent urine screens issued after the effective date of March 1, 2017, violated N.J. Admin. Code § 13:35-7.6(f)(2) and (5).
In its Posthearing Brief and Exceptions, the Government alleged that “when issuing prescriptions for opioids practitioners must determine `that the issuance of the subsequent prescription does not present an undue risk of abuse, addiction or diversion and [must] document[ ] that determination.' ” Govt Posthearing, at 15-16 (citing N.J. Stat. Ann. § 24:21-15.2(c)(3)). The Section of the statute that the Government cited appears to apply only when issuing a subsequent prescription “no less than four days after issuing the initial prescription.” N.J. Stat. Ann. § 24:21-15.2(c). It is not clear from the plain language of the subsection that the risk assessment would be required for
Respondent argued that the statute does not specify the requirement to document noncompliance with the pain management agreement.
Therefore, I find sufficient evidence to sustain violations of N.J. Stat. Ann. § 24:21-15.2 for the three prescriptions occurring after it was effective on May 16, 2017. I further find that these provisions support Dr. Kaufman's testimony regarding the importance under the New Jersey standard of care of documenting not only the fact that counseling occurred, but also the resolution of such counseling.
The laws that New Jersey has implemented clearly demonstrate the extent to which the applicable standard of care in New Jersey relies on, not just checking for compliance with the pain management agreement, but that breaches, such as inconsistent urine screens are discussed and “the plan after that discussion” is documented in the patient record. N.J. Admin. Code § 13:35-7.6(f)(5) (West 2020). These laws require more than lip service to safeguards, but actual rational, thoughtfulness on the part of the practitioner in making the decision to reissue a prescription to someone who is presenting red flags or danger AND the memorialization of that decision. To preserve the value of New Jersey law, I cannot agree with the ALJ here that this is “not the sort of recordkeeping violation that would defeat the purpose of the Controlled Substances Act.” RD, at 150.
As found above, the Government's case establishes by substantial evidence that Respondent issued controlled substance prescriptions outside the usual course of the professional practice. I, therefore, conclude that Respondent engaged in misconduct which supports the revocation of her registration.
For purposes of the imminent danger inquiry, my findings also lead to the conclusion that Respondent has “fail[ed] . . . to maintain effective controls against diversion or otherwise comply with the obligations of a registrant” under the CSA. 21 U.S.C. 824(d)(2). The substantial evidence that Respondent issued controlled substance prescriptions outside the usual course of the professional practice establishes that there was “a substantial likelihood of an immediate threat that death, serious bodily harm, or abuse of a controlled substance . . . [would] occur in the absence of the immediate suspension” of Respondent's registrations.
Where, as here, the Government has met its
The CSA authorizes the Attorney General to “promulgate and enforce any rules, regulations, and procedures which he may deem necessary and appropriate for the efficient execution of his functions under this subchapter.” 21 U.S.C. 871(b). This authority specifically relates “to `registration' and `control,' and `for the efficient execution of his functions' under the statute.”
In evaluating the degree of a respondent's acceptance of responsibility required to entrust her with a registration, in
Respondent's mitigating evidence and the Government's mistakes have whittled down or softened some of the violations in this case; however, I see no evidence from Respondent that demonstrates that she will “prevent the re-occurrence of similar acts.”
In sanction determinations, the Agency has historically considered its interest in deterring similar acts, both with respect to the respondent in a particular case and the community of registrants.
Although the ALJ ultimately recommended a sanction short of revocation, I cannot agree, because there is insufficient evidence in the record to demonstrate that Respondent can be entrusted with a registration.
Accordingly, I shall order the sanctions the Government requested, as contained in the Order below.
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a), I hereby revoke DEA Certificate of Registration BK9710939 issued to Kaniz F. Khan-Jaffery, M.D. Further, pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I hereby deny any pending application of Kaniz F. Khan-Jaffery, M.D., to renew or modify this registration, as well as any other applications of Kaniz F. Khan-Jaffery, M.D. for additional registration in New Jersey. This Order is effective August 28, 2020.
On June 29, 2017, the Acting Assistant Administrator, Diversion Control Division, Drug Enforcement Administration (hereinafter, DEA or Government), issued an Order to Show Cause to Hamada Makarita, D.D.S. (hereinafter, Applicant), of McLean, Virginia. Administrative Law Judge Exhibit (hereinafter, ALJX) 1 (Order to Show Cause (hereinafter, OSC)), at 1. The OSC proposes the denial of Applicant's application for a DEA certificate of registration (hereinafter, registration) alleging that he does not have authority to handle Schedule II to IV controlled substances in Virginia, he has been convicted of felony counts related to controlled substances, and his registration would be inconsistent with the public interest.
The Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision of the Administrative Law Judge in this matter (hereinafter, RD) states that Applicant's hearing request was “timely filed.” RD, at 2;
The substantive grounds at issue in this proceeding, as more specifically alleged in the OSC, include that Applicant, “[o]n April 12, 2013, . . . [was] convicted of eight felony counts in the United States District Court for the Eastern District of Virginia, Alexandria Division, six of which were related to controlled substances,” one of which was for health care fraud, and one of which was for aggravated identity theft. OSC, at 2-3 (citing 21 U.S.C. 823(f)(3) and 824(a)(2) and (a)(4)). The OSC also alleges that Applicant “fail[ed] to accept responsibility for . . . [his] convictions.” OSC, at 3.
Regarding the allegation that Applicant's registration would be inconsistent with the public interest, the OSC alleges twelve findings of fact by the Virginia Board of Dentistry (hereinafter, VBD) concerning Applicant's prescribing controlled substances without or beyond a legitimate dental purpose.
The OSC notified Applicant of his right to request a hearing on the allegations or to submit a written statement while waiving his right to a hearing, the procedures for electing each option, and the consequences for failing to elect either option.
The matter was placed on the docket of the Office of Administrative Law Judges and assigned to Chief Administrative Law Judge (hereinafter, ALJ) John J. Mulrooney, II. The parties initially submitted seven stipulations.
“1. On September 20, 2016, the Respondent filed an application for a DEA COR, Control No. W16093263C, seeking registration as a practitioner in Schedule V with a registered address of 4103 Chain Bridge Road, Suite LL 100, Fairfax, Virginia 22030.
“2. The Respondent currently possesses Dental License number 0401007149 from the Commonwealth of Virginia. His dental license expires on its own terms on March 31, 2018.
“3. The Respondent lacks authority in the Commonwealth of Virginia to handle Schedule II, III, or IV Controlled Substances.
“4. In the Respondent's Request for Hearing, he withdrew a prior request for Schedule II-IV authority.
“5. On April 12, 2013, the Respondent was convicted of eight felony counts in the United States District Court for the Eastern District of Virginia, Alexandria Division.
“6. The Respondent applied for reinstatement of his state dental license in 2016. The Virginia Board of Dentistry made a number of findings on September 22, 2016, regarding the Respondent's treatment of a number of patients.
“7. Following the hearing, the Board reinstated the Respondent's state dental license with conditions on September 22, 2016.”
On September 20, 2017, the parties filed additional Joint Stipulations, ALJX 10, agreeing to the authenticity of four of the seven Government Exhibits (hereinafter, GX) and five Applicant Exhibits (hereinafter, RX). ALJX 10, at 1-2.
The hearing in this matter lasted one day and took place in Arlington, Virginia on October 10, 2017. The Chief ALJ filed his RD on January 19, 2018. Neither party filed exceptions to the RD and the time for filing exceptions has expired. Letter of the Chief ALJ to the Acting Administrator, dated Feb. 14, 2018, at 1.
Having examined and considered the record in its entirety, I agree with the Chief ALJ that substantial record evidence establishes Applicant's six federal felony convictions relating to the dispensing of controlled substances, the Fourth Circuit's affirmance of those felony convictions, and Applicant's completion of his appeals of those convictions. I find substantial record evidence of the VBD's finding that Applicant illegally prescribed over 2,700 dosage units of Schedule II through IV controlled substances. I find that Applicant did not unequivocally accept responsibility for all of this proven controlled substance-related wrongdoing. Accordingly, I conclude that granting Applicant's request for a
Applicant is licensed as a dentist in the Commonwealth of Virginia.
After Applicant served his sentence and was released from federal custody, the VBD limited Applicant's authorization to issue controlled substance prescriptions to Schedule V. GX 3 (Order Before the Virginia Board of Dentistry In Re Hamada R. Makarita, D.D.S., License Number: 0401-007149, Case Number: 86781, 136371, 143367, 152192, dated, entered, and mailed on September 22, 2016 (hereinafter, VBD Order)), at 11;
A DEA field investigation of Applicant began because he responded “yes” to “a few liability questions on an application.”
I found out my office manager was using my DEA license to call in rx to herself and friends and I called the FBI and she convinced the FBI agent I was the on [sic] who told her to. This was a lie. The judge said I was responsible for my ploys [sic] actions so I was convicted of conspiracy to distribute narcotics. She said I gave her permission which is not true at all or why would i [sic] have called the authorities and go to a lawyer and fire her?
I voluntarily surrendered my DEA license and also I am applying only for schedule 5 drugs so I can treat my patients with NSAids [sic] for pain and antibiotics. I had my hearing with the board of Dentistry last week and my license was reinstated. It was a mandatory suspension because of the conviction. I will be pressing charges against this office manager again! I only wish to have permission for schedule 5 for now as it is a must to teat [sic] infections etc with antibiotics as well as NSAIDS for pain.
The second question to which Applicant answered “yes” asks, “Has the applicant ever surrendered (for cause) or had a federal controlled substance registration revoked, suspended, restricted or denied, or is any such action pending?” GX 7, at 3. For “nature of incident” regarding his “yes” answer to the second liability question, Applicant's submission was the same as his submission for the first liability question. GX 1, at 2. Likewise, Applicant wrote the same “result” concerning the second liability question as he wrote for the first liability question.
The third question to which Applicant answered “yes” asks, “Has the applicant ever surrendered (for cause) or had a state professional license or controlled substance registration revoked, suspended, denied, restricted, or placed on probation, or is any such action pending?” GX 7, at 3. Concerning “nature of incident” regarding his “yes” answer to the third liability question, Applicant wrote:
Due to conviction, the state dental board had to suspend (not revoke) my license because it is in the statutes. Although they had not hear [sic] day case until last week in full, and once they did and were presented with proofs of who was the culprit, they reinstated my license with no fines at all.
According to Government counsel, the “basis of the Government's
There is factual agreement among the witnesses on a number of matters. When there is factual disagreement, I apply my credibility determinations and the credibility recommendations of the Chief ALJ.
The Government called one witness, the DEA Diversion Investigator case agent (hereinafter, DI). The
DI's testimony addressed Applicant's application, the process of referring that application for investigation, and her investigation of the application, including her obtaining documents relevant to the application and her communicating with Applicant.
DI testified that she had email and telephonic contact with Applicant.
On cross examination, as clarified on redirect, DI recounted her recollection that Applicant admitted, in his application for a DEA registration, to having been criminally convicted.
According to the prosecution's expert witness in the criminal case, Dr. Lawrence Singer, fentanyl is “outside the scope of dentistry or oral surgery and `is only appropriate for a chronic pain patient who has cancer pain or . . . something extremely debilitating and may be chronically ill.' ” 576 F. App'x at 257 (GX 5, at 5). Based on Dr. Singer's testimony, Applicant's admission that he used the fentanyl patch on his back to see if it might relieve oral pain implicates illegal prescribing, dispensing, and use of a Schedule II controlled substance.
I agree with the Chief ALJ that DI “presented testimony that was detailed, plausible, internally consistent, and devoid of any indication of any cognizable motive to fabricate. She gave every appearance of an impartial investigator/regulator, was forthcoming and candid in her responses to questions, and her testimony is accepted here as fully credible.” RD, at 13.
The Government's admitted documentary evidence consists of documents detailing the disposition of the felony criminal charges brought against Applicant, the Circuit Court's affirmance of the charges of which Applicant was convicted, and the VBD's findings of fact, conclusions of law, and Order concerning Applicant's medical license and controlled substance prescribing authority. GX 2, 3, and 5, respectively. The Government also put in the record Applicant's correspondence with DEA and DI related to his registration application and background information to help contextualize that correspondence. GX 1, 4, 6, and 7.
GX 2 consists of six sheets concerning Applicant's eight felony convictions in the Eastern District of Virginia. GX 2 (Judgment,
The first count listed on the Judgment of the Eight Felony Conviction Trial is conspiracy to distribute and dispense controlled substances in violation of 21 U.S.C. 846.
Applicant's former dental assistant similarly testified that Applicant wrote a Valium prescription in her name and instructed her to fill it so that he could give it to his girlfriend. 576 F. App'x at 255 (GX 5, at 4). The former dental assistant also testified that Applicant wrote a Vicodin prescription in her name and instructed her to fill it so that he could use it himself.
The Eight Felony Conviction Trial “Judgment in a Criminal Case” sheet shows that the second, third, tenth, twelfth, and thirteenth counts are for dispensing controlled substances in violation of 21 U.S.C. 841(a)(1). GX 2, at 1. Applicant also appealed his conviction on these counts arguing that there was “insufficient evidence to support his distribution offenses.” 576 F. App'x at 263 (GX 5, at 10). The Fourth Circuit Conviction Affirmance found Applicant's argument to be “without merit,” stating “after a careful review of the record, we conclude substantial evidence clearly supports that . . . [Applicant] distributed and dispensed a variety of controlled substances for recreational purposes and not for a legitimate medical and dental purpose.”
The fentanyl patch testimony of Applicant's former office manager was also relevant to these counts. Dr. Singer found that Applicant “wrote prescriptions . . . [for her] for what [a]ll amounted to a few hundred—several hundred doses of narcotics.' ” 576 F. App'x at 257 (GX 5, at 5). According to the expert, a fentanyl patch is “outside the scope of dentistry or oral surgery and `is only appropriate for a chronic pain patient who has cancer pain or . . . something extremely debilitating and may be chronically ill.' ”
Likewise, the testimony of Applicant's former dental assistant/patient was relevant to these counts. Dr. Singer opined that Applicant had no clinical notes to support the writing of Valium or Vicodin prescriptions for her.
The fourteenth felony count in the indictment of Applicant is health care fraud, a violation of 18 U.S.C. 1347.
Applicant challenged the health care fraud conviction on two grounds. First, he argued that he was not bound by the terms of the health insurance plan because he was not a party to the contract. 576 F. App'x at 263 (GX 5, at 10). The Fourth Circuit Conviction Affirmance rejected this argument, stating that being a party to an insurance contract “is not relevant to whether . . . [Applicant] formed the specific intent to commit health care fraud.” 576 F. App'x at 264 (GX 5, at 10). Second, Applicant claimed that the record evidence was insufficient to support a finding that the health insurance plan was a “health care benefit program” as defined by the criminal statute.
In sum, the Fourth Circuit Conviction Affirmance found no reversible error and affirmed the results of the Eight Felony Conviction Trial. 576 F. App'x at 254 (GX 5, at 3).
GX 3 is the VBD Order regarding Applicant's state dental license. Applicant testified about his post-release preparations for, and his participation in, the “14-hour [VBD] hearing nonstop . . . [that] lasted until 2:00 a.m.” Tr. 50-51. The Order notes Applicant's appearance at the hearing “not represented by legal counsel.” GX 3, at 1. The VBD's post-hearing Order reinstated, indefinitely suspended, and then stayed the indefinite suspension of Applicant's dental license “contingent upon continued compliance” with specified terms and conditions.
The “Findings of Fact” section of the VBD Order spans eight pages. GX 3, at 1-8. It lists, among other things, eight categories of fact findings about Applicant's illegal actions related to controlled substances from 2006 through 2011.
At the hearing, Applicant testified and called one other witness, his current assistant. Tr. 9, 55. He also introduced five exhibits concerning “the circumstances and . . . the work that . . . [Applicant] has done.”
During his testimony, Applicant described his credentials and professional affiliations, the establishment and nature of his current dental practice, when he would prescribe Schedule V controlled substances in his current practice, and his “feel[ing] like . . . [he is currently] helping . . . [patients] 80 percent of the way versus if they had muscle relaxants to take at night . . . which helps them not clench and grind and so forth from being in the wrong bite position. That would help them.”
Applicant admitted that he was convicted of eight federal felonies in the Eastern District of Virginia and, regarding fault, stated, “The buck stops here. It's a hundred percent my fault.”
Applicant admitted that the VBD “suspended . . . [his] license because of the convictions.”
Applicant testified that he had just received a letter from the VBD about the unannounced inspection that was conducted pursuant to Term #3 of the VBD Order and the ensuing VBD review of the inspection report and patient records.
Applicant testified about other courses, such as in cosmetic dentistry, he has taken, stating that “I do a lot of continuing education . . . . I'm constantly taking courses all over the country.”
Applicant specifically addressed what he had “previously said in an email or on an application,” presumably concerning his amending the DEA application he submitted from requesting only Schedule V authority to requesting Schedule II through V authority.
Applicant listed the changes he made in his practice since his felony convictions. He stated that “[e]verything is in a locked safe . . . , you need a key and a combination . . . [, and] [t]here's a camera on it.”
Applicant testified that the only time he took a controlled substance was “15 years ago or something . . . [when] the oral surgeon prescribed . . . [him] Tylenol #3 or something back then.”
The Chief ALJ, who observed Applicant's demeanor during the hearing, assessed Applicant's credibility and included his observations and conclusions in the RD. According to the Chief ALJ, “Even beyond the obvious reality that, as the applicant, the . . . [Applicant] has the most at stake regarding the outcome of the proceedings, his presentation conflicted with the incontrovertible evidence, was blatantly self-serving, and struck as inconsistent even with his own exhibits.” RD, at 25. The Chief ALJ concluded that “there was some testimony of the . . . [Applicant] that can certainly be credited in this recommended decision, such as biographical information . . . . Where his recitation of relevant facts conflicts with incontrovertible evidence, such as facts subsumed by his convictions and the findings rendered by the . . . [VBD], his testimony is not just legally incapable of belief; it is factually unworthy of credibility.”
My review and analysis of the record are consistent with the Chief ALJ's conclusions. For example, according to the record transcript, Applicant testified that the only time he took a controlled substance was “15 years ago or something . . . [when] the oral surgeon prescribed . . . [him] Tylenol #3 or something back then.” Tr. 111. According to the Fourth Circuit Conviction Affirmance, however, Applicant “corroborated” his former office manager's testimony that he applied a fentanyl patch to his body in her presence.
By way of further example, the Chief ALJ asked Applicant whether it would be incorrect “if someone said that . . . [he] intentionally wrote up prescriptions or gave them to people for other than a legitimate medical purpose.” Tr. 121. Applicant agreed, “That would be wrong.”
Applicant's lack of credibility is exhibited in ways in addition to blatant conflicts between his record testimony and the records of the Eight Felony Conviction Trial, the Fourth Circuit Conviction Affirmance, and the VBD Order. For example, Applicant could have sought access to, and potentially introduced into the record, Prescription Drug Monitoring files to support his answer to his own counsel's question about whether he ever took Schedule II or Schedule III controlled substances. Tr. 111. There are no such files in the record, however. Neither did Applicant submit any evidence explaining why he did not seek to obtain or offer any such corroborating evidence.
By way of further example, Applicant testified that the software used in his dental office, Dentrix, includes an audit trail, “[s]o, everything that's put in there cannot be erased.”
In sum, I agree with the Chief ALJ's credibility assessment of Applicant. Further, I afford no weight to Applicant's claims of innocence when he failed to produce the documentary evidence that he testified exists and supports those innocence claims.
The second witness Applicant called was his current assistant, a certified dental assistant (hereinafter, CDA), whose employment with him began after his release from incarceration.
I agree with the Chief ALJ's assessment that CDA's “testimony presented no basis to conclude that she was not credible. She appeared candid and forthright, and her testimony was sufficiently detailed, internally consistent, and plausible to be fully credited.” RD, at 27.
As already discussed, the OSC charged that Applicant's application for a registration should be denied due to his having been convicted of six felonies related to controlled substances. OSC, at 1. Applicant does not dispute that he was criminally convicted of eight felonies in the Eastern District of
Pursuant to section 303(f) of the CSA, “[t]he Attorney General shall register practitioners . . . to dispense . . . controlled substances . . . if the applicant is authorized to dispense . . . controlled substances under the laws of the State in which he practices.” 21 U.S.C. 823(f). Section 303(f) further provides that an application for a practitioner's registration may be denied upon a determination that “the issuance of such registration . . . would be inconsistent with the public interest.”
(1) The recommendation of the appropriate State licensing board or professional disciplinary authority.
(2) The applicant's experience in dispensing . . . controlled substances.
(3) The applicant's conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.
(4) Compliance with applicable State, Federal, or local laws relating to controlled substances.
(5) Such other conduct which may threaten the public health and safety.
These factors are considered in the disjunctive.
Pursuant to section 304(a)(2), the Attorney General is authorized to suspend or revoke a registration “upon a finding that the registrant . . . has been convicted of a felony under this subchapter or subchapter II of this chapter or any other law of the United States . . . relating to any substance defined in this subchapter as a controlled substance or a list I chemical.” 21 U.S.C. 824(a)(2). It is well established that the various grounds for revocation or suspension of an existing registration that Congress enumerated in this section are also properly considered in deciding whether to grant or deny an application under section 303.
The Government has the burden of proof in this proceeding. 21 CFR 1301.44. Both parties submitted documentary evidence. All of the documentary evidence was admitted without objection.
As already discussed, I found that Applicant's convictions for conspiracy to dispense controlled substances and for illegally distributing or dispensing controlled substances are six felony convictions relating to controlled substances.
Factor One calls for consideration of the “recommendation of the appropriate state licensing board or professional disciplinary authority” in the public interest determination. 21 U.S.C. 823(f)(1). Neither the VBD Order nor any other record evidence constitutes a direct recommendation to the Agency from the VBD about Applicant's registration application.
As already discussed, after suspending Applicant's dental license about ten days after entry of Judgment in the Eight Felony Conviction Trial, the VBD reinstated Applicant's dental license, placed it on indefinite suspension, and stayed that suspension “contingent upon continued compliance” with various terms and conditions. GX 3, at 10-11. One such term and condition was that Applicant was not to “prescribe or dispense Schedule II, III, and IV controlled substances for a period of two (2) years from the date of this Order,” September 22, 2016. GX 3, at 11-12. Both parties implicitly interpret this VBD term as authorizing Applicant to prescribe and dispense Schedule V controlled substances in Virginia.
The record does not include a comparison of the evidence presented in the Eight Felony Conviction Trial and in the VBD hearing. Clearly, though, the Fourth Circuit Conviction Affirmance and the VBD Order do not discuss all of the same incidents or evidence.
My predecessor recently addressed Factor One and its application in a matter when the state board granted a doctor limited controlled substance authority based on less evidence of misconduct than the Government had presented during the OSC proceeding.
I apply the same analysis and reach the same conclusion here given the differences between the evidence set out in the VBD Order and the evidence before me, including the evidence addressed in the Fourth Circuit Conviction Affirmance. In sum, while the terms of the VBD Order are not dispositive of the public interest inquiry in this case and are minimized due to the differences in the evidence in the VBD Order and the uncontroverted record evidence in this matter, I consider the VBD's grant of Schedule V authority in Applicant's favor.
Factors Two and Four call for consideration of Applicant's “experience in dispensing . . . controlled substances” and his “[c]ompliance with applicable State, Federal, or local laws relating to controlled substances.” 21 U.S.C. 823(f)(2) and (4), respectively. I reviewed all of the record evidence concerning Applicant's controlled substance dispensing experience and compliance with applicable laws relating to controlled substances, including the testimony received during the adjudication of this OSC, and Applicant's position on it. I evaluated the evidence using the credibility assessments already discussed.
Relevant, uncontroverted record evidence concerning Factors Two and Four is in the VBD Order documenting Applicant's unlawful 2,711 dosage unit dispensing of controlled substances in Schedule II (1,740 dosage units), Schedule III (290 dosage units), and Schedule IV (681 dosage units). GX 2, at 2-10;
Other record evidence concerning Applicant's controlled substance experience and dispensing is Applicant's testimony and written communications. During the hearing, for example, Applicant admitted that he wrote prescriptions that he “shouldn't have written and that was a mistake and that would never, ever happen again.” Tr. 130. By way of further example, Applicant also admitted that he “wrote prescriptions, a few prescriptions that were not medically necessary. . . . I made a mistake, stupidity, naiveté, not being responsible.”
While admitting he wrote controlled substance prescriptions that were not legitimate, Applicant also testified that “as far as . . . [his] trying to get any kind of favors or money or anything like that, that is not the case.”
In sum, I carefully considered all of the record evidence relevant to Factors One, Two, Three, and Four and Applicant's arguments about that evidence. I applied my and the Chief ALJ's credibility assessments to that evidence. I conclude that the Government met its
Where, as here, the Government presented a
The extent of Applicant's misconduct proven by the record evidence is eight felonies, six of which relate to controlled substances and all of which were affirmed on appeal, and the unlawful dispensing of over 2,700 dosage units of controlled substances in Schedules II, III, and IV. In addition, as already discussed, Applicant's testimony was not always marked by candor.
While Applicant took responsibility for some of his wrongdoing, he did not take unequivocal responsibility for all of it. First, despite the Fourth Circuit Conviction Affirmance, Applicant testified that he did not conspire to distribute and dispense controlled substances in violation of 21 U.S.C. 846. Tr. 115 (denying that he ever unlawfully directed employees to go to pharmacies to pick up prescriptions and return them to him);
As the Chief ALJ stated, “It would be illogical for the Agency to entrust . . . [Applicant] with the weighty responsibilities of a DEA registrant where he is unable to even accept the proposition that he has engaged in the misconduct that he was convicted of and which was sustained by the . . . [VBD].” RD, at 42. “[S]o long as . . . Applicant adheres to his (almost bizarre) state of denial regarding the actual facts subsumed in his convictions (and Board findings),” the Chief ALJ continued, “it would be unreasonable to believe that he will alter his conduct.”
Applicant testified that he is not currently prescribing controlled substances in his dental practice and that he does not expect the income he realizes from his practice to increase if he had that authority. Tr. 46-48,113-14. Instead, he stated, he would like authority to prescribe Schedule V controlled substances for the sake of his patients' comfort.
I agree with the Chief ALJ that “consideration of the egregiousness of . . . [Applicant's] transgressions likewise does not support a sanction less than an outright denial of . . . [Applicant's] application.” RD, at 43.
The record in this case paints a picture of a registrant out of control. He distributed and dispensed drugs to himself and others with no justifiable reason, tasked his employees with taking controlled substance scrips to pharmacies and filling them so that he could dole them out to himself, friends, and other non-patients, slapped a fentanyl patch on himself in front of his staff, handed out powerful controlled drugs to his love interests, and prescribed scores of controlled substances to multiple patients without a legitimate medical purpose.
Given my decision that Applicant's application is not in the public interest, I conclude that Applicant's proposed Corrective Action Plan provides no basis for me to discontinue or defer this proceeding.
Accordingly, I shall order the denial of Applicant's application.
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I hereby deny the application submitted by Hamada Makarita, D.D.S., Control No. W16093263C, seeking registration in Virginia as a practitioner in Schedule V, and any other pending application submitted by Hamada Makarita, D.D.S. for a DEA registration in the Commonwealth of Virginia. This Order is effective August 28, 2020
Notice of application.
Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before September 28, 2020.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.
In accordance with 21 CFR 1301.33(a), this is notice that on June 5, 2020, Euticals Inc., 2460 W Bennett Street, Springfield, Missouri 65807-1229, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substances:
The company plans to manufacture the above-listed controlled substances in bulk for distribution to its customers. No other activities for these drug codes are authorized for this registration.
Notice of application.
Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before September 28, 2020.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.
In accordance with 21 CFR 1301.33(a), this is notice that on May 21, 2020, Siegfried USA, LLC, 33 Industrial Park Road, Pennsville, New Jersey 08070-3244, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substances:
The company plans to manufacture the above-listed controlled substances in bulk for sale to its customers.
Community Relations Service, Department of Justice.
30-Day notice.
The Department of Justice (DOJ), Community Relations Service (CRS), intends to request approval from the Office of Management and Budget (OMB) for a generic information collection clearance that will allow CRS to conduct a variety of participant feedback studies. CRS will submit the request for review and approval in accordance with the Paperwork Reduction Act of 1995. Over the next three years, CRS anticipates collecting program impact evaluation data for reassessing ongoing programs across several areas within community outreach. The purpose of these collections is to gather feedback from participants who attended CRS programs and to use that information to measure the impact of the programs. This work may entail redesigning and/or modifying existing programs based upon received feedback. CRS envisions using surveys, interviews, and other electronic data collection instruments.
Comments are encouraged and will be accepted for 60 days until September 28, 2020.
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)
(4)
(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.405A, Washington, DC 20530.
Pursuant to Section 112 of the 1976 amendments to the Federal Election Campaign Act, 52 U.S.C. 30116(c), the Secretary of Labor has certified to the Chairman of the Federal Election Commission and publishes this notice in the
Signed at Washington, DC.
Pursuant to Section 33105(c) of Title 49, United States Code, and the delegation of the Secretary of Transportation's responsibilities under that Act to the Administrator of the Federal Highway Administration (49 CFR, Section 1.95(a)), the Secretary of Labor has certified to the Administrator and published this notice in the
Signed at Washington, DC.
Notice.
The Department of Labor's (DOL) Veterans' Employment and Training Service (VETS) is soliciting comments concerning a proposed authority to conduct the information collection request (ICR) titled, “Employment Navigator Data Collection and Matching.” This comment request is part of continuing Departmental efforts to reduce paperwork and respondent burden in accordance with the Paperwork Reduction Act of 1995 (PRA).
Consideration will be given to all written comments received by September 28, 2020.
A copy of this ICR with applicable supporting documentation, including a description of the likely respondents, proposed frequency of response, and estimated total burden, may be obtained at no cost by contacting Luke Murren by telephone at 202-693-4711 (this is not a toll-free number), or by email at
Submit written comments about, or requests for a copy of, this ICR by mail or courier to the U.S. Department of Labor, Veterans' Employment and Training Service, Transition Assistance Program, 200 Constitution Ave. NW, Room S1212, Washington, DC 20210; or by email:
Luke Murren by telephone at 202-693-4711 (this is not a toll-free number) or by email at
DOL, as part of continuing efforts to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies an opportunity to comment on proposed and/or continuing collections of information before submitting them to the Office of Management and Budget (OMB) for final approval. This program helps to ensure requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements can be properly assessed.
DOL seeks approval of a new information collection request (ICR) titled “Employment Navigator Data Collection and Matching”. This request is for a “common forms” clearance process. There are three forms included in this ICR. The first form is a data collection mechanism for transitioning service members to provide general characteristics and background information as services are received from Employment Navigators. The second form includes additional data that is captured from government and non-government partners who will provide the service member, veteran, or spouse addition job seeker assistance after Employment Navigator data entry is complete. This form also includes any employment-related outcomes (
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number. See 5 CFR 1320.5(a) and 1320.6.
Interested parties are encouraged to provide comments to the contact shown
Submitted comments will also be a matter of public record for this ICR and posted on the internet, without redaction. DOL encourages commenters not to include personally identifiable information, confidential business data, or other sensitive statements/information in any comments.
DOL is particularly interested in comments that:
• 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;
• 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;
• Enhance the quality, utility, and clarity of the information to be collected; and
• 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, (
Legal Services Corporation.
Request for comments.
The Legal Services Corporation (“LSC”) Board of Directors (“Board”) is in the process of updating LSC's strategic plan for the years 2021-2024. The LSC Board is soliciting comments on the current LSC Strategic Plan 2017-2020 and whether the current goals and initiatives remain suitable and timely and if new goals or initiatives should be implemented.
All comments and recommendations must be received on or before the close of business on August 28, 2020.
You may submit comments by email to
Rebecca Fertig Cohen,
Created and funded by Congress, LSC's fundamental mission is to pursue equal access to our justice system and serve as the single largest funder of civil legal aid programs in the country. With this mission in mind, the LSC Board adopted a plan in 2012 setting forth the strategic goals that would guide LSC for five years, ending in 2016 (“Initial Strategic Plan”). The LSC Board updated the Initial Strategic Plan for an additional four-year period covering 2017-2020 (“LSC Strategic Plan 2017-2020”). The LSC Board is now in the process of updating and revising the strategic plan for an additional four-year period from 2021-2024. As part of this process, the LSC Board is seeking input from the public and interested stakeholders on whether the goals articulated in the current LSC Strategic Plan 2017-2020, which is available at
The first and primary goal listed in the LSC Strategic Plan 2017-2020 is to maximize the availability, quality, and effectiveness of the civil legal services that LSC's grantees provide to eligible low-income individuals. LSC identifies three avenues through which it can best accomplish this goal: (1) Continue the identification, validation, and sharing of best practices to ensure grantees are most effectively meeting the civil legal needs of low-income Americans; (2) continue the development and implementation of meaningful performance standards and metrics to ensure assessment of grantees in as fair, objective, and effective a way as possible while supporting the best possible performance of all grantees; and (3) provide legal practice and operational support to grantees to further improve the quality of civil legal services to low-income Americans and assess and prioritize actions to ensure grantees have the training and technical assistance required to support grantees effectively.
The second goal listed in the LSC Strategic Plan 2017-2020 is to expand the role of LSC as a convener and leading voice for civil legal services for eligible persons living in poverty in the United States.
The third and final goal listed in the LSC Strategic Plan 2017-2020 is to continue to achieve the highest standards of fiscal responsibility both for itself and its grantees. As a steward of congressional funds collected from the American taxpayer, LSC has a duty to prudently use the resources allocated to it. LSC's goal is to comply with the parameters expressed by Congress and conform to the highest professional standards of fiscal transparency and accountability, both within the Corporation and in its fiscal oversight of those who receive funds from LSC.
Nuclear Regulatory Commission.
Order; modification.
The U.S. Nuclear Regulatory Commission (NRC) has issued a general license to the Wolf Creek Nuclear
This Order became effective on July 22, 2020.
Please refer to Docket ID NRC-2020-0172 or NRC Docket No. 72-0079 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:
•
•
Tomeka Terry, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Rockville, MD 20852; telephone: 301-415-1488; email:
The text of the Order is attached.
For the Nuclear Regulatory Commission.
Pursuant to § 2.106 of title 10 of the
The NRC has issued a general license to Wolf Creek Nuclear Operating Corporation, (Wolf Creek), authorizing the operation of an ISFSI, in accordance with the Atomic Energy Act of 1954, as amended, and 10 CFR part 72. This Order is being issued to Wolf Creek because WOLF CREEK has identified near-term plans to store spent fuel in an ISFSI under the general license provisions of 10 CFR part 72. The Commission's regulations at 10 CFR 72.212(b)(5), 10 CFR 50.54(p)(1), and 10 CFR 73.55(c)(5) require licensees to maintain safeguards contingency plan procedures to respond to threats of radiological sabotage and to protect the spent fuel against the threat of radiological sabotage, in accordance with 10 CFR part 73, appendix C. Specific physical security requirements are contained in 10 CFR 73.51 or 73.55, as applicable.
Inasmuch as an insider has an opportunity equal to, or greater than, any other person, to commit radiological sabotage, the Commission has determined these measures to be prudent. Comparable Orders have been issued to all licensees that currently store spent fuel or have identified near-term plans to store spent fuel in an ISFSI.
On September 11, 2001, terrorists simultaneously attacked targets in New York, NY, and near Washington, DC, using large commercial aircraft as weapons. In response to the attacks and intelligence information subsequently obtained, the Commission issued a number of Safeguards and Threat Advisories to its licensees to strengthen licensees' capabilities and readiness to respond to a potential attack on a nuclear facility. On October 16, 2002, the Commission issued Orders to the licensees of operating ISFSIs, to place the actions taken in response to the Advisories into the established regulatory framework and to implement additional security enhancements that emerged from NRC's ongoing comprehensive review. The Commission has also communicated with other Federal, State, and local government agencies and industry representatives to discuss and evaluate the current threat environment in order to assess the adequacy of security measures at licensed facilities. In addition, the Commission has conducted a comprehensive review of its safeguards and security programs and requirements.
As a result of its consideration of current safeguards and security requirements, as well as a review of information provided by the intelligence community, the Commission has determined that certain additional security measures (ASMs) are required to address the current threat environment, in a consistent manner throughout the nuclear ISFSI community. Therefore, the Commission is imposing requirements, as set forth in Attachments 1 and 2 of this Order, on all licensees of these facilities. These requirements, which supplement existing regulatory requirements, will provide the Commission with reasonable assurance that the public health and safety, and the environment, continue to be adequately protected, and that the common defense and security continue to be adequately protected, in the current threat environment. These requirements will remain in effect until the Commission determines otherwise.
The Commission recognizes that licensees may have already initiated many of the measures set forth in Attachments 1 and 2 to this Order, in response to previously issued Advisories, or on their own. It also recognizes that some measures may not be possible or necessary at some sites, or may need to be tailored to accommodate the specific circumstances existing at Wolf Creek's facility, to achieve the intended objectives and avoid any unforeseen effect on the safe storage of spent fuel.
Although the ASMs implemented by licensees in response to the Safeguards and Threat Advisories have been sufficient to promote the common defense and security and to provide
To provide assurance that Wolf Creek is implementing prudent measures to achieve a consistent level of protection to address the current threat environment, Wolf Creek's general license issued pursuant to 10 CFR 72.210 shall be modified to include the requirements identified in Attachments 1 and 2 to this Order. In addition, pursuant to 10 CFR 2.202, I find that, in light of the common defense and security circumstances described above, the public health, safety, and interest require that this Order be effective immediately.
Accordingly, pursuant to Sections 53, 103, 104, 147, 149, 161b, 161i, 161o, 182, and 186 of the Atomic Energy Act of 1954, as amended, and the NRC's regulations in 10 CFR 2.202 and 10 CFR parts 50, 72, and 73,
A. Wolf Creek shall comply with the requirements described in Attachments 1 and 2 to this Order, except to the extent that a more stringent requirement is set forth in the Wolf Creek Generating Station's physical security plan. Wolf Creek shall demonstrate its ability to comply with the requirements in Attachments 1 and 2 to the Order no later than 365 days from the date of this Order or 90 days before the first day that spent fuel is initially placed in the ISFSI, whichever is earlier. Wolf Creek must implement these requirements before initially placing spent fuel in the ISFSI. Additionally, Wolf Creek must receive written verification from the NRC (Office of Nuclear Material Safety and Safeguards) that it has adequately demonstrated compliance with these requirements before initially placing spent fuel in the ISFSI.
B. 1. Wolf Creek shall, within twenty (20) days of the date of this Order, notify the Commission: (1) If it is unable to comply with any of the requirements described in Attachments 1 and 2; (2) if compliance with any of the requirements is unnecessary, in its specific circumstances; or (3) if implementation of any of the requirements would cause Wolf Creek to be in violation of the provisions of any Commission regulation or the facility license. The notification shall provide Wolf Creek's justification for seeking relief from, or variation of, any specific requirement.
2. If Wolf Creek considers that implementation of any of the requirements described in Attachments 1 and 2 to this Order would adversely impact the safe storage of spent fuel, Wolf Creek must notify the Commission, within twenty (20) days of this Order, of the adverse safety impact, the basis for its determination that the requirement has an adverse safety impact, and either a proposal for achieving the same objectives specified in Attachments 1 and 2 requirements in question, or a schedule for modifying the facility, to address the adverse safety condition. If neither approach is appropriate, Wolf Creek must supplement its response to Condition B.1 of this Order to identify the condition as a requirement with which it cannot comply, with attendant justifications, as required under Condition B.1.
C. 1. Wolf Creek shall, within twenty (20) days of this Order, submit to the Commission a schedule for achieving compliance with each requirement described in Attachments 1 and 2.
2. Wolf Creek shall report to the Commission when it has achieved full compliance with the requirements described in Attachments 1 and 2.
D. All measures implemented or actions taken in response to this Order shall be maintained until the Commission determines otherwise.
Wolf Creek's response to Conditions B.1, B.2, C.1, and C.2, above, shall be submitted in accordance with 10 CFR 72.4. In addition, submittals and documents produced by Wolf Creek as a result of this Order, that contain Safeguards Information as defined by 10 CFR 73.22, shall be properly marked and handled, in accordance with 10 CFR 73.21 and 73.22.
The Director, Office of Nuclear Material Safety and Safeguards, may, in writing, relax or rescind any of the above conditions, for good cause.
In accordance with 10 CFR 2.202, Wolf Creek must, and any other person adversely affected by this Order may, submit an answer to this Order within 20 days of its publication in the
The answer may consent to this Order. If the answer includes a request for a hearing, it shall, under oath or affirmation, specifically set forth the matters of fact and law on which Wolf Creek relies and the reasons as to why the Order should not have been issued. If a person other than Wolf Creek requests a hearing, that person shall set forth with particularity the manner in which his/her interest is adversely affected by this Order and shall address the criteria set forth in 10 CFR 2.309(d) and (f).
All documents filed in NRC adjudicatory proceedings, including a request for hearing and petition for leave to intervene (petition), any motion or other document filed in the proceeding prior to the submission of a request for hearing or petition to intervene, and documents filed by interested governmental entities participating under 10 CFR 2.315(c), must be filed in accordance with the NRC E-filing rule (72 FR 49139, August 28, 2007, as amended at 77 FR 46562; August 3, 2012). The E-filing process requires participants to submit and serve all adjudicatory documents electronically, or in some cases to mail copies on electronic storage media. Detailed guidance on making electronic submissions may be found in the Guidance for Electronic Submissions to the NRC and on the NRC website at
To comply with the procedural requirements of E-Filing, at least ten 10 days prior to the filing deadline, the participant should contact the Office of the Secretary by email at
Information about applying for a digital ID certificate is available on NRC's public website at
A person filing electronically using the agency's adjudicatory E-Filing system may seek assistance by contacting the NRC Electronic Filing Help Desk through the “Contact Us” link located on the NRC website at
Participants who believe that they have a good cause for not submitting documents electronically must file an exemption request, in accordance with 10 CFR 2.302(g), with their initial paper filing requesting authorization to continue to submit documents in paper format. Such filings must be submitted by: (1) First class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemaking and Adjudications Staff; or (2) courier, express mail, or expedited delivery service to the Office of the Secretary of the Commission, Sixteenth Floor, One White Flint North, 11555 Rockville Pike, Rockville, Maryland, 20852, Attention: Rulemaking and Adjudications Staff. Participants filing a document in this manner are responsible for serving the document on all other participants. Filing is considered complete by first-class mail as of the time of deposit in the mail, or by courier, express mail, or expedited delivery service upon depositing the document with the provider of the service. A presiding officer, having granted an exemption request from using E-Filing, may require a participant or party to use E-Filing if the presiding officer subsequently determines that the reason for granting the exemption from use of E-Filing no longer exists.
Documents submitted in adjudicatory proceedings will appear in NRC's electronic hearing docket which is available to the public at
If a hearing is requested by Wolf Creek or a person whose interest is adversely affected, the Commission will issue an Order designating the time and place of any hearing. If a hearing is held, the issue to be considered at such hearing shall be whether this Order should be sustained.
Pursuant to 10 CFR 2.202(c)(2)(i), Wolf Creek may, in addition to requesting a hearing, at the time the answer is filed or sooner, move the presiding officer to set aside the immediate effectiveness of the Order on the grounds that the Order, including the need for immediate effectiveness, is not based on adequate evidence, but on mere suspicion, unfounded allegations, or error.
In the absence of any request for hearing, or written approval of an extension of time in which to request a hearing, the provisions as specified in Section III shall be final twenty (20) days from the date this Order is published in the
Dated: July 22, 2020.
For the Nuclear Regulatory Commission.
Attachment 1—Additional Security Measures (ASMs) for Physical Protection of Dry Independent Spent Fuel Storage Installations (ISFSIs) contains Safeguards Information and is not included in this
Attachment 2—Additional Security Measures for Access Authorization and Fingerprinting at Independent Spent Fuel Storage Installations, dated July 2, 2020.
1. These additional security measures (ASMs) are established to delineate an independent spent fuel storage installation (ISFSI) licensee's responsibility to enhance security measures related to authorization for unescorted access to the protected area of an ISFSI in response to the current threat environment.
2. Licensees whose ISFSI is collocated with a power reactor may choose to comply with the U.S. Nuclear Regulatory Commission (NRC)-approved reactor access authorization program for the associated reactor as an alternative means to satisfy the provisions of sections B through G below. Otherwise, licensees shall comply with the access authorization and fingerprinting requirements of section B through G of these ASMs.
3. Licensees shall clearly distinguish in their 20-day response which method they intend to use in order to comply with these ASMs.
1. The licensee shall develop, implement and maintain a program, or enhance its existing program, designed to ensure that persons granted unescorted access to the protected area of an ISFSI are trustworthy and reliable and do not constitute an unreasonable risk to the public health and safety for the common defense and security, including a potential to commit radiological sabotage.
a. To establish trustworthiness and reliability, the licensee shall develop, implement, and maintain procedures for conducting and completing background investigations, prior to granting access. The scope of background investigations must address at least the past three years and, as a minimum, must include:
i. Fingerprinting and a Federal Bureau of Investigation (FBI) identification and criminal history records check (CHRC). Where an applicant for unescorted access has been previously fingerprinted with a favorably completed CHRC, (such as a CHRC pursuant to compliance with orders for access to safeguards information) the licensee may accept the results of that CHRC, and need not submit another set of fingerprints, provided the CHRC was completed not more than three years from the date of the application for unescorted access.
ii. Verification of employment with each previous employer for the most recent year from the date of application.
iii. Verification of employment with an employer of the longest duration during any calendar month for the remaining next most recent two years.
iv. A full credit history review.
v. An interview with not less than two character references, developed by the investigator.
vi. A review of official identification (
vii. Licensees shall confirm eligibility for employment through the regulations of the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, and shall verify and ensure, to the extent possible, the accuracy of the provided social security number and alien registration number, as applicable.
b. The procedures developed or enhanced shall include measures for confirming the term, duration, and character of military service for the past three years, and/or academic enrollment and attendance in lieu of employment, for the past five years.
c. Licensees need not conduct an independent investigation for individuals employed at a facility who possess active “Q” or “L” clearances or possess another active U.S. Government-granted security clearance (
d. A review of the applicant's criminal history, obtained from local criminal justice resources, may be included in addition to the FBI CHRC, and is encouraged if the results of the FBI CHRC, employment check, or credit check disclose derogatory information. The scope of the applicant's local criminal history check shall cover all residences of record for the past three years from the date of the application for unescorted access.
2. The licensee shall use any information obtained as part of a CHRC solely for the purpose of determining an individual's suitability for unescorted access to the protected area of an ISFSI.
3. The licensee shall document the basis for its determination for granting or denying access to the protected area of an ISFSI.
4. The licensee shall develop, implement, and maintain procedures for updating background investigations for persons who are applying for reinstatement of unescorted access. Licensees need not conduct an independent reinvestigation for individuals who possess active “Q” or “L” clearances or possess another active U.S. Government granted security clearance,
5. The licensee shall develop, implement, and maintain procedures for reinvestigations of persons granted unescorted access, at intervals not to exceed five years. Licensees need not conduct an independent reinvestigation for individuals employed at a facility who possess active “Q” or “L” clearances or possess another active U.S. Government granted security clearance,
6. The licensee shall develop, implement, and maintain procedures designed to ensure that persons who have been denied unescorted access authorization to the facility are not allowed access to the facility, even under escort.
7. The licensee shall develop, implement, and maintain an audit program for licensee and contractor/vendor access authorization programs that evaluate all program elements and include a person knowledgeable and practiced in access authorization program performance objectives to assist in the overall assessment of the site's program effectiveness.
1. In a letter to the NRC, the licensee must nominate an individual who will review the results of the FBI CHRCs to make trustworthiness and reliability determinations for unescorted access to an ISFSI. This individual, referred to as the “reviewing official,” must be someone who requires unescorted access to the ISFSI. The NRC will review the CHRC of any individual nominated to perform the reviewing official function. Based on the results of the CHRC, the NRC staff will determine whether this individual may have access. If the NRC determines that the nominee may not be granted such access, that individual will be prohibited from obtaining access.
2. No person may have access to Safeguards Information (SGI) or unescorted access to any facility subject to NRC regulation, if the NRC has determined, in accordance with its administrative review process based on fingerprinting and an FBI identification and CHRC, that the person may not have access to SGI or unescorted access to any facility subject to NRC regulation.
3. All fingerprints obtained by the licensee under this Order, must be submitted to the Commission for transmission to the FBI.
4. The licensee shall notify each affected individual that the fingerprints will be used to conduct a review of his/her criminal history record and inform
5. Fingerprints need not be taken if the employed individual (
1. A licensee shall not base a final determination to deny an individual unescorted access to the protected area of an ISFSI solely on the basis of information received from the FBI involving: an arrest more than one (1) year old for which there is no information of the disposition of the case, or an arrest that resulted in dismissal of the charge, or an acquittal.
2. A licensee shall not use information received from a CHRC obtained pursuant to this Order in a manner that would infringe upon the rights of any individual under the First Amendment to the Constitution of the United States, nor shall the licensee use the information in any way that would discriminate among individuals on the basis of race, religion, national origin, sex, or age.
1. For the purpose of complying with this Order, licensees shall, using an appropriate method listed in 10 CFR 73.4, submit to the NRC's Division of Physical and Cyber Security Policy, Mail Stop T-08B20M, one completed, legible standard fingerprint card (Form FD-258, ORIMDNRCOOOZ) or, where practicable, other fingerprint records for each individual seeking unescorted access to an ISFSI, to the Director of the Division of Physical and Cyber Security Policy, marked for the attention of the Criminal History Check Section. Copies of these forms may be obtained by writing the Office of Information Services, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by email to
2. The NRC will review submitted fingerprint cards for completeness. Any Form FD-258 fingerprint record containing omissions or evident errors will be returned to the licensee for corrections. The fee for processing fingerprint checks includes one re-submission if the initial submission is returned by the FBI because the fingerprint impressions cannot be classified. The one free re-submission must have the FBI Transaction Control Number reflected on the re-submission. If additional submissions are necessary, they will be treated as initial submittals and will require a second payment of the processing fee.
3. Fees for processing fingerprint checks are due upon application. The licensee shall submit payment of the processing fees electronically. To be able to submit secure electronic payments, licensees will need to establish an account with
4. The Commission will forward to the submitting licensee all data received from the FBI as a result of the licensee's application(s) for CHRCs, including the FBI fingerprint record.
1. Prior to any final adverse determination, the licensee shall make available to the individual the contents of any criminal history records obtained from the FBI for the purpose of assuring correct and complete information. Written confirmation by the individual of receipt of this notification must be maintained by the licensee for a period of one (1) year from the date of notification.
2. If, after reviewing the record, an individual believes that it is incorrect or incomplete in any respect and wishes to change, correct, or update the alleged deficiency, or to explain any matter in the record, the individual may initiate challenge procedures. These procedures include either direct application by the individual challenging the record to the agency (
1. The licensee shall develop, implement, and maintain a system for personnel information management with appropriate procedures for the protection of personal, confidential information. This system shall be designed to prohibit unauthorized access to sensitive information and to
2. Each licensee who obtains a criminal history record on an individual pursuant to this Order shall establish and maintain a system of files and procedures, for protecting the record and the personal information from unauthorized disclosure.
3. The licensee may not disclose the record or personal information collected and maintained to persons other than the subject individual, his/her representative, or to those who have a need to access the information in performing assigned duties in the process of determining suitability for unescorted access to the protected area of an ISFSI. No individual authorized to have access to the information may re-disseminate the information to any other individual who does not have the appropriate need to know.
4. The personal information obtained on an individual from a CHRC may be transferred to another licensee if the gaining licensee receives the individual's written request to re-disseminate the information contained in his/her file, and the gaining licensee verifies information such as the individual's name, date of birth, social security number, sex, and other applicable physical characteristics for identification purposes.
5. The licensee shall make criminal history records, obtained under this section, available for examination by an authorized representative of the NRC to determine compliance with the regulations and laws.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
The Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to negotiated service agreement(s). The request(s) may propose the addition or removal of a negotiated service agreement from the market dominant or the competitive product list, or the modification of an existing product currently appearing on the market dominant or the competitive product list.
Section II identifies the docket number(s) associated with each Postal Service request, the title of each Postal Service request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 (Public Representative). Section II also establishes comment deadline(s) pertaining to each request.
The public portions of the Postal Service's request(s) can be accessed via the Commission's website (
The Commission invites comments on whether the Postal Service's request(s) in the captioned docket(s) are consistent with the policies of title 39. For request(s) that the Postal Service states concern market dominant product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3622, 39 U.S.C. 3642, 39 CFR part 3030, and 39 CFR part 3040, subpart B. For request(s) that the Postal Service states concern competitive product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3035, and 39 CFR part 3040, subpart B. Comment deadline(s) for each request appear in section II.
1.
This Notice will be published in the
Thursday, August 6, 2020, at 11:00 a.m.; and Friday, August 7, 2020, at 9:00 a.m.
Washington, DC, at U.S. Postal Service Headquarters, 475 L'Enfant Plaza SW, in the Benjamin Franklin Room.
Thursday, August 6, 2020, at 11:00 a.m.—Closed; Friday, August 7, 2020, at 9:00 a.m.—Open.
1. Strategic Issues.
2. Financial and Operational Matters.
3. Compensation and Personnel Matters.
4. Administrative Items.
1. Remarks of the Chairman of the Board of Governors.
2. Remarks of the Postmaster General and CEO.
3. Approval of Minutes of Previous Meetings.
4. Committee Reports.
5. Quarterly Financial Report.
6. Quarterly Service Performance Report.
7. Approval of Tentative Agenda for November Meetings.
Katherine Sigler, acting Secretary of the Board, U.S. Postal Service, 475 L'Enfant
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a Priority Mail Express International, Priority Mail International, First-Class Package International Service & Commercial ePacket contract to the list of Negotiated Service Agreements in the Competitive Product List in the Mail Classification Schedule.
Christopher C. Meyerson, (202) 268-7820.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on July 23, 2020, it filed with the Postal Regulatory Commission a
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 Rule 6.7. The text of the proposed rule change is provided below.
Rules of Cboe Exchange, Inc.
(a)-(c) No change.
(d)
(1) The notice must indicate (A) the Exchange-listed options positions to be transferred, (B) the nature of the transaction, (C) the enumerated provision(s) under paragraph (a) pursuant to which the positions are being transferred, (D) the name of the counterparty(ies), (E) the anticipated transfer date, (F) the method for determining the transfer price under paragraph [(d) below]
(g)
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.
Rule 6.7 describes exceptions to the prohibition against off-floor transactions set forth in Rule 5.12, subject to certain conditions. The exception in Rule 6.7(a)(2) provides that off-floor transfers of positions are permissible if from one account to another account where no change in ownership is involved (
The proposed rule change excepts off-floor position transfers effected pursuant to Rule 6.7(a)(2) from the prior written notice requirement in paragraph (d) and from repeated, recurring use restriction in paragraph (g). Off-floor position transfers pursuant to Rule 6.7(a)(2) do not involve a change in ownership. In other words, such transfers may only occur between the same individual or legal entity. These types of transfers are merely transfers of positions from one account to another, both of which accounts are attributable to the same individual or legal entity, and thus the transferred option positions will continue to be attributable to the same Person. A market participant effecting an off-floor position transfer pursuant to Rule 6.7(a)(2) is analogous to an individual transferring funds from a checking account to a savings account, or from an account at one bank to an account at another bank—the money still belongs to the same person, who is just holding it in a different account for personal financial reasons.
Because there is no change in ownership of positions transferred pursuant to Rule 6.7(a)(2), the Exchange believes it is appropriate to permit them to occur as routinely and repeatedly as a market participant would like. These transfers will continue to be subject to the prohibition on netting set forth in Rule 6.7(b), and thus may not result in the closing of any positions. While the off-floor position transfers permitted by Rule 6.7 were intended to accommodate non-routine and non-recurring transfers, the Exchange believes permitting routine, recurring off-floor position transfers that do not result in a change in ownership or reduction in open interest is consistent with the purpose of not being used to circumvent the normal auction purpose. Additionally, given that these transfers may occur on a regular basis in accordance with a market participants' business needs and procedures, the Exchange believes prior written notice would be onerous and would not serve any purpose given the lack of change in ownership and in open interest. The Exchange believes this will provide market participants with additional flexibility to structure their option position accounts as they believe is appropriate and move their positions between accounts as they deem necessary and appropriate for their business and trading needs, including for risk management purposes.
The proposed rule change also corrects an erroneous cross-reference in Rule 6.7(d)(1), as the method for determining the transfer price is in paragraph (c) rather than paragraph (d) of Rule 6.7.
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 and, in particular, the requirements of Section 6(b) of the Act.
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, and, in general, to protect investors and the public interest because it will provide market participants with a more efficient process to transfer open positions between their own accounts in accordance with their own business and trading needs, including to respond to then-current market conditions. Because these transfers would not result in a change in ownership or a reduction in open interest, the Exchange believes the proposed rule change remains consistent with the purpose of Rule 6.7, which was to prohibit use of the off-floor transfer procedure in circumvention of the normal auction process, as the normal auction process involves the opening or closing of positions through a transaction among multiple market participants. Market participants may maintain different accounts for a variety of reasons, such as the structure of their businesses, the manner in which they trade, their risk management procedures, and for capital purposes. Given that these transfers may occur on a regular basis in accordance with a market participants' business needs and procedures, the Exchange believes prior written notice would be onerous and would not serve any purpose given the lack of change in ownership and in open interest. Therefore, the proposed rule change will benefit investors by permitting market participants to manage the open positions in their accounts in a manner consistent with their businesses.
The Exchange recognizes the numerous benefits of executing options transactions on an exchange, including price transparency, potential price improvement, and a clearing guarantee. However, the Exchange believes it is appropriate to permit position transfers among accounts of the same individual or legal entity where there is no impact on open interest to occur off the exchange, as these benefits are inapplicable to those transfers. These transfers have a narrow scope and are intended to permit market participants to achieve their own business needs. These transfers are not intended to be a competitive trading tool. There is no need for price discovery or improvement, as the transfer merely moves positions to different accounts for the same Person and does not open or close any positions. These transfers will result in no change in ownership. The transactions that resulted in the open positions to be transferred pursuant to Rule 6.7(a)(2) were already guaranteed by a clearing member of The Options Clearing Corporation (“OCC”), and the positions may not be closed pursuant to the transfer and will continue to be subject to OCC rules, as they will continue to be held in an account with an OCC clearing member.
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. The proposed rule change is not intended to address competitive issues. 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 rule change will apply to all market participants in the same manner. All market participants will be able to effect off-floor position transfers pursuant to Rule 6.7(a)(2) on a recurring or routine basis without providing the Exchange with notice of such transfers. The Exchange does not
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
At any time within 60 days of the filing of the 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. If the Commission takes such action, the Commission will institute proceedings to determine whether the proposed rule change should be approved or 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.
Pursuant to Section 19(b)(1)
The Exchange proposes to amend Rule 7.37 to update the Exchange's source of data feeds from MEMX LLC (“MEMX”) for purposes of order handling, order execution, order routing, and regulatory compliance. The proposed rule change is available on the Exchange's website at
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 Exchange proposes to update and amend the use of data feeds table in Rule 7.37, which sets forth on a market-by-market basis the specific securities information processor (“SIP”) and proprietary data feeds that the Exchange utilizes for the handling, execution, and routing of orders, and for performing the regulatory compliance checks related to each of those functions. Specifically, the Exchange proposes to amend the table in Rule 7.37(d) to specify that, with respect to MEMX, the Exchange will receive the SIP feed as its primary source of data for order handling, order execution, order routing, and regulatory compliance. The Exchange will not have a secondary source for data from MEMX.
The Exchange proposes that this proposed rule change would be operative on the day that MEMX launches operations as an equities exchange, which is currently expected on September 4, 2020.
The proposed rule change is consistent with Section 6(b) of the Act,
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. The proposed change is not designed to address any competitive issue, but rather would provide the public and market participants with up-to-date information about the data feeds the Exchange will use for the handling, execution, and routing of orders, as well as for regulatory compliance.
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
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. If the Commission takes such action, the Commission shall institute proceedings under Section 19(b)(2)(B)
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.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
FINRA is proposing to amend Rule 2360 (Options) to increase the position and exercise limits for conventional options on certain exchange-traded funds (“ETFs”).
Below is the text of the proposed rule change. Proposed new language is in italics; proposed deletions are in brackets.
(a) No Change.
(1) through (2) No Change.
(A) Stock Options—
(i) through (ii) No Change.
(iii) Conventional Equity Options.
a. For purposes of this paragraph (b), standardized equity option contracts of the put class and call class on the same side of the market overlying the same security shall not be aggregated with conventional equity option contracts or FLEX Equity Option contracts overlying the same security on the same side of the market. Conventional equity option contracts of the put class and call class on the same side of the market overlying the same security shall be subject to a position limit of:
1. through 5. No Change.
6. for selected conventional options on exchange-traded funds (“ETF”), the position limits are listed in the chart below:
b. No Change.
(B) through (D) No Change.
(4) through (24) No Change.
(c) No Change.
.01 through .03 No Change.
In its filing with the Commission, FINRA 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. FINRA has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
FINRA Rule 2360(b)(3)(A) imposes a position limit on the number of equity options contracts in each class on the same side of the market that can be held or written by a member, a person associated with a member, or a customer or a group of customers acting in concert. Position limits are intended to prevent the establishment of options positions that can be used to manipulate or disrupt the underlying market or might create incentives to manipulate or disrupt the underlying market so as to benefit the options position. In addition, position limits serve to reduce the potential for disruption of the options market itself, especially in illiquid options classes.
Rule 2360(b)(3)(A)(i) does not independently establish a position limit for standardized equity options. Rather, the position limit established by the rules of an options exchange for a particular equity option is the applicable position limit for purposes of Rule 2360.
The proposed rule change would amend the table provided in Rule 2360(b)(3)(A)(iii)a.6. as follows:
• The position limits for options on SPY would be increased from 1,800,000 contracts to 3,600,000 contracts;
• The position limit for options on EFA would be increased from 500,000 contracts to 1,000,000 contracts; and
• The position limit for options on FXI would be increased from 500,000 contracts to 1,000,000 contracts.
In addition, the proposed rule change would add to the table provided in Rule 2360(b)(3)(A)(iii)a.6. as follows, with the effect of each ETF being increased from the current position limit of 250,000 contracts:
• The position limit for options on HYG would be increased to 500,000 contracts; and
• The position limit for options on XLF would be increased to 500,000 contracts.
FINRA notes the proposed position limits on EFA and FXI are consistent with existing position limits for options on the iShares Russell 2000 ETF (“IWM”) and the iShares MSCI Emerging Markets ETF (“EEM”), and the proposed limits for options on XLF and HYG are consistent with current position limits for options on the iShares MSCI Brazil Capped ETF (“EWZ”), iShares 20+Year Treasury Bond Fund ETF (“TLT”), and iShares MSCI Japan ETF (“EWJ”).
In support of the proposed rule change, as noted by Cboe, position limits are determined by the option exchange's rules.
In supporting the proposed position limit increases, FINRA considered both liquidity of the Underlying ETFs and the component securities of the Underlying ETFs, as well as the availability of economically equivalent products to the overlying options and their respective position limits. For instance, some of the Underlying ETFs are based upon broad-based indices that underlie cash-settled options, and therefore the options on the Underlying ETFs are economically equivalent to the options on those indices, which have no position limits. Other Underlying ETFs are based upon broad-based indices that underlie cash-settled options with position limits reflecting notional values that are larger than current position limits for options on the ETF analogues. For indexes that are tracked by an Underlying ETF but on which there are no options listed, FINRA believes, based on the liquidity, depth and breadth of the underlying market of the components of the indexes, that each of the indexes referenced by the applicable ETFs would be considered a broad-based index under options exchange rules. Additionally, if in some cases certain position limits are appropriate for the options overlying comparable indexes or basket of securities that the Underlying ETFs track then those economically equivalent position limits should be appropriate for the options overlying the Underlying ETFs.
FINRA notes that Cboe has compiled the following trading statistics regarding shares of and exchange-traded options on the Underlying ETFs, as well as the component securities or components underlying the referenced index (as applicable):
Further, Cboe has collected the same trading statistics, where applicable, as above regarding a sample of other ETFs, as well as the current position limits for options on such ETFs, to draw comparisons in support of proposed position limit increases for options on a number of the Underlying ETFs:
FINRA agrees with Cboe that, overall, the liquidity in the shares of the Underlying ETFs and in the component securities of the Underlying ETFs, and in their overlying options, as well as the large market capitalizations and structure of each of the Underlying ETFs, support the proposal to increase the position limits for each option class. Given the robust liquidity and capitalization in the Underlying ETFs and in the component securities of the Underlying ETFs, FINRA believes the market capitalization of the underlying component securities of the applicable ETF is large enough to adequately absorb potential price movements that may be caused by large trades. The following analyses for the Underlying ETFs, which FINRA agrees with in support of the proposed rule change, as well as the statistics presented in support thereof, were presented by Cboe in their initial filing, which was approved by the Commission.
Specifically, Cboe notes that SPY tracks the performance of the S&P 500® Index, which is an index of diversified large cap U.S. companies.
EFA tracks the performance of MSCI EAFE Index, which is composed of over 900 large and mid-cap securities across 21 developed markets, including countries in Europe, Australia and the Far East, excluding the U.S. and Canada.
FXI tracks the performance of the FTSE China 50 Index, which is composed of the 50 largest Chinese stocks.
XLF invests in a wide array of financial service firms with diversified business lines ranging from investment management to commercial and investment banking. It generally corresponds to the price and yield performance of publicly traded equity securities of companies in the SPDR Financial Select Sector Index.
Finally, HYG attempts to track the investment results of Markit iBoxx USD Liquid High Yield Index, which is composed of U.S. dollar-denominated, high-yield corporate bonds and is one of the most widely used high-yield bond ETFs.
FINRA believes that increasing the position limits for conventional options subject to the proposed rule change would lead to a more liquid and competitive market for these options, which will benefit customers interested in these products.
FINRA believes that the creation and redemption process for ETFs will lessen the potential for manipulative activity with options on the Underlying ETFs. When an ETF provider wants to create more shares, it looks to an Authorized Participant (generally a market maker or other large financial institution) to acquire the securities the ETF is to hold. For instance, when an ETF is designed to track the performance of an index, the Authorized Participant can purchase all the constituent securities in the exact same weight as the index, then deliver those shares to the ETF provider. In exchange, the ETF provider gives the Authorized Participant a block of equally valued ETF shares, on a one-for-one fair value basis. The price is based on the net asset value, not the market value at which the ETF is trading. The creation of new ETF units can be conducted during an entire trading day, and is not subject to position limits. This process works in reverse where the ETF provider seeks to decrease the number of shares that are available to trade. The creation and redemption process, therefore, creates a direct link to the underlying components of the ETF, and serves to mitigate potential price impact of the ETF shares that might otherwise result from increased position limits for the ETF options.
FINRA understands that the ETF creation and redemption process seeks to keep an ETF's share price trading in line with the ETF's underlying net asset value. Because an ETF trades like a stock, its share price will fluctuate during the trading day, due to simple supply and demand. If demand to buy an ETF is high, for instance, the ETF's share price might rise above the value of its underlying securities. When this happens, the Authorized Participant believes the ETF may now be overpriced, so it may buy shares of the component securities and then sell ETF shares in the open market (
FINRA believes that the increased position limits provisions are appropriate in light of the existing surveillance procedures and reporting requirements at FINRA,
In addition, large stock holdings must be disclosed to the Commission by way of Schedules 13D or 13G.
Finally, FINRA believes that the current financial requirements imposed by FINRA and by the Commission adequately address financial responsibility concerns that a member or its customer will maintain an inordinately large unhedged position in any option with a higher position limit. Current margin and risk-based haircut methodologies serve to limit the size of positions maintained by any one account by increasing the margin or capital that a member must maintain for a large position. Under Rule 4210(f)(8)(A), FINRA also may impose a higher margin requirement upon a member when FINRA determines a higher requirement is warranted. In addition, the Commission's net capital rule
FINRA has filed the proposed rule change for immediate effectiveness and has requested that the SEC waive the requirement that the proposed rule change not become operative for 30 days after the date of the filing, so FINRA can implement the proposed rule change immediately.
FINRA believes that the proposed rule change is consistent with the provisions of Section 15A(b)(6) of the Act,
In addition, FINRA believes that the structure of the Underlying ETFs, the considerable market capitalization of the funds, underlying component securities, and the liquidity of the markets for the applicable options and underlying component securities will mitigate concerns regarding potential manipulation of the products or disruption of the underlying markets upon increasing the relevant position limits. As a general principle, increases in market capitalizations, active trading volume, and deep liquidity of securities tend to deter manipulation or disruption. This general principle applies to the recently observed increased levels of market capitalization, trading volume, and liquidity in shares of the Underlying ETFs, and the components of the Underlying ETFs (as described above). FINRA does not believe that the options markets or underlying markets would become susceptible to manipulation or disruption as a result of the proposed position limit increases.
Increased position limits for select actively traded options, such as those proposed herein, are not novel and have been previously approved by the Commission. For example, a position limit of 1,800,000 contracts on options on SPY has been established.
FINRA's existing surveillance and reporting safeguards are designed to deter and detect possible manipulative behavior that might arise from changing position and exercise limits.
FINRA does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
FINRA has undertaken an economic impact assessment, as set forth below, to analyze the potential economic impacts, including anticipated costs, benefits, and distributional and competitive effects transfers of wealth, relative to the current baseline, and the alternatives FINRA considered in assessing how to best meet its regulatory objectives.
FINRA is proposing to amend Rule 2360 to harmonize FINRA's position limits for conventional options with the position limit for standardized options.
Per FINRA Rule 2360(b)(3)(A)(iii) conventional equity options are subject to a basic position limit of 25,000 contracts or higher for conventional option contracts on securities that underlie exchange-traded options qualifying for a higher tier as determined by option exchange rules. The existing position limits for conventional options on ETFs are: 1,800,000 contracts for SPY, 500,000 contracts for EFA or FXI and 250,000 contracts for HYG or XLF. Cboe has recently increased position limit options on these ETFs.
As noted above, the proposed rule change would amend Rule 2360 to harmonize FINRA's position limits for conventional options with the position limits for standardized options.
For investors that trade conventional equity options, there is likely to be a natural size for an executed order that minimizes fixed and variable transaction costs, including but not limited to, the bid-ask spread, price impact, and transaction fees. If the existing position limits for conventional equity options on select ETFs constrains the order size such that fixed and variable transaction costs are higher than optimal, then investors may benefit if the new position limit is no less than the natural size. In such an event, the cost to hedge an ETF would decline, thereby making it less costly to manage downside risk.
In addition, if the existing position limits serve as a constraint, then an increase in the position limits for conventional options on select ETFs could permit investors to more easily find a counterparty. If the number of counterparties increases, then the cost of hedging should decline as the half-spread narrows, thereby making it less expensive to manage downside risk.
The extent of the constraint imposed by the current limit on conventional options is related to the ability of an investor to achieve similar economic exposure through other means. If there are other securities, such as an option on a closely related index, that exist and provide similar economic exposure less expensively, then the value of lessening the position limits on conventional options on ETFs is lower.
Members may rely on information and data feeds from the Options Clearing Corporation to assist in their monitoring position limits. Because position limits on the standardized and conventional side have traditionally been consistent, members have relied on this feed for both standardized and conventional options. If the position limits between standardized and conventional options are conformed, then the cost from monitoring position limits should decline for member firms. Having the same position limits on standardized and conventional options, reduces the potential for excess loss that may be incurred when different limits are applied to the standardized versus conventional options on the same ETF. The economic loss may arise from building and maintaining trading and compliance systems to support the different regimes. Furthermore, the harmonization of position limits on standardized and conventional options eliminates the potential risk and cost arising from regulatory arbitrage.
The proposed rule change may impose limited operational cost on member firms that trade conventional options on ETFs, as these same firms would need to revise position limits that are used in trading systems. However, the proposed rule change should not impose additional costs, because it is difficult to disrupt or manipulate the underlying market, create an incentive to disrupt or manipulate the underlying market for the purpose of profiting from the options position, or disrupt or manipulate the options market for conventional options on ETFs affected by this proposed rule. ETFs that underlie options subject to the proposed rule change are highly liquid and are based on a broad set of highly liquid securities, which makes the market difficult to manipulate or disrupt. In fact, options on certain broad-based security indexes have no position limits. Furthermore, the creation and redemption process for these ETFs reduces the potential for disruptive or manipulative activity. New ETF units may be created at any time during the trading day and are not subject to position limits. Consequently, there is a direct link between the underlying components of the ETF and the ETF, which keeps the ETF's share prices trading in line with the ETF's underlying net asset value.
No further alternatives are under consideration.
Written comments were neither solicited nor received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days after the date of the filing, or such shorter time as the Commission may designate if consistent with the protection of investors and the public interest, it has become effective pursuant to Section 19(b)(3)(A) of the Act
FINRA has asked the Commission to waive the 30-day operative delay so that FINRA may immediately harmonize position limits with those of other self-regulatory organizations to ensure consistent regulation. For this reason, the Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest. Therefore, the Commission hereby waives the operative delay and designates the proposal operative upon filing.
At any time within 60 days of the filing of the 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. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or 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.
Pursuant to Section 19(b)(1)
The Exchange proposes to amend Rule 7.37 to update the Exchange's source of data feeds from MEMX LLC (“MEMX”) for purposes of order handling, order execution, order routing, and regulatory compliance. The proposed rule change is available on the Exchange's website at
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 Exchange proposes to update and amend the use of data feeds table in Rule 7.37, which sets forth on a market-by-market basis the specific securities information processor (“SIP”) and proprietary data feeds that the Exchange utilizes for the handling, execution, and routing of orders, and for performing the regulatory compliance checks related to each of those functions. Specifically, the Exchange proposes to amend the table in Rule 7.37(d) to specify that, with respect to MEMX, the Exchange will receive the SIP feed as its primary source of data for order handling, order execution, order routing, and regulatory compliance. The Exchange will not have a secondary source for data from MEMX.
The Exchange proposes that this proposed rule change would be operative on the day that MEMX launches operations as an equities exchange, which is currently expected on September 4, 2020.
The proposed rule change is consistent with Section 6(b) of the Act,
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. The proposed change is not designed to address any competitive issue, but rather would provide the public and market participants with up-to-date information about the data feeds the Exchange will use for the handling, execution, and routing of orders, as well as for regulatory compliance.
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
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. If the Commission takes such action, the Commission shall institute proceedings under Section 19(b)(2)(B)
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.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend Listing Rule IM-5900-4 to waive the All-Inclusive Annual Listing Fee for any company not listed on a national securities exchange that is listing upon closing of its acquisition of a special purpose acquisition company listed on another national securities exchange.
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.
Nasdaq proposes to amend Listing Rule IM-5900-4 to waive the All-Inclusive Annual Listing Fee for any company not listed on a national securities exchange that is listing upon closing of its acquisition of a special purpose acquisition company (“Acquisition Company”) listed on another national securities exchange.
When an Acquisition Company consummates its business combination, it may choose a new listing venue for its post-business combination existence as an operating company. In most such cases, the Acquisition Company is the legal acquirer in the business combination transaction and thus the company transferring its listing to Nasdaq is the same entity as was listed on the other national securities exchange prior to the acquisition (
However, in fulfilling the requirements for an Acquisition Company to complete an acquisition under applicable exchange rules, occasionally the Acquisition Company is not the legal acquirer in the business combination and, instead, the business combination is structured so that the Acquisition Company is acquired by the operating company. Under the current
To address this disparity, Nasdaq proposes to amend the fee waiver provisions of Listing Rule IM-5900-4. Specifically, the Exchange proposes to extend to any company that is not listed immediately prior to listing its class of primary equity securities upon closing of its acquisition of an Acquisition Company listed on another national securities exchange the benefits similar to those provided by Listing Rule IM-5900-4 that waives for companies transferring their securities from another exchange the requirement to pay the All-Inclusive Annual Listing Fee with respect to that class of primary equity securities or any other securities transferred in conjunction therewith for the remainder of the calendar year in which the transfer occurs. The decision whether to structure a business combination with the Acquisition Company as the legal acquirer rather than the other party does not result in the listing of a substantively different entity. Accordingly, the Exchange believes there is no basis for charging fees purely on the basis of the structure of the business combination chosen by the parties. The Exchange does not expect there to be a significant number of listings in which this proposed fee waiver will be applicable. Consequently, the proposed rule change would not affect the Exchange's commitment of resources to its regulatory oversight of the listing process or its regulatory programs.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
As a preliminary matter, Nasdaq competes for listings with other national securities exchanges and companies can easily choose to list on, or transfer to, those alternative venues. As a result, the fees Nasdaq can charge listed companies are constrained by the fees charged by its competitors and Nasdaq cannot charge prices in a manner that would be unreasonable, inequitable, or unfairly discriminatory.
The Exchange believes that the proposed fee waivers are equitable as it being implemented to avoid an anomalous fee outcome arising from the manner in which an Acquisition Company business combination has been structured.
The Exchange believes that the proposal is not unfairly discriminatory, because the proposed waivers are intended to avoid the impact on a small group of issuers of an anomalous fee outcome arising from the manner in which an Acquisition Company business combination has been structured. Nasdaq also notes that such waiver is not intended to provide these issuers with any benefit that would place them in a more favorable position than other newly-listed companies, including specifically other previously unlisted companies that list upon completion of an acquisition of a company listed on Nasdaq.
Accordingly, the Exchange is proposing to amend its fee structure to reflect the incidental nature of the resulting Acquisition Company business combination and to avoid treating companies undergoing similar business combinations disparately.
By contrast to an Acquisition Company business combination, there are typically more significant limitations on the ability of the parties to a merger between two operating companies to make decisions about which entity will be the acquirer, including, for example, the desire to maintain the acquirer's SEC registration and concerns about how to present the combined entity to the market. As such, it is much more likely that the listing fee implications of how the transaction is structured would be a major consideration for the parties to an Acquisition Company business combination than would be the case in a merger between two operating companies. As the implications of the proposed fee waivers for decisions relating to the transaction structures utilized by unlisted companies listing in connection with the acquisition of an Acquisition Company are typically greater than for other companies listing in conjunction with merger transactions, the proposed waivers are not unfairly discriminatory.
For the foregoing reasons, the Exchange believes that the proposal is consistent with the Act.
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.
The proposed waiver will be available to all similarly situated issuers on the same basis. The Exchange does not believe that the proposed waivers will have any meaningful effect on the competition among issuers listed on the Exchange.
The Exchange operates in a highly competitive market in which issuers can readily choose to list new securities on other exchanges and transfer listings to other exchanges if they deem fee levels at those other venues to be more favorable. Because competitors are free to modify their own fees in response, and because issuers may change their listing venue, the Exchange does not believe its proposed fee change can impose any burden on intermarket competition.
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) 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.
Pursuant to Section 19(b)(1)
The Exchange proposes to amend Rule 7.37-E to update the Exchange's source of data feeds from MEMX LLC (“MEMX”) for purposes of order handling, order execution, order routing, and regulatory compliance. The proposed rule change is available on the Exchange's website at
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 Exchange proposes to update and amend the use of data feeds table in Rule 7.37-E, which sets forth on a market-by-market basis the specific securities information processor (“SIP”) and proprietary data feeds that the Exchange utilizes for the handling, execution, and routing of orders, and for performing the regulatory compliance checks related to each of those functions. Specifically, the Exchange proposes to amend the table in Rule 7.37-E(d) to specify that, with respect to MEMX, the Exchange will receive the SIP feed as its primary source of data for order handling, order execution, order routing, and regulatory compliance. The Exchange will not have a secondary source for data from MEMX.
The Exchange proposes that this proposed rule change would be operative on the day that MEMX launches operations as an equities exchange, which is currently expected on September 4, 2020.
The proposed rule change is consistent with Section 6(b) of the Act,
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. The proposed change is not designed to address any competitive issue, but rather would provide the public and market participants with up-to-date information about the data feeds the Exchange will use for the handling, execution, and routing of orders, as well as for regulatory compliance.
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
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. If the Commission takes such action, the Commission shall institute proceedings under Section 19(b)(2)(B)
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.
The Social Security Administration (SSA) publishes a list of information collection packages requiring clearance by the Office of Management and Budget (OMB) in compliance with Public Law 104-13, the Paperwork Reduction Act of 1995, effective October 1, 1995. This notice includes extensions and revisions of OMB-approved information collections, as well as two new collections.
SSA is soliciting comments on the accuracy of the agency's burden estimate; the need for the information; its practical utility; ways to enhance its quality, utility, and clarity; and ways to minimize burden on respondents, including the use of automated collection techniques or other forms of information technology. Mail, email, or fax your comments and recommendations on the information collection(s) to the OMB Desk Officer and SSA Reports Clearance Officer at the following addresses or fax numbers.
Or you may submit your comments online through
I. The information collections below are pending at SSA. SSA will submit them to OMB within 60 days from the date of this notice. To be sure we consider your comments, we must receive them no later than September 28, 2020. Individuals can obtain copies of the collection instruments by writing to the above email address.
• Reporting Requirements—Each IAR agency agrees to:
(a) Notify SSA of receipt of an authorization for initial claims or cases the agency is appealing;
(b) submit a copy of that authorization either through a manual or electronic process;
(c) inform SSA of the amount of reimbursement;
(d) submit a written request for dispute resolution on a determination;
(e) notify SSA of interim assistance paid (using the SSA-8125 or the SSA-L8125-F6);
(f) inform SSA of any deceased claimants who participate in the IAR program;
(g) review and sign an agreement with SSA.
• Recordkeeping Requirements (h & i)—the IAR agencies agree to retain all notices, agreement, authorizations, and accounting forms for the period defined in the IAR agreement so SSA may verify transactions covered under the agreement.
• Third Party Disclosure Requirements (j)—each participating IAR agency agrees to send written notices from the IAR agency to the recipient regarding payment amounts and appeal rights.
• Periodic Review of Agency Accounting Process (k-m)—the IAR agency makes the IAR accounting records of paid cases available for SSA review and verification. SSA conducts reviews either onsite or through the mail of the authorization forms, notices to the claimant and accounting forms. Upon completion of the review, SSA provides a written report of findings to the IAR agency director.
The respondents are State IAR officers.
Under the auspices of Executive Order 12862, Setting Customer Service Standards, SSA conducts multiple satisfaction surveys each year. This proposed information collection activity provides a means to garner qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with SSA's commitment to improving service delivery. By qualitative feedback we mean information that provides useful insights on perceptions and opinions, but are not statistical surveys that yield quantitative results that can be generalized to the population of study. This feedback will provide insights into customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative, and actionable communications between SSA and our customers and stakeholders.
The solicitation of feedback will target areas such as: Timeliness; appropriateness; accuracy of information; courtesy; efficiency of service delivery; and resolution of issues with service delivery. We will assess responses to plan and inform efforts to improve or maintain the quality of service offered to the public. If we do not collect this information, we would not have access to vital feedback from customers and stakeholders on SSA's services.
We will only submit a collection for approval under this generic clearance if it meets the following conditions: (1) The collections are voluntary; (2) 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; (3) the collections are non-controversial and do not raise issues of concern to other Federal agencies; (4) any collection targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program in the near future; (5) we collect personally identifiable information (PII) only to the extent necessary and we do not retain it; (6) we will use information gathered only internally for general service improvement and program management
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 non-response 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.
The respondents are recipients of SSA services (including most members of the public), professionals, and individuals who work on behalf of SSA beneficiaries.
Below we provide projected average estimates for the next three years:
II. SSA submitted the information collection below to OMB for clearance. Your comments regarding this information collection would be most useful if OMB and SSA receive them 30 days from the date of this publication. To be sure we consider your comments, we must receive them no later than August 28, 2020. Individuals can obtain copies of the OMB clearance package by writing to
Federal Aviation Administration (FAA), DOT.
Request for Public Comments.
Notice is being given that the FAA is considering a request from the Town of Old Town, ME to change the land use from Aeronautical to Non Aeronautical for 31.2 acres of airport land. The land use change will allow the development of a solar farm on land that is not needed for aeronautical purposes. The revenue generated by the lease of airport land for the solar farm will be placed into the airport's operation and maintenance fund.
Comments must be received on or before August 25, 2020.
You may send comments using any of the following methods:
•
•
•
•
Interested persons may inspect the request and supporting documents by contacting the FAA at the address listed under
Mr. Jorge E. Panteli, Compliance and Land Use Specialist, Federal Aviation Administration New England Region Airports Division, 1200 District Avenue, Burlington, Massachusetts 01803. Telephone: 781-238-7618.
Federal Aviation Administration (FAA), DOT.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. The collection involves extracting flight data such as aircraft, routing speed, etc. from domestic and international flights. FAA Form 7233-1, Flight Plan: Domestic flight plan information is used to govern the flight of aircraft for the protection and identification of aircraft and property and persons on the ground. The information is used by air traffic controllers, search and rescue (SAR) personnel, flight standards inspectors, accident investigators, military, law enforcement, and the Department of Homeland Security. FAA Form 7233-4, International Flight Plan: International flight plan information is used for the same purposes as domestic flight plans; in addition, it is used by Customs and international controllers.
Written comments should be submitted by August 28, 2020.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Aldwin Humphrey by email at:
Almost 100 percent of flight plans are filed electronically. However, as a courtesy to the aviation public, flight plans may be submitted in paper form. Flight plans may be filed in the following ways:
• Air carrier and air taxi operations, and certain corporate aviation departments, have been granted authority to electronically file flight plans directly with the FAA. The majority of air carrier and air taxi flights are processed in this manner.
• Air carrier and air taxi operators may submit pre-stored flight plan information on scheduled flights to Air Route Traffic Control Centers (ARTCC) to be entered electronically at the appropriate times.
• Pilots may call 1-800-WX-BRIEF (992-7433) and file flight plans with a flight service station specialist who enters the information directly into a computer system that automatically transmits the information to the appropriate air traffic facility. Pilots calling certain flight service stations have the option of using a voice recorder to store the information that will later be entered by a specialist.
• Private and corporate pilots who fly the same aircraft and routes at regular times may prestore flight plans with flight service stations. The flight plans will then be entered automatically into the air traffic system at the appropriate time.
• Pilots who visit a flight service station in person may choose to a file flight plan by using a paper form. The data will then be entered into a computer and filed electronically. The pilot will often keep the paper copy for his/her record.
Federal Aviation Administration, DOT.
Notice of availability.
In accordance with the National Environmental Policy Act of 1969, as amended (NEPA), Council on Environmental Quality NEPA implementing regulations, and FAA Order 1050.1F,
Daniel Czelusniak, Environmental Protection Specialist, Federal Aviation Administration, 800 Independence Avenue SW, Suite 325, Washington, DC 20591; phone (202) 267-5924; email
SpaceX is applying to the FAA for launch licenses to launch the Falcon 9 and Falcon Heavy from Kennedy Space Center's (KSC) Launch Complex 39A (LC-39A) and Cape Canaveral Air Force Station's (CCAFS) Launch Complex 40 (LC-40). SpaceX is also applying to the FAA for reentry licenses for Dragon reentry operations. The FAA's proposal to issue licenses to SpaceX is considered a major federal action subject to environmental review under NEPA. Due to SpaceX's ability to launch more frequently at KSC and CCAFS, SpaceX's launch manifest includes more annual Falcon launches and Dragon reentries than were considered in previous NEPA analyses. Also, SpaceX is proposing to add a new Falcon 9 southern launch trajectory from Florida for payloads requiring polar orbits. SpaceX is also proposing to construct a mobile service tower (MST) at LC-39A to support commercial launches and the U.S. Air Force's National Security Space Launch program. NASA is responsible for approving the construction of the MST at LC-39A. The FAA has no federal action related to the construction of the MST.
The Final EA evaluated the potential environmental impacts of the Proposed Action and the No Action Alternative. Under the No Action Alternative, the FAA would not modify existing SpaceX licenses or issue new licenses to SpaceX for Falcon launches or Dragon reentry operations at KSC and CCAFS. SpaceX would continue Falcon 9 and Falcon Heavy launch operations at KSC and CCAFS, as well as Dragon reentry operations, as analyzed in previous NEPA and environmental reviews and in accordance with existing FAA licenses until the licenses expire.
The FAA published a Draft EA for public comment on February 27, 2020. The FAA received six public comment submissions. The FAA has posted the Final EA and FONSI on the FAA Office of Commercial Space Transportation website:
Pipeline and Hazardous Materials Safety Administration (PHMSA), U.S. Department of Transportation (DOT).
Notice of public meeting; correction.
PHMSA published a document in the
Steven Webb or Aaron Wiener, PHMSA, U.S. Department of Transportation. Telephone: (202)-366-8553. Email:
In the
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.
The Specially Designated Nationals and Blocked Persons List and additional information concerning OFAC sanctions programs are available on OFAC's website (
On July 13, 2020, OFAC determined that the property and interests in property subject to U.S. jurisdiction of the following persons are blocked under the relevant sanctions authorities listed below.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Internal Revenue Service (IRS), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on information collections, as required by the Paperwork Reduction Act of 1995. The IRS is soliciting comments concerning Form 943, Employer's Annual Tax Return for Agricultural Employees, 943-PR, Planilla Para La Declarcion Annual De La Contribucion Federal Del Patrono De Empleados Agricolas, 943-A, Agricultural Employer's Record of Federal Tax Liability, and 943A-PR, Registro De La Obligacion Contributiva Del Patrono Agricola, and 943 (Schedule R), Allocation Schedule for Aggregate Form 943 Filers.
Written comments should be received on or before September 28, 2020 to be assured of consideration.
Direct all written comments to Kinna Brewington, Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington, DC 20224.
Requests for additional information or copies of the form and instructions should be directed to Martha R. Brinson, at (202) 317-5753, or at Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington, DC 20224, or through the internet at
New lines were added to report qualified sick leave wages and qualified family leave wages, to calculate the employee share of social security tax on qualified sick and family leave wages, and to report the nonrefundable portion of the credit for qualified sick and family leave wages and retention credit. The instructions will have a worksheet to figure these amounts. Additional lines are added to report total nonrefundable credits, to report the deferred payment of the employer share of social security tax, to report the refundable portion of the credit for qualified sick and family leave wages and refundable portion of the employee retention credit. Editorial changes and lines to report the totals, and request additional information related to the new credits were also added.
Schedule R (Form 943) has been revised to accommodate all of the new lines added to the 2020 Form 943.
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
National Cemetery Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the National Cemetery Administration (NCA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and it includes the actual data collection instrument.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
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. The
By direction of the Secretary.
The Department of Veterans Affairs (VA) gives notice under the Federal Advisory Committee Act that the Veterans' Advisory Committee on Rehabilitation (VACOR) will meet virtually on Wednesday, August 19 and Thursday, August 20, 2020 from 10:00 a.m. to 3:00 p.m. EST both days. The virtual meeting sessions is open to the public.
The purpose of the Committee is to advise the Secretary of VA on the rehabilitation needs of Veterans with disabilities and on the administration of VA's rehabilitation programs.
On August 19, 2020, Committee members will welcome members and provide briefings from the Central Texas Veterans Health Care System on various tele-health services designed to enhance the rehabilitation potential of Veterans, particularly Veterans in rural areas.
On August 20, 2020, Committee members will receive briefings from the Waco Regional Office on various virtual services designed to enhance the
Time will be allocated for receiving oral comments from the public. Members of the public may submit written comments for review by the Committee to Latrese Arnold, Designated Federal Officer, Veterans Benefits Administration (28), 810 Vermont Avenue NW, Washington, DC 20420, or at
National Cemetery Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the National Cemetery Administration (NCA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and it includes the actual data collection instrument.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
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. The
By direction of the Secretary.
(a) have a high cost sharing requirement for either insulin or injectable epinephrine;
(b) have a high unmet deductible; or
(c) have no health care insurance.
(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
(a) facilitating grants to individuals of waivers of the prohibition of importation of prescription drugs, provided such importation poses no additional risk to public safety and results in lower costs to American patients, pursuant to section 804(j)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 384(j)(2);
(b) authorizing the re-importation of insulin products upon a finding by the Secretary that it is required for emergency medical care pursuant to section 801(d) of the FDCA, 21 U.S.C. 381(d); and
(c) completing the rulemaking process regarding the proposed rule to implement section 804(b) through (h) of the FDCA, 21 U.S.C. 384(b) through (h), to allow importation of certain prescription drugs from Canada.
(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
(a) exclude from safe harbor protections under the anti-kickback statute, section 1128B(b) of the Social Security Act, 42 U.S.C. 1320a-7b, certain retrospective reductions in price that are not applied at the point-of-sale or other remuneration that drug manufacturers provide to health plan sponsors, pharmacies, or PBMs in operating the Medicare Part D program; and
(b) establish new safe harbors that would permit health plan sponsors, pharmacies, and PBMs to apply discounts at the patient's point-of-sale in order to lower the patient's out-of-pocket costs, and that would permit the use of certain bona fide PBM service fees.
(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.