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Federal Energy Regulatory Commission, Department of Energy.
Final rule.
In this order, the Federal Energy Regulatory Commission (Commission) addresses arguments raised on rehearing, sets aside in part and clarifies in part Order No. 2222-A.
This rule will become effective August 27, 2021.
1. On September 17, 2020, the Federal Energy Regulatory Commission (Commission) issued its final rule (final rule or Order No. 2222) adopting reforms to remove barriers to the participation of distributed energy resource
2. More specifically, Order No. 2222 requires each RTO/ISO to revise its tariff to establish distributed energy resource aggregators as a type of market participant that can register distributed energy resource aggregations under one or more participation models in the RTO/ISO tariff that accommodate the physical and operational characteristics of each distributed energy resource aggregation.
3. On March 18, 2021, the Commission issued Order No. 2222-A, which addressed arguments raised on rehearing, set aside in part, and clarified in part the Commission's determinations in Order No. 2222. While the Commission largely affirmed its findings in Order No. 2222, the Commission set aside the finding that the participation of demand response in distributed energy resource aggregations is subject to the opt-out and opt-in requirements of Order Nos. 719 and 719-A.
4. On April 19, 2021, the Edison Electric Institute (EEI); the Louisiana Public Service Commission and the Mississippi Public Service Commission (together, the Southern Regulators); the National Association of Regulatory Utility Commissioners (NARUC); the North Carolina Utilities Commission (the North Carolina Commission); and the MISO Transmission Owners
5. Pursuant to
6. Specifically, we set aside the decision in Order No. 2222-A to decline to extend the opt-out and opt-in requirements of Order Nos. 719 and 719-A to demand response resources participating in heterogeneous distributed energy resource aggregations. We also provide further clarification regarding appropriate restrictions to avoid double counting of services and the compensation of demand response resources that participate in heterogeneous distributed energy resource aggregations, as discussed further below.
7. In Order No. 2222, the Commission stated that the final rule does not affect the ability of relevant electric retail regulatory authorities (RERRA) to prohibit retail customers' demand response from being bid into RTO/ISO markets by aggregators pursuant to Order No. 719.
8. In Order No. 2222-A, the Commission set aside in part the Commission's conclusion that the participation of demand response in distributed energy resource aggregations is subject to the opt-out and opt-in requirements of Order Nos. 719 and
9. The Commission found that extending the Order No. 719 opt-out to demand response resources in heterogeneous distributed energy resource aggregations would undermine the potential of Order No. 2222 to break down barriers to competition, which would interfere with the Commission's responsibility to ensure that wholesale rates are just and reasonable.
10. The Commission stated that it did not propose to overturn the Order No. 719 opt-out in this rulemaking and, to the extent that parties asked the Commission to do so on rehearing, it found that such requests were out of scope.
11. Some petitioners argue that the Commission's opt-out finding in Order No. 2222-A violated the Commission's jurisdiction under the FPA or usurped state authority.
12. The Southern Regulators argue that the Commission contravened
13. The North Carolina Commission similarly argues that the Commission did not account for the long-standing authority of the states and the traditional, cooperative roles played by federal and state regulators in promoting adequate, reliable, safe, clean, and affordable electric services.
14. NARUC argues that, by eliminating the opt-out for demand response resources in heterogeneous aggregations, the Commission usurped authority from states that used the Order
15. NARUC disputes the Commission's position that “[b]ecause the terms of wholesale market participation are a matter under exclusive Commission jurisdiction, today's order does not infringe upon or otherwise diminish state authority.”
16. Multiple petitioners argue that the Commission violated the Administrative Procedure Act (APA) by effectively eliminating the Order No. 719 opt-out without providing adequate notice and without soliciting comments and evidence from RERRAs that have adopted and relied upon that opt-out.
17. The Southern Regulators argue that they were prejudiced by the Commission's failure to provide notice that the Order No. 719 opt-out was at risk in Docket No. RM18-9.
18. In addition, NARUC and the Southern Regulators argue that eliminating the Order No. 719 opt-out for demand response resources in heterogeneous aggregations is outside the scope of Order No. 2222.
19. Several petitioners argue that the Commission acted arbitrarily and capriciously by departing from its policy in Order Nos. 719 and 719-A in Order. No. 2222-A without acknowledgment, an adequate explanation, or an examination of the policy considerations in support of the opt-out.
20. Next, several petitioners claim that the Commission failed to acknowledge the states' role in overseeing demand response activities within their borders.
21. Next, some petitioners argue that the Commission relies on a false distinction between heterogeneous and homogeneous distributed energy resource aggregations to justify eliminating state opt-out authority.
22. NARUC challenges the Commission's finding that “heterogeneous distributed energy resource aggregations that include demand response resources do not fall squarely within the Order No. 719 opt-out, as set forth in our regulations because they are not solely aggregations of retail customers,” because the definition of “aggregator of retail customers” that the Commission relies upon does not say that the aggregations are exclusively retail loads, just “mostly.”
23. Some petitioners also object to the Commission's characterization of demand response resources in declining to extend the opt-out to heterogeneous distributed energy resource aggregations. The Southern Regulators criticize the Commission's reliance on the ability of distributed energy resources to take advantage of operating attributes and complementary
24. Several petitioners further argue that the Commission's decision is arbitrary and capricious because it would allow distributed energy resource aggregations comprised primarily of demand response resources to evade state regulations.
25. Finally, EEI argues that it was arbitrary and capricious for the Commission to remove the opt-out without allowing an opportunity for public comment in Docket No. RM21-14-000, where the Commission has opened a far-reaching inquiry about removing the demand response opt-out from its regulations.
26. Upon reviewing the requests for rehearing, we set aside our prior decision not to extend the Order No. 719 opt-out to demand response resources that participate in heterogeneous distributed energy resource aggregations. As discussed below, we find that these issues are better addressed in Docket No. RM21-14-000.
27. As an initial matter, we disagree with the arguments on rehearing that the Commission's interpretation of the Order No. 719 opt-out in Order No. 2222-A would have exceeded the Commission's jurisdiction under the FPA. The Southern Regulators rely on
28. Nonetheless, we acknowledge that, in implementing the opt-out in Order No. 719, a number of states broadly prohibited demand response participation in RTO/ISO markets,
29. Because we set aside our prior decision in Order No. 2222-A to not extend the Order No. 719 opt-out to demand response resources that participate in heterogeneous distributed energy resource aggregations, we find that, as the Commission stated in Order No. 2222, “the participation of demand response in distributed energy resource aggregations is subject to the opt-out and opt-in requirements of Order Nos. 719 and 719-A. Therefore, if the relevant electric retail regulatory authority where a demand response resource is located has either chosen to opt out or has not opted in [pursuant to Order Nos. 719 and 719-A], then the demand response resource may not participate in a distributed energy resource aggregation.”
30. Order No. 2222 requires each RTO/ISO to revise its tariff to allow market participation by heterogeneous distributed energy resource aggregations.
31. In Order No. 2222-A, for purposes of applying the opt-out, the Commission clarified the definition of heterogeneous aggregations as “those that are made up of different types of resources including demand response as opposed to those made up solely of demand response.”
32. Voltus requests clarification that demand response paired with a behind-the-meter distributed energy resource constitutes a heterogeneous distributed energy resource aggregation not subject to the Order No. 719 opt-out.
33. Voltus argues that clarification is necessary because paragraph 29 of Order No. 2222-A has caused MISO to propose that an aggregation of demand response using behind-the-meter generation and/or storage to reduce load would be subject to the Order No. 719 opt-out.
34. Voltus argues that classifying demand response paired with behind-the-meter resources as a heterogeneous aggregation is consistent with AEE/AEMA's request for clarification that a behind-the-meter distributed energy resource used to serve onsite load should be paid at the locational marginal price (LMP), as required by Order No. 745. Voltus argues that LMP payments are proper because Order No. 2222-A did not change Order No. 745's payment structure for resources that reduce load to the bulk power system.
35. Because we set aside the Commission's decision in Order No. 2222-A to decline to extend the Order No. 719 opt-out to heterogeneous distributed energy resource aggregations, we find that Voltus's request for clarification is largely moot.
36. Nevertheless, with respect to potential confusion underlying Voltus's request for clarification, we note that the Commission has stated previously that load reductions in demand response programs can be facilitated by a variety of technologies and still constitute demand response.
37. In Order No. 2222, the Commission clarified that the requirements in Order No. 745 would apply to demand response resources participating in heterogeneous aggregations.
38. With respect to double counting, the Commission in Order No. 2222 required each RTO/ISO to include any appropriate restrictions on distributed energy resource participation in RTO/ISO markets through distributed energy resource aggregations, if narrowly designed to avoid counting more than once the services provided by distributed energy resources in RTO/ISO markets.
39. AEE/AEMA seek clarification—or, in the alternative, rehearing—that behind-the-meter distributed energy resources used to serve onsite load, therefore reducing power consumption from the bulk power system, should be compensated at full locational marginal price (LMP) in compliance with Order No. 745 with no need to eliminate retail savings generated by the distributed energy resource, and that payment of full LMP to behind-the-meter distributed energy resources does not constitute double counting.
40. AEE/AEMA maintain that the Supreme Court in
41. AEE/AEMA state that their members are encountering continued confusion in ongoing RTO/ISO stakeholder processes regarding the double counting restrictions in Order No. 2222, specifically regarding compensation for wholesale market services provided by aggregations.
42. We grant, in part, AEE/AEMA's request for clarification. As an initial matter, we disagree with AEE/AEMA's claim that Order No. 2222 modified the definition of demand response. In Order Nos. 745 and 2222, the Commission cited to the same definition of demand response contained in the Commission's regulations.
43. We clarify that payment of full LMP in the energy market to behind-the-
44. With respect to the participation of demand response resources in distributed energy resource aggregations, we clarify that, if an individual distributed energy resource is a behind-the-meter generator, it may participate within a distributed energy resource aggregation as a demand response resource or as a different type of distributed energy resource. If the distributed energy resource participates as demand response, the requirements in Order No. 745 would apply, and the RTOs/ISOs are required to allow that distributed energy resource to aggregate with other types of distributed energy resources in a heterogeneous distributed energy resource aggregation.
45. We reiterate, however, that we will evaluate each RTO's/ISO's “proposal submitted on compliance to determine whether it meets the goals of this final rule to allow distributed energy resources to provide all services that they are technically capable of providing through aggregation,”
46. The burden estimates have not changed from the final rule.
47. The Regulatory Flexibility Act of 1980 (RFA)
48. In addition to publishing the full text of this document in the
49. From the Commission's Home Page on the internet, this information is available on eLibrary. The full text of this document is available on eLibrary in PDF and Microsoft Word format for viewing, printing, and/or downloading. To access this document in eLibrary, type the docket number excluding the last three digits of this document in the docket number field.
50. User assistance is available for eLibrary and the Commission's website during normal business hours from FERC Online Support at (202)-502-6652 (toll free at 1-866-208-3676) or email at
51. This rule is effective August 27, 2021.
By the Commission.
Commissioner Chatterjee is concurring with a separate statement attached.
Commissioner Danly is concurring with a separate statement attached.
Commissioner Christie is concurring in part and dissenting in part with a separate statement attached.
CHATTERJEE, Commissioner,
1. I concur with today's order because it continues to find that the Commission was under no legal obligation to provide the Order No. 719 opt-out.
2. I write separately to reiterate and emphasize my support for eliminating the Order No. 719 opt-out, which has for years prevented demand response resources in many states from participating in our wholesale markets. The outdated Order No. 719 opt-out cannot be reconciled with the competitive principles underpinning Order No. 2222 and the Commission's statutory responsibility to ensure rates subject to the Commission's jurisdiction are just and reasonable and not unduly discriminatory or preferential.
For these reasons, I respectfully concur.
DANLY, Commissioner,
1. I agree with the Commission's order today granting rehearing to extend the states' existing rights to opt-out of wholesale demand response programs
2. I write separately to highlight that even if the Commission is correct that it has jurisdiction over distributed energy resource aggregations—including those “aggregations” comprised of a single resource
For these reasons, I respectfully concur.
CHRISTIE, Commissioner,
1. I concur with the first sentence of Paragraph 26 and other provisions of the order which set “aside our prior decision [in Order No. 2222-A] not to extend the Order No. 719 opt-out to demand response resources that participate in heterogeneous distributed energy resource aggregations . . . .”
2. As the second sentence in Paragraph 26 and other provisions in today's order indicate, however, there is no decision affirmatively to preserve those Order No. 719 opt-out provisions;
3. Beyond the parts of this order that restore, at least temporarily, those opt-out provisions, I dissent from the remainder of the order, because I would have voted against Order No. 2222 had I been a member of the Commission at that time and I did vote against Order No. 2222-A. As I said in my dissent to the latter:
Today the majority . . . sides against the consumers who for years to come will almost surely pay billions of dollars for grid expenditures likely to be rate-based in the name of “Order 2222 compliance.”
. . .
Sadly, instead of making the states, municipal and public-power authorities and electric co-operatives truly equal partners in managing the timing and conditions of deployment of behind-the-meter DERs in ways that are sensitive to local needs and challenges—both
4. To ameliorate at least some of the damaging effects caused by Order Nos. 2222 and 2222-A, I would authorize states and other RERRAs the right to exercise an opt-out from the requirements of those orders, if not permanently then at least for some period of years to enable them better to prepare for the impacts on retail customers and distribution grids they now face.
For these reasons, I respectfully concur in part and dissent in part.
Drug Enforcement Administration, Department of Justice.
Final rule.
The Drug Enforcement Administration (DEA) is publishing this final rule to revise existing regulations for narcotic treatment programs (NTPs) to allow the operation of a mobile
This final rule is effective July 28, 2021.
Scott A. Brinks, Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, Diversion Control Division; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (571) 776-2265.
The Controlled Substances Act (CSA) generally provides, with certain exceptions, that all persons who are required to register under the Act must obtain a separate registration “at each principal place of business or professional practice” where such persons manufacture, distribute, or dispense a controlled substance. 21 U.S.C. 822(e)(1). However, the CSA authorizes the Attorney General to issue regulations waiving the requirement of registration of certain manufacturers, distributors, or dispensers if he finds it consistent with the public health and safety. 21 U.S.C. 822(d). The Attorney General has delegated this authority to the Administrator of the Drug Enforcement Administration (Administrator of DEA or Administrator). Pursuant to this authority, DEA is hereby finalizing a regulation that would waive the requirement of a separate registration for narcotic treatment programs (NTPs) that utilize mobile components under certain conditions. Specifically, under this final rule, an NTP is permitted to dispense narcotic drugs in schedules II-V from a mobile component at location(s) remote from, but within the same State as, the NTP's registered location, for the purpose of maintenance or detoxification treatment. Under this final rule, the NTP does not need to obtain a separate DEA registration for dispensing from the mobile component at a separate location as long as it complies with the requirements of the final rule. Such remote dispensing from an NTP's mobile component is deemed under the final rule to be a coincident activity permitted under the NTP's registration. In the interest of helping to alleviate the ongoing opioid epidemic in the United States, the Acting Administrator of DEA (Acting Administrator) finds that this waiver of registration is consistent with the public health and safety.
The final rule also contains additional requirements specified in the proposed rule to reduce the likelihood of diversion. Certain aspects of these additional requirements, which were raised by the commenters, are addressed below in the discussion of the comments. In addition, a section-by-section analysis of the final rule is provided following the discussion of the comments.
On February 26, 2020, DEA published a notice of proposed rulemaking (NPRM) in the
DEA received a total of 114 comments on the NPRM, copies of which are available online at
One comment was a general statement of support for the rule, with no discussion of the proposed regulatory changes. Some commenters sought clarification of certain provisions in the proposed rule or recommended additional changes. The majority of commenters expressed support for various provisions in the proposed rule. That said, some commenters offered only partial support for the rule, agreeing with its general purpose but disagreeing with particular provisions; some of these commenters offered suggestions and proposed amendments to the rule that they thought would help DEA achieve its purpose. Three comments were outside of the scope of the rule. One comment—a general complaint about the government's COVID-19 response, unrelated to DEA—was outside the scope of the rulemaking and will therefore not be addressed. Another commenter suggested lengthening the five-year term for nurse anesthetists to treat patients with substance use disorder, which is a matter beyond the scope of this rule and will not be addressed. A third commenter suggested future rule changes DEA should consider to reduce patient access burdens, including: Reducing adherence requirements for take-home dosing, allowing community pharmacies to dispense methadone treatment, and allowing physicians outside of NTPs to prescribe methadone treatment for patients with opioid use disorders (OUDs). These issues are outside the scope of the rule and will not be addressed.
After a review of the comments, DEA noted that there were thirteen main issues that commenters raised, and many commenters raised multiple issues in their comments. Each issue is summarized below, along with DEA's responses. DEA has also summarized the remainder of the comments that did not fit into one of the thirteen main issues.
This CSA requirement of separate registrations for each principal place of business or professional practice where the practitioner dispenses controlled substances allows DEA to monitor the dispensing of controlled substances. This requirement thereby reduces the potential for diversion of those substances. Accordingly, the CSA only authorizes the Administrator (by delegation from the Attorney General) to issue regulations waiving this requirement if he finds doing so to be consistent with the public health and safety. 21 U.S.C. 822(d).
As explained in the NPRM and above, DEA has concluded that allowing NTPs to operate mobile NTPs under the conditions specified in this rule is consistent with the public health and safety.
In this rulemaking, DEA has not considered whether waiving the separate registration requirement in any other circumstances would be consistent with the public health and safety, because such a determination was not necessary for this rulemaking. It is, in other words, beyond the scope of this rule. This final rule, therefore, does not change the requirement for separate registrations at each principal place of business or professional practice for any other registrants (including specialty doctors) that dispense controlled substances. To the degree interested parties believe that the separate registration requirement should be waived in other circumstances, they may petition DEA to do so by regulation.
Another commenter expressed concern that NTPs would choose to only operate within their own State if (1) State methadone authorities hesitated to license a mobile component with a registered location in another State, or (2) States placed more onerous licensing processes on mobile components from another State. The commenter suggested that DEA should not prohibit this at the Federal level. The commenter further suggested that if States are willing to approve mobile components that are based in another State to promote access for their own citizens, DEA should defer to the States and permit mobile NTPs to operate in a different State than that of the NTP's registered location if the provider can obtain the requisite license from the State methadone authority.
Finally, one organization and an anonymous commenter supported the requirement that a mobile NTP only operate in the same State in which the NTP is registered with DEA. The organization noted that State regulations can vary greatly, and the organization was aware of the immediate regulatory crisis that would exist if DEA promulgated Federal regulations around mobile NTPs that permitted the mobile NTPs to dispense controlled substances in States in which they are not registered. The organization expressed concern that any potential for conflict within the treatment delivery system could put patient care in jeopardy and foster confusion that may fuel additional stigma against an already overly stigmatized medical treatment. The organization also noted that mobile NTPs are governed by State regulations in addition to the Federal regulations promulgated by DEA and the Substance Abuse and Mental Health Services Administration (SAMHSA). The organization further noted that operating a mobile NTP across State lines would call into question which
As stated in the preamble to the proposed rule, however, the CSA and DEA regulations have always required, with limited exceptions, practitioners to have separate registrations in each State in which they dispense controlled substances.
DEA also cannot authorize NTPs to avoid this requirement by allowing a single mobile NTP to partner with multiple NTPs with registered locations in different States. This rule authorizes a registered NTP to operate a mobile component away from its registered location as a coincident activity of its DEA registration, which, as stated above, is predicated on state authorization. Moreover, this arrangement is critical to ensuring that a registered NTP maintains effective security and recordkeeping oversight of its mobile NTP operations to safeguard against diversion of the mobile NTP's controlled substances. Allowing multiple registered NTPs to share the same mobile component would diminish any individual location's perceived authority and responsibility for the controlled substances contained on the mobile NTP. For example, it would complicate the NTP's task of reconciling the dispensing logs from both the mobile component and the NTP's registered location to ensure that only the NTP's enrolled patients are receiving controlled substances. Furthermore, the task of recording (and investigators' task of tracing) the movement of controlled substances received at the NTP's registered location and transferred to the mobile NTP components would also be complicated. Thus, as reflected in the rule, DEA has concluded that each mobile NTP component may only operate under the DEA registration of a single NTP location—and may only operate in the State in which that registered NTP is licensed.
Two associations, one representing NTPs and the other representing the interests of individuals in medication-assisted treatment (MAT), noted a potential funding source available through the U.S. Department of Agriculture (USDA). Both associations mentioned that the funding is available to assist NTPs with the purchase of mobile vans, if the NTPs meet USDA criteria in serving rural communities as defined by a population of 50,000 or less. Both associations also stated that they would advise NTPs to actively pursue this funding, working in
Several commenters also pointed out the advantages of allowing practitioners to dispense controlled substances at multiple locations, as the rule would facilitate. One commenter provided her personal experiences that she currently can only treat patients with opioid addiction at the DEA-registered location, where the injectable buprenorphine is delivered. The commenter believed that allowing providers to have more than one location is essential for good health care, because this would greatly increase access and treatment options for those suffering from opioid addiction.
Finally, several commenters mentioned how the current COVID-19 public health emergency would have negative effects on individuals who were suffering from OUD, because of State-mandated stay-at-home orders, social distancing requirements, and severe limitations on some of the transportation options on which these individuals rely. Commenters further noted that these negative consequences of the public health emergency could cause increases in isolation and an inability to reach treatment clinics, which could result in an increase in overdoses or even deaths. These commenters said that the use of mobile components would ensure that these individuals would be able to continue treatment.
The intent of the rule is to ensure that there is greater access to treatment for those who are suffering from OUD, and who are unable to access treatment because of rural or geographic limitations, mobility issues, etc. Furthermore, DEA has no objection to NTPs seeking grants or funding from government programs, or partnering with other organizations in order to defray the costs of purchasing and outfitting a mobile component. Regarding the COVID-19 public health emergency, this is an unprecedented event that has resulted in many agencies and organizations changing the way they operate. As a result of the public health emergency, DEA has worked closely with SAMHSA to provide guidance and support to opioid treatment programs to ensure that any individual who relies on MAT is able to continue treatment without disruption. It is DEA's hope that these mobile NTPs will be able to ensure greater access in in the future, especially when public health emergencies like this arise.
Another commenter expressed concerns that the security requirements DEA proposed were administratively burdensome, and specifically mentioned the requirement that the mobile component return to the NTP's registered location on a daily basis. The commenter stated that this requirement would increase the amount of time spent traveling, which would result in additional wear and tear on the vehicles and less time to work with patients who need care and rely on the mobile component. The commenter thus indicated that this requirement would detract from the increased access to treatment and reduced costs of expanded access that this regulation aims to achieve.
Likewise, a number of commenters also noted that requiring the mobile components to return to the NTP's registered location every day would be costly when factoring in staff time, travel costs, and the wear and tear on the vehicles. Several commenters postulated that these expenses could easily rival the cost of opening a new brick-and-mortar NTP. Two commenters estimated the cost for a mobile NTP, with at least one nurse and one medical assistant, traveling 100 miles round trip, six times per week for a year, as approaching $62,000. Both commenters stated this this amount could be more expensive than renting space for a new registered NTP location in some areas. Several commenters suggested that this requirement might hinder the effectiveness of the rule, particularly in rural areas, due to the extra costs and travel time associated with traveling back and forth daily. One commenter further stated that although DEA asserted that the proposed rule would benefit rural areas, this assertion was incorrect due to the scarcity of registered NTP locations near rural areas, and the costs that would be incurred if a mobile NTP attempted to
Many commenters suggested that DEA allow these mobile components to stay in the field for longer periods of time. The commenters indicated that costs would be reduced significantly and there would be more time for providing care to patients, thus making the mobile components more effective, if the components were allowed to return to the registered location less frequently. The majority of commenters proposed only requiring the mobile NTPs to return to the registered location once a week, while another commenter suggested a 72-hour turnaround time, and another commenter simply requested that the mobile NTP be allowed to remain in the field for “multiple days.” One of the commenters who suggested returning once a week, alternatively recommended the mobile NTPs not be required to return more frequently than every other day. Another commenter stated that DEA should not specify when the mobile component must return or, as an alternative, suggested that DEA should consider increasing the intervals between returns and only requiring weekly returns.
Most commenters believed that requiring the mobile components to return to the registered location less frequently would increase access to treatment while still maintaining appropriate safeguards against potential theft and diversion. Indeed, several commenters asserted that these longer turnaround times were feasible given that DEA was proposing to apply existing security protocols to mobile components. One commenter similarly stated that the security measures required by the proposed rule were adequate to prevent diversion while the mobile component is in the field. However, one commenter suggested that if the mobile components are allowed to stay in the field for longer periods of time, additional security measures should be taken. The commenter suggested requiring an armed guard outside the mobile component or requiring the mobile component to be locked in a secure, fenced-in location.
Finally, one commenter stated that in the absence of evidence of abuse, DEA should not require the mobile component to return to the registered NTP location daily or store the controlled substances in the registered location at the end of each day. The commenter stated that the proposed rule includes multiple safety measures and procedures that are adequate to protect controlled substances, which the commenter felt acted as a significant check against theft and diversion. The commenter further contended that it is not clear that moving the mobile component back to the registered location and removing the controlled substances daily decreases the risk of diversion. Furthermore, the commenter asserted that DEA does not provide evidence or reasoning to explain how these requirements reduce the risk of diversion. The commenter insisted that pending the development of better information regarding the risks of diversion, DEA should not specify when the mobile component must return to the NTP's registered location.
Several concerns drive DEA's conclusion that, upon the completion of their daily operations, mobile NTPs generally must return to their registered locations and secure all controlled substances within their registered location.
The first and most important concern is the danger associated with controlled substances that mobile NTPs will be carrying, should those substances be diverted. Of course, mobile NTPs will primarily be storing and distributing methadone, and methadone is an extremely dangerous drug if abused. More specifically, methadone is a potent schedule II opioid with a relatively long elimination half-life of 8-59 hours with an average of 24 hours depending on the individual.
Methadone is also a demonstrated diversion risk.
So long as methadone remains in a mobile component, it is at an elevated risk of theft both because the mobile conveyance itself could be stolen, and because security measures in a mobile NTP will generally be less robust than those at the NTP's registered location. This risk is manageable when the mobile NTP is in operation and thus secured by staff to guard against theft. However, the risk becomes unwieldy—especially given that dangers posed by such quantities of methadone—when the mobile NTP is not in use and is unattended, generally at night, and the likelihood of theft is greater. Thus, by requiring NTPs to secure their controlled substances within their registered NTP location after operation each day, DEA decreases the risk that those controlled substances will be stolen—and thereby decreases the risk
Requiring the mobile NTP and its controlled substances to return to the registered location of the NTP also reduces the likelihood that controlled substances will be lost or mishandled. Requiring an NTP's mobile component to return nightly better enables the NTP to monitor its mobile component's dispensing, and thus become more readily aware of any problems—such as the “double-dipping” discussed below (under Recordkeeping Requirements for Mobile Components)—or other discrepancies that may signal that the mobile NTP's controlled substances are being diverted or otherwise improperly dispensed.
Additionally, allowing mobile NTPs to remain in operation for multiple days without returning to their registered locations not only presents an elevated risk of diversion, there are alternative options that make it generally unnecessary. For example, nothing in this rule impacts the ability of an NTP to register at an additional physical location. Thus, if an NTP wishes to treat patients with methadone at a remote correctional facility or similar rural location, that NTP could simply register a physical location in the area to which to return its mobile component and where to secure its controlled substances. Indeed, a correctional facility can itself register with DEA as an NTP. While some correctional facilities have obtained an NTP registration, DEA wishes to emphasize this option for those who may be unaware of it. Moreover, many OUD patients may be successfully treated with alternative medications such as buprenorphine or naltrexone. Buprenorphine is a schedule III narcotic drug approved by the U.S. Food and Drug Administration (FDA) for the treatment of OUD, and, as such, may be dispensed for such purpose without the dispenser being registered as an NTP.
In sum, DEA has concluded, for the reasons stated above, that it is necessary and appropriate to maintain in the final rule the requirement that a mobile NTP return to its registered location each day. However, in view of the comments DEA received on this issue, DEA wishes to emphasize that it has decided to add to the text of the final rule a provision that expressly allows NTPs to apply for an exception to this requirement. The process for applying for such an exception will be as set forth in 21 CFR 1307.03, which allows any person to apply for an exception to any provision of the DEA regulations. As with all applications for an exception to any provision of the regulations submitted pursuant to section 1307.03, each application for an exception to the requirement that a mobile NTP return each day will be evaluated by DEA on a case-by-case basis in determining whether the applicant has demonstrated exceptional circumstances that warrant a waiver of the regulation. In making this determination, DEA will consider the applicant's security and recordkeeping as well as other factors relevant to determining whether effective controls against diversion will be maintained. DEA is revising 21 CFR 1301.72(e) (from that proposed in the NPRM) to reflect this change to the regulatory text.
In addition, DEA will continue to evaluate the risk of diversion that might result from eliminating, in some circumstances, the requirement that a mobile NTP return to its registered location each day. DEA will closely monitor applications seeking an exception to that requirement. One year after this rule is finalized, DEA will review whether additional rulemaking is necessary to improve access to treatment via mobile NTPs. In conducting its review, DEA will consult with the Department of Health and Human Services (HHS) and the Office of National Drug Control Policy (ONDCP). If the volume and nature of such applications and an evaluation of the associated risk of diversion warrant it, DEA will further amend the regulations to allow mobile NTPs to be excepted from this requirement—without having to apply for an exception—under certain specified circumstances. If DEA determines that such additional amendment to the regulations is warranted, it will initiate a separate rulemaking proceeding to do so in accordance with the Administrative Procedure Act (APA).
One commenter pointed out the known criminal activity risks associated with having controlled substances on site, such as theft, and noted that “brick-and-mortar” NTPs often protect their employees and patients through various security measures. The commenter provided two examples of these measures: (1) A panic button that, when activated, triggers law enforcement to immediately respond, and (2) the local law enforcement knows the existence and whereabouts of an NTP and, therefore, can respond quickly and efficiently to an emergency. In contrast, the commenter stated that the proposed rule fails to mention whether mobile NTPs must take any explicit security measures to protect their employees and patients, including installing panic buttons, or making local law enforcement aware of the mobile NTPs' exact locations at any given moment, including during travel. The commenter
Of course, under certain circumstances, mobile NTPs may need additional security measures beyond those specifically required by DEA regulations to effectively protect against theft or diversion of controlled substances. Because the need for such measures is circumstance-specific, DEA is not including them in the final rule, but rather will rely on local DEA personnel, NTPs themselves, and any other relevant laws and regulations to determine what additional measures, if any, are necessary. In particular, DEA will leave the decision on whether armed or unarmed security personnel will be utilized by the mobile component while it is away from its registered location to the NTP, as there are many factors that should be considered when making this decision. For example, the NTP may want to consider the location to which the mobile components will be traveling, the cost of security personnel, and whether or not these security personnel would fit in to any standard operating procedures used by the NTP. Thus, DEA will not mandate that armed or unarmed security personnel be utilized by these mobile components.
The proposed rule stated in proposed 21 CFR 1301.72(e) that the mobile component must be returned to the registered location on a daily basis.
For similar reasons, DEA will leave the decision on what safety measures the NTP would like to take to ensure the safety of the mobile component's staff and patients to the NTP and any relevant government bodies outside of DEA. There are many factors like the location of the NTP, the number of patients it treats, cost, etc., which would affect the NTP's decision when deciding which safety measures would ensure patient and staff safety. Aside from DEA security requirements, there are other Federal, State, local, and tribal laws these NTPs must take into consideration when making their decision. Thus, because the appropriate safety measures for a mobile NTP will vary based on circumstances and legal requirements, DEA will not attempt to specify additional safety requirements for NTPs as part of this rule. If such requirements are necessary, other Federal, State, local, and tribal authorities can create them.
As a result, the commenter believed this provision to not be clear or transparent and could lead to DEA field offices unevenly or arbitrarily applying the regulations. The commenter further stated that a registered NTP considering starting a mobile NTP would likely have to reach out to the local DEA field office early in the planning phase which could result in delays getting the mobile component up and running. Therefore, the commenter recommended that DEA not finalize this proposed provision, or at the very minimum, that DEA provide clarity in the final rule preamble regarding the factors and additional security measures.
Another commenter noted that current regulations provide DEA discretion to prescribe security requirements to the NTP based on certain factors. However, this commenter stated that it would seem practically impossible for DEA to fully exercise its discretion under 21 CFR 1301.73(l) and effectively set security standards for mobile components, given the changing locations of mobile components when contrasted with registered NTP locations.
DEA, however, cannot forego case-by-case determinations, even if they inevitably bring some risk of delay or enforcement discrepancies. As discussed above, although this final rule and DEA regulations more broadly articulate basic security requirements, they cannot account for all security situations. Some situations may require additional security measures for a mobile NTP to be able to adequately guard against loss through theft or other forms of diversion. Attempting to account for all such scenarios in advance through regulation is ineffective and may impose unnecessary restrictions on other mobile NTPs. DEA can best ensure that mobile NTPs provide adequate security by enabling local DEA offices to conduct case-by-case evaluations as appropriate. That said, DEA is slightly modifying the proposed regulatory language describing how these case-by-case evaluations are conducted in this final rule to clarify that DEA, not any other entity, applies the factors.
DEA has concluded that mobile NTPs' changing locations will not compromise its ability to make such assessments. DEA already evaluates the security arrangements provided by a wide range of registrants under many different circumstances. Although mobile NTPs do present some unique challenges, DEA is confident that it can work with mobile NTPs to ensure that they operate securely.
DEA also notes the commenter's concerns about the requirement that
Finally, two commenters mentioned the use of mobile components in emergency situations, such as during Hurricanes Katrina and Sandy. One of these commenters mentioned how mobile methadone components are an important part of the broad continuum of care for individuals with OUD, and stated these mobile components provided essential treatment services during Hurricane Katrina. However, the other commenter noted that mobile components had been largely unavailable to providers responding to emergency situations. That commenter mentioned that during Hurricane Sandy in 2012, affected NTPs employed strategies such as alternative transportation, take-home dosing, and guest dosing at nearby programs (
Other commenters mentioned the savings that would be realized by allowing the mobile components to register only once. One commenter estimated savings between $1,270,670 and $1,482,272 would be possible over five years “simply because operating out of the mobile unit would allow more treatments to be dispensed and operating over multiple locations would bring in more revenue.” However, the commenter did not explain the basis for this estimate.
Conversely, one State behavioral health agency expressed general concerns about the startup costs associated with operating a mobile component, and stated that some NTPs may find this expense to be a barrier to establishing a mobile component. The commenter further indicated that as a result, some NTPs may desire to partner with agencies who already own well-equipped mobile components. The commenter recommended that DEA explicitly indicate whether it will allow a registered NTP to partner with an organization who owns a mobile NTP (
As discussed in detail above, many commenters were opposed to requiring the mobile component to return to the NTP's registered location on a daily basis; the costs of the daily round trips were chief among the issues raised when voicing their concerns. These commenters generally believed that the costs associated with traveling to and from the communities served by mobile NTPs (
Three commenters also detailed other expenses that might result from operating the mobile component. One commenter stated that while the proposed rule provided potential safeguards addressing security, theft, and misuse, the rule did not discuss in its cost-benefit analysis the intangible costs associated with detecting any violation of either operating the mobile component as a treatment center or any of the rule's other prohibitions. However, the commenter did not detail any specific cost numbers for these intangible costs. One commenter expressed concerns that the costs associated with paying an entire team of healthcare professionals for their travel time would likely be expensive and possibly even cost prohibitive, particularly if mobile NTPs will provide the same interdisciplinary services offered at registered NTP locations. This commenter further stated that the proposed rule failed to address these costs. Another commenter also mentioned the small, extra expense of hiring security personnel to protect the mobile NTP, which the commenter recommended if the regulations would no longer require the mobile NTPs to return to the DEA-registered location at the end of each day.
Finally, a commenter expressed great appreciation that the proposed rule's economic analysis qualitatively described benefits and cost-savings that cannot be quantified, including reduced health care costs, criminal justice costs, and lost productivity costs that will be reduced as a result of increased access to treatment. However, the commenter stated that this analysis omitted other important unquantifiable benefits, such as improved quality of life and improved dignity for patients who can access treatment. The commenter stated that the major benefit of this proposed rule is its expected effect on the cost to treat each patient with OUD and the number of patients who have access to such treatment (
DEA's estimation of operating costs for a mobile NTP represents the average costs for an NTP choosing to operate a mobile component. As one commenter noted, in certain rural locations throughout the United States, these operating costs may be higher than the average costs presented in the regulatory analysis because NTPs may choose to travel further distances on a more frequent basis in order to reach patients in particularly remote areas. These operating costs may even surpass the costs associated with opening another registered location. Delivering treatment to patients in very remote locations will always carry higher transaction costs than delivering treatment to patients in readily accessible locations such as urban or suburban centers. Absent this rule, however, treating patients in these remote areas would likely require opening not just one more registered location, but many. DEA is confident that the operating costs of a single mobile NTP servicing a wide geographic area will always be less than those of multiple additional registered NTP locations that would be required to treat the patients dispersed throughout the same area.
Additionally, DEA recognizes that some mobile components may indeed travel greater distances than the 100 miles per week estimated in the proposed rule. However, DEA considers this mileage estimate to be a reasonable average of the weekly distance any particular mobile component might travel to treat patients, especially when factoring in mobile components that will operate in more densely-packed urban and suburban settings. As another commenter noted, operating a mobile component may also result in higher cost savings than what is presented in the regulatory analysis due to the possible increased volume of patients treated by a mobile component. Again, DEA's analysis represents average cost savings when comparing the operation of a mobile NTP with a registered location, and therefore, this is factored into the agency's conclusions below.
Regarding one commenter's challenge that the labor costs for the healthcare professionals needed to staff a mobile component would likely be prohibitive, DEA assumes that the labor required to provide MAT services are the same in a mobile component and a registered NTP setting. Therefore, any particular NTP would incur those labor costs when choosing to expand operations, whether via starting a mobile component or opening an additional registered NTP location.
DEA agrees with the commenter stating that this rule is likely to result in an increase in quality of life and personal dignity for previously untreated patients who are able to receive care from a mobile NTP. DEA believes that these benefits are already discussed in the regulatory analysis below, and no further expansion is necessary.
DEA also agrees with the commenter's summation that the framework for the analysis presented in the regulatory impact analysis of this rule is a marginal cost framework,
One commenter suggested that DEA revise the proposed amendment, 21 CFR 1301.13(4)(ii), to state explicitly that mobile NTPs are allowed to conduct the necessary medical and psychosocial services required to induct and maintain MAT/medications for opioid use disorder (MOUD); to utilize a Qualified Service Organization Agreement (QSOA) with an entity or entities that can provide these services; and to provide counseling services electronically (
Another commenter noted that the proposed rule did not include guidance on ancillary requirements for NTP patients such as toxicology and serology, and stated that the NTP registrant should be required to indicate whether physical examinations, toxicology testing, and serology testing would be conducted in the mobile NTP or at the registered NTP location. The commenter also asked if the mobile NTP could conduct these services, and if not, recommended that the rule include clear guidance as to where these services could be provided or if these services could be conducted in coordination with a partner, like a hospital.
Finally, another commenter suggested that the final rule should expressly state that services such as infectious disease screenings and harm reduction interventions are available in mobile NTPs just as they are at the registered NTP locations. As these mobile NTP components are to operate as “coincident,” or equivalent, to the registered NTP location, the commenter suggested, a mobile NTP should provide most or all of the same supplemental services that are logistically possible. The commenter stated further that the exclusion of such language could be interpreted as prohibiting these critical public health interventions that are essential to addressing disparate rates of sexually transmitted and other infectious diseases among persons with substance use disorder, especially those who inject drugs.
In the preamble of the proposed rule, DEA stated it was proposing to waive the requirement of a separate registration for NTPs that utilize mobile components, and that specifically, an NTP would be permitted to dispense narcotic drugs in schedules II-V at location(s) remote from, but within the
Some commenters noted that existing mobile NTPs have proven to be helpful in providing treatment for incarcerated individuals; however, no specific examples were provided. Another commenter, a non-profit organization, gave an example where mobile NTPs in Atlantic County, New Jersey provide medication (methadone, buprenorphine, and naltrexone) and counseling to inmates onsite, and link those being released from correctional facilities to community-based NTPs. The non-profit also stated that one NTP that shared that its mobile NTP had treated more than 1,000 inmates in more than two years, and that these inmates subsequently had a lower recidivism rate compared to the general correctional facility population. Other commenters cited studies that showed how access to MAT services would decrease the rates of recidivism and post-release mortality as patients successfully transition from the correctional environment into an outpatient treatment setting. Two commenters both referenced data from a study in Rhode Island; the commenters reported that the data showed that offering MAT during incarceration and upon release resulted in a 60 percent decrease in overdose mortality among people who were recently incarcerated. One of the commenters described the study as “recent,” but neither provided a specific citation for the study.
Finally, a pharmaceutical manufacturer sought clarity for itself, and its treatment provider customers, on whether NTPs operating a mobile component as described in the proposed rule would be allowed to regularly use the mobile component to transport and provide NTP services, including methadone treatment, to inmates housed in correctional facilities. The manufacturer believed the plain language of the proposed rule's legal authority, as well as the proposed changes to 21 CFR 1301.13(e)(4), authorize a properly registered NTP operating a mobile component to dispense narcotic drugs for addiction treatment to inmates at a correctional facility.
Several commenters expressed concern that SAMHSA's current requirement of daily dosing at the initiation of methadone treatment would limit the reach of newly operationalized mobile components to just one region/one community, given that a mobile component would have to repeatedly return to the same location(s) each day to provide daily methadone doses to newly initiated patients. To expand access to treatment, the commenters urged DEA to work with SAMHSA to revise regulations restricting take-home medications. Four commenters also suggested that DEA should work with SAMHSA to allow NTP providers to prescribe medications to be filled at community pharmacies and to allow non-NTP providers to prescribe methadone.
DEA is using its discretion to approve mobile components under the authority granted to it by the CSA. 21 U.S.C. 822(d). Any NTP that wishes to use a mobile component for maintenance or detoxification treatment will be able to start the approval process once the final rule has been published to ensure that all interested NTPs would be subject to the same requirements.
One commenter recommended that the rule acknowledges that States may have additional requirements for NTPs beyond the Federal regulations. The commenter also inquired if all requirements that apply to a registered NTP location apply to a mobile component. The commenter expressed concern that without explicit guidance, it could lead to a misinterpretation of NTP requirements. The commenter also recommended adding language to the proposed regulation to clarify the expectation that a mobile NTP will provide services beyond the administration of the medication, such as counseling.
DEA's NTP regulations seek to minimize diversion or abuse of the controlled substances dispensed by NTPs, but DEA does not establish broader treatment standards for NTPs. Thus, to the degree commenters wish
DEA regulations in 21 CFR 1301.28 include provisions for exemption from separate registration requirements for individual practitioners dispensing or prescribing schedule III-V narcotic controlled drugs approved by FDA for maintenance or detoxification treatment provided they meet certain conditions, including being a “qualifying physician” or “qualifying other practitioner,” as defined in 21 U.S.C. 823(g)(2)(G)(ii) or (g)(2)(G)(iv), respectively. Thus, the request to clarify the role of Hospital/Clinic in accordance with 21 CFR 1301.28 is beyond the scope of this final rule.
DEA continually reviews the programs that fall under its regulatory authority; if it determines that adjustments are required to ensure compliance or to ensure that the rule's effect is more successful, the appropriate action will be taken.
DEA is finalizing the proposed rule with certain modifications to 21 CFR 1300.01, 1301.13, and 1301.72. In brief, this rule slightly revises the mobile NTP definition at § 1300.01(b) from that proposed. The definition is revised to clarify that it is the operation of the mobile NTP (
Also, this rule revises the proposed new § 1301.13(e)(4) by adding a third subparagraph (iii) to clarify that a mobile NTP may operate at a location or locations, including correctional facilities, away from, but within the same State as, the NTP's registered location. Previously, the proposed rule was silent as to correctional facilities. Relatedly, in several places, references in the proposed rule to the remote “location” where the mobile NTP operates are replaced with references to the mobile NTP's “location or locations” to clarify that a mobile NTP can operate at more than one remote location under appropriate circumstances.
This rule revises the proposed new § 1301.72(e) to allow the mobile component to be parked at the registered location or any secure, fenced-in area when the mobile component is not in use. Prior to parking the conveyance at a secure, fenced-in location, all controlled substances must be removed from the conveyance and returned to the registered location and, the local DEA office must be notified of the location of
This final rule does not change the proposed new requirement in § 1301.72(e), that upon completion of the operation of the mobile NTP on a given day, the conveyance must be immediately returned to the registered location, and all controlled substances must be removed from the conveyance and secured within the registered location. However, this rule adds a provision in § 1301.72(e) that expressly allows NTPs to apply for an exception to this requirement, following the process set forth in 21 CFR 1307.03, which allows any person to apply for an exception to any provision of the DEA regulations. In addition, the revised § 1301.72(e) specifically provides that the application must include certain other information, and that DEA will evaluate each application on a case-by-case basis to determine whether the applicant has demonstrated exceptional circumstances that warrant a waiver of the daily return requirement.
Finally, this rule makes a variety of minor changes in capitalization, abbreviation, word choice, and grammar throughout the regulatory text, but these are not intended as substantive revisions. For example, whereas the proposed text used both “narcotic treatment program” and “NTP,” the revised text more consistently uses “NTP” throughout. Similarly, proposed new § 1301.74(j) and (l) referred to an NTP “physician,” whereas the revised text uses the more general term “practitioner.”
Below are summaries of provisions contained in the final rule.
In section 1300.01, DEA adds a definition for a mobile NTP. This definition reflects that a mobile NTP is an NTP operating from a motor vehicle that serves as a mobile component of the NTP. As such, a mobile NTP engages in maintenance and/or detoxification treatment with narcotic drugs in schedules II-V, at a location or locations remote from, but within the same State as, the registered NTP, and operates under the registration of the NTP. Because the mobile NTP definition references a motor vehicle, DEA also separately defines “motor vehicle” as a vehicle propelled under its own motive power and lawfully used on public streets, roads, or highways with more than three wheels in contact with the ground; a motor vehicle does not include a trailer in this context. Therefore, a trailer could not serve as a mobile NTP.
DEA regulations have always required that all registrants maintain effective security to guard against theft and diversion of controlled substances.
In this final rule, DEA revises section 1301.13 to make operating a mobile component of an NTP a coincident activity of an existing NTP registration, provided the NTP has obtained prior approval from the local DEA office. DEA intends to reduce the regulatory burden on NTPs by waiving the separate DEA registration requirement, as discussed above, and allowing them to operate a mobile component of an NTP in the same State as the registered NTP, under its existing registration. As a result, the mobile component of a registered NTP will not have to apply for a separate registration, as its operation is considered coincident activity. In addition, DEA specifies in the regulations that the records generated during the operations of a mobile component of an NTP shall be maintained at the NTP's registered location, rather than requiring such records to be stored in the mobile component. Section 1301.13 is also revised to explicitly state that registered NTPs may operate mobile components at correctional facilities where otherwise permitted by law.
DEA revises section 1301.72 to ensure controlled substances in a mobile component of an NTP are protected against theft and diversion. To achieve this end, the security requirements under 21 CFR 1301.72(a)(1) and 21 CFR 1301.72(d) apply to the mobile component of an NTP. The storage area for controlled substances in a mobile component of an NTP must not be accessible from outside the vehicle. The requirement to secure the controlled substances in a securely locked safe in the conveyance will assist in adequately securing the controlled substances. Since small quantities of controlled substances will be present in the mobile component, DEA is requiring that the safe used by these mobile components have safeguards against forced entry, lock manipulation, and radiological attacks. The safe must also be bolted or cemented to the floor or wall in such a way that it cannot be readily moved. DEA is also requiring that the safe be equipped with an alarm system that transmits a signal directly to a central protection company or a local or State police agency which has a legal duty to respond, or a 24-hour control station operated by the registrant, or such other protection as the Administrator may approve if there is an attempted unauthorized entry into the safe.
Upon completion of the operation of the mobile NTP on a given day, the conveyance will need to immediately return to the registered location, and all controlled substances removed from the conveyance and secured within the registered location. After the controlled substances have been removed, the conveyance may be parked until its next use at the registered location or any secure, fenced-in area, once the local DEA office has been notified of the location of this secure, fenced-in area. If the mobile component is disabled for any reason (mechanical failure, accident, fire, etc.), the registrant will be required to have a protocol in place to ensure that the controlled substances on the conveyance are secure and accounted for. If the conveyance is taken to an automotive repair shop, all controlled substances will need to be removed and secured at the registered location.
NTPs will not be required to obtain a separate registration for conveyances (mobile components) utilized by the registrant to transport controlled substances away from registered locations for dispensing within the same State at unregistered locations. Vehicles must possess valid county/city and State information (
Regarding the requirement for the mobile NTP to return daily to the registered location, and to store its controlled substances at the registered location, DEA revises 21 CFR 1301.72(e) to expressly allow the NTP to apply for an exception to this requirement, following the process set forth in 21 CFR 1307.03. In addition, the revised § 1301.72(e) specifically provides that the application must include the proposed alternate return period, enhanced security measures, and any other factors the applicant wishes the Administrator to consider. DEA will evaluate each application on a case-by-case basis to determine whether the
DEA revises 21 CFR 1301.74 to include mobile components of DEA-registered NTPs, since the existing regulations do not contain such a provision. As described in the revisions to section 1301.74, personnel who are authorized to dispense controlled substances for narcotic treatment must ensure proper security measures and patient dosage. For example, DEA is now requiring that persons enrolled in any NTP, including those who receive treatment at a mobile NTP, wait in an area that is physically separated from the narcotic storage and dispensing area by a physical entrance such as a door or other entryway.
Mobile NTPs may only be stocked with narcotic drugs in schedules II-V from the registered NTP location. Personnel designated to transfer narcotic drugs in schedules II-V from the registered location to mobile NTPs are not able to: Receive narcotic drugs in schedules II-V from other mobile NTPs or any other entity; deliver narcotic drugs in schedules II-V to other mobile NTPs or any other entity; or conduct reverse distribution of controlled substances on a mobile NTP. Any controlled substances being transported to the registered NTP location for disposal from the dispensing location(s) of the mobile component shall be secured and disposed of in compliance with 21 CFR part 1317 and all other applicable Federal, State, tribal, and local laws and regulations.
Finally, the physical security controls of mobile components will need to be implemented by the NTP pursuant to 21 CFR 1301.72 and 1301.74. In the event of a security breach in which controlled substances are lost or stolen, the registrant must determine the significance of the loss and comply with the theft and significant loss reporting requirements in 21 CFR 1301.74(c).
Under the final rule, the recordkeeping requirements of 21 CFR part 1304 apply to mobile components of NTPs. DEA revises sections 1304.04 and 1304.24 to include mobile components. As with registered NTP locations, the records of the mobile components will be stored at the registered location of the NTP in a manner that meets all applicable security and confidentiality requirements, and must be readily retrievable.
21 CFR 1304.24(b) requires that an NTP maintain the records, required by 21 CFR 1304.24(a), in a dispensing log at the registered location. It is understood that this log is in paper form. As an alternative to maintaining a paper dispensing log, DEA is permitting an NTP or its mobile component to also use an automated/computerized data processing system for the storage and retrieval of its dispensing records, if a number of conditions are met: The automated system maintains the same information required in 21 CFR 1304.24(a) for paper records; the automated system has the capability of producing a hard copy printout of the program's dispensing records; the NTP or its mobile component prints a hard copy of each daily dispensing log, which is then initialed appropriately by each practitioner who dispensed medication to the NTP's patients; and the automated system is approved by DEA.
The NTP's computer software program must be capable of producing accurate summary dispensing reports for the registered NTP location and its mobile component, for any time-frame selected by DEA personnel during an investigation. Further, if summary reports are maintained in hard copy form, they should be stored in a systematically organized file at the registered location of the NTP. Additionally, a back-up of all computer generated records of dispensing by the NTP and its mobile component is required to be maintained off-site.
Finally, NTPs are required to retain all records for the registered NTP location as well as any mobile components for two years from the date of execution. This time period is the same period as that required by 21 CFR 1304.04(a). However, because some States require that records be retained for longer than two years, the NTP should contact its State opioid treatment authority for information about State requirements.
DEA examined each of the provisions of the final rule to estimate its economic impact. DEA's analytic approach focuses on comparing the costs and/or cost-savings of a “no action” baseline regulatory environment with the costs and/or cost-savings of the regulatory environment that would result from the promulgation of this final rule. This is the standard analytic framework codified in the Office of Management and Budget (OMB) Circular A-4, published on September 17, 2003. This final rule is an enabling rule designed to expand access to MAT offered by NTPs in underserved communities. Previously, DEA had only authorized mobile NTPs on an ad hoc basis, and had placed a moratorium on further such authorizations in 2007. Thus, DEA compared the costs of delivering MAT services in a baseline regulatory environment, in which no new mobile NTPs are authorized, to the costs of delivering an equivalent level of MAT services in the final rule's regulatory environment, in which a registered NTP may begin to operate a mobile component as a coincident activity, if authorized by DEA. This analysis, detailed below, finds that this final rule will result in a cost savings for DEA-registered NTPs in the form of reduced startup, labor, and operating costs of MAT services delivered via a mobile component. DEA also recognizes that this final rule is likely to result in benefits in the form of economic burden reductions (healthcare costs, criminal justice costs, and lost productivity costs) as access to treatment for underserved communities is expected to expand. However, DEA does not have a basis to estimate the totality of this benefit with any accuracy since data on the number of patients treated via existing mobile components are not available. Thus, while these benefits are not quantified, DEA expects that this final rule will result in a net benefit to society.
MAT has been shown to be an effective opioid treatment option—a 2014 meta-analysis concluded that MAT has significantly increased treatment retention and decreased illicit opioid use.
Without this rule permitting registered NTPs to operate mobile components as coincident activity, an NTP wishing to provide MAT services to patient populations with little or no access to an NTP would be required to register and open another NTP location in the underserved geographic area. The many fixed capital and operating expenses associated with the startup and ongoing operation of a new facility discourage providers from doing this. For example, registrants would be required to obtain another NTP registration at $296 per year and incur the cost of renting additional office space, and ensuring that the new location meets DEA requirements, that it is appropriately licensed by the State, and that it is accredited by an accrediting organization approved by SAMHSA. Additionally, opening a new location would entail additional staffing and facilities costs. Under the final rule's regulatory provisions, registrants are able to operate a mobile component as a coincident activity of their existing registered location, foregoing the expenses of opening and operating a new registered location, in favor of the comparatively lower cost of operating a mobile component.
DEA believes it is reasonable to assume that in any given geographic region, the fixed capital expenses of opening a new registered location (most significantly office rent) will always exceed the capital expenses of operating a mobile component (most significantly the purchase price of a conveyance to be converted to a mobile NTP). These major capital expenses are discussed and compared in detail in the following paragraph; however, it is important to first set boundaries for this analysis by discussing what costs will not be included and why. DEA assumes that two significant expenses are the same for both activities, and therefore, are excluded from the analysis: The labor required to dispense narcotic drugs in schedules II-V, and the cost to outfit an NTP office or mobile conveyance with sufficient medical and office equipment. Labor costs are considered to be equal for both activities as the final rule does not change the requirements for the personnel that are authorized to dispense controlled substances. Whether an NTP expands via a new registered location or a mobile component, DEA assumes that the registrant would need to expand the quantity and type of labor required to dispense narcotic drugs in schedules II-V, at the same rate for both. However, it is likely that registered locations would be required to employ a medical administrative assistant to handle records management, billing, and reception; functions that a mobile component of an existing NTP would outsource to the labor provided by the associated registered NTP. DEA assumes that a new registered NTP location requires one medical assistant, and calculates the total annual compensation for this medical assistant to be $48,994.
DEA also recognizes that there are startup costs that will be the same for both activities. This includes the purchase of medical equipment and basic office supplies, and the installation of an alarm system compliant with 21 CFR 1301.72(a)(iii). Such startup costs are accordingly also omitted from this analysis. Whether MAT services are being rendered via a mobile NTP or the traditional office environment, the same type and quantity of labor, medical equipment, and security equipment is assumed necessary to deliver the same amount of treatment while adhering to DEA regulations.
According to the National Association of Realtors, the average annual price per square foot for office space throughout the United States was $46 in the first quarter of 2017 (the most recent year in which this figure was updated).
There are also several operating expenses that are unique to a mobile component that should be factored into this analysis. The first is the cost of the narcotic safe and associated installation costs. DEA recognizes that while both a mobile component and a traditional NTP office require a safe, the confined space of a mobile component likely requires some amount of customization in the installation process in order to meet the requirements of 21 CFR 1301.72(a)(1). To account for this unique installation cost, DEA doubled the highest quoted price of the safe
Comparing the present value of the costs associated with operating a mobile NTP over a five-year period with the present value of the costs associated with opening an additional NTP location over a five-year period yields a net present value of cost savings between $319,069 (at a 7 percent discount rate) and $359,369 (at a 3 percent discount rate) for the operation of a mobile NTP. The comparison of costs between the baseline and proposed regulatory environment are summarized in the tables below:
DEA
For the reasons outlined in the comparative analysis discussed above, DEA concludes that moving from the baseline regulatory environment to the regulatory environment of the final rule results in a cost reduction for NTP registrants that wish to expand their services to new geographic areas, and will spur an increase in the number of mobile NTPs. Therefore, this final rule is a deregulatory action that will result in a net cost savings between $3,509,759 and $3,953,059.
This final rule was developed in accordance with the principles of Executive Orders (E.O.) 12866 and 13563. E.O. 12866 directs agencies to
For a number of years, DEA has allowed registered NTPs to utilize mobile components as part of their programs through special arrangements with local DEA field offices. The use of these mobile components was in response to the opioid epidemic that is currently affecting the nation. With the number of deaths attributed to overdoses increasing, the demand for access to medication-assisted treatment increased. In many areas, this has resulted in long wait lists and high service fees for services provided by NTPs. Alternative guidelines and methods were sought to increase accessibility to treatment for people with substance use disorder, including OUD, especially in rural areas or areas where NTPs are not accessible, or to allow those who have health conditions that prevent them from traveling long distances to receive maintenance or detoxification treatment. Mobile components associated with the registered NTP were seen as an alternative because they increased accessibility to treatment in the areas that needed it.
This final rule builds on the existing experience and provides additional flexibility for NTPs in operating mobile components, subject to regulatory restrictions put into place to prevent the diversion of controlled substances. DEA is revising 21 CFR 1301.13 to make operating a mobile component of an NTP a coincident activity of an existing NTP registration, and this provision will reduce the regulatory burden on NTPs by waiving the separate DEA registration requirement. These mobile NTPs are required to maintain effective security to guard against theft and diversion of controlled substances in accordance with 21 CFR 1301.72. The mobile NTPs are also subject to the recordkeeping requirements in 21 CFR 1304.04 and 1304.24. Many of the current mobile NTPs are already following these regulatory requirements. This final rule ensures that these regulatory requirements can be enforced consistently over any current or future NTP wishing to operate a mobile NTP.
Thus, this final rule will enable any NTP registered with DEA to engage in an activity that was previously authorized through special arrangements with DEA field offices. Furthermore, DEA's purpose for allowing registered NTPs to operate a mobile component as a coincident activity is to expand the availability of MAT in accordance with the priorities outlined in the President's Commission on Combating Drug Addiction and The Opioid Crisis, published on November 1, 2017.
While the findings of the regulatory impact analysis of this final rule support the conclusion that this rulemaking is not economically significant, the Office of Information and Regulatory Affairs (OIRA) has nonetheless determined that the final rule is a “significant regulatory action” under E.O. 12866, section 3(f). Accordingly, this rule has been reviewed by OIRA.
This final rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of E.O. 12988, Civil Justice Reform, to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burden.
This final rule does not have federalism implications warranting the application of E.O. 13132. The final rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
This final rule does not have tribal implications warranting the application of E.O. 13175. It does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.
In accordance with the Regulatory Flexibility Act (RFA), DEA evaluated the impact of this final rule on small entities. DEA's evaluation of economic impact by size category indicates that the final rule will not have a significant economic impact on a substantial number of these 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 purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. DEA evaluated the impact of this rule on small entities and discussions of its findings are below.
To determine the final rule's effect on small entities, DEA must first calculate the total number of affected entities. To do this, DEA must determine the total number of NTP entities in the United States, as those are the entities that are able to take advantage of this enabling rule.
DEA begins with the number of relevant DEA registrations—that is, NTP registrations. The number of NTP entities differs from the number of NTP registrations, however, because NTP entities often hold more than one DEA registration, such as where a registrant handles controlled substances at multiple locations, requiring the entity to hold registrations for each of these locations. DEA does not, in the general course of business, collect or otherwise maintain information regarding associated or parent organizations holding multiple registrations. Therefore, to derive the total number of NTP entities from the number of NTP
To do so, DEA first determined the North American Industry Classification System (NAICS)
DEA then gathered economic data for those codes using the U.S. Census Bureau, Statistics of U.S. Businesses (SUSB). Specifically, DEA used the SUSB data to determine the number of “firms” and the number of “establishments” in the United States that correspond to each relevant NAICS code. (For the purposes of this analysis, the term “firm” as defined in the SUSB is used interchangeably with “entity” as defined in the RFA.) From this, DEA calculated a firm-to-establishment ratio—
Because
Thus, based on these calculations, DEA estimates that 1,026 entities could currently operate a mobile NTP, including the eight NTP entities that currently operate mobile NTP components. Of these, DEA estimates that at least an additional eleven entities will choose to operate a mobile NTP as a coincident activity in response to the final rule, matching the previous total of nineteen mobile NTPs that were in operation over the previous five years. Because the final rule is an enabling rule and thus does not affect entities that choose not to change their behavior in response to it, only NTP entities that choose to establish mobile NTP units will be affected by the rule. Therefore, DEA estimates that 1.07 percent (11 of 1,026) of total NTP entities in the United States will be affected by this final rule.
To estimate the number of NTP entities that are small entities for RFA purposes, DEA used a process similar to that used to estimate the total number of NTP entities. As described above,
DEA used SUSB data to estimate the number of small firms for each of these NAICS codes. In 2012, the last year for which the SUSB has published the necessary receipts data,
In consultation with the SBA's Office of Advocacy, DEA has adopted the SBA standard that the amount of small entities affected by a final rule is “substantial” if 30% or more of the relevant group of small entities will be affected by the rule. As described in the Summary of Costs and Benefits section, this final rule is an enabling rule and a deregulatory action resulting in a total cost savings of at least $3,509,759 over a five-year period. The final rule allows NTP registrants another option for expanding the reach of their services, if they so choose, without requiring that current or future NTP registrants change their business practices or incur any costs. DEA estimates that only an additional eleven entities will choose to operate a mobile NTP as a coincident activity in response to the final rule. Because the final rule is an enabling rule and thus does not affect entities that do not change their behavior in response to it, only these 11 NTP entities and the 8 NTPs currently operating units under ad hoc agreements are affected by the rule. Therefore, DEA estimates that 1.85 percent (19 of 1,026) of total NTP entities in the United States are affected by this final rule. DEA estimates that 11 NTPs not already operating a mobile NTP (or 1.07 percent of all NTPs) will choose to operate a mobile NTP. DEA has no reason to conclude that the percentage of small NTP entities that begin operating mobile components in response to the rule will differ from the percentage of total NTPs (11 of 1,026, or 1.07 percent), especially since most NTP entities are small. Thus, DEA estimates that 1.07 percent (9 of the 873
The nine affected small entities are estimated to realize the same cost savings as other affected entities, as calculated above: Between $319,069 (at a 7 percent discount rate) and $359,369 (at a 3 percent discount rate) per entity over a five-year period. DEA generally considers impacts that are greater than 3% of yearly revenue to be a “significant economic impact” on an entity, and recognizes that this amount of cost savings rises above that threshold for those small entities.
The table below summarizes the analysis.
DEA examined the economic impact of the final rule for each affected industry for various size ranges. Based on the analysis above, and because of these facts, DEA certifies this final rule will not have a significant economic impact on a substantial number of small entities.
In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 1501
This action does not impose a new collection of information requirement under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521. This action will not impose new recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. Although the final rule revises certain recordkeeping and reporting provisions to explicitly apply them to mobile NTPs, these provisions already apply to NTPs in general and thus do not impose any new collection of information requirement.
This final rule is not a major rule as defined by the Congressional Review Act (CRA), 5 U.S.C. 804. This final rule will not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets. Accordingly, this final rule is not subject to the reporting requirements under the CRA.
Chemicals, traffic control.
Administrative practice and procedure, Drug traffic control, Security measures.
Drug traffic control, Reporting and recordkeeping requirements.
For the reasons stated in the preamble, DEA amends 21 CFR parts 1300, 1301, and 1304 as follows:
21 U.S.C. 802, 821, 822, 829, 871(b), 951, 958(f).
(b) * * *
21 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877, 886a, 951, 952, 956, 957, 958, 965 unless otherwise noted.
(e) * * *
(1) * * *
(4) For any narcotic treatment program (NTP) intending to operate a mobile NTP, the registrant must notify the local DEA office, in writing, of its intent to do so, and the NTP must receive explicit written approval from the local DEA office prior to operating the mobile NTP. The mobile NTP may only operate in the same State in which the NTP is registered.
(i) Registrants are not required to obtain a separate registration for conveyances (mobile components) utilized by the registrant to transport controlled substances away from registered locations for dispensing at unregistered locations as part of a mobile NTP. Vehicles must possess valid county/city and State information (
(ii) A mobile NTP is not permitted to reverse distribute, share, or transfer controlled substances from one mobile component to another mobile component while deployed away from the registered location. NTPs with mobile components are not allowed to modify their registrations to authorize their mobile components to act as collectors under 21 CFR 1301.51 and 1317.40. Mobile components of NTPs may not function as hospitals, long-term care facilities, or emergency medical service vehicles, and will not transport patients.
(iii) A mobile NTP may operate at any remote location or locations within the same State as its registered location, including correctional facilities, so long as doing so is otherwise consistent with applicable Federal, State, tribal, and local laws and regulations, and so long as the local DEA office, when notified pursuant to this section, does not otherwise direct.
(e)
(2) With regard to the requirement of paragraph (e)(1) of this section, that upon completion of the operation of the mobile NTP on a given day, the conveyance must be immediately returned to the registered location, and all controlled substances must be removed from the conveyance and secured within the registered location, an NTP may apply for an exception to this requirement as provided in this paragraph. The application for such an exception must be submitted in accordance with § 1307.03 of this chapter and must include the proposed alternate return period, enhanced security measures, and any other factors the applicant wishes the Administrator to consider. The Administrator may grant such an exception in his discretion and will evaluate each application on a case-by-case basis in determining whether the applicant has demonstrated exceptional circumstances that warrant the exception. In making this determination, the Administrator will consider the applicant's security and recordkeeping as well as any other factors he deems relevant to determining whether effective controls against diversion will be maintained.
The revisions and additions read as follows:
(j) Persons enrolled in any narcotic treatment program (NTP), including those receiving treatment at a mobile NTP, will be required to wait in an area that is physically separated from the narcotic storage and dispensing area by a physical entrance such as a door or other entryway. Patients must wait outside of a mobile NTP component if that conveyance does not have seating or a reception area that is separated from the narcotic storage and dispensing area. This requirement will be enforced by the program practitioner and NTP employees.
(k) All NTPs, including mobile NTPs, must comply with standards established by the Secretary of Health and Human Services (after consultation with the Administration) respecting the quantities of narcotic drugs which may be provided to persons enrolled in a NTP or mobile NTP for unsupervised use (
(l) DEA may exercise discretion regarding the degree of security required in NTPs, including mobile NTPs, based on such factors as the location of a program, the number of patients enrolled in a program, and the number of practitioners, staff members, and security guards. Personnel that are authorized to dispense controlled substances for narcotic treatment must ensure proper security measures and patient dosage. Similarly, DEA will consider such factors when evaluating existing security or requiring new security at a narcotic treatment program or mobile NTP.
(m) Any controlled substances being transported for disposal from the dispensing location of a mobile NTP shall be secured and disposed of in compliance with part 1317, and all other applicable Federal, State, tribal, and local laws and regulations.
(n) A conveyance used as part of a mobile NTP may only be supplied with narcotic drugs by the registered NTP that operates such conveyance. Persons permitted to dispense controlled substances to mobile NTPs shall not:
(1) Receive controlled substances from other mobile NTPs or any other entity;
(2) Deliver controlled substances to other mobile NTPs or any other entity; or
(3) Conduct reverse distribution of controlled substances on a mobile NTP.
21 U.S.C. 821, 827, 831, 871(b), 958(e)-(g), and 965, unless otherwise noted.
(a) Each person registered or authorized (by § 1301.22 of this chapter) to maintain and/or detoxify controlled substance users in a narcotic treatment program (NTP), including a mobile NTP, shall maintain records with the following information for each narcotic controlled substance:
(1) Name of substance;
(2) Strength of substance;
(3) Dosage form;
(4) Date dispensed;
(5) Adequate identification of patient (consumer);
(6) Amount consumed;
(7) Amount and dosage form taken home by patient; and
(8) Dispenser's initials.
(b) The records required by paragraph (a) of this section will be maintained in a dispensing log at the NTP site, or in the case of a mobile NTP, at the registered site of the NTP, and will be maintained in compliance with § 1304.22 without reference to § 1304.03.
(1) As an alternative to maintaining a paper dispensing log, an NTP or its mobile component may also use an automated/computerized data processing system for the storage and retrieval of the program's dispensing records, if the following conditions are met:
(i) The automated system maintains the information required in paragraph (a);
(ii) The automated system has the capability of producing a hard copy printout of the program's dispensing records;
(iii) The NTP or its mobile component prints a hard copy of each day's dispensing log, which is then initialed appropriately by each person who dispensed medication to the program's patients;
(iv) The automated system is approved by DEA;
(v) The NTP or its mobile component maintains an off-site back-up of all computer generated program information; and
(vi) The automated system is capable of producing accurate summary reports for both the registered site of the NTP and any mobile component, for any time-frame selected by DEA personnel during an investigation. If these summary reports are maintained in hard copy form, they must be kept in a systematically organized file located at the registered site of the NTP.
(2) The NTP must retain all records for the NTP as well as any mobile component two years from the date of execution, in accordance with § 1304.04(a). However, if the State in which the NTP is located requires that records be retained longer than two years, the NTP should contact its State opioid treatment authority for information about State requirements.
Department of Defense (DoD) Office of General Counsel, DoD.
Interim final rule; correction.
The Department of Defense is correcting an interim final rule that appeared in the
This correction is effective on July 19, 2021.
Patricia Toppings, 571-372-0485.
In FR Doc. 2021-12815, appearing at 86 FR 32194-32215 in the
Coast Guard, DHS.
Final rule.
The Coast Guard is changing the operating schedule that governs the Welch Causeway (SR 699) Bridge, Gulf Intracoastal Waterway mile 122.8, at Madeira Beach, Florida. This change will place the drawbridge on a daily operating schedule to alleviate vehicle congestion due to on demand bridge openings and balance the needs of all modes of transportation due to the
This rule is effective July 28, 2021.
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 Clark W. Sanford, U.S. Coast Guard, Sector Saint Petersburg Waterways Management Division; telephone 727-824-7506, email
On December 18, 2020 the Coast Guard published a Test Deviation entitled Drawbridge Operation Regulation; Gulf Intracoastal Waterway, Madeira Beach, FL in the
On April 30, 2021, the Coast Guard published a Notice of Proposed Rulemaking, with a request for comments, entitled “Drawbridge Operation Regulation; Gulf Intracoastal Waterway, Madeira Beach, FL” in the
The Coast Guard is issuing this rule under authority 33 U.S.C. 499. The City of Madeira Beach, Florida has requested the current operating schedule be modified due to the increased economic growth and vehicle traffic in the area, as well as a school located in close proximity to the bridge. The bridge owner, Florida Department of Transportation (FDOT), is in support of the proposed changes.
The Welch Causeway (SR 699) Bridge across the Gulf Intracoastal Waterway, mile 122.8, at Madeira Beach, Florida is a double-leaf bascule bridge with a 25 foot vertical clearance at mean high water in the closed position and an 89 foot horizontal clearance between fenders. The normal operating schedule for the bridge is found in 33 CFR 117.287(h). Navigation on the waterway is commercial and recreational.
The Coast Guard is changing the operating schedule that governs the Welch Causeway (SR 699) Bridge, mile 122.8 at Madeira Beach, Florida. The bridge currently operates on demand, and will continue to open on demand with the following exception; from 7 a.m. to 7 p.m. daily, except Federal holidays, the draw need only open on the hour and half hour.
One comment was received. The commenter felt the bridge should remain on demand, not limit when vessels can pass and that better vehicle traffic control would solve any traffic congestion. Due to the increase in vehicle traffic, the Coast Guard has determined that placing the bridge on a schedule will alleviate some congestion while still meeting the reasonable needs of navigation. Additionally, vessels able to pass beneath the bridge without an opening may do so at any time.
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 protesters.
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. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget (OMB).
This regulatory action determination is based on the ability that vessels can still transit the bridge given advanced notice.
The Regulatory Flexibility Act of 1980 (RFA), 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 received zero comments from the Small Business Administration on this rule. 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 bridge 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 contact 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 calls for no 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
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 Management Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning Policy COMDTINST 5090.1 (series) which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f). The Coast Guard has 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 promulgates the operating regulations or procedures for drawbridges and is categorically excluded from further review, under paragraph L49, of Chapter 3, Table 3-1 of the U.S. Coast Guard Environmental Planning Implementation Procedures.
Neither a Record of Environmental Consideration nor a Memorandum for the Record are required for this rule.
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Bridges.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 117 as follows:
33 U.S.C. 499; 33 CFR 1.05-1; and Department of Homeland Security Delegation No. 0170.1.
(h) The draw of the Welch Causeway (SR 699) Bridge, Gulf Intracoastal Waterway mile 122.8, at Madeira Beach, Florida, shall open on signal; except that, from 7 a.m. to 7 p.m. daily, except Federal holidays, the draw need only open on the hour and half hour.
Coast Guard, DHS.
Notification of non-enforcement of regulation.
The Coast Guard will not enforce the Safety Zone for the Seattle Seafair Firework Display in Lake Washington, Seattle, WA in July 2021. The Captain of the Port Sector Puget Sound has determined that enforcement of this regulation is not necessary because Seafair the event was cancelled.
The Coast Guard does not plan to enforce the Safety Zone for the Seattle Seafair Firework Display in Lake Washington in 33 CFR 165.1332 in July 2021.
If you have questions about this notification of non-enforcement, call or email Lieutenant Peter McAndrew, Sector Puget Sound Waterways Management Division, U.S. Coast Guard; telephone 206-217-6051, email
The Coast Guard normally enforces the safety zone for the Seattle Seafair Firework Display in Lake Washington, Seattle, WA found in 33 CFR 165.1332 annually during the month of July. This year, the event organizers cancelled Seafair. Therefore, the Coast Guard does not plan to enforce the safety zone for the Seattle Seafair Firework Display in Lake Washington, Seattle, WA found in 33 CFR 165.1332, in July 2021.
In addition to this notification of non-enforcement in the
Coast Guard, DHS.
Notification of non-enforcement of regulation.
The Coast Guard will not enforce the safety zone for the Seafair Air Show Performance in Lake Washington, Seattle, WA in July and August 2021. The Captain of the Port Sector Puget Sound has determined enforcement of this regulation is not necessary because this event is cancelled.
The Coast Guard does not plan to enforce regulations in 33 CFR 165.1319 in July and August 2021.
If you have questions about this notification of non-enforcement, call or email Lieutenant Peter McAndrew,
The Coast Guard normally enforces the safety zone in 33 CFR 165.1319 for the Seattle Seafair Air Show Performance held in Lake Washington, Seattle, WA. This event is typically held annually during last week of July and the first 2 weeks of August. This year, the event organizers cancelled Seafair. Therefore, the Coast Guard does not plan to enforce the safety zone in 33 CFR 165.1319 in July or August 2021.
In addition to this notification of non-enforcement in the
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone for certain waters of the Upper Potomac River. The safety zone is needed to protect personnel, vessels, and the marine environment on these navigable waters at Washington, DC, on July 4, 2021, (with alternate date of July 5, 2021) from potential hazards during a fireworks display to commemorate the July 4th holiday. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port, Maryland-National Capital Region or a designated representative.
This rule is effective from 8 p.m. on July 4, 2021, through 11 p.m. on July 5, 2021.
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, 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 it is impracticable and contrary to the public interest to publish an NPRM because we must take immediate action to establish this safety zone by July 4, 2021, to respond to potential safety hazards associated with the the fireworks display. Potential safety hazards include the accidental discharge of fireworks, dangerous projectiles, and falling hot embers or other debris. Event planners did not notify the Coast Guard of the event until June 17, 2021.
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, Maryland—National Capital Region (COTP) has determined that potential hazards associated with the fireworks to be used in this July 4, 2021, display will be a safety concern for anyone near these fireworks discharge sites. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone before, during, and after the scheduled event.
This rule establishes a temporary safety zone from 8 p.m. on July 4, 2021, to 11 p.m. on July 5, 2021. The safety zone will cover all navigable waters of the Upper Potomac River, including the Tidal Basin, encompassed by a line connecting the following points: Beginning at the shoreline of West Potomac Park at position latitude 38°53′04.2″ N, longitude 077°02′52.7″ W, thence southwest to latitude 38°52′57.1″ N, longitude 077°02′59.9″ W, thence southeast to the northern extent of the George Mason Bridge at latitude 38°52′36.9″ N, longitude 077°02′29.0″ W, thence northeast along the bridge to the shoreline at latitude 38°52′44.1″ N, longitude 077°02′21.8″ W, thence west and north along the shoreline to latitude 38°52′55.6″ N, longitude 077°02′15.0″ W, thence northwest across the Tidal Basin to the shoreline at latitude 38°53′11.3″ N, longitude 077°02′27.9″ W, thence south and west along the shoreline to and terminating at the point of origin located in Washington, DC. The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters before, during, and after the scheduled 9:09 to 9:20 p.m. fireworks display. 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. This rule has not been designated a “significant regulatory action” under Executive Order 12866. Accordingly, this rule has not been reviewed by the
This regulatory action determination is based on the location, duration, and time-of-day of the safety zone. Vessel traffic will be able to safely transit around this safety zone, which will impact a small designated area of the Upper Potomac River for 3 hours during the evening when vessel traffic is normally low. Moreover, the Coast Guard will issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the 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 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 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 safety zone lasting only 3 hours that will prohibit entry within a portion of the Upper Potomac River, including the Tidal Basin. 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) To seek permission to enter, 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 vessels enforcing this section can be contacted on Marine Band Radio VHF-FM channel 16 (156.8 MHz).
(3) 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.
(d)
(e)
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes an exemption from the requirement of a tolerance for residues of the plant growth regulator 1-aminocyclopropane-1-carboxylic acid (1-ACC) in or on apples and stone fruit when used in accordance with good agricultural practices. Valent BioSciences, LLC., submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance for residues of the plant growth regulator 1-aminocyclopropane-1-carboxylic acid (1-ACC) in or on apples and stone fruit when used in accordance with good agricultural practices. This regulation eliminates the need to establish a maximum permissible level for residues of 1-aminocyclopropane-1-carboxylic acid (1-ACC).
This regulation is effective June 28, 2021. Objections and requests for hearings must be received on or before August 27, 2021 and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2019-0515, is available at
Charles Smith, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of 40 CFR part 180 through the Government Publishing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2019-0515 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before August 27, 2021. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2019-0515, by one of the following methods:
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•
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Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
In the
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .” Additionally, FFDCA section 408(b)(2)(D) requires that the Agency consider “available information concerning the cumulative effects of a particular pesticide's residues” and “other substances that have a common mechanism of toxicity.”
EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.
Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability, and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.
1-ACC is a naturally occurring non-protein amino acid found in all plants. It acts as a plant growth regulator (PGR), precursing ethylene, a plant hormone regulating a wide variety of vegetative and developmental processes. The only conversion of 1-ACC for residues will most likely be into ethylene, which would not be measurable as ethylene is a quickly dissipating gas. Ethylene has been reviewed by EPA and is exempt from tolerance (40 CFR 180.1016).
As a biochemical pesticide, 1-ACC is intended for use on apples and stone fruits for fruit thinning and enhanced return bloom and is foliarly applied with calibrated spray equipment (
With regard to the overall toxicological profile of the active ingredient 1-ACC, the active ingredient is of minimal toxicity through the acute oral, acute dermal and acute inhalation routes of exposure. The active ingredient is only mildly irritating to the eye and the skin; and it is not a dermal sensitizer. With regard to the subchronic toxicity, developmental toxicity, reproductive toxicity and mutagenicity data requirements for the active ingredient 1-ACC, all data requirements were satisfied by guideline studies. There were no adverse subchronic effects for any oral or dermal routes of exposure. The active ingredient was determined to be non-mutagenic, and no adverse effects were identified relative to either developmental toxicity or reproductive toxicity. Based on this toxicological profile, EPA did not identify any toxicological endpoints of concern for assessing risk for this chemical.
Additionally, humans have a history of safe natural exposure to 1-ACC as it is present in all fruits and vegetables and, therefore, is a regular part of the human diet. With specific regard to human oral toxicity, the Agency notes that the human digestive system has evolved to accommodate 1-ACC in its digestive processes.
As part of its qualitative risk assessment for 1-ACC, the Agency also considered the potential for exposure to residues of 1-ACC, including dietary and non-occupational exposures. EPA concludes that dietary (food and drinking water) exposures are likely to be negligible, due to the short half-life and biodegradable nature of the pesticide. It is noted that dietary exposures to the residues of 1-ACC are not anticipated to exceed the naturally occurring background levels as exogenously applied 1-ACC is highly biodegradable. It has a half-life of less than 8.5 days on the plant and is even more biodegradable in aqueous soil conditions. No residential uses have been proposed.
Based on 1-ACC's low toxicity, anticipated minimal dietary exposure, and history of safe consumption in foods, no risks of concern have been identified from aggregate exposure to 1-ACC. Similarly, no risks of concern were identified for cumulative exposures to 1-ACC since no common mechanism of toxicity was identified for either 1-ACC or its metabolites. Therefore, based on the lack of toxicity and expected negligible exposures, EPA has determined that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to 1-ACC.
A full explanation of the data upon which EPA relied and its risk assessment based on those data can be found within the November 16, 2020, document entitled “Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for 1-aminocyclopropane-1-carboxylic acid (ACC).” This document, as well as other relevant information, is available in the docket for this action as described under
Based on the Agency's assessment, EPA concludes that there is reasonable
An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation. However, the analytical methods Ultra High-Performance Liquid Chromatography-Tandem Mass Spectrometry is available to EPA for the detection and measurement of the pesticide residues
Therefore, an exemption is established for residues of 1-aminocyclopropane-1-carboxylic acid (1-ACC) in or on apple and stone fruit when used in accordance to good agricultural practices.
This action establishes an exemption from the requirement of a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), nor is it considered a regulatory action under Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
An exemption from the requirement of a tolerance is established for 1-aminocyclopropane-1-carboxylic acid (1-ACC) in or on apple and stone fruit when applied in accordance with good agricultural practices.
Environmental Protection Agency (EPA).
Final approval.
Pursuant to the Resource Conservation and Recovery Act (RCRA), the Environmental Protection Agency (EPA) is approving the Texas Commission on Environmental Quality's partial State Coal Combustion Residuals (CCR) Permit Program, which will now operate in lieu of the Federal CCR program, with the exception of certain provisions for which the State did not seek approval. EPA has determined that the Texas partial CCR permit program meets the standard for approval under RCRA. Facilities operating under the State's program requirements and resulting permit provisions are also subject to EPA's information gathering and inspection and enforcement authorities under RCRA and other applicable statutory and regulatory provisions.
The final approval of the Texas partial CCR Permit Program is effective on July 28, 2021.
Michelle Long, Office of Resource Conservation and Recovery, Materials Recovery and Waste Management Division, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue NW, MC 5304P, Washington, DC 20460; telephone number: (703) 347-8953; email address:
Throughout this document “we,” “us,” and “our” means the EPA.
1.
2.
EPA is approving, in part, the Texas CCR permit program, pursuant to RCRA section 4005(d)(1)(B). 42 U.S.C. 6945(d)(1)(B). The Texas CCR permit program authorizes the Texas Commission on Environmental Quality (“TCEQ” or the “commission”) to enforce state regulations related to CCR activities as well as to handle permit applications and to enforce permit violations. The Texas CCR permit program will operate in lieu of the Federal CCR program, (40 CFR part 257, subpart D) with the exception of the provisions for which the state did not seek approval, as further explained in Unit III.B. of this document. For the state provisions for which the state did not seek EPA approval, the corresponding Federal requirements will continue to apply directly to facilities, and therefore facilities must comply with both the Federal requirements and the state requirements.
The fact that Texas is receiving partial program approval does not mean the state must subsequently apply for a full program approval. However, Texas could choose to revise its CCR permit program at some point in the future and to apply for another partial or full program approval (as appropriate) based on its revisions at that time. EPA retains its inspection and enforcement authorities under RCRA sections 3007 and 3008, 42 U.S.C. 6927 and 6928, in the case of both partial and full program approvals.
EPA also engaged federally-recognized tribes within the State of Texas in consultation and coordination regarding the program authorizations for the TCEQ. EPA established opportunities for formal as well as informal discussion throughout the consultation period, beginning with an initial conference call on October 19, 2020. Tribal consultation was conducted in accordance with the EPA policy on Consultation and Coordination with Indian Tribes (
CCR are generated from the combustion of coal, including solid fuels classified as anthracite, bituminous coal, subbituminous coal, and lignite, for the purpose of generating steam to power a generator to produce electricity or electricity and other thermal energy by electric utilities and independent power producers. CCR, commonly known as coal ash, include fly ash, bottom ash, boiler slag, and flue gas desulfurization materials. CCR can be sent offsite for disposal or beneficial use, or disposed of in on-site landfills or surface impoundments.
On April 17, 2015, EPA published a final rule, creating 40 CFR part 257, subpart D, that established a comprehensive set of minimum Federal requirements for the disposal of CCR in landfills and surface impoundments (80 FR 21302) (“Federal CCR regulations” or “2015 CCR rule”). The rule created a self-implementing program which regulates the location, design, operating criteria, and groundwater monitoring and corrective action for CCR units, as well as the closure and post-closure care of CCR units. It also requires recordkeeping and notifications for CCR units. The Federal CCR regulations do not apply to “beneficial use” of CCR, as that term is defined in 40 CFR 257.53.
On August 5, 2016, EPA published a direct final rule (81 FR 51802), responding to an order issued by the United States Court of Appeals for the District of Columbia Circuit (D.C. Circuit) in
On July 30, 2018, EPA published a final rule,
On August 28, 2020, EPA published a final rule
EPA is issuing this action pursuant to sections 4005(d) and 7004(b)(1) of RCRA.
Under RCRA section 4005(d)(1)(A), 42 U.S.C. 6945(d)(1)(A), states seeking approval must submit to the Administrator “in such form as the Administrator may establish, evidence of a permit program or other system of prior approval and conditions under State law for regulation by the State of coal combustion residuals units that are located in the State.” EPA shall approve a state permit program if the Administrator determines that the state program will require each CCR unit located in the state to achieve compliance with either: (1) The Federal CCR requirements at 40 CFR part 257, subpart D; or (2) other state criteria that the Administrator, after consultation with the state, determines to be “at least as protective as” the Federal requirements.
RCRA section 7004(b) applies to all RCRA programs, directing that “public participation in the development, revision, implementation, and enforcement of any . . . program under this chapter shall be provided for, encouraged, and assisted by the Administrator and the States.” 42 U.S.C. 6974(b)(1).
Once a program is approved, the Administrator must review the approved state CCR permit program not less frequently than every 12 years, as well as no later than three years after a revision to an applicable section of 40 CFR part 257, subpart D or one year after any unauthorized significant release from a CCR unit located in the state. EPA also must review an approved program at the request of another state alleging that the soil, groundwater, or surface water of the requesting state is or is likely to be adversely affected by a release from a CCR unit in the approved state.
In a state with an approved state CCR permit program, EPA may commence administrative or judicial enforcement actions under section 3008 of RCRA, 42 U.S.C. 6928, if the state requests assistance or if EPA determines that an EPA enforcement action is likely to be necessary to ensure that a CCR unit is operating in accordance with the criteria of the state's permit program.
On September 11, 2020, the TCEQ submitted its state CCR permit program application to EPA Region 6 requesting approval of the State's partial CCR permit program. After receiving comments from EPA, Texas provided revisions to its Program Description on November 9, 2020, and November 23, 2020.
Throughout this document, EPA interchangeably uses the Texas terms of “registration” and “permit” and “Program Description” to mean the “Narrative” document as described in the
As discussed in Unit I.C. of this document, RCRA section 4005(d) requires EPA to evaluate two components of a CCR state permit program to determine whether it meets the standard for approval. RCRA section 4005(d)(1)(A) directs the state to provide evidence of a state permit program, in such form as EPA may determine. In turn, RCRA section 4005(d)(1)(B) directs EPA to approve the state program based upon a determination that the program “requires each coal combustion residuals unit located in the State to achieve compliance with the applicable [Federal or state] criteria.” In other words, the statute directs EPA to determine that the state has sufficient authority to require compliance from all CCR units located within the state. See also, 42 U.S.C. 6945(d)(1)(D)(ii)(I). To make this determination EPA evaluates the state's authority to issue permits and impose conditions in those permits, as well as the state's authority for compliance monitoring and enforcement.
EPA also determines during this portion of the review whether the state permit program contains procedures consistent with the directive in RCRA
Although 40 CFR part 239 applies to the approval of State Municipal Solid Waste Landfill (MSWLF) programs under RCRA section 4005(c)(1) rather than EPA's evaluation of CCR permit programs under RCRA section 4005(d), the specific criteria outlined in 40 CFR part 239 provide a helpful framework to examine the relevant aspects of a state's permit program. In addition, states are familiar with these criteria as a consequence of the MSWLF program (all states have MSWLF programs that have been approved pursuant to these regulations) and the regulations are generally regarded as protective and appropriate.
Consequently, EPA relied on the four categories of criteria outlined in 40 CFR part 239 as guidelines to evaluate an adequate permit program: permitting requirements, requirements for compliance monitoring authority, requirements for enforcement authority, and requirements for intervention in civil enforcement proceedings.
Second, EPA is to evaluate the adequacy of the technical criteria that will be included in each permit, to determine whether they are the same as the Federal criteria, or to the extent they differ, whether the modified criteria are “at least as protective as” the Federal requirements.
On that basis, EPA conducted an analysis of the Texas CCR permit program as described in its State CCR Permit Program Application, including a thorough analysis of the Texas CCR regulations and their adoption by reference of portions of 40 CFR part 257, subpart D. As noted, Texas has requested approval of its partial CCR permit program.
Based on this analysis, EPA has determined that the portions of the Texas CCR permit program that have been submitted for approval meet the standard in sections 4005(d)(1)(A) and (B) of RCRA. The Texas CCR permit program includes all the elements of an adequate CCR state permit program as discussed in more detail in Unit III.A. It also contains all of the technical criteria in 40 CFR part 257, subpart D, except for the provisions specifically discussed in Unit III.B. Consequently, EPA approves the Texas CCR permit program “in part.” 42 U.S.C. 6945(d)(1)(B). EPA's analysis and findings are discussed in greater detail in Unit III.B and in the Technical Support Document, which is available in the docket supporting this Action.
RCRA section 4005(d)(1)(A), 42 U.S.C. 6945(d)(1)(A), requires a state seeking program approval to submit to EPA an application with “in such form as the Administrator may establish, evidence of a permit program or other system of prior approval and conditions under state law for regulation by the state of coal combustion residuals units that are located in the State.” Although the statute directs EPA to establish the form of such evidence, the statute does not require EPA to promulgate regulations governing the process or standard for determining the adequacy of such state programs. EPA, therefore, developed the Guidance Document (82 FR 38685, August 15, 2017). The Guidance Document provides recommendations on a process and standards that states may choose to use to apply for EPA approval of its CCR permit programs, based on the standards in RCRA section 4005(d), existing regulations at 40 CFR part 239, and the Agency's experience in reviewing and approving state programs.
EPA evaluated the Texas CCR permit program using the process, statutory and regulatory standards discussed in the Units II.C and IV.A. EPA's findings are summarized below and provided in more detail in the Technical Support Document located in the docket supporting this preliminary determination. RCRA section 7004(b) applies to all RCRA programs, directing that “public participation in the development, revision, implementation, and enforcement of any . . . program under this chapter shall be provided for, encouraged, and assisted by the Administrator and the States.” 42 U.S.C. 6974(b)(1). In general, EPA considers that a state CCR permit program would meet the RCRA section 7004(b)(1) directive regarding public participation if the state program is consistent with the 40 CFR part 239 provisions. Although 40 CFR part 239 applies to approval of state MSWLF programs under RCRA 4005(c)(1), rather than EPA's evaluation of CCR permit programs under RCRA 4005(d), 40 CFR part 239 provides a helpful framework to more broadly examine the various aspects of the Texas CCR permit program. States are familiar with these criteria through the MSWLF permit program (all states with approved MSWLF permit programs have been approved pursuant to these regulations) and the regulations are generally regarded as protective and appropriate.
To complete its evaluation process, EPA relied on information contained in the Texas Application, as well as all materials submitted during the public comment period and at the public hearing. A summary of EPA's findings is provided in this Unit, organized by the program elements identified in the 40 CFR part 239 regulations and EPA's Guidance Document.
It is EPA's judgment that an adequate state CCR permit program will ensure that: (1) Existing and new facilities are permitted or otherwise approved and in compliance with either 40 CFR part 257 or other state criteria; (2) the state has the authority to collect all information necessary to issue permits that are adequate to ensure compliance with relevant 40 CFR part 257, subpart D requirements; and (3) the state has the authority to impose requirements for CCR units adequate to ensure compliance with either 40 CFR part 257, subpart D or such other state criteria that have been determined and approved by the Administrator to be at least as protective as 40 CFR part 257, subpart D.
EPA determined that the Texas approach to CCR registration applications and approvals is adequate. At Title 30 of the Texas Administrative Code (TAC) sections 352.101 through 352.141, Texas has State-specific provisions imposing requirements for CCR registration, registration characteristics and conditions, registration duration, registration amendments, and the issuance and transfer of registrations. 30 TAC section 352.101 specifically requires registration for the management or disposal of CCR in an existing landfill, in an existing or inactive surface impoundment, and for a new or lateral expansion of a landfill or surface impoundment. Such registrations are subject to the state's standard permit characteristics and conditions established in 30 TAC Chapter 305, Subchapter F (See 30 TAC section 352.111). Under 30 TAC section 352.121, a registration may be issued for the active life of the unit, as well as any post-closure care period, as needed; however, the registration may be revoked or amended at any time that the
Texas also requires that a change in a term, condition or provision of a registration requires an amendment pursuant to 30 TAC section 352.131. An application requesting an amendment is processed as a major amendment or a minor amendment in accordance with 30 TAC section 305.62. At 30 TAC section 305.62(c)(1), Texas describes a major amendment as “an amendment that changes a substantive term, provision, requirement, or a limiting parameter of a permit.” At 30 TAC section 305.62(c)(2), Texas describes a minor amendment as “an amendment to improve or maintain the permitted quality or method of disposal of waste, . . .” and which includes any other change “that will not cause or relax a standard or criterion which may result in a potential deterioration of quality of water in the state.” Under 30 TAC section 305.62(d), the executive director may initiate a major amendment or a minor amendment if good cause exists.
The Texas provision at 30 TAC section 352.141 prohibits the transfer of a registration from one person to another without complying with provisions of 30 TAC section 305.64 relating to the transfer of permits. Under 30 TAC section 305.64, the registrant or the transferee must submit an application to the executive director at least 30 days before the proposed transfer date and receive approval of the application from the commission before the registration can be transferred. The Texas regulations provide that a registration cannot be transferred from one facility to another. The specific CCR registration application requirements are established in 30 TAC sections 352.201 through 352.311 where Texas has State-specific provisions addressing CCR registration application contents and information requirements. Under 30 TAC sections 352.241 through 352.301, Texas requires sufficient information to ensure that all the 40 CFR part 257, subpart D technical requirements will be followed. Specifically, a registration application shall include sufficient information and reports to: (1) Characterize the geology and hydrogeology at the facility; (2) demonstrate compliance with location restrictions; (3) demonstrate compliance with design criteria; (4) demonstrate compliance with operating criteria; (5) demonstrate compliance with applicable groundwater monitoring and corrective action requirements; and (6) demonstrate compliance with applicable closure and post-closure requirements. The provision at 30 TAC section 352.311 requires the owner or operator to keep records of data used to complete the application and any supplemental information or material throughout the term of the registration.
At 30 TAC sections 352.401 through 352.481, Texas adopted State-specific provisions addressing procedures for registration application deficiencies, public notifications, and registration decisions by the executive director. As part of the State's evaluation of the completeness of a registration application, 30 TAC section 352.401 requires the executive director to notify an applicant of any additional information or application materials required to complete the application by transmitting a notice of deficiency (NOD) to the applicant. The NOD specifies a deadline for the NOD response of up to 60 days from the executive director's transmittal of the NOD. If the executive director does not receive an adequate and timely response to a notice of deficiency by the response deadline, the executive director may return the incomplete application to the applicant (30 TAC section 352.421).
EPA determined that the Texas approach to CCR registration applications and approvals is adequate, and that this aspect of the Texas CCR permit program meets the standard for program approval.
Based on RCRA section 7004, 42 U.S.C. 6974, it is EPA's judgment that an adequate state CCR permit program will ensure that: (1) Documents for permit determinations are made available for public review and comment; (2) final determinations on permit applications are made known to the public; and (3) public comments on permit determinations are considered. Texas has adopted public participation opportunities for the CCR program that can provide an inclusive dialogue, allowing interested parties to talk openly and frankly about issues within the CCR program and search for mutually agreeable solutions to differences. An overview of the Texas public participation provisions is provided below.
Under 30 TAC section 39.418, the TCEQ requires that no later than 30 days after the executive director declares an application to be complete, the applicant must publish a Notice of Receipt of Application and Intent to Obtain Permit in a newspaper of largest circulation in the county in which the facility is located, or, if a newspaper is not published in the county, the notice must be published in any newspaper of general circulation in the county in which the facility is located or proposed to be located. Registration applications are also made available to the public on the applicant's publicly accessible CCR internet site. Under 30 TAC section 352.461(a)(1), the applicant is also required to make a copy of the application available for review and copying at a public place in the county in which the facility is located. Upon completion of the application review, the TCEQ publishes a public notice of the TCEQ's receipt of the registration application, the executive director's initial decision on the application, and provides an opportunity for public comments or for the public to request a public meeting in accordance with the procedures contained in 30 TAC sections 39.503(c), 39.405(f) and 39.405(h).
30 TAC section 352.471 gives the executive director the authority to prepare a draft registration upon a preliminary determination that an application for a new registration or a major amendment of a registration meets the regulatory requirements for issuance of a registration. When the executive director has prepared a draft registration, copies of it are also made available to the public, along with a technical summary. The technical summary provides information regarding the application, staff review, and agency contacts available to assist members of the public in answering questions about the application. In addition, the commission records are open to the public for review subject to statutory privileges and claims of confidentiality consistent with the Texas Public Information Act. See Texas Government Code Annotated, Chapter 552 and 30 TAC 1.5.
30 TAC section 352.461 subjects all public notices to the requirements in (1) 30 TAC section 39.405 (relating to General Notice Provisions); (2) 30 TAC section 39.407 (relating to Mailing Lists); (3) 30 TAC section 39.409 (relating to Deadline for Public Comment, and for Requests for Reconsideration, Contested Case Hearing, or Notice and Comment Hearing); (4) 30 TAC section 39.411 (relating to Text of Public Notice); (5) 30 TAC section 39.413 (relating to Mailed Notice); and (6) 30 TAC section 39.420 (relating to Transmittal of the Executive Director's Response to Comments and Decision). 30 TAC section 352.431(c) requires that the text of the public notices on the application include the
Texas requires a minimum of a 30-day public comment period for CCR registration applications pursuant to 30 TAC section 352.431(d). Pursuant to 30 TAC section 352.431(e), the executive director shall consider all public comments received before the close of the public comment period. 30 TAC section 352.461(c) requires the executive director to prepare a response to all timely, relevant and material, or significant public comment. The executive director's response and decision are sent to the mailing list, including all commenters, as required under 30 TAC section 39.420.
Under 30 TAC section 352.451(a), the owner or operator and the commission may hold a public meeting under 30 TAC section 55.154 for a new CCR registration application or a major amendment to a CCR registration in the county in which the facility is located, based on the criteria of 30 TAC sections 39.503(e), 55.154(c) or 352.961(c), as cited in 30 TAC section 352.461(b). The purpose of a public meeting is to provide information and receive public comment. Under 30 TAC sections 39.503(e)(1) and 55.154(c)(1) through (2), the TCEQ is required to hold a public meeting upon request of a member of the legislature who represents the general area in which the facility is proposed to be located for an application for a new facility or when the executive director determines that there is substantial public interest in the application or proposed facility. 30 TAC section 39.503(e)(3) provides, for example, that a “substantial public interest” is demonstrated when a request for a public meeting is filed by a homeowners' or property owners' association formally organized or chartered and having at least ten members located in the general area in which the facility is located or proposed to be located; or a group of ten or more local residents, property owners, or businesses located in the general area in which the facility is located or proposed to be located. Finally, under 30 TAC section 352.961(c), a public meeting must be held on applications for registrations that authorize corrective action and selection of a remedy as provided in 40 CFR 257.96(e). 30 TAC section 352.451(c) requires that a notice of the public meeting must be provided in accordance with the procedures contained in 30 TAC section 39.503(e)(6), including newspaper publication and mailed notice from the chief clerk to persons listed in 30 TAC section 39.413.
30 TAC section 352.481 provides that the executive director's action on a CCR application for a new registration or an amendment of a registration is subject to 30 TAC sections 50.139 and 80.272 which provide the public with a right to file a rehearing request for decisions made in administrative hearing and a right to file a motion to overturn the executive director's action on an application decision.
EPA determined that the Texas approach to public participation requirements provides adequate opportunities for public participation in the permitting process sufficient to meet the standard for program approval.
It is EPA's judgment that an adequate permit program should provide the state with the authority to gather information about compliance, perform inspections, and ensure that information it gathers is suitable for enforcement. The TCEQ has compliance monitoring authority under its Texas Health and Safety Code (THSC) and the Texas Water Code (TWC). Specifically, THSC section 361.032 provides the authority for environmental investigators to enter public or private property and conduct inspections or investigate solid waste facilities, including CCR units. In addition, TWC section 5.102 gives the commission the powers to perform any acts specifically authorized by this code, another law, implied by this code, or other law necessary and convenient to the exercise of its jurisdiction, as provided by the laws of the state rules, orders and permits. The TCEQ Enforcement Division maintains compliance schedules and reviews the schedules regularly to determine whether a facility is complying with its schedule. If a facility fails to meet its compliance schedule, the facility is deemed to be in violation of the TWC, the THSC, or TCEQ rules.
EPA determined that these compliance monitoring authorities are adequate, and that this aspect of the Texas CCR permit program meets the standard for program approval.
It is EPA's judgment that an adequate state CCR permit program should provide the state with adequate enforcement authority to administer its state CCR permit program, including the authority to: (1) Restrain any person from engaging in activity which may damage human health or the environment, (2) sue to enjoin prohibited activity, and (3) sue to recover civil penalties for prohibited activity.
The TCEQ has adequate enforcement authority for its existing programs under TWC sections 5.512, 7.002, 7.032, 7.051, 7.052, 7.101, 7.103 and 7.105—7.110. Under TWC section 7.002, the state has the authority to initiate an enforcement action to enforce the provisions of the Texas Water Code, the Texas Health and Safety Code within the commission's jurisdiction, and rules adopted under those provisions. Under TWC section 5.512, the TCEQ has specific authority to issue an emergency order concerning an activity of solid waste management under its commission's jurisdiction, even if that activity is not covered by a permit, if it finds that an emergency requiring immediate action to protect the public health and safety exists.
The state also has the authority to sue in a court of competent jurisdiction and may enforce a state rule or a provision of a permit by injunction or other appropriate remedy that may include corrective action (TWC section 7.032). On request of the executive director, the attorney general may initiate a suit in the name of the state for injunctive relief (TWC section 7.032(e)).
The TCEQ may assess administrative penalties and civil penalties for solid waste violations under TWC section 7.051, 7.101, 7.103 and 7.105 through 7.110. Under TWC section 7.052(c) and
EPA determined that this aspect of the Texas CCR permit program meets the standard for program approval.
Based on section 7004 of RCRA, it is EPA's judgment that an adequate state CCR permit program should provide an opportunity for citizen intervention in civil enforcement proceedings. Specifically, the state must either: (a) Provide for citizen intervention as a matter of right or b) have in place a process to: (1) Provide notice and opportunity for public involvement in civil enforcement actions, (2) investigate and provide responses to citizen complaints about violations, and (3) not oppose citizen intervention when permissive intervention is allowed by statute, rule, or regulation.
Under TWC sections 7.075, and 7.110, Texas has specific authorities and the TCEQ rules that provide opportunity for public participation in state enforcement proceedings by allowing persons to comment or intervene in certain administrative and civil actions. Notice of the opportunity to comment on the action is published in the Texas Register. Specifically, TWC sections 7.075(a) and 7.110(a) and (b) allow for a 30-day public comment period for administrative enforcement actions and civil enforcement actions. The commission, under TWC section 7.075(b) and the Office of Attorney General under TWC section 7.110(c), must consider any written comments and may withdraw or withhold consent to a proposed order, judgment or other agreement if the comments disclose facts or considerations that indicate that the consent is inappropriate, improper, inadequate, or inconsistent with the requirements of the commission's statutes, rules, or permits.
The TCEQ rules also provide at least two other opportunities for public participation in enforcement actions, including: (1) When an agreement is reached in an enforcement action between a respondent and the executive director, by providing public notice in the Texas Register and a 30-day public comment period (30 TAC section 70.10(c)); and (2) by providing opportunity for public comments at commission meetings on enforcement orders, pursuant to the Texas Open Meetings Act under 30 TAC Chapter 10. Texas Water Code sections 5.176 through 5.1773 provides for a public process for submitting and participating in complaints about a matter within the commission's jurisdiction. If a complaint relating to an entity regulated by the commission is filed with the commission, the commission must notify the parties to the complaint at least quarterly of the status of the complaint until the complaint reaches final disposition. Additionally, in accordance with TWC section 5.176 through 5.1765, the commission maintains a public website that contains public education materials informing the public about the commission's complaint policies and procedures, the collection and preservation of citizen collected evidence, and the status of environmental complaints and pending enforcement actions, as well as administrative and judicial orders. Under TWC section 7.110(d), the Office of the Attorney General may not oppose intervention by a person who has standing to intervene as provided by Rule 60, Texas Rules of Civil Procedure.
EPA determined that these authorities provide for an adequate level of citizen involvement in the enforcement process, and that this aspect of the Texas CCR permit program meets the standard for program approval.
EPA has determined that the technical portions of the Texas CCR permit program that were submitted for approval meet the standard for partial program approval under RCRA section 4005(d)(1)(B)(i), 42 U.S.C. 6945(d)(1)(B)(i). To make this determination, EPA compared the technical requirements in the Texas CCR regulations submitted for approval to their analogs in 40 CFR part 257 to determine whether they differed from the Federal requirements, and if so, whether those differences met the standard in RCRA sections 4005(d)(1)(B)(ii) and (C), 42 U.S.C. 6945(d)(1)(B)(ii) and (C). The Texas CCR regulations are contained in 30 TAC Chapter 352, which in general are identical or analogous to the requirements of 40 CFR part 257, subpart D. At 30 TAC Chapter 352, the TCEQ largely adopted by reference the requirements of 40 CFR part 257, subpart D, and implements procedural requirements for a registration and compliance monitoring program to authorize CCR units subject to the Federal CCR regulations. Specifically, Texas adopted by reference 40 CFR 257.52, 40 CFR 257.53, 40 CFR 257.60 through 257.107, and the 40 CFR part 257 Appendices, as amended through August 5, 2016 (81 FR 51807), and as modified by the
In addition to the technical criteria in 30 TAC Chapter 352, Texas has adopted State-specific registration for CCR units and public participation requirements in 30 TAC sections 352.101 through 352.481; State financial assurance requirements in 30 TAC sections 352.1101 and 352.1111; and for certain activities, Texas has additional requirements for State notifications by owners and operators of CCR units, and State approvals by the executive director employed by the commission.
Specifically, in addition to what is required by 40 CFR part 257, the State CCR regulations contain additional State-specific requirements for the use of licensed professional engineers and geoscientists in 30 TAC section 352.4; use of laboratories accredited and certified by the State in 30 TAC section 352.5; State notifications and approvals for specific CCR activities by owners and operators in 30 TAC sections 352.731(b), 352.741(b), 352.831(b), 352.841(b), 352.902, 352.911(b) and (c), 352.931(b), 352.941(b) through (d), 352.951(c) through (e), 352.981(b) and (c), 352.1221(b) and 352.1241(b) and (c); pre-opening inspection requirements for new and lateral expansions of CCR landfills and surface impoundments in 30 TAC section 352.851; groundwater monitoring and corrective action in 30 TAC sections 352.911(d), 352.951(b) and 352.991; recordkeeping in 30 TAC section 352.1301(b); and posting of information on the publicly accessible website in 30 TAC section 352.1321(c) and (d). The TCEQ is seeking EPA approval of its partial state CCR permit program, pursuant to RCRA section 4005(d). The TCEQ's rules implement the Federal regulations promulgated through August 5, 2016, and as modified by
1. 30 TAC section 352.1(b)(2); this state provision is the analog to the Federal exclusion of inactive impoundments at inactive facilities, found at 40 CFR 257.50(e), that was vacated in
2. The state provision that is the analog to the Federal requirement that multiunit groundwater monitoring systems with unlined CCR surface impoundments must retrofit or close, found at 40 CFR 257.91(d)(2), which is no longer relevant, as all unlined CCR surface impoundments must close;
3. The state provision that is the analog to the Federal requirement that unlined CCR surface impoundments must retrofit or close after an assessment of corrective measures is required, found at 40 CFR 257.95(g)(5), which references a provision that was vacated in
4. 30 TAC sections 352.711(a)(4) and 352.1211(b); these state provisions relate to the date for unlined surface impoundments to cease receipt of waste. EPA has since revised the Federal regulation and the state has not adopted the Federal revision, found at 40 CFR 257.101(a)(1) or 257.101(b)(1)(i);
5. 30 TAC section 352.1231; this state provision is the analog to the Federal alternative closure requirements of CCR units, found at 40 CFR 257.103. EPA has since revised the Federal regulation and the state has not adopted the Federal revision.
With the exception of the five provisions noted above, EPA determined that the Texas CCR regulations contain all of the technical elements of the Federal CCR regulations, including requirements for location restrictions, design and operating criteria, groundwater monitoring and corrective action, closure requirements and post-closure care, recordkeeping, notification and publicly accessible CCR internet site posting requirements. The Texas CCR permit program also contains State-specific language, references, definitions, and State-specific requirements that differ from the Federal CCR regulations, but which EPA has determined to be “at least as protective as” the Federal criteria.
The effect of granting approval of a partial program is that the Texas CCR permit program will apply in lieu of the Federal regulations, with the exception of the five provisions for which the State did not seek EPA approval. For those provisions for which the State did not seek EPA approval, the corresponding Federal requirements will continue to apply directly to facilities, and therefore facilities must comply with both the Federal requirements and the state requirements.
EPA has therefore determined that the technical criteria in the Texas partial CCR permit program submitted for approval meet the standard for partial program approval under RCRA section 4005(d)(1)(B), 42 U.S.C. 6945(d)(1)(B).
EPA announced its proposal to approve, in part, the Texas CCR permit program, and a 60-day public comment period on December 8, 2020 (85 FR 78980). EPA also held a virtual public hearing on February 2, 2021. The public hearing provided interested persons the opportunity to present information, views, or arguments concerning EPA's proposal. Oral comments received during the public hearing are documented in the transcript of the hearing, which, along with the written comments received during the public comment period, is included in the docket for this Action.
EPA received 14 written public comments and 2 comments from the virtual public hearing during the comment period. The major comments received by EPA focused on five primary topics: 1. Lifetime Registrations, 2. Citizen Suit or Civil Intervention Provisions, 3. Partial Program and Texas Adoption of the Federal Regulations, 4. Groundwater Contamination, and 5. Issues with the Federal CCR Regulations. For several of these issues, EPA sent follow-up questions on March 23, 2021, to TCEQ; a copy of the TCEQ responses to the EPA questions
Furthermore, permits for the life of a CCR unit remain subject to periodic review by both Texas and EPA. First, 30 TAC section 352.131 (relating to registration amendments) contemplates review of registrations as part of the registration modification or amendment process. Additionally, facility-initiated amendment applications related to administrative, technical and/or operational changes would require a review of the application that may result in revisions to the CCR registration. TCEQ's EPA-approved MSWLF programs provides a helpful example of
Second, RCRA section 4005(d) requires EPA to periodically review state CCR permit programs or other system of prior approval; RCRA section 4005(d)(1)(D)(i)(I) requires review no less frequently than once every 12 years. Moreover, RCRA section 4005(d)(1)(D)(i)(II) provides that the Administrator shall review a state permit program not later than 3 years after the date on which the EPA revises the regulations for CCR units under 40 CFR part 257, subpart D. As a result, the state would be expected to submit a revised state CCR permit program application for elements of its program that are no longer as protective as the Federal CCR program. If the state fails to submit a revised permit program, the statute provides for EPA to issue a notice of deficiency and potentially to withdraw the program. 42 U.S.C. 6945(d)(1)(D)(ii), (iii). Additionally, RCRA 4005(d)(1)(D)(i)(III), provides that EPA will review a state program “not later than 1 year after the date of a significant release . . . that was not authorized at the time the release occurred, from a [CCR] unit located in that state.”
The comments suggest that during the approval process of a specific CCR registration, the public will not be able to present evidence of harm and malpractice as a reason or basis for rejection of a registration application. As a result of the inability to present such evidence, public participation in the registration application process will be severely restricted. Citizens will not be able to offer testimony and supporting evidence to demonstrate the need for more vigorous enforcement within a registration application. In sum, Texas' appears to sidestep or limit the community involvement process.
Furthermore, commenters said making registration applications that are not subject to a contested case or evidentiary administrative hearing conflicts with the General Notice Provisions found at 30 TAC section 352.461, which outlines the requirements for public notices such as mailing lists, established deadline for public comments, and the process for contested case hearings.
Texas has specific authorities that provide for public participation in state enforcement proceedings. First, Texas' program provides for notice and comment in enforcement actions. TWC sections 7.075(a) and 7.110(a) and (b) require a 30-day public comment period for administrative and civil enforcement actions. Furthermore, Texas must consider any written comments and may withdraw or withhold consent to a proposed order, judgment or other agreement if the comments disclose facts or considerations that indicate that the settlement is inappropriate, improper, inadequate, or inconsistent with the requirements of the commission's statutes, rules, or permits. See TWC sections 7.075(b), and 7.110(c). Texas also allows public comments at commission meetings on enforcement orders, pursuant to the Texas Open Meetings Act under 30 TAC Chapter 10.
Second, TWC section 5.176 through 5.1773 provides a process for investigating and responding to citizen complaints. Citizens have a right to file complaints with TCEQ regarding facility's regulated by TCEQ, and TCEQ must provide the complainant with status updates on the complaint at least quarterly until the complaint reaches final disposition. Additionally, in accordance with TWC section 5.176(b), TCEQ maintains a public website
Third, Texas has opportunities for citizen intervention in civil procedures. Under TWC section 7.110(d), the Office of the Attorney General may not oppose intervention by a person who has standing to intervene as provided by Rule 60, Texas Rules of Civil Procedure.
In addition to Texas' specific authorities providing for civil enforcement of state CCR regulations, citizens are provided enforcement opportunities under RCRA's citizen suit provisions. Citizen suits are authorized by RCRA section 7002(a). Citizens' ability to file RCRA citizen suits are not affected by RCRA section 4005(d), establishing a process for approving state CCR programs.
Finally, EPA disagrees that the Texas CCR permit program severely restricts citizen participation in the registration process by precluding the presentation of evidence with respect to alleged harm or malpractice. As a general matter, Texas' program provides for public notice and comment in the registration process and for major amendments as described in Unit III.A.2.a. More specifically, Texas' regulations pertaining to CCR units or public participation in state environmental permitting decisions do not include limitations on the type of comments the public can submit in response to a registration application. Additionally, TCEQ is required to consider all public comments received and prepare a response to all timely, relevant and material, or significant public comments. 30 TAC sections 352.431(e), 352.461(c). Citizens may also request a public meeting or contested case hearing pertaining to the registration application pursuant to 30 TAC sections 55.201, 55.154, and 352.451(a). Furthermore, citizens also have a right to seek judicial review of TCEQ's final decision on a registration application. A person affected by a final ruling, order, or decision of TCEQ may file a petition for judicial review within 30 days after the effective date of the decision (TWC section 5.351).
The Texas CCR permit program will require each CCR unit located in the state to achieve compliance with the regulations that are part of their approved program as well as the Federal CCR requirements that were mentioned above that are not being approved as part of the Texas CCR permit program.
Upon signature of today's notice, the partial Texas CCR permit program, as described in its Application and Units II and III, is approved. Because this is a partial program approval, only the state requirements that have been approved will operate in lieu of the analogous Federal requirements. Accordingly, owners and operators of CCR units in Texas will remain responsible for compliance with all applicable requirements in 40 CFR part 257 for which Texas did not seek approval listed in Unit III.B. EPA will implement such provisions under the Federal CCR program, until and unless Texas submits a revised CCR permit program application and receives approval for these provisions. A permit, or registration, issued by a state is not a shield for noncompliance with these 40 CFR part 257 provisions. For those CCR units that do not yet have CCR registrations, the Federal regulations at 40 CFR part 257 will remain in effect until such time that TCEQ registrations under its approved CCR permit program are in effect for those units.
RCRA section 4005(d)(1)(D) specifies that EPA will review a state CCR permit program:
• From time to time, as the Administrator determines necessary, but not less frequently than once every 12 years;
• Not later than 3 years after the date on which the Administrator revises the applicable criteria for CCR units under part 257 of title 40, CFR (or successor regulations promulgated pursuant to RCRA sections 1008(a)(3) and 4004(a));
• Not later than 1 year after the date of a significant release (as defined by the Administrator), that was not authorized at the time the release occurred, from a CCR unit located in the state; and
• In request of any other state that asserts that the soil, groundwater, or surface water of the state is or is likely
RCRA section 4005(d)(4)(B) also provides that in a state with an approved CCR permitting program, the Administrator may commence an administrative or judicial enforcement action under section 3008 if:
• The state requests that the Administrator provide assistance in the performance of an enforcement action; or
• After consideration of any other administrative or judicial enforcement action involving the CCR unit, the Administrator determines that an enforcement action is likely to be necessary to ensure that the CCR unit is operating in accordance with the criteria established under the state's permit program.
In accordance with 42 U.S.C. 6945(d), EPA is approving the Texas partial CCR state permit program.
In rule document 2020-26819, beginning on page 85866, in the issue of Tuesday, December 29, 2020, make the following corrections:
1. On page 85866, in the 2nd column, in the
2. On page 86261, in the 2nd column, in the 14th and 15th lines, “December 4, 2021” should read “December 4, 2020”.
Federal Communications Commission.
Final rule.
In this document, the Federal Communications Commission (Commission) takes steps towards establishing a spectrum allocation and licensing framework that will provide regulatory certainty and improved efficiency and that will promote innovation and investment in the United States commercial space launch industry. Specifically, in the Report and Order, the Commission allocates the 2200-2290 MHz band for space operations on a secondary basis to permit non-federal use in specific portions of this band for purposes of
Effective July 28, 2021.
Federal Communications Commission, 45 L Street NE, Washington, DC 20554.
Nicholas Oros, Deputy Chief, Policy and Rules Division, Office of Engineering and Technology, at (202) 418-0636 or
This is a summary of the Commission's
1. Commercial space launch entities are proliferating and are increasingly involved in all aspects of U.S.-based space activities, such as transportation of cargo and people into space, orbital launches to place satellites and other payloads into space, and suborbital launches. There are a growing number of companies offering services to both private entities and government organizations. For example, the National Aeronautics and Space Administration (NASA) has engaged two private companies to take cargo and crew to the International Space Station (ISS), and companies such as Space Exploration Technologies (SpaceX) and Northrop Grumman have completed numerous successful missions to the ISS. SpaceX has recently ferried people to the ISS, and Boeing is developing a spacecraft to do the same. Other companies, such as Virgin Galactic and Blue Origin, intend to take private citizens on suborbital flights. These commercial space launch companies are also actively transporting communications satellites into orbit. SpaceX, for example, has conducted over 100 launches. Several companies, such as Rocket Lab and Astra, are focusing on propelling small satellites into orbit. Bigelow Aerospace plans to deploy a manned space station. To support these commercial space ventures, entities such as the New Mexico Spaceport Authority, the Virginia Commercial Space Flight Authority and the Houston Airport System have established non-Federal spaceports.
2. The Commission adopts a footnote to the Allocation Table for specified frequencies in the 2200-2290 MHz band to support commercial space launches and enable continued growth of a vibrant commercial space industry. This allocation shall be limited to use by space operations for the telemetry and tracking operations of launch vehicles during pre-launch testing and space launch operations.
3. The
4. The 2200-2290 MHz band is currently allocated on a primary basis to multiple services for Federal use and is widely used. The only permitted non-Federal use of the band is for stations in the space research, space operation, and Earth exploration-satellite services to transmit to NASA's Tracking and Data Relay Satellite System (TDRSS) on a non-interference basis. According to NTIA, the 2200-2290 MHz band is heavily used by the Department of Defense (DoD) and other agencies and these uses are vital for mission-critical systems. NTIA emphasizes that use of the band during commercial launches must be carefully coordinated to protect these Federal operations and suggests that the commercial space launch industry be limited to four frequency segments to facilitate this coordination. Because of the importance of Federal systems in the band, NTIA supports adding a secondary non-Federal space operations allocation to this band instead of the proposed primary allocation. As the private sector began to participate in launch activities, companies needed access to spectrum to facilitate communications associated with launch activities, a need that has continued to increase in recent years. The STA mechanism that the Commission and NTIA have used to provide access to the 2200-2290 MHz band during launches is not ideal to handle the increased volume of commercial space launch activities because applicants are often required to file multiple STAs for a single launch and the STAs expire after six months. STA requests are coordinated with NTIA manually, through email, whereas other non-Federal applications requiring coordination are processed through the Office of Engineering and Technology's Frequency Assignment System (OFACS). In the
5. Although commenters disagreed as to whether a non-Federal allocation is warranted or whether continued reliance on STAs is acceptable, all commenters agreed that access to this band for telemetry during launches is necessary. The Commercial Spaceflight Federation expressed the importance of access to this band on a co-primary basis for launch telemetry and pointed out that allocating spectrum even on a secondary basis can eliminate the unnecessary STA process. A coalition of several space launch providers asserted that they must make one or more requests for STAs for every launch and reentry because no spectrum is currently allocated for these purposes, even on a secondary basis. SpaceX supports the first proposal to add a footnote to the U.S. Table providing a
6. SpaceX states that the STA process is suboptimal as commercial space launches are occurring more frequently. SpaceX explains that the STA process creates significant business planning challenges due to the lack of certainty regarding approval timing as it relates to the scheduled launch date as well as the inherent uncertainty of non-interference status. Both SpaceX and the Commercial Spaceflight Federation note that applicants have no visibility into the coordination process. According to SpaceX, implementing the proposed allocation will streamline licensing, reduce the amount of required coordination, and provide greater certainty regarding approvals. Orbital Sciences (now Northrop Grumman) endorses the addition of a co-primary allocation to a subset of the frequencies in the relevant band to remedy the STA process shortcomings—notably, that communications can be interrupted at any time and that it takes a significant amount of time to obtain STAs.
7. The Satellite Industry Association, Boeing, and Lockheed Martin argue that a non-Federal allocation in this band is unnecessary and that non-Federal launches currently enjoy
8. The Commission concludes that adopting a non-Federal secondary allocation for this band for use during commercial space launches will help meet the future needs of the growing commercial space industry. Adopting this new allocation is the first step in a process that will allow the Commission to adopt technical and other service rules to govern commercial launch operations which, in turn, will give operators more certainty with respect to spectrum use in these bands during commercial space launches. Access to spectrum under a more predictable, collaborative, and transparent regulatory process is important to the fledgling commercial space launch industry because of the large monetary investment required for each launch. By operating on a regular, licensed basis, commercial space operators will have certainty as to which frequency bands can be used for non-federal space launch operations, which will promote the advance planning and investment necessary for future space launch activities. Although there will be coordination with NTIA prior to each launch, the Commission will continue to work with NTIA to facilitate efforts to streamline the coordination process to further improve certainty with respect to spectrum access. The need for reliable access to launch spectrum is becoming even more important as commercial launch operators shift beyond cargo supply activities into manned space missions. SpaceX recently completed a successful manned mission to the ISS and Boeing is developing a craft to take people to the ISS. The Commission also notes that the current process of obtaining an STA places burdens on launch providers, which must prepare numerous duplicative applications. Significantly, SpaceX and Blue Origin, who have obtained dozens of STAs for spectrum in the 2200-2290 MHz band, favor an allocation in lieu of continued reliance on STAs. As the U.S. commercial space industry continues to expand, the Commission expect the burdens and uncertainties associated with continuing the current STA process would only increase.
9. The Commission is not convinced by the claims of several commenters that there is no need for change because the current STA process provides
10. Adopting a non-Federal Space Operation allocation for the 2200-2290 MHz band will allow us to develop rules that meet the specific needs of the commercial space industry, rather than trying to stretch the experimental rules to meet these unique needs. There are several reasons for this. First, because the dynamics for frequency use during launch activities are now well established, they are no longer considered truly experimental and should be transitioned to a set of permanent rules to bring certainty to the process. Second, because of the nature of experimentation, which often involves transmitters that have not gone through the equipment approval process, the rules governing experimental use do not provide any long term sustainability or interference protection from allocated services. Third, the Commission finds that carving out a specific exemption from our experimental rules to provide interference protection for launch activities—as requested by Boeing, Lockheed Martin, and the Satellite
11. As advised by NTIA, the Commission is adopting a secondary Space Operation service allocation for the 2200-2290 MHz band rather than the primary allocation proposed in the
12. The Commission believes that providing access to the spectrum by adding a footnote to the U.S. Table is a better alternative than establishing an allocation in the U.S. Table for these bands. Adding a footnote instead of establishing an allocation is consistent with existing precedent that an allocation that is lightly used or highly restricted is implemented by using a footnote rather than placing in the U.S. Table. In this case, use of the band will continue to be restricted even as the U.S. commercial space industry continues to grow because of the need to coordinate with the Federal operations in the band. The Commission notes that either a direct table entry or footnote entry will provide future space operations licensees with equivalent status in the band.
13. Hence, the Commission is implementing this secondary non-Federal Space Operation allocation by adding a footnote (US96) to the 2200-2290 MHz band in the U.S. Table. This footnote limits use of the allocation to use during pre-launch testing and during space launch operations; requires coordination with NTIA prior to each launch; and limits non-Federal use to the 2208.5-2213.5 MHz, 2212.5-2217.5 MHz, 2270-2275 MHz, and 2285-2290 MHz portions of the 2200-2290 MHz band. The limitation to use during pre-launch testing and space launches is consistent with NTIA's advisement as well as the proposal in the
14. The limitation on non-Federal use of the band to the 2208.5-2213.5 MHz, 2212.5-2217.5 MHz, 2270-2275 MHz, and 2285-2290 MHz portions of the band was requested by NTIA. The
15. In addition, the Commission will not add developmental testing to the permitted uses of the Space Operations allocation, as requested by SpaceX and the Commercial Spaceflight Federation. As SpaceX admits, developmental testing is relatively infrequent and likely to occur at only a few discrete locations. Such testing can, and should, be conducted under Part 5 experimental licenses.
16. When the Commission proposed allocating the three band segments in the 2200-2290 MHz band for commercial launch operations, the Commission also invited comment on whether the spectrum in those band segments would be sufficient to support the expected growth of the commercial launch industry. In its comments, SpaceX requests that the Commission expand the lower sub-band proposed in the
17. Adopting a non-Federal allocation for the 2200-2290 MHz band, however, is only a first step in providing licenses for commercial launch operations. In the
18.
19. The Commission concludes based on the record that other bands are not suitable alternatives to the 2200-2290 MHz band for telemetry to support space launch operations. No commenters supported use of 2360-2395 MHz as a replacement for the 2200-2290 MHz band. The increasing use of the 2200-2290 MHz band for space launch telemetry justifies the allocation the Commission is adopting. Allowing access to the 2200-2290 MHz band for commercial space launches will allow space launch providers to benefit from the economies of scale inherent from using the same radio systems for both Federal agencies and commercial customers. Requiring commercial space launches to use another band, such as 2360-2395 MHz, would require space launch providers to develop separate communications systems for use depending on whether the space launch operation they are conducting is considered a Federal or non-Federal launch. Such an approach would impose considerable burden on the nascent commercial space launch industry, undermining the United States' leadership on space-based services.
20.
21. All industry commenters who addressed this issue opposed the restriction to Federal launch ranges. The New Mexico Spaceport Authority is concerned that this restriction may prevent access to spectrum for launches at FAA-licensed commercial launch sites and argues that limiting use of this band to Federal ranges would be inconsistent with the National Space Policy. SpaceX claims to be pursuing a launch site that is not in a Federal range. The New Mexico Spaceport Authority and SpaceX suggest permitting use of the spectrum at both Federal ranges and FAA-licensed launch sites. Blue Origin would not be able to operate its New Shepard launch vehicle in its current configuration with the Federal range limitation, because it launches from a private site in West Texas that is not an FAA-licensed launch site and is not co-located with a Federal range. NTIA has requested that non-Federal use of the 2200-2290 MHz band be limited to use during space launches and pre-launch testing at Federal ranges and FAA-licensed launch sites.
22. The Commission will not restrict the locations where the new non-Federal allocation for the 2200-2290 MHz band may be used. The Commission recognizes that as the commercial space industry continues to develop, launches will likely not be limited to Federal ranges, and, consequently, the Commission does not believe it would be in the public interest to limit future non-Federal space launch operations to Federal ranges. The Commission also will not adopt the alternative suggested by NTIA and some commenters that the Commission limit use of this non-Federal allocation to FAA-licensed launch sites. As the FAA does not require that all launches be conducted at locations where it has issued a launch site license, restricting use of the allocation to launches at FAA-licensed launch sites would prevent some launch providers from obtaining a license for this spectrum band. Regardless of where a launch occurs, the Commission will require coordination with NTIA. However, because of the expense involved in constructing a launch site and the need to conduct launches at remote locations because of safety concerns, the Commission expects the number of locations where launches will occur to remain small. Consequently, our decision should not significantly increase the burden on NTIA and Federal agency coordinators.
23.
24.
25. All commenters addressing this issue urge the Commission to consider all launches licensed by the FAA to be non-Federal. SpaceX claims that none of the factors listed in the
26. A threshold issue for deciding whether a Commission license is required is the Communications Act's provision excluding radio stations “belonging to and operated by the United States” from the Commission's jurisdiction. If radio equipment used during a launch both belongs to and is operated by the United States Government, no Commission license is necessary. Otherwise, a Commission license is required. While launches that require FAA licensing might be expected to involve operation of non-Federal stations and require a Commission license, our jurisdiction is defined in the Communications Act. The key determination under the Communications Act is whether the radio equipment at issue belongs to and is operated by the United States Government. Consistent with the Communications Act, all radio equipment supporting space launches require a Commission license or authorization prior to transmitting, unless such equipment “belong[s] to and [is] operated by the United States [Government].”
27.
28.
29.
30. The Commission has determined, and the Administrator of the Office of Information and Regulatory Affairs, Office of Management and Budget, concurs that this rule is non-major under the Congressional Review Act, 5 U.S.C. 804(2). The Commission will send a copy of this Report & Order to Congress and the Government Accountability Office pursuant to 5 U.S.C. 801(a)(1)(A).
31. Accordingly,
32.
33.
34.
Communications equipment, Radio, Telecommunications.
For the reasons discussed in the preamble, the Federal Communications
47 U.S.C. 154, 302a, 303, and 336, unless otherwise noted.
The revision and addition read as follows:
US96 The band 2200-2290 MHz is allocated to the space operation service (space-to-Earth) on a secondary basis for non-Federal use subject to the following conditions. Non-Federal stations shall be:
(a) Restricted to transmissions from the launch vehicle in the sub-bands 2208.5-2213.5 MHz, 2212.5-2217.5 MHz, 2270-2275 MHz, and 2285-2290 MHz (necessary bandwidth shall be contained within these ranges);
(b) Restricted to use for pre-launch testing and space launch operations, except as provided under US303; and
(c) Subject to coordination with NTIA prior to each launch.
Department of State.
Final rule.
The Department of State (DOS) is adopting as final an interim rule amending the Department of State Acquisition Regulation (DOSAR) to provide new guidance prescribing more stringent safety requirements for certain overseas construction and services projects.
This final rule is effective on June 28, 2021.
Ms. Tandra Jones, Office of the Procurement Executive, A/OPE, 1735 North Lynn Street, Room 442, Arlington VA 22209. Telephone 703-875-6643.
The Department of State published an Interim Rule, Public Notice 9703, at 82 FR 58351, on December 12, 2017, with a request for comments. The comment period closed February 12, 2018. No comments on the rule were received.
In accordance with 5 U.S.C. 553(a)(2), which exempts from the Administrative Procedure Act matters relating to contracts, the Department published this rulemaking as an interim final rule, and provided 60 days for public comment.
This rulemaking is not a “rule” as defined by the Regulatory Flexibility Act (5 U.S.C. 601
This final rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any year and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Act of 1995.
This rule is not a major rule as defined by the Small Business Regulatory Enforcement Act of 1996 (5 U.S.C. 801
Executive Orders (E.O.) 12866 and 13563 direct agencies to assess 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 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility.
The Department has reviewed the regulation to ensure its consistency with the regulatory philosophy and principles set forth in the Executive Orders and finds that the benefits of this rule outweigh any costs, which the Department assesses to be minimal. This interim final rule is not subject to the requirements of Executive Order 13771 because this final rule has been determined to be non-significant within the meaning of the Executive Order 12866.
This rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with section 6 of Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to require consultations or warrant the preparation of a federalism summary impact statement.
The Department has determined that this rulemaking will not have tribal implications, will not impose substantial direct compliance costs on Indian tribal governments, and will not pre-empt tribal law. Accordingly, the requirements of Executive Order 13175 do not apply to this rulemaking.
This final rule does not impose or modify any information collections under the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). The information collection related to this rulemaking has been assigned OMB Control Number 1405-0050.
Government procurement.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS implements an accountability measure (AM) for commercial king mackerel in the northern zone of the Gulf of Mexico (Gulf) exclusive economic zone (EEZ). NMFS projects that the commercial quota for king mackerel in the northern zone of the Gulf EEZ has been reached. Therefore, NMFS closes the northern zone of the Gulf EEZ to commercial king mackerel fishing on June 28, 2021. This closure is necessary to protect the Gulf king mackerel resource.
The closure is effective at 12:01 a.m., local time, June 28, 2021, until October 1, 2021.
Kelli O'Donnell, NMFS Southeast Regional Office, telephone: 727-824-5305, email:
The fishery for coastal migratory pelagic fish in the Gulf includes king mackerel, Spanish mackerel, and cobia in the Gulf and on the east coast of Florida, and is managed under the Fishery Management Plan for the Coastal Migratory Pelagic Resources of the Gulf of Mexico and Atlantic Region (FMP). The FMP was prepared by the Gulf of Mexico and South Atlantic Fishery Management Councils. The FMP is implemented by NMFS under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622. All weights described for king mackerel in the Gulf EEZ apply as either round or gutted weight.
The commercial annual catch limit (equal to the commercial quota) for the Gulf migratory group of king mackerel (Gulf king mackerel) is 2.74 million lb (1.24 million kg). Commercial fishing for Gulf king mackerel is divided into multiple zones for management purposes. The commercial quota for Gulf king mackerel in the northern zone is 493,200 lb (223,712 kg) for the current fishing year, October 1, 2020, through September 30, 2021 (50 CFR 622.384(b)(1)(ii)).
The northern zone for Gulf king mackerel is located in the EEZ between a line at 87°31.6′ W longitude, which is a line extending due south of the state boundary of Alabama and Florida, and a line at 26°19.48′ N latitude, which is a line extending due west from the boundary of Lee and Collier Counties in southwest Florida 50 CFR 622.369(a)(1)(ii).
Regulations at 50 CFR 622.388(a)(1)(i) require NMFS to close the commercial sector for Gulf king mackerel in the northern zone when the commercial quota is reached, or is projected to be reached, by filing a notification to that effect with the Office of the Federal Register. NMFS has determined the commercial quota for Gulf king mackerel in the northern zone has been reached. Accordingly, NMFS closes the northern zone to commercial fishing for Gulf king mackerel effective from 12:01 a.m., local time, on June 28, 2021, 2021, through September 30, 2021, the end of the current fishing year.
During the closure, a person on board a vessel that has been issued a valid Federal commercial or charter vessel/headboat permit for coastal migratory pelagic fish may continue to retain the king mackerel in the northern zone under the recreational bag and possession limits specified in 50 CFR 622.382(a)(1)(ii) and (a)(2), as long as the recreational sector for Gulf king mackerel in the northern zone is open (50 CFR 622.384(e)(1)).
Also during the closure, Gulf king mackerel from the closed zone, including those harvested under the bag and possession limits, may not be purchased or sold. This prohibition does not apply to king mackerel from the closed zone that were harvested, landed ashore, and sold prior to the closure and were held in cold storage by a dealer or processor (50 CFR 622.384(e)(2)).
NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act. This action is required by 50 CFR 622.384(e) and 622.388(a)(1)(i), which were issued pursuant to section 304(b) of the Magnuson-Stevens Act, and is exempt from review under Executive Order 12866.
Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice and an opportunity for public comment on this action, as notice and comment are unnecessary and contrary to the public interest. Such procedures are unnecessary because the rule implementing the commercial quota and the associated AM has already been subject to notice and public comment, and all that remains is to notify the public of the closure. Such procedures are also contrary to the public interest because of the need to immediately implement the closure to protect the Gulf king mackerel stock. The capacity of the fishing fleet allows for rapid harvest of the commercial quota and the quota has already been met. Prior notice and opportunity for public comment would require time and could result in additional harvest.
For the aforementioned reasons, there is good cause to waive the 30-day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3).
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS implements an accountability measure (AM) for commercial Spanish mackerel in the northern zone of the Atlantic exclusive economic zone (EEZ). NMFS projects that the commercial quota for Spanish mackerel in the northern zone of the Atlantic EEZ will be reached by June 28, 2021. Therefore, NMFS closes the northern zone in the Atlantic EEZ to commercial harvest of Spanish mackerel on June 28, 2021. This closure is necessary to protect the Spanish mackerel resource in the Atlantic.
This temporary rule is effective at 12:01 a.m., eastern time, on June 28,
Mary Vara, NMFS Southeast Regional Office, telephone: 727-824-5305, or email:
The fishery for coastal migratory pelagic fish in the Atlantic includes king mackerel, Spanish mackerel, and cobia on the east coast of Florida, and is managed under the Fishery Management Plan for Coastal Migratory Pelagic Resources of the Gulf of Mexico and Atlantic Region (FMP). The FMP was prepared by the Gulf of Mexico and South Atlantic Fishery Management Councils. The FMP is implemented by NMFS under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622. All weights described for Spanish mackerel in the Atlantic EEZ apply as either round or gutted weight.
The commercial annual catch limit (equal to the commercial quota) for the Atlantic migratory group of Spanish mackerel (Atlantic Spanish mackerel) is 3.33 million lb (1.51 million kg). Atlantic Spanish mackerel are divided into northern and southern zones for management purposes. The northern zone commercial quota for Atlantic Spanish mackerel is 662,670 lb (300,582 kg) for the current fishing year, which is March 1, 2021, through February 28, 2022 (50 CFR 622.384(c)(2)(i)).
The northern zone for Atlantic Spanish mackerel extends in Federal waters from New York through North Carolina. The northern boundary of the northern zone extends from an intersection point off New York, Connecticut, and Rhode Island at 41°18′16.249″ N latitude-71°54′28.477″ W longitude, and proceeds southeast to 37°22′32.75″ N latitude and the intersection point with the outward boundary of the EEZ. The southern boundary of the northern zone extends from the North Carolina and South Carolina state border along a line in a direction of 135°34′55″ from true north beginning at 33°51′07.9″ N latitude-78°32′32.6″ W longitude to the intersection point with the outward boundary of the EEZ (50 CFR 622.369(b)(2)). See Figure 2 of appendix G to part 622—Spanish Mackerel for an illustration of the management zones.
Regulations at 50 CFR 622.388(d)(1)(i) require NMFS to close the commercial sector for Atlantic Spanish mackerel in the northern zone when the commercial quota for that zone is reached, or is projected to be reached, by filing such a notification with the Office of the Federal Register. NMFS projects that the commercial quota of 662,670 lb (300,582 kg) for Atlantic Spanish mackerel in the northern zone will be reached by June 28, 2021. Accordingly, the commercial sector for Atlantic Spanish mackerel in the northern zone is closed effective at 12:01 a.m., eastern time, on June 28, 2021, through February 28, 2022, the end of the current fishing year.
During the commercial closure, a person on a vessel that has been issued a valid Federal commercial permit to harvest Atlantic Spanish mackerel may continue to retain this species in the northern zone under the recreational bag and possession limits specified in 50 CFR 622.382(a)(1)(iii) and (a)(2), if recreational harvest of Atlantic Spanish mackerel in the northern zone has not been closed (50 CFR 622.384(e)(1)).
Also during the closure, Atlantic Spanish mackerel from the northern zone, including those harvested under the recreational bag and possession limits, may not be purchased or sold. This prohibition does not apply to Atlantic Spanish mackerel from the northern zone that were harvested, landed ashore, and sold prior to the closure and were held in cold storage by a dealer or processor (50 CFR 622.384(e)(2)).
NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act. This action is required by 50 CFR 622.8(b), 622.384(e)(2), and 622.388(d)(1)(i), which were issued pursuant to section 304(b) of the Magnuson-Stevens Act, and is exempt from review under Executive Order 12866.
Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice and an opportunity for public comment on this action, as notice and comment are unnecessary and contrary to the public interest. Such procedures are unnecessary because the rule implementing the commercial quota and the associated AM has already been subject to notice and public comment, and all that remains is to notify the public of the closure. Such procedures are also contrary to the public interest because of the need to immediately implement the closure to protect Atlantic Spanish mackerel, because the capacity of the fishing fleet allows for rapid harvest of the commercial quota. Prior notice and opportunity for public comment would require time and could result in a harvest that exceeds the established commercial quota.
For the aforementioned reasons, the Acting Assistant Administrator for NMFS also finds good cause to waive the 30-day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3).
16 U.S.C. 1801
Agricultural Marketing Service, USDA.
Proposed rule.
This proposed rule would adjust the number of member seats apportioned to each district represented on the Florida Tomato Committee (Committee). The Department of Agriculture (USDA) is taking this action based on an amendatory change to the marketing order for tomatoes grown in Florida, which reduced the size of the Committee from 12 members to 10. This action would reduce the member seats in each of the two districts from six members and their alternates to five members and their alternates.
Comments must be received by July 28, 2021.
Interested persons are invited to submit written comments concerning this proposal. Comments must be sent to the Docket Clerk, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250-0237; Fax: (202) 720-8938; or internet:
Steven W. Kauffman, Marketing Specialist, or Christian D. Nissen, Regional Director, Southeast Marketing Field Office, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA; Telephone: (863) 324-3375, Fax: (863) 291-8614, or email:
Small businesses may request information on complying with this regulation by contacting Richard Lower, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, or email:
This action, pursuant to 5 U.S.C. 553, proposes an amendment to regulations issued to carry out a marketing order as defined in 7 CFR 900.2(j). This proposed rule is issued under Marketing Agreement No. 125 and Order No. 966, as amended (7 CFR part 966), regulating the handling of tomatoes grown in Florida. Part 966 (referred to as the “Order”) is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” The Committee locally administers the Order and is comprised of producers operating within the production area.
The Department of Agriculture (USDA) is issuing this proposed rule in conformance with Executive Orders 12866 and 13563. Executive Orders 12866 and 13563 direct 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). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. This action falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review.
This proposed rule has been reviewed under Executive Order 13175—Consultation and Coordination with Indian Tribal Governments, which requires agencies to consider whether their rulemaking actions would have tribal implications. AMS has determined this proposed rule is unlikely to 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.
This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. This proposed rule is not intended to have retroactive effect.
The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.
This proposed rule invites comments on changes to the Committee membership as prescribed in the Order. USDA is taking this action as a conforming change following amendments to the Order published in the
Section 966.22 provides for the establishment of membership on the Committee. The ten members and their alternates shall be producers, or officers or employees of a corporate producer, in
Section 966.25 provides the authority for the Committee to recommend, with the approval of the Secretary, reapportionment of members among districts, and the reestablishment of districts within the production area. Section 966.161 apportions Committee membership among the two districts pursuant to § 966.25.
The Committee met on November 1, 2018, and February 27, 2019, to recommend changes to the Order. These recommendations included reducing the Committee size from 12 members to 10; reducing the number of districts in the production area from four districts to two, maintaining that membership on the Committee be divided evenly between the two districts. The reduction to two districts and the reapportionment of Committee membership that provided equal representation of six members in each of those newly formed districts were completed under a separate rulemaking action published in the
During the Committee's discussion of the amendments and the reduction in Committee size, members indicated they wanted to maintain the equity in membership between the two districts. With the reduction in the Committee size from 12 members and their alternates to 10 members and their alternates, this rule would make a conforming change to the Committee membership as apportioned in § 966.161. This action would reduce the seats in each district from six members and their alternates to five members and their alternates. This would maintain the equitable representation on the Committee and bring the number of apportioned seats in line with the reduced number of members authorized in the Order.
Accordingly, each district would nominate five members and five alternates for a total of 10 members and 10 alternate nominees to serve on the Committee.
Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this proposed rule on small entities. Accordingly, AMS has prepared this initial regulatory flexibility analysis.
The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.
There are approximately 65 producers of Florida tomatoes in the production area and 41 handlers subject to regulation under the Order. Small agricultural producers are defined by the Small Business Administration (SBA) as those having annual receipts less than $1,000,000 and small agricultural service firms are defined as those whose annual receipts are less than $30,000,000 (13 CFR 121.201).
With an estimated producer price of $14.00 per 25-pound container, the number of Florida tomato producers, and a normal distribution assumed, the average annual producer revenue is above $1,000,000, ($14.00 times 22.3 million containers equals $312,200,000 divided by 65 producers equals $4,803,077 per producer). Thus, the majority of producers of Florida tomatoes may be classified as large entities.
According to industry and Committee data, the average annual price for fresh Florida tomatoes during the 2019-20 season was approximately $19.07 per 25-pound container, and total fresh shipments were 22.3 million containers. Using the average price and shipment information, the number of handlers, and a normal distribution assumed, the majority of handlers have average annual receipts of less than $30,000,000, ($19.07 times 22.3 million containers equals $425,261,000 divided by 41 handlers equals $10,372,220 per handler). Thus, the majority of handlers of Florida tomatoes may be classified as small entities.
This proposed rule would adjust the number of member seats apportioned on the Committee. USDA is taking this action based on an amendatory change to the Order, which reduced the size of the Committee from 12 members to 10. This action would reduce the member seats in each of the two districts from six members and their alternates to five members and their alternates. This change would revise § 966.161 pursuant to the authority in § 966.25.
It is not anticipated that this action would impose any additional costs on the industry. This change is a conforming change and would not establish any new regulatory requirements on handlers. There would be no change in financial costs, reporting, or recordkeeping requirements because of this action.
This action would reduce the apportioned members from six members and their alternates to five members and their alternates in each of the two districts to reflect the recent amendatory action which reduced the size of the Committee. The balance of representation on the Committee would remain the same with member seats divided evenly between the two districts. The effects of this rule would not be disproportionately greater or less for small entities than for larger entities.
Alternatives to reapportionment were discussed and considered by the Committee. However, these alternatives were rejected. The Committee agreed that given the number of producers had decreased, reducing the Committee size would make it more reflective of today's industry. The Committee also wanted to maintain the balance of representation between the two districts. With the amendatory change to the Order, this action is necessary to make the regulations conform to the Order requirements.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Order's information collection requirements have been previously approved by OMB and assigned OMB No. 0581-0178, Vegetable and Specialty Crops. No changes in those requirements would be necessary because of this proposed rule. Should any changes become necessary, they would be submitted to OMB for approval.
This proposed rule would not impose any additional reporting or recordkeeping requirements on either small or large Florida tomato handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.
The Committee's meetings are widely publicized throughout the Florida tomato industry, and all interested persons are invited to attend the meetings and participate in Committee deliberations on all issues. Like all Committee meetings, the November 1, 2018, and February 27, 2019, meetings were open to the public, and all entities, both large and small, were able to express their views on this issue. Finally, interested persons are invited to submit comments on this proposed rule, including the regulatory and information collection impacts of this action on small businesses.
AMS is committed to complying with the E-Government Act, to promote the
USDA has not identified any relevant Federal rules that duplicate, overlap or conflict with this proposed rule.
A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at:
A 30-day comment period is provided to allow interested persons to respond to this proposal. All written comments timely received will be considered before a final determination is made on this matter.
Marketing agreements, Reporting and recordkeeping requirements, Tomatoes.
For the reasons set forth in the preamble, 7 CFR part 966 is proposed to be amended as follows:
7 U.S.C. 601-674.
Pursuant to § 966.25, industry membership on the Florida Tomato Committee shall be reapportioned as follows:
(a) District 1—five members and their alternates.
(b) District 2—five members and their alternates.
Federal Aviation Administration (FAA), DOT.
Proposed rule; withdrawal.
The FAA is withdrawing a notice of proposed rulemaking (NPRM) that proposed to supersede airworthiness directive (AD) AD 2015-23-03 for Pacific Aerospace Limited Model 750XL airplanes. The NPRM was prompted by mandatory continuing airworthiness information (MCAI) issued by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as fatigue cracks on the fin forward pickup plates. Since issuance of the NPRM, the FAA has determined that the actions required by AD 2015-23-03 address the unsafe condition. Accordingly, the NPRM is withdrawn.
As of June 28, 2021, the proposed rule, which published in the
You may examine the AD docket at
Mike Kiesov, Aviation Safety Engineer, FAA, General Aviation & Rotorcraft Section, International Validation Branch, 901 Locust, Room 301, Kansas City, MO 64106; phone: (816) 329-4144; fax: (816) 329-4090; email:
The FAA issued an NPRM that proposed to amend 14 CFR part 39 by adding an AD that would apply to certain Pacific Aerospace Limited Model 750XL airplanes. The NPRM was published in the
This [CAA] AD revised to introduce Pacific Aerospace Limited Mandatory Service Bulletin (MSB) PACSB/XL/068 issue 6, dated 8 January 2018. The changes to the SB are limited to minor editorial changes, and the addition of alternate P/N [part number] hi-lok fasteners due to limited availability of the original P/N. There are no changes to the AD applicability or the requirements.
After issuance of the NPRM, the FAA has determined that the actions required by AD 2015-23-03 address the unsafe condition. The new service information is unchanged except for editorial changes and the addition of alternate hi-lok fasteners. AD 2015-23-03 only requires the procedures in the service information that was incorporated by reference and not the materials. Thus, operators may use the new hi-lok fasteners to comply with AD 2015-23-03 without an alternative method of compliance. Based on the above information, the FAA has determined that AD action is not warranted and the proposal should be withdrawn.
Withdrawal of the NPRM constitutes only such action and does not preclude the FAA from further rulemaking on this issue, nor does it commit the FAA to any course of action in the future.
Since this action only withdraws an NPRM, it is neither a proposed AD nor a final rule. This action, therefore, is not covered under Executive Order 12866 or the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to adopt a new airworthiness directive (AD) for all Viking Air Limited Model DHC-3 airplanes. This proposed AD was prompted by mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI identifies the unsafe condition as fatigue damage of the wing strut lug fitting components and the fuselage to wing strut attachment (tie-bar). This proposed AD would require determining service life limits for the wing strut fitting on the main spar and for the tie-bar and following instructions for removal and replacement of affected parts. The FAA is proposing this AD to address the unsafe condition on these products.
The FAA must receive comments on this proposed AD by August 12, 2021.
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 Viking Air Limited Technical Support, 1959 De Havilland Way, Sidney, British Columbia, Canada, V8L 5V5; phone: (North America) (800) 663-8444; fax: (250) 656-0673; email:
You may examine the AD docket at
Aziz Ahmed, Aviation Safety Engineer, New York ACO Branch, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone: (516) 287-7329; fax: (516) 794-5531; email:
The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under
Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to
CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Aziz Ahmed, Aviation Safety Engineer, New York ACO Branch, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.
Transport Canada, which is the aviation authority for Canada, has issued AD Number CF-2017-29, dated August 24, 2017 (referred to after this as “the MCAI”), to correct an unsafe condition for Viking Air Limited Model DHC-3 airplanes. The MCAI states:
It has been determined that the current maintenance program does not adequately address potential fatigue damage of the wing strut lug fitting components or the fuselage to wing strut attachment (Tie Bar). Affected parts must be replaced before specified air time limits are reached to avoid fatigue cracking of the affected parts. Cracking which is not detected may compromise the structural integrity of the wing or the Tie-Bar.
Fatigue damage occurs more rapidly on aeroplanes that are operated at higher gross weights. For that reason, the corrective actions of this [Transport Canada] AD must be accomplished sooner for aeroplanes that have been certified for operation at higher gross weights.
Fatigue damage also occurs more rapidly on aeroplanes that are operated below 2000 feet above ground level (AGL) over land due to higher and more frequent gust and maneuvering loads. Low level flights over water are not known to produce increased fatigue damage on the DHC-3. For that reason, the corrective actions of this [Transport Canada] AD must be accomplished sooner for aeroplanes that have been operated at low altitudes over land.
This condition, if not addressed, could result in cracking and failure of the structural integrity of the wing or the tie-bar.
You may examine the MCAI in the AD docket at
The FAA reviewed Viking Air Limited DHC-3 Otter Service Bulletin Number V3/0008, Revision NC, dated February 9, 2017. The service information specifies determining service life limits for the wing strut fitting on the main spar and for the tie-bar, and contains instructions for removal and replacement. De Havilland Aircraft of Canada has issued DHC-3 Otter Service Bulletin Number 3/37, Revision B, dated October 8, 1982. The service information specifies instructions for removal and replacement of the Fuselage to Wing Strut Attachment Tie-Bar. 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
This product has been approved by the aviation authority of another country and is approved for operation in the United States. Pursuant to our bilateral agreement with this State of Design Authority, it has notified the FAA of the unsafe condition described in the MCAI and service information referenced above. The FAA is issuing this NPRM after determining the unsafe condition described previously is likely to exist or develop on other products of the same type design.
This AD requires accomplishing the actions specified in the service information already described.
The MCAI requires calculating the compliance time by using a formula and estimating the altitudes at which an airplane has operated. The MCAI also instructs operators to assume operations below 2,000 feet AGL when the operating altitude of the airplane is unknown. Because the FAA has no regulatory requirement for owners or operators to record or maintain the operating altitude history of an aircraft, this proposed AD would require calculating the compliance time by assuming all operations occurred below 2,000 feel AGL.
The FAA estimates that this AD, if adopted as proposed, would affect 41 airplanes of U.S. registry.
The FAA also estimates that it would take about 300 work-hours per airplane to replace both the wing strut fitting and the tie-bar. The average labor rate is $85 per work-hour. Required parts would cost about $5,599 per airplane.
Based on these figures, the FAA estimates the cost of the proposed AD on U.S. operators to be $1,275,059 or $31,099 per airplane.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Would not affect intrastate aviation in Alaska, and
(3) Would not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
The FAA must receive comments on this airworthiness directive (AD) by August 12, 2021.
None.
This AD applies to Viking Air Limited Model DHC-3 airplanes, all serial numbers, certificated in any category.
Joint Aircraft System Component (JASC) Code 5700, Wings.
This AD was prompted by mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as fatigue damage of the wing strut lug fitting components or the fuselage to wing strut attachment (tie-bar). The FAA is issuing this AD to identify and correct potential fatigue damage of the wing strut lug fitting components of the fuselage to wing strut attachment. The unsafe condition, if not addressed, could result in cracking and failure of the structural integrity of the wing or the tie-bar.
Unless already done, do the following actions in paragraphs (f)(1) through (3):
(1)
(2)
(i) Before the part accumulates 40,000 equivalent air time hours, or
(ii) Within 12 months after the effective date of this AD.
(3)
(i) Before the part accumulates 32,200 equivalent air time hours, or
(ii) Within 12 months after the effective date of this AD.
(1) The Manager, New York ACO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO Branch, send it to the attention of the person identified in paragraph (h)(1) of this AD.
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(1) For more information about this AD, contact Aziz Ahmed, Aviation Safety Engineer, New York ACO Branch, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone: (516) 287-7329; fax: (516) 794-5531; email:
(2) Refer to Transport Canada AD Number CF-2017-29, dated August 24, 2017, for more information. You may examine the Transport Canada AD in the AD docket at
(3) For service information identified in this AD, contact Viking Air Limited Technical Support, 1959 De Havilland Way, Sidney, British Columbia, Canada, V8L 5V5; phone: (North America) (800) 663-8444; fax: (250) 656-0673; email:
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to adopt a new airworthiness directive (AD) for certain Bell Textron Canada Limited (Bell) Model 429 helicopters. This proposed AD was prompted by reports of tail rotor gearbox assemblies found loose on the gearbox support. This proposed AD would require repetitive torque checks of the tail rotor gearbox attachment hardware, and corrective action if necessary. The FAA is proposing this AD to address the unsafe condition on these products.
The FAA must receive comments on this proposed AD by August 12, 2021.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
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For service information identified in this NPRM, contact Bell Textron Canada Limited, 12,800 Rue de l'Avenir, Mirabel, Quebec J7J 1R4, Canada; telephone 1-450-437-2862 or 1-800-363-8023; fax 1-450-433-0272; email
You may examine the AD docket at
Darren Gassetto, Aerospace Engineer, COS Program Management Section, FAA, Operational Safety Branch, Compliance & Airworthiness Division, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone (516) 228-7323; email
The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under
Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to
CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such
Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian AD CF-2018-35, dated December 19, 2018 (Canadian AD CF-2018-35), to correct an unsafe condition for Bell Textron Canada Limited Model 429 helicopters. Transport Canada advises that there have been reports of tail rotor gearbox assemblies found loose on the gearbox support. Transport Canada issued Emergency Canadian Airworthiness Directive CF-2018-18, dated July 11, 2018, which corresponds to FAA AD 2018-16-51, Amendment 39-19421 (83 FR 53171, October 22, 2018), to address the immediate safety concern. An ongoing investigation determined that this condition-loose tail rotor gearbox assemblies-could return even after the corrective actions by the previous AD have been completed. This condition, if not addressed, could result in structural damage and possible loss of control of the helicopter.
Accordingly, Canadian AD CF-2018-35 requires repetitive torque checks of the tail rotor gearbox attachment hardware and corrective actions if necessary. The corrective action is doing additional repetitive torque checks at intervals of 10 to 25 hours air time until the torque stabilizes on all the nuts.
The helicopter has been approved by the aviation authority of Canada and is approved for operation in the United States. Pursuant to the FAA's bilateral agreement with Canada, Transport Canada, its technical representative, has notified the FAA of the unsafe condition described in its AD. The FAA is proposing this AD after evaluating all known relevant information and determining that the unsafe condition described previously is likely to exist or develop on other helicopters of the same type design.
The FAA reviewed Bell Alert Service Bulletin 429-18-41, dated July 24, 2018. This service information specifies procedures for repetitive torque checks of the tail rotor gearbox attachment hardware.
This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
This proposed AD would require accomplishing the actions specified in the service information already described, except as discussed under “Differences Between this Proposed AD and the Transport Canada AD.”
Where Canadian AD CF-2018-35 refers to “200-hour” inspections and “10 to 25 hours air time” for the torque checks, for this proposed AD use “time-in-service” instead.
The FAA estimates that this AD, if adopted as proposed, would affect 98 helicopters 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 on-condition actions that would be required based on the results of any required actions. The FAA has no way of determining the number of helicopters that might need these on-condition actions:
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Would not affect intrastate aviation in Alaska, and
(3) Would not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
The FAA must receive comments on this airworthiness directive (AD) by August 12, 2021.
None.
This AD applies to Bell Textron Canada Limited (type certificate previously held by Bell Helicopter Textron Canada Limited) Model 429 helicopters, certificated in any category, serial numbers 57001 and subsequent.
Joint Aircraft Service Component (JASC) Code: 6500, Tail Rotor Drive System; and 6520, Tail Rotor Gearbox.
This AD was prompted by reports of tail rotor gearbox assemblies found loose on the gearbox support. The FAA is issuing this AD address tail rotor gearbox assemblies found loose on the gearbox support. The unsafe condition, if not addressed, could result in structural damage and possible loss of control of the helicopter.
Comply with this AD within the compliance times specified, unless already done.
Within 12 months after the effective date of this AD; or at the next scheduled 200-hours time-in-service (TIS) or 12-month inspection, whichever occurs first, do a torque check of the tail rotor gearbox attachment hardware, in accordance with the Accomplishment Instructions, paragraph 2., of Bell Alert Service Bulletin 429-18-41, dated July 24, 2018. Repeat the torque check thereafter at intervals not to exceed 200 hours TIS or 12 months, whichever occurs first.
If, during any torque check required by paragraph (g) of this AD, any tail rotor gearbox attachment moves during any torque check, repeat the torque check specified in paragraph (g) of this AD at intervals no less than 10 hours TIS and not to exceed 25 hours TIS until the torque stabilizes on all the nuts. Stabilization has occurred when, at the next torque check, the value has remained within the specified acceptable limits (160 to 200 inch-pounds (in-lbs) or 19 to 22 newton meters (Nms), inclusive), preventing movement of the gearbox housing. After the torque stabilizes on all the nuts, the repetitive torque checks specified in paragraph (g) of this AD are still required.
This paragraph provides credit for the initial torque check required by paragraph (g) of this AD, if that action was done before the effective date of this AD as required by paragraph (f)(2) of AD 2018-16-51, Amendment 39-19421 (83 FR 53171, October 22, 2018).
(1) The Manager, International Validation Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the International Validation Branch, send it to the attention of the person identified in paragraph (k)(1) of this AD. Information may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(1) For more information about this AD, contact Darren Gassetto, Aerospace Engineer, COS Program Management Section, FAA, Operational Safety Branch, Compliance & Airworthiness Division, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone (516) 228-7323; email
(2) For service information identified in this AD, contact Bell Textron Canada Limited, 12,800 Rue de l'Avenir, Mirabel, Quebec J7J 1R4, Canada; telephone 1-450-437-2862 or 1-800-363-8023; fax 1-450-433-0272; email
(3) The subject of this AD is addressed in Transport Canada AD CF-2018-35, dated December 19, 2018. You may view the Transport Canada AD on the internet at
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to amend Class E airspace extending upward from 700 feet above the surface at Malden Regional Airport, (formerly Malden Municipal Airport), Malden, MO. The FAA is proposing this action as a result of an airspace review caused by the decommissioning of the Malden Very High Frequency Omnidirectional Range (VOR) collocated with Tactical Air Navigation (TACAN) (VORTAC) navigation aid as part of the VOR Minimum Operational Network (MON) Program. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) in the area.
Comments must be received on or before August 12, 2021.
Send comments on this proposal to: The U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE, West Building Ground Floor, Room W12-140, Washington, DC 20590-0001; Telephone: (800) 647-5527, or (202) 366-9826. You must identify the Docket No. FAA-2021-0424; Airspace Docket
FAA Order 7400.11E Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, 1701 Columbia Avenue, College Park, GA 30337; Telephone (404) 305-6364.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority, as it amends Class E airspace in Malden, MO, to support IFR operations in the area.
Interested persons are invited to comment on this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers (Docket No. FAA-2021-0424 and Airspace Docket No. 21-ACE-13) and be submitted in triplicate to DOT Docket Operations (see
Persons wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed stamped postcard on which the following statement is made: “Comments to FAA Docket No. FAA-2021-0424; Airspace Docket No. 21-ACE-13.” The postcard will be date/time stamped and returned to the commenter.
All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this document may be changed in light of the comments received. All comments submitted will be available for examination in the public docket both before and after the comment closing date. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.
An electronic copy of this document may be downloaded through the internet at
You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Office (see the
This document proposes to amend FAA Order 7400.11E, Airspace Designations and Reporting Points, dated July 21, 2020, and effective September 15, 2020. FAA Order 7400.11E is publicly available as listed in the
The FAA proposes an amendment to 14 CFR part 71 to amend Class E airspace extending upward from 700 feet above the surface for Malden Regional Airport, MO, as the Malden VORTAC has been decommissioned and all associated airspace extensions of Class E airspace extending upward from 700 feet above the surface, off the Malden VORTAC have been eliminated. The Class E airspace extending upward from 700 feet above the surface would be amended by increasing the radius to 7.3 miles (previously 6.7 miles). Also the airport's name (formerly Malden Municipal Airport) and geographic coordinates would be updated to coincide with the FAA's data base.
Class E airspace designations are published in Paragraph 6005, of FAA Order 7400.11E, dated July 21, 2020, and effective September 15, 2020, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.
FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures”, prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 700 feet above the surface within a 7.3-mile radius of the Malden Regional Airport.
Environmental Protection Agency (EPA).
Filing of petitions and request for comment.
This document announces the Agency's receipt of initial filings of pesticide petitions requesting the establishment or modification of regulations for residues of pesticide chemicals in or on various commodities.
Comments must be received on or before July 28, 2021.
Submit your comments, identified by docket identification (ID) number and the pesticide petition (PP) of interest as shown in the body of this document, by one of the following methods:
•
•
•
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
Marietta Echeverria, Registration Division (7505P), main telephone number: (703) 305-7090, email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
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EPA is announcing receipt of pesticide petitions filed under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, requesting the establishment or modification of regulations in 40 CFR part 174 or part 180 for residues of pesticide chemicals in or on various food commodities. The Agency is taking public comment on the requests before responding to the petitioners. EPA is not proposing any particular action at this time. EPA has determined that the pesticide petitions described in this document contain data or information prescribed in FFDCA section 408(d)(2),
Pursuant to 40 CFR 180.7(f), summaries of the petitions that are the subject of this document, prepared by the petitioners, are included in dockets EPA has created for these rulemakings. The dockets for these petitions are available at
As specified in FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), EPA is publishing notice of the petitions so that the public has an opportunity to comment on these requests for the establishment or modification of regulations for residues of pesticides in or on food commodities. Further information on the petitions may be obtained through the petition summaries referenced in this unit.
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21 U.S.C. 346a.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing reporting and recordkeeping requirements for Per- and Polyfluoroalkyl Substances (PFAS) under the Toxic Substances Control Act (TSCA). In accordance with obligations under TSCA, as amended by the National Defense Authorization Act for Fiscal Year 2020, EPA proposes to require certain persons that manufacture (including import) or have manufactured these chemical substances in any year since January 1, 2011, to electronically report information regarding PFAS uses, production volumes, disposal, exposures, and hazards. EPA is requesting public comment on all aspects of this proposed rule and has also identified items of particular interest for public input. In addition to fulfilling statutory obligations under TSCA, this document will enable EPA to better characterize the sources and quantities of manufactured PFAS in the United States.
Comments must be received on or before August 27, 2021. Under the Paperwork Reduction Act, comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of your comments on or before July 28, 2021.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2020-0549, using the Federal eRulemaking Portal at
Due to the public health concerns related to COVID-19, the EPA Docket Center (EPA/DC) and Reading Room is closed to visitors with limited exceptions. The staff continues to provide remote customer service via email, phone, and webform. For the latest status information on EPA/DC services and docket access, visit
You may be potentially affected by this action if you currently or have previously manufactured (defined by statute at 15 U.S.C. 2602(9) to include import) a chemical substance that is a PFAS between January 1, 2011 and the effective date of the final rule. Note that this rule is limited to manufacturers
The manufacture of PFAS as a byproduct is not exempt for the purpose of this proposed rule. Unlike TSCA section 8(a)(1), which specifically provides an exemption for small manufacturers and processors, TSCA section 8(a)(7) provides no such exemption. Therefore, this proposed rule under TSCA section 8(a)(7) does not exempt small manufacturers from reporting and recordkeeping requirements. See the discussion under Unit II.D. for further discussion of the inclusion of small manufacturers in this proposed rule. The Agency's previous experience with TSCA section 8(a)(1) collections, as well as the Agency's understanding of disposal and other waste management methods involving PFAS, suggests that most respondents affected by this collection activity may be from the following North American Industrial Classification System (NAICS) code categories:
• NAICS 324—Petroleum and Coal Product Manufacturing;
• NAICS 325—Chemical Manufacturing;
• NAICS 326113—Unlaminated Plastics Film and Sheet (except Packaging) Manufacturing;
• NAICS 327910—Abrasive Product Manufacturing;
• NAICS 333999—All Other Miscellaneous General Purpose Machinery Manufacturing;
• NAICS 334511—Search, Detection, Navigation, Guidance, Aeronautical, and Nautical System and Instrument Manufacturing;
• NAICS 336111—Automobile Manufacturing;
• NAICS 423510—Metal Service Centers and Other Metal Merchant Wholesalers;
• NAICS 424690—Other Chemical and Allied Products Merchant Wholesalers;
• NAICS 447190—Other Gasoline Stations;
• NAICS 551112—Offices of Other Holding Companies;
• NAICS 562—Waste Management and Remediation Services.
Since other entities may also be affected, the Agency has not attempted to describe all the specific entities and corresponding NAICS codes for entities that may be interested in or affected by this action, but rather has provided a guide to help readers determine whether this document applies to them. If you have any questions regarding the applicability of this action to a particular entity, consult the technical contact person listed under
In addition, please note that any use of the term “manufacture” in this document will encompass “import” and the term “manufacturer” will encompass “importer.”
EPA is proposing this rule pursuant to its authority in TSCA section 8(a)(7) (15 U.S.C. 2607(a)(7)). The National Defense Authorization Act for Fiscal Year 2020 (Pub. L. 116-92, section 7351) amended TSCA section 8(a) in December 2019, adding section 8(a)(7), titled
TSCA section 14 imposes requirements for the assertion, substantiation, and review of information that is claimed as confidential (also known as confidential business information (CBI)).
EPA is proposing reporting and recordkeeping requirements under TSCA section 8(a)(7) for PFAS manufactured in any year since January 1, 2011. EPA is providing a comment period during which the public will have the opportunity to comment on this proposed action and its proposed requirements. Commenters are encouraged to provide comments and feedback related to the proposed reporting and recordkeeping requirements presented in this Notification of Proposed Rulemaking (NPRM), including the scope of PFAS covered by the rule (see Unit V. for more discussion on specific items for which the Agency is requesting comments). EPA is providing a comment period of 60 days from the publication date of this NPRM.
The Agency is proposing this action pursuant to TSCA section 8(a)(7) to obtain certain information known to or reasonably ascertainable by manufacturers of PFAS. TSCA section 8(a)(7) requires the Agency to publish a final rule not later than January 1, 2023.
EPA has prepared an economic analysis of the potential impacts associated with this proposed rule (Ref. 13). The primary purpose of this proposed rule is the collection of detailed data on PFAS, as required under TSCA section (8)(a)(7). One potential benefit of this action is the information collected may serve as a basis to better understand potential routes of exposure to PFAS and potential human health and environmental impacts of certain PFAS, among other research needs listed in the Agency's PFAS Action Plan.
The industry is expected to incur one-time burdens and costs associated with rule familiarization, form completion, CBI claim substantiation, recordkeeping, and electronic reporting activities. Under the proposed rule, EPA estimates a total industry burden of approximately 122,104 hours, with a cost of approximately $9.8 million. The affected small businesses subject to the proposed rule are expected to incur $1,788,506 in costs for this one-time reporting, with per-firm costs estimated to range from $16,864 to $92,390. The Agency is expected to incur a burden of approximately 7,361 hours and a cost of $948,078. The total social burden and cost are therefore estimated to be approximately 129,465 hours and $10.8 million, respectively (Ref. 13).
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TSCA section 8(a)(1) authorizes EPA to promulgate rules which require entities, that are not considered small manufacturers or processors, who manufacture, process, or propose to manufacture or process a chemical substance, to maintain such records and submit such reports as the EPA Administrator may reasonably require. Similarly, under those rules, entities who manufacture, process, or propose to manufacture or process a mixture or a chemical substance in small quantities (subject to limitations) must maintain records and submit reports to the extent necessary for the effective enforcement of TSCA.
Under TSCA section 8(a)(2), EPA may require recordkeeping and reporting of the following information:
• The covered common or trade name, chemical identity and molecular structure of each chemical substance or mixture;
• Categories or proposed categories of use for each substance or mixture;
• Total amount of each substance or mixture manufactured or processed, the amounts manufactured or processed for each category of use, and reasonable estimates of the respective proposed amounts;
• Descriptions of byproducts resulting from the manufacture, processing, use, or disposal of each substance or mixture;
• All existing information concerning the environmental and health effects of each substance or mixture;
• The number of individuals exposed, and reasonable estimates on the number of individuals who will be exposed, to each substance or mixture in their places of work and the duration of their exposure, and;
• The manner or method of disposal of each substance or mixture, and any change in such manner or method.
Under TSCA section 8(a)(7), EPA must promulgate a rule to require each person who has manufactured PFAS in any year since 2011 to report the data described in TSCA section 8(a)(2)(A) through (G) to EPA.
PFAS are synthetic organic compounds that do not occur naturally in the environment. PFAS contain an alkyl carbon on which the hydrogen atoms have been partially or completely replaced by fluorine atoms. The strong carbon-fluorine bonds of PFAS make some of them resistant to degradation and thus highly persistent in the environment (Refs. 1 and 2). Some of these chemicals have been used for decades in a wide variety of consumer and industrial products (Ref. 1). Some PFAS have been detected in wildlife, including higher trophic organisms, indicating that at least some PFAS have the ability to bioaccumulate (Ref. 2). Some PFAS can accumulate in humans and remain in the human body for long periods of time (
Under TSCA section 8(b), EPA maintains the TSCA Chemical Substance Inventory (“Inventory”), which contains all existing chemical substances manufactured, processed, or imported in the United States that do not qualify for an exemption or exclusion under TSCA (Ref. 5). EPA has identified 1,346 PFAS on the Inventory as of April 2021, 669 of which are on the active Inventory (
EPA is proposing that manufacturers will report information to the extent that the information is known to or reasonably ascertainable by the manufacturer (see TSCA section 8(b)(2)). “Known to or reasonably ascertainable by” would be defined to include “all information in a person's possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know.” This reporting standard would require reporting entities to evaluate their current level of knowledge of their manufactured products (including imports), as well as evaluate whether there is additional information that a reasonable person, similarly situated, would be expected to know, possess, or control. This standard carries with it an exercise of due diligence, and the information-gathering activities that may be necessary for manufacturers to achieve this reporting standard may vary from case-to-case.
This standard would require that submitters conduct a reasonable inquiry within the full scope of their organization (not just the information known to managerial or supervisory employees). This standard may also entail inquiries outside the organization to fill gaps in the submitter's knowledge. Such activities may, though not necessarily, include phone calls or email inquiries to upstream suppliers or downstream users or employees or other agents of the manufacturer, including persons involved in the research and development, import or production, or marketing of the PFAS. Examples of types of information that are considered to be in a manufacturer's possession or control, or that a reasonable person similarly situated might be expected to possess, control, or know include: Files maintained by the manufacturer such as marketing studies, sales reports, or customer surveys; information contained in standard references showing use information or concentrations of chemical substances in mixtures, such as a Safety Data Sheet or a supplier notification; and information from the Chemical Abstracts Service (CAS) or from Dun & Bradstreet (D-U-N-S). This information may also include knowledge gained through discussions, conferences, and technical publications. This definition is identical to the definition of the same term at 40 CFR 704.3. In addition, this is the same reporting standard employed in the TSCA section 8(a) Chemical Data Reporting (CDR) rule (
In the event that a manufacturer does not have actual data (
Unlike TSCA section 8(a)(1), which provides an express exemption for small manufacturers and processors, TSCA section 8(a)(7) specifically states that “each person who has manufactured a chemical substance that is a perfluoroalkyl or polyfluoroalkyl substance” shall be subject to the rule. Rather than amend TSCA section 8(a)(1), Congress chose to add an entirely new, standalone subsection to TSCA section 8(a). This indicates an intent for TSCA section 8(a)(7) to constitute separate, freestanding rulemaking authority; therefore, it is not constrained by requirements and provisions in TSCA section 8(a)(1).
However, in carrying out TSCA section 8, EPA shall, to the extent feasible: (A) Not require reporting which is unnecessary or duplicative; (B) Minimize the cost of compliance with TSCA section 8 and the rules issued thereunder on small manufacturers and processors; and (C) Apply any reporting obligations to those persons likely to have information relevant to the effective implementation of this subchapter (TSCA section 8(a)(5)).
TSCA section 8(a)(7) is silent on how the information collected under the TSCA section 8(a)(7) rule is to be used. However, collecting information on PFAS identities, uses, production volumes by category of use, byproducts, environmental and health effects, workers exposure, and disposal supports the Agency's mission in the PFAS Action Plan to identify and better understand these chemicals and to increase scientific research on them.
EPA intends to use information on these chemicals to support assessments of new and existing chemicals under TSCA. For instance, information collected under this proposed rule will help inform future assessments of potential exposure to these PFAS. The Agency would also benefit from receiving all existing information related to human health and environmental effects of such substances, in order to fulfill additional environmental protection mandates beyond the TSCA program. For instance, information on PFAS use, exposure, and effects may be used to inform regulatory activities under the Safe Drinking Water Act (42 U.S.C. 300f
Additionally, TSCA section 9(e) requires the EPA Administrator to make information related to exposure or releases available to other EPA offices or federal agencies if such exposures may be prevented or reduced under another law. EPA may share such information collected under this proposed rule as appropriate.
EPA is proposing reporting and recordkeeping requirements for manufacturers of PFAS pursuant to TSCA section 8(a)(7).
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For the purposes of this proposed action, the structural definition of PFAS includes per- and polyfluorinated substances that structurally contain the unit R-(CF2)-C(F)(R′)R″. Both the CF2 and CF moieties are saturated carbons and none of the R groups (R, R′ or R″) can be hydrogen. It should be noted that this structural definition of PFAS is a working definition which has been used by EPA's Office of Pollution Prevention and Toxics when identifying PFAS on the TSCA Inventory. This definition may not be identical to other definitions of PFAS used within EPA and/or other organizations. To assist potential reporters with determining whether certain substances may be covered under this structural definition, EPA has identified specific PFAS covered by this proposed rule. These will be included as non-exhaustive examples in the rule where it is possible to do so without divulging information claimed as CBI. The scope of PFAS examples listed in this proposal includes:
• All PFAS listed as active on the TSCA Inventory. This includes PFAS that are identified by CAS number; confidential chemicals whose generic names contain “fluor” and are identified by Accession number; and confidential chemicals whose generic names do not contain “fluor”, and therefore, are not listed by CASRNs, Accession numbers, or low-volume exemptions (LVE) case numbers (see note on structural diagram examples below).
• All PFAS that are subject to TSCA section 5 (new chemicals) LVE applications per 40 CFR 723.50 that have been granted by EPA. This includes the PFAS that were subject to granted LVE applications that have since been withdrawn by the LVE application submitter. Additional discussion on LVEs is below.
Under TSCA section 5, any person who intends to manufacture a chemical not on the TSCA Inventory must first notify EPA. Typically, this is done by submission of a premanufacture notice (PMN) (Ref. 8). However, for low-volume chemical substances (
LVE submitters may choose to withdraw their granted LVE application. In order to compile a comprehensive dataset as authorized under TSCA section 8(a)(7), EPA is including these
• This proposed rule will also include structural diagrams to capture any PFAS whose CAS or Accession numbers could not be divulged due to CBI claims, whose identity is not listed on the TSCA Inventory because it is subject to an LVE, or which is a byproduct not listed on the Inventory and not subject to an LVE, yet meets the structural definition. The list of identified PFAS and structural diagrams can also be found in the docket (Ref. 7). The PFAS included in the list and identified by the structural diagrams are examples of substances that meet this rule's definition of PFAS; it is not a comprehensive list of all substances within this rule's scope.
EPA is providing these examples of PFAS for the purpose of assisting manufacturers in determining whether a chemical substance they have manufactured in any year since 2011 meets this proposed rule's definition of PFAS. Because the Inventory's active designation dates back to June 2006, it is possible for a firm to have manufactured one of these listed PFAS yet not be required to report under this proposed rule, if they have manufactured it only in the period prior to January 1, 2011.
This list was developed as of April 2021. EPA anticipates updating this list prior to promulgating the final rule, both in response to public comment, and as a result of PMNs added to the Inventory and LVEs granted by EPA between April 2021 and the date of publication of the final rule.
For the purposes of this proposed rule, articles containing PFAS, including imported articles containing PFAS (such as articles containing PFAS as part of surface coatings), are included in the scope of reportable chemical substances. TSCA does not define articles, nor does the statute define articles as a category of substances exclusive of chemical substances. EPA therefore considers its ability to regulate chemical substances to encompass authority to regulate articles containing such chemical substances. Additionally, the Agency would benefit from collecting the requested information on PFAS-containing articles (including articles containing PFAS as part of surface coatings) because the information would improve the Agency's knowledge of various products which may contain PFAS, their categories of use, production volumes, and exposure data. Such data are not currently known to EPA. However, EPA acknowledges that some article manufacturers, including article importers, may not have such information known to or reasonably ascertainable by them and may not meet the reporting standard as described in Unit II.C. To this end, information that helps EPA better understand data gaps is useful information for EPA to have. Therefore, articles are within the scope of reportable substances under this proposed rule, though EPA is requesting comments on whether imported articles containing PFAS should be within scope (see Unit IV.1).
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• Physical state of the chemical or mixture;
• Industrial processing and use type, sector(s), functional category(ies), and percent of production volume for each use;
• Consumer and/or commercial indicator, product category(ies), functional category(ies), percent of production volume for each use, indicator for use in products intended for children, and maximum concentration in the product, and;
• Number of workers reasonably likely to be exposed for each combination of industrial processing or use operation, sector, and function, and the number of commercial workers reasonably likely to be exposed if the PFAS is contained in a commercial product.
If a manufacturer covered under this proposed rule has previously submitted required information to EPA for some years since 2011, but not for all years, EPA is proposing that the manufacturer may indicate in the reporting tool the year(s) for which the manufacturer has already submitted that data to EPA as part of CDR. For instance, CDR reporters are required to submit the total annual domestically manufactured production volume and the total annual imported volume separately, only for the principal reporting year (
• Domestically manufactured production volume;
• Imported production volume;
• Volume directly exported; and
• Indicator for imported but never physically at site.
EPA welcomes public comment on concerns related to duplicative reporting (see Unit V.).
EPA proposes that persons who have manufactured a PFAS at any time since January 1, 2011, would report to EPA during a six-month submission period, which would begin six months following the effective date of the final rule. Therefore, manufacturers would ultimately have one year following the effective date of the final rule to collect and submit all required information to EPA. EPA believes by providing six months between the effective date of the rule and the start of the submission period, this would allow sufficient time for both the Agency to finalize the reporting tool and for reporters to familiarize themselves with the rule and compile the required information. Since this section 8(a)(7) reporting rule will be collecting similar information as CDR, EPA anticipates many reporters will be familiar with the types of information requested and how to report. The CDR submission period is four months, every four years. Since this proposed rule spans a longer time than the four-year CDR reporting cycle, EPA acknowledges additional time may be needed in the PFAS submission period. EPA believes that six months is adequate time for submissions, in addition to the six-
EPA is also asking for public comment on the submission period start date and duration (see Unit V.).
TSCA section 8(a)(7) specifies that, under the final rule, manufacturers would report on “information described in subparagraphs (A) through (G) of paragraph (2) [of section 8].” Therefore, this TSCA section 8(a)(7) rule proposes one-time reporting of the information described in section 8(a)(2)(A) through (G), which includes specific chemical identity, categories of use, production volume, byproducts, environmental and health effects, number of persons exposed and duration of exposure, and disposal.
Specifically, EPA is proposing to request the following information:
1. Chemical name (multiple if mixture), or the generic name(s) if the chemical name(s) is CBI.
2. Chemical ID(s) (CASRN, TSCA Accession Number, or LVE case number).
3. Trade name or common name.
4. Representative molecular structure.
5. Physical form of chemical or mixture.
6. Industrial processing and use:
a. Type of process or use;
b. Sector(s);
c. Functional use category(ies);
d. Percent of production volume for each use.
7. Consumer and commercial use:
a. Indicator for whether this is a consumer and/or commercial product;
b. Product category; functional use category(ies);
c. Percent production volume for each use; maximum concentration in any product;
d. Indicator for use in products intended for children.
8. Production volumes:
a. Domestically manufactured;
b. Imported;
c. Directly exported;
d. Maximum first 12 months production volume;
e. Maximum yearly production volume in any 3 years.
9. Indicator for imported but never physically at site.
10. Indicator for site-limited.
11. Maximum quantity stored on-site at any time.
12. Total volume recycled (on-site).
13. For byproducts produced during the manufacture, processing, use, or disposal of each PFAS:
a. Chemical name(s) or description (if identity is unknown), or the generic name(s) if the byproduct name(s) is CBI;
b. Chemical ID(s) (CASRN, TSCA Accession Number, or LVE case number);
c. Indicator for whether the byproduct(s) production resulted from manufacture, process, use, or disposal; and
d. Indicator for whether the byproduct(s) is released to the environment; if so, volume of byproduct(s) released and to which environmental media.
14. Worker exposure: Description of worker activity(ies) at manufacturing site.
15. Worker exposure at the manufacturing site:
a. Number of workers reasonably likely to be exposed at the manufacturing site, for each worker activity;
b. Maximum duration of exposure for any worker, for each worker activity (both hours per day and days per year).
16. Worker exposure for each industrial process and use:
a. Number of workers reasonably likely to be exposed for each industrial process and use;
b. Maximum duration of exposure for any worker for each industrial process and use (both hours per day and days per year).
17. Worker exposure for each commercial use:
a. Number of workers reasonably likely to be exposed for each commercial use;
b. Maximum duration of exposure for any worker for each commercial use (both hours per day and days per year).
18. Description of disposal process(es), and description of any changes to the disposal process or methods since 2011.
19. Total volume released:
a. Land disposal;
b. Water releases;
c. Air releases.
20. Total volume incinerated (on-site) and incineration temperature.
21. All existing information related to health and environmental effects, using the Organization of Economic Cooperation and Development (OECD) harmonized template relevant to the existing study, as well as full study reports and any other supporting information (for additional information on the use of the OECD harmonized templates, see the discussion in the following section, Unit III.D.).
22. Other data relevant to health and environmental effects (
A list of the proposed reporting requirements is available in the docket for public review (Ref. 10).
EPA developed an information reporting platform for CDR (Ref. 9) and intends to modify it for purposes of this proposed rule. Certain information that is requested in the CDR that falls under TSCA section 8(a)(2)(A) through (G) would be required by this proposed rule, such as information on specific chemical identity, categories of use, production volume, byproducts, and number of persons exposed and duration of exposure (see Unit III.A.2. for the discussion on duplicative reporting). In instances where PFAS manufacturers under this proposed rule have already reported the requested information to EPA, they will not be required to re-report. As discussed in Unit III.A.2, EPA is proposing the reporters simply indicate they have already submitted such information to EPA.
Additionally, any person required to report under this proposed rule would supply the information identified in the form to the extent it is known to or reasonably ascertainable by them, or a reasonable estimate when actual data are not available (
EPA is requesting “all existing information concerning the environmental and health effects” of the PFAS chemicals covered by this rule. It is intended that “environmental and health effects information” be interpreted broadly. This information would include but is not limited to:
• Toxicity information (
• Other data relevant to environmental and health effects including range-finding studies, preliminary studies, OSHA medical screening or surveillance standards reports, adverse effects reports.
Chemical identity is always part of a health and safety study, and TSCA section 14(b) limits the extent to which health and safety studies and information from studies may be withheld from the public as confidential.
EPA is proposing to require all existing information concerning health and environmental effects be submitted in the format of OECD harmonized templates, where such templates exist for the type of data, in addition to submitting full study reports. OECD
EPA is requesting comments on what environmental and health effects information should be within the scope of this rule. EPA is also requesting comment on whether any information proposed to be requested is duplicative of information collected by EPA under other federal statutes and, thus, should be excluded. Please identify the information that you believe is duplicative and the statute under which it is submitted.
EPA is proposing to require electronic reporting similar to the requirements established in 2013 for submitting other information under TSCA (see 40 CFR 704.20(e)). EPA is proposing to require submitters to use EPA's CDX, the Agency's electronic reporting portal, for all reporting under this rule. In 2013, EPA finalized a rule to require electronic reporting of certain information submitted to the Agency under TSCA sections 4, 5, 8(a) and 8(d) (Ref. 12, page 72818). The final rule followed two previous rules requiring similar electronic reporting of information submitted to EPA for TSCA CDR and for PMNs. In proposing to require similar electronic reporting under this rule, EPA intends to save time, improve data quality and increase efficiencies for both the submitters and the Agency.
EPA developed the Chemical Information Submission System (CISS) for use in submitting data electronically to the Agency for TSCA sections 4, 5, 6, 8(a), 8(b), 8(d), 8(e), and Title VI. CISS, a web-based reporting tool housed within the CDX environment, provides submitters with user-friendly applications to build and submit data packages to EPA within a secure, encrypted environment. CISS applications provide for the capture of both fielded data as well as the attachment of additional information using a wide variety of file types. Submitted information is rendered into PDF and XML formats, which are provided to submitters in the form of a Copy of Record.
EPA is proposing to require submitters to follow the same submission procedures used for other TSCA submissions,
Within CDX, CISS is available under the “Submission for Chemical Safety and Pesticide Program (CSPP)” CDX flow. Users who have previously submitted under TSCA through CDX, including submitting information under sections 4 and 5, CDR, or reporting under the TSCA Inventory Notification (Active-Inactive) Requirements rule (82 FR 37520, Aug. 11, 2017) (FRL-9964-22), will already have the CSPP flow linked to their account. Users reporting to EPA using other CDX housed applications, including the Toxics Release Inventory TRI-MEweb, would be able to add the CSPP flow to their existing CDX accounts.
All submitters would be required to use CISS to prepare their submissions. CISS guides users through a “hands-on” process of creating an electronic submission. Once a user completes the relevant data fields and attaches appropriate PDF files, or other file types, such as XML files, the web-based tool validates the submission by performing a basic error check and makes sure all the required fields and attachments are provided and complete. Further instructions for uploading PDF attachments or other file types, such as XML, and completing metadata information would be available through CISS reporting guidance.
CISS, a web-based reporting tool, also allows the user to choose to “Preview,” “Save,” or “Submit” the data package. Once the submission process is initiated, the user is asked to certify the information and provide requested information to complete the submission process. The data package is then sent, in an encrypted state, to the Agency. The user can login to the application and check the submission status of their data package. Upon successful receipt of the submission by EPA, the submission status of the submissions will be flagged as “Completed” and a confirmation email will be sent to the submitter's CDX inbox. The CDX inbox is used to notify the users when submissions are received by EPA or to notify users when a submission-specific communication has been received and how to locate and access the communication. Information on accessing the CDX user inbox is provided in the guidance document for CDX at
EPA believes that electronic reporting reduces the reporting burden for submitters by reducing the cost and time required to review, edit, and transmit data to the Agency. It also allows submitters to share a draft submission within their organization, and more easily save a copy for their records or future use. Additionally, EPA believes that many of the anticipated reporters under this proposed rule have experience with reporting electronically to EPA through CDX. The resource and time requirements to review and process data by the Agency will also be reduced and document storage and retrieval will require fewer resources. EPA expects to benefit from receiving electronic submissions and communicating electronically with submitters.
The 2016 amendments to TSCA included new procedural requirements for the submission and Agency management of CBI claims, including new substantiation requirements, generic name requirements, a certification requirement, and a requirement for Agency review of specified CBI claims within 90 days after receipt of the claim, 15 U.S.C. 2613. The Agency recently finalized a rule amending the CDR reporting requirements that implemented the new requirements for confidentiality claims
TSCA section 14 further requires that substantiation be provided when a confidentiality claim is asserted. However, TSCA section 14(c)(2) exempts certain information from the substantiation requirements (
Any information which is claimed as confidential will be disclosed by EPA only in accordance with the procedures and requirements of TSCA section 14 and 40 CFR part 2. TSCA limits confidentiality protections for health and safety studies, information from health and safety studies (except to the extent such studies or information reveals “information that discloses processes used in the manufacturing or processing of a chemical substance or mixture or, in the case of a mixture, the portion of the mixture comprised by any of the chemical substances in the mixture”), and certain other information. Submitters asserting a confidentiality claim for such information in health and safety studies will be required to submit a sanitized copy of the study, removing only that information which is claimed as confidential and that discloses the process or portion of mixture information described in TSCA section 14(b).
EPA proposes that each person who is subject to the reporting requirements must retain records that document any information reported to EPA. Consistent with the CDR rule, EPA is proposing a five-year recordkeeping period, beginning on the last date of the submission period. The five-year retention requirement corresponds with the statute of limitations for violations and is necessary to preserve records to support future regulatory activities that would be informed by this information collection. Further, EPA believes the burden of retaining these records, which are likely electronic, is minimal.
EPA is seeking public comment on all aspects of this proposed rule and the Economic Analysis prepared in support of this proposed rule (Ref. 14). In addition to specific requests for comment included throughout this document, EPA is interested in comments pertaining to the specific issues discussed in this unit. EPA encourages all interested persons to submit comments on the issues identified in this Notification and to identify any other relevant issues as well. This input will assist the Agency in developing a final rule that successfully addresses information needs while minimizing potential reporting burdens associated with the rule. EPA requests that commenters making specific recommendations include supporting documentation where appropriate.
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The following is a list of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not physically located in the docket. For assistance in locating these other documents, please consult the technical person listed under
Additional information about these statutes and Executive Orders can be found at
This action is a significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011). EPA prepared an analysis of the estimated costs and benefits associated
The information collection activities in this proposed rule have been submitted for approval to the Office of Management and Budget (OMB) under the PRA, 44 U.S.C. 3501
The reporting requirements identified in the proposed rule would enable EPA to meet the statutory obligations required by TSCA section 8(a)(7) and collect data related to the identities, manufacture, use, exposure, and disposal of PFAS manufactured in the United States since 2011. These proposed reporting requirements would also help the Agency to collect existing information on the health and environmental effects of PFAS. EPA intends to use information collected under the rule to assist in chemical assessments under TSCA, and to inform any additional work necessary under environmental protection mandates beyond TSCA. Respondents may claim some of the information reported to EPA under the proposed rule as CBI under TSCA section 14. TSCA section 14(c) requires a supporting statement and certification for confidentiality claims asserted after June 22, 2016.
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 OMB control numbers for the EPA's regulations in 40 CFR are listed in 40 CFR part 9.
Submit your comments on the Agency's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden to the EPA using the docket identified at the beginning of this rule. You may also send your ICR-related comments to OMB's Office of Information and Regulatory Affairs via email to
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA (5 U.S.C. 601
However, EPA expects that article importers may incur a range of costs depending on the number of articles they import, their level of knowledge of their imported articles, the complexity of supply chains, and whether PFAS is present in their articles. Importers of articles that contain PFAS may incur costs for rule familiarization ($69.79 per firm); identifying the type of imported articles that potentially use PFAS ($1,641-$1,932 per firm); identifying suppliers involved ($1,185 per firm); collecting data from suppliers ($0-644 per article); and recordkeeping ($12 per firm). Details of this analysis are presented in the Economic Analysis of the proposed rule (Ref. 14), which is available in the docket.
This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The requirements of this action would primarily affect manufacturers (including importers) of PFAS. The total quantified one-time costs of the proposed rule are approximately $9.8 million.
This action does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
This action does not have tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000). It will not have substantial direct effects on tribal governments, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes. Thus, E.O. 13175 does not apply to this action.
EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) as applying only to those regulatory actions that concern environmental health or safety risks that the Agency has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not a covered regulatory action because it is not “economically significant” under Executive Order 12866 and it does not concern an environmental health risk or safety risk. Although this action would not establish an environmental standard
This action is not a “significant energy action” as defined in Executive Order 13211 (66 FR 28355, May 22, 2001) because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy and has not otherwise been designated by the Administrator of OMB's Office of Information and Regulatory Affairs as a “significant energy action.”
Because this action does not involve any technical standards, NTTAA section 12(d), 15 U.S.C. 272 note, does not apply to this action.
EPA believes that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994).
The requirements of the proposed rule are directed at manufacturers (including importers) of PFAS chemicals for which basic production, use, and toxicity information is currently unavailable. The costs and the benefits of the proposed rule would not be disproportionately distributed across different geographic regions or among different categories of individuals. Consumers of these chemical products, workers who come into contact with these chemical substances, and communities neighboring PFAS manufacturing sites could benefit from EPA's assessment of information required under the proposed rule. The Agency believes that the information collected under this proposed rule, if finalized, will assist EPA and others in determining the potential hazards and risks associated with PFAS chemicals. Although not directly impacting environmental justice-related concerns, this information will enable the Agency to better protect human health and the environment, including in low-income and minority communities.
Chemicals, Environmental protection, Hazardous Materials, Recordkeeping, and Reporting Requirements.
Therefore, for the reasons stated in the preamble, the Environmental Protection Agency proposes to amend 40 CFR chapter I by adding part 705 to read as follows:
15 U.S.C. 2607(a)(7).
This part specifies reporting and recordkeeping procedures for manufacturers (including importers) of certain per- and polyfluoroalkyl substances (hereafter referred to as PFAS) under section 8(a)(7) of the Toxic Substances Control Act (TSCA).
(1) Not only is information which arises as a result of a formal, disciplined study included, but other information relating to the effects of a chemical substance or mixture on health or the environment is also included. Any information that bears on the effects of a chemical substance on health or the environment would be included.
(2) Examples are:
(i) Long- and short-term tests of mutagenicity, carcinogenicity, or teratogenicity; data on behavioral disorders; dermatoxicity; pharmacological effects; mammalian absorption, distribution, metabolism, and excretion; cumulative, additive, and synergistic effects; and acute, subchronic, and chronic effects.
(ii) Tests for ecological or other environmental effects on invertebrates, fish, or other animals, and plants, including: Acute toxicity tests, chronic toxicity tests, critical life-stage tests, behavioral tests, algal growth tests, seed germination tests, plant growth or damage tests, microbial function tests, bioconcentration or bioaccumulation tests, and model ecosystem (microcosm) studies.
(iii) Assessments of human and environmental exposure, including workplace exposure, and impacts of a particular chemical substance or mixture on the environment, including surveys, tests, and studies of: Biological, photochemical, and chemical degradation; structure/activity relationships; air, water, and soil transport; biomagnification and bioconcentration; and chemical and physical properties,
(iv) Monitoring data, when they have been aggregated and analyzed to measure the exposure of humans or the environment to a chemical substance or mixture.
(1) Is the product commonly recognized (
(2) Does the manufacturer of the product state through product labeling or other written materials that the product is intended for or will be used by children age 14 or younger?
(3) Is the advertising, promotion, or marketing of the product aimed at children age 14 or younger?
(i) For commercial distribution, including for test marketing.
(ii) For use by the manufacturer, including use for product research and development, or as an intermediate.
(2) Manufacture for commercial purposes also applies to substances that are produced coincidentally during the manufacture, processing, use, or disposal of another substance or mixture, including both byproducts that are separated from that other substance or mixture and impurities that remain in that substance or mixture. Such byproducts and impurities may, or may not, in themselves have commercial value. They are nonetheless produced for the purpose of obtaining a commercial advantage since they are part of the manufacture of a chemical product for a commercial purpose.
The requirements of this part apply to all chemical substances and mixtures that are PFAS, consistent with the definition of PFAS at § 705.3. This includes, but is not limited to, all PFAS listed or otherwise described in this section. This section contains 5 listings of examples of chemical substances or mixtures that meet this definition. Paragraph (a) of this section is a list of chemical substances on the TSCA Inventory that have an associated Chemical Abstract Services (CAS) Registry Number. Paragraph (b) of this section is a list of chemical substances that have an associated TSCA Accession Number. Paragraph (c) of this section is a list of chemical substances that have both an associated low-volume exemption (LVE) case number and a non-confidential CASRN. Paragraph (d) of this section is a list of chemical substances with an LVE case number but no CASRN. Paragraph (e) of this section is a list of structural diagram examples of PFAS and those CASRNs.
(c)
Persons who have manufactured a chemical substance identified in § 705.5 at any period from January 1, 2011 to the effective date of this rule.
For the one-time submission, persons identified in § 705.10 of this part must report to EPA, for each site of each of the chemical substances identified in § 705.5, the following information to the extent known to or reasonably ascertainable by them. In the event that actual data is not known to or reasonably ascertainable by the submitter, then reasonable estimates may be submitted:
(a)
(1) The highest-level U.S. parent company name, address, and Dun and Bradstreet D-U-N-S® (D&B) number. A submitter under this part must obtain a D&B number for the U.S. parent company if none exists.
(2) The name of a person who will serve as Authorized Official for the submitter company, and who will be able to sign the certification statement as described in paragraph (i) of this section, the Authorized Official's full mailing address, telephone number, and email address.
(3) The name of a person who will serve as technical contact for the submitter company, and who will be able to answer questions about the information submitted by the company to EPA, the contact person's full mailing address, telephone number, and email address.
(4) The name, full street address, and six-digit North American Industry Classification System (NAICS) code(s) of the site. A submitter under this part must include the appropriate D&B number for each plant site reported, and the county or parish (or other jurisdictional indicator) in which the plant site is located. A submitter under this part must obtain a D&B number for the site reported if none exists. A submitter under this part must also provide other site identification numbers, including the Facility Registry Service (FRS) identification number, if they exist.
(b)
(1) The common or trade name, the chemical identity, and the representative molecular structure of each PFAS for which such a report is required.
(i) The specific, currently correct CA Index name as used to list the chemical substance on the TSCA Inventory and the correct corresponding CASRN for each reportable PFAS at each site. Submitters who wish to report chemical substances listed on the confidential portion of the TSCA Inventory will need to report the chemical substance using a TSCA Accession Number. If a submitter has a low-volume exemption (LVE) case number for the chemical substance, that number may also be used if a CASRN is not known to or reasonably ascertainable by the submitter.
(ii) In addition to reporting the number itself, submitters must specify the type of number they are reporting by selecting from among the codes in Table 1 of this paragraph.
(2) The physical form(s) of the PFAS as it is sent off-site from each site. If the PFAS is site-limited, you must report the physical form(s) of the PFAS at the time it is reacted on-site to produce a different chemical substance. For each PFAS at each site, the submitter must report as many physical forms as applicable from among the physical forms listed in this unit:
(i) Dry powder.
(ii) Pellets or large crystals.
(iii) Water- or solvent-wet solid.
(iv) Other solid.
(v) Gas or vapor.
(vi) Liquid.
(c) Categories of use. For each year since January 1, 2011, report the following information on categories or proposed categories of use of each PFAS manufactured.
(1)
(2) A code indicating the sector(s) that best describe the industrial activities associated with each industrial processing or use operation reported under this section. For each chemical substance, report the code that corresponds to the appropriate sector(s) listed in Table 3. A particular sector code may need to be reported more than once, to the extent that a submitter reports more than one function code that applies to a given sector code under this paragraph.
(3) For each sector reported under paragraph (c)(2) of this section, the applicable code(s) from Table 4 must be selected to designate the function category(ies) that best represents the specific manner in which the chemical substance is used.
(4)
(5) For each consumer and commercial product category reported under paragraph (c)(4) of this section, the applicable code(s) described in Table 4 under paragraph (c)(3) of this section must be selected to designate the function category(ies) that best represents the specific manner in which the PFAS is used.
(6) Submitters must indicate, for each consumer and commercial product category reported under paragraph (c)(4) of this section, whether the use is a consumer or a commercial use, or both.
(7) Submitters must determine, within each consumer and commercial product category reported under paragraph (c)(4) of this section, whether any amount of each reportable chemical substance manufactured (including imported) by the submitter is present in (for example, a plasticizer chemical substance used to make pacifiers) or on (for example, as a component in the paint on a toy) any consumer products intended for use by children age 14 or younger, regardless of the concentration of the chemical substance remaining in or on the product. Submitters must select from the following options: The chemical substance is used in or on any consumer products intended for use by children; the chemical substance is not used in or on any consumer products intended for use by children; or information as to whether the chemical substance is used in or on any consumer products intended for use by children is not known to or reasonably ascertainable by the submitter.
(8) For each year where the PFAS is used in consumer or commercial products, the estimated typical maximum concentration, measured by weight, of the chemical substance in each consumer and commercial product category reported under paragraph (c)(4) of this section. For each PFAS in each commercial and consumer product category reported under paragraph (c)(4) of this section, submitters must select from among the ranges of concentrations listed in Table 6 of this paragraph and report the corresponding code (
(d) For each year since January 1, 2011, the total amounts manufactured or processed of each PFAS, including the amounts manufactured or processed in each calendar year for each category of use as described in paragraph (c) of this section.
(1) For each year the PFAS was manufactured, the total annual volume (in pounds) of each PFAS domestically manufactured or imported at each site. The total annual domestically manufactured volume (not including imported volume) and the total annual imported volume must be separately reported. These amounts must be reported to two significant figures of accuracy.
(2) A designation indicating, for each PFAS at each site, whether the imported PFAS is physically present at the reporting site.
(3) The volume directly exported of each PFAS domestically manufactured or imported at each site. These amounts must be reported to two significant figures of accuracy.
(4) The estimated percentage, rounded off to the closest 10 percent, of total production volume of the reportable chemical substance associated with each combination of industrial processing or use operation, sector, and function category as reported in paragraph (c) of this section. Where a particular combination of industrial processing or use operation, sector, and function category accounts for less than 5 percent of the submitter's site's total production volume of a reportable chemical substance, the percentage must not be rounded off to 0 percent. Instead, in such a case, submitters must report the percentage, rounded off to the closest 1 percent, of the submitter's site's total production volume of the reportable chemical substance associated with the particular combination of industrial processing or use operation, sector, and function category.
(5) The estimated percentage, rounded off to the closest 10 percent, of the submitter's site's total production volume of the PFAS associated with each consumer and commercial product category as reported in paragraph (c)(4) of this section. Where a particular consumer and commercial product category accounts for less than 5 percent of the total production volume of a reportable chemical substance, the percentage must not be rounded off to 0 percent. Instead, in such a case, submitters must report the percentage, rounded off to the closest 1 percent, of the submitter's site's total production volume of the reportable chemical substance associated with the particular consumer and commercial product category.
(6) The estimated maximum amount (in pounds) to be manufactured or imported during the first year of production within the covered reporting period (
(7) An indication of whether the PFAS was site-limited.
(8) The estimated maximum amount (in pounds) of the PFAS on site at any point in time since January 1, 2011. This amount is not limited to quantities being actively manufactured or used, and includes quantities stored.
(9) The total volume (in pounds) of each PFAS recycled on-site since January 1, 2011.
(e) A description of the byproducts resulting from the manufacture, processing, use, or disposal of each PFAS since January 1, 2011.
(1) For each byproduct produced from the manufacture, processing, use, or disposal of a PFAS, the submitter will identify the byproduct by its specific, currently correct CA Index name as used to list the chemical substance on the TSCA Inventory and the correct corresponding CASRN. A submitter under this part may use an EPA-designated TSCA Accession Number for a chemical substance in lieu of a CASRN when a CASRN is not known to or reasonably ascertainable by the submitter. Submitters who wish to report chemical substances listed on the confidential portion of the TSCA Inventory will need to report the chemical substance using a TSCA Accession Number.
(i) In addition to reporting the number itself, submitters must specify the type of number they are reporting by selecting from among the codes in Table 1 of paragraph (b)(1)(i) of this section.
(ii) If the specific identity of the byproduct is unknown to the submitter, the submitter may provide a description of the chemical substance.
(iii) An indication of which specific PFAS activity(ies) (
(2) An indication of whether the byproduct is released to the environment, and if so, the environmental medium (a) to which it is released (
(3) For each year, the byproduct volume (in pounds) released to the environment.
(f) All existing environmental and health effects information of such substance or mixture. The scope of this information shall not be limited to studies conducted or published since 2011.
(1) For each published study report, the submitter shall complete an Organization for Economic Cooperation and Development (OECD) Harmonized Templates for Reporting Chemical Test Summaries, and submit the accompanying study reports and supporting information.
(2) Submitters shall also provide any additional human health data not in study reports, including but not limited to any preliminary studies, informal test results in workers, or inhalation studies.
(g) The number of individuals exposed to PFAS in their places of employment and the duration of such exposure for each year since January 1, 2011.
(1) A narrative description of worker activities involving the PFAS at the manufacturing site, such as bag dumping, sampling, cleaning, or unloading drums.
(2) For each worker activity in this paragraph, indicate the number of workers reasonably likely to be exposed. The submitter must select from among the worker ranges listed in Table 8 of
(3) For each PFAS, the maximum duration of exposure for any worker at the manufacturing site, in hours per day and days per year.
(4) For each combination of industrial processing or use operation, sector, and function category identified in paragraph (c) of this section, the submitter must estimate the number of workers reasonably likely to be exposed to each PFAS. For each combination associated with each chemical substance, the submitter must select from among the worker ranges listed in Table 8 under paragraph (g)(1)(i) of this section and report the corresponding code (
(5) For each PFAS, the maximum duration of exposure for any worker for each combination of industrial processing or use operation, sector, and function category, in hours per day and days per year.
(6) Where the PFAS is used in a commercial product, the submitter must estimate the number of commercial workers reasonably likely to be exposed to each reportable chemical substance. For each commercial use associated with each substance, the submitter must select from among the worker ranges listed in Table 8 under paragraph (g)(1)(i) of this section and report the corresponding code (
(7) For each PFAS, the maximum duration of exposure for any worker for each commercial use, in hours per day and days per year.
(h) During the years in which the PFAS was manufactured, the manners or methods of its disposal, and any changes to the disposal methods or processes since January 1, 2011.
(1) Description of disposal processes or methods, using the appropriate codes in Table 9 of paragraph (h)(1) of this section, and additional descriptions as needed.
(2) Describe any changes to the disposal process(es) or method(s) indicated in paragraph (h)(1) for any PFAS manufactured since 2011.
(3) Indicate total volume released to each environmental medium since 2011 for each PFAS.
(4) Indicate total volume incinerated on-site since 2011 for each PFAS. If incineration occurred, indicate the temperature at which the PFAS was incinerated.
(i)
All information reported to EPA in response to the requirements of this part must be submitted during the applicable submission period. The submission period shall begin six months following the effective date of this rule and last for six months.
(a) If a person identified in § 705.10 has already reported certain information in § 705.15 to EPA pursuant to TSCA section 8(a), then duplicative reporting of that information is not required of the years for which the information has already been reported. Any person covered in this part may notify EPA through the electronic reporting system in § 705.35 that such information has
(1) Physical state of the chemical or mixture, pursuant to § 711.15(b)(3)(C)(ix);
(2) Industrial processing and use type, sector(s), functional category(ies), and percent of production volume for each use, pursuant to § 711.15(b)(4)(i)(A) through (D);
(3) Consumer and/or commercial indicator, product category(ies), functional category(ies), percent of production volume for each use, indicator for use in products intended for children, and maximum concentration in the product, pursuant to § 711.15(b)(4)(ii)(A) through (F);
(4) Number of workers reasonably likely to be exposed for each combination of industrial processing or use operation, sector, and function, pursuant to § 711.15(b)(4)(i)(F), and the number of commercial workers reasonably likely to be exposed when the substance is used in a commercial product, pursuant to § 711.15(b)(4)(ii)(G).
(b) Any person covered in this part must report all information to EPA in § 705.15 for each year since January 1, 2011. If a person has already reported any of the data elements identified in paragraph (a) of this section, but not for all years since 2011, then that person must submit the required information for the intervening years.
Each person who is subject to the reporting requirements of this part must retain records that document any information reported to EPA. Relevant records must be retained for a period of 5 years beginning on the last day of the submission period.
(a)
(2)
(i) For chemical identities listed on the public portion of the TSCA Inventory;
(ii) For processing and use data elements required by § 705.15(c)(1) through (7); or
(iii) When a response is left blank or designated as “not known or reasonably ascertainable.”
(3)
(b) Unless exempted,
(1) Production volume information required pursuant to § 705.15(d)(1), (5), and (6).
(c)
(d)
“I certify that all claims for confidentiality asserted with this submission are true and correct, and all information submitted herein to substantiate such claims is true and correct. Any knowing and willful misrepresentation is subject to criminal penalty pursuant to 18 U.S.C. 1001. I further certify that: (1) I have taken reasonable measures to protect the confidentiality of the information; (2) I have determined that the information is not required to be disclosed or otherwise made available to the public under any other Federal law; (3) I have a reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to the competitive position of my company; and (4) I have a reasonable basis to believe that the information is not readily discoverable through reverse engineering.”
(e) Substantiation requirements for
(1) Will disclosure of the information claimed as confidential likely cause substantial harm to your business's competitive position? If you answered yes, describe the substantial harmful effects that would likely result to your competitive position if the information is disclosed, including but not limited to how a competitor could use such information, and the causal relationship between the disclosure and the harmful effects.
(2) Has your business taken precautions to protect the confidentiality of the disclosed information? If yes, please explain and identify the specific measures, including but not limited to internal controls, that your business has taken to protect the information claimed as confidential.
(3)(i) Is any of the information claimed as confidential required to be publicly disclosed under any other Federal law? If yes, please explain.
(ii) Does any of the information claimed as confidential otherwise appear in any public documents, including (but not limited to) safety data sheets; advertising or promotional material; professional or trade publications; state, local, or Federal agency files; or any other media or publications available to the general public? If yes, please explain why the information should be treated as confidential.
(iii) Does any of the information claimed as confidential appear in one or more patents or patent applications? If yes, please provide the associated patent number or patent application number (or numbers) and explain why the information should be treated as confidential.
(4) Does any of the information that you are claiming as confidential constitute a trade secret? If yes, please explain how the information you are claiming as confidential constitutes a trade secret.
(5) Is the claim of confidentiality intended to last less than 10 years (see TSCA section 14(e)(1)(B))? If yes, please indicate the number of years (between
(6) Has EPA, another federal agency, or court made any confidentiality determination regarding information associated with this chemical substance? If yes, please provide the circumstances associated with the prior determination, whether the information was found to be entitled to confidential treatment, the entity that made the decision, and the date of the determination.
(f)
(1) Is this chemical substance publicly known (including by your competitors) to be in U.S. commerce? If yes, please explain why the specific chemical identity should still be afforded confidential status (
I certify that on the date referenced, I searched the internet for the chemical substance identity (
(2) Does this particular chemical substance leave the site of manufacture (including import) in any form,
(3) If the chemical substance leaves the site in a form that is available to the public or your competitors, can the chemical identity be readily discovered by analysis of the substance (
(4) Would disclosure of the specific chemical name release confidential process information? If yes, please explain.
(g)
You must use CDX to complete and submit the reporting form required under this part. Submissions may only be made as set forth in this paragraph. Submissions must be sent electronically to EPA via CDX. The information submitted and all attachments (unless the attachment appears in scientific literature) must be in English. All information must be true and correct. Access the PFAS reporting tool and instructions, as follows:
(1) By website. Access the PFAS reporting tool via the CDX homepage at
(2) By phone or email. Contact the EPA TSCA Hotline at (202) 554-1404 or
Agricultural Marketing Service, USDA.
Notice.
The designation of the official agency listed in
Applications and comments must be received by July 28, 2021.
Submit applications and comments concerning this Notice using any of the following methods:
•
•
Jessica Dreier at
The designation of the official agency listed below will end on the prescribed date:
Section 7(f) of the United States Grain Standards Act (USGSA) authorizes the Secretary to designate a qualified applicant to provide official services in a specified area after determining that the applicant is better able than any other applicant to provide such official services (7 U.S.C. 79(f)). Under section 7(g) of the USGSA, designations of official agencies are effective for no longer than five years, unless terminated by the Secretary, and may be renewed according to the criteria and procedures prescribed in section 7(f) of the USGSA.
Interested persons or governmental agencies may apply for designation to provide official services in the geographic area of the official agency specified above under the provisions of section 7(f) of the USGSA and 7 CFR 800.196. Designation in the specified geographic area for Titus begins July 1, 2021. To apply for designation or to request more information on the geographic area serviced by this official agency, contact Jessica Dreier at the address listed above.
We are publishing this Notice to provide interested persons the opportunity to comment on the quality of services provided by the Titus official agency. In the designation process, we are particularly interested in receiving comments citing reasons and pertinent data supporting or objecting to the designation of the applicant. Such comments should be submitted through the Federal e-rulemaking portal at
We consider applications, comments, and other available information when determining which applicant will be designated.
7 U.S.C. 71-87k.
Agricultural Marketing Service, USDA.
Notice of final action.
This action is being taken under the authority of the Agricultural Marketing Act of 1946, as amended (AMA). The United States Department of Agriculture's (USDA) Agricultural Marketing Service (AMS) is revising the method of interpretation for the determination of “sample grade criteria” in the Bean Inspection Handbook, pertaining to the class “Blackeye beans” in the U.S. Standards for Beans. Stakeholders in the dry bean processing/handling industry requested that AMS amend the definition of
Loren Almond, USDA AMS; Telephone: (816) 702-3925; Email:
Under the authority of the AMA (7 U.S.C. 1621-1627), as amended, AMS establishes and maintains a variety of quality and grade standards for agricultural commodities that serve as a fundamental starting point to define commodity quality in the domestic and global marketplace.
Standards developed under the AMA include those for rice, whole dry peas, split peas, feed peas, lentils, and beans. The U.S. Standards for whole dry peas, split peas, feed peas, lentils and beans no longer appear in the Code of Federal Regulations, but are now maintained by USDA-AMS-Federal Grain Inspection Service (FGIS). The U.S. Standards for beans are voluntary and widely used in private contracts, government procurement, marketing communication, and for some commodities, consumer information.
The bean standards facilitate bean marketing and define U.S. bean quality in the domestic and global marketplace. The standards define commonly used industry terms; contain basic principles governing the application of standards, such as the type of sample used for a particular quality analysis; provide the basis of determination; and specify grades and grade requirements. Official procedures for determining grading factors are provided in the Bean Inspection Handbook. Together, the grading standards and testing procedures allow buyers and sellers to communicate quality requirements, compare bean quality using equivalent forms of measurement, and assist in price discovery.
AMS engages in outreach with stakeholders to ensure commodity standards maintain relevance to the modern market. Bean industry stakeholders include the US Dry Bean Council (USDBC), California Dry Bean Advisory Board, California Bean Shippers Association, and Cal Bean and Grain, among others.
The United States Standards for Beans and the official inspection procedures for beans in the Bean Inspection Handbook are available on the AMS public website. The United States Standards for Beans were last revised in 2017. Currently, sample grade tolerances for IWOF in all classes of beans are determined on a count basis of two or more beans in 1,000 grams. Also, CCWB is considered a sample grade and damage factor. This type of insect filth found in the Blackeye bean is not due to storage practices, but originates in the field, brought on by years of drought, and is the result of challenges associated with applying aerial pesticides. These elements have contributed to an increase of IWOF (beans and pieces of beans which contain webbing, refuse, excreta, dead insects, larvae, or eggs) in the Blackeye bean crops for years. With the current sample grade factor tolerance, difficulty in meeting contract specifications is problematic. Specifically, industry stakeholders asked AMS to revise the sample grade tolerance for IWOF and adjust CCWB to only be considered a damage factor, only in the class Blackeye beans.
Stakeholders recommended AMS revise the Bean Inspection Handbook criteria for Blackeye bean sample grade tolerances of IWOF from counts to percentages, and change CCWB from a sample grade and damage factor to a damage factor only. AMS and stakeholders worked collaboratively to redefine the tolerances for IWOF and CCWB in Blackeye beans. Additionally, these changes were recommended to AMS by the specifically named stakeholder organizations identified above to facilitate the current marketing practices.
AMS published a Notice in the
AMS believes these revisions will facilitate inspections, better reflect current marketing practices, be cost efficient, and facilitate purchasing and selling of Blackeye beans. Accordingly, AMS is making no changes to the revised Blackeye bean inspection methods as proposed. The revisions to Blackeye bean inspection are effective upon publication in the
AMS-FGIS is revising the Blackeye bean inspection criteria by amending the Bean Inspection Handbook to change the sample grade tolerance for IWOF in the Blackeye bean class only, from a count of two or more beans in 1,000 grams, to more than 0.10 percent on the basis of the representative sample as a whole, and remove CCWB as a sample grade factor.
7 U.S.C. 1621-1627.
Forest Service, USDA.
Notice of meeting.
The Eastern Idaho Resource Advisory Committee (RAC) will hold a virtual meeting by phone and/or video conference. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with Title II of the Act as well as make recommendations on recreation fee proposals for sites on the Caribou-Targhee National Forest within Bannack, Bear Lake, Bonneville, Caribou, Clark, Franklin, Fremont, Madison, 0neida, and Teton County, consistent with the Federal Lands Recreation Enhancement Act. RAC information and virtual meeting information can be found at the following website:
The meeting will be held on July 27, 2021 at 1:30 p.m., Mountain Daylight Time.
All RAC meetings are subject to cancellation. For status of the meeting prior to attendance, please contact the person listed under
The meeting will be held virtually via telephone and/or video conference.
Written comments may be submitted as described under
Bill Davis, Committee Coordinator, by phone at 208-374-5422 or email at
Individuals who use telecommunication devices for the hearing-impaired (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Daylight Time, Monday through Friday.
The purpose of the meeting is to discuss a recreation fee proposal and make a recommendation for the Jensen Cabin located on the Palisades Ranger District in Bonneville County, Idaho.
The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by July 12, 2021, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time for oral comments must be sent to Bill Davis, P.O. Box 46, Dubois, ID 83423; or by email to
Rural Business—Cooperative Service, USDA.
Notice of solicitation of applications.
This Notice announces that the Rural Business-Cooperative Service (Agency) is accepting fiscal year (FY) 2021 applications for the Agriculture Innovation Demonstration Center (AIC) program. In FY 2021, the program has $7,392,479 available for grant funding.
The purpose of this program is to establish and operate Agriculture Innovation Centers (Centers) that provide technical and business development assistance to agricultural producers seeking to engage in the marketing or the production of Value-Added products. Eligible applicants include nonprofit and for-profit corporations, public bodies, and institutions of higher education. Consortiums are also eligible to apply, but they must select a single organization to represent the consortium as the applicant. Only the applicant organization must meet the eligibility requirements. This program supports Rural Development's (RD) mission of improving the quality of life for rural Americans and commitment to directing resources to those who most need them.
We will offer two training sessions for potential applicants approximately one month after this Notice is published. The training sessions will be similar and will be offered on different dates and at different times to accommodate applicants in different time zones. The training sessions will provide an overview of the requirements for the program and address questions posed by potential applicants. It is expected that the sessions will be offered via webinar and will have a duration of approximately two hours. Details regarding the specific dates, times, and access information will be posted at least two weeks prior to the sessions on the program's website at:
Completed applications for grants must be submitted electronically by no later than 11:59 p.m. Eastern Time, September 27, 2021, through
Gail Thuner, Grants Division, Cooperative Programs, Rural Business-Cooperative Service, United States Department of Agriculture, 1400 Independence Avenue SW, MS 3201, Room 5803—South, Washington, DC 20250-3250, or call 202-720-1400, or email
In accordance with the Paperwork Reduction Act, the paperwork burden associated with this Notice has been approved by the Office of Management and Budget (OMB) under OMB Control Number 0570-0045.
The AIC program is authorized by section 7608 of the Farm Security and Rural Investment Act of 2002 (7 U.S.C. 1632b) and is implemented by 7 CFR part 4284 Subparts A and K, which are incorporated by reference into this Notice. The primary objective of the AIC program is to provide technical assistance to agricultural producers to market value-added agricultural products through Centers. Grants are available to public bodies, institutions of higher education, nonprofit corporations, and for-profit corporations. Consortiums are also eligible to apply, but they must select a single organization to represent the consortium as the applicant. Only the applicant organization must meet the eligibility requirements. It is expected that recipients will establish and operate independently-governed Centers whose boards of directors meet the representation requirements described in Section D.2(j) of this Notice.
The terms you need to understand are defined and published at 7 CFR 4284.3, 7 CFR 4284.1004, and 7 CFR 4284.902. The term “you” referenced throughout this Notice should be understood to mean “you” the applicant. Additional definitions are included below.
You must meet all of the following eligibility requirements. Applicants and/or applications which fail to meet any of these requirements by the application deadline will not be evaluated further or considered for funding.
1.
(a) An applicant is ineligible if they have been debarred or suspended or otherwise excluded from or ineligible for participation in Federal assistance programs under Executive Order 12549, “Debarment and Suspension.” In addition, an applicant will be considered ineligible for a grant due to an outstanding judgment obtained by the U.S. in a Federal Court (other than U.S. Tax Court), is delinquent on the payment of Federal income taxes, or is delinquent on Federal debt. The applicant must certify as part of the application that they do not have an outstanding judgment against them. The
(b) Any corporation (i) that has been convicted of a felony criminal violation under any Federal law within the past 24 months or (ii) that has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability, is not eligible for financial assistance provided with funds appropriated by the Consolidated Appropriations Act, 2021 (Pub. L. 116-260), unless a Federal agency has considered suspension or debarment of the corporation and has made a determination that this further action is not necessary to protect the interests of the Government. (See also Section D.2.e of this Notice.)
2.
3.
In addition to the above uses of Grant Award funds, your Matching Funds contribution can be used to provide the following services directly to agricultural producers for the purpose of producing and marketing a value-added agricultural product:
For information on selected items that are not allowable for funding under this Notice, please review section D(6) of this Notice, “Funding Restrictions.”
The application template for applying for this funding opportunity is located at
Your application must be submitted electronically through
You can locate the
When you enter the
To use
You must submit all application documents electronically through
After applying electronically through
Your application must contain the following required forms and other components:
(a) Standard Form SF-424, “Application for Federal Assistance,” to include your Unique Entity Identifier and SAM Commercial and Government Entity (CAGE) code and expiration date. If you do not include your DUNS number and your CAGE code or your DUNS number or Cage code is inactive or expired, we will not consider your application for funding.
(b) Form SF-424A, “Budget Information-Non-Construction Programs.” This form must be completed and submitted as part of the application package.
(c) You must certify that there are no current outstanding Federal judgments against your property and that you will not use grant funds to pay for any judgment obtained by the United States. You must also certify that you are not delinquent on the payment of Federal income taxes, or any Federal debt. To satisfy the Certification requirement, you must include this statement in your application: “[INSERT NAME OF APPLICANT] certifies that the United States has not obtained an unsatisfied judgment against its property, is not delinquent on the payment of Federal income taxes, or any Federal debt, and will not use grant funds to pay any judgments obtained by the United States.” A separate signature is not required.
(d) Certification on Lobbying. Your authorized representative must sign a certification which contains the entire statement from 2 CFR part 418, Appendix A.
(e) Financial Capability. You must include your most recent audit (including the Letter to the Managers).
(f) Applicant Eligibility. You must verify your legal status and demonstrate your eligibility for the program.
• Public bodies must provide the legal citation that authorizes their organization.
• Non-profit and for-profit corporations must submit the State's Certificate of Good Standing (or the equivalent tribal documentation if incorporated under tribal law) and your Articles of Incorporation.
• Institutions of Higher Education must demonstrate that you qualify as an Institution of Higher Education as defined at 20 U.S.C. 1001. The most common way to demonstrate this qualification is to provide the legal citation that authorizes the institution.
(g) Verification of Matching Funds. Matching funds must be provided for at least one-third of the total project cost. For example, if your total project cost is $1,500,000, you must provide at least $500,000 in matching funds. Matching funds can be provided in cash by the applicant organization or a third-party. They can also be provided in-kind by a third-party organization. You must verify the amount of funds to be contributed, the source of the funds, the availability of the funds, and the purpose for which the funds will be used. All verification must be done on an organization's letterhead and be signed by the organization's authorized representative.
(h) Governance Structure of the Center. The Center does not need to be an independent legal entity; however, it must be independently governed. You must provide an explanation of how the governance of the Center works (or will work if it hasn't been established at the time of application). In particular, you must address how the Center carries out personnel decisions, including hiring and firing employees and contractors; sets its policies and procedures, including personnel and procurement; develops and approves its budget; and selects its own Board of Directors.
(i) Board of Directors. You must provide the following information:
For the representatives from the two General Agricultural Organizations with the greatest number of members in your State, you must identify the representatives, the organizations, their purposes, and the number of members they have in your State. You must also explain how you determined that the organizations have the most (or second most) members. Acceptable sources for this information can include the state Department of Agriculture, or its equivalent, or a third-party, reliable source, such as a trade journal or university agriculture department.
For the representative from the State Department of Agriculture (or equivalent) or State legislator, you must identify the representative and include the person's title and job responsibility if from the Department of Agriculture or identify the district the State legislator represents.
For representatives from four Agricultural Commodity Organizations, you must identify each representative and the organization they represent. You must use data from the State Department of Agriculture, or its equivalent, to demonstrate that the commodities are produced in your state and provide a copy of the information used.
You must also submit a signed statement from each representative stating that they either are currently on the Center's Board of Directors or that they commit to being on the Center's Board of Directors during the proposed period of performance.
If your application is selected for funding, we will confirm the Board of Directors still meets the requirements. If at any time, the Center's Board of Directors does not meet the requirements during the period of performance, the award will either be suspended until the requirements can be met or it will be terminated if the requirements can no longer be met.
(j) Existing Capability to Provide Services. The applicant organization must be able to demonstrate that it has previously provided services similar to the Producer Services defined in 7 CFR 4284.1004 or that it has the capability to provide those services.
To demonstrate previously providing services, you must include a chart or narrative that describes the services provided during the last three to five years, as needed, to show that you can meet the requirement. The description must include the specific type of service provided, the role of the Center in providing the service, how many times it has been provided, and the outcomes of the services provided (preferably with quantitative measurements).
If the Center does not have at least three years of experience providing Producer Services during the last five years, you must provide a chart or narrative that describes the key personnel's experience with providing Producer Services during the last three to five years, as needed, to show that you can meet the requirement. The narrative must include a description of the services provided, the role of the key personnel in providing the service, how many times it has been provided, and the outcomes of the services provided (preferably with quantitative measurements).
We will assess the capability of each applicant organization based only on what is submitted with the application.
(k) Support of the Agricultural Community. You must include at least three letters of support from agricultural organizations, other than the applicant organization, that are relevant to the project. Evidence of support includes contributions of cash or in-kind matching funds. Other examples of support include referring clients and intent to collaborate. We will consider
(l) Strategic Coordination and Alliances. Describe arrangements in place or planned with end users (for example, processing and distribution companies and regional grocers) as well as with entities that have technical research capabilities, broad support from the agricultural community in the State or region, significant coordination with end users, strategic alliances with entities having technical research capabilities and a focused delivery plan for reaching out to the producer community.
(m) Title Page. Your application must contain a Title Page. It is recommended that your Title Page include a short title for your proposed project as well as contact information or other application identifying information.
(n) Table of Contents. Your application must contain a detailed Table of Contents (TOC). The TOC must include page numbers for each part of the application, including each evaluation criterion. Page numbers should begin immediately following the TOC.
(o) Executive Summary. A summary of the proposal, not to exceed one page, must briefly describe the Project, tasks to be completed, and other relevant information that provides a general overview of the Project.
(p) Goals of the Project. You must include a listing of each Producer Service to be offered during the project. You must also identify one or more specific goals relating to increasing and improving the ability of identified local agricultural producers to develop a market or process for Value-Added agricultural commodities or products.
(q) Work Plan. You must include a description of your proposed work for the project, including how your project focuses on increasing and improving the ability of local agricultural producers to develop markets and processes for Value-Added agricultural commodities or products. This description must include the actions that will be taken in order for the Producer Services to be available from the Center. Each action should include a target date for completion. General start-up tasks should be listed, followed by specific tasks listed for each Producer Service to be offered. Tasks associated with the start-up of the Center should include a focused marketing and delivery plan directed at the local agricultural producers that were identified in the Goals section of your application. The actions to be taken should include steps for identifying customers, hiring key personnel (if not already hired), contracting for services for the Center, and making arrangements for strategic alliances. Each defined task needs to have a description, assigned key personnel, and an expected time frame for accomplishment. You must also clearly demonstrate how your project will provide services to new customers or provide new services to existing customers.
Note that the work you propose to accomplish must be allowable based on Sec. C.3 of this Notice. Funding restrictions are described in Sec. D.6.
(r) Budget Justification. You must provide additional information regarding the budget you submit on the SF-424A, including your matching funds. This additional information must describe each category of expense and what specific costs are included in each category as well as how your Matching Funds will be used. For example, the Salaries justification must include the names of each staff member (not just key personnel) who will be paid and how much they will be paid. The Fringe Benefits category must include a description of how fringe benefits are calculated and what is included. The Contracts category must identify the contractors by name (if known) as well as the amounts expected for each contract and the purpose of each contract. The Other category must include the expected expenses (
(s) Scoring Criteria. Each of the scoring criteria in this Notice must be addressed in narrative form, with a maximum of three pages for each individual scoring criterion, unless otherwise specified. Failure to address each scoring criteria will result in the application being determined ineligible.
System for Awards Management. All program applicants must be registered in the System for Awards Management (SAM) prior to submitting an application, unless determined exempt under 2 CFR 25.110. Grant recipients must maintain an active SAM registration with current information at all times during which it has an active Federal award or an application under consideration by the Agency. The applicant must ensure that the information in the database is current, accurate, and complete. Applicants must ensure they complete the Financial Assistance General Certifications and Representations in SAM.
To be eligible, you are required to:
(a) Provide a valid Unique Entity Identifier (formerly known as the DUNS number) in your application, which can be obtained at no cost via a toll-free request line at (866) 705-5711 or at
(b) Register in SAM at no cost at
(c) Continue to maintain an active SAM registration with current information at all times during which you have an active Federal award or an application or plan under consideration by a Federal awarding agency.
If you have not fully complied with all applicable Unique Entity Identifier and SAM requirements, the Agency may determine that the applicant is not qualified to receive a Federal award and the Agency may use that determination as a basis for making an award to another applicant. Please refer to Section F.2 for additional submission requirements that apply to grantees selected for this program.
Executive Order (E.O.) 12372, “Intergovernmental Review of Federal Programs,” applies to this program. This E.O. requires that Federal agencies provide opportunities for consultation on proposed assistance with State and local governments. Many States have established a Single Point of Contact
If your State has a SPOC, you may submit a copy of the application directly for review. Any comments obtained through the SPOC must be provided to us for consideration as part of your application. If your State has not established a SPOC, or if you do not want to submit a copy of the application, we will submit your application to the SPOC or other appropriate agency or agencies.
No funds made available under this solicitation shall be used to:
(a) Plan, repair, rehabilitate, acquire, or construct a building or facility, including a processing facility;
(b) Purchase, rent, or install fixed equipment, including processing equipment;
(c) Purchase vehicles, including boats;
(d) Pay for the preparation of the grant application;
(e) Pay expenses not directly related to the funded Project;
(f) Fund political or lobbying activities;
(g) Fund any activities considered unallowable by the applicable grant cost principles, including 2 CFR part 200, subpart E and the Federal Acquisition Regulation;
(h) Fund architectural work for a specific physical facility;
(i) Fund any direct expenses for the production of any commodity or product to which value will be added, including seed, rootstock, labor for harvesting the crop, and delivery of the commodity to a processing facility;
(j) Fund manufacturing or processing expenses;
(k) Purchase land;
(l) Duplicate current activities or activities paid for by another Federal grant program;
(m) Pay costs of the Project incurred prior to the date of award approval;
(n) Pay for assistance to any private business enterprise that does not have at least 51 percent ownership by those who are either citizens of the United States or reside in the United States after being legally admitted for permanent residence;
(o) Pay any judgment or debt owed to the United States;
(p) Pay for Research and Development; or
(q) Pay for any goods or services from a person who has a Conflict of Interest with the recipient.
In addition, your application will not be considered for funding if it does any of the following:
• Requests less than the minimum or more than the maximum grant amount;
• Focuses assistance on only one agriculture producer or business;
• Proposes ineligible costs that equal more than 10 percent of total grant funds requested;
• Earns revenue from processing or selling a product as part of the project. Centers may charge fees for services provided, but they cannot earn revenue on actually processing a product or from sales associated with a product they helped develop; or
• Provides services to entities other than Agricultural Producers on behalf of and at the request of Agricultural Producers.
We will consider your application for funding if it includes ineligible costs of 10 percent or less of total grant funds requested, if it is determined eligible otherwise. However, if your application is successful, those ineligible costs must be removed. If time permits, the Agency may allow those ineligible costs to be replaced with allowable costs. Otherwise, the amount of the grant award will be reduced accordingly. If we cannot determine the percentage of ineligible costs, your application will not be considered for funding.
(a) National Environmental Policy Act. This Notice has been reviewed in accordance with 7 CFR part 1970, “Environmental Policies and Procedures.” We have determined that an Environmental Impact Statement is not required in connection with the issuance of this Notice because the issuance of regulations and instructions, as well as amendments to them, describing administrative and financial procedures for processing, approving, and implementing the Agency's financial programs is categorically excluded in the Agency's National Environmental Policy Act (NEPA) regulation found at 7 CFR 1970.53(f). We have determined that this Notice does not constitute a major Federal action significantly affecting the quality of the human environment.
The Agency will review each grant application to determine its compliance with 7 CFR part 1970. The applicant may be asked to provide additional information or documentation to assist the Agency with this determination.
(b) Civil Rights Compliance Requirements. All grants made under this Notice are subject to Title VI of the Civil Rights Act of 1964 as required by USDA (7 CFR part 15, subpart A) and Section 504 of the Rehabilitation Act of 1973.
We will review applications to determine if they are eligible for assistance based on requirements in this Notice, and other applicable Federal laws and regulations. If we determine that your application is eligible for assistance, your application will be scored by a panel of USDA employees based on the Scoring Criteria specified in this Notice. The highest scoring application will be funded up to the maximum amount available. Additional applications that cannot be fully funded may be offered partial funding at the Agency's discretion.
All eligible and complete applications will be evaluated based on the following criteria. Evaluators will base scores only on the information provided in the application. This is a competitive program, so you will receive scores based on the quality of the information provided. Simply addressing the criteria will not guarantee higher scores. The total points possible for the criteria are 80.
(a) Ability to Deliver (maximum score of 15 points). The application will be evaluated as to whether it evidences unique abilities to deliver Producer Services so as to create sustainable Value-Added ventures. Abilities that are transferable to a wide range of agricultural Value-Added commodities are preferred over highly specialized skills. Strong skills must be accompanied by a credible and thoughtful plan.
Points will be awarded as follows:
(i) 0 points will be awarded if you do not substantively address the criterion.
(ii) 1-4 points will be awarded for unique abilities, that is, abilities that are not available through other organizations in the Center's service area.
(iii) 1-4 points will be awarded for the expected sustainability of the Value-Added ventures supported by the project. For example, applications that propose to work with ventures where the expected sustainability has been assessed will receive more points than applications that do not address expected sustainability. By sustainability, we mean that the venture assisted will generate wealth (
(iv) 1-4 points will be awarded for the transferability of the abilities identified. Abilities that are transferable to a wide
(v) 1-3 points will be awarded for plans to accomplish work that are thoughtful and seem reasonable. For example, do the services the Center will provide match the stated goals (from Section D.2.q). Are the results measurable and attainable within the proposed project period?
(b) Successful Track Record (maximum score of 15 points). The applicant organization's track record in achieving Value-Added successes will be evaluated.
Points will be awarded as follows:
(i) 0 points will be awarded if you do not substantively address the criterion.
(ii) 1-3 points will be awarded if the applicant has more than three years of experience in accomplishing Value-Added successes. More points will be given for more years of experience, based on the distribution of what all eligible applicants submit. No credit will be given for activities that did not directly result in a Value-Added success. Note that we consider a success to include working with an organization and providing coaching to indicate that the proposed venture is not feasible.
(iii) 1-4 points will be awarded based on the number of Value-Added successes. More points will be given for higher numbers, based on the distribution of what eligible applicants submit.
(iv) 1-4 points will be awarded based on the significance of Value-Added successes. More points will be given for more significant successes, based on the distribution of what eligible applicants submit.
(v) 1-4 points will be awarded based on the complexity of the role that the applicant organization played in the Value-Added successes.
(c) Work Plan/Budget (maximum of 15 points). We will review the work plan for detailed actions and an accompanying timetable for implementing the proposed work. We will review budgets for completeness and the strength of non-Federal funding commitments. Note that there is no additional information required for this criterion. We will use the Work Plan and Budget Justification for our evaluation.
Points will be awarded as follows:
(i) 0 points will be awarded if you do not substantively address this criterion.
(ii) 1-6 points will be awarded for work plans that describe each task, including objectives and potential outcomes, and how that task connects to the goal of the project. More points will be awarded for work plans that completely describe tasks and show measurable outcomes as well as for work plans that show a cohesive plan for the achievement of the goal(s) of the project.
(iii) 1-3 points will be awarded for work plans that show a reasonable and differentiated timetable for the proposed tasks. For example, a work plan that shows a schedule for how a Center will begin operation, then market its services, and then provide its services would be awarded more points that a work plan that simply states all Producer Services will be offered for 12 months. We will also consider how you will identify customers. Applications with a specific description of customer identification will receive more points.
(iv) 1-3 points will be awarded for the budget justification. More points will be awarded for justifications that completely describe all categories of cost, including indirect costs. We consider that a complete description includes identification of key personnel (including any contractors) and the salaries and fringe benefits associated with their time on the project as well as identification of all travel events (including who will be traveling and what the purpose of the trip is), individual contract amounts and purposes, and items that are categorized, such as computers, printers, scanners, copiers, and other office items.
(v) 1-3 points will be awarded for higher quality matching funds. We consider cash match to be of higher quality than in-kind. Thus, we will award more points for applications that have a larger percentage of matching funds coming from cash, based on the distribution of what is submitted by applicants.
(d) Qualifications of Key Personnel (maximum of 15 points). Describe the qualifications of the key personnel for the project. Key personnel may include employees of the Center or consultants/contractors, but they do not include administrative or financial staff whose purpose is to support the administrative requirements of the award. Your description should include the number of years of experience that a person has doing the type of work that will be assigned during the project as well as metrics indicating the number of times the person has provided the assistance and the outcomes of that assistance. You must also include the total hours that will be contributed to the project by each person. Points will be awarded as follows:
(i) 0 points will be awarded if you do not adequately address this criterion.
(ii) 1-5 points based on the percentage of work that will be carried out by Center employees. We will calculate the percentage by adding the hours of the key personnel and dividing the number of hours from Center employees by the total hours.
a. 1 point for 10-20% of the work carried out by Center employees;
b. 2 points for 21-40% of the work carried out by Center employees;
c. 3 points for 41-60% of the work carried out by Center employees;
d. 4 points for 61-80% of the work carried out by Center employees; and
e. 5 points for 81-100% of the work carried out by Center employees.
(iii) 1-10 points based on the qualifications of the key personnel. More points will be awarded in cases where the key personnel are assigned to specific tasks that match their experience and skills.
(e) Local support (maximum of 5 points). You must show that the Center has local support from and coordination with other developmental organizations in the proposed service area and with tribal, state, and local institutions. Support documentation should include recognition of rural values that balance employment opportunities with environmental stewardship and other rural amenities.
Points will be awarded as follows:
(i) 0 points are awarded if you do not adequately address this criterion or if you do not provide at least three letters of support.
(ii) 1 point will be awarded for a support letter from a developmental organization in the proposed service area that shows coordination with your project.
(iii) 1 point will be awarded for a support letter from a state institution.
(iv) 1 point will be awarded for a support letter from a tribal institution.
(v) 1 point will be awarded for a support letter from a local institution.
(vi) 1 point will be awarded for support that includes recognition of rural values that balance employment opportunities with environmental stewardship and other rural amenities.
You may submit a maximum of 3 letters of support for this criterion (or you may reference other letters submitted with the application). When awarding points for this criterion, we will only consider support letters from developmental organizations in the proposed service area, and state and local institutions. Additionally, identical form letters signed by multiple organizations will not be included in the count of support letters received. Support letters must be included as an attachment to the application.
(f) Future support (maximum of 15 points). Describe the vision for funding
Points will be awarded as follows:
(i) 0 points will be awarded if you do not substantively address the criterion.
(ii) 1-5 points will be awarded for applications that describe a specific plan for obtaining future funding for the Center. More points will be awarded for plans that show concrete actions for at least 3 years into the future.
(iii) 1-5 points will be awarded for applications that show a diversification of funding sources. Possible funding sources include Federal awards, tribal, state and local awards, private donations, and pay-for-service plans. More points will be awarded for plans that include multiple, committed funding sources. You may summarize the funding sources/support in a chart or narrative and you must include the following information for each source: Name of the organization, the amount of funds committed, the expected time period for commitment, and the purpose for which the funds can be used.
(iv) 1-5 points will be awarded for applications that show how in-house capacity for providing technical assistance will be improved. More points will be awarded for Centers that have a specific plan for training and hiring in-house technical assistance experts.
We will review applications to determine if they are eligible for assistance based on requirements in this Notice, and other applicable Federal laws and regulations. If we determine that your application meets the requirements, it will be scored by a panel of USDA employees in accordance with the Scoring Criteria and point allocation specified in this Notice. The review panel will convene to reach a consensus on the scores for each of the eligible applications. Applications will be ranked solely based on the points awarded, and they will be funded in rank order until available funds are expended or a minimum score of 40 points is reached. If an application cannot be fully funded, we will offer partial funding to the extent funds are available. If the applicant offered partial funding does not accept, we will offer the funding to the next highest-ranked applicant until we find an applicant that accepts the funding or no additional eligible applicants exist.
If your application is ranked and not funded, it will not be carried forward into the next competition.
If you are selected for funding, you will receive a signed Letter of Conditions containing instructions on requirements necessary to proceed with execution and performance of the award. If you are able to meet the conditions of the award within the specified time frame (typically up to 90 calendar days), we will proceed with approving an award. If you are not able to meet the conditions of the award, we may terminate consideration of your application at our discretion and choose to award the funds to the next highest-ranked applicant.
If you are not selected for funding, you will be notified in writing and informed of any review and appeal rights. Funding of successfully appealed applications will be limited to available FY 2021 funding.
Additional requirements that apply to grantees selected for this program can be found in 2 CFR parts 200, 400, 415, 417, 418, and 421. All recipients of Federal financial assistance are required to report information about first-tier subawards and executive compensation (See 2 CFR part 170). You will be required to have the necessary processes and systems in place to comply with the Federal Funding Accountability and Transparency Act reporting requirements (See 2 CFR 170.200(b), unless you are exempt under 2 CFR 170.110(b)). These regulations may be obtained at: The following link:
Applicants selected for this program will be required to execute the following additional documentation:
• Agency-approved Grant Agreement.
• Form RD 1940-1, “Request for Obligation of Funds.”
• Form RD 1942-46, “Letter of Intent to Meet Conditions.”
• Form RD 400-4, “Assurance Agreement.” By signing Form 400-4, Assurance Agreement, recipients affirm that they will operate the program free from discrimination. The recipient will maintain the race and ethnic data on the board members and beneficiaries of the program. The Recipient will provide alternative forms of communication to persons with limited English proficiency. The Agency will conduct Civil Rights Compliance Reviews on recipients to identify the collection of racial and ethnic data on Program beneficiaries. In addition, the Compliance review will ensure that equal access to the Program benefits and activities are provided for persons with disabilities and language barriers.
• SF LLL, “Disclosure of Lobbying Activities,” if applicable.
• Certification of Lobbying. Your authorized representative must sign a certification which contains the entire statement from 2 CFR part 418, Appendix A.
After award approval, you will be required to provide the following:
a. A SF-425, “Federal Financial Report,” and a project performance report will be required on a quarterly basis (due 30 calendar days after end of each quarter) for the first year of the project to ensure that all recipients are able to complete start-up activities and begin providing technical assistance. Recipients may submit financial and performance reports on a semi-annual basis for the second year of the project, provided they are on schedule for project completion. For the purposes of this program, quarters end on March 31, June 30, September 30, and December 31. The project performance reports shall include a comparison of actual accomplishments to the objectives established for that period.
b. Reasons why established objectives were not met, if applicable.
c. Reasons for any problems, delays, or adverse conditions, if any, which have affected or will affect attainment of overall project objectives, prevent meeting time schedules or objectives, or preclude the attainment of particular objectives during established time periods. This disclosure shall be accompanied by a statement of the action taken or planned to resolve the situation.
d. Objectives and timetable established for the next reporting period.
e. Provide a final project and financial status report within 90 calendar days after the expiration or termination of the award.
f. Provide outcome project performance reports and final deliverables.
For general questions about this announcement and for program Technical Assistance, please contact National Office staff: Gail Thuner, Management and Program Analyst,
In accordance with Federal civil rights law and U.S. Department of Agriculture (USDA) civil rights regulations and policies, the USDA, its Agencies, offices, and employees, and institutions participating in or administering USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). Remedies and complaint filing deadlines vary by program or incident.
Persons with disabilities who require alternative means of communication for program information (
To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form, AD-3027, found online at
U.S. Commission on Civil Rights.
Notice; correction to meeting purpose, time, and access information.
The Commission on Civil Rights published a notice in the
Mallory Trachtenberg at
Census Bureau, Commerce.
Notice of information collection, request for comment.
The Department of Commerce, in accordance with the Paperwork Reduction Act (PRA) of 1995, invites the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. The purpose of this notice is to allow for 60 days of public comment on the proposed revision of 2021 Business Enterprise Research and Development Survey, prior to the submission of the information collection request (ICR) to OMB for approval.
To ensure consideration, comments regarding this proposed information collection must be received on or before August 27, 2021.
Interested persons are invited to submit written comments by email to
Requests for additional information or specific questions related to collection activities should be directed to Michael Flaherty, U.S. Census Bureau, Chief, Research, Development & Innovation Surveys Branch, 301-763-7699,
The U.S. Census Bureau, with support from the National Center for Science and Engineering Statistics (NCSES) within the National Science Foundation, plans to conduct the Business Enterprise Research and Development Survey (BERD) for the 2021-2023 survey years. BERD covers all domestic, non-farm, for-profit businesses with at least 10 paid employees. BERD provides the only comprehensive national data on Research and Development (R&D) costs and detailed expenses by type and industry.
The Census Bureau has conducted an R&D survey since 1957, collecting primarily financial information on the systematic work companies undertake to discover new knowledge or use
Beginning in 2020, in an effort to reduce burden, BERD began rotating select content off the survey in alternating years. In 2020, questions related to detail of R&D performed by others, activities with academia, industries of business and specific federal agency funding R&D, and areas of application for R&D were removed from BERD. In 2021, all of those questions will be reintroduced to the survey and the Intellectual Property and Technology Transfer Section will be removed from the survey.
Beginning in 2021, the BERD will revise its existing Capital Expenditures section to collect additional information on assets. Cognitive testing on these questions conducted by the Census Bureau in 2018 revealed that these questions pose no substantive impact on burden (the data requested are all readily available in most companies' books) and would provide context on capital stock of R&D active companies not currently available in any other data source.
The 2021-2023 BERD will continue to collect the following types of information:
• R&D expense based on accepted accounting standards.
• Worldwide R&D of domestic companies.
• Business segment detail.
• R&D-related capital expenditures.
• Detailed data about the R&D workforce.
• R&D strategy and data on the potential impact of R&D on the market.
• R&D directed to application areas of particular national interest.
• Data measuring intellectual property protection activities and technology transfer.
Domestic and foreign researchers in academia, business, and government analyze and cite data from the BERD. Among the federal government users are the Bureau of Economic Analysis (BEA) and the White House's Office of Science and Technology Policy (OSTP). BEA includes R&D in the system of national accounts that measures the economic well-being of the country. BERD data are key inputs into these accounts, which feed into the calculation of the U.S. Gross Domestic Product (GDP). The White House, in 2006, issued the American Competitiveness Initiative to “increase investments in research and development, strengthen education, and encourage entrepreneurship.” In support of this initiative and in response to legislative mandates, data on R&D are delivered to OSTP, primarily in the biennial National Science Board report Science and Engineering Indicators. Also, the National Science Foundation (NSF) produces a series of publications containing R&D data including the National Patterns of R&D Resources series, the S&E State Profile series, and the annual Business Enterprise Research and Development Survey series. Special reports and other publications are also prepared.
BERD will follow a primarily electronic collection strategy. The form will be available on the website to assist respondents with gathering the required data prior to reporting online. Paper forms will also be sent to respondents upon request, however no paper forms will be included in initial mail packets. The online survey automatically skips questions that do not apply [based on previous responses] and checks for common errors. Links to detailed question-by-question instructions will be embedded in the electronic instrument. Excel spreadsheets are available to facilitate the electronic collection of information from various areas of the companies. Respondents have the capability to download the spreadsheets from the Census Bureau's website. A consolidator spreadsheet is also available to assist companies that need to gather information from business units and then compile the information into one company report.
The due date will be six weeks after mail out.
We are soliciting public comments to permit the Department/Bureau to: (a) Evaluate whether the proposed information collection is necessary for the proper functions of the Department, including whether the information will have practical utility; (b) Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used; (c) Evaluate ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms 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 may 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 application has been submitted to the Foreign-Trade Zones (FTZ) Board by the Caddo-Bossier Parishes Port Commission, grantee of FTZ 145, requesting authority to reorganize the zone under the alternative site framework (ASF) adopted by the FTZ Board (15 CFR 400.2(c)). The ASF is an option for grantees for the establishment or reorganization of zones and can permit significantly greater flexibility in the designation of new subzones or
FTZ 145 was approved by the FTZ Board on January 7, 1988 (Board Order 370, 53 FR 1503, January 20, 1988) and expanded on March 25, 1996 (Board Order 809, 61 FR 15217, April 5, 1996). The current zone includes the following sites:
The grantee's proposed service area under the ASF would be Caddo and Bossier Parishes, Louisiana, as described in the application. If approved, the grantee would be able to serve sites throughout the service area based on companies' needs for FTZ designation. The application indicates that the proposed service area is within and adjacent to the Shreveport Customs and Border Protection port of entry.
The applicant is requesting authority to reorganize its existing zone to include both of the existing sites as “magnet” sites. The ASF allows for the possible exemption of one magnet site from the “sunset” time limits that generally apply to sites under the ASF, and the applicant proposes that Site 2 be so exempted. No subzones/usage-driven sites are being requested at this time. The application would have no impact on FTZ 145's previously authorized subzones.
In accordance with the FTZ Board's regulations, Camille Evans of the FTZ Staff is designated examiner to evaluate and analyze the facts and information presented in the application and case record and to report findings and recommendations to the FTZ Board.
Public comment is invited from interested parties. Submissions shall be addressed to the FTZ Board's Executive Secretary and sent to:
A copy of the application will be available for public inspection in the “Reading Room” section of the FTZ Board's website, which is accessible via
For further information, contact Camille Evans at
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) preliminarily determines that sales of certain cold-drawn mechanical tubing of carbon and alloy steel (cold-drawn mechanical tubing) from India were made at less than normal value during the period of review (POR) June 1, 2019, through May 31, 2020. We invite interested parties to comment on these preliminary results.
Applicable June 28, 2021.
Alexis Cherry or Samantha Kinney, AD/CVD Operations, Office VIII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-0607 or (202) 482-2285, respectively.
On June 11, 2018, Commerce published the antidumping duty order on cold-drawn mechanical tubing from India.
Pursuant to section 751(a)(3)(A) of the Tariff Act of 1930, as amended (the Act), Commerce determined that it was not practicable to complete the preliminary results of this review within 245 days and extended the deadline for the preliminary results of this review by 120 days, until June 30, 2021.
The product covered by this
Commerce is conducting this review in accordance with section 751(a) of the Act. For a full description of the methodology underlying these preliminary results,
We preliminarily determine that the following weighted-average dumping margin exists for the period June 1, 2019, through May 31, 2020:
We preliminarily determine that Goodluck had no shipments of the subject merchandise to the United States during the POR.
We intend to disclose the calculations performed to parties within five days after public announcement of the preliminary results.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS. An electronically-filed document must be received successfully in its entirety by Commerce's electronic records system, ACCESS, by 5:00 p.m. Eastern Time within 30 days after the date of publication of this notice. Requests should contain: (1) The party's name, address, and telephone number; (2) the number of participants; and (3) a list of issues to be discussed. Issues raised in the hearing will be limited to those raised in the respective case and rebuttal briefs. If a request for a hearing is made, Commerce intends to hold the hearing at a time and date to be determined.
Pursuant to section 751(a)(2)(A) of the Act and 19 CFR 351.212(b)(1), Commerce will determine, and CBP shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with the final results of this review. Commerce intends to issue assessment instructions to CBP 35 days after the date of publication of the final results of this administrative review in the
For any individually examined respondent whose weighted-average dumping margin is above
For each company which we determined had “no shipments” of the subject merchandise during the POR, upon completion of the final results, we will instruct CBP to liquidate all POR entries associated with that company at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction, consistent with Commerce's reseller policy.
For entries of subject merchandise during the POR produced by each individually examined respondent for which it did not know its merchandise was destined for the United States, we will instruct CBP to liquidate such entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction. The final results of this review shall be the basis for the assessment of antidumping duties on entries of merchandise covered by the final results of this review and for future deposits of estimated duties, where applicable.
As noted in the
The following cash deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the finals results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) The cash deposit rate for TII will be equal to the weighted-average dumping margin established in the final results of this administrative review; (2) for merchandise exported by producers or exporters not covered in this review but covered in a prior segment of the proceeding, the cash deposit rate will continue to be the company-specific rate published for the most recently-completed segment of this proceeding in which they were reviewed; (3) if the exporter is not a firm covered in this review or the original investigation but the producer is, the cash deposit rate will be the rate established for the most recently completed segment of this proceeding for the producer of the merchandise; (4) the cash deposit rate for all other producers or exporters will continue to be 5.87 percent,
Unless otherwise extended, Commerce intends to issue the final results of this administrative review, including the results of our analysis of issues raised by the parties in the written comments, within 120 days of publication of these preliminary results in the
This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of doubled antidumping duties.
These preliminary results are being issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.221(b)(4).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) intends to revoke, in part, the antidumping duty (AD) and countervailing duty (CVD) orders on crystalline silicon photovoltaic cells, whether or not assembled into modules (solar cells), from the People's Republic of China (China) with respect certain off-grid small portable CSPV panels. Interested parties are invited to comment on these preliminary results.
Applicable June 28, 2021.
Thomas Hanna, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-0835.
On December 7, 2012, Commerce published the AD and CVD orders on solar cells from China.
On March 15, 2021, we initiated the requested CCRs.
The merchandise covered by these orders is crystalline silicon photovoltaic cells, and modules, laminates, and panels, consisting of crystalline silicon photovoltaic cells, whether or not partially or fully assembled into other products, including, but not limited to, modules, laminates, panels and building integrated materials.
These orders cover crystalline silicon photovoltaic cells of thickness equal to or greater than 20 micrometers, having a p/n junction formed by any means, whether or not the cell has undergone other processing, including, but not limited to, cleaning, etching, coating, and/or addition of materials (including, but not limited to, metallization and conductor patterns) to collect and forward the electricity that is generated by the cell.
Merchandise under consideration may be described at the time of importation as parts for final finished products that are assembled after importation, including, but not limited to, modules, laminates, panels, building-integrated modules, building-integrated panels, or other finished goods kits. Such parts that otherwise meet the definition of merchandise
Excluded from the scope of these orders are thin film photovoltaic products produced from amorphous silicon (a-Si), cadmium telluride (CdTe), or copper indium gallium selenide (CIGS).
Also excluded from the scope of these orders are crystalline silicon photovoltaic cells, not exceeding 10,000 mm
Additionally, excluded from the scope of the orders are panels with surface area from 3,450 mm
Also excluded from the scope of the orders are:
1. Off grid CSPV panels in rigid form with a glass cover, with the following characteristics:
(A) A total power output of 100 watts or less per panel;
(B) a maximum surface area of 8,000 cm
(C) do not include a built-in inverter;
(D) must include a permanently connected wire that terminates in either an 8 mm male barrel connector, or a two-port rectangular connector with two pins in square housings of different colors;
(E) must include visible parallel grid collector metallic wire lines every 1-4 millimeters across each solar cell; and
(F) must be in individual retail packaging (for purposes of this provision, retail packaging typically includes graphics, the product name, its description and/or features, and foam for transport); and
2. Off grid CSPV panels without a glass cover, with the following characteristics:
(A) A total power output of 100 watts or less per panel;
(B) a maximum surface area of 8,000 cm2 per panel;
(C) do not include a built-in inverter;
(D) must include visible parallel grid collector metallic wire lines every 1-4 millimeters across each solar cell; and
(E) each panel is
1. permanently integrated into a consumer good;
2. encased in a laminated material without stitching, or
3. has all of the following characteristics: (i) The panel is encased in sewn fabric with visible stitching, (ii) includes a mesh zippered storage pocket, and (iii) includes a permanently attached wire that terminates in a female USB-A connector.
Modules, laminates, and panels produced in a third-country from cells produced in China are covered by the orders; however, modules, laminates, and panels produced in China from cells produced in a third-country are not covered by these orders.
Merchandise covered by these orders is currently classified in the Harmonized Tariff System of the United States (HTSUS) under subheadings 8501.61.0000, 8507.20.80, 8541.40.6020, 8541.40.6030, and 8501.31.8000. These HTSUS subheadings are provided for convenience and customs purposes; the written description of the scope of these orders is dispositive.
Pursuant to section 751(d)(1) of the Act, and 19 CFR 351.222(g), Commerce may revoke an order, in whole or in part, based on a review under section 751(b) of the Act (
SOURCE Global submitted letters from SunPower Manufacturing Oregon, LLC (SPMOR), a U.S. producer of the domestic like product and a petitioner in the underlying investigations, indicating that it does not object to the scope modification proposed by SOURCE Global which would exclude certain off-grid small portable CSPV panels from the
In light of SPMOR's lack of interest in maintaining the
Accordingly, we are notifying the public of our intent to revoke the
Off-grid CSPV panels in rigid form with a glass cover, with each of the following physical characteristics, whether or not assembled into a fully completed off-grid hydropanel whose function is conversion of water vapor into liquid water:
(A) A total power output of no more than 80 watts per panel;
(B) A surface area of less than 5,000 square centimeters (cm
(C) Do not include a built-in inverter;
(D) Do not have a frame around the edges of the panel;
(E) Include a clear glass back panel; and
(F) Must include a permanently connected wire that terminates in a two-port rectangular connector.
We will consider comments from interested parties on these preliminary results before issuing the final results of these CCRs.
Interested parties are invited to comment on these preliminary results of CCRs in accordance with 19 CFR 351.309(c)(1)(ii). Written comments may be submitted no later than 14 days after the date of publication of these preliminary results in the
Commerce will issue the final results of these CCRs, which will include its analysis of any written comments, no later than 270 days after the date on which these reviews were initiated.
The current requirement for cash deposits of estimated antidumping and countervailing duties on all entries of subject merchandise will continue unless they are modified pursuant to the final results of these CCRs.
These preliminary results of CCRs and this notice are published in accordance with sections 751(b) and 777(i) of the Act and 19 CFR 351.216, 19 CFR 351.221(c)(3), and 19 CFR 351.222.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) preliminarily determines that sales of certain frozen warmwater shrimp (shrimp) from Thailand have been made below normal value during the period of review (POR), February 1, 2019, through January 31, 2020. We invite interested parties to comment on these preliminary results.
Applicable June 28, 2021.
Benjamin A. Luberda, AD/CVD Operations, Office II, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-2185.
Commerce is conducting an administrative review of the antidumping duty order on shrimp from Thailand.
The merchandise subject to the
Commerce is conducting this review in accordance with section 751(a)(1)(B) and (2) of the Tariff Act of 1930, as amended (the Act). Export price and constructed export price are calculated in accordance with section 772 of the Act. Normal value is calculated in accordance with section 773 of the Act.
For a full description of the methodology underlying our conclusions,
As a result of this review, we preliminarily determine that the following weighted-average dumping margin exists for the period February 1, 2019, through January 31, 2020:
Commerce intends to disclose the calculations performed in connection with these preliminary results to interested parties within five days after the date of publication of this notice.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Acting Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS. An electronically-filed document must be received successfully in its entirety by ACCESS by 5:00 p.m. Eastern Time within 30 days after the date of publication of this notice.
Commerce intends to issue the final results of this administrative review, including the results of its analysis raised in any written briefs, not later than 120 days after the publication date of this notice, pursuant to section 751(a)(3)(A) of the Act, unless otherwise extended.
Upon issuance of the final results, Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review.
Pursuant to 19 CFR 351.212(b)(1), because Thai Union reported the entered value of its U.S. sales, we calculated importer-specific
Commerce's “automatic assessment” practice will apply to entries of subject merchandise during the POR produced by companies included in these final results of review for which the reviewed companies did not know that the merchandise they sold to the intermediary (
Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the
The following deposit requirements will be effective for all shipments of shrimp from Thailand entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) The cash deposit rate for the exporter listed above will be that established in the final results of this review, except if the rate is less than 0.50 percent and, therefore,
This notice serves as a reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
We are issuing and publishing these results in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.221(b)(4).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) preliminarily determines that the producer/exporter subject to this administrative review made sales of subject merchandise at less than normal value (NV). Interested parties are invited to comment on these preliminary results.
Applicable June 28, 2021.
William Miller, AD/CVD Operations, Office II, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-3908.
On April 8, 2020, based on timely requests for review, in accordance with 19 CFR 351.221(c)(1)(i), we initiated an administrative review of the antidumping duty order on large residential washers from Mexico, for one company, Electrolux Home Products Corp. N.V. and Electrolux Home Products de Mexico, S.A. de C.V. (collectively, Electrolux).
The products covered by the order are all large residential washers and certain subassemblies thereof from Mexico.
Commerce is conducting this review in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act). Constructed export price is calculated in accordance with section 772 of the Act. NV is calculated in accordance with section 773 of the Act. For a full description of the methodology underlying our conclusions,
We preliminarily determine that the following weighted-average dumping margin exists for the period February 1, 2019, through January 31, 2020:
Upon completion of this administrative review, Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries.
Pursuant to 19 CFR 351.212(b)(1), we calculated importer-specific
We intend to issue instructions to CBP 41 days after the publication date of the final results of this review.
The following cash deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) The cash deposit rate for Electrolux will be that established in the final results of this review, except if the rate is less than 0.50 percent and, therefore,
Commerce intends to disclose the calculations performed in connection with these preliminary results to interested parties within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).
Interested parties may submit case briefs no later than 30 days after the date of publication of this notice.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS within 30 days after the date of publication of this notice.
An electronically-filed document must be received successfully in its entirety by ACCESS by 5 p.m. Eastern Time on the established deadline.
Commerce intends to issue the final results of this administrative review, including the results of its analysis of issues raised in any written briefs, not later than 120 days after the date of publication of this notice, unless the deadline is extended.
This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
We are issuing and publishing these results in accordance with sections 751(a)(1) and 777(i)(1) of the Act.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) preliminarily determines that Carbon Activated Tianjin Co., Ltd. (Carbon Activated) and Datong Juqiang Activated Carbon Co., Ltd. (Datong Juqiang), exporters of certain activated carbon from the People's Republic of China (China), sold subject merchandise in the United States at prices below normal value (NV) during the period of review (POR) April 1, 2019, through March 31, 2020. Interested parties are invited to comment on these preliminary results.
Applicable June 28, 2021.
Jinny Ahn or Joshua Simonidis, AD/CVD Operations, Office VIII, Enforcement and Compliance, International Trade Administration, Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-0339 or (202) 482-0608, respectively.
This administrative review is being conducted in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act). Commerce published the notice of initiation of this administrative review on June 8, 2020.
The merchandise subject to the
Based on our analysis of U.S. Customs and Border Protection (CBP) information, and the no shipment certifications submitted by Beijing Pacific Activated Carbon Products Co., Ltd., Jilin Bright Future Chemicals Co., Ltd., Shanxi Dapu International Trade Co., Ltd., Shanxi Industry Technology Trading Co., Ltd., Shanxi Tianxi Purification Filter Co., Ltd., and Tianjin Channel Filters Co., Ltd., Commerce preliminarily determines that these companies had no shipments of subject merchandise during the POR. For additional information regarding this determination,
Consistent with our practice in non-market economy (NME) cases, we are not rescinding this review but instead intend to complete the review with respect to these six companies for which we have preliminarily found no shipments and issue appropriate instructions to CBP based on the final results of the review.
Commerce is conducting this review in accordance with section 751(a)(1)(B) of the Act. We calculated export prices and constructed export prices in accordance with section 772 of the Act. Because China is an NME country within the meaning of section 771(18) of the Act, NV has been calculated in accordance with section 773(c) of the Act.
For a full description of the methodology underlying our conclusions,
Commerce preliminarily finds that 61 companies for which a review was requested
For those companies that have established their eligibility for a separate rate,
For the
Commerce intends to disclose the calculations performed for these preliminary results to the parties no later than five days after the date of publication of this notice in accordance with 19 CFR 351.224(b). Pursuant to 19 CFR 351.309(c)(ii), interested parties may submit case briefs no later than 30 days after the date of publication of these preliminary results of review. Parties who submit case briefs or rebuttal briefs in this proceeding are encouraged to submit with each argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities. Rebuttal briefs, limited to issues raised in the case briefs, may be filed no later than seven days after the case briefs are filed.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance within 30 days of the date of publication of this notice. Requests should contain: (1) The party's name, address and telephone number; (2) the number of participants; and (3) a list of issues parties intend to discuss. Issues raised in the hearing will be limited to those raised in the respective case and rebuttal briefs.
All submissions to Commerce must be filed electronically using ACCESS
Unless otherwise extended, Commerce intends to issue the final results of this administrative review, which will include the results of its analysis of issues raised in any briefs, within 120 days of publication of these preliminary results, pursuant to section 751(a)(3)(A) of the Act.
Upon issuance of the final results, Commerce will determine, and CBP shall assess, antidumping duties on all appropriate entries covered by this review.
For the respondents that were not selected for individual examination in this administrative review but qualified for a separate rate, the assessment rate will be the margin established for these companies in the final results of this review.
For the final results, if we continue to treat the 61 companies, identified at Appendix II to this notice, as part of the China-wide entity, we will instruct CBP to apply a per-unit assessment rate of $2.42 per kilogram to all entries of subject merchandise during the POR which were exported by those companies.
For entries that were not reported in the U.S. sales data submitted by companies individually examined during this review, Commerce will instruct CBP to liquidate such entries at the rate for the China-wide entity.
In accordance with section 751(a)(2)(C) of the Act, the final results of this review shall be the basis for the assessment of antidumping duties on entries of merchandise covered by the final results of this review and for future deposits of estimated antidumping duties, as applicable.
The following cash deposit requirements will be effective upon publication of the final results of this administrative review for shipments of the subject merchandise from China entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided by section 751(a)(2)(C) of the Act: (1) For each specific company listed in the final results of this review, the cash deposit rate will be equal to the weighted-average dumping margin established in the final results of this review (except that if the
This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
This administrative review and notice are issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act, 19 CFR 351.213, and 19 CFR 351.221(b)(4).
National Institute of Standards and Technology (NIST), Commerce.
Notice of information collection, request for comment.
The Department of Commerce, in accordance with the Paperwork Reduction Act of 1995 (PRA), invites the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. The purpose of this notice is to allow for 60 days of public comment preceding submission of the collection to OMB.
To ensure consideration, comments regarding this proposed information collection must be received on or before August 27, 2021.
Interested persons are invited to submit written comments by mail to Maureen O'Reilly, Management Analyst, NIST by email to
Requests for additional information or specific questions related to collection activities should be directed to Danielle Santos, NICE Program Office, (301) 975-5048;
As part of NIST's charge for National Cybersecurity Awareness and Education outlined in the Cybersecurity Enhancement Act of 2014, the National Initiative for Cybersecurity Education (NICE) energizes and promotes a robust network and an ecosystem of cybersecurity education, training, and workforce development. NICE, led by NIST, fulfills this mission by coordinating with government, academic, and industry partners to build on existing successful programs, facilitate change and innovation, and bring leadership and vision to increase the number of skilled cybersecurity professionals helping to keep our Nation secure.
Further, the NICE Strategic Plan emphasizes a goal to promote the discovery of cybersecurity careers and multiple pathways. In support of this goal, Cybersecurity Career Awareness Week aims to inspire, educate, and engage children through adults to pursue careers in cybersecurity. The annual week-long celebration provides for learning about the contributions, innovations, and opportunities that can be found by exploring cybersecurity as a field of study or career choice. The NICE community is encouraged to organize and participate in activities and initiatives during the week that:
• Create excitement around increasing public awareness and engagement in building a strong cybersecurity workforce.
• Emphasize the demand and opportunities in the field of cybersecurity.
• Increase awareness around the multiple career options within the field of cybersecurity.
• Highlight the numerous pathways to enter the cybersecurity career field.
• Showcase programs that increase participation of women, minorities, veterans, persons with disabilities, and other underrepresented populations in the cybersecurity workforce.
• Advance the NICE Strategic Plan objective to inspire cybersecurity career awareness.
This collection is necessary to support the NICE Strategic Plan objective to inspire cybersecurity career awareness. The collection of information will allow the NICE Program Office to share with the public a compiled list of events and opportunities to learn about cybersecurity careers. Doing so will provide a resource for potential attendees, extend the reach of programs and efforts, serve as a source of metrics for outreach activities and impact, and encourage more stakeholders to get involved in National Cybersecurity Career Awareness Week.
The information gathered in this collection will be populated into publicly accessible list on
Information collected includes basic contact information, such as name, however the data is referential in nature only. Records will not be retrieved by a personal identifier; therefore, this is not a Privacy Act System of Records and does not require a SORN or Privacy Act Statement. The primary goal for this collection is to learn what kind of events are happening and where.
The primary method of collection will be via an electronic (internet) submission form.
We are soliciting public comments to permit the Department/Bureau to: (a)
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 may 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.
Office for Coastal Management (OCM), National Ocean Service (NOS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).
Notice of public meeting and opportunity to comment.
NOAA's Office for Coastal Management will hold a public meeting to solicit comments on the performance evaluation of the San Francisco Bay National Estuarine Research Reserve.
NOAA will consider all written comments received by Friday, August 20, 2021. A virtual public meeting will be held on Wednesday, August 11, 2021 at 12 p.m. PDT.
Comments may be submitted by:
•
•
Carrie Hall, Evaluator, NOAA Office for Coastal Management by email at
Section 312 of the Coastal Zone Management Act (CZMA), 16 U.S.C. 1458, requires NOAA to conduct periodic evaluations of federally approved national estuarine research reserves. The process includes one or more public meetings, consideration of written public comments, and consultations with interested Federal, state, and local agencies and members of the public. During the evaluation, NOAA will consider the extent to which the state of California has met the national objectives, adhered to the reserve's management plan approved by the Secretary of Commerce, and adhered to the terms of financial assistance under the CZMA. When the evaluation is completed, NOAA's Office for Coastal Management will place a notice in the
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public meeting; via webinar.
The Gulf of Mexico Fishery Management Council will hold a meeting of its Coastal Migratory Pelagic Advisory Panel via webinar.
The webinar will convene on Thursday, July 22, 2021, 1 p.m.-4 p.m., EDT.
The meeting will be held via webinar; visit the Gulf Council website for registration and log in information.
Dr. Natasha Mendez-Ferrer, Fishery Biologist, Gulf of Mexico Fishery Management Council;
The following items are on the agenda, though agenda items may be addressed out of order (changes will be noted on the Council's website when possible).
The meeting will begin with Adoption of Agenda; Approval of Minutes from the March 24, 2021 webinar; and, review of Scope of Work with its members.
The Advisory Panel (AP) will receive a summary of the SEDAR 38 Update for Gulf of Mexico King Mackerel with presentations on the stock assessment and results, recommendations from the Scientific and Statistical Committee (SSC), and results from the Council's Something's Fishy tool.
The AP will be presented with a draft of Coastal Migratory Pelagics Amendment 33: Modifications to the Gulf of Mexico Migratory Group King Mackerel Catch Limits and Sector Allocations. The AP will then provide recommendations.
The AP will receive public comment; and, discuss any Other Business items.
The meeting will be held via webinar. You may register for the webinar by visiting
The Agenda is subject to change, and the latest version along with other meeting materials will be posted on
Although other non-emergency issues not on the agenda may come before the Advisory Panel for discussion, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act, those issues may not be the subject of formal action during this meeting. Actions of the Advisory Panel will be restricted to those issues specifically identified in the agenda and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take-action to address the emergency.
Office of National Marine Sanctuaries (ONMS), National Ocean Service (NOS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).
Notice of open public meeting.
Notice is hereby given of a meeting of the Sanctuary System Business Advisory Council (council). The meeting is open to the public, and an opportunity for oral and written comments will be provided.
The meeting will be held Wednesday, July 7, 2021, from 1:30 p.m. to 4 p.m. ET, and an opportunity for public comment will be provided around 3:30 p.m. ET. Both times and agenda topics are subject to change.
The meeting will be held virtually using Google Meet. To participate, please use the website provided below. If you are unable to participate online, you can also connect to the public meeting using the phone number provided.
Katie Denman, Office of National Marine Sanctuaries, 1305 East West Highway, Silver Spring, Maryland 20910 (Phone: 240-533-0702; Email:
ONMS serves as the trustee for a network of underwater parks encompassing more than 620,000 square miles of marine and Great Lakes waters from Washington State to the Florida Keys, and from Lake Huron to American Samoa. The network includes a system of 14 national marine sanctuaries and Papahānaumokuākea and Rose Atoll marine national monuments. National marine sanctuaries protect our Nation's most vital coastal and marine natural and cultural resources, and through active research, management, and public engagement, sustain healthy environments that are the foundation for thriving communities and stable economies.
One of the many ways ONMS ensures public participation in the designation and management of national marine sanctuaries is through the formation of advisory councils. The Sanctuary System Business Advisory Council (council) has been formed to provide advice and recommendations to the Director regarding the relationship of ONMS with the business community. Additional information on the council can be found at
16 U.S.C. Sections 1431,
Commodity Futures Trading Commission.
Notice of meeting.
The Commodity Futures Trading Commission (CFTC) announces that on July 13, 2021, from 9:30 a.m. to 12:00 p.m. (Eastern Daylight Time), the Market Risk Advisory Committee (MRAC) will hold a public meeting via teleconference. At this meeting, the MRAC will receive reports from its CCP Risk and Governance and Interest Rate Benchmark Reform Subcommittees. In addition, the MRAC will vote on recommendations from the Interest Rate Benchmark Reform Subcommittee regarding a market best practice for switching interdealer trading conventions from LIBOR to the Secured Overnight Financing Rate for U.S. Dollar linear interest rate swaps.
The meeting will be held on July 13, 2021, from 9:30 a.m. to 12:00 p.m. (Eastern Daylight Time). Please note that the teleconference may end early if the MRAC has completed its business. Members of the public who wish to submit written statements in connection with the meeting should submit them by July 20, 2021.
The meeting will be held via teleconference. You may submit public comments, identified by “Market Risk Advisory Committee,” through the CFTC website at
Alicia L. Lewis, MRAC Designated Federal Officer, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street NW, Washington, DC 20581; (202) 418-5862.
The meeting will be open to the public. Members of the public may listen to the meeting by telephone by calling a domestic toll-free telephone or international toll or toll-free number to connect to a live, listen-only audio feed. Call-in participants should be prepared to provide their first name, last name, and affiliation.
The meeting agenda may change to accommodate other MRAC priorities. For agenda updates, please visit the MRAC committee site at:
All written submissions provided to the CFTC in any form will also be published on the CFTC's website. Persons requiring special accommodations to attend the meeting because of a disability should notify the contact person above.
Wednesday, June 30, 2021—10:00 a.m.
This meeting will be conducted by remote means.
Commission Meeting—Closed to the Public.
Decisional Matter.
Alberta E. Mills, Secretary, Division of the Secretariat, Office of the General Counsel, U.S. Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814, (301) 504-7479 (Office) or 240-863-8938 (cell).
Office of the Under Secretary of Defense (Acquisition and Sustainment), Department of Defense.
Notice of Chinese military companies.
The Secretary of Defense has removed the designation of “Communist Chinese military companies” from entities previously listed as such in accordance with the Strom Thurmond National Defense Authorization Act (NDAA) for Fiscal Year (FY) 1999. There are currently no entities designated as Communist Chinese military companies under this authority.
Jesse Salazar, (703) 697-0051.
Section 1237(b) of the Strom Thurmond NDAA for FY 1999 (Pub. L. 105-261), as amended, directs the Secretary of Defense to determine those persons operating directly or indirectly in the United States or any of its territories and possessions that are “Communist Chinese military companies” (CCMCs).
The Secretary of Defense has removed the designation of “Communist Chinese military companies” from entities previously listed as such in accordance with Section 1237 of the Strom Thurmond National Defense Authorization Act for Fiscal Year 1999 (Pub. L. 105-261).
There are currently no entities designated as Communist Chinese military companies under this authority.
Office of the Under Secretary of Defense (Acquisition and Sustainment), Department of Defense.
Notice of Chinese military companies.
The Secretary of Defense has determined that the entities listed in the
Jesse Salazar, (703) 697-0051.
Section 1260H of the William M. (Mac) Thornberry NDAA for FY21 (Pub. L. 116-283) directs the Secretary of Defense to continue to list “Chinese military companies” (CMCs) annually until December 31, 2030. Paragraph (a)(2) of this section directs the Secretary of Defense to publish the unclassified portion of such list in the
The Secretary of Defense has determined that the following entities qualify as “Chinese military companies” in accordance with Section 1260H of the William M. (Mac) Thornberry NDAA for FY21 (Pub. L. 116-283):
National Advisory Committee on Institutional Quality and Integrity (NACIQI), Office of Postsecondary Education, U.S. Department of Education.
Announcement of meeting.
This notice sets forth the agenda, time, and instructions to access or participate in the July 27-29, 2021 virtual meeting of the National Advisory Committee on Institutional Quality and Integrity (NACIQI) and provides information to members of the public regarding the meeting, including requesting to make oral comments. The notice of this meeting is required under section 10(a)(2) of the Federal Advisory Committee Act (FACA) and section 114(d)(1)(B) of the Higher Education Act (HEA) of 1965, as amended.
The virtual NACIQI meeting will be held on July 27-29, 2021, from 9:00 a.m. to 5:00 p.m. Eastern Standard Time each day.
George Alan Smith, Executive Director/Designated Federal Official, NACIQI, U.S. Department of Education, 400 Maryland Avenue SW, Room 2C-159, Washington, DC 20202, telephone: (202) 453-7757, or email:
• The establishment and enforcement of the standards of accrediting agencies or associations under subpart 2, part H, Title IV of the HEA, as amended.
• The recognition of specific accrediting agencies or associations.
• The preparation and publication of the list of nationally recognized accrediting agencies and associations.
• The eligibility and certification process for institutions of higher education under Title IV of the HEA and part C, subchapter I, chapter 34, Title 42, together with recommendations for improvement in such process.
• The relationship between (1) accreditation of institutions of higher education and the certification and eligibility of such institutions, and (2) State licensing responsibilities with respect to such institutions.
• Any other advisory function relating to accreditation and institutional eligibility that the Secretary of Education may prescribe by regulation.
You may register for the meeting on your computer with each day's designated entry link, after which you will receive a confirmation email containing personalized dial-in details, access code, and meeting web link. You must register for each day that you plan to attend.
You must pre-register at
You must pre-register at
You must pre-register at
Please note that the review of the Accreditation Council for Independent Colleges and School's (ACICS) petition for renewal of recognition has been removed from the July 2021 NACIQI meeting agenda.
Agenda items for the July 27-29, 2021, meeting are listed below.
1. Accreditation Commission for Acupuncture and Oriental Medicine. Scope of recognition: The accreditation and pre-accreditation (“Candidacy”) throughout the United States of professional non-degree and graduate degree programs, including professional doctoral programs, in the field of acupuncture and/or Oriental medicine, as well as freestanding institutions and colleges of acupuncture and/or Oriental medicine that offer such programs.
2. Accrediting Bureau of Health Education Schools. Scope of recognition: The accreditation of private, postsecondary institutions in the United States offering predominantly allied health education programs leading to a certificate,
3. Commission on Accrediting of the Association of Theological Schools. Scope of recognition: The accreditation of theological schools and seminaries, as well as schools or programs that are parts of colleges or universities, in the United States, offering post baccalaureate degrees in professional and academic theological education, including delivery via distance education.
4. Accrediting Commission of Career Schools and Colleges. Scope of recognition: The accreditation of postsecondary, non-degree-granting institutions and degree-granting institutions in the United States, including those granting associate, baccalaureate and master's degrees, that are predominantly organized to educate students for occupational, trade and technical careers, and including institutions that offer programs via distance education.
5. Council on Occupational Education. Scope of recognition: The accreditation and pre-accreditation (“Candidacy Status”) throughout the United States of postsecondary occupational education institutions offering non-degree and applied associate degree programs in specific career and technical education fields, including institutions that offer programs via distance education.
6. American Bar Association, Council of the Section of Legal Education and Admissions to the Bar. Scope of recognition: The accreditation throughout the United States of programs in legal education that lead to the first professional degree in law, including those offered via distance education, as well as freestanding law schools offering such programs. The scope extends to the Accreditation Committee of the Section of Legal Education (Accreditation Committee) for decisions involving continued accreditation (referred to by the agency as “approval”) of law schools.
7. American Psychological Association, Commission on Accreditation. Scope of recognition: The accreditation in the United States of doctoral programs in clinical, counseling, school and combined professional-scientific psychology; doctoral internship programs in health service psychology; and postdoctoral residency programs in health service psychology; and the pre-accreditation in the United States of doctoral internship programs in health service psychology; and postdoctoral residency programs in health service psychology.
8. American Osteopathic Association, Commission on Osteopathic College Accreditation. Scope of recognition: The accreditation and pre-accreditation (“Provisional Accreditation”) throughout the United States of freestanding institutions of osteopathic medicine and programs leading to the degree of Doctor of Osteopathy or Doctor of Osteopathic Medicine.
9. Transnational Association of Christian Colleges and Schools, Accreditation Commission. Scope of recognition: The accreditation and pre-accreditation (“Candidate” status) of Christian postsecondary institutions in the United States that offer certificates, diplomas, and associate, baccalaureate, and graduate degrees, including institutions that offer distance education.
Dr. Michelle Asha Cooper, Acting Assistant Secretary for the Office of Postsecondary Education, will discuss the Administration's higher education policy priorities.
Brian Fu, Program and Management Analyst, Office of Planning, Evaluation, and Policy Development (OPEPD), will provide a training on the use of the accreditor dashboards, with time for questions and discussion among NACIQI members.
In addition to its review of accrediting agencies and State approval agencies for Secretarial recognition, the meeting agenda will include additional time for Committee discussions regarding any of the categories within NACIQI's statutory authority in its capacity as an advisory committee.
The subcommittee will provide a report on its work that focuses on 34 CFR 602.16(a)(1)(i), accreditation and pre-accreditation standards.
Additional written comments regarding a specific agency or state approval agency under review will not be accepted at this time. However, members of the public may submit written statements regarding other issues within the scope of NACIQI's authority for consideration by NACIQI in the manner described below.
Oral comments may not exceed three minutes. Oral comments about an agency's recognition when a compliance report has been required by the senior Department official or the Secretary must relate to the criteria for recognition cited in the senior Department official's letter that requested the report, or in the Secretary's appeal decision, if any. Oral comments about an agency seeking expansion of scope must be directed to the agency's ability to serve as a recognized accrediting agency with respect to the kinds of institutions or programs requested to be added. Oral comments about the renewal of an agency's recognition must relate to its compliance with the Criteria for the Recognition of Accrediting Agencies, which are available at
To request to make a third-party oral comment of three minutes or less during the July 27-29, 2021 meeting, please follow either Method One or Method Two below. To submit a written statement to NACIQI concerning its work outside a specific accrediting agency under review, please follow Method One.
Bonneville Power Administration, Department of Energy.
Notice of information collection; request for comments.
The Department of Energy (DOE), Bonneville Power Administration (BPA), invites public comment on a collection of information that BPA is developing for submission to the Office of Management and Budget (OMB) pursuant to the Paperwork Reduction Act of 1995.
Comments regarding this proposed information collection must be received on or before September 1, 2021.
Written comments may be sent to Bonneville Power Administration, Attn: Theodore Rydmark, Privacy Program, CGI-7, P.O. Box 3621, Portland, OR 97208-3621, or by email at
Requests for additional information or copies of the information collection instrument and instructions should be directed to Attn: Theodore Rydmark, Privacy Program, by email at
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) 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) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
This information collection request contains:
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This constitutes notice, in accordance with 18 CFR 385.2201(b), of the receipt of prohibited and exempt off-the-record communications.
Order No. 607 (64 FR 51222, September 22, 1999) requires Commission decisional employees, who make or receive a prohibited or exempt off-the-record communication relevant to the merits of a contested proceeding, to deliver to the Secretary of the Commission, a copy of the communication, if written, or a summary of the substance of any oral communication.
Prohibited communications are included in a public, non-decisional file associated with, but not a part of, the decisional record of the proceeding. Unless the Commission determines that the prohibited communication and any responses thereto should become a part of the decisional record, the prohibited off-the-record communication will not be considered by the Commission in reaching its decision. Parties to a proceeding may seek the opportunity to respond to any facts or contentions made in a prohibited off-the-record communication and may request that the Commission place the prohibited communication and responses thereto in the decisional record. The Commission will grant such a request only when it determines that fairness so requires. Any person identified below as having made a prohibited off-the-record communication shall serve the document on all parties listed on the official service list for the applicable proceeding in accordance with Rule 2010, 18 CFR 385.2010.
Exempt off-the-record communications are included in the decisional record of the proceeding, unless the communication was with a cooperating agency as described by 40 CFR 1501.6, made under 18 CFR 385.2201(e)(1) (v).
The following is a list of off-the-record communications recently received by the Secretary of the Commission. The communications listed are grouped by docket numbers in ascending order. These filings are available for electronic review at the Commission in the Public Reference Room or may be viewed on the Commission's website at
Take notice that the Commission received the following exempt wholesale generator filings:
Take notice that the Commission received the following electric rate 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 the Commission has received the following Natural Gas Pipeline Rate and Refund Report 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 June 17, 2021, Roaring Fork Interstate Gas Transmission, LLC (RFIGT), 1125 17th Street, Suite 650, Denver, Colorado 80202, filed an application under section 7(c) of the Natural Gas Act (NGA) and Part 157 of the Commission's regulations requesting: (1) Authorization to acquire, own, and operate the approximately 30-mile, 6- and 8-inch-diameter Silo Pipeline located in Laramie County, Wyoming and Weld County, Colorado and currently owned and operated by Kaiser-Frontier Midstream, LLC (Kaiser-Frontier); (2) a Part 157, Subpart F blanket certificate; (3) a Part 284, Subpart G blanket certificate; (4) approval of its proposed pro forma tariff and initial rates; and (5) certain waivers. RFIGT will purchase the Silo Pipeline for $18,200,000. RFIGT and Kaiser-Frontier have entered into a precedent agreement for up to 20 million cubic feet per day of capacity, all as more fully set forth in the application which is on file with the Commission and open for public inspection.
Additionally, on June 17, 2021, Kaiser-Frontier, 6733 S Yale Avenue, Tulsa, Oklahoma 74136, filed an application under section 7(b) of the NGA and Part 157 of the Commission's regulations requesting authority to: (1) Abandon by sale to RFIGT the Silo Pipeline and (2) abandon its Part 157, Subpart F blanket certificate, all as more fully set forth in the application which is on file with the Commission and open for public inspection.
In addition to publishing the full text of this document in the
Any questions regarding RFIGT's application may be directed to Daniel E. Watson, Chief Executive Officer, Roaring Fork Interstate Gas Transmission, LLC, 1125 17th Street, Suite 650, Denver, Colorado 80202, by telephone at (720) 923-5583 or by email at
Any questions regarding Kaiser-Frontier's application may be directed to John A. Boone, Kaiser-Frontier Midstream, LLC, 6733 S Yale Avenue, Tulsa, Oklahoma 74136, by telephone at (918) 491-4440 or by email at
Pursuant to Section 157.9 of the Commission's Rules of Practice and Procedure,
There are three ways to become involved in the Commission's review of this project: You can file a protest to the project, you can file a motion to intervene in the proceeding, and you can file comments on the project. There is no fee or cost for filing protests, motions to intervene, or comments. The deadline for filing protests, motions to intervene, and comments is 5:00 p.m. Eastern Time on July 13, 2021. How to file comments and motions to intervene is explained below.
Any person wishing to comment on the project may do so. The Commission considers all comments received about the project in determining the appropriate action to be taken. To ensure that your comments are timely and properly recorded, please submit your comments on or before July 13, 2021. However, the filing of a comment alone will not serve to make the filer a party to the proceeding. To become a party, you must intervene in the proceeding.
Persons who comment on the environmental review of this project will be placed on the Commission's environmental mailing list, and will receive notification when the environmental documents (EA or EIS) are issued for this project and will be notified of meetings associated with the Commission's environmental review process.
Any person, which includes individuals, organizations, businesses, municipalities, and other entities,
To intervene, you must submit a motion to intervene to the Commission in accordance with Rule 214 of the Commission's Rules of Practice and Procedure
All timely, unopposed motions to intervene are automatically granted by operation of Rule 214(c)(1). Motions to intervene that are filed after the intervention deadline are untimely and may be denied. Any late-filed motion to intervene must show good cause for being late and must explain why the time limitation should be waived and provide justification by reference to factors set forth in Rule 214(d) of the Commission's Rules and Regulations. A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies (paper or electronic) of all documents filed by the applicant and by all other parties.
There are two ways to submit your comments and motions to intervene to the Commission. In all instances, please reference the Project docket numbers CP21-462-000 and CP21-464-000 in your submission. The Commission encourages electronic filing of submissions.
(1) You may file your comments or motions to intervene electronically by using the eFiling feature, which is located on the Commission's website (
(2) You can file a paper copy of your comments by mailing them to the following address below. Your written comments must reference the Project docket numbers (CP21-462-000 and CP21-464-000).
Motions to intervene must be served on the applicants either by mail or email (with a link to the document) at: Roaring Fork Interstate Gas Transmission, LLC, 1125 17th Street, Suite 650, Denver, Colorado 80202 or at
All timely, unopposed
Throughout the proceeding, additional information about the projects will be available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC website at
In addition, the Commission offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. For more information and to register, go to
Western Area Power Administration, DOE.
Notice of proposed firm power fixed rate and transmission and ancillary services formula rates.
The Colorado River Storage Project Management Center (CRSP MC) of the Western Area Power Administration (WAPA) proposes a new Salt Lake City Area Integrated Projects (SLCA/IP) fixed firm power rates for use December 1, 2021, through December 31, 2023. The existing rates for these services are not set to expire until September 30, 2025; however, CRSP MC is initiating this rate action in response to a 35-percent projected increase to the firm power composite rate caused by a large increase in purchased power costs due to on-going drought conditions and a small increase to Operation, Maintenance, and Replacement (OM&R) expenses. Based on the FY 2021 toll on the Upper Colorado River Basin Fund (Basin Fund) and the drought-induced purchased power projections from the Reclamation May 24-Month Study, existing rates will not sustain a balance in the Basin Fund capable of supporting operations. CRSP MC proposes modifying how purchased power is calculated, and purchased power costs would be assessed on a pass-through-cost basis charged to each customer. CRSP MC proposes modifying language to implement the Cost Recovery Charge (CRC) throughout the year, if warranted, and would be able to implement a CRC if water levels drop below the intake structures at Glen Canyon Dam. Additionally, updated Colorado River Storage Project (CRSP) transmission and ancillary services rate schedules are proposed for use December 1, 2021, through December 31, 2023, with no material change proposed other than updating effective dates.
A consultation and comment period will begin June 28, 2021 and end August 31, 2021. This provides approximately 65 days for public comment, in accordance with WAPA's authority under 10 CFR 903.14 to shorten the otherwise 90-day comment period for good cause. Concluding the comment period by August 31, 2021, will enable CRSP MC to implement the rates by the effective date of December 1, 2021. Further delaying implementation to January 1, 2022, given projected costs of purchased power, would reduce the Basin Fund by a further $10 million due to the deficiency of current rates in light of escalating purchased power costs. CRSP MC will present a detailed explanation of the proposed rates and other modifications at a public information forum on July 7, 2021, 12 p.m. to 2 p.m. Mountain Daylight Time (MDT). CRSP MC will present a purchased-power-specific public information forum on July 28, 2021, 12 p.m. to 2 p.m. MDT. CRSP MC will present a CRC-specific public information forum on July 29, 2021, 12 p.m. to 2 p.m. MDT. CRSP MC will accept oral and written comments at a public comment forum on August 11, 2021, 12 p.m. to no later than 2 p.m. MDT. CRSP MC will accept written comments any time during the consultation and comment period. CRSP MC will provide a 14-day consultation and comment period specifically for purchased power after the CRSP MC posts the final purchased power amounts to its website at:
Written comments and requests for information about Federal Energy Regulatory Commission (FERC) actions concerning the proposed rates submitted by WAPA to FERC for approval should be sent to: Mr. Rodney Bailey, Acting CRSP Manager, Colorado River Storage Project Management Center, Western Area Power Administration, 1800 South Rio Grande Avenue, Montrose, CO 81401, or email:
The public information and comment forums will be conducted online. CRSP MC will post webinar and call-in information a week before each respective forum to its website at:
Mr. Thomas Hackett, Rates Manager, Colorado River Storage Project Management Center, Western Area Power Administration, (801) 524-5503, or email:
On August 17, 2020, under Rate Order No. WAPA-190, WAPA's Administrator placed the following rate schedules into effect on an interim basis, effective October 1, 2020, and through September 30, 2025, pending confirmation and final approval by FERC:
WAPA is proposing a 2-year rate to address worsening drought conditions in the southwestern United States and volatile purchased power costs. The proposed firm power rate is a fixed rate; the proposed transmission and ancillary services rates continue to use the formula-based methodology that includes an annual update to the financial and load data in the rate formulas. The proposed rates would go into effect December 1, 2021, and remain in effect until December 31, 2023, or until WAPA supersedes or changes the rates through another public rate process pursuant to 10 CFR part 903, whichever occurs first.
The proposed base rates would provide sufficient revenue to recover annual OM&R expenses, interest expense, irrigation assistance, and capital repayment requirements within the cost recovery criteria set forth in Department of Energy (DOE) Order No. RA 6120.2.
WAPA proposes that purchased power required to supplement hydropower deliveries up to contractual levels would be passed through to firm power customers under a separate charge, which would be in addition to the base rate for hydropower deliveries. Any customer not wanting to receive its share of the purchased power costs would not be charged the purchased power charge and would receive a proportionate amount of capacity and energy from WAPA each month, charged at the base rate, reflecting actual hydropower generation levels. If WAPA identifies a viable proposal to reduce the total purchased power expenses in the power rate and provide additional flexibility to the customers, it will be set forth during a public information forum. WAPA will develop a rate schedule to pass through the purchased power costs. A draft of the new rate schedule will be included in the brochure.
Under the current Rate Schedule SLIP-11, the energy rate is 11.43 mills per kilowatthour (mills/kWh), and the capacity rate is $4.85 per kilowattmonth ($/kWmonth). The composite rate of all charges, used for reference only as a comparison against other wholesale power rates, is 27.45 mills/kWh.
The revenue requirement for the proposed rate is based upon the most current data available, specifically the fiscal year (FY) 2020 historical financial data and the FY 2023 work plans for WAPA and the Bureau of Reclamation (Reclamation), and the
Currently, WAPA uses Reclamation's most-probable monthly water releases and end-of-month elevations as reported in Reclamation's
WAPA will continue to use a Cost Recovery Charge (CRC), if necessary, as a mechanism to adequately recover and maintain a sufficient balance in the Basin Fund in the event projected expenses significantly exceed projected revenue estimates. The Basin Fund is a revolving fund and operates without annual appropriations. The CRC is an additional surcharge on all Sustainable Hydro Power (SHP) energy deliveries, which are long-term energy sales provided under WAPA's SLCA/IP firm electric service contracts. The CRC may be implemented when, among other things, the Basin Fund's cash balance is at risk due to low hydropower generation, high prices for firming power, or emergency capitalized investment funding. The CRC is based only on Basin Fund cash analysis and is independent of the SLCA/IP Power Repayment Study calculations.
WAPA proposes to reserve the right to implement a CRC throughout the year using guidance from the existing implementation tiers and the latest 24-month Study from Reclamation. An established CRC would be in effect for 12 months from the date implemented. If circumstances dictate the need to reassess an established CRC, the updated CRC would supersede the previous CRC and remain in effect for 12 months. The CRC is implemented at WAPA's discretion based on the balance of the Basin Fund and WAPA's ability to meet contractual requirements.
The minimum Basin Fund carryover balance is $40 million.
Under this proposal, WAPA reserves the right to implement a CRC throughout the year using the criteria in Table 3 if annual water releases from Glen Canyon Dam fall below 8.23 million acre-feet regardless of the Basin Fund balance.
WAPA would establish an energy waiver level (WL) using the CRC formula. Customers could accept either the CRC or WL. The WL provides WAPA the ability to reduce purchase power expenses by delivering less energy than its contractual obligations. For those customers who agree to schedule no more energy than their proportionate share of the WL, WAPA would waive the CRC for that year.
WAPA continues to refine the CRC process and the details of the CRC calculations. Any recommended changes will be provided in the customer rate brochure and set forth at the public information forum for the CRC.
WAPA does not propose any changes to the existing formula rate for calculating ATRR, applicable to both Network Integration and Point-to-Point transmission service rates. The ATRR is the annual cost of the CRSP Transmission System adjusted for Non-Firm Point-to-Point revenue credits, other miscellaneous charges or credits, and the prior year true-up.
WAPA proposes no changes to the Unreserved Use penalty rate.
WAPA proposes no changes to the Energy Imbalance and Generator Imbalance Rate Schedule. These services are provided to CRSP, as a Transmission Service Provider, by the Western Area Colorado Missouri Balancing Authority under Rate Schedule L-AS9.
WAPA proposes no changes to the Operating Reserves—Spinning and Supplemental Reserves Services formula rate.
WAPA proposes no changes to the rate schedule for the sale of the following surplus energy and capacity products: Energy, regulation, reserves, and frequency response.
Joint Dispatch Transmission Service is currently being added, in a separate parallel process, to WAPA's rates under Rate Order No. WAPA-195
Existing DOE procedures for public participation in power and transmission rate adjustments (10 CFR part 903) were published on September 18, 1985, and February 21, 2019.
CRSP MC is proposing the SLCA/IP firm power rate and revised CRSP transmission and ancillary services formula rates in accordance with section 302 of the DOE Organization Act (42 U.S.C. 7152).
By Delegation Order No. 00-037.00B, effective November 19, 2016, the Secretary of Energy delegated: (1) The authority to develop power and transmission rates to WAPA's Administrator; (2) the authority to confirm, approve, and place such rates into effect on an interim basis to the Deputy Secretary of Energy; and (3) the authority to confirm, approve, and place into effect on a final basis, or to remand or disapprove such rates, to FERC. By Delegation Order No. S1-DEL-S4-2021, effective February 25, 2021, the Acting Secretary of Energy also delegated the authority to confirm, approve, and place such rates into effect on an interim basis to the Under Secretary for Science (and Energy). By Redelegation Order No. S4-DEL-OE1-2021, effective March 25, 2021, the Acting Under Secretary for Science (and Energy) redelegated the authority to confirm, approve, and place such rates into effect on an interim basis to the Assistant Secretary for Electricity. By Redelegation Order No. 00-002.10-05, effective July 8, 2020, the Assistant Secretary for Electricity further redelegated the authority to confirm, approve, and place such rates into effect on an interim basis to WAPA's Administrator. This redelegation order, despite predating the February 2021 and March 2021 delegations, remains valid.
All brochures, studies, comments, letters, memoranda, or other documents that the CRSP MC initiates or uses to develop the proposed rates are available for inspection and copying at the Colorado River Storage Project Management Center, 1800 South Rio Grande Avenue, Montrose, Colorado.
WAPA is in the process of determining whether an environmental assessment or an environmental impact statement should be prepared or if this action can be categorically excluded from those requirements.
WAPA has an exemption from centralized regulatory review under Executive Order 12866; accordingly, no clearance of this notice by the Office of Management and Budget is required.
This document of the Department of Energy was signed on June 21, 2021, by Tracey A. LeBeau, Interim Administrator, Western Area Power Administration, pursuant to delegated authority from the Secretary of Energy. That document, with the original signature and date, is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the
Environmental Protection Agency (EPA).
Notice.
EPA has authorized its contractor Avanti Corporation of Alexandria, VA, to access information which has been submitted to EPA under all Sections of the Toxic Substances Control Act (TSCA). Some of the information may be claimed or determined to be Confidential Business Information (CBI).
Access to the confidential data will occur no sooner than July 6, 2021.
This action is directed to the public in general. This action may, however, be of interest to all who manufacture, process, or distribute industrial chemicals. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action.
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPPT-2003-0004, is available at
Under contract number 47QRAA20D002D, task order number 68HERC21F0043, contractor Avanti, Corporation of 6621 Richmond Hwy. #200, Alexandria, VA will assist the Office of Pollution Prevention and Toxics (OPPT) by providing administrative and technical support to the TSCA New Chemicals Program utilizing EPA CBI databases and software to create documents, databases, attend meetings, previewing CBI claims, transferring sanitized documents from the CBI LAN to ADMIN and transfer non-CBI files to the CBI LAN for special projects.
In accordance with 40 CFR 2.306(j), EPA has determined that under EPA contract number 47QRAA20D002D, task order number 68HERC21F0043, Avanti will require access to CBI submitted under all Sections of TSCA to perform successfully the duties specified under the contract. Avanti's personnel will be given access to information claimed or determined to be CBI information submitted to EPA under all sections of TSCA.
EPA is issuing this notice to inform all submitters of information under all sections of TSCA that EPA will provide Avanti access to these CBI materials on a need-to-know basis only. All access to TSCA CBI under this contract will take place at EPA Headquarters, in accordance with EPA's
Access to TSCA data, including CBI, will continue until October 31, 2023. If the contract is extended, this access will also continue for the duration of the extended contract without further notice.
Avanti's personnel will be required to sign nondisclosure agreements and will be briefed on specific security procedures for TSCA CBI.
15 U.S.C. 2601
Environmental Protection Agency (EPA).
Notice.
In compliance with the Paperwork Reduction Act (PRA), this document announces that EPA is planning to submit a request to renew and consolidate existing approved Information Collection Requests (ICRs) to the Office of Management and Budget (OMB). Before submitting the consolidated ICR to OMB for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection that is summarized in this document. The consolidated ICR is entitled: “Safer Choice Program Product and Partner Recognition Activities” identified by EPA ICR No. 2692.01 and OMB Control No. 2070-[new]. The ICR and accompanying material are available in the docket for public review and comment.
Comments must be received on or before August 27, 2021.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2021-0245, online using the Federal eRulemaking Portal at
Due to the public health concerns related to COVID-19, the EPA Docket Center (EPA/DC) and Reading Room is closed to visitors with limited exceptions. The staff continues to provide remote customer service via email, phone, and webform. For the latest status information on EPA/DC and docket access, visit
Pursuant to PRA section 3506(c)(2)(A) (44 U.S.C. 3506(c)(2)(A)), EPA specifically solicits comments and information to enable it to:
1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility.
2. Evaluate the accuracy of the Agency's estimates of the burden of the proposed collection of information, including the validity of the methodology and assumptions used.
3. Enhance the quality, utility, and clarity of the information to be collected.
4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology,
You may find the following suggestions helpful for preparing your comments:
1. Explain your views as clearly as possible and provide specific examples.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used that support your views.
4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.
5. Submit your comments by the deadline identified under
6. Identify the docket ID number assigned to the ICR in the subject line on the first page of your response. You may also provide the ICR title and related EPA and OMB numbers.
An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information subject to PRA approval unless it displays a currently valid OMB control number. The OMB control numbers for the EPA regulations in title 40 of the Code of Federal Regulations (CFR), after appearing in the preamble of the final rule, are further displayed either by publication in the
As used in the PRA context, burden is defined in 5 CFR 1320.3(b).
• 325180 Other Basic Inorganic Chemical Manufacturing;
• 325199 All Other Basic Organic Chemical Manufacturing (Primary);
• 325320 Pesticide and Other Agricultural Chemical Manufacturing;
• 325510 Paint and Coating Manufacturing;
• 325520 Adhesive Manufacturing;
• 3256 Soap, Cleaning Compound, and Toilet Preparation Manufacturing;
• 325611 Soap and Other Detergent Manufacturing;
• 325612 Polish and Other Sanitation Good Manufacturing;
• 325613 Surface Active Agent Manufacturing (Primary);
• 325620 Toilet Preparation Manufacturing;
• 325910 Printing Ink Manufacturing;
• 325992 Photographic Film, Paper, Plate, and Chemical Manufacturing;
• 325998 All Other Miscellaneous Chemical Product and Preparation Manufacturing;
• 423850 Service Establishment Equipment and Supplies Merchant Wholesalers (Primary);
• 424490 Other Grocery and Related Products Merchant Wholesalers;
• 424690 Other Chemical and Allied Products Merchant Wholesalers (Primary);
• 424990 Other Miscellaneous Nondurable Goods Merchant Wholesalers;
• 4451 Grocery Stores;
• 445110 Supermarkets and Other Grocery (except Convenience) Stores (Primary);
• 445299 All Other Specialty Food Stores;
• 446110 Pharmacies and Drug Stores;
• 453210 Office Supplies and Stationery Stores;
• 453998 All Other Miscellaneous Store Retailers (except Tobacco Stores) (Primary);
• 454110 Electronic Shopping and Mail-Order Houses;
• 481 Air Transportation;
• 531120 Lessors of Nonresidential Buildings (except Mini-warehouses);
• 531312 Nonresidential Property Managers;
• 541714 Research and Development in Biotechnology (except Nanobiotechnology) (Primary);
• 561210 Facilities Support Services;
• 561720 Janitorial Services;
• 561740 Carpet and Upholstery Cleaning Services;
• 611110 Elementary and Secondary Schools;
• 611310 Colleges, Universities, and Professional Schools;
• 622110 General Medical and Surgical Hospitals;
• 711310 Promoters of Performing Arts, Sports, and Similar Events with Facilities;
• 7211 Traveler Accommodation;
• 722511 Full-Service Restaurants;
• 8123 Dry cleaning and Laundry Services;
• 813410 Civic and Social Organizations (Primary);
• 813910 Business Associations (Primary);
• 921190 Other General Government Support; and
• 924110 Administration of Air and Water Resource and Solid Waste Management Programs (Primary).
The consolidation of the currently approved ICRs is expected to result in an overall increase of 1,558 hours in the total estimated combined respondent burden that is currently approved by OMB. This information collection combines the burdens from two previously approved ICRs, EPA ICR No. 2302.03 and EPA ICR No. 2487.02. The difference between the current burden request and the previously approved requests is primarily due to the inclusion of Partner of the Year Awards collection activities when calculating the burden of this ICR. Additionally, minor adjustments were made in EPA's estimates of the number of respondents and of the burden.
The total combined cost burden from these two previously approved ICRs was $2,045,616. The total cost burden requested for this ICR is $2,208,906. The difference between the current cost burden request and the previously approved requests are due to the inclusion of Partner of the Year Awards collection activities when calculating the burden, as well as adjustments in EPA's estimates of the number of respondents and of the burden. In addition to the adjustments listed above, the wage rates and material costs were revised to reflect 2020 dollars for this information collection request.
In addition, OMB has requested that EPA move towards using the 18-question format for ICR Supporting Statements used by other federal agencies and departments and is based on the submission instructions established by OMB in 1995, replacing the alternate format developed by EPA and OMB prior to 1995. The Agency does not expect the change in format to result in substantive changes to the information collection activities or related estimated burden and costs.
EPA will consider the comments received and amend the consolidated ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval pursuant to 5 CFR 1320.12. EPA will issue another
If you have any questions about this ICR or the approval process, please contact the technical person listed under
44 U.S.C. 3501
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) is planning to submit the information collection request (ICR), Revisions to the RCRA Definition of Solid Waste (EPA ICR No. 2310.07, OMB Control No. 2050-0202) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA). Before doing so, the EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a proposed extension of the ICR, which is currently approved through March 31, 2022. 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.
Comments must be submitted on or before August 27, 2021.
Submit your comments, referencing by Docket ID No. EPA-HQ-OLEM-2018-0013, online using
EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
Tracy Atagi, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: 703-308-8672; fax number: 703-308-8880; email address:
Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at
Pursuant to section 3506(c)(2)(A) of the PRA, the EPA is soliciting comments and information to enable it to: (i) 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; (ii) 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; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) 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,
• Under the generator-controlled exclusion at 40 CFR 261.4(a)(23), the tolling contractor has to maintain at its facility for no less than three years records of hazardous secondary materials received pursuant to its written contract with the tolling manufacturer, and the tolling manufacturer must maintain at its facility for no less than three years records of hazardous secondary materials shipped pursuant to its written contract with the tolling contractor. In addition, facilities performing the recycling of hazardous secondary materials under the generator-controlled exclusions at 40 CFR 261.4(a)(23) to maintain documentation of their legitimacy determination onsite.
• Under the transfer-based exclusion at 40 CFR 261.4(a)(24), a generator sending secondary hazardous materials to a facility that does not have a permit, would be required to conduct a “reasonable efforts” environmental audit of the receiving facility; and a hazardous secondary materials recycler must meet the following conditions: Having financial assurance in place, having trained personnel, and meeting emergency preparedness and response conditions.
• Under the export requirements of the transfer-based exclusion at 40 CFR 261.4(a)(25), exporters of hazardous secondary material must provide notice and obtain consent of the receiving country and file an annual report.
• Under the remanufacturing exclusion at 40 CFR 261.4(a)(27), both the hazardous secondary material generator and the remanufacturer must maintain records of shipments and confirmations of receipts for a period of three years from the dates of the shipments.
• Under the revised speculative accumulation requirement in 261.1(c)(8), all persons subject to the speculative accumulation requirements must label the storage unit by indicating the first date that the material began to be accumulated.
This ICR renewal does not include the burden associated with filling out form 8700-12 because that burden is included under OMB Control Number 2050-0024.
The Commission hereby gives notice of the filing of the following agreements under the Shipping Act of 1984. Interested parties may submit comments, relevant information, or documents regarding the agreements to the Secretary by email at
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 July 13, 2021.
A.
1.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Agency Order.
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces the extension of an Order under Section 361 of the Public Health Service Act to temporarily halt residential evictions to prevent the further spread of COVID-19.
This Order is effective July 1, 2021, through July 31, 2021.
Tiffany Brown, Deputy Chief of Staff, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS H21-10, Atlanta, GA 30329. Phone: 404-639-7000. Email:
This Order further extends the original temporary eviction moratorium Order published on September 4, 2020, as initially extended by the Consolidated Appropriations Act, 2021, and further extended by the Orders published on January 29, 2021 and March 31, 2021 set to expire on June 30, 2021. Because of COVID-19, household crowding and transmission, and the increased risk of individuals sheltering in close quarters in congregate settings such as homeless shelters, which may be unable to provide adequate social distancing as populations increase, extending the temporary halt on evictions is appropriate. This Order further extends the prior Eviction Moratoria for what is currently intended to be a final 30 day-period, until July 31, 2021.
The Order is extended through July 31, 2021 based on current and projected epidemiological context of SARS-CoV-2 transmission throughout the United States.
A copy of the Order is provided below. A copy of the signed Order and Declaration form can be found at:
Subject to the limitations under “Applicability,” a landlord, owner of a residential property, or other person
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(1) The individual has used best efforts to obtain all available government assistance for rent or housing;
(2) The individual either (i) earned no more than $99,000 (or $198,000 if filing jointly) in Calendar Year 2020, or expects to earn no more than $99,000 in annual income for Calendar Year 2021 (or no more than $198,000 if filing a joint tax return),
(3) The individual is unable to pay the full rent or make a full housing payment due to substantial loss of household income, loss of compensable hours of work or wages, a lay-off, or extraordinary
(4) The individual is using best efforts to make timely partial payments that are as close to the full payment as the individual's circumstances may permit, taking into account other nondiscretionary expenses; and
(5) Eviction would likely render the individual homeless—or force the individual to move into and live in close quarters in a new congregate or shared living setting—because the individual has no other available housing options.
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This Order shall be interpreted and implemented in a manner as to achieve the following objectives:
• Mitigating the spread of COVID-19 within crowded, congregate or shared living settings, or through unsheltered homelessness;
• Mitigating the further spread of COVID-19 from one State or territory into any other State or territory;
• Mitigating the further spread of COVID-19 by temporarily suspending the eviction of covered persons from residential property for nonpayment of rent; and
• Supporting response efforts to COVID-19 at the Federal, State, local, territorial, and tribal levels.
Since January 2020, the respiratory disease known as “COVID-19,” caused by a novel coronavirus (SARS-COV-2), has spread globally, including cases reported in all fifty states within the United States, plus the District of Columbia and U.S. territories. As of June 23, 2021, there have been over 179 million cases of COVID-19 globally, resulting in over 3,800,000 deaths.
The virus that causes COVID-19 spreads very easily and sustainably between people, particularly those who are in close contact with one another (within about 6 feet, but occasionally over longer distances), mainly through respiratory droplets produced when an infected person coughs, sneezes, or talks. Individuals without symptoms can also spread the virus.
COVID-19 vaccines are now widely available in the United States, and all
New variants of SARS-CoV-2 have emerged globally,
In the context of a pandemic, eviction moratoria—like quarantine, isolation, and social distancing—can be an effective public health measure utilized to prevent the spread of communicable disease. Eviction moratoria facilitate self-isolation and self-quarantine by people who become ill or who are at risk of transmitting COVID-19.
Congress passed the Coronavirus Aid, Relief, and Economic Security (CARES) Act (Pub. L. 116-136) to aid individuals and businesses adversely affected by COVID-19 in March 2020. Section 4024 of the CARES Act provided a 120-day moratorium on eviction filings as well as other protections for tenants in certain rental properties with Federal assistance or federally related financing. These protections helped alleviate the public health consequences of tenant displacement during the COVID-19 pandemic. The CARES Act eviction moratorium expired on July 24, 2020. The protections in the CARES Act supplemented temporary eviction moratoria and rent freezes implemented by governors and other local officials using emergency powers.
Researchers estimated that this temporary Federal moratorium provided relief to a material portion of the nation's roughly 43 million renters.
The Federal moratorium provided by the CARES Act, however, did not reach all renters. Many renters who fell outside the scope of the Federal moratorium were instead protected under State and local moratoria. In early March, 2021, the Census Household Pulse Survey estimated that 6.4 million households were behind on rent, and just under half fear imminent eviction.
On September 4, 2020, the CDC Director issued an Order temporarily halting evictions in the United States for the reasons described therein. That Order was set to expire on December 31, 2020, subject to further extension, modification, or rescission. Section 502 of Title V, Division N of the Consolidated Appropriations Act, 2021 extended the Order until January 31, 2021, and approved the Order as an exercise of the CDC's authority under Section 361 of the Public Health Service Act (42 U.S.C. 264). With the extension of the Order, Congress also provided $25 billion for emergency rental
On January 29, 2021, following an assessment of the ongoing pandemic, the CDC Director renewed the Order until March 31, 2021. On March 28, 2021, the CDC Director modified and extended the Order until June 30, 2021. This Order further extends the prior Eviction Moratoria for what is currently intended to be a final 30-day period, until July 31, 2021, for the reasons described herein. Although this Order is subject to revision based on the changing public health landscape, absent an unexpected change in the trajectory of the pandemic, CDC does not plan to extend the Order further. To the extent any provision of this Order conflicts with prior Orders, this Order is controlling.
Researchers estimate that, in 2020, Federal, State, and local eviction moratoria led to over one million fewer evictions than the previous year.
By February 10, 2021, the U.S. Department of the Treasury had paid all of the $25 billion made available by the Consolidated Appropriations Act of 2021 to states, territories, localities and tribes for the purpose of providing emergency rental assistance to eligible households in their jurisdictions. Additionally, as directed in the Act, Treasury has also made available 40 percent—more than $8.6 billion—of the additional funding to states, territories and localities for emergency rental assistance provided in the American Rescue Plan. Based on data collected from grantees, Treasury reports that over 630,000 households had already applied for emergency rental assistance by the end of March—when many State and local programs had not yet opened for applications. Though there are indications that emergency rental assistance has started to reach increasing numbers of families over recent months, State and local agencies likely have hundreds of thousands of applications for assistance that currently remain outstanding as programs accelerate their activity. According to Treasury, more households—over 96,000—were served in April than in the entire first quarter. Assistance accelerated in May, with over a fifty percent increase in households served compared to the previous month. The level of assistance provided to low income households is expected to continue increasing because some states started accepting rental assistance applications in late May, including as late as June 1, and now all states are operating programs. Based on analysis of grantee reporting, Treasury believes that State and local emergency rental assistance programs will collectively deploy more rental assistance in July than in any previous month. In addition to Emergency Rental Assistance, there are coordinated efforts across Federal agencies to—in partnership with states and localities—promote eviction prevention strategies.
An unprecedented and avoidable surge of evictions is likely to occur if the national moratorium were to conclude on June 30. Recent data from the U.S. Census Household Pulse Survey demonstrates that an increased percentage of households behind on rent believe that an eviction is likely in the next two months.
Evicted renters must move, which leads to multiple outcomes that increase the risk of COVID-19 spread. Specifically, many evicted renters move into close quarters in shared housing or other congregate settings. These moves may require crossing State borders. According to the Census Bureau American Housing Survey, 32% of renters reported that they would move in with friends or family members upon eviction, which would introduce new household members and potentially increase household crowding. Studies show that COVID-19 transmission occurs readily within households. The secondary attack rate in households has been estimated to be 17%, and household contacts are estimated to be 6 times more likely to become infected by an index case of COVID-19 than other close contacts.
Shared housing is not limited to friends and family. It includes a broad range of settings, including transitional housing and domestic violence and abuse shelters. Special considerations exist for such housing because of the challenges of maintaining social distance. Residents often gather closely or use shared equipment, such as kitchen appliances, laundry facilities, stairwells, and elevators. Residents may have unique needs, such as disabilities, chronic health conditions, cognitive
Modeling studies and preliminary observational data from the pre-vaccine phase of the COVID-19 pandemic comparing incidence between states that implemented and lifted eviction moratoria indicate that evictions substantially contribute to COVID-19 transmission. In mathematical models where eviction led exclusively to sharing housing with friends or family, lifting eviction moratoria led to a 30% increased risk of contracting COVID-19 among people who were evicted and those with whom they shared housing after eviction.
An analysis of observational data from State-based eviction moratoria in 43 states and the District of Columbia showed significant increases in COVID-19 incidence and mortality approximately 2-3 months after eviction moratoria were lifted (pre-peer review). Specifically, the authors compared the COVID-19 incidence and mortality rates in states that lifted their moratoria with the rates in states that maintained their moratoria. In these models, the authors accounted for time-varying indicators of each State's test count as well as major public-health interventions including lifting stay-at-home orders, school closures, and mask mandates. After adjusting for these other changes, they found that the incidence of COVID-19 in states that lifted their moratoria was 1.6 times that of states that did not at 10 weeks post-lifting (95% CI 1.0, 2.3), a ratio that grew to 2.1 at ≥16 weeks (CI 1.1, 3.9). Similarly, they found that mortality in states that lifted their moratoria was 1.6 times that of states that did not at 7 weeks post-lifting (CI 1.2, 2.3), a ratio that grew to 5.4 at ≥16 weeks (CI 3.1, 9.3). The authors estimated that, nationally, over 433,000 cases of COVID-19 and over 10,000 deaths could be attributed to lifting State moratoria.
Although data are limited, available evidence suggests evictions lead to interstate spread of COVID-19 in two ways. First, an eviction may lead the evicted members of a household to move across State lines. Of the 35 million people in America who move each year, 15% move to a new State. Second, even if a particular eviction, standing alone, would not always result in interstate displacement, the mass evictions that would occur in the absence of this Order would inevitably increase the interstate spread of COVID-19. This Order cannot effectively mitigate interstate transmission of COVID-19 without covering intrastate evictions (evictions occurring within the boundaries of a State or territory), as the level of spread of SARS-CoV-2 resulting from these evictions can lead to SARS-CoV-2 transmission across State borders.
Moreover, intrastate spread facilitates interstate spread in the context of communicable disease spread, given the nature of infectious disease. In the aggregate, the mass-scale evictions that will likely occur in the absence of this Order will inevitably increase interstate spread of COVID-19.
Evicted individuals without access to support or other assistance options may become homeless, including older adults or those with underlying medical conditions, who are more at risk for severe illness from COVID-19 than the general population. In Seattle-King County, 5-15% of people experiencing homelessness between 2018 and 2020 cited eviction as the primary reason for becoming homeless.
Extensive outbreaks of COVID-19 have been identified in homeless shelters. In Seattle, Washington, a network of three related homeless shelters experienced an outbreak that led to 43 cases among residents and staff members. In Boston, Massachusetts, universal COVID-19 testing at a single shelter revealed 147 cases, representing 36% of shelter residents. COVID-19 testing in a single shelter in San Francisco led to the identification of 101 cases (67% of those tested). Data from 557 universal diagnostic testing events at homeless shelters in 21 states show an average of 6% positivity among shelter clients. Data comparing the incidence or severity of COVID-19 among people experiencing homelessness directly to the general population are limited. However, during the 15-day period of the outbreak in Boston, MA, researchers estimated a cumulative incidence of 46.3 cases of COVID-19 per 1000 persons experiencing homelessness, as compared to 1.9 cases per 1000 among Massachusetts adults (pre-print).
CDC guidance recommends increasing physical distance between beds in homeless shelters, which is likely to decrease capacity, while community transmission of COVID-19 is occurring. These guidelines are similar to other guidance issued for other congregate settings such as prisons and jails. To adhere to this guidance, shelters have limited the number of people served throughout the United States. In many places, considerably fewer beds are available to individuals who become homeless. Shelters that do not adhere to the guidance, and operate at ordinary or increased occupancy, are at greater risk for the types of outbreaks described above. The challenge of mitigating disease transmission in homeless shelters has been compounded because some organizations have chosen to stop or limit volunteer access and participation.
At this time, communities with high rates of eviction may currently have lower coverage of COVID-19 vaccination—a focus for current
The Department of the Treasury continues to distribute emergency rental assistance funds that may help mitigate spikes in COVID-19 transmission due to increases in evictions. These funds are expected to make a meaningful difference for hundreds of thousands of people who are expected to receive the rental assistance in the 30-day horizon of this Order, alongside other Federal and State efforts to prevent evictions.
On September 4, 2020, the CDC Director issued an Order temporarily halting evictions in the United States for the reasons described therein. That Order was set to expire on December 31, 2020, subject to further extension, modification, or rescission. Section 502 of Title V, Division N of the Consolidated Appropriations Act, 2021 extended the Order until January 31, 2021. With the extension of the Order, Congress also provided $25 billion for emergency rental assistance for the payment of rent and rental arrears. Congress later provided an additional $21.55 billion in emergency rental assistance when it passed the American Rescue Plan.
On January 29, 2021, following an assessment of the ongoing pandemic, the CDC Director renewed the Order until March 31, 2021. On March 28, the CDC Director renewed the Order until June 30, 2021. This Order further extends the prior Eviction Moratorium until July 31, 2021, for the reasons described herein, while the Department of the Treasury disburses the remaining ERA funds to State and local jurisdictions, and those grantees continue to accelerate efforts to deploy rental assistance on behalf of tenants. To the extent any provision of this Order conflicts with prior Orders, this Order is controlling.
This Order does not apply in any State, local, territorial, or tribal area with a moratorium on residential evictions that provides the same or greater level of public-health protection than the requirements listed in this Order or to the extent its application is prohibited by Federal court order. In accordance with 42 U.S.C. 264(e), this Order does not preclude State, local, territorial, and tribal authorities from imposing additional requirements that provide greater public-health protection and are more restrictive than the requirements in this Order.
This Order is a temporary eviction moratorium to prevent the further spread of COVID-19. This Order does not relieve any individual of any obligation to pay rent, make a housing payment, or comply with any other obligation that the individual may have under a tenancy, lease, or similar contract. Nothing in this Order precludes the charging or collecting of fees, penalties, or interest as a result of the failure to pay rent or other housing payment on a timely basis, under the terms of any applicable contract. Nothing in this Order precludes evictions based on a tenant, lessee, or resident: (1) Engaging in criminal activity while on the premises; (2) threatening the health or safety of other residents;
Any evictions for nonpayment of rent initiated prior to September 4, 2020, but not yet completed, are subject to this Order. Any tenant, lessee, or resident of a residential property who qualifies as a “Covered Person” and is still present in a rental unit is entitled to protections under this Order. Any eviction that was completed prior to September 4, 2020, is not subject to this Order.
Under this Order, covered persons may be evicted for engaging in criminal activity while on the premises. But covered persons may not be evicted on the sole basis that they are alleged to have committed the crime of trespass (or similar State-law offense) where the underlying activity is a covered person remaining in a residential property for nonpayment of rent. Permitting such evictions would result in substantially more evictions overall, thus increasing the risk of disease transmission as otherwise covered persons move into congregate settings or experience homelessness. This result would be contrary to the stated objectives of this Order, and therefore would diminish their effectiveness. Moreover, to the extent such criminal trespass laws are invoked to establish criminal activity solely based on a tenant, lessee, or resident of a residential property remaining in a residential property despite the nonpayment of rent, such invocation conflicts with this Order and is preempted pursuant to 42 U.S.C. 264(e).
Individuals who are confirmed to have, who have been exposed to, or who might have COVID-19 and take reasonable precautions to not spread the disease may not be evicted on grounds that they may pose a health or safety threat to other residents.
The Order is extended through July 31, 2021, based on the current and projected epidemiological context of SARS-CoV-2 transmission throughout the United States. This 30-day extension, intended to be the final iteration, will allow the assessment of natural changes to COVID-19 incidence, the influences of new variants, additional distribution of emergency rental assistance funds, and the expansion of COVID-19 vaccine uptake.
To qualify for the protections of this Order, a tenant, lessee, or resident of a residential property must provide a completed and signed copy of a declaration with the elements listed in the definition of “Covered person” to their landlord, owner of the residential property where they live, or other person who has a right to have them evicted or removed from where they live. To assist tenants and landlords, the CDC created a standardized declaration form that can be downloaded here:
Tenants, lessees, and residents of residential property are not obligated to use the CDC form. Any written document that an eligible tenant, lessee, or residents of residential property presents to their landlord will comply with this Order, as long as it contains
All declarations, regardless of form used, must be signed, and must include a statement that the tenant, lessee, or resident of a residential property understands that they could be liable for perjury for any false or misleading statements or omissions in the declaration. This Order does not preclude a landlord challenging the truthfulness of a tenant's, lessee's, or resident's declaration in court, as permitted under State or local law.
In certain circumstances, such as individuals filing a joint tax return, it may be appropriate for one member of the residence to provide an executed declaration on behalf of the other adult residents party to the lease, rental agreement, or housing contract. The declaration may be signed and transmitted either electronically or by hard copy.
As long as the information in a previously signed declaration submitted under a previous order remains submit a new declaration under this Order.
For the reasons described herein, I am extending the September 4, 2020 Order, as extended by section 502 of Title V, Division N of the Consolidated Appropriations Act, 2021 and further extended and modified by the January 29, 2021 and March 28, 2021 Orders. I have determined based on the information below that extending the temporary halt in evictions in this Order constitutes a reasonably necessary measure under 42 CFR 70.2 to prevent the further spread of COVID-19 throughout the United States. I have further determined that measures by states, localities, or territories that do not meet or exceed these minimum protections are insufficient to prevent the interstate spread of COVID-19.
State and local jurisdictions continue to distribute emergency rental assistance funds, provided by the Department of Treasury, that will help avert a spate of evictions and thus mitigate corresponding spikes in COVID-19 transmission. Although trends have improved dramatically since January 2021, there continues to be ongoing transmission of approximately 10,000 cases per day in the United States.
Congress has appropriated approximately $46 billion—of which almost three-quarters is currently available to State and local grantees—to help pay rent and rental arrears for tenants who may otherwise be at high risk of eviction. According to estimates based on the U.S. Census Household Pulse Survey, approximately 6.4 million renter households are behind on their rent as of March 29, 2021. The successful delivery of those funds by states and localities should greatly reduce the incidence of eviction that would occur in the absence of that support. However, many states and localities are still ramping up the collection and processing of applications and the delivery of assistance and putting in place other eviction prevention strategies. It was only in the beginning of June that all State-run emergency rental assistance programs had opened for applications. If the moratorium expires on June 30, a wave of evictions, on the order of hundreds of thousands, could occur this summer and early fall, exacerbating the spread of COVID-19 among the significant percentage of the population that remains unvaccinated. In appropriating these emergency rental assistance funds, Congress intended that the funding would work in concert with the eviction moratorium, providing time for rental assistance to reach eligible tenants and landlords to sustainably reduce the threat of an eviction wave after an eviction moratorium was no longer in effect. While the pace of assistance is continuing to increase, without additional time for states and localities to deliver this needed relief and engage in other efforts to prevent evictions, a surge of evictions would occur upon the conclusion of the national moratorium. A surge in evictions would lead to immediate movement, crowding, and increased stress on the homeless service system. In combination with ongoing COVID-19 transmission, and the overlapping factors described above, this would create considerable risk for the rapid transmission of COVID-19 in high-risk settings. Allowing additional time for rent relief to reach renters—alongside other Federal and State actions to prevent evictions—by an extension through the month of July 2021 can decrease the numbers of likely evictions and avert the potential of COVID-19 resurgence among people who experience eviction, their communities, and other regions of the country affected by the resulting transmission.
Based on the convergence of these issues, I have determined that extending the temporary halt on evictions is appropriate.
Therefore, under 42 CFR 70.2, subject to the limitations under the “Applicability” section, the September 4, 2020 Order, as extended and modified by the January 29, 2021 and March 28, 2021 Orders, is hereby extended through July 31, 2021.
Accordingly, a landlord, owner of a residential property, or other person with a legal right to pursue eviction or possessory action shall not evict any covered person from any residential property in any State or U.S. territory where there are documented cases of COVID-19 and the State or U.S. territory has provided a level of public-health protections below the requirements listed in this Order.
This Order is not a rule within the meaning of the Administrative Procedure Act (APA) but rather an emergency action taken under the existing authority of 42 CFR 70.2. The purpose of § 70.2, which was promulgated through notice-and-comment rulemaking, is to enable CDC to take swift steps to prevent contagion without having to seek a second round of public comments and without a delay in effective date.
In the event this Order qualifies as a rule under the APA, there is good cause to dispense with prior public notice and comment and a delay in effective date. See 5 U.S.C. 553(b)(B), (d)(3). Good cause exists, in sum, because the public health emergency caused by the COVID-19 pandemic and the unpredictability of the trajectory of the pandemic make it impracticable and contrary to the public health, and by extension the public interest, to delay the issuance and effective date of this Order.
In the September 4, 2020 Order, the previous CDC Director determined that good cause existed because the public health emergency caused by COVID-19 made it impracticable and contrary to the public health, and by extension the public interest, to delay the issuance and effective date of the Order. The previous Director also found that a delay in the effective date of the Order would permit the occurrence of evictions—potentially on a mass scale—that would have potentially significant consequences. For these reasons, the previous Director concluded that the delay in the effective date of the Order
The rapidly changing nature of the pandemic requires not only that CDC act swiftly, but also deftly to ensure that its actions are commensurate with the threat. This necessarily involves assessing evolving conditions that inform CDC's determinations. And although the pandemic is showing positive trends, the fundamental public health threat that existed on September 4, 2020, January 29, 2021, and March 28, 2021—the risk of large numbers of residential evictions contributing to the spread of COVID-19 throughout the United States—continues to exist. Without this Order, there is every reason to expect that evictions will increase. It is imperative that public health authorities act quickly to mitigate such an increase of evictions, which could increase the likelihood of new spikes in SARS-CoV-2 transmission even as COVID-19 morbidity and mortality may be waning. Such mass evictions and the attendant public-health consequences could unravel positive trends, and would be very difficult to reverse.
For all of these reasons, I hereby conclude that immediate action is again necessary and that notice-and-comment rulemaking and a delay in effective date would be impracticable and contrary to the public interest.
Similarly, if this Order qualifies as a rule under the APA, the Office of Information and Regulatory Affairs (OIRA) has determined that it would be an economically significant regulatory action pursuant to Executive Order 12866 and a major rule under Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (the Congressional Review Act or CRA), 5 U.S.C. 804(2). Thus, this action has been reviewed by OIRA. CDC has determined that for the same reasons given above, there would be good cause under the CRA to make the requirements herein effective immediately. 5 U.S.C. 808(2).
If any provision of this Order, or the application of any provision to any persons, entities, or circumstances, shall be held invalid, the remainder of the provisions, or the application of such provisions to any persons, entities, or circumstances other than those to which it is held invalid, shall remain valid and in effect.
This Order shall be enforced by Federal authorities and cooperating State and local authorities through the provisions of 18 U.S.C. 3559, 3571; 42 U.S.C. 243, 268, 271; and 42 CFR 70.18. However, this Order has no effect on the contractual obligations of renters to pay rent and shall not preclude charging or collecting fees, penalties, or interest as a result of the failure to pay rent or other housing payment on a timely basis, under the terms of any applicable contract.
Under 18 U.S.C. 3559, 3571; 42 U.S.C. 271; and 42 CFR 70.18, a person violating this Order may be subject to a fine of no more than $100,000 or one year in jail, or both, if the violation does not result in a death, or a fine of no more than $250,000 or one year in jail, or both if the violation results in a death, or as otherwise provided by law. An organization violating this Order may be subject to a fine of no more than $200,000 per event if the violation does not result in a death or $500,000 per event if the violation results in a death or as otherwise provided by law. The U.S. Department of Justice may initiate criminal proceedings as appropriate seeking imposition of these criminal penalties.
Under 42 U.S.C. 243, the U.S. Department of Health and Human Services is authorized to cooperate with and aid State and local authorities in the enforcement of their quarantine and other health regulations and to accept State and local assistance in the enforcement of Federal quarantine rules and regulations, including in the enforcement of this Order.
While this Order to prevent eviction is effectuated to protect the public health, the states and units of local government are reminded that the Federal Government has deployed unprecedented resources to address the pandemic, including housing assistance.
The Department of Housing and Urban Development (HUD), the Department of Agriculture, and the Department of the Treasury have informed CDC that unprecedented emergency resources have been appropriated through various Federal agencies that assist renters and landlords during the pandemic, including $46.55 billion to the Treasury through the Consolidated Appropriations Act of 2021 and the American Rescue Plan (ARP). Furthermore, in 2020 44 states and 310 local jurisdictions allocated about $3.9 billion toward emergency rental assistance, largely from funds appropriated to HUD from the Coronavirus Aid, Relief, and Economic Security (CARES).
Visit
For program support, including technical assistance, please visit
This Order is effective on July 1, 2021, and will remain in effect through July 31, 2021, subject to revision based on the changing public health landscape.
The authority for this Order is Section 361 of the Public Health Service Act (42 U.S.C. 264) and 42 CFR 70.2.
Office of Community Services, Administration for Children and Families, HHS.
Request for public comment.
The Office of Community Services (OCS) requests a three-year extension of the forms Community Services Block Grant (CSBG) State Plan, CSBG Eligible Entity Master List, and the American Customer Survey Index (ACSI) (OMB #0970-0382, expiration 6/30/2021). There are minimal changes requested to the State Plan and the Master List. No changes are proposed to the ACSI.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
OCS proposes to revise the automated CSBG State Plan format for states and territories by revising questions for clarity and system compatibility. OCS does not anticipate that these revisions will cause any additional burden to CSBG grantees as they have completed the automated plan for six years. It is anticipated that the burden will continue to diminish in subsequent years due to improved automation.
In addition to the CSBG State Plan, OCS requests that all grantees revise their CSBG Eligible Entity Master List in year one to add the executive director and website for each agency. Grantees will revise the Master List as necessary in subsequent years. As the CSBG Eligible Entity Master List is already completed and states have the information about their eligible entities (or sub-grantees), the burden will be minimal to the states to provide the additional requested information.
Lastly, the request includes a survey for the sub-grantees (or CSBG-eligible entities). The survey focuses on the customer service that the CSBG sub-grantees receive from the CSBG grantees. The survey is optional, and this will be the fifth time that the CSBG sub-grantees that chose to submit will complete it. There are no revisions proposed to the survey.
Sec. 676, Pub. L. 105-285, 112 Stat. 2735 (42 U.S.C. 9908)
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Smallpox and Monkeypox Vaccine, Live and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Anyone with knowledge that any of the dates as published (see
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before August 27, 2021. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human biologic product Smallpox and Monkeypox Vaccine, Live (Modified Vaccinia Ankara). Smallpox and Monkeypox Vaccine, Live, is indicated for prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection. Subsequent to this approval, the USPTO received a patent term restoration application for Smallpox and Monkeypox Vaccine, Live (U.S. Patent No. 7,335,364) from Bavarian Nordic A/S, and the USPTO requested FDA's
FDA has determined that the applicable regulatory review period for Smallpox and Monkeypox Vaccine, Live is 5,650 days. Of this time, 5,315 days occurred during the testing phase of the regulatory review period, while 335 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,825 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
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 “Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for Investigational New Drug Application and Bioavailability/Bioequivalence Studies.” The draft guidance provides recommendations for sponsors and sponsor-investigators to comply with the requirements of investigational new drug application (IND) safety reporting and safety reporting for bioavailability (BA) and bioequivalence (BE) studies. In doing so, the guidance provides recommendations related to the two IND safety reporting provisions that require assessment of aggregate data to facilitate appropriate IND safety reporting practices. An earlier draft guidance for industry entitled “Safety Assessment for IND Safety Reporting” (December 2015) (the 2015 draft guidance) has been incorporated into this draft guidance. However, this content was revised to address feedback from stakeholders and comments received on the 2015 draft guidance. Concurrent with the publication of this draft guidance, we are withdrawing the 2015 draft guidance. Additionally, this draft guidance incorporates content from the final guidance for industry and investigators entitled “Safety Reporting Requirements for INDs and BA/BE Studies” (December 2012) (the 2012 final guidance). This incorporated content remains largely unchanged in this draft guidance.
Submit either electronic or written comments on the draft guidance by September 27, 2021 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:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
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. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Paul Gouge, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6328, Silver Spring, MD 20993-0002,
FDA is announcing the availability of a draft guidance for industry entitled “Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for Investigational New Drug Application and Bioavailability/Bioequivalence Studies.” The draft guidance provides recommendations for sponsors and sponsor-investigators to facilitate compliance with the requirements of IND safety reporting and safety reporting for BA and BE studies under §§ 312.32 and 320.31(d)(3) (21 CFR 312.32 and 320.31(d)(3)). In doing so, the draft guidance provides recommendations for sponsors related to the two IND safety reporting provisions (§ 312.32(c)(1)(i)(C) and (iv)) that require assessment of aggregate data to facilitate appropriate IND safety reporting practices. More generally, it provides sponsors and sponsor-investigators recommendations regarding expedited safety reporting requirements for human drug and biological products that are being investigated under an IND and for drugs that are the subject of BA and BE studies that are exempt from the IND requirements.
In the
Further, this draft guidance incorporates content from the 2012 final guidance entitled “Safety Reporting Requirements for INDs and BA/BE Studies”. The content from the 2012 final guidance remains largely unchanged in this draft guidance; however, this draft guidance does not incorporate the investigator provisions of the 2012 final guidance. FDA intends to publish a separate draft guidance on investigator's responsibilities for safety reporting for human drug and biological products that are being investigated under an IND.
When this draft guidance and the draft guidance on investigator's responsibilities for IND safety reporting are finalized, FDA plans to withdraw the 2012 final guidance. However, until FDA finalizes these two draft guidances, the 2012 final guidance remains in effect and represents FDA's current thinking.
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 “Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for Investigational New Drug Application and Bioavailability/Bioequivalence Studies.” 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.
While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not required for this guidance. The previously approved collections of information are subject to review by
Persons with access to the internet may obtain the draft guidance at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TAZVERIK and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Anyone with knowledge that any of the dates as published (see
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before August 27, 2021. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic
A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product, TAZVERIK (tazemetostat). TAZVERIK is indicated for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Subsequent to this approval, the USPTO received a patent term restoration application for TAZVERIK (U.S. Patent No. 8,410,088) from Epizyme, Inc., and the USPTO requested FDA's assistance in determining the patent's eligibility for patent term restoration. In a letter dated March 1, 2021, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of TAZVERIK represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for TAZVERIK is 1,618 days. Of this time, 1,372 days occurred during the testing phase of the regulatory review period, while 246 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 650 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) has determined the regulatory review period for GORE CARDIOFORM ASD OCCLUDER and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Anyone with knowledge that any of the dates as published (see
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before August 27, 2021. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: A testing phase and an approval phase. For medical devices, the testing phase begins with a clinical investigation of the device and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a medical device will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(3)(B).
FDA has approved for marketing the medical device, GORE CARDIOFORM ASD OCCLUDER. GORE CARDIOFORM ASD OCCLUDER is indicated for the percutaneous, transcatheter closure of the following defects of the atrial septum: Ostium secundum atrial septal defects (ASDs), patent foramen ovale to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude known causes of ischemic stroke. Subsequent to this approval, the USPTO received a patent term restoration application for GORE CARDIOFORM ASD OCCLUDER (U.S. Patent No. 9,474,517) from W.L. Gore & Associates, Inc., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated January 21, 2020, FDA advised the USPTO that this medical device had undergone a regulatory review period and that the approval of GORE CARDIOFORM ASD OCCLUDER represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for GORE CARDIOFORM ASD OCCLUDER is 931 days. Of this time, 751 days occurred during the testing phase of the regulatory review period, while 180
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 556 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Office of the Secretary, HHS.
Notice.
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Comments on the ICR must be received on or before August 27, 2021.
Submit your comments to
When submitting comments or requesting information, please include the document identifier 0990-0281-60D and project title for reference, to Sherrette A. Funn, email:
Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
The program is requesting a 3-year extension of the clearance.
Office of Disease Prevention and Health Promotion, Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services.
Notice.
The U.S. Department of Health and Human Services' (HHS) Office of Disease Prevention and Health Promotion (ODPHP) invites public and private sector organizations that support Healthy People 2030 (HP2030), the nation's disease prevention and health promotion plan, to become a Healthy People 2030 Champion (HP2030 Champion).
HP2030 Champions will receive recognition from ODPHP on
The following activities may be considered as an organization's demonstrated commitment to HP2030's overarching goals and objectives:
• Promoting and increasing access to disease prevention and health promotion activities;
• Providing access to training or certification programs for disease prevention and health promotion;
• Addressing SDOH, eliminating disparities, achieving health equity, and/or promoting well-being;
• Providing training and other necessary resources to adapt or modify disease prevention and health promotion activities to meet the needs of diverse populations, address SDOH, eliminate disparities, achieve health equity, and/or promote well-being;
• Developing partnerships across a variety of sectors, including business, community, academia, education, faith-based, government, health care, media, public health, and technology;
• Working across sectors to address SDOH, eliminate disparities, and achieve health equity;
• Evaluating health promotion and disease prevention programs or partnering with academic institutions or public health organizations to evaluate health promotion and disease prevention activities;
• Including information in their public facing materials about programs for disease prevention, health promotion, addressing SDOH, eliminating disparities, achieving health equity, and/or promoting well-being in community needs assessments;
• Adopting or implementing the HP2030 framework (
• Promoting HP2030; providing opportunities and venues for disease prevention and health promotion activities;
• Partnering with national, state, tribal, or local volunteer organizations to provide education, training, or programs regarding health promotion, disease prevention, SDOH, health disparities, health equity, and well-being;
• Supporting an entity with the responsibility to organize and coordinate efforts within and across sectors to foster health promotion and well-being;
• Promoting collaboration across all levels, including neighborhoods, communities, tribes, cities, states, counties, and localities, to increase and expand participation in health
• Disseminating through a variety of platforms messaging about the benefits of and resources available to promote disease prevention, health promotion, well-being and the importance of addressing SDOH, health disparities, and health equity;
• Supporting the coordination and standardization of data to enable comparisons across national, state, local, county, and/or tribal levels;
• Providing grants, funding opportunities, and other resources to programs that address disease prevention, health promotion, well-being, SDOH, health equity, and health disparities.
Letters of interest to become a HP2030 Champion should be submitted to
Letters of interest can be submitted via email to
Emmeline Ochiai, Office of Disease Prevention and Health Promotion, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services; 1101 Wootton Parkway, Suite 420, Rockville, MD 20852; Telephone: (240) 453-8280. Email:
The HP2030 framework and objectives outline the nation's plan for achieving the HP2030 vision of a society in which all people can achieve their full potential for health and well-being across the lifespan. HP2030's framework includes its vision, mission, overarching goals, guiding foundational principles, and is supported by over 350 specific measurable objectives with targets, LHIs, and OHMs. HP2030 serves as a resource and provides user-centered tools for disease prevention and health promotion, including science-based objectives, national and population-level data, evidence-based resources, and SDOH literature summaries. Detailed information about HP2030 is available at
ODPHP invites organizations that support HP2030, disease prevention, health promotion, and well-being and that demonstrate efforts toward addressing SDOH, eliminating health disparities, and achieving health equity in the United States to submit a letter of interest to become an HP2030 Champion.
Submission of a letter of interest does not guarantee acceptance as an HP2030 Champion. ODPHP will review and evaluate letters of interest for alignment with the HP2030 vision.
42 U.S.C. 300u(a).
Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, PAR-20-181: Limited Competition: National Primate Research Centers (P51), July 01, 2021, 10:00 a.m. to July 02, 2021, 06:00 p.m., National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 which was published in the
This meeting is being amended to change the start date from July 01, 2021 to June 29, 2021 and the start time from 10:00 a.m. to 12:30 p.m. The meeting is closed to the public.
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 section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the NIH Clinical Center Research Hospital Board.
The meeting will be held as a virtual meeting and open to the public. Individuals who plan to view the virtual meeting and need special assistance or other reasonable accommodations to view the meeting should notify the Contact Person listed below in advance of the meeting. The meeting can be accessed from the NIH Videocast
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
U.S. Customs and Border Protection, Department of Homeland Security.
30-Day notice and request for comments; extension of an existing collection of information.
The Department of Homeland Security, U.S. Customs and Border Protection will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). The information collection is published in the
Comments are encouraged and must be submitted (no later than July 28, 2021) to be assured of consideration.
Written comments and/or suggestions regarding the item(s) contained in this notice should be sent within 30 days of publication of this notice to
Requests for additional PRA information should be directed to Seth Renkema, Chief, Economic Impact Analysis Branch, U.S. Customs and Border Protection, Office of Trade, Regulations and Rulings, 90 K Street NE, 10th Floor, Washington, DC 20229-1177, Telephone number 202-325-0056 or via email
CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
To establish an ACE Portal account, participants submit information such as their name, their employer identification number (EIN) or social security number (SSN), and if applicable, a statement certifying their capability to connect to the internet. This information is submitted through the ACE Secure Data Portal which is accessible at:
There is a standalone capability for electronically filing protests in ACE. This capability is available for participants who have not established ACE Portal Accounts for other trade activities, but desire to file protests electronically. A protest is a procedure whereby a private party may administratively challenge a CBP decision regarding imported merchandise and certain other CBP decisions. Trade members can establish a protest filer account in ACE through a separate application and the submission of specific data elements.
U.S. Citizenship and Immigration Services, Department of Homeland Security.
30-Day notice.
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The purpose of this notice is to allow an additional 30 days for public comments.
Comments are encouraged and will be accepted until July 28, 2021.
Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, must be submitted via the Federal eRulemaking Portal website at
USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Chief, Telephone number (240) 721-3000 (This is not a toll-free number; comments are not accepted via telephone message.). Please note contact information provided here is solely for questions regarding this notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS website at
The information collection notice was previously published in the
You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at:
Written comments and suggestions from the public and affected agencies should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
(1)
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Fish and Wildlife Service, Interior.
Notice of receipt of permit applications; request for comments.
We, the U.S. Fish and Wildlife Service, have received applications for permits to conduct activities intended to enhance the propagation or survival of endangered or threatened species under the Endangered Species Act. We invite the public and local, State, Tribal, and Federal agencies to comment on these applications. Before issuing any of the requested permits, we will take into consideration any information that we receive during the public comment period.
We must receive your written comments on or before July 28, 2021.
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Nathan Rathbun, 612-713-5343 (phone);
The Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531
A recovery permit issued by us under section 10(a)(1)(A) of the ESA authorizes the permittee to conduct activities with endangered species for scientific purposes that promote recovery or for enhancement of propagation or survival of the species. Our regulations implementing section 10(a)(1)(A) for these permits are found at 50 CFR 17.22 for endangered wildlife species, 50 CFR 17.32 for threatened wildlife species, 50 CFR 17.62 for endangered plant species, and 50 CFR 17.72 for threatened plant species.
We invite local, State, and Federal agencies; Tribes; and the public to comment on the following applications:
Written comments we receive become part of the administrative record associated with this action. 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 request in your comment that we withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. Moreover, all submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, will be made available for public disclosure in their entirety.
If we decide to issue permits to any of the applicants listed in this notice, we will publish a notice in the
We publish this notice under section 10(c) of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
Fish and Wildlife Service, Interior.
Notice of receipt of permit applications; request for comments.
We, the U.S. Fish and Wildlife Service, have received applications for permits to conduct activities intended to enhance the propagation or survival of endangered or threatened species under the Endangered Species Act. We invite the public and local, State, Tribal, and Federal agencies to comment on these applications. Before issuing any of the requested permits, we will take into consideration any information that we receive during the public comment period.
We must receive your written comments on or before July 28, 2021.
•
•
Nathan Rathbun, 612-713-5343 (phone);
The Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531
A recovery permit issued by us under section 10(a)(1)(A) of the ESA authorizes the permittee to conduct activities with endangered species for scientific purposes that promote recovery or for enhancement of propagation or survival of the species. Our regulations implementing section 10(a)(1)(A) for these permits are found at 50 CFR 17.22 for endangered wildlife species, 50 CFR 17.32 for threatened wildlife species, 50 CFR 17.62 for endangered plant species, and 50 CFR 17.72 for threatened plant species.
We invite local, State, and Federal agencies; Tribes; and the public to comment on the following applications:
Written comments we receive become part of the administrative record associated with this action. 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 request in your comment that we withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. Moreover, all submissions from organizations or businesses, and from individuals
If we decide to issue permits to any of the applicants listed in this notice, we will publish a notice in the
We publish this notice under section 10(c) of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
U.S. Department of the Interior, Office of the Secretary, Office of Financial Management.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the Office of Financial Management, Office of the Secretary, Department of the Interior are proposing to renew an information collection.
Interested persons are invited to submit comments on or before August 27, 2021.
Send your comments on this information collection request (ICR) by mail to Paul Batlan, Office of Financial Management, 1849 C St. NW, MS 5530 MIB, Washington, DC 20240, or via email at
To request additional information about this ICR, contact Paul Batlan, Office of Financial Management, 1849 C St. NW, MS 5530 MIB, Washington, DC 20240, or via email at
In accordance with the Paperwork Reduction Act of 1995 (PRA, 44 U.S.C. 3501
As part of our continuing effort to reduce paperwork and respondent burdens, we invite the public and other Federal agencies 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.
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 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.
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 information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995 (PRA), the Bureau of Land Management (BLM) proposes a new information collection.
Interested persons are invited to submit comments on or before August 27, 2021.
Send your written comments on this information collection request (ICR) by mail to Darrin King, Information Collection Clearance Officer, U.S. Department of the Interior, Bureau of Land Management, Attention PRA Office, 440 W 200 S #500, Salt Lake City, UT 84101; or by email to
To request additional information about this ICR, contact Matt Blocker, Outdoor Recreation Planner, by email at
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
As part of our continuing effort to reduce paperwork and respondent burdens, we invite the public and other Federal agencies to comment on new, proposed, revised, and continuing collections of information. This helps the BLM assess impacts of its information collection requirements and minimize the public's reporting burden. It also helps the public understand BLM information collection requirements and provide the requested data in the desired format.
The BLM is especially interested in public comment addressing the following:
(1) Whether 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) determination of the accuracy of BLM's estimate of the burden for collection of information, including the validity of the methodology and assumptions used;
(3) methods to enhance the quality, utility, and clarity of the information to be collected; and
(4) how might the agency minimize the burden of information collection on those who respond, including use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Comments submitted in response to this notice are a matter of public record. The BLM will include or summarize each comment in its 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.
An agency may not conduct or sponsor and, notwithstanding any other provision of law, 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 closure.
Notice is hereby given that the Bureau of Land Management (BLM) Hassayampa Field Office will close certain public lands in the White Tank Mountain/Miller Road area in Maricopa County, Arizona, to all public use and entry to provide for public health and safety at the site.
The closure will be in effect for three years from 12:01 a.m., July 28, 2021, or until the completion of site remediation.
Leon Thomas, District Manager, 21605 North 7th Avenue, Phoenix, AZ 85027;
This closure affects public lands in the White Tank Mountains/Miller Road area in Maricopa County, Arizona. The legal description of the affected public lands is:
The area described is 1,370.64 acres in Maricopa County, Arizona.
The closure is necessary to protect public health and address safety risks resulting from the potential hazards of lead and other heavy metals from recreational shooting on the public lands. The Hassayampa Field Office is in the process of executing a remedial action work plan for the site, which includes reclamation. Once the site is reclaimed, the BLM will reopen the lands to the public.
During the pendency of the closure, all forms of public use and entry, including target shooting and other recreational activities, will be prohibited. However, public roads crossing the closed area, the North Tonopah-Salome Highway and North Parker Liberty Power Road, will remain open to through traffic.
The BLM will post closure signs at main entry points to this area. This closure order will be posted in the Hassayampa Field Office. Maps of the affected area and other documents pertaining to this closure are available at the Hassayampa Field Office, 21605 North 7th Avenue, Phoenix, AZ 85027. Under the authority of Section 303(a) of FLPMA (43 U.S.C. 1733(a)), 43 CFR 8360.0-7, and 43 CFR 8364.1, the BLM will enforce the following closure within certain public lands in the White Tank Mountain/Miller Road area: All public, whether motorized, on foot, or otherwise, is prohibited.
National Park Service, Interior.
Notice of designation.
This notice issues the official trail market insignia of the New England National Scenic Trail. The original graphic image was developed in 2010. It first came into public use in 2011. This publication accomplishes the official designation of the insignia now in use by the National Park Service.
Kelly Fellner, Superintendent; New England National Scenic Trail; National Park Service; One Armory Square, Suite 2, Springfield, MA 01105; via email at
The primary author of this document is Kelly Fellner, Superintendent of the New England National Scenic Trail.
The insignia depicted below is prescribed as the official trail marker logo for the New England National Scenic Trail, administered by the National Park Service, New England National Scenic Trail office, Springfield, MA. Authorization for use of this trail marker is controlled by the administrator of the trail.
In making this prescription, notice is hereby given that whoever manufactures, sells, or possesses this insignia, or any colorable imitation thereof, or photographs or prints or in any other manner makes or executes any
National Trails System Act, 16 U.S.C. 1246(c); and Protection of Official Badges, Insignia, etc., 18 U.S.C. 701.
National Park Service, Interior.
Notification of boundary revision.
Pursuant to the Judgment in
The effective date of this boundary revision is June 28, 2021.
The map depicting the boundary revision is available for inspection at the following locations: National Park Service, Interior Regions 3, 4 & 5, Land Resources Program, 601 Riverfront Drive, Omaha, Nebraska 68102 and National Park Service, Department of the Interior, 1849 C Street NW, Washington, DC 20240.
Acting Chief, Land Resources Program Michael Bockman, National Park Service, Interior Regions 3, 4 & 5, 601 Riverfront Drive, Omaha, Nebraska 68102, telephone (402) 661-1780.
The Niobrara Scenic River Designation Act of 1991, (Pub. L. 102-50, 105 Stat. 254), designated certain segments of the Niobrara River in Nebraska as components of the Wild and Scenic Rivers System. Included within the boundary of the designated river are 12.45 acres of unimproved non-Federal land.
The Niobrara Scenic River Designation Act is subject to the Wild and Scenic Rivers Act of October 2, 1968, (Pub. L. 90-542, 82 Stat. 906), as amended, 16 U.S.C. 1271-1287. Section 3(b) of that Act, 16 U.S.C. 1274(b), provides that “Notice of availability of the boundaries and classification, and of subject boundary amendments shall be published in the
This boundary amendment will remove a portion of Tract 00001 containing 12.45 acres of unimproved, non-Federal land, more or less, from the Niobrara National Scenic River pursuant to the Judgment of the U.S. District Court in
Office of Surface Mining Reclamation and Enforcement, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the Office of Surface Mining Reclamation and Enforcement (OSMRE), are proposing to renew an information collection.
Interested persons are invited to submit comments on or before July 28, 2021.
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 Paperwork Reduction Act of 1995 (PRA; 44 U.S.C. 3501
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 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.
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, we, the Office of Surface Mining Reclamation and Enforcement (OSMRE), are proposing to renew an information collection.
Interested persons are invited to submit comments on or before July 28, 2021.
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 Paperwork Reduction Act of 1995 (PRA; 44 U.S.C. 3501
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 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.
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
U.S. International Trade Commission.
Notice.
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on May 21, 2021, under section 337 of the Tariff Act of 1930, as amended, on behalf of Arigna Technology Limited of Ireland. Supplements were filed on May 26, 2021, June 9, 2021, June 10, 2021, and June 11, 2021. The complaint, as supplemented, alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain power inverters and converters, vehicles containing the same, and components thereof by reason of infringement of certain claims of U.S. Patent No. 8,247,867 (“the '867 patent”) and U.S. Patent No. 8,289,082 (“the '082 patent”). The complaint further alleges that an industry in the United States exists or is in the process of being established as required by the applicable Federal Statute. The complainant requests that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.
The complaint, except for any confidential information contained therein, may be viewed on the Commission's electronic docket (EDIS) at
Pathenia M. Proctor, The Office of Unfair Import Investigations, U.S. International Trade Commission, telephone (202) 205-2560.
(1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain products identified in paragraph (2) by reason of infringement of one or more of claims 1, 2, 8, and 9 of the '867 patent and claims 1-6, 13, 17-22, and 29 of the '082 patent; and whether an industry in the United States exists or is in the process of being established as required by subsection (a)(2) of section 337;
(2) Pursuant to section 210.10(b)(1) of the Commission's Rules of Practice and Procedure, 19 CFR 210.10(b)(1), the plain language description of the accused products or category of accused products, which defines the scope of the investigation, is “power inverters and converters used in automobiles, components thereof, and automobiles containing those power inverters or converters”;
(3) Pursuant to Commission Rule 210.50(b)(l), 19 CFR 210.50(b)(1), the presiding administrative law judge shall take evidence or other information and hear arguments from the parties or other interested persons with respect to the public interest in this investigation, as appropriate, and provide the Commission with findings of fact and a recommended determination on this issue, which shall be limited to the statutory public interest factors set forth in 19 U.S.C. l337(d)(l), (f)(1), (g)(1);
(4) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served:
(a) The complainant is: Arigna Technology Limited, The Hyde Building, Carrickmines, Suite 23, Dublin 18, Ireland.
(b) The respondents are the following entities alleged to be in violation of section 337, and are the parties upon which the complaint is to be served:
(c) The Office of Unfair Import Investigations, U.S. International Trade Commission, 500 E Street SW, Suite 401, Washington, DC 20436; and
(5) For the investigation so instituted, the Chief Administrative Law Judge, U.S. International Trade Commission, shall designate the presiding Administrative Law Judge.
Responses to the complaint and the notice of investigation must be submitted by the named respondents in accordance with section 210.13 of the Commission's Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(e) and 210.13(a), as amended in 85 FR 15798 (March 19, 2020), such responses will be considered by the Commission if received not later than 20 days after the date of service by the complainant of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown.
Failure of a respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter an initial determination and a final determination containing such findings, and may result in the issuance of an exclusion order or a cease and desist order or both directed against the respondent.
By order of the Commission.
Judicial Conference of the United States.
Advisory Committee on Appellate Rules; Notice of open meeting.
The Advisory Committee on Appellate Rules will hold a meeting on October 7, 2021 in Washington, DC. The meeting is open to the public for observation but not participation. An agenda and supporting materials will be posted at least 7 days in advance of the meeting at:
October 7, 2021, 9 a.m.-5 p.m. (Eastern).
Julie Wilson, Esq., Acting Chief Counsel, Rules Committee Staff, Administrative Office of the U.S. Courts, Thurgood Marshall Federal Judiciary Building, One Columbus Circle NE, Suite 7-300, Washington, DC 20544, Phone (202) 502-1820,
Judicial Conference of the United States.
Advisory Committee on Bankruptcy Rules; Notice of open meeting.
The Advisory Committee on Bankruptcy Rules will hold a meeting on September 14, 2021 in Washington, DC. The meeting is open to the public for observation but not participation. An agenda and supporting materials will be posted at least 7 days in advance of the meeting at:
September 14, 2021, 9 a.m.-5 p.m. (Eastern).
Julie Wilson, Esq., Acting Chief Counsel, Rules Committee Staff, Administrative Office of the U.S. Courts, Thurgood Marshall Federal Judiciary Building, One Columbus Circle NE, Suite 7-300, Washington, DC 20544, Phone (202) 502-1820,
Judicial Conference of the United States.
Advisory Committee on Civil Rules; Notice of open meeting.
The Advisory Committee on Civil Rules will hold a meeting on October 5, 2021 in Washington, DC. The meeting is open to the public for observation but not participation. An agenda and supporting materials will be posted at least 7 days in advance of the meeting at:
October 5, 2021, 9 a.m.-5 p.m. (Eastern).
Julie Wilson, Esq., Acting Chief Counsel, Rules Committee Staff, Administrative Office of the U.S. Courts, Thurgood Marshall Federal Judiciary Building, One Columbus Circle NE, Suite 7-300, Washington, DC 20544, Phone (202) 502-1820,
Judicial Conference of the United States.
Advisory Committee on Criminal Rules; Notice of open meeting.
The Advisory Committee on Criminal Rules will hold a meeting on November 4, 2021 in San Diego, CA. The meeting is open to the public for observation but not participation. An agenda and supporting materials will be posted at least 7 days in advance of the meeting at:
November 4, 2021, 9 a.m.-5 p.m. (Pacific).
Julie Wilson, Esq., Acting Chief Counsel, Rules Committee Staff, Administrative Office of the U.S. Courts, Thurgood Marshall Federal Judiciary Building, One Columbus Circle NE, Suite 7-300, Washington, DC 20544, Phone (202) 502-1820,
Judicial Conference of the United States.
Advisory Committee on Evidence Rules; Notice of open meeting.
The Advisory Committee on Evidence Rules will hold a meeting on November 5, 2021 in San Diego, CA. The meeting is open to the public for observation but not participation. An agenda and supporting materials will be posted at least 7 days in advance of the meeting at:
November 5, 2021, 9 a.m.-5 p.m. (Pacific).
Julie Wilson, Esq., Acting Chief Counsel, Rules Committee Staff, Administrative Office of the U.S. Courts, Thurgood Marshall Federal Judiciary Building, One Columbus Circle NE, Suite 7-300, Washington, DC 20544, Phone (202) 502-1820,
Judicial Conference of the United States.
Committee on Rules of Practice and Procedure; Notice of open meeting.
The Committee on Rules of Practice and Procedure will hold a meeting on January 4, 2022 in Miami, FL. The meeting is open to the public for observation but not participation. An agenda and supporting materials will be posted at least 7 days in advance of the meeting at:
January 4, 2022, 9 a.m.-5 p.m. (Eastern).
Julie Wilson, Esq., Acting Chief Counsel, Rules Committee Staff, Administrative Office of the U.S. Courts, Thurgood Marshall Federal Judiciary Building, One Columbus Circle NE, Suite 7-300, Washington, DC 20544, Phone (202) 502-1820,
Drug Enforcement Administration, Justice.
Notice of application.
Chemic Laboratories, has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
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 August 27, 2021. Such persons may also file a written request for a hearing on the application on or before August 27, 2021.
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 April 30, 2021, Chemic Laboratories, 480 Neponset Street, Building 7, Canton, Massachusetts 02021-1971, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):
The company plans to manufacture small quantities of the listed controlled substances for research and development in preclinical studies for sale to its customers. No other activities for these drug codes are authorized for this registration.
Drug Enforcement Administration, Justice.
Notice of application.
AMRI Rensselaer, Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
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 July 28, 2021. Such persons may also file a written request for a hearing on the application on or before July 28, 2021.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.
In accordance with 21 CFR 1301.34(a), this is notice that on May 20, 2021, AMRI Rensselaer, Inc., 33 Riverside Avenue, Rensselaer, New York 12144, applied to be registered as an importer of the following basic class(es) of controlled substance(s):
The company plans to import the listed controlled substance to manufacture a bulk controlled substance for distribution to its customers.
Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale.
Bureau of Justice Statistics, Department of Justice.
30-Day notice.
The Department of Justice (DOJ), Office of Justice Programs, Bureau of Justice Statistics, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection was previously published in the
Comments are encouraged and will be accepted for an additional 30 days until July 28, 2021.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
(1)
(2)
(3)
(4)
(5)
(6)
Bureau of Justice Statistics, Department of Justice.
60-Day notice.
The Department of Justice (DOJ), Office of Justice Programs, Bureau of Justice Statistics, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
Comments are encouraged and will be accepted for 60 days until August 27, 2021.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Erika Harrell, Statistician, Bureau of Justice Statistics, 810 Seventh Street NW, Washington, DC 20531 (email:
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.
Office of Justice Programs, Department of Justice.
60-Day notice.
The Department of Justice (DOJ), Bureau of Justice Assistance will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The Death in Custody Reporting Act (DCRA) requires states and federal law enforcement agencies to report certain information to the Attorney General regarding the death of any person occurring during interactions with law enforcement officers or while in custody. It further requires the Attorney General and the Department of Justice (Department) to collect the information, establish guidelines on how it should be reported, annually determine whether each state has complied with the reporting requirements, and address any state's noncompliance.
Comments are encouraged and will be accepted for 60 days until August 27, 2021.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Laura Wyckoff, Bureau of Justice Assistance, 810 Seventh Street NW, Washington, DC 20531 (email:
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.
For each quarter in a fiscal year, a State must complete the Quarterly Summary (Form DCR-1) and submit it by the reporting deadline. The Quarterly Summary is a list of all reportable deaths that occurred in the State during the corresponding quarter with basic information about the circumstances of each death. If a State did not have a reportable death during the quarter, the State must so indicate on the Quarterly Summary. The reporting deadline to submit the Quarterly Summary is the last day of the month following the close of the quarter. For each quarter, BJA will send two reminders prior to the reporting deadline.
For each reportable death identified in the Quarterly Summary, a State must complete and submit by the same reporting deadline an Incident Report (Form DCR-1A), which contains specific information on the circumstances of the death and additional characteristics of the decedent. These include:
• The decedent's name, year of birth, gender, race, and ethnicity.
• The date, time, and location of the death.
• The law enforcement or correctional agency involved.
• Description of the manner of death.
States must answer all questions on the Incident Report before they can submit the form. If the State does not have sufficient information to complete one of the questions, then the State may select the “unknown” answer, if available, and then identify when the information is anticipated to be obtained.
4.
DOJ proposes the following plan to collect DCRA information at the end of fiscal year 2019 and beyond. The plan, which constitutes “guidelines established by the Attorney General” pursuant to section 2(a) of the DCRA, encompasses provisions specifically required by the statute.
For purposes of this notice, the term “reportable death” means any death that the DCRA or the Department's guidelines require States to report. Generally, these are deaths that occurred during interactions with law enforcement personnel or while the decedent was in their custody or in the custody, under the supervision, or under the jurisdiction of a State or local law enforcement or correctional agency, such as a jail or prison. Specifically, the DCRA requires States to report “information regarding the death of any person who is detained, under arrest, or is in the process of being arrested, is en route to be incarcerated, or is incarcerated at a municipal or county jail, State prison, State-run boot camp prison, boot camp prison that is contracted out by the State, any State or local contract facility, or other local or State correctional facility (including any juvenile facility).” 34 U.S.C. 60105(a).
Please note that the DCRA information that States submit to the Department must originate from official government records, documents, or personnel.
The DCRA requires quarterly reporting. Beginning with the first quarter of FY 2020 (October 2019), quarterly DCRA reporting to BJA will include all reportable deaths—deaths occurring during interactions with law enforcement personnel or while in their custody and deaths in jail, prison, or detention settings (
5.
6.
For FY 2020 and beyond, the total projected respondent burden is 13,756.49 hours. States will need an estimated 4.00 hours to complete each Quarterly Summary for a total of 4,480.00 hours, 0.25 hours to complete each corresponding Incident Reports (DCR-1A) for a total of 1,713.49 hours. For LEAs, the estimated burden to assist States in completing the Quarterly Summaries is 0.40 hours per Report for a total of 1,696.00 hours, and a total of 1,425.00 hours, at 0.75 hours for each corresponding Incident Report. The estimated burden for jails is a total of 960.00 hours to assist States in completing the Quarterly Summaries and 789.75 hours in completing Incident Reports. Finally, the estimated burden for prisons to assist States in completing the Quarterly Summaries is a total of 80.00 hours, and a total of 2,612.25 hours to assist States in completing Incident Reports.
Employee Benefits Security Administration, Labor.
Notice of proposed exemption.
This document provides notice of the pendency before the Department of Labor (the Department) of a proposed individual exemption from certain of the prohibited transaction restrictions of the Employee Retirement Income Security Act of 1974 (ERISA or the Act) and/or the Internal Revenue Code of 1986 (the Code).
If granted, the exemption will be in effect as of the date the grant notice is published in the
All written comments and requests for a hearing should be sent to the Employee Benefits Security Administration (EBSA), Office of Exemption Determinations, Attention: Application No. D-12003 via email to
Frank Gonzalez of the Department, telephone (202) 693-8553. (This is not a toll-free number.)
In light of the current circumstances surrounding the COVID-19 pandemic caused by the novel coronavirus which may result in disruption to the receipt of comments by U.S. Mail or hand delivery/courier, persons are encouraged to submit all comments
1. Mitsubishi UJF Trust and Banking Corporation is a foreign banking corporation organized under the laws of Japan, and a subsidiary of Mitsubishi UFJ Financial Group. MUFG Alternative Fund Services (Cayman) Limited is an ordinary resident company organized under the laws of the Cayman Islands, and is an indirectly wholly-owned subsidiary of Mitsubishi UJF Trust and Banking Corporation (collectively, Mitsubishi Bank or the Applicant). Mitsubishi Bank may act as the sole lender (a Lender) or agent for a Lender (an Agent) in arranging revolving lines of credit (Credit Facilities) that are used by certain investment vehicles (the Funds). The Funds may be structured as limited partnerships, limited liability companies, or other business entities organized under applicable law. Investors in the Funds (the Investors) include employee benefit plans subject to ERISA and plans subject to Code section 4975 (the Covered Plans). The Covered Plans invest in the Funds, and the Funds, in turn, may invest directly or indirectly in private equity investments, real estate or real estate related investments, non-real estate operating company ventures, or other investment opportunities.
2. The Funds may use capital calls to facilitate Fund investments. A capital call (Capital Call) is when a Fund exercises its right to call on Investors to make cash capital contributions to the Fund. These cash capital contributions from Investors to a Fund (Capital Contributions) enable the Fund to make its investments. Investors typically have 10 to 15 days after a Capital Call to make a Capital Contribution. A Fund's use of Capital Calls to make investments can take days, thereby reducing a Fund's investing flexibility and increasing costs to the Fund's Investors, including the Covered Plans.
3. In addition to Capital Calls, a Fund may use a Credit Facility to facilitate investments. For purposes of this proposed exemption, a Credit Facility is a secured revolving line of credit between Mitsubishi Bank, as sole Lender, or as Agent, and one or more Funds (or an entity through which a Fund invests). The Fund may use its credit under the Credit Facility for: (a) Direct or indirect borrowings; (b) requesting letters of credit; (c) other similar forms of credit arrangements; or (d) a combination of any of the foregoing.
4. Mitsubishi may be a party in interest to a Covered Plan investing in a Fund that uses a Credit Facility with respect to which Mitsubishi is a Lender or Agent for one or more Lenders. However, Mitsubishi will not be a fiduciary with respect to the Covered Plan when relying on the exemption.
5. In most instances, the Credit Facility will be a recourse obligation of a Covered Plan to the Fund that will not exceed the Covered Plan's capital commitment. The following will secure the Fund's repayments to the Credit Facility: (a) A pledge and assignment of all the rights of the Fund and its general partner (General Partner) or manager (Manager), including the right to call for and receive payments of capital committed by Investors, and rights against defaulting Investors; (b) the right to make Capital Calls on Investors, and apply the proceeds to the repayment obligations of the Fund under the Credit Facility, in the event of a default under the Credit Facility; (c) a pledge or first priority security interest in an account (the Collateral Account) that the Fund maintains with a financial institution or entity into which capital contributions are made; and (d) Investor agreements evidencing, among other things, the Investor's acknowledgement of the assignment of rights to the Lenders by the General Partner (or the Manager) and the Fund (the Investor Consent).
6. In connection with securing a Credit Facility, and to the extent Mitsubishi Bank requests or requires, either as sole Lender or Agent, an Investor will execute an Investor Consent consenting to, acknowledging, and confirming certain aspects of the Credit Facility. The Investor Consent may include the following documentation: (a) An acknowledgment and confirmation of the Investor's obligation to deliver the Investor's financial information statements to Mitsubishi Bank, as sole Lender or Agent; (b) an acknowledgment, and confirmation, of the Investor's unpaid, and owing, capital commitment amount, and of the Investor's obligation to contribute capital (up to its unfunded capital commitment amount) to satisfy the indebtedness the Fund incurred under the Credit Facility; (c) an Investor's acknowledgment of the Fund's, and its General Partner's (or Manager's), assignment and pledge to Mitsubishi Bank as sole Lender or Agent, of the right to make Capital Calls upon the Investors, and to collect and enforce the same; (d) an Investor's agreement to make Capital Contributions to the Fund without setoff, reduction, counterclaim, or defense of any kind or nature, for the purpose of repayment of the Credit Facility; (e) a representation that the Investor has no knowledge of claims, offsets, or defenses that would adversely affect its obligation to fund Capital Contributions under the Fund Agreements, or events, which with the passage of time would constitute a default, or would constitute a defense to, or right of offset against the Investor's obligation to fund its capital commitment to the Fund; and (f) an agreement that the Investor will fund Capital Contributions only into the Collateral Account (except in certain limited circumstances).
7. With respect to the Fund and its activities, the only direct contractual relationship between an Investor and Mitsubishi Bank, or any Lender, will be the execution of the Investor Consent. The Investor will separately agree in an “Agreement to Fund” that, in the event of default under the Credit Facility, the Investor will make its Capital Contribution to the Collateral Account in response to a Capital Call for repayment of the Credit Facility, without setoff, reduction, counterclaim, or defense of any kind or nature.
8. The Investor Consent acknowledges, and confirms, existing rights of the Lenders that are created by operation of the Fund Agreements. The Agreement to Fund does not limit the Investor's right to assert any claim, or defense, in a separate action against either the Fund or the General Partner (or Manager).
9. An executed Investor Consent is integral to the Credit Facility, and the Credit Facility is an integral part of the Fund's investment program. Prior to, or at the time of, a plan fiduciary's decision to invest in the Fund, the plan fiduciaries will be aware that the Fund will have: (a) The power to borrow money; (b) enter into a loan agreement in which the Fund may pledge its assets, including the capital commitments of the Investors; and (c) have the right to make Capital Calls, thereby giving the secured party the right, under certain circumstances, to make Capital Calls, directly.
10. A Fund Agreement is the written organizing and governing document forming a Fund that obligates each Investor to make Capital Contributions, with respect to capital commitments, upon receipt of a Capital Call from Mitsubishi Bank, either as sole Lender or as Agent. The Fund Agreement will also allow the Fund, or its general partner (the General Partner), or its manager (the Manager), to make Capital Calls for any lawful purpose of the Fund that is consistent with the terms of the Fund Agreement and other governing documents.
11. Generally, the Fund Agreement will allow the Fund to: (a) Incur indebtedness (including indebtedness related to a Credit Facility) for the acquisition of investments, and to provide the Fund with working capital, among other things; and (b) consummate investments quickly without having to finalize the debt/equity structure for an investment, or arrange, for interim or permanent financing, prior to making an investment, and will have additional advantages to the Investors and the Fund.
12. Some Fund Agreements contain an Agreement to Fund (or similar language) in which case the Investor Consent merely acknowledges and confirms the Investor's funding obligation. All other aspects of the transaction, including the negotiation of all terms of the Credit Facility, will be exclusively between Mitsubishi Bank, as sole Lender or Agent, and the Fund.
13. The Applicant is requesting an exemption that would permit:
(a) The granting by the Funds to Mitsubishi Bank, as sole Lender or Agent for one or more Lenders (including Mitsubishi Bank) that will fund a Credit Facility, of a security interest in and lien on the Capital Commitments, reserve amounts, and Capital Contributions of Investors that are Covered Plans investing in the Fund;
(b) Any Fund's collateral assignment and pledge to Mitsubishi Bank, as sole Lender or Agent, of the Fund's security interest in an Investor/Covered Plan's equity interest in such Fund;
(c) The Fund's granting to Mitsubishi Bank, as sole Lender or Agent, of a security interest in a collateral account (Collateral Account) to which all Capital Contributions in the Fund will be deposited when paid (except in certain limited circumstances that do not involve Covered Plans);
(d) The granting by the Fund and/or its General Partner or Manager to Mitsubishi Bank, as sole Lender or Agent, of its right to make Capital Calls under the operative Fund Agreements, to enforce the Capital Calls, collect the
(e) A Covered Plan's execution of the Investor Consent, consenting to the assignment by the Fund and General Partner (or Manager) to Mitsubishi Bank, as sole Lender or Agent, of their right to make Capital Calls.
14. Absent an administrative exemption, these transactions may violate ERISA section 406(a)(l)(A) through (D), and the corresponding provisions of the Code. The Applicant represents that since the Lenders, including Mitsubishi Bank, will be generally large, national, and international financial institutions, it is likely that, in any given Credit Facility, one or more Lenders will have a relationship with a Covered Plan, making it a party in interest with respect to the Covered Plan. However, as a condition of this exemption, no Lender, including Mitsubishi Bank, will be a fiduciary for any of the Covered Plans in connection with their investment in the Fund.
15. ERISA section 406(a)(l)(A) prohibits a sale, exchange, or lease, of any property between a plan and a party in interest. Pursuant to the Investor Consent, a Covered Plan will make cash contributions to the Collateral Account for the benefit of a Lender. Because the cash contribution may come from the Covered Plan's assets, the execution of the Investor Consent agreement involves an exchange of property between the Covered Plan and the Lender, which includes Mitsubishi Bank, as sole Lender or Agent, in violation of section 406(a)(1)(A) of ERISA.
16. In addition, ERISA section 406(a)(1)(B) prohibits the lending of money, or other extension of credit, between a plan and a party in interest. The Credit Facility's direct extension of credit to the Fund, resulting in an indirect extension of credit to Covered Plans investing in that Fund, pursuant to the Investor Consent, violates section ERISA 406(a)(1)(B).
17. Further, ERISA section 406(a)(1)(C) prohibits the furnishing of goods, services, or facilities between a plan and a party in interest. By servicing the loans under the Credit Facility, Mitsubishi Bank provides indirect services to the Covered Plan Investor. Furthermore, from time to time, there may be interactions between Mitsubishi Bank Lenders and the Covered Plan Investors which involve Mitsubishi's provision of services. For example, Covered Plan Investors may inquire about the status and/or request information from Mitsubishi Bank Lenders with respect to the Credit Facility and the outstanding obligations thereunder, although, typically, such communications would be relayed by the Covered Plan Investors through the Fund to Mitsubishi Bank Lenders, and not made directly.
18. Finally, ERISA section 406(a)(l)(D) prohibits, the transfer to, or use by, or for the benefit of a party in interest of any assets of a plan. Because an Investor will make cash contributions to the Collateral Account for the benefit of the Lender, which includes Mitsubishi Bank, as sole Lender or Agent, cash contribution from Plan assets would be considered a transfer of Plan assets to a party in interest, in violation of ERISA section 406(a)(1)(D).
19. According to the Applicant, absent the requested exemption, the inability to use the financing structure described above will result in economic loss to Investors that are Covered Plans, and their participants and beneficiaries, due to more onerous, and expensive, financing terms and conditions that would be required for Plans to invest in these types of investment ventures. In this regard, the types of Funds involved in the Covered Transactions are an important element of a Covered Plan's diversified investment portfolio. Real estate investments can be valuable components of plan portfolios. However, investments in a large, diversified limited partnership or similar entity may have advantages over direct ownership of real estate properties, and other securities, including limited liability with respect to such property, if risks are minimized. Most diversified real estate and other investment programs are carried out through partnerships or limited liability companies that are substantially-similar to the Funds.
20. According to the Applicant, a Credit Facility will allow a Fund to manage its Capital Calls on a scheduled basis and to move quickly to fund desired investments likely resulting in a more favorable investment portfolio for the Fund and its Investors, and a potentially higher return, without appreciably higher risk. In addition, the ability of the Investors to delay payment on capital commitments allows such amounts to remain in other investments of the Investor and allows the Investor to achieve greater overall investment returns.
21. Mitsubishi Bank, as sole Lender or Agent, may receive a pledge of the Investors' capital commitments, and rights to make Capital Calls and to collect and enforce the same, in the event of default. The Investor Consent is an important component of the Credit Facility arrangement. Absent the Investor Consent, Mitsubishi Bank may be required to foreclose on the collateral in order to effect a Capital Call for repayment of the Credit Facility. The Investor Consent, which would be required by this exemption, enables Mitsubishi Bank, as sole Lender or Agent, to make a Capital Call immediately on the Investors for repayment, without the need to first foreclose on the collateral.
22. When the Fund Agreements do not contain the agreement of the Investors to make capital commitments without setoff, reduction, counterclaim, or defense of any kind or nature, the Investor Consent will contain this agreement, thereby permitting Lenders to be repaid for amounts that have been extended to the Fund prior to the time Capital Contributions are called, without the risk of repayment being challenged, or delayed, by claims the Investors may have against the Fund. This arrangement will keep the risk of the Fund's investment transactions between the Fund and the Investors.
23. The proposed exemption will be subject to a number of substantive conditions. The decision to invest in the Fund on behalf of each Covered Plan and to execute an Investor Consent in favor of Mitsubishi Bank, as sole Lender or Agent, will be made by fiduciaries of the Covered Plan that are not included among, are independent of, and are unaffiliated with, the Lenders (including Mitsubishi Bank) and the Fund. Further, in each Credit Facility covered under this proposed exemption, no Lender, including Mitsubishi Bank, will be a fiduciary for any of the Covered Plans in connection with their investment in the Fund. Relief in this proposed exemption does not extend to Funds that contain “plan assets” for purposes of ERISA or Code section 4975.
24. Each transaction must be on terms that are no less favorable to the Covered Plans than those which the Covered Plans could obtain in arm's-length transactions with unrelated parties. At the time of the execution of an Investor Consent, the Covered Plan must have assets of not less than $100 million. Not more than 5% of the assets of any Covered Plan, measured at the time of the execution of an Investor Consent, may be invested in the Fund.
25. The proposed exemption requires that the applicable fiduciaries for Covered Plans that are Investors provide a representation to Mitsubishi Bank, including a statement, that such fiduciary is responsible for making the Covered Plan's decision to invest in the Fund, and is and will be independent of, and unaffiliated with, the Lenders.
26. In addition, no Lender may have any influence, authority, or control over a Client Plan's investment in the Fund. No Covered Transaction may be part of an arrangement, agreement or understanding, designed to benefit a party in interest or disqualified person with respect to a Covered Plan. Finally, any service covered by the exemption must be necessary for the establishment or operation of the plan, and no more than reasonable compensation may be paid therefor. Finally, all the facts and representations set forth in the Summary of Facts and Representations must be true and accurate.
27.
28.
28.
30. Based on the record developed in connection with this proposed exemption, the Department has tentatively determined that the relief sought by the Applicant satisfies the statutory requirements for an exemption under ERISA section 408(a).
Notice of the proposed exemption will be given to all interested persons within 15 days of the publication of the notice of proposed exemption in the
All comments will be made available to the public.
The attention of interested persons is directed to the following:
(1) The fact that a transaction is the subject of an exemption under section 408(a) of the Act and/or section 4975(c)(2) of the Code does not relieve a fiduciary or other party in interest or disqualified person from certain other provisions of the Act and/or the Code, including any prohibited transaction provisions to which the exemption does not apply and the general fiduciary responsibility provisions of section 404 of the Act, which, among other things, require a fiduciary to discharge his duties respecting the plan solely in the interest of the participants and beneficiaries of the plan and in a prudent fashion in accordance with section 404(a)(1)(b) of the Act; nor does it affect the requirement of section 401(a) of the Code that the plan must operate for the exclusive benefit of the employees of the employer maintaining the plan and their beneficiaries;
(2) Before an exemption may be granted under section 408(a) of the Act and/or section 4975(c)(2) of the Code, the Department must find that the exemption is administratively feasible, in the interests of the plan and of its participants and beneficiaries, and protective of the rights of participants and beneficiaries of the plan;
(3) The proposed exemption, if granted, will be supplemental to, and not in derogation of, any other provisions of the Act and/or the Code, including statutory or administrative exemptions and transitional rules. Furthermore, the fact that a transaction is subject to an administrative or statutory exemption is not dispositive of whether the transaction is in fact a prohibited transaction; and
(4) The proposed exemption, if granted, will be subject to the express condition that the material facts and representations contained in each application are true and complete, and that each application accurately describes all material terms of the transaction which is the subject of the exemption.
If the proposed exemption is granted, the restrictions of ERISA sections 406(a)(1)(A)-(D), and the sanctions resulting from the application of Code section 4975, by reason of section Code section 4975(c)(l)(A)-(D), shall not apply to:
(a) The granting by the Funds to Mitsubishi UFJ Trust and Banking Corporation (Mitsubishi Bank), as an agent (Agent) for one or more financial institutions (Lender(s)), which may include, without limitation, Mitsubishi Bank) or as sole Lender, that will fund a credit facility (Credit Facility) providing credit to certain investment funds (Fund(s)), of a security interest in and lien on the capital commitments (Capital Commitments), reserve amounts, and capital contributions
(b) Any Fund's collateral assignment and pledge to Mitsubishi Bank, as sole Lender or Agent, of the Fund's security interest in an Investor Covered Plan's equity interest in such Fund;
(c) The Fund's grant to Mitsubishi Bank, as sole Lender or Agent, of a security interest in a collateral account (Collateral Account) to which all Capital Contributions in the Fund will be deposited when paid (except in certain limited circumstances that do not involve Covered Plans);
(d) The granting by the Fund and/or its general partner (General Partner) or manager (Manager) to Mitsubishi Bank, as sole Lender or Agent, of its right to make calls on Covered Plan Investors for Capital Contributions (the Capital Call), which shall be in cash, under the operative Fund Agreements (as defined in Section II(d)), enforce the Capital Calls, collect the Capital Contributions, and apply them to any amount due under the Credit Facility; and
(e) A Covered Plan's execution of an agreement (the Investor Consent) consenting to the assignment by the Fund and General Partner (or Manager) to Mitsubishi Bank, as sole Lender or Agent, of their right to make Capital Calls.
(a) The terms “Covered Plan” or “Covered Plans” means an investor in a Fund (as defined below) that is an employee benefit plan, as defined in ERISA section 3(3) and that is covered by Title I, Part 4 of ERISA, and/or a plan defined in Code section 4975, that satisfies the conditions set forth herein in Section II;
(b) The terms “Covered Transaction” or “Covered Transactions” mean any combination of transactions described in Section I(a) through (d), in conjunction with the Investor Consent described in Section I(e);
(c) The terms “Fund” or “Funds” means an investment or venture capital fund (organized as a corporation, limited partnership, limited liability company, or another business entity authorized by applicable law) in which one or more investors invest, including employee benefit plans or special purpose entities holding “plan assets” subject to ERISA, as described herein, by making capital contributions in cash to such Fund, pursuant to specific Capital Commitments as established by the Fund Agreement(s) and other operative documents executed by the parties, for purposes of making certain real estate investments (including real estate-related investments, such as venture capital investments) or non-real estate investments (including, without limitation, assets and/or interests relating to infrastructure, maritime, energy, etc.).
Each Covered Plan investing in such special purpose entity must satisfy the conditions set forth herein in Section II. The term “Fund” includes an entity created by the Fund that may borrow, or receive, funds from the Credit Facility, provided that such entity is considered an affiliate of the Fund as a subsidiary or other controlled entity;
(d) The terms “Fund Agreement” or “Fund Agreements” mean the written agreements under which a Fund (as defined above) is formed (such as a limited partnership agreement, a limited liability company agreement, trust agreement, or articles of incorporation, together with ancillary related agreements, such as subscription agreements) that obligate each Investor to make cash contributions of capital with respect to Capital Commitments, upon receipt of a call for Capital Contributions;
(e) The term “officer” means a president, any vice president in charge of a principal business unit, division or function (such as sales, administration or finance), or any other officer who performs a policy-making function for the entity;
(f) The term “Mitsubishi Bank” means Mitsubishi UJF Trust and Banking Corporation, which is a foreign banking corporation organized under the laws of Japan, and its indirectly wholly-owned subsidiary named MUFG Alternative Fund Services (Cayman) Limited, an ordinary resident company incorporated and existing under the laws of the Cayman Islands. This exemption is intended to cover Mitsubishi Bank, and all of its current and future branches;
(g) For purposes of determining whether a fiduciary is not included among, is independent of, and unaffiliated with, a Fund, the term Fund shall be deemed, as appropriate, to include the governing entity of the Fund, or a member of the governing body of the Fund, as appropriate,
(i) The fiduciary is not, directly or indirectly, through one or more intermediaries, controlling, controlled by, or under common control with such Lender or Fund;
(ii) The fiduciary is not an officer, director, employee or relative of, or partner in, such Lender or Fund; and
(iii) No officer, director, highly-compensated employee (within the meaning of Code Section 4975(e)(2)(H)), or partner of the Fund, or any officer, director or highly-compensated employee, or partner of the Lender who is involved in the transactions described in Section I of the exemption request, is also an officer, director, highly-compensated employee, or partner of the fiduciary. However, if such individual is a director of the Lender, and if he or she abstains from participation in, and is not otherwise involved with, the decision made by the Covered Plan to invest in the Fund, then this condition shall be deemed satisfied.
(a) The decision to invest in the Fund on behalf of each Covered Plan and to execute an Investor Consent in favor of Mitsubishi Bank, as sole Lender or Agent, is made by fiduciaries of the Covered Plan that are not included among and are independent of and unaffiliated with, the Lenders (including Mitsubishi Bank) and the Fund;
(b) The transaction is on terms that are no less favorable to the Covered Plans than those which the Covered Plans could obtain in arm's-length transactions with unrelated parties;
(c) At the time of the execution of an Investor Consent, the Covered Plan has assets of not less than $100 million. In the case of multiple plans maintained by the same employer, or by members of a controlled group of corporations (within the meaning of Code Section 414(b)), or members of a group of trades or businesses under common control (within the meaning of Code Section 414(c)) (hereafter, referred to as “members of a controlled group”), whose assets are invested on a commingled basis (
(d) Not more than 5% of the assets of any Covered Plan, measured at the time of the execution of an Investor Consent,
(e) Neither Mitsubishi Bank, nor any Lender, has discretionary authority or control with respect to a Covered Plan's investment in the Fund nor renders investment advice (within the meaning of 29 CFR 2510.3-21(c)) with respect to such investment;
(f) Upon request, the Covered Plan fiduciaries must receive from Mitsubishi Bank, a copy of this notice of proposed exemption and a copy of the final exemption, as published in the
(g) Mitsubishi Bank receives from the Covered Plan fiduciaries a written representation, or a written authorization, that permits Mitsubishi Bank to rely on a written representation made to the Fund, that the conditions set forth above in Section III(a), (c), and (d) are satisfied for such transaction with respect to the Covered Plan for which they are fiduciaries;
(h) No Covered Transaction is part of an arrangement, agreement or understanding, designed to benefit a party in interest or disqualified person with respect to a Covered Plan.
(i) The Funds will not hold “plan assets” for purposes of ERISA or Code section 4975;
(j) Any service covered by the exemption must be necessary for the establishment or operation of the plan, and no more than reasonable compensation may be paid;
(k) No Lender will have any influence, authority, or control over a Client Plan's investment in the Fund; and
(l) All the facts and representations set forth in the Summary of Facts and Representations are true and accurate.
Employee Benefits Security Administration, Labor.
Notice of Exemption.
This document contains a notice of an exemption issued by the Department of Labor (the Department) from certain of the prohibited transaction restrictions of the Employee Retirement Income Security Act of 1974 (ERISA or the Act). The exemption permits: (a) The sale (the Sale) by the Electrical Joint Apprenticeship and Training Trust (the EJAT Trust) of 5.11 acres of unimproved real property (the Property) to the Electrical Insurance Trustees Insurance Fund (the EIT Fund), a party in interest with respect to the EJAT Trust; and (b) the EIT Fund's granting of a right of first offer (the Right of First Offer) to the EJAT Trust to purchase the Property back from the EIT Fund, provided all of the conditions described below are satisfied.
This exemption will be in effect on the date that this grant notice is published in the
Mr. Joseph Brennan of the Department at (202) 693-8456. (This is not a toll-free number.)
On March 22, 2021, the Department published a notice of proposed exemption in the
This exemption provides only the relief specified in the text of the exemption. It provides no relief from violations of any law other than the prohibited transaction provisions of ERISA.
The Department makes the requisite findings under ERISA section 408(a) based on adherence to all of the conditions of the exemption. Accordingly, affected parties should be aware that the conditions incorporated in this exemption are, taken as a whole, necessary for the Department to grant the relief requested by the Applicants. Absent these or similar conditions, the Department would not have granted this exemption.
The Applicants requested an individual exemption pursuant to ERISA section 408(a) in accordance with the procedures set forth in 29 CFR part 2570, subpart B (76 FR 66637, 66644, October 27, 2011). Effective December 31, 1978, section 102 of the Reorganization Plan No. 4 of 1978, 5 U.S.C. App. 1 (1996), transferred the authority of the Secretary of the Treasury to issue administrative exemptions under section 4975(c)(2) of the Code to the Secretary of Labor. Accordingly, the Department grants this exemption under its sole authority.
In the proposed exemption, the Department invited all interested persons to submit written comments and/or requests for a public hearing with respect to the notice of proposed exemption. All comments and requests for a hearing were due to the Department by May 6, 2021. The Department received one written comment and one request for a public hearing. The commenter raised no substantive issues regarding the proposed transactions, and the hearing requestor provided no reasons for requesting the hearing.
The complete application files (L-12000 & L-12001) are available for public inspection in the Public Disclosure Room of the Employee Benefits Security Administration, Room N-1515, U.S. Department of Labor, 200 Constitution Avenue NW, Washington, DC 20210. For a more complete statement of the facts and representations supporting the Department's decision to grant this exemption, refer to the notice of proposed exemption published on March 22, 2021, at 86 FR 15258.
The attention of interested persons is directed to the following:
(1) The fact that a transaction is the subject of an exemption under ERISA section 408(a) does not relieve a fiduciary or other party in interest from certain requirements of other ERISA provisions, including any prohibited transaction provisions to which the exemption does not apply and the general fiduciary responsibility provisions of ERISA section 404, which, among other things, require a fiduciary to discharge his or her duties respecting the plan solely in the interest of the plan's participants and beneficiaries and in a prudent fashion in accordance with ERISA section 404(a)(1)(B).
(2) As required by ERISA section 408(a), the Department hereby finds that the exemption is (1) administratively feasible, (2) in the interests of affected plans and of their participants and beneficiaries, and (3) protective of the rights of participants and beneficiaries of such plans;
(3) The exemption is supplemental to, and not in derogation of, any other ERISA provisions, including statutory or administrative exemptions and transitional rules. Furthermore, the fact that a transaction is subject to an administrative or statutory exemption is not dispositive of determining whether the transaction is in fact a prohibited transaction; and
(4) The availability of this exemption is subject to the express condition that the material facts and representations contained in the application accurately describe all material terms of the transaction that are the subject of the exemption.
Accordingly, the following exemption is granted under the authority of ERISA section 408(a)and in accordance with the procedures set forth in 29 CFR part 2570, subpart B (76 FR 66637, 66644, October 27, 2011):
The restrictions of ERISA sections 406(a)(1)(A), 406(a)(1)(D), 406(b)(1), and 406(b)(2) shall not apply to: (a) EJAT Trust's sale of the Property to the EIT Fund, which is a party in interest with respect to the EJAT Trust;
(a) The Sale is a one-time transaction for cash;
(b) The terms and conditions of the Sale are at least as favorable to the EJAT Trust and the EIT Fund as an arm's-length transaction between unrelated and independent parties each of whom have full knowledge of the relevant facts and are not under any compulsion to buy or sell;
(c) The EJAT Trust Independent Fiduciary has not and will not enter into any agreement or instrument that violates section 410 of ERISA, and prudently:
(1) Represents the EJAT Trust's interests for all purposes with respect to the Sale;
(2) Determines that the Sale is in the interest and protective of the EJAT Trust and the EJAT Trust participants based on, among other things, an updated appraisal report described in (c)(5) below;
(3) Reviews and approves the terms and conditions of the Sale;
(4) Engages the EJAT Trust Independent Appraiser, ensures the Appraiser's independence, and ensures that the Appraiser bases its opinions upon complete, current, and accurate information;
(5) Ensures that the EJAT Trust's Independent Appraiser renders an updated fair market valuation of the Property, which is current as of the date of the Sale;
(6) Reviews the EJAT Independent Appraisal Report and the updated appraisal described in (c)(5), confirms that the underlying methodologies are reasonable and accurate, and prudently concludes that the appraisals can reasonably be relied upon; and
(7) Determines whether it is appropriate for the EJAT Trust to proceed with the Sale and whether the Sale is consistent with each condition of this exemption;
(d) The EIT Fund Independent Fiduciary has not and will not enter into any agreement or instrument that violates section 410 of ERISA, and prudently:
(1) Represents the EIT Fund's interests for all purposes with respect to the Sale;
(2) Determines that the Sale is in the interest and protective of the EIT Fund and the EIT Fund participants based on, among other things, an updated appraisal report described in (d)(5) below;
(3) Reviews and approves the terms and conditions of the Sale;
(4) Engages the EIT Fund Independent Appraiser for the Sale, ensures the Appraiser's Independence, and ensures that the Appraiser bases its opinions upon complete, current, and accurate information;
(5) Ensures that the EIT Fund's Independent Appraiser renders an updated fair market valuation of the Property, which is current as of the date of the Sale;
(6) Reviews the EIT Fund Independent Appraisal Report and the updated appraisal described in (d)(5), confirms that the underlying methodologies are reasonable and accurate, and prudently concludes that the appraisals can reasonably be relied upon; and
(7) Determines whether it is appropriate for the EIT Fund to proceed with the Sale consistent with each condition of this exemption;
(e) The Sale is not part of an agreement, arrangement, or understanding designed to benefit any party other than the EJAT Trust and the EIT Fund;
(f) Any use of the Property by the EIT Fund and the Related Plans that is described in PTEs 76-1 and 77-10 complies with the conditions of those exemptions;
(g) No later than 90 days after the Sale is completed, the EJAT Trust and the EIT Fund Independent Fiduciaries each will submit a written statement to the Department documenting that the Sale has met all of the exemption requirements;
(h) The EIT Fund Independent Fiduciary may not enter, and has not entered, into any agreement, arrangement or understanding regarding the Sale that indemnifies the EIT Fund Independent Fiduciary, in whole or in part, or waives any liability for negligence or for violation of state or federal law by the EIT Fund Independent Fiduciary;
(i) The Independent Appraiser selected by the EIT Fund Independent Fiduciary may not enter, and has not entered, into any agreement, arrangement or understanding regarding the Sale that indemnifies the EIT Fund Independent Appraiser, in whole or in part, or waives any liability for negligence or for any violation of state or federal law by the Independent Appraiser;
(j) The EJAT Trust Independent Fiduciary may not enter, and has not entered, into any agreement, arrangement or understanding regarding the Sale that indemnifies the EJAT Trust Independent Fiduciary, in whole or in part, or waives any liability for negligence or for any violation of state or federal law by the EJAT Trust Independent Fiduciary;
(k) The Independent Appraiser selected by the EJAT Trust Independent Fiduciary may not enter, and has not entered, into any agreement,
(l) The EJAT Trust may not re-purchase the Property from the EIT Fund absent an individual exemption granted by the Department.
Electronic Board Meeting to be held via email exchanges Thursday, July 8, 2021, 8:00 a.m. (PDT), through Wednesday, July 21, 2021.
Board of Trustees Meeting held via email.
This special meeting of the Board of Trustees, to be held Electronically (in accordance with the Operating Procedures of the Board of Trustees of the Morris K. Udall and Stewart L. Udall Foundation), is open to the public. Members of the public who would like to participate in this electronic meeting should email Elizabeth E. Monroe, Executive Assistant, Morris K. Udall and Stewart L. Udall Foundation, at
Draft Udall Foundation 2022-2026 Strategic Plan.
David P. Brown, Executive Director, 130 South Scott Avenue, Tucson, AZ 85701, (520) 901-8500.
National Aeronautics and Space Administration.
Request for information; correction.
The National Aeronautics and Space Administration (NASA) published a document in the
Issues regarding submission or questions on this RFI can be sent to Dorice Kenely, Procurement Analyst, Office of Procurement at (202) 358-0443 or
In the
On page 31738, in the third column, correct the second sentence of the last paragraph to read:
To that end, NASA will hold a public meeting on July 13, 2021, from 1:00 p.m. to 3:30 p.m.
In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science Foundation (NSF) announces the following meeting:
NSF will provide the Zoom coordinates for each meeting (All times are Eastern Daylight Time (EDT)).
Weeks of June 28, July 5, 12, 19, 26, August 2, 2021.
Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland.
Public.
There are no meetings scheduled for the week of June 28, 2021.
There are no meetings scheduled for the week of July 5, 2021.
There are no meetings scheduled for the week of July 12, 2021.
There are no meetings scheduled for the week of July 19, 2021.
There are no meetings scheduled for the week of July 26, 2021.
There are no meetings scheduled for the week of August 2, 2021.
For more information or to verify the status of meetings, contact Wesley Held at 301-287-3591 or via email at
The NRC Commission Meeting Schedule can be found on the internet at:
The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in these public meetings or need this meeting notice or the transcript or other information from the public meetings in another format (
Members of the public may request to receive this information electronically. If you would like to be added to the distribution, please contact the Nuclear Regulatory Commission, Office of the Secretary, Washington, DC 20555, at 301-415-1969, or by email at
The NRC is holding the meetings under the authority of the Government in the Sunshine Act, 5 U.S.C. 552b.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Regulatory guide; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is issuing a new Regulatory Guide (RG) 4.26, “Volcanic Hazards Assessment for Proposed Nuclear Power Reactor Sites.” This RG provides guidance for facilitating the NRC staff's review of volcanic hazards assessments performed by applicants to support the siting of new nuclear power reactors. The RG also provides applicants with the methods and approaches the NRC staff considers acceptable for the assessment of volcanic hazards in license applications for sites with Quaternary volcanoes within the site region or with Quaternary volcanic deposits within the site vicinity.
RG 4.26 is available on June 28, 2021.
Please refer to Docket ID NRC-2020-0076 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:
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RG 4.26 and the regulatory analysis may be found in ADAMS under Accession Nos. ML20272A168 and ML20007D618, respectively.
Regulatory guides are not copyrighted, and NRC approval is not required to reproduce them.
Jenise Thompson, Office of Nuclear Reactor Regulation, telephone: 301-415-1811, email:
The NRC is issuing a new guide in the NRC's “Regulatory Guide” series. This series was developed to describe and make available to the public information regarding methods that are acceptable to the NRC staff for implementing specific parts of the agency's regulations, techniques that the NRC staff uses in evaluating specific issues or postulated events, and data that the NRC staff needs in its review of applications for permits and licenses.
RG 4.26 was issued with a temporary identification of Draft Regulatory Guide, DG-4028.
The NRC published a notice of the availability of DG-4028 in the
This RG is a rule as defined in the Congressional Review Act (5 U.S.C. 801-808). However, the Office of Management and Budget has not found it to be a major rule as defined in the Congressional Review Act.
Issuance of this RG does not constitute backfitting as defined in section 50.109 of title 10 of the
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Notice of submission to the Office of Management and Budget; request for comment.
The U.S. Nuclear Regulatory Commission (NRC) has recently submitted a request for renewal of an existing collection of information to the Office of Management and Budget (OMB) for review. The information collection is entitled, “US NRC Acquisition Regulation.”
Submit comments by July 28, 2021. Comments received after this date will be considered if it is practical to do so, but the Commission is able to ensure consideration only for comments received on or before this date.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
David Cullison, NRC Clearance Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2084; email:
Please refer to Docket ID NRC-2020-0190 when contacting the NRC about the availability of information for this action. You may obtain publicly available information related to this action by any of the following methods; however, the NRC encourages electronic comment submission through the Federal Rulemaking website:
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Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
The NRC cautions you not to include identifying or contact information in comment submissions that you do not want to be publicly disclosed in your comment submission. All comment submissions are posted at
If you are requesting or aggregating comments from other persons for submission to the OMB, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that comment submissions are not routinely edited to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.
Under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the NRC recently submitted a request for renewal of an existing collection of information to OMB for review entitled, “US NRC Acquisition Regulation.” The NRC hereby informs potential respondents that an agency may not conduct or sponsor, and that a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
The NRC published a
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For the Nuclear Regulatory Commission.
Office of Personnel Management.
30-Day notice and request for comments.
Retirement Services, Office of Personnel Management (OPM) offers the general public and other federal agencies the opportunity to comment on an expiring information collection request (ICR) with minor edits, Marital Status Certification Survey, RI 25-7.
Comments are encouraged and will be accepted until July 28, 2021.
Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503, Attention: Desk Officer for the Office of Personnel Management or sent via electronic mail to:
A copy of this ICR with applicable supporting documentation, may be obtained by contacting the Retirement Services Publications Team, Office of Personnel Management, 1900 E Street NW, Room 3316-L, Washington, DC 20415, Attention: Cyrus S. Benson, or sent via electronic mail to
As required by the Paperwork Reduction Act of 1995 OPM is soliciting comments for this collection. The information collection (OMB No. 3206-0033) was previously published in the
The Office of Management and Budget is particularly interested in comments that:
1. Evaluate whether the proposed collection of information is necessary for the proper performance of functions of the agency, including whether the information will have practical utility;
2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to be collected; and
4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
RI 25-7 is used to determine whether widows, widowers, and former spouses receiving survivor annuities from OPM have remarried before reaching age 55 and, thus, are no longer eligible for benefits.
Office of Personnel Management.
30-Day notice and request for comments.
Retirement Services, Office of Personnel Management (OPM) offers the general public and other federal agencies the opportunity to comment on an expiring information collection request (ICR) with minor edits, Request for Change to Unreduced Annuity, RI 20-120.
Comments are encouraged and will be accepted until July 28, 2021.
Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503, Attention: Desk Officer for the Office of Personnel Management or sent via electronic mail to
A copy of this ICR, with applicable supporting documentation, may be obtained by contacting the Retirement Services Publications Team, Office of Personnel Management, 1900 E Street NW, Room 3316-L, Washington, DC 20415, Attention: Cyrus S. Benson, or sent via electronic mail to
As required by the Paperwork Reduction Act of 1995, (Pub. L. 104-13, 44 U.S.C. chapter 35) as amended by the Clinger-Cohen Act (Pub. L. 104-106), OPM is soliciting comments for this collection.
1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to be collected; and
4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
RI 20-120 is designed to collect information the Office of Personnel Management needs to comply with the wishes of the retired Federal employee whose marriage has ended. This form provides an organized way for the retiree to give us everything at one time.
Office of Personnel Management.
30-Day Notice and request for comments.
Retirement Services, Office of Personnel Management (OPM) offers the general public and other federal agencies the opportunity to comment on an expiring information collection request (ICR) with minor edits, Verification of Who is Getting Payments RI 38-107 and RI 38-147.
Comments are encouraged and will be accepted until July 28, 2021.
Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503, Attention: Desk Officer for the Office of Personnel Management or sent via electronic mail to
A copy of this information collection, with applicable supporting documentation, may be obtained by contacting the Retirement Services Publications Team, Office of Personnel Management, 1900 E Street NW, Room 3316-L, Washington, DC 20415, Attention: Cyrus S. Benson, or sent via electronic mail to
As required by the Paperwork Reduction Act of 1995 OPM is soliciting comments for this collection. The information collection (OMB No. 3206-0197) was previously published in the
1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to be collected; and
4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
RI 38-107 is designed for use by the Retirement Inspection Branch when OPM, for any reason, must verify that the entitled person is indeed receiving the monies payable. RI 38-147 collects the same information and is used by other groups within Retirement Operations. Failure to collect this information would cause OPM to pay monies absent the assurance of a correct payee.
Office of Personnel Management.
30-Day notice and request for comments.
Retirement Services, Office of Personnel Management (OPM) offers the general public and other federal agencies the opportunity to comment on an expiring information collection request (ICR) with minor edits,
Comments are encouraged and will be accepted until July 28, 2021.
Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503, Attention: Desk Officer for the Office of Personnel Management or sent via electronic mail to:
A copy of this ICR with applicable supporting documentation, may be obtained by contacting the Retirement Services Publications Team, Office of Personnel Management, 1900 E Street NW, Room 3316-L, Washington, DC 20415, Attention: Cyrus S. Benson, or sent via electronic mail to
As required by the Paperwork Reduction Act of 1995 OPM is soliciting comments for this collection. The information collection (OMB No. 3206-0170) was previously published in the
The Office of Management and Budget is particularly interested in comments that:
1. Evaluate whether the proposed collection of information is necessary for the proper performance of functions of the agency, including whether the information will have practical utility;
2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to be collected; and
4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Standard Form 3106, Application for Refund of Retirement Deductions under FERS is used by former Federal employees under FERS, to apply for a refund of retirement deductions withheld during Federal employment, plus any interest provided by law. Standard Form 3106A, Current/Former Spouse(s) Notification of Application for Refund of Retirement Deductions under FERS, is used by refund applicants to notify their current/former spouse(s) that they are applying for a refund of retirement deductions, which is required by law.
The RRB invites comments on the proposed collections of information to determine (1) the practical utility of the collections; (2) the accuracy of the estimated burden of the collections; (3) ways to enhance the quality, utility, and clarity of the information that is the subject of collection; and (4) ways to minimize the burden of collections on respondents, including the use of automated collection techniques or other forms of information technology. Comments to the RRB or OIRA must contain the OMB control number of the ICR. For proper consideration of your comments, it is best if the RRB and OIRA receive them within 30 days of the publication date.
Under Section 7(b)(3) of the Railroad Retirement Act (RRA) (45 U.S.C. 231f), and Section 5(c) of the Railroad Unemployment Insurance Act (RUIA) (45 U.S.C. 355) any person aggrieved by a decision made by an office of the RRB on his or her application for an annuity or benefit under those Acts has the right to appeal to the RRB. This right is prescribed in 20 CFR 260 and 20 CFR 320. The notification letter, which is provided at the time of filing the
To file a request for an appeal the applicant must complete Form HA-1,
Under Section 2(g) of the Railroad Unemployment Insurance Act (45 U.S.C. 352), benefits that accrued but were not paid because of the death of the employee shall be paid to the same individual(s) to whom benefits are payable under Section 6(a)(1) of the Railroad Retirement Act. The provisions relating to the payment of such benefits are prescribed in 20 CFR 325.5 and 20 CFR 335.5.
The RRB provides Form UI-63, Application for Benefits Due But Unpaid at Death, to those applying for the accrued sickness or unemployment benefits unpaid at the death of the employee and for obtaining the information needed to identify the proper payee. One response is requested of each respondent. Completion is required to obtain a benefit.
Under Section 7(d) of the Railroad Retirement Act (RRA) (45 U.S.C. 231f), the Railroad Retirement Board (RRB) administers the Medicare program for persons covered by the railroad retirement system. The RRB uses Form AA-6, Employee Application for Medicare; Form AA-7, Spouse/Divorced Spouse Application for Medicare; and Form AA-8, Widow/Widower Application for Medicare; to obtain the information needed to determine whether individuals who have not yet filed for benefits under the RRA are qualified for Medicare payments provided under Title XVIII of the Social Security Act.
Further, in order to determine if a qualified railroad retirement beneficiary who is claiming supplementary medical insurance coverage under Medicare is entitled to a Special Enrollment Period (SEP) and/or premium surcharge relief because of coverage under an Employer Group Health Plan (EGHP), the RRB needs to obtain information regarding the claimant's EGHP coverage, if any. The RRB uses Form RL-311-F, Evidence of Coverage Under An Employer Group Health Plan, to obtain the basic information needed to establish EGHP coverage for a qualified railroad retirement beneficiary.
Completion of the forms is required to obtain a benefit. One response is requested of each respondent.
• Add the option to return the form by facsimile.
• Changed question 4 to replace working with employed, add an employment start date for the employee, and add additional instructions.
Under Section 2 of the Railroad Retirement Act (RRA) (45 U.S.C. 231a), a railroad employee's retirement annuity or an annuity paid to the spouse of a railroad employee is subject to work deductions in the Tier II component of the annuity and any employee supplemental annuity for any month in which the annuitant works for a Last Pre-Retirement Non-Railroad Employer (LPE). The LPE is defined as the last person, company, or institution, other than a railroad employer, that employed an employee or spouse annuitant. In addition, the employee, spouse, or divorced spouse Tier I annuity benefit is subject to work deductions under Section 2(f)(1) of the RRA for earnings from any non-railroad employer that are over the annual exempt amount. The regulations pertaining to non-payment of annuities by reason of work and LPE are contained in 20 CFR 230.1 and 230.2.
The RRB utilizes Form RL-231-F, Request to Non-Railroad Employer for Information About Annuitant's Work and Earnings, to obtain the information needed to determine if a work deduction should be applied because an annuitant worked in non-railroad employment after the annuity beginning date. One response is requested of each respondent. Completion is voluntary.
Under Section 2(e)(3) of the Railroad Retirement Act (RRA) (45 U.S.C. 231a), an annuity is not payable for any month in which a beneficiary works for a railroad. In addition, an annuity is reduced for any month in which the beneficiary works for an employer other than a railroad employer and earns more than a prescribed amount. Under the 1988 amendments to the RRA, the Tier II portion of the regular annuity and any supplemental annuity must be reduced by one dollar for each two dollars of Last Pre-Retirement Non-Railroad Employment (LPE) earnings for each month of such service. However, the reduction cannot exceed 50 percent of the Tier II and supplemental annuity amount for the month to which such deductions apply. The LPE generally refers to an annuitant's last employment with a non-railroad person, company, or institution prior to retirement, which was performed at the same time as railroad employment or after the annuitant stopped railroad employment. The collection obtains earnings information needed by the RRB to determine if possible reductions in annuities are in order due to LPE.
The RRB utilizes Form G-19L,
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
White House Office of Science and Technology Policy.
Notice of request for information.
The White House Office of Science and Technology Policy (OSTP) seeks information to help improve the effectiveness of Federal scientific integrity policies to enhance public trust in science. The January 27, 2021 Presidential Memorandum on Restoring Trust in Government Through Scientific Integrity and Evidence-Based Policymaking (Memorandum) directs OSTP to convene an interagency task force under the National Science and Technology Council to review the effectiveness of policies developed since the issuance of the Presidential Memorandum on scientific integrity issued on March 9, 2009 in preventing improper political interference in the conduct of scientific research and the collection of data; preventing the suppression or distortion of findings, data, information, conclusions, or technical results; supporting scientists and researchers of all genders, races, ethnicities, and backgrounds; and advancing the equitable delivery of the Federal Government's programs. To support this assessment, OSTP seeks information about: (1) The effectiveness of Federal scientific integrity policies and needed areas of improvement; (2) good practices Federal agencies could adopt to improve scientific integrity, including in the communication of scientific information, addressing emerging technologies and evolving scientific practices, supporting professional development of Federal scientists, and promoting transparency in the implementation of agency scientific integrity policies; and (3) other topics or concerns that Federal scientific integrity policies should address. Please note the purpose of this RFI is not to receive reports on alleged offenses that are in violation of Federal scientific integrity policies. If you have witnessed or experienced any harmful acts that may undermine scientific integrity and you would like to report these allegations, please contact the Scientific Integrity Officer or Office of the Inspector General at the relevant Federal agency.
Interested persons and organizations are invited to submit comments on or before 5:00 p.m. ET on July 28, 2021.
Interested individuals and organizations should submit comments electronically to
Response to this RFI is voluntary. Each responding entity (individual or organization) is requested to submit only one response. OSTP welcomes any responses to inform and guide the work of the Scientific Integrity Fast-Track Action Committee (SI-FTAC). Please feel free to respond to one or as many prompts as you choose. Submission must not exceed 7 pages in 12-point or larger font, with a page number provided on each page. Responses should include the name of the person(s) or organization(s) filing the comment, as well as the respondent type (
In accordance with FAR 15.202(3), responses to this notice are not offers and cannot be accepted by the Federal Government to form a binding contract. Additionally, those submitting responses are solely responsible for all expenses associated with response preparation.
For additional information, please direct questions to Ryan Donohue at
The 2009 Presidential Memorandum articulates 6 principles to guide recommendations for Presidential Action to guarantee scientific integrity throughout the executive branch: (1) Selection and retention of candidates for science and technology positions in the executive branch should be based on the candidate's knowledge, credentials, experience, and integrity; (2) Agencies should have appropriate rules and procedures to ensure the integrity of the scientific process within the agency; (3) Scientific and technical information used in agency decisions should be subject to established scientific processes, including peer review; (4) Agencies should make available to the public the scientific or technological findings or conclusions considered or relied upon in policy decisions (to the extent release is not restricted); (5) Agencies should have in place procedures to identify and address instances in which the scientific process or the integrity of scientific and technological information may be compromised; and (6) Agencies should adopt procedures, including whistleblower protections, needed to ensure the integrity of scientific and technological information and processes used for decision-making or otherwise prepared.
The 2010 OSTP Memorandum provides further guidance to executive departments and agencies for implementing scientific integrity policies. It identifies 4 foundations of scientific integrity in government: (1) Ensure a culture of scientific integrity by shielding scientific data and analyses from inappropriate political interference and preventing political officials from suppressing or altering scientific or technological findings; (2) Strengthen the actual and perceived credibility of government research through: Hiring decisions based on candidates' knowledge, credentials, experience, and integrity; ensuring data and research used to support policy decisions undergoes independent peer review; setting clear standards for governing conflicts-of-interest; and adopting whistleblower protections; (3) Facilitate the free flow of scientific and technological information, consistent with privacy and classification standards; and (4) Establish principles for conveying scientific and technological information to the public, including underlying assumptions and uncertainties. The 2010 OSTP Memorandum also establishes guidance for public communication about scientific and technological matters that maximizes openness and transparency with the media; use of Federal Advisory Committees tasked with providing scientific advice; and professional development of government scientists and engineers. It directs Agencies to report back to OSTP on actions taken to develop and implement policies specified in the memorandum.
By December 2016, 24 Federal departments and agencies had developed and published policies to support scientific integrity. These agencies and departments included all major U.S. science agencies (
The 2021 Presidential Memorandum calls for the establishment of an interagency task force (established as the SI-FTAC) of the National Science and Technology Council (NSTC) to conduct a thorough review of the effectiveness of agency integrity policies developed since the issuance of the Presidential Memorandum of March 9, 2009 on scientific integrity. Specifically, the 2021 Presidential Memorandum charges the task force to: (1) Consider whether existing Federal scientific integrity policies prevent improper political interference in the conduct of scientific research and the collection of scientific or technological data; prevent the suppression or distortion of scientific or technological findings, data, information, conclusions, or technical results; support scientists and researchers of all genders, races, ethnicities, and backgrounds; and advance the equitable delivery of the Federal Government's programs; (2) analyze instances in which existing scientific integrity policies have not been followed or enforced; and (3) identify effective practices for implementing scientific integrity policies in specific areas of particular interest, including improving the communication of scientific information, addressing emerging technologies and evolving scientific practices, supporting professional development of Federal scientists, and effective reporting practices that promote transparency in the implementation of agency scientific integrity policies and in the handling of any allegations of misconduct.
This request for information aims to support the task force's work by providing input from stakeholders on issues specified in the 2021 Presidential Memorandum and related topics. The information collected in response to this RFI will inform the task force (SI-FTAC), OSTP, and OMB as they work with Federal agencies and other stakeholders to review the effectiveness of agency scientific integrity policies and practices.
Information about the strengths and weaknesses of Federal scientific integrity policies, including where additional efforts are needed to meet the broad ambition to establish trust in Federal science by protecting against: Political or other improper interference in the conduct of scientific research, the
Consider practices related but not limited to: Engagement of Federal scientists and contractors working on scientific matters with news media and on social media; protection of scientific independence during clearance and review processes; avoidance of political or other improper interference in research or data collection; differentiation in official government communications of references to scientific publications and peer-reviewed research versus science-based or science-informed policy statements and determinations.
Consider practices related but not limited to: Handling scientific disagreements about research methods and conclusions; addressing gaps in current scientific integrity policies related to emerging technologies, such as artificial intelligence and machine-learning, and evolving scientific practices, such as citizen science and community-engaged research; supporting the professional development of Federal scientists; supporting scientists and researchers of all genders, races, ethnicities, and backgrounds and advance the equitable delivery of the Federal Government's programs; and Ensuring the independence, autonomy, and effectiveness of scientific integrity officials and chief science officers.
Consider practices related but not limited to: Educating and informing employees, contractors, and grantees in scientific and technical positions, as well as those who manage, communicate, or make decisions based on science and technology, of their rights and responsibilities related to agency scientific integrity policies; reporting practices that promote transparency in the implementation of agency scientific integrity policies and in the handling of any allegations of misconduct; communicating to the public about alleged lapses in scientific integrity, substantiated violations of scientific integrity policies, and remedial actions taken; and minimizing conflicts of interest in Federal science and research misconduct.
Consider other elements that should be included and addressed in the scientific integrity policies of Federal agencies, beyond those specified in the 2009 Presidential Memorandum, 2010 OSTP Memorandum, and 2021 Presidential Memorandum. Consider also effective practices, in addition to those specified above, that Federal agencies could put in place to improve scientific integrity and public trust in Federal science, including for proactively promoting rigorous, objective scientific research and streamlining implementation within and across Federal departments and agencies.
Securities and Exchange Commission.
Notice.
Notice of an application for an order under section 6(c) of the Investment Company Act of 1940 (the “Act”) for an exemption from sections 23(a), 23(b) and 63 of the Act, an pursuant sections 57(a)(4) and 57(i) of the Act and rule 17d-1 under the Act permitting certain joint transactions otherwise prohibited by section 57(a)(4) of the Act, and pursuant section 23(c)(3) of the Act for an exemption from section 23(c) of the Act.
Capital Southwest Corporation (“Company” or “Applicant”), requests an order (“Order”) to permit it to (i) issue restricted shares of its common stock (“Restricted Stock”) under the terms of its 2021 Employee Restricted Stock Award Plan (the “2021 Plan”) as part of the compensation package for certain of its employees in the 2021 Plan, and (ii) withhold shares of the Company's common stock or purchase shares of the Company's common stock from the participants to satisfy tax withholding obligations relating to the vesting of Restricted Stock pursuant to the 2021 Plan.
Capital Southwest Corporation
The application was filed on March 29, 2021, and amended on May 17, 2021 and on June 14, 2021.
An order granting the requested relief will be issued unless the Commission orders a hearing. Interested persons may request a hearing by emailing the Commission's Secretary at
The Commission:
Asen Parachkevov, Senior Counsel, at (202) 551-6908 or Lisa Reid Ragen, Branch Chief, at (202) 551-6825
The following is a summary of the application. The complete application may be obtained via the Commission's website by searching for the file number, or for an applicant using the Company name box, at
1. The Company, a Texas corporation, is an internally managed, non-diversified, closed-end investment company that has elected to be regulated as a business development company (“BDC”) under the Act.
2. Shares of the Company's common stock are traded on the NASDAQ Global Select Market under the symbol “CSWC.” As of March 31, 2021, there were 23,344,836 and 21,005,324 shares of the Company's common stock issued and outstanding, respectively. As of March 31, 2021, the Company had an aggregate of 21 employees.
3. The Company currently has a seven-member board of directors (the “Board”), of whom one is an “interested person” of the Company within the meaning of section 2(a)(19) of the Act and six are not interested persons (the “Non-interested Directors”). The Company has six directors who are neither officers nor employees of the Company.
4. The Company believes that its successful performance depends on its ability to offer fair compensation packages to its professionals that are competitive with those offered by other investment management businesses. The Company believes the highly specialized nature of its business, the competitiveness of its market and the small size of its employee base relative to its assets and revenue make such retentions even more critical for the Company, and that the ability to offer equity-based compensation to its professionals is vital to the Company's future growth and success.
5. The Commission previously issued certain exemptive orders (the “Prior Orders”), which, among other things, (i) permit the Company to issue restricted shares of its common stock under the terms of the Company's 2010 Restricted Stock Award Plan (the “2010 Plan”) as part of the compensation packages for certain of its employees and certain employees of its wholly-owned subsidiaries, and (ii) allow the Company to withhold shares of the Company's common stock or purchase shares of the Company's common stock from the Participants (as defined in the 2010 Plan) to satisfy tax withholding obligations relating to the vesting of Restricted Stock (as defined in the 2010 Plan) pursuant to the 2010 Plan.
6. The Company states that the right to grant restricted stock awards under the 2010 Plan will terminate on July 18, 2021 and that in connection with the termination of the 2010 Plan, the Board approved the 2021 Plan as part of the compensation packages for certain of its employees, the terms of which are, in all material respects, identical to the 2010 Plan. The Company states that the relief that Applicant is requesting under the Order would provide the same relief with respect to the 2021 Plan as previously provided by the Commission in the Prior Orders with respect to the 2010 plan. The Order would supersede the Prior Orders, with the result that the Company will no longer rely on the Prior Orders if the Order is granted.
7. The 2021 Plan will authorize the issuance of shares of Restricted Stock by the Company to certain of its employees. The Company states that the Restricted Stock will be subject to restrictions on transferability and other restrictions as required by the Compensation Committee of the Board, which will be comprised solely of “non-employee directors” within the meaning of rule 16b-3 under the Securities Exchange Act of 1934 (the “Exchange Act”), each of whom also is not an “interested person” of the Company within the meaning of section 2(a)(19) of the Act. The Company states that except to the extent restricted under the terms of the 2021 Plan, a Participant (as defined in the 2021 Plan) who is granted Restricted Stock will have all the rights of any other shareholder, including the right to vote the Restricted Stock and the right to receive dividends. The Company states that during the restriction period (
8. The Company states that the value of Restricted Stock generally will be taxable to the recipient as ordinary income in the years in which the restrictions on the shares lapse and that such value will be the fair market value of the shares on the dates the restrictions lapse. The Company states that the 2021 Plan authorizes the Company to withhold common stock (in whole or in part) from any award of restricted shares granted at the time the Restricted Stock is taxed in satisfaction of a Participant's tax obligations.
9. The Company states that maximum amount of Restricted Stock that may be issued and outstanding will not at the time of issuance of any Restricted Stock exceed 10% of the Company's outstanding voting securities.
10. The Company states that each issuance of Restricted Stock under the 2021 Plan will be approved by the required majority, as defined in section 57(o) of the Act,
11. The Company states that the 2021 Plan was approved by the Board as a whole, including the required majority as defined in section 57(o) of the Act, on
1. Under section 63 of the Act, the provisions of section 23(a) of the Act generally prohibiting a registered closed-end investment company from issuing securities for services or for property other than cash or securities are made applicable to BDCs. This provision would prohibit the issuance of Restricted Stock as a part of the 2021 Plan.
2. Section 23(b) generally prohibits a registered closed-end management investment company from selling its common stock at a price below its current net asset value (“NAV”). Section 63(2) makes section 23(b) applicable to BDCs unless certain conditions are met. Because Restricted Stock that would be granted under the 2021 Plan would not meet the terms of section 63(2), sections 23(b) and 63 prohibit the issuance of the Restricted Stock.
3. Section 6(c) provides, in part, that the Commission may, by order upon application, conditionally or unconditionally exempt any person, security, or transaction, or any class or classes of persons, securities or transactions, from any provision of the Act, if and to the extent that the exemption is necessary or appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Act.
4. The Company requests an order pursuant to section 6(c) of the Act granting an exemption from the provisions of sections 23(a) and (b) and section 63 of the Act. The Company states that the concerns underlying those sections include: (a) Preferential treatment of investment company insiders and the use of options and other rights by insiders to obtain control of the investment company; (b) complication of the investment company's structure that makes it difficult to determine the value of the company's shares; and (c) dilution of shareholders' equity in the investment company. The Company states that the 2021 Plan does not raise concerns about preferential treatment of the Company's insiders because the 2021 Plan is a bona fide compensation plan of the type common among corporations generally. In addition, section 61(a)(3)(B) of the Act permits a BDC to issue to its officers, directors and employees, pursuant to an executive compensation plan, warrants, options and rights to purchase the BDC's voting securities, subject to certain requirements. The Company states that, for reasons that are unclear, section 61 and its legislative history do not address the issuance by a BDC of restricted stock as incentive compensation. The Company states, however, that the issuance of Restricted Stock is substantially similar, for purposes of investor protection under the Act, to the issuance of warrants, options, and rights as contemplated by section 61 of the Act. The Company also asserts that the 2021 Plan would not become a means for insiders to obtain control of the Company because the number of shares of the Company issuable under the 2021 Plan would be limited as set forth in the application.
5. The Company further states that the 2021 Plan will not unduly complicate the Company's structure because equity-based compensation arrangements are widely used among corporations and commonly known to investors. The Company notes that the 2021 Plan will be submitted to its shareholders for their approval. The Company represents that a concise, “plain English” description of the 2021 Plan, including its potential dilutive effect, will be provided in the proxy materials that will be submitted to the Company's shareholders. The Company also states that it will comply with the proxy disclosure requirements in Item 10 of Schedule 14A under the Exchange Act. The Company further notes that the 2021 Plan will be disclosed to investors in accordance with the requirements of the Form N-2 registration statement for closed-end investment companies, and pursuant to the standards and guidelines adopted by the Financial Accounting Standards Board for operating companies. In addition, the Company will comply with the disclosure requirements for executive compensation plans applicable to BDCs.
6. The Company acknowledges that, while awards granted under the 2021 Plan would have a dilutive effect on the shareholders' equity in the Company, that effect would be outweighed by the anticipated benefits of the 2021 Plan to the Company and its shareholders. The Company asserts that it needs the flexibility to provide the requested equity-based employee compensation in order to be able to compete effectively with other financial services firms for talented professionals. These professionals, the Company suggests, in turn are likely to increase the Company's performance and shareholder value. The Company also asserts that equity-based compensation will help align the interests of the Company's employees with those of its shareholders. In addition, the Company states that its shareholders will be further protected by the conditions to the requested order that assure continuing oversight of the operation of the 2021 Plan by the Company's Board.
7. Section 57(a) proscribes certain transactions between a BDC and persons related to the BDC in the manner described in section 57(b) (“57(b) persons”), absent a Commission order. Section 57(a)(4) generally prohibits a 57(b) person from effecting a transaction in which the BDC is a joint participant absent such an order. Rule 17d-1, made applicable to BDCs by section 57(i), proscribes participation in a “joint enterprise or other joint arrangement or profit-sharing plan,” which includes a stock option or purchase plan. Employees and directors of a BDC are 57(b) persons. Thus, the issuance of shares of Restricted Stock could be deemed to involve a joint transaction involving a BDC and a 57(b) person in contravention of section 57(a)(4). Rule 17d-1(b) provides that, in considering relief pursuant to the rule, the Commission will consider (i) whether the participation of the company in a joint enterprise is consistent with the Act's policies and purposes and (ii) the extent to which that participation is on a basis different from or less advantageous than that of other participants.
8. The Company requests an order pursuant to sections 57(a)(4) and 57(i) of the Act and under rule 17d-1 to permit the Company to issue Restricted Stock under the 2021 Plan. The Company states that the 2021 Plan, although benefiting the Participants and The Company in different ways, is in the interests of the Company's shareholders because the 2021 Plan will help align the interests of the Company's employees and officers with those of its shareholders, which will encourage conduct on the part of those employees and officers designed to produce a better return for the Company's shareholders.
9. Section 23(c) of the Act, which is made applicable to BDCs by section 63 of the Act, generally prohibits a BDC from purchasing any securities of which it is the issuer except in the open market pursuant to tenders, or under other circumstances as the Commission may permit to ensure that the purchases are made in a manner or on a basis that does not unfairly discriminate against any holders of the class or classes of securities to be purchased. Applicant states that the withholding or purchase of shares of Restricted Stock and common stock in payment of applicable withholding tax obligations or of common stock in payment for the exercise price of a stock option might be deemed to be purchases by the Company of its own securities within the meaning of section 23(c) and therefore prohibited by the Act.
10. Section 23(c)(3) of the Act permits a BDC to purchase securities of which it is the issuer in circumstances in which the repurchase is made in a manner or on a basis that does not unfairly discriminate against any holders of the class or classes of securities to be purchased. Applicant believes that the requested relief meets the standards of section 23(c)(3).
11. Applicant submits that these purchases will be made in a manner that does not unfairly discriminate against Applicant's stockholders because all purchases of Applicant's stock will be at the closing price of the common stock on the Nasdaq Global Market (or any primary exchange on which its shares of common stock may be traded in the future) on the relevant date (
12. Applicant represents that the withholding provisions in the 2021 Plan do not raise concerns about preferential treatment of Applicant's insiders because the 2021 Plan is a bona fide compensation plan of the type that is common among corporations generally. Furthermore, the vesting schedule is determined at the time of the initial grant of the Restricted Stock. Applicant represents that all purchases may be made only as permitted by the 2021 Plan, which will be approved by the Applicant's stockholders prior to any application of the relief. Applicant believes that granting the requested relief would be consistent with the policies underlying the provisions of the Act permitting the use of equity compensation as well as prior exemptive relief granted by the Commission under section 23(c) of the Act.
Applicant agrees that the order granting the requested relief will be subject to the following conditions:
1. The 2021 Plan will be authorized by the Company's shareholders.
2. Each issuance of Restricted Stock to officers and employees will be approved by the required majority, as defined in section 57(o) of the Act, of the Company's directors on the basis that such grant is in the best interests of the Company and its shareholders.
3. The amount of voting securities that would result from the exercise of all of the Company's outstanding warrants, options, and rights, together with any Restricted Stock issued and outstanding pursuant to the 2021 Plan and any other compensation plans of the Company, at the time of issuance shall not exceed 25% of the outstanding voting securities of the Company, except that if the amount of voting securities that would result from the exercise of all of the Company's outstanding warrants, options, and rights issued to the Company's directors, officers, and employees, together with any Restricted Stock issued pursuant to the 2021 Plan and any other compensation plans of the Company, would exceed 15% of the outstanding voting securities of the Company, then the total amount of voting securities that would result from the exercise of all outstanding warrants, options, and rights, together with any Restricted Stock issued pursuant to the 2021 Plan and any other compensation plans of the Company, at the time of issuance shall not exceed 20% of the outstanding voting securities of the Company.
4. The amount of Restricted Stock issued and outstanding will not at the time of issuance of any Restricted Stock exceed 10% of the Company's outstanding voting securities.
5. The Board will review the 2021 Plan at least annually. In addition, the Board will review periodically the potential impact that the issuance of Restricted Stock under the 2021 Plan could have on the Company's earnings and NAV per share, such review to take place prior to any decisions to grant Restricted Stock under the 2021 Plan, but in no event less frequently than annually. Adequate procedures and records will be maintained to permit such review. The Board will be authorized to take appropriate steps to ensure that the issuance of Restricted Stock under the 2021 Plan will be in the best interests of the Company's shareholders. This authority will include the authority to prevent or limit the granting of additional Restricted Stock under the 2021 Plan. All records maintained pursuant to this condition will be subject to examination by the Commission and its staff.
For the Commission, by the Division of Investment Management, under delegated authority.
Pursuant to Section 19(b)(1)
Pursuant to the provisions of Section 19(b)(1) under the Act,
The text of the proposed rule change is available at 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 these statement may be examined at the places specified in Item IV below. The self-regulatory organization has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.
In light of the operational challenges that IEX Members
IEX Rule 5.110(c), Internal Inspections, requires,
On March 13, 2020 the United States declared a national emergency in response to the pandemic.
These pandemic-related operational changes have made it impracticable for Members to conduct on-site inspections of OSJs, branch offices, and non-branch locations because this compliance function requires employees of the Member to travel to geographically dispersed locations. Such travel not only has been restricted at times by government orders, but also puts the health and safety of employees at great risk of contracting and spreading COVID-19.
In recognition of the logistical challenges firms were facing at that time to satisfy their on-site inspection obligations, FINRA adopted Rule 3110.16 (Temporary Extension of Time to Complete Office Inspections), extending the time by which firms must complete their calendar year 2020 inspection obligations under FINRA Rule 3110(c) to March 31, 2021, but emphasizing that the extension of time did not relieve firms from conducting the on-site portion of the inspections of their OSJs, branch offices, and non-branch locations.
The acute health and safety concerns related to COVID-19 persist, with the number of confirmed cases of COVID-19 in the U.S. continuing to increase since March 13, 2020.
Based on feedback described in FINRA's Regulatory Notice 20-16, in comment letters submitted in response to FINRA's proposed rule changes, and discussions with industry representatives, FINRA understood that beginning in or about March 2020, many firms had suspended the on-site component of their inspections scheduled for calendar year 2020. With no certainty as to when pandemic-related health concerns and restrictions will subside, firms will have a considerable backlog of 2020 inspections. Moreover, planning on-site inspections for calendar year 2021 for OSJs, branch offices, and non-branch locations in the current environment may be impacted as well. In light of pandemic-related developments, IEX believes further sensible and tailored temporary relief is warranted for Members to meet their inspection obligations under IEX Rule 5.110(c) for calendar year 2021.
In order to proactively address these concerns and to align its Supervision rule with corresponding FINRA rules covered by its regulatory services agreement with FINRA, IEX is proposing to adopt Supplementary Material .15. As proposed, Supplementary Material .15 would provide Members, subject to specified requirements therein, the option to conduct remotely the inspections of their OSJs, branch offices, and non-branch locations for any inspections to be conducted in calendar year 2021, without the requirement to conduct an on-site visit to such office or location. As described further below, the proposed rule change would set forth the dates by which inspections for calendar year 2021 are due, the requirement to amend or supplement written supervisory procedures for remote inspections, the use of remote inspections as part of an effective supervisory system, and documentation requirements. The Exchange believes this temporary remote inspection option is a reasonable alternative to provide to Members to fulfill their IEX Rule 5.110(c) obligations during these pressing times, and is designed to achieve the investor protection objectives of the inspection requirements under these unique circumstances.
The responsibility of Members to supervise their associated persons is a critical component of broker-dealer regulation. IEX Rule 5.110(a) requires that “[e]ach Member . . . establish and maintain a system to supervise the activities of each associated person that is reasonably designed to achieve compliance with applicable securities laws and regulations, and with applicable IEX Rules . . . .” The proposed Supplementary Material is not intended to alter this core responsibility. The advent of technology and automation in the financial industry has significantly changed the way in which Members and their associated persons conduct their business, communicate, and meet their regulatory obligations. IEX recognizes that Members generally use an array of technological tools to facilitate their supervisory practices (
IEX believes that proposed Supplementary Material .15 to IEX Rule 5.110 would provide a sensibly tailored regulatory alternative for Members to fulfill their obligations under IEX Rule 5.110(c) that would not materially diminish, and is reasonably designed to achieve, the investor protection objectives of the inspection requirements under these unique circumstances. IEX further notes that the proposed relief would be limited in duration to align with the extended date set forth under FINRA Rule 3110.16 of December 31, 2021 for calendar year 2021 inspections.
Currently, IEX Rule 5.110(c)(1) provides that an inspection of an office or location must occur on a designated frequency, and the periodicity of the required inspection varies depending on the classification of the location or the nature of the activities that take place. OSJs and supervisory branch offices must be inspected at least annually (on a calendar-year basis); non-supervisory branch offices, at least every three years; and non-branch locations, on a periodic schedule at least once every three years.
Proposed Supplementary Material .15(a) would provide that a Member that is obligated to complete a 2021 inspection of an OSJ, branch office or non-branch location, pursuant to the applicable periodicity set forth under
IEX Rule 5.110(a) requires that Members establish and maintain a supervisory system that is tailored specifically to the member firm's business and addresses the activities of all its associated persons. The Rule requires that a Member's supervisory system shall include a number of elements, including “[t]he establishment and maintenance of written procedures required by this IEX Rule 5.110 . . . .” Under IEX Rule 5.110(b) (Written Procedures) a Member must establish, maintain, and enforce written procedures to supervise the types of business in which it engages and the activities of its associated persons that are reasonably designed to achieve compliance with applicable securities laws and regulations, and with applicable IEX rules.
To underscore the importance of this existing requirement in the context of remote inspections, proposed Supplementary Material .15(b) would expressly provide that consistent with a Member's obligation under Rule 5.110(b)(1), a Member that elects to conduct its calendar year 2021 inspections remotely must amend or supplement its written supervisory procedures to provide for remote inspections that are reasonably designed to assist in detecting and preventing violations of and achieving compliance with applicable securities laws and regulations, and with applicable IEX rules. As proposed by the Exchange, reasonably designed procedures for conducting remote inspection of offices or locations should include, among other things, a description of the methodology, including technologies permitted by the member, that may be used to conduct remote inspections. In addition, such procedures should include the use of other risk-based systems employed generally by the Member to identify and prioritize for review those areas that pose the greatest risk of potential violations of applicable securities laws and regulations, and of applicable IEX rules.
Internal inspections are a critical component of a Member's fundamental obligation under IEX Rule 5.110 to establish and maintain a system to supervise the activities of each associated person that is reasonably designed to achieve compliance with applicable securities laws and regulations, and with applicable IEX rules. Proposed Supplementary Material .15(c) would expressly affirm this principle that: (i) The requirement to conduct inspections of offices and locations is one part of the Member's overall ongoing obligation to have an effective supervisory system; and (ii) a Member must continue with its reviews of the activities and functions occurring at all offices and locations, whether or not such offices or locations are due for an inspection under IEX Rule 5.110(c) in a given year or the Member's election to conduct such inspections remotely. In addition, under the proposed Supplementary Material, a Member's remote inspection of an office or location, like the traditional on-site inspection, would be held to the same standards for review as set forth under IEX Rule 5.110, Supplementary Material .12 (Standards for Reasonable Review).
In general, IEX Rule 5.110(c)(2) describes the documentation requirements associated with conducting internal inspections. The rule requires a member to reduce the inspection and review conducted under IEX Rule 5.110(c)(1) to a written report and specifies how long the member must keep the report on file.
In addition, during the time that proposed Supplementary Material .15 remains in effect, IEX will closely monitor the effectiveness of remote inspections and their impacts—positive or negative—on Members' overall supervisory systems to assess whether to propose to make permanent a remote inspection option for some or all locations that would not materially diminish, and is reasonably designed to achieve, the investor protection objectives underpinning the requirement to inspect branch offices or locations in accordance with IEX Rule 5.110(c).
IEX 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 IEX can implement the proposed rule change immediately.
IEX believes that the proposed rule change is consistent with the provisions of Section 6(b)
In recognition of the impact of COVID-19 on performing on-site inspections, the proposed rule change is intended to provide firms a temporary regulatory option to conduct inspections of offices and locations remotely for
IEX 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. The proposed rule change is not designed to address any competitive issue but to align the Exchange's rules with those of FINRA, which will assist FINRA in its oversight work done pursuant to a regulatory services agreement with IEX. The proposed rule change will also provide for consistent application of the Exchange's supervision rules with those of FINRA, on which they are based. Consequently, the Exchange does not believe that the proposed change implicates competition at all.
Written comments on the proposed rule change were neither solicited nor received.
The Exchange has designated this rule filing as non-controversial under Section 19(b)(3)(A)
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 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.
You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-IEX-2021-09 and should be submitted on or before
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 the Exchange's transaction fees, at Equity 7, Section 118(e), as described further below.
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange operates on the “taker-maker” model, whereby it generally pays credits to members that take liquidity and charges fees to members that provide liquidity. Currently, the Exchange has a schedule, at Equity 7, Section 118(e), which consists of several different credits and fees for Retail Orders
Currently, the Exchange charges a fee of $0.0025 per share executed for RPI Orders that provide liquidity. The Exchange proposes to adopt a new fee of $0.0018 per share executed for RPI Orders entered by a member that (i) quotes Retail Price Improvement Orders in at least 2,500 symbols on average per day and (ii) provides liquidity through Retail Price Improvement Orders equal to or exceeding an average daily volume of 2,500,000 shares. The Exchange will continue to charge a fee of $0.0025 per share executed for all other RPI Orders that provide liquidity. The Exchange hopes that the proposed lower fee will encourage member organizations to increase liquidity providing activity on RPI Orders on the Exchange. If the proposal is effective in achieving this purpose, then the quality of the Exchange's market will improve, particularly with respect to RPI and retail orders to the benefit of all participants, especially those who submit RPI and Retail Orders.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange's proposed change to its schedule of credits and charges is reasonable in several respects. As a threshold matter, the Exchange is subject to significant competitive forces in the market for equity securities transaction services that constrain its pricing determinations in that market. The fact that this market is competitive has long been recognized by the courts. In
The Commission and the courts have repeatedly expressed their preference for competition over regulatory intervention in determining prices, products, and services in the securities markets. In Regulation NMS, while adopting a series of steps to improve the current market model, the Commission highlighted the importance of market forces in determining prices and SRO revenues and, also, recognized that current regulation of the market system “has been remarkably successful in promoting market competition in its broader forms that are most important to investors and listed companies.”
Numerous indicia demonstrate the competitive nature of this market. For example, clear substitutes to the Exchange exist in the market for equity security transaction services. The Exchange is only one of several equity venues to which market participants may direct their order flow, and it represents a small percentage of the overall market. It is also only one of several taker-maker exchanges. Competing equity exchanges offer similar tiered pricing structures to that of the Exchange, including schedules of rebates and fees that apply based upon members achieving certain volume thresholds.
Within this environment, market participants can freely and often do shift their order flow among the Exchange and competing venues in response to changes in their respective pricing schedules.
The Exchange believes it is reasonable and equitable to adopt a new $0.0018 per share executed fee for RPI Orders entered by a member that (i) quotes Retail Price Improvement Orders in at least 2,500 symbols on average per day and (ii) provides liquidity through Retail Price Improvement Orders equal to or exceeding an average daily volume of 2,500,000 shares. As discussed above, the Exchange's goal is to increase liquidity adding activity in RPI Orders on its platform. It is reasonable and equitable to address this need by
The Exchange believes that the proposal is not unfairly discriminatory. As an initial matter, the Exchange believes that nothing about its volume-based tiered pricing model is inherently unfair; instead, it is a rational pricing model that is well-established and ubiquitous in today's economy among firms in various industries—from co-branded credit cards to grocery stores to cellular telephone data plans—that use it to reward the loyalty of their best customers that provide high levels of business activity and incent other customers to increase the extent of their business activity. It is also a pricing model that the Exchange and its competitors have long employed with the assent of the Commission. It is fair because it incentivizes customer activity that increases liquidity, enhances price discovery, and improves the overall quality of the equity markets.
The Exchange intends for its proposal to improve market quality for all members that submit RPI and Retail Orders on the Exchange and by extension attract more liquidity to the market, improving market wide quality and price discovery. Although net adders of liquidity for RPI Orders will benefit most from the proposal, this result is fair insofar as increased liquidity adding activity in RPI Orders will help to improve market quality and the attractiveness of the Nasdaq BX market to all existing and prospective retail participants.
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 Exchange does not believe that its proposal will place any category of Exchange participant at a competitive disadvantage. As noted above, all member organizations of the Exchange will benefit from any increase in market activity that the proposal effectuates. Member organizations may modify their businesses so that they can meet the required thresholds and pay lower charges. Moreover, members are free to trade on other venues to the extent they believe that the fees assessed, and credits provided, are not attractive. As one can observe by looking at any market share chart, price competition between exchanges is fierce, with liquidity and market share moving freely between exchanges in reaction to fee and credit changes. The Exchange notes that the tier structure is consistent with broker-dealer fee practices as well as the other industries, as described above.
The Exchange believes that its proposed modifications to its schedule of credits and charges will not impose a burden on competition because the Exchange's execution services are completely voluntary and subject to extensive competition from the other live exchanges and from off-exchange venues, which include alternative trading systems that trade national market system stock. The Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing venues if they deem fee levels at a particular venue to be excessive, or rebate opportunities available at other venues to be more favorable. In such an environment, the Exchange must continually adjust its fees to remain competitive with other exchanges and with alternative trading systems that have been exempted from compliance with the statutory standards applicable to exchanges. Because competitors are free to modify their own fees in response, and because market participants may readily adjust their order routing practices, the Exchange believes that the degree to which fee changes in this market may impose any burden on competition is extremely limited.
The proposed charge for adding liquidity is reflective of this competition because, as a threshold issue, the Exchange is a relatively small market so its ability to burden intermarket competition is limited. In this regard, even the largest U.S. equities exchange by volume has less than 17-18% market share, which in most markets could hardly be categorized as having enough market power to burden competition. Moreover, as noted above, price competition between exchanges is fierce, with liquidity and market share moving freely between exchanges in reaction to fee and credit changes. This is in addition to free flow of order flow to and among off-exchange venues which comprised more than 40% of industry volume in recent months.
In sum, the Exchange intends for the proposed change to its fees for RPI Orders, in the aggregate, to increase member incentives to engage in the addition of liquidity on the Exchange. If the additional fee proposed herein is unattractive to market participants, it is likely that the Exchange will lose market share as a result. Accordingly, the Exchange does not believe that the proposed changes will impair the ability of members or competing order execution venues to maintain their competitive standing in the financial markets.
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.
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: (i) Necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) 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) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend Options 2, Section 4, Obligations of Market Makers. The Exchange also proposes to add a new Options 4C.
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend Options 2, Section 4, Obligations of Market Makers. The Exchange also proposes to add a new Options 4C.
The Exchange proposes to remove the following rule text from Options 2, Section 4(a), which has been in place since MRX's inception:
(1) Refrain from purchasing a call option or a put option at a price more than $0.25 below parity, although a larger amount may be appropriate considering the particular market conditions. In the case of calls, parity is measured by the bid in the underlying security, and in the case of puts, parity is measured by the offer in the underlying security.
(2) The $0.25 amount above may be increased, or the provisions of this Rule may be waived, by the Exchange on a series-by-series basis.
This proposed rule text also previously existed on Cboe Exchange, Inc. within prior Rule 8.7
The Exchange proposes to amend Options 2, Section 4(b)(4) and Options 4A, Section 12(b)(i) to centralize the bid/ask differentials. Specifically, the Exchange proposes to state within new Options 2, Section 4(b)(4)(iii) that,
Bid/ask differentials shall not apply to any options series until the time to expiration is less than nine (9) months for equity options and exchange-traded products. Bid/ask differentials shall not apply to any options series until the time to expiration is less than twelve (12) months for index options.
The Exchange proposes to relocate Supplementary Material .02 to Options 2, Section 4, concerning business continuity and disaster recovery plans, to General 2, Section 12, which is currently reserved. The Exchange proposes to title General 2, Section 12 as “Business Continuity and Disaster Recovery Plan Testing Requirements for Members Pursuant to Regulation SCI.” The rule text is being relocated without change. The Exchange proposes to relocate this rule text to harmonize MRX's rules with that of Nasdaq PHLX LLC (“Phlx”), Nasdaq BX, Inc. and The Nasdaq Stock Market LLC which all have business continuity and disaster recovery plans located within General 2, Section 12 of their respective rulebooks.
The Exchange proposes to add new Options 4C and mark it as reserved. Phlx added a 4C to its Rulebook and this rule change will harmonize MRX's Rulebook structure to Phlx's Rulebook Structure.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange's proposal to remove certain rule text from Options 2, Section 4(a) that refrains Market Makers from purchasing a call option or a put option at a price more than $0.25 below parity is consistent with the Act. The Exchange desires to remove this restriction on Market Makers which does not exist on Cboe or other Nasdaq affiliated markets.
The Exchange's proposal to amend Options 2, Section 4(b)(4)(i) and Options 4A, Section 12(b)(i) to centralize the bid/ask differentials is consistent with the Act. Currently, MRX Options 4 and Options 4A rules are incorporated by reference to ISE. The Exchange recently filed a rule change
The Exchange's proposal to relocate Supplementary Material .02 to Options 2, Section 4, concerning business continuity and disaster recovery plans, to General 2, Section 12, which is currently reserved, is consistent with the Act. This rule text will harmonize MRX's rules with that of Phlx, Nasdaq BX, Inc. and The Nasdaq Stock Market LLC which all have business continuity and disaster recovery plans located within General 2, Section 12 of their respective rulebooks.
Adding Options 4C and reserving it is a non-substantive amendment which will harmonize MRX's Rulebook structure to Phlx's Rulebook Structure.
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 Exchange's proposal to remove certain rule text from Options 2, Section 4(a) that refrains Market Makers from purchasing a call option or a put option at a price more than $0.25 below parity does not impose an undue burden on competition. The Exchange desires to remove this restriction on Market Makers which does not exist on Cboe or other Nasdaq affiliated markets.
The Exchange's proposal to amend Options 2, Section 4(b)(4) and Options 4A, Section 12(b)(i) to relocate text concerning bid/ask differentials for long-term option series does not impose an undue burden on competition. The Exchange's proposal will centralize the bid/ask differentials within new Options 2, Section 4(b)(4)(iii) and add a sentence to both Options 4, Section 8(a) and Options 4A, Section 12(b)(i) that cites to Options 2, Section 4(b)(4)(iii) for information on bid/ask differentials for the various products. The Exchange believes that this relocation will provide Primary Market Makers and Competitive Market Makers with centralized information regarding their bid/ask differential requirements.
The Exchange's proposal to relocate Supplementary Material .02 to Options 2, Section 4, concerning business continuity and disaster recovery plans, to General 2, Section 12, which is currently reserved, does not impose an undue burden on competition. This rule text will harmonize MRX's rules with that of Phlx, Nasdaq BX, Inc. and The Nasdaq Stock Market LLC which all have business continuity and disaster recovery plans located within General 2, Section 12 of their respective rulebooks.
Adding Options 4C and reserving it is a non-substantive amendment which will harmonize MRX's Rulebook structure to Phlx's Rulebook Structure.
No written comments were either solicited or 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 from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective 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 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.
2:00 p.m. on Thursday, July 1, 2021.
The meeting will be held via remote means and/or at the Commission's headquarters, 100 F Street NE, Washington, DC 20549.
This meeting will be closed to the public.
Commissioners, Counsel to the Commissioners, the Secretary to the Commission, and recording secretaries will attend the closed meeting. Certain staff members who have an interest in the matters also may be present.
In the event that the time, date, or location of this meeting changes, an announcement of the change, along with the new time, date, and/or place of the meeting will be posted on the Commission's website at
The General Counsel of the Commission, or his designee, has certified that, in his opinion, one or more of the exemptions set forth in 5 U.S.C. 552b(c)(3), (5), (6), (7), (8), 9(B) and (10) and 17 CFR 200.402(a)(3), (a)(5), (a)(6), (a)(7), (a)(8), (a)(9)(ii) and (a)(10), permit consideration of the scheduled matters at the closed meeting.
The subject matter of the closed meeting will consist of the following topics:
Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings;
Resolution of litigation claims; and
Other matters relating to examinations and enforcement proceedings.
At times, changes in Commission priorities require alterations in the scheduling of meeting agenda items that may consist of adjudicatory, examination, litigation, or regulatory matters.
For further information, please contact Vanessa A. Countryman from the Office of the Secretary at (202) 551-5400.
Pursuant to Section 19(b)(1)
The Exchange proposes to amend its Price List to extend the end of the Decommission Period from June 2021 to August 2021. The Exchange proposes to implement these changes to its Price List effective June 10, 2021.
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 purpose of this filing is to provide additional time for member organizations to finalize their transition from older to newer and more efficient Pillar technology. The Exchange is not proposing to adjust the amount of the port fees or the fees charged to offset the Exchange's continuing costs of supporting legacy ports, which will remain at the current level for all market participants.
Effective July 3, 2019, the Exchange introduced transition pricing designed to provide member organizations an extended transition period to connect to the Exchange using Pillar technology with no fee increase. Specifically, the Exchange (1) adopted a cap on monthly fees for the use of certain ports connecting to the Exchange for the billing months July 2019 through March 2020 (the “Transition Period”); (2) adopted a Decommission Extension Fee applicable for the billing months April 2020 through September 2020 (the “Decommission Period”) for legacy port connections; and (3) prorated the monthly fee for certain ports activated after July 1, 2019, effective April 1, 2020.
Effective March 2, 2020, the Exchange (1) extended the end of the Transition Period from March 2020 to August 2020 for member organizations to transition to the utilization of ports that connect to the Exchange using Pillar technology; (2) shortened the Decommission Period from six months (April 2020-September 2020) to four months (September-December 2020); (3) extended the effective date that the Exchange would prorate the monthly fee for certain ports activated on or after July 1, 2019 from April 1, 2020 to September 1, 2020; and (4) revised the fees charged for legacy port connections during the Decommission Period.
Effective August 1, 2020, the Exchange (1) extended the end of the Transition Period from August 2020 to October 2020; (2) extended the beginning of the Decommission Period from September 2020 to November 2020 and the end of the Decommission Period from December 2020 to February 2021; and (3) extended the effective date that the Exchange would prorate the monthly fee for ports activated on or after July 1, 2019 from September 1, 2020 to November 1, 2020.
Effective October 1, 2020, the Exchange (1) extended the end of the Transition Period from October 2020 to December 2020; (2) extended the beginning of the Decommission Period from November 2020 to January 2021 and the end of the Decommission Period from February 2021 to April 2021; and (3) extended the effective date that the Exchange would prorate the monthly fee for ports activated on or after July 1, 2019 from November 1, 2020 to January 1, 2021.
Effective December 1, 2020, the Exchange (1) extended the end of the Transition Period from December 2020 to February 2021; (2) extended the beginning of the Decommission Period from January 2021 to March 2021 and the end of the Decommission Period from April 2021 to June 2021; and (3) extended the effective date that the Exchange would prorate the monthly fee for ports activated on or after July 1, 2019 from January 1, 2021 to March 1, 2021.
The Exchange proposes to extend the end of the Decommission Period two months from June 2021 to August 2021 in order to allow member organizations that did not complete the transition during the Transition Period the ability to choose to continue using Phase I ports until August 2021.
The Exchange proposes to implement these changes to its Price List effective June 1, 2021.
The Exchange operates in a highly competitive market. The Commission has repeatedly expressed its preference for competition over regulatory intervention in determining prices, products, and services in the securities markets. In Regulation NMS, the Commission highlighted the importance of market forces in determining prices and SRO revenues and, also, recognized that current regulation of the market system “has been remarkably successful in promoting market competition in its broader forms that are most important to investors and listed companies.”
While Regulation NMS has enhanced competition, it has also fostered a “fragmented” market structure where trading in a single stock can occur across multiple trading centers. When multiple trading centers compete for order flow in the same stock, the Commission has recognized that “such competition can lead to the fragmentation of order flow in that stock.”
The Exchange is proposing these changes in the context of a competitive environment in which market participants can and do shift order flow, or discontinue or reduce use of certain categories of products, in response to fee changes. Because ports are used by member organizations to trade electronically on the Exchange, fees associated with ports are subject to these same competitive forces. The Exchange believes that the proposal represents a reasonable attempt to provide member organizations with additional time to finalize an orderly transition to upgraded technology.
Member organizations enter orders and order instructions, and receive information from the Exchange, by
Currently, member organizations that have not transitioned to Phase II ports and are still utilizing Phase I ports during the billing months of March 2021 through June 2021 (
The Exchange proposes that the Decommission Period would end two months later, in August 2021. As proposed, the Price List would also be amended to provide that ports using Pillar phase I protocols would no longer be available beginning September 1, 2021.
As noted above, the Exchange believes that, to the extent that member organizations do not complete the transition during the Transition Period, the proposed rule change will offer member organizations the ability to choose to continue using Phase I ports until August 2021.
The proposed changes are not otherwise intended to address any other issues, and the Exchange is not aware of any problems that member organizations would have in complying with the proposed change.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
The Exchange operates in a highly competitive market. The Commission has repeatedly expressed its preference for competition over regulatory intervention in determining prices, products, and services in the securities markets. In Regulation NMS, the Commission highlighted the importance of market forces in determining prices and SRO revenues and, also, recognized that current regulation of the market system “has been remarkably successful in promoting market competition in its broader forms that are most important to investors and listed companies.”
While Regulation NMS has enhanced competition, it has also fostered a “fragmented” market structure where trading in a single stock can occur across multiple trading centers. When multiple trading centers compete for order flow in the same stock, the Commission has recognized that “such competition can lead to the fragmentation of order flow in that stock.”
The Exchange believes that the ever-shifting market share among the exchanges from month to month demonstrates that market participants can shift order flow, or discontinue or reduce use of certain categories of products, including ports, in response to fee changes. Accordingly, the Exchange's fees, including port fees, are reasonably constrained by competitive alternatives and market participants can readily trade on competing venues if they deem pricing levels at those other venues to be more favorable.
If a particular exchange charges excessive fees for connectivity, impacted members and non-members may opt to terminate their connectivity arrangements with that exchange, and adopt a possible range of alternative strategies, including routing to the applicable exchange through another participant or market center or taking that exchange's data indirectly. Accordingly, if the Exchange charges excessive fees, it would stand to lose not only connectivity revenues but also revenues associated with the execution of orders routed to it, and, to the extent applicable, market data revenues. The Exchange believes that this competitive dynamic imposes powerful restraints on the ability of any exchange to charge unreasonable fees for connectivity.
Given this competitive environment, the proposal represents a fair and reasonable attempt to provide member organizations with additional time to finalize an orderly transition to upgraded technology. As of April 2021, 16.2% of legacy ports have not been cancelled. The pricing is designed so that these few remaining member organizations utilizing legacy ports would pay for the Exchange to continue to support their Phase I ports through August 2021.
The Exchange believes its proposal equitably allocates its fees among its market participants. The Exchange is not proposing to adjust the amount of the port fees or the fees charged fees to offset the Exchange's continuing costs of supporting legacy ports, which will remain at the current level for all market participants. Rather, the proposal would provide additional time for member organizations to transition from older to newer and more efficient Pillar technology and would charge the same fee for those few member organizations that choose not to transition to Phase II ports during the extended Transition Period.
The proposal constitutes an equitable allocation of fees because all similarly situated member organizations and other market participants that, following the transition period, choose to connect to the Exchange through the use of Phase I ports during the Decommission Period would continue to be charged the same, unchanged Decommission Extension Fee.
The Exchange believes that the proposal is not unfairly discriminatory. In the prevailing competitive environment, member organizations are free to disfavor the Exchange's pricing if they believe that alternatives offer them better value, and are free to discontinue to connect to the Exchange through its ports. As noted, the Exchange is offering upgraded connections in an effort to keep pace with changes in the industry and evolving customer needs as new technologies emerge and products continue to develop and change.
The proposal neither targets nor will it have a disparate impact on any particular category of market participant. The Exchange believes that the proposal does not permit unfair discrimination because the proposal would be applied to all similarly situated member organizations and other market participants would be charged the same rates, which will remain unchanged.
The Exchange believes that the proposal does not permit unfair discrimination because the Decommission Extension Fee would apply equally to all member organizations that require additional time to complete their transition to the Phase II ports. At any point during the Decommission Period, a member organization could cease to be subject to the Decommission Fee by expediting its transition to the new ports. The Decommission Fee would thus apply equally to all member organizations during the proposed extended Decommission Period that choose to continue to connect to the Exchange through the use of legacy ports. As noted, to the extent a member organization continues to use ports activated before July 1, 2019 to connect to the Exchange during the proposed extended Decommission Period, the Exchange believes it is fair, equitable and not unfairly discriminatory to continue to charge flat fees for such ports until such time that connection to the Exchange through the use of old ports is no longer available beginning, as proposed, on September 1, 2021.
Finally, the Exchange believes that it is subject to significant competitive forces, as described below in the Exchange's statement regarding the burden on competition.
For the foregoing reasons, the Exchange believes that the proposal is consistent with the Act.
In accordance with Section 6(b)(8) of the Act,
As noted, the no single exchange has more than 16% of the market share of executed volume of equity trades (whether excluding or including auction volume).
The Exchange is proposing these changes in the context of a competitive environment in which market participants can and do shift order flow, or discontinue or reduce use of certain categories of products, in response to fee changes. Because ports are used by member organizations to trade electronically on the Exchange, fees associated with ports are subject to these same competitive forces. The Exchange therefore believes that the proposal would not impose an undue burden on intermarket competition because the purpose of this filing is not to change the rates charged for ports or to offset the Exchange's continuing costs of supporting legacy ports but rather to provide member organizations with more time to effect an orderly transition to upgraded technology without needing to incur any additional costs.
No written comments were solicited or received with respect to the proposed rule change.
The foregoing rule change is effective upon filing pursuant to Section 19(b)(3)(A)
At any time within 60 days of the filing of such proposed rule change, the
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.
86 FR 32993, June 23, 2021.
Thursday, June 24, 2021 at 2:00 p.m.
The Closed Meeting scheduled for Thursday, June 24, 2021 at 2:00 p.m., has been cancelled.
For further information; please contact Vanessa A. Countryman from the Office of the Secretary at (202) 551-5400.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act” or “Exchange Act”)
FINRA is proposing to amend Rule 2165 (Financial Exploitation of Specified Adults) to permit member firms to: (1) Extend a temporary hold on a disbursement of funds or securities or a transaction in securities for an additional 30-business days if the member firm has reported the matter to a state regulator or agency or a court of competent jurisdiction; and (2) place a temporary hold on a securities transactions where there is a reasonable belief of financial exploitation.
The text of the proposed rule change is available on FINRA's website at
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.
The protection of senior investors is a top priority for FINRA. FINRA has prioritized protecting senior investors and addressed financial exploitation of senior investors in numerous ways, including:
• Identifying senior investor issues as an examination priority;
• Launching the dedicated FINRA Securities Helpline for Seniors®—available at 844-57-HELPS—to provide
• Creating national standards that give member firms tools—including permitting firms to place temporary holds on disbursements when they have a reasonable belief of financial exploitation and requiring firms to request information from customers about a trusted contact—to address suspected financial exploitation of senior investors and other vulnerable adults (
• Collaborating with the North American Securities Administrators Association (NASAA) and the SEC to address senior investor protection, including issuing a Senior Safe Act Fact Sheet designed to raise awareness among member firms, investment advisers and transfer agents about the Act and its immunity provisions;
• Issuing alerts and articles educating investors about important issues and highlighting risks facing senior investors;
• Conducting and funding research on senior investors and financial fraud, and engaging with national, state and grassroots partners to develop and distribute fraud prevention resources, educate consumers, and provide training for law enforcement professionals, victim advocates, and other people on the front lines of fighting financial fraud;
• Issuing
• Bringing disciplinary actions for misconduct against senior investors.
In August 2019, FINRA launched a retrospective review to assess the effectiveness and efficiency of its rules and administrative processes that help protect senior investors from financial exploitation. The retrospective review process has two phases: The assessment phase and the action phase.
In addition, FINRA obtained input from several advisory committees comprising member firms of different sizes and business models, investor protection advocates, member firms, and trade associations. FINRA also obtained the perspective of its operating departments that touch the rules and their administration. Moreover, FINRA considered examination observations and findings involving senior issues. In this regard, FINRA previously had identified as an examination priority reviewing member firms' controls regarding Rule 2165, to the extent firms anticipated using the rule's safe harbor, and Rule 4512's trusted-contact provision.
Finally, FINRA developed an anonymous survey that was distributed to all member firms in the first quarter of 2020. The purpose of the survey was to collect information in order to validate the feedback received and to provide an additional opportunity for all member firms to provide their views.
The review indicated that FINRA's steps to protect seniors have provided helpful and effective tools in the fight against financial exploitation, but it also suggested some additional tools, guidance and rule changes. In October 2020, FINRA published
Rule 2165 is the first uniform national standard for placing temporary holds on disbursements to address suspected financial exploitation.
To address these concerns, Rule 2165 provides member firms and their associated persons with a safe harbor from FINRA Rules 2010 (Standards of Commercial Honor and Principles of Trade), 2150 (Improper Use of Customers' Securities or Funds; Prohibition Against Guarantees and Sharing in Accounts) and 11870 (Customer Account Transfer Contracts) when member firms exercise discretion in placing temporary holds on disbursements of funds or securities from the accounts of specified adults consistent with the requirements of Rule 2165. FINRA encourages member firms to take advantage of the Rule 2165 safe harbor where there is a reasonable belief of customer financial exploitation.
Rule 2165 also includes important safeguards that are designed to ensure that there is not a misapplication of the rule, including the requirements that:
(1) A member firm provide notification of the hold and the reason for the hold to all parties authorized to transact business on the account, including the customer and the customer's trusted contact person no later than two business days after the date that the member firm first placed the hold;
(2) A member firm that places a hold pursuant to the rule immediately initiate an internal review of the facts and circumstances that caused the member to reasonably believe that the financial exploitation of the specified adult has occurred, is occurring, has been attempted, or will be attempted;
(3) In addition to the general supervisory and recordkeeping requirements of FINRA Rules 3110, 3120, 3130, 3150, and Rule 4510 Series, a member relying on the rule establish and maintain written supervisory procedures reasonably designed to achieve compliance with the rule, including, but not limited to, procedures related to the identification, escalation and reporting of matters related to the financial exploitation of specified adults;
(4) Any request for a hold be escalated to a supervisor, compliance department or legal department rather than allowing an associated person handling an account to independently place a hold;
(5) A member firm relying on the rule develop and document training policies or programs reasonably designed to ensure that associated persons comply with the requirements of the rule;
(6) A member firm relying on the rule retain records related to compliance with the rule, which shall be readily available to FINRA, upon request.
Importantly, a temporary hold pursuant to Rule 2165 may be placed on a particular suspicious disbursement(s) (
Temporary holds on disbursements have played a critical role in providing member firms a way to quickly respond to suspicions of financial exploitation before potentially ruinous losses occur for the customer. For example, FINRA's report for the five-year anniversary of the FINRA Securities Helpline for Seniors® highlights several matters that illustrate the positive impact of placing temporary holds on disbursements to address financial exploitation.
• $200,000 (representing approximately two-thirds of the investor's account) related to a Central Intelligence Agency (CIA) lawsuit scam;
• $10,000 in a lottery scam;
• $60,000 in a romance scam; and
• $50,000 to financial exploitation by a brother-in-law.
The retrospective review indicated that Rule 2165 has been an effective tool in the fight against financial exploitation,
Rule 2165 currently allows a member firm to place a temporary hold on a specified adult customer's account for up to 25-business days if the criteria in the rule are satisfied. More specifically, the temporary hold authorized by Rule 2165 would expire not later than 15-business days after the date that the member first placed the temporary hold on the disbursement of funds or securities, unless otherwise terminated or extended by a state regulator or agency or court of competent jurisdiction.
Retrospective Review Stakeholders and commenters to the
During exams in 2019 focusing on Rule 2165, member firms expressed to FINRA the need for additional time to conduct investigations and resolve matters.
FINRA recognizes that placing or extending a temporary hold on a disbursement is a serious step for a member and the affected customer. While FINRA recognizes that customers may be affected by temporary holds, the costs of financial exploitation can be devastating to customers, particularly older customers who rely on their savings and investments to pay their living expenses and who may not have the ability to offset a significant loss over time. Furthermore, the rule's safeguards are designed to ensure that there is not a misapplication of the rule.
To provide member firms with additional time to resolve matters and for APS agencies, state regulators and law enforcement to conduct thorough investigations, FINRA is proposing amending Rule 2165 to permit extending a temporary hold on a disbursement of funds or securities or a transaction in securities for an additional 30-business days if the member firm has reported the matter to a state regulator or agency or a court of competent jurisdiction.
In addition, Rule 2165(d) requires members to retain records related to compliance with the rule, which shall be readily available to FINRA, upon request. To evidence compliance with Rule 2165 in placing or extending a temporary hold, FINRA is proposing to require that a member firm retain records of the reason and support for any extension of a temporary hold, including information regarding any communications with or by a state regulator or agency of competent jurisdiction or a court of competent jurisdiction.
While placing a hold pursuant to Rule 2165 stops funds or securities from leaving a customer's account, the rule currently does not apply to transactions in securities.
Currently, there are 34 states with laws that allow investment advisers or broker-dealers to place some form of hold. Several Retrospective Review
While some state laws permit placing holds on transactions, FINRA is proposing to amend Rule 2165 to create the first uniform national standard for placing holds on securities transactions related to suspected financial exploitation. Under the safe harbor approach, a member firm would be permitted, but not required, to place a temporary hold on a transaction when there is a reasonable belief that the customer is being financially exploited.
FINRA recognizes that placing a temporary hold on a transaction is a serious step for a member firm and the affected customer. But FINRA also recognizes that placing a temporary hold on the underlying transaction may prevent significant negative financial consequences for the customer. These negative financial consequences can result even if a temporary hold is placed on any related disbursement of funds out of the customer's account. Moreover, as discussed above, the rule includes important safeguards designed to avoid misapplication of the rule.
Retrospective Review Stakeholders and commenters to the
As discussed in greater detail in section C
In evaluating concerns about potential misuse of Rule 2165, neither FINRA nor commenters were able to identify any reported customer complaints on Forms U4 or U5 or pursuant to Rule 4530 related to placing a temporary hold pursuant to Rule 2165. Moreover, respondents to FINRA's survey to member firms indicated that they had not reported a complaint on Form U4 or Form U5 or pursuant to Rule 4530 related to placing any temporary holds. In addition, neither FINRA nor the states have brought any disciplinary action due to misuse of Rule 2165 or any state temporary hold law.
The demonstrated and potential benefits of Rule 2165 weigh in favor of the proposed rule change. Notably, Rule 2165 has been used by member firms to address suspected financial exploitation and these temporary holds have prevented significant financial harm to customers.
Some Retrospective Review Stakeholders and commenters to the
In considering the proposed extension of Rule 2165 to securities transactions, it is notable that approximately 50% of the U.S. population lives in a state that permits broker-dealers and investment advisers to place holds on suspicious securities transactions pursuant to state law.
These state laws represent a patchwork where some customers may be afforded greater protection from financial exploitation than other customers. In contrast, Rule 2165 provides a uniform national standard for placing temporary holds when there is a reasonable belief of financial exploitation. Moreover, Rule 2165 incorporates numerous safeguards that apply to each temporary hold and that are designed to ensure that there is not a misapplication of the rule.
If the Commission approves the proposed rule change, FINRA will announce the implementation date of the proposed rule change in a
The proposed rule change is consistent with the provisions of Section 15A(b)(6) of the Act,
FINRA does not believe that the proposed rule change would result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. All member firms would be subject to the proposed rule change.
FINRA has undertaken an economic impact assessment, as set forth below, to further analyze the regulatory need for the proposed rule change, its potential economic impacts, including anticipated costs, benefits, and distributional and competitive effects, relative to the current baseline, and the alternatives FINRA considered in assessing how best to meet its regulatory objective.
FINRA is active in its efforts to protect senior investors from financial exploitation. In the context of these efforts, and with evidence of a growing trend of such exploitation,
The economic baseline for the proposed rule amendments is the current Rule 2165 and its use by member firms, as well as existing firm policies and state laws related to protecting senior investors. As discussed above, in August 2019, FINRA launched a retrospective review to assess the effectiveness and efficiency of its rules and administrative processes that help protect senior investors from financial exploitation. To conduct the assessment phase of the retrospective rule review, FINRA first sought comment in
FINRA also distributed a survey to all member firms in the first quarter of 2020, to which a subset of firms, ranging from small to large firms, responded. The purpose of the survey was to collect information and to provide member firms an additional opportunity to provide their views. The economic baseline, regarding the current application of the rule by firms and the effectiveness and efficiency of the rule, is established using the information obtained during the assessment phase.
As noted above, with respect to the use of Rule 2165 in placing a temporary hold on disbursements, of the member firms that indicated having placed a temporary hold,
With respect to the issue of placing a temporary hold on transactions, currently 20 states (with approximately half of the U.S. population) have enacted laws permitting investment advisers and broker-dealers to place temporary holds on disbursements
FINRA has analyzed the potential costs and benefits of the proposed amendments, and the different parties that are expected to be affected. FINRA has identified senior investors and member firms that serve senior investors as the main parties to be impacted by the proposed amendments.
The proposed amendments to Rule 2165 would permit extending a temporary hold for an additional 30-business days if the member firm has reported the matter to a state agency or a court of competent jurisdiction. FINRA believes that allowing an extension to the temporary hold period would provide firms additional time to resolve matters and for APS agencies, state regulators and law enforcement to conduct thorough investigations of suspected financial exploitation. Moreover, extensions may allow for greater collaboration and interaction between the member firm placing the hold and other authorities or regulators, on a local, state or national level. Customers would benefit from this extension in instances where the additional time allows for a positive identification of financial exploitation and retention of the disbursement amount within the account. Alternatively, if the additional time leads to a determination that no financial exploitation occurred, customers may incur costs from the extended delay in access to the funds.
The proposed amendments would also extend Rule 2165 to permit a member firm to place a temporary hold on a transaction in securities when the firm has a reasonable belief that the customer is being financially exploited. Twenty states, together containing approximately half of the U.S. population, already permit firms to place temporary holds on transactions. The proposed amendments would impact firms in all states by providing a safe harbor under FINRA rules for firms to place holds on transactions. The extent of the impact would vary across firms depending on their decision to take advantage of the proposed extension of Rule 2165 to
FINRA considered various alternatives to the proposed rule amendments. First, FINRA considered different possible extensions of the temporary hold period, ranging from no extension to an extension of up to 75-business days. On the one hand, a longer temporary hold period would allow member firms more time to investigate and contact the relevant parties, as well as obtain input from a state regulator, agency, or court if needed. Alternatively, an extended temporary hold period could result in increased costs to both investors and firms.
Second, FINRA considered not extending Rule 2165 to transactions, but rather keeping the temporary hold option only for disbursements. FINRA weighed the costs and benefits of doing so, as discussed above, also considering that some states already permit such a hold on transactions. Ultimately, FINRA has found the proposed amendment to expand Rule 2165 to transactions to strike an appropriate balance between regulatory burden, investor protection and investor choice.
Third, FINRA considered requiring firms to place temporary holds, for either disbursements or transactions, rather than permitting it. FINRA believes that providing firms with the discretion of placing a hold, versus a requirement, results in incentives to use the hold option in a way that ultimately benefits both the firm and its' customers.
Finally, FINRA considered extending Rule 2165 to situations where a firm has a reasonable belief that one of its customers is exhibiting signs of diminished capacity or cognitive decline, affecting the customers' ability to protect their own financial interests, without any evidence of financial exploitation. FINRA believes that the associated costs with establishing such a standard outweigh the potential benefits. Such an extension would give discretion to member firms that could directly or indirectly impede informed investor choice, with potential costs that might exceed the potential benefits from investor protection.
The proposed rule change was published for comment in
The comments and FINRA's responses are set forth in detail below.
Fourteen commenters expressed support for the
LPL supported the proposed amendments but requested that the hold period be further extended to allow for holds of up to 100-business days. Regarding the hold period in Rule 2165, FINRA has tried to strike a reasonable balance in giving member firms adequate time to investigate and contact the relevant parties, as well as seek input from a state regulator or agency or a court if needed, but also not permitting an open-ended hold period in recognition of the seriousness of placing a temporary hold. Rule 2165 would continue to permit the temporary hold to be terminated or extended by a state regulator, state agency or court of competent jurisdiction. In addition, if the proposed hold period does not provide member firms adequate time to investigate and contact the relevant parties, as well as seek input from a state regulator or agency or a court if needed, FINRA may consider extending the temporary hold period in future rulemaking.
PIABA supports enhanced protections for investors but expressed concern that member firms could misuse the proposed amendments. PIABA recommended that FINRA require in Rule 2165 that the member firm: (1) Update its written supervisory manuals to include training and review transactions suspected of elder abuse; (2) include in its retained records documentation of the firm's reasonable efforts to quickly investigate the matter; and (3) file a report with the appropriate APS agency and state regulator as soon as reasonably practical but no later than seven business days from the initial hold period.
Regarding PIABA's suggested requirements, Rule 2165 currently includes several safeguards designed to prevent misapplication of the rule, including requiring that member firms that intend to place a hold pursuant to Rule 2165 must: (1) Retain records related to the firm's internal investigation;
NASAA's letter acknowledges that neither FINRA nor the states have brought disciplinary action due to misuse of Rule 2165 or any state temporary hold laws by a member firm. However, as discussed in greater detail below, NASAA does not support extending the temporary hold period and expressed concern about the potential impact of a longer hold period on customers. FINRA's responses to NASAA's detailed concerns are included below in section C under “Hold Period” and “Transactions in Securities.”
Pittsburgh Clinic does not support current Rule 2165 or the proposed amendments because it believes that member firms could misuse temporary holds for their financial benefit. FINRA has extensively addressed the concerns of potential misuse above in section A under the “Need for the Proposed Amendments.”
Pittsburgh Clinic also said that the survey of member firms should not be relied on to assess Rule 2165 or the proposed amendments because: (1) The survey respondents are member firms that stand to benefit from an increase to the extension of the hold period, as well as the rule's safe harbor provisions; (2) the survey respondents were not required to provide any information to support their claims; and (3) the survey respondents represent an inadequate and unrepresentative sample size (the survey was provided to 3,516 member firms, of which only 238 member firms responded).
FINRA engaged in extensive internal and external stakeholder outreach during the assessment phase of the retrospective review to assess the effectiveness and efficiency of FINRA's rules and administrative processes that help protect senior investors from financial exploitation. This outreach included: (1) Seeking comment in
The purpose of the survey distributed to all member firms was to collect information in order to validate the feedback received and to provide an additional opportunity for all member firms to provide their views. There were 238 firms that responded to the survey, and the breakdown of these firm survey respondents according to firm size, as measured by the number of registered representatives, and the comparison to the general population of member firms, is provided in Table 1 below. With respect to the Pittsburgh Clinic comment letter, FINRA notes that: (1) The membership survey is one tool frequently used by FINRA in its outreach efforts to solicit information from its members; (2) the response rate mentioned is a lower bound when considering relevant member firms; and (3) the breakdown of survey respondents by firm size is mostly representative with respect to the full member firm population, as summarized in Table 1.
The majority of commenters supported the proposed amendment to extend a temporary hold for an additional 30 business days if the member firm has reported the matter to a state regulator or agency or a court of competent jurisdiction.
While NAPSA and Philadelphia Financial Exploitation Task Force previously supported a 60-business day extension in their comments to
While acknowledging that an adequate period for review of the facts and circumstances must be allowed,
NASAA believes that the current 25-business day hold period, with the authority for state regulators or agencies or the courts to terminate or extend, is the better approach as it provides time to conduct the investigation and avoids unintended hardships from lengthy delays. Moreover, NASAA supports involving state regulators or agencies or the courts within the initial 15-business day hold period specified in Rule 2165(b)(2).
Information gathered during the assessment phase of the retrospective review, including discussions during exams in 2019 focusing on Rule 2165 and a survey to FINRA membership, supports the need for additional time to conduct investigations and resolve matters. NAPSA—representing APS programs which play a critical role in investigating suspicions of financial exploitation—also expressed the need for additional time to conduct investigations. NAPSA's data that the average investigation duration of reported matters to the NAMRS is 52.6 days also highlights the need for a longer period to conduct investigations and resolve matters.
Retrospective Review Stakeholders and comments to the
To provide member firms with additional time to resolve matters and for APS agencies, state regulators and law enforcement to conduct thorough investigations, FINRA is proposing amending Rule 2165 to permit extending a temporary hold for an additional 30 business days if the member firm has reported the matter to a state agency or a court of competent jurisdiction. Extending the hold period as proposed is intended to address the complex matters that need additional time to resolve. In addition, some states mandate reporting of suspected financial exploitation by financial institutions, including broker-dealers, within a specified period of time. FINRA expects member firms to comply with all applicable state requirements, including reporting requirements.
In addition, FINRA agrees with the commenters who stressed the need for a temporary hold not to interfere with non-suspicious disbursements that are needed for the customer's expenses. A temporary hold pursuant to Rule 2165 may be placed
Commonwealth supported the proposed extension of the temporary hold period and stated that there should be some additional remedy when a matter is not resolved at the end of the hold period. As previously addressed in the rule filing to adopt Rule 2165, if a member firm is unable to resolve an issue due to circumstances beyond its control, there may be circumstances in which a member firm may extend a temporary hold after the period provided under the safe harbor.
NAPSA and the Philadelphia Financial Exploitation Task Force requested clarification on whether “a state regulator or agency of competent jurisdiction” would include state or local law enforcement. For purposes of Rule 2165, FINRA would interpret state or local law enforcement to be “a state regulator or agency of competent jurisdiction” and, accordingly, state or local law enforcement may terminate or extend a temporary hold pursuant to Rule 2165.
SIFMA noted that, depending on the jurisdiction, APS may be a state or local agency and suggested revising proposed Rule 2165(b)(4) to refer to a “state regulator, or an agency of competent jurisdiction” to more clearly cover local APS. The inclusion of “a state regulator or agency of competent jurisdiction” in proposed Rule 2165(b)(4) is consistent with the language in current Rule 2165(b)(2) and (3). For purposes of Rule 2165, FINRA would interpret state or local APS to be “a state regulator or agency of competent jurisdiction” and, accordingly, state or local APS may terminate or extend a temporary hold pursuant to Rule 2165.
The majority of commenters supported the proposed amendment to permit member firms to place a temporary hold on a securities transactions where there is a reasonable belief of financial exploitation.
In its comment to
NASAA stated that if FINRA extends Rule 2165 to permit placing holds on securities transactions, the supervision and documentation requirements under
FINRA recognizes that placing a temporary hold on a transaction is a serious step for a member and the affected customer. Requiring that a member firm make a disbursement hold the default and use transaction holds only where a disbursement hold cannot adequately protect the customer would add complexity and uncertainty into the decision to place a temporary hold as the member firm would be required to weigh the consequences to the customer of placing the hold at different stages. Moreover, placing a temporary hold on the underlying transaction may prevent significant negative financial consequences for the customer. These negative financial consequences can result even if a temporary hold is placed on any related disbursement of funds out of the customer's account.
Importantly, the ability to place a hold on a transaction pursuant to Rule 2165 would apply only if the firm had a reasonable belief that the customer was being financially exploited. As noted above, FINRA would pursue disciplinary action against a firm that uses Rule 2165 for inappropriate purposes. As discussed in
Some member firms already place holds on securities transactions pursuant to state law. As noted in section A of this filing, currently, 20 states (with approximately half of the U.S. population) have enacted laws permitting investment advisers and broker-dealers to place temporary holds on disbursements and transactions. Amending Rule 2165 as proposed would create the first uniform national standard for placing holds on transactions related to suspected financial exploitation. Moreover, extending Rule 2165 to transactions would allow for consistent, national safeguards to avoid misapplication of temporary holds.
NASAA also noted that the NASAA Model Act is limited to disbursements, in part, because a delay in a securities transaction could be deemed inconsistent with best execution requirements. Regarding whether the best execution obligation applies to a member firm's decision to place a temporary hold on a securities transaction where there is a reasonable belief of customer financial exploitation, “[b]roker-dealers are reminded that nothing under the federal securities laws or FINRA rules obligates them to accept an order where they believe that the associated compliance or legal risks are unacceptable.”
Miami Investor Rights Clinic noted that Rule 2165 is a safe harbor and that FINRA should consider amendments to Rule 2165 requiring that member firms place temporary holds. FINRA believes that a member firm using its discretion to place a temporary hold allows for the judicious use of temporary holds to protect customers from financial exploitation.
Some commenters supported extending Rule 2165 to situations where a firm has a reasonable belief that the customer has an impairment, such as diminished capacity, that renders the individual unable to protect his or her own interests, even though there is no evidence of financial exploitation.
FINRA has not proposed to extend Rule 2165 to situations where a member firm has a reasonable belief that the customer has cognitive decline or diminished capacity but there is no evidence of financial exploitation due to the concerns expressed that such an extension would give member firms too much discretion or would unfairly impede customer autonomy. Rather than rulemaking, FINRA summarized the information obtained about member firms' procedures and practices in this area in
Where a customer has not named a trusted contact person, Wells Fargo suggested that FINRA give member firms the flexibility to contact a person “reasonably associated” with the customer's account.
Under Rule 2165 as originally proposed in
NAPSA and the Philadelphia Financial Exploitation Task Force recommended that FINRA pursue efforts to promote use of trusted contact
Several commenters expressed concern that Rule 2165's safe harbor does not extend to complaints reportable on Forms U4 (Uniform Application for Securities Industry Registration or Transfer) or U5 (Uniform Termination Notice for Securities Industry Registration), or pursuant to Rule 4530 about an associated person whose actions were within the safe harbor and stated that some member firms and associated persons may choose not to place a hold pursuant to Rule 2165 because of concerns about a possible customer complaint.
As discussed in
FINRA does not currently plan to propose guidance regarding when a Rule 2165-related complaint would be reportable or develop a specific problem code for reporting any Rule 2165-related complaint to FINRA pursuant to FINRA Rule 4530. In considering whether a complaint is reportable, member firms should use the existing publicly available guidance. FINRA may reconsider this issue or develop a specified problem code for reporting any Rule 2165-related complaint to FINRA pursuant to FINRA Rule 4530 if complaints are reported in the future and they appear to have a detrimental impact on the protection of seniors and other vulnerable adults.
Cambridge supported extending the safe harbor provided by Rule 2165 to protecting member firms and registered representatives from customer actions as a result of steps taken by a member firm pursuant to Rule 2165. FINRA previously addressed this issue when adopting Rule 2165, noting that member firms today make judgments with regard to making or withholding disbursements and already face litigation risks with respect to these decisions.
Because some state temporary hold laws cover customers younger than 65 years of age, LPL suggested that FINRA amend the definition of “specified adult” in Rule 2165(a)(1) to include persons 60 years of age and older. In adopting Rule 2165, FINRA solicited feedback regarding whether the ages used in the definition of “specified adult” in proposed Rule 2165 should be modified or eliminated. As discussed in the rule filing proposing Rule 2165, some commenters suggested including an age lower than 65 and some commenters suggested including an age over 65 in the definition.
Manabat stated that FINRA rules protecting senior investors should apply to non-U.S. investors. For clarity, FINRA rules apply to U.S. and non-U.S. customers of member firms.
NAPSA and the Philadelphia Financial Exploitation Task Force recommended that investment companies, such as mutual funds, be permitted to place temporary holds. In 2018, staff in the SEC's Division of Investment Management issued a no-action letter to the Investment Company Institute stating that the staff would not recommend enforcement action if, consistent with the conditions in the letter, a transfer agent, acting on behalf of a mutual fund, temporarily delayed for more than seven days the disbursement of redemption proceeds from the mutual fund account of a specified adult held directly with the transfer agent based on a reasonable belief that financial exploitation of the specified adult has occurred, is occurring, has been attempted, or will be attempted.
If a member firm places a temporary hold, Rule 2165 requires the member to immediately initiate an internal review of the facts and circumstances that caused the member to reasonably believe that financial exploitation of the specified adult has occurred, is occurring, has been attempted or will be attempted. FSI recommended that FINRA provide additional guidance to member firms on conducting these internal reviews. FSI stated that state regulators and agencies have the appropriate expertise to conduct these types of investigations and member firms work cooperatively to provide state regulators and agencies with requested information. FSI stated that member firms have access to internal records that evidence the customer's regular trading and account disbursement activity, but firms do not want to, for example, front-run and jeopardize a criminal investigation by trying to contact and interview witnesses.
As stated in the rule filing proposing the adoption of Rule 2165, FINRA believes that the appropriate internal review will depend on the facts and circumstances of the situation.
If Rule 2165 is extended to allow for temporary holds on transactions in securities, FSI suggested that FINRA expand the application of the safe harbor provided by Rule 2165 to cover both FINRA Rule 3260 (Discretionary Accounts) and FINRA Rule 5310.01 (Execution of Marketable Customer Orders).
Rule 3260's scope and purpose are distinguishable from permitting a member firm to place a temporary hold on a transaction when there is a reasonable belief that the customer is being financially exploited. Rules 3260 addresses the creation and maintenance of discretionary accounts and requires firms to have procedures to identify and prevent excessive trading or “churning” in such accounts. Rule 3260 is intended to protect customers from the misuse of discretionary power by firms and associated persons.
In considering whether Rule 2165's safe harbor needs to be extended to address rules relating to order execution, “[b]roker-dealers are reminded that nothing under the federal securities laws or FINRA rules obligates them to accept an order where they believe that the associated compliance or legal risks are unacceptable.”
CAI requested that FINRA coordinate with state authorities and SEC on measures to address financial exploitation. FINRA has and will continue to prioritize senior investors and address financial exploitation of senior investors, including through:
• Carrying out a multi-faceted investor protection campaign through the FINRA Foundation aimed at promoting awareness about, and support for, the prevention of financial fraud and exploitation, while simultaneously empowering financial consumers to protect themselves and their loved ones, using tactics including:
○ Training law enforcement and victim advocates to detect, investigate, and assist consumers with concerns of financial fraud and exploitation in collaboration with federal and state securities regulators, APS groups, NAPSA, the National Center for Victims of Crime, the National White Collar Crime Center, and staff from FINRA's National Cause and Financial Crimes Detection Programs;
○ Engaging in consumer outreach—often in coordination with the SEC, CFPB, state securities regulators, and nonprofits such as AARP and Better Business Bureaus—to empower financial consumers to spot, avoid, and report financial fraud;
○ Conducting, supporting, and disseminating research focused on financial exploitation and fraud as well as aging and financial decision-making, which is shared with internal and external stakeholders;
○ Collaborating with Committees and Task Forces focused on issues of financial fraud and exploitation, including working with the Department of Justice's Elder Justice Initiative, serving on NAPSA's Financial Exploitation Advisory Board, serving on NASAA's Senior Issues and Diminished Capacity Committee Advisory Council, participating on various multi-disciplinary teams (MDTs) aimed at protecting and assisting vulnerable adults, and holding joint trainings with the CFPB's Office of Older Americans, and meeting periodically with state securities regulators and states' attorneys general to discuss senior investor protection issues;
• Issuing alerts and articles that educate investors about important issues and highlighting risks facing senior investors;
• Launching the dedicated FINRA Securities Helpline for Seniors®—available at (844) 57-HELPS—to provide senior investors and their family members with a supportive place to get assistance from specially trained FINRA staff related to concerns they have with their brokerage accounts and investments;
• Collaborating with NASAA and the SEC to address senior investor protection, including issuing a Senior Safe Act Fact Sheet designed to raise awareness among member firms, investment advisers and transfer agents about the Act and its immunity provisions;
• Producing and presenting on in-person and virtual panels addressing senior investor protection with the SEC, state securities regulators, NASAA, APS offices, NAPSA, FBI and other agencies; and
• Meeting with adult protective services staff in multiple states, in part through NAPSA, to increase coordination of senior investor protection efforts and highlight FINRA Rule 2165's provision that APS can direct a member firm to terminate or extend a temporary hold authorized by the Rule.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove such proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend Options 2, Section 4, Obligations of Market Makers; Options 4, Section 3, Criteria for Underlying Securities; Options 4, Section 8, Long-Term Options Contracts; and Options 4A, Section 12, Terms of Index Options Contracts.
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend Options 2, Section 4, Obligations of Market Makers; Options 4, Section 3, Criteria for Underlying Securities; Options 4, Section 8, Long-Term Options Contracts; and Options 4A, Section 12, Terms of Index Options Contracts. Each change will be described below.
The Exchange proposes to remove the following rule text from Options 2, Section 4(a), which has been in place since ISE's inception:
(1) Refrain from purchasing a call option or a put option at a price more than $0.25 below parity, although a larger amount may be appropriate considering the particular market conditions. In the case of calls, parity is measured by the bid in the underlying security, and in the case of puts, parity is measured by the offer in the underlying security.
(2) The $0.25 amount above may be increased, or the provisions of this Rule may be waived, by the Exchange on a series-by-series basis.
The Exchange proposes to amend Options 2, Section 4(b)(4) and Options 4A, Section 12(b)(i) to relocate text concerning bid/ask differentials for long-term option series. Currently, Options 4, Section 8(a) describes the bid/ask differentials for long-term options series for equity options and exchange-traded products and Options 4A, Section 12(b)(i) describes the bid/ask differentials for long-term options series for indexes. Currently, the bid/ask differentials shall not apply to any options series until the time to expiration is less than nine (9) months for equity options and exchange-traded funds as provided for within Options 4, Section 8(a). Currently, bid/ask differentials shall not apply to any options series until the time to expiration is less than twelve (12) months for index options as provided for within Options 4A, Section 12(b)(i).
The Exchange proposes to centralize the bid/ask differentials within new Options 2, Section 4(b)(4)(iii) and add a sentence to both Options 4, Section 8(a) and Options 4A, Section 12(b)(i) that cites to Options 2, Section 4(b)(4)(iii) for information on bid/ask differentials for the various products. The Exchange believes that this relocation will provide Primary Market Makers and Competitive Market Makers with centralized information regarding their bid/ask differential requirements. The Exchange is not amending the bid/ask differentials; the rule text is simply being relocated.
The Exchange proposes to relocate Supplementary Material .02 to Options 2, Section 4, concerning business continuity and disaster recovery plans, to General 2, Section 12, which is currently reserved. The Exchange proposes to title General 2, Section 12 as “Business Continuity and Disaster Recovery Plan Testing Requirements for Members Pursuant to Regulation SCI.” The rule text is being relocated without change. The Exchange proposes to relocate this rule text to harmonize ISE's rules with that of Nasdaq PHLX LLC (“Phlx”), Nasdaq BX, Inc. and The Nasdaq Stock Market LLC which all have business continuity and disaster recovery plans located within General 2, Section 12 of their respective rulebooks.
The Exchange proposes to remove the following products from Options 4, Section 3(h): The ETFS Silver Trust, the ETFS Palladium Trust, the ETFS Platinum Trust or the Sprott Physical Gold Trust. The Exchange no longer lists these products and proposes to remove them the products from its listing rules. The Exchange will file a proposal with the Commission if it determines to list these products in the future.
The Exchange proposes to amend Options 4, Section 3(h) by removing the rule text at the end of the paragraph which provides, “all of the following conditions are met.” Paragraph (h) would simply end with “provided that:” and direct market participants to subparagraphs (1) and (2). The Exchange also proposes to capitalize “the” at the beginning of Options 4, Section 3(h)(1) and remove “; and” at the end of the paragraph and instead at a period so that subparagraphs (1) and (2) are not linked, but rather read independently. Today, Options 4, Section 3(h)(1) applies to all Exchange-Traded Fund Shares. The Exchange proposes to clarify that Options 4, Section 3(h)(2) applies to only international or global Exchange-Traded Fund Shares. Specifically, the Exchange proposes to amend Options 4, Section 3(h)(2) to provide, “Exchange-Traded Fund Shares based on international or global indexes, or portfolios that include non-U.S. securities, shall meet the following criteria.” Phlx Options 4, Section 3(h) currently has similar rule text.
The Exchange proposes to amend Options 4, Section 3(h)(2)(A) to remove the phrase “for series of portfolio depositary receipts and index fund shares based on international or global indexes,”. Today, Options 4, Section 3(h), subparagraphs (h)(1)
The Exchange also proposes to amend the term “comprehensive surveillance agreement” within Options 4, Section 3(h)(2)(A)-(D) to instead provide “comprehensive surveillance sharing agreement.” This amendment will bring greater clarity to the term.
Further, the Exchange proposes to add the phrase “if not available or applicable, the Exchange-Traded Fund's” within Options 4, Section 3(h)(2)(B), (C), and (D) to clarify that when component securities are not available, the portfolio of securities upon which the Exchange-Traded Fund Share is based can be used instead. The Exchange notes that “not available” is intended for cases where the Exchange does not have access to the index components, in those cases the Exchange would look to the portfolio components. The term “not applicable” is intended if the fund is active and does not track an index and only the portfolio is available. As noted above, this rule text currently exists within Phlx Options 4, Section 3(h).
The Exchange also proposes to wordsmith Options 4, Section 3(h)(2)(B) to amend the phrase to provide, “any non-U.S. component securities of an index on which the Exchange-Traded Fund Shares are based or if not available or applicable, the Exchange-Traded Fund's portfolio of securities that are not subject to comprehensive surveillance sharing agreements do not in the aggregate represent more than 50% of the weight of the index or portfolio;”. The Exchange believes that the revised wording will bring greater clarity to the rule text.
Similarly, the Exchange proposes to wordsmith Options 4, Section 3(h)(2)(C) and (D) to relocate the phrase “on which the Exchange-Traded Fund Shares are based” and add “or portfolio” to bring greater clarity to the rule text by conforming the rule text of (C) and (D) to the language within (B).
The Exchange proposes a non-substantive technical amendment to Options 4, Section 3(C)(2)(A)(ii) to correct a typographical error by changing a “than” to a “that”. The Exchange proposes a non-substantive technical amendment to Options 4, Section 3(g)(2) to capitalize “section”. The Exchange proposes a non-substantive technical amendment to Options 4, Section 3(h)(1) to change “In” to “in”.
Finally, the Exchange proposes to add new Options 4C and mark it as reserved. Phlx added a 4C to its Rulebook and this rule change will harmonize ISE's Rulebook structure to Phlx's Rulebook Structure.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange's proposal to remove certain rule text from Options 2, Section 4(a) that refrains Market Makers from purchasing a call option or a put option at a price more than $0.25 below parity is consistent with the Act. The Exchange desires to remove this restriction on Market Makers which does not exist on Cboe or other Nasdaq affiliated markets.
The Exchange's proposal to amend Options 2, Section 4(b)(4) and Options 4A, Section 12(b)(i) to relocate text concerning bid/ask differentials for long-term option series is consistent with the Act. The Exchange's proposal will centralize the bid/ask differentials within new Options 2, Section 4(b)(4)(iii) and add a sentence to both Options 4, Section 8(a) and Options 4A, Section 12(b)(i) that cites to Options 2, Section 4(b)(4)(iii) for information on bid/ask differentials for the various products. The Exchange is not amending the bid/ask differentials; the rule text is simply being relocated. The Exchange believes that this relocation will provide Primary Market Makers and Competitive Market Makers with centralized information regarding their bid/ask differential requirements.
The Exchange's proposal to relocate Supplementary Material .02 to Options 2, Section 4, concerning business continuity and disaster recovery plans, to General 2, Section 12, which is currently reserved, is consistent with the Act. This rule text will harmonize ISE's rules with that of Phlx, Nasdaq BX, Inc. and The Nasdaq Stock Market LLC which all have business continuity and disaster recovery plans located within General 2, Section 12 of their respective rulebooks.
The Exchange's proposal to remove the following products from Options 4, Section 3(h): The ETFS Silver Trust, the ETFS Palladium Trust, the ETFS Platinum Trust or the Sprott Physical Gold Trust is consistent with the Act because the Exchange no longer lists these products and proposes to remove them the products from its listing rules. The Exchange will file a proposal with the Commission if it determines to list these products in the future.
The Exchange's proposal to amend Options 4, Section 3(h) by removing the rule text at the end of the paragraph which provides, “all of the following conditions are met,” and creating separate paragraphs for Options 4, Section 3(h)(1) and (2) is consistent with the Act. These amendments will de-link these subparagraphs so they are read independently. Today, Options 4, Section 3(h)(1) applies to all Exchange-Traded Fund Shares. The Exchange's proposal to clarify that Options 4, Section 3(h)(2) applies to only international or global indexes or portfolios that include non-U.S. securities will bring greater clarity to the qualification standards for listing options on Exchange-Traded Fund Shares. Phlx Options 4, Section 3(h) currently has similar rule text.
The Exchange's proposal to amend Options 4, Section 3(h)(2)(A) to remove the phrase “for series of portfolio depositary receipts and index fund shares based on international or global indexes,” is consistent with the Act. Today, Options 4, Section 3(h), subparagraphs (h)(1)
The Exchange's proposal to amend the term “comprehensive surveillance agreement” within Options 4, Section 3(h)(2) (A)-(D) to instead provide “comprehensive surveillance sharing agreement” is consistent with the Act as the amendment will bring greater clarity to the term.
The Exchange's proposal to add the phrase “if not available or applicable, the Exchange-Traded Fund's” to Options 4, Section 3(h)(2)(B), (C), and (D) is consistent with the Act as it will clarify that when component securities are not available, the portfolio of securities upon which the Exchange-Traded Fund Share is based can be used instead. This rule text currently exists within Phlx Options 4, Section 3(h).
The Exchange's proposal to amend and relocate the rule text within Options 4, Section 3(h)(2)(B), (C), and (D) will bring greater clarity to the current rule text by explicitly providing that the index being referenced is the one on which the Exchange-Traded Fund Shares is based. Also, adding “or portfolio” to Options 4, Section 3(h)(2)(C), and (D) will bring greater clarity to the rule text by conforming the rule text of (C) and (D) to the language within (B).
The Exchange's proposal to make certain non-substantive technical amendment to Options 4, Section 3(C)(2)(A)(ii), Options 4, Section 3(g)(2) and Options 4, Section 3(h)(1) are consistent with the Act. Also, adding Options 4C and reserving it within the rules is a non-substantive amendment which will harmonize ISE's Rulebook structure to Phlx's Rulebook Structure.
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 Exchange's proposal to remove certain rule text from Options 2, Section 4(a) that refrains Market Makers from purchasing a call option or a put option at a price more than $0.25 below parity
The Exchange's proposal to amend Options 2, Section 4(b)(4) and Options 4A, Section 12(b)(i) to relocate text concerning bid/ask differentials for long-term option series does not impose an undue burden on competition. The Exchange's proposal will centralize the bid/ask differentials within new Options 2, Section 4(b)(4)(iii) and add a sentence to both Options 4, Section 8(a) and Options 4A, Section 12(b)(i) that cites to Options 2, Section 4(b)(4)(iii) for information on bid/ask differentials for the various products. The Exchange believes that this relocation will provide Primary Market Makers and Competitive Market Makers with centralized information regarding their bid/ask differential requirements.
The Exchange's proposal to relocate Supplementary Material .02 to Options 2, Section 4, concerning business continuity and disaster recovery plans, to General 2, Section 12, which is currently reserved, does not impose an undue burden on competition. This rule text will harmonize ISE's rules with that of Phlx, Nasdaq BX, Inc. and The Nasdaq Stock Market LLC which all have business continuity and disaster recovery plans located within General 2, Section 12 of their respective rulebooks.
The Exchange's proposal to remove the following products from Options 4, Section 3(h): The ETFS Silver Trust, the ETFS Palladium Trust, the ETFS Platinum Trust or the Sprott Physical Gold Trust does not impose an undue burden on competition because the Exchange no longer lists these products and proposes to remove them the products from its listing rules. No Member will be permitted to trade these products on ISE.
The Exchange's proposal to amend Options 4, Section 3(h) by removing the rule text at the end of the paragraph which provides, “all of the following conditions are met,” and creating separate paragraphs for Options 4, Section 3(h)(1) and (2) does not impose an undue burden on competition. These amendments will de-link these subparagraphs so they are read independently. Today, Options 4, Section 3(h)(1) applies to all Exchange-Traded Fund Shares. The Exchange's proposal to clarify that Options 4, Section 3(h)(2) applies to only international or global Exchange-Traded Fund Shares that include non-U.S. securities will bring greater clarity to the qualification standards for listing options on Exchange-Traded Fund Shares. Specifically, this language is intended to serve as a guidepost and clarify that (1) subparagraph (h)(2) does not apply to an Exchange-Traded Fund Shares based on a U.S. domestic index or portfolio, and (2) subparagraph (h)(2) includes Exchange-Traded Fund Shares that track a portfolio and do not track an index. This amendment will uniformly apply the criteria within Options 4, Section 3 when it lists options products on ISE.
The Exchange's proposal to amend Options 4, Section 3(h)(2)(A) to remove the phrase “for series of portfolio depositary receipts and index fund shares based on international or global indexes,” does not impose an undue burden on competition. Today, Options 4, Section 3(h), subparagraphs (h)(1)
The Exchange's proposal to amend the term “comprehensive surveillance agreement” within Options 4, Section 3(h)(2) (A)-(D) to instead provide “comprehensive surveillance sharing agreement” does not impose an undue burden on competition as the amendment will bring greater clarity to the term.
The Exchange's proposal to add the phrase “if not available or applicable, the Exchange-Traded Fund's” to Options 4, Section 3(h)(2)(B), (C), and (D) does not impose an undue burden on competition as it will clarify that when component securities are not available, the portfolio of securities upon which the Exchange-Traded Fund Share is based can be used instead.
The Exchange's proposal to amend and relocate the rule text within Options 4, Section 3(h)(2)(B), (C), and (D) will bring greater clarity to the current rule text by explicitly providing that the index being referenced is the one on which the Exchange-Traded Fund Shares is based. Also, adding “or portfolio” to Options 4, Section 3(h)(2)(C), and (D) will bring greater clarity to the rule text by conforming the rule text of (C) and (D) to the language within (B).
The Exchange's proposal to make certain non-substantive technical amendment to Options 4, Section 3(C)(2)(A)(ii), Options 4, Section 3(g)(2) and Options 4, Section 3(h)(1) does no impose an undue burden on competition. Also, adding Options 4C and reserving it within the rules is a non-substantive amendment which will harmonize ISE's Rulebook structure to Phlx's Rulebook Structure.
No written comments were either solicited or received.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
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.
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 from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective 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 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) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend the Exchange's pricing schedule at Equity 7, Section 3, as described further below. The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend its pricing schedule, at Equity 7, Section 3, to adopt a new $0.0033 per share executed credit for member organizations that provide displayed liquidity to the Exchange and receive an execution priced at or between $1.00 and $5.00. The Exchange proposes to add this new credit and target it at securities executed at prices between $1.00 and $5.00 because the Exchange observes that, at present, liquidity in securities in this lower price segment is less robust on the Exchange than it is in other price segments.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange's proposed change to its schedule of credits is reasonable in several respects. As a threshold matter, the Exchange is subject to significant competitive forces in the market for equity securities transaction services that constrain its pricing determinations in that market. The fact that this market is competitive has long been recognized by the courts. In
The Commission and the courts have repeatedly expressed their preference for competition over regulatory intervention in determining prices, products, and services in the securities markets. In Regulation NMS, while adopting a series of steps to improve the current market model, the Commission highlighted the importance of market forces in determining prices and SRO revenues and, also, recognized that current regulation of the market system “has been remarkably successful in promoting market competition in its broader forms that are most important to investors and listed companies.”
Numerous indicia demonstrate the competitive nature of this market. For example, clear substitutes to the Exchange exist in the market for equity security transaction services. The Exchange is only one of several equity venues to which market participants may direct their order flow.
Within this environment, market participants can freely and often do shift their order flow among the Exchange and competing venues in response to changes in their respective pricing schedules.
The Exchange believes that it is reasonable and equitable to adopt a new $0.0033 per share executed credit for member organizations that provide displayed liquidity in securities that execute at prices at or between $1.00 and $5.00 per share. As discussed above, the Exchange observes a particular need to increase displayed liquidity in securities at these prices because liquidity on the Exchange in such lower priced securities is less robust than it is in other market segments. It is reasonable and equitable to address this need by allocating its limited resources to offer member organizations a credit to incent them to provide the liquidity needed. If the proposal is effective in achieving this purpose, then the quality of the Exchange's market will improve, to the benefit of all participants.
The Exchange believes that the proposal is not unfairly discriminatory. The Exchange intends for its proposal to increase displayed liquidity in securities executed at or between $1.00 and $5.00 per share, where the Exchange observes that liquidity in such lower securities is less robust than it is in other market segments. Additional liquidity is needed for the Exchange to maintain and improve its market quality. Although member organizations that are able to provide liquidity in such securities are likely to benefit directly
Although there may be value in offering credits to members that provide liquidity in securities executed at other prices, or that satisfy other criteria, the Exchange has limited resources available to it to offer its members market-improving incentives, and it allocates those limited resources to those segments of the market where it perceives the need to be greatest and/or where it determines that the incentive is likely to achieve its intended objective.
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 Exchange does not believe that its proposal will place any category of Exchange participants at a competitive disadvantage. As noted above, all member organizations of the Exchange will benefit from an increase in the addition of liquidity in securities priced at or between $1.00 and $5.00. Moreover, member organizations are free to trade on other venues to the extent they believe that the credit provided is not attractive. As one can observe by looking at any market share chart, price competition between exchanges is fierce, with liquidity and market share moving freely between exchanges in reaction to fee and credit changes.
The Exchange believes that its proposed new credit will not impose a burden on competition because the Exchange's execution services are completely voluntary and subject to extensive competition both from the other live exchanges and from off-exchange venues, which include alternative trading systems that trade national market system stock. The Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing venues if they deem fee levels at a particular venue to be excessive, or rebate opportunities available at other venues to be more favorable. In such an environment, the Exchange must continually adjust its fees to remain competitive with other exchanges and with alternative trading systems that have been exempted from compliance with the statutory standards applicable to exchanges. Because competitors are free to modify their own fees in response, and because market participants may readily adjust their order routing practices, the Exchange believes that the degree to which fee changes in this market may impose any burden on competition is extremely limited.
The proposed credit for adding liquidity is reflective of this competition because, as a threshold issue, the Exchange is a relatively small market so its ability to burden intermarket competition is limited. In this regard, even the largest U.S. equities exchange by volume only has 17-18% market share, which in most markets could hardly be categorized as having enough market power to burden competition. Moreover, as noted above, price competition between exchanges is fierce, with liquidity and market share moving freely between exchanges in reaction to fee and credit changes. This is in addition to free flow of order flow to and among off-exchange venues which comprises more than 40% of industry volume in recent months.
In sum, the Exchange intends for the proposed credit to incent member organizations to add displayed liquidity to the Exchange in securities within a certain price range, and to thereby contribute to market quality, which is reflective of fierce competition for order flow noted above; however, if the proposed credit is unattractive to market participants, it is likely that the Exchange will either fail to increase its market share or even lose market share as a result. Accordingly, the Exchange does not believe that the proposed new credit will impair the ability of member organizations or competing order execution venues to maintain their competitive standing in the financial markets.
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.
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: (i) Necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) 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) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend Options 2, Section 4, Obligations of Market Makers. The Exchange also proposes to add a new Options 4C.
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend Options 2, Section 4, Obligations of Market Makers. The Exchange also proposes to add a new Options 4C.
The Exchange proposes to remove the following rule text from Options 2, Section 4(a), which has been in place since GEMX's inception:
(1) Refrain from purchasing a call option or a put option at a price more than $0.25 below parity, although a larger amount may be appropriate considering the particular market conditions. In the case of calls, parity is measured by the bid in the underlying security, and in the case of puts, parity is measured by the offer in the underlying security.
(2) The $0.25 amount above may be increased, or the provisions of this Rule may be waived, by the Exchange on a series-by-series basis. This proposed rule text also previously existed on Cboe Exchange, Inc. within prior Rule 8.7
The Exchange proposes to amend Options 2, Section 4(b)(4) and Options 4A, Section 12(b)(i) to centralize the bid/ask differentials. Specifically, the Exchange proposes to state within new Options 2, Section 4(b)(4)(iii) that,
Bid/ask differentials shall not apply to any options series until the time to expiration is less than nine (9) months for equity options and exchange-traded products. Bid/ask differentials shall not apply to any options series until the time to expiration is less than twelve (12) months for index options.
The Exchange proposes to relocate Supplementary Material .02 to Options 2, Section 4, concerning business continuity and disaster recovery plans, to General 2, Section 12, which is currently reserved. The Exchange proposes to title General 2, Section 12 as “Business Continuity and Disaster Recovery Plan Testing Requirements for Members Pursuant to Regulation SCI.” The rule text is being relocated without change. The Exchange proposes to relocate this rule text to harmonize GEMX's rules with that of Nasdaq PHLX LLC (“Phlx”), Nasdaq BX, Inc. and The Nasdaq Stock Market LLC which all have business continuity and disaster recovery plans located within General 2, Section 12 of their respective rulebooks.
The Exchange proposes to add new Options 4C and mark it as reserved. Phlx added a 4C to its Rulebook and this rule change will harmonize GEMX's Rulebook structure to Phlx's Rulebook Structure.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange's proposal to remove certain rule text from Options 2, Section 4(a) that refrains Market Makers from purchasing a call option or a put option at a price more than $0.25 below parity is consistent with the Act. The Exchange desires to remove this restriction on Market Makers which does not exist on Cboe or other Nasdaq affiliated markets.
The Exchange's proposal to amend Options 2, Section 4(b)(4)(i) and Options 4A, Section 12(b)(i) to centralize the bid/ask differentials is consistent with the Act. Currently, GEMX Options 4 and Options 4A rules are incorporated by reference to ISE. The Exchange recently filed a rule change
The Exchange's proposal to relocate Supplementary Material .02 to Options 2, Section 4, concerning business continuity and disaster recovery plans, to General 2, Section 12, which is currently reserved, is consistent with the Act. This rule text will harmonize GEMX's rules with that of Phlx, Nasdaq BX, Inc. and The Nasdaq Stock Market LLC which all have business continuity and disaster recovery plans located within General 2, Section 12 of their respective rulebooks.
Adding Options 4C and reserving it is a non-substantive amendment which will harmonize GEMX's Rulebook structure to Phlx's Rulebook Structure.
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 Exchange's proposal to remove certain rule text from Options 2, Section 4(a) that refrains Market Makers from purchasing a call option or a put option at a price more than $0.25 below parity does not impose an undue burden on competition. The Exchange desires to remove this restriction on Market Makers which does not exist on Cboe or other Nasdaq affiliated markets.
The Exchange's proposal to amend Options 2, Section 4(b)(4) and Options 4A, Section 12(b)(i) to relocate text concerning bid/ask differentials for long-term option series does not impose an undue burden on competition. The Exchange's proposal will centralize the bid/ask differentials within new Options 2, Section 4(b)(4)(iii) and add a sentence to both Options 4, Section 8(a) and Options 4A, Section 12(b)(i) that cites to Options 2, Section 4(b)(4)(iii) for information on bid/ask differentials for the various products. The Exchange believes that this relocation will provide Primary Market Makers and Competitive Market Makers with centralized information regarding their bid/ask differential requirements.
The Exchange's proposal to relocate Supplementary Material .02 to Options 2, Section 4, concerning business continuity and disaster recovery plans, to General 2, Section 12, which is currently reserved, does not impose an undue burden on competition. This rule text will harmonize GEMX's rules with that of Phlx, Nasdaq BX, Inc. and The Nasdaq Stock Market LLC which all have business continuity and disaster recovery plans located within General 2, Section 12 of their respective rulebooks.
Adding Options 4C and reserving it is a non-substantive amendment which will harmonize GEMX's Rulebook structure to Phlx's Rulebook Structure.
No written comments were either solicited or 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 from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective 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 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.
On April 23, 2021, NYSE Arca, Inc. (“NYSE Arca”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
Section 19(b)(2) of the Act
The Commission finds that it is appropriate to designate a longer period within which to take action on the proposed rule change so that it has sufficient time to consider the proposed rule change and the comments received. Accordingly, pursuant to Section 19(b)(2) of the Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Securities and Exchange Commission.
Notice.
Notice of application for an order under sections 6(c) and 23(c)(3) of the Investment Company Act of 1940 (the “Act”) for an exemption from rule 23c-3 under the Act.
Applicants request an order under sections 6(c) and 23(c)(3) of the Act for an exemption from certain provisions of rule 23c-3 to permit certain registered closed-end investment companies to make repurchase offers on a monthly basis.
Lord Abbett Floating Rate High Income Fund (the “Fund”), Lord Abbett & Co. LLC (the “Adviser”) and Lord Abbett Distributor LLC (the “Distributor”).
The application was filed on February 21, 2020 and amended on September 11, 2020 and February 23, 2021.
An order granting the requested relief will be issued unless the Commission orders a hearing. Interested persons may request a hearing by emailing the Commission's Secretary at
The Commission:
Bruce R. MacNeil, Senior Counsel, at (202) 551-6817 or Kaitlin C. Bottock, Branch Chief, at (202) 551-6825 (Division of Investment Management, Chief Counsel's Office).
The following is a summary of the application. The complete application may be obtained via the Commission's website by searching for the file number, or for an applicant using the Company name box, at
1. The Fund is a Delaware statutory trust that is registered under the Act as a non-diversified, closed-end management investment company that will be operated as an interval fund. The Adviser is a Delaware limited liability company and is registered as an investment adviser under the Investment Advisers Act of 1940. The Adviser serves as investment adviser to the Fund. The Distributor, a New York limited liability company and subsidiary of the Adviser, is a registered broker-dealer and is the Fund's principal underwriter and distributor.
2. Applicants request that any relief granted also apply to any registered closed-end management investment company that operates as an interval fund pursuant to rule 23c-3 for which the Adviser or any entity controlling, controlled by, or under common control with the Adviser, or any successor in interest to any such entity,
3. The Fund's common shares are not offered or traded in the secondary market and are not listed on any exchange or quoted on any quotation medium.
4. Applicants request an order to permit each Fund to offer to repurchase a portion of its common shares at one-month intervals, rather than the three, six, or twelve-month intervals specified by rule 23c-3. Each Fund will disclose in its prospectus and annual reports its fundamental policy to make monthly offers to repurchase a portion of its common shares at net asset value, less deduction of a repurchase fee, if any, as permitted by rule 23c-3(b)(1).
5. Each Fund's fundamental policies will specify the means to determine the repurchase request deadline and the maximum number of days between each repurchase request deadline and the repurchase pricing date. Each Fund's repurchase pricing date normally will be the same date as the repurchase request deadline and pricing will be determined after close of business on that date.
6. Pursuant to rule 23c-3(b)(1), each Fund will repurchase shares for cash on or before the repurchase payment deadline, which will be no later than seven calendar days after the repurchase pricing date. The Fund (and any Future Fund) currently intends to make payment by the fifth business day or seventh calendar day (whichever period is shorter) following the repurchase pricing date. Each Fund will make payment for shares repurchased in the previous month's repurchase offer at least five business days before sending notification of the next repurchase offer. The Fund and a Future Fund may deduct a repurchase fee in an amount not to exceed 2% from the repurchase proceeds payable to tendering shareholders, in compliance with rule 23c-3(b)(1).
7. Each Fund will provide common shareholders with notification of each repurchase offer no less than seven days and no more than fourteen days prior to the repurchase request deadline. The notification will include all information required by rule 23c-3(b)(4)(i). Each Fund will file the notification and the Form N-23c-3 with the Commission within three business days after sending the notification to its respective common shareholders.
8. Each Fund will not suspend or postpone a repurchase offer except pursuant to the vote of a majority of its Trustees, including a majority of its Disinterested Trustees, and only under the limited circumstances specified in rule 23c-3(b)(3)(i). Each Fund will not condition a repurchase offer upon tender of any minimum amount of shares. In addition, each Fund will comply with the pro ration and other allocation requirements of rule 23c-3(b)(5) if common shareholders tender more than the repurchase offer amount. Further, each Fund will permit tenders to be withdrawn or modified at any time until the repurchase request deadline, but will not permit tenders to be withdrawn or modified thereafter.
9. From the time a Fund sends its notification to shareholders of the repurchase offer until the repurchase pricing date, a percentage of such Fund's assets equal to at least 100% of the repurchase offer amount will consist of: (a) Assets that can be sold or disposed of in the ordinary course of business at approximately the price at which such Fund has valued such investment within a period equal to the period between the repurchase request deadline and the repurchase payment deadline; or (b) assets that mature by the next repurchase payment deadline. In the event the assets of a Fund fail to comply with this requirement, the Board will cause such Fund to take such action as it deems appropriate to ensure compliance.
10. In compliance with the asset coverage requirements of section 18 of the Act, any senior security issued by, or other indebtedness of, a Fund will either mature by the next repurchase pricing date or provide for such Fund's ability to call, repay or redeem such senior security or other indebtedness by the next repurchase pricing date, either in whole or in part, without penalty or premium, as necessary to permit that Fund to complete the repurchase offer in such amounts determined by its Board.
11. The Board of each Fund will adopt written procedures to ensure that such Fund's portfolio assets are sufficiently liquid so that it can comply with its fundamental policy on repurchases and the liquidity requirements of rule 23c-3(b)(10)(i). The Board of each Fund will review the overall composition of the portfolio and make and approve such changes to the procedures as it deems necessary.
1. Section 6(c) of the Act provides that the Commission may exempt any person, security, or transaction, or any class or classes of persons, securities, or transactions, from any provision of the Act or rule thereunder, if and to the extent that such exemption is necessary or appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Act.
2. Section 23(c) of the Act provides in relevant part that no registered closed-end investment company shall purchase any securities of any class of which it is the issuer except: (a) On a securities exchange or other open market; (b) pursuant to tenders, after reasonable opportunity to submit tenders given to all holders of securities of the class to be purchased; or (c) under such other circumstances as the Commission may permit by rules and regulations or orders for the protection of investors.
3. Rule 23c-3 under the Act permits a registered closed-end investment company to make repurchase offers for its common stock at net asset value at periodic intervals pursuant to a fundamental policy of the investment company. “Periodic interval” is defined in rule 23c-3(a)(1) as an interval of three, six, or twelve months. Rule 23c-3(b)(4) requires that notification of each repurchase offer be sent to shareholders no less than 21 calendar days and no more than 42 calendar days before the repurchase request deadline.
4. Applicants request an order pursuant to sections 6(c) and 23(c) of the Act exempting them from rule 23c-3(a)(1) to the extent necessary to permit the Funds to make monthly repurchase offers. Applicants also request an
5. Applicants contend that monthly repurchase offers are in the public interest and in the common shareholders' interests and consistent with the policies underlying rule 23c-3. Applicants assert that monthly repurchase offers will provide investors with more liquidity than quarterly repurchase offers. Applicants assert that shareholders will be better able to manage their investments and plan transactions, because if they decide to forego a repurchase offer, they will only need to wait one month for the next offer. Applicants also contend that the portfolio of each Fund will be managed to provide ample liquidity for monthly repurchase offers.
6. Applicants propose to send notification to shareholders at least seven days, but no more than fourteen calendar days, in advance of a repurchase request deadline. Applicants assert that, because each Fund intends to make payment on the fifth business day or seventh calendar day (whichever period is shorter) following the repurchase pricing date, the entire procedure will be completed before the next notification is sent out to shareholders, thus avoiding any overlap. Applicants believe that these procedures will eliminate any possibility of investor confusion. Applicants also state that monthly repurchase offers will be a fundamental feature of the Funds, and their prospectuses will provide a clear explanation of the repurchase program.
7. Applicants submit that for the reasons given above the requested relief is appropriate in the public interest and is consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Act.
Applicants agree that any order granting the requested relief shall be subject to the following conditions:
1. The Fund (and any Future Fund relying on this relief) will make a repurchase offer pursuant to rule 23c-3(b) for a repurchase offer amount of not less than 5% in any one-month period. In addition, the repurchase offer amount for the then-current monthly period, plus the repurchase offer amounts for the two monthly periods immediately preceding the then-current monthly period, will not exceed 25% of the Fund's (or Future Fund's, as applicable) outstanding common shares. The Fund (and any Future Fund relying on this relief) may repurchase additional tendered common shares pursuant to rule 23c-3(b)(5) only to the extent the percentage of additional common shares so repurchased does not exceed 2% in any three-month period.
2. Payment for repurchased common shares will occur at least five business days before notification of the next repurchase offer is sent to common shareholders of the Fund (or any Future Fund relying on this relief).
For the Commission, by the Division of Investment Management, under delegated authority.
Surface Transportation Board.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the Surface Transportation Board (Board) gives notice of its intent to request from the Office of Management and Budget (OMB) approval without change of the six existing collections described below.
Comments on these information collections should be submitted by August 27, 2021.
Direct all comments to Chris Oehrle, PRA Officer, Surface Transportation Board, 395 E Street SW, Washington, DC 20423-0001, or to
Comments are requested concerning each collection as to (1) whether the particular collection of information is necessary for the proper performance of the functions of the Board, including whether the collection has practical utility; (2) the accuracy of the Board's burden estimates; (3) ways to enhance the quality, utility, and clarity of the information collected; and (4) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology, when appropriate. Submitted comments will be included and summarized in the Board's request for OMB approval.
The Board makes this submission because, under the PRA, a federal agency that conducts or sponsors a collection of information must display a currently valid OMB control number. A collection of information, which is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c), includes agency requirements that persons submit reports, keep records, or provide information to the agency, third parties, or the public. Under 44 U.S.C. 3506(c)(2)(A), federal agencies are required to provide, prior to an agency's submitting a collection to OMB for approval, a 60-day notice and comment period through publication in the
Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).
Notice of renewal of exemptions; request for comments.
FMCSA announces its decision to renew exemptions for 59 individuals from the vision requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) for interstate commercial motor vehicle (CMV) drivers. The exemptions enable these individuals to continue to operate CMVs in interstate commerce without meeting the vision requirements in one eye.
Each group of renewed exemptions were applicable on the dates stated in the discussions below and will expire on the dates stated in the discussions below. Comments must be received on or before July 28, 2021.
You may submit comments identified by the Federal Docket Management System (FDMS) Docket No. FMCSA-1998-4334, Docket No. FMCSA-2000-7918, Docket No. FMCSA-2003-14504, Docket No. FMCSA-2003-15268, Docket No. FMCSA-2004-17984, Docket No. FMCSA-2004-18885, Docket No. FMCSA-2005-20027, Docket No. FMCSA-2005-21254, Docket No. FMCSA-2006-26066, Docket No. FMCSA-2006-26653, Docket No. FMCSA-2008-0106, Docket No. FMCSA-2008-0340, Docket No. FMCSA-2009-0086, Docket No. FMCSA-2010-0385, Docket No. FMCSA-2011-0010, Docket No. FMCSA-2011-0102, Docket No. FMCSA-2012-0279, Docket No. FMCSA-2012-0337, Docket No. FMCSA-2013-0022, Docket No. FMCSA-2013-0027, Docket No. FMCSA-2013-0028, Docket No. FMCSA-2013-0029, Docket No. FMCSA-2013-0169, Docket No. FMCSA-2014-0004, Docket No. FMCSA-2014-0006, Docket No. FMCSA-2014-0008, Docket No. FMCSA-2014-0298, Docket No. FMCSA-2014-0300, Docket No. FMCSA-2014-0301, Docket No. FMCSA-2014-0304, Docket No. FMCSA-2014-0305, Docket No. FMCSA-2015-0055, Docket No. FMCSA-2015-0350, Docket No. FMCSA-2016-0024, Docket No. FMCSA-2016-0213, Docket No. FMCSA-2016-0377, Docket No. FMCSA-2017-0014, Docket No. FMCSA-2017-0019, Docket No. FMCSA-2018-0018, Docket No. FMCSA-2018-0208, Docket No. FMCSA-2018-0209, Docket No. FMCSA-2019-0004, Docket No. FMCSA-2019-0005, or Docket No. FMCSA-2019-0011 using any of the following methods:
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To avoid duplication, please use only one of these four methods. See the “Public Participation” portion of the
Ms. Christine A. Hydock, Chief, Medical Programs Division, (202) 366-4001,
If you submit a comment, please include the docket number for this notice (Docket No. FMCSA-1998-4334; FMCSA-2000-7918; FMCSA-2003-14504; FMCSA-2003-15268; FMCSA-2004-17984; FMCSA-2004-18885; FMCSA-2005-20027; FMCSA-2005-21254; FMCSA-2006-26066; FMCSA-2006-26653; FMCSA-2008-0106; FMCSA-2008-0340; FMCSA-2009-0086; FMCSA-2010-0385; FMCSA-2011-0010; FMCSA-2011-0102; FMCSA-2012-0279; FMCSA-2012-0337; FMCSA-2013-0022; FMCSA-2013-0027; FMCSA-2013-0028; FMCSA-2013-0029; FMCSA-2013-0169; FMCSA-2014-0004; FMCSA-2014-0006; FMCSA-2014-0008; FMCSA-2014-0298; FMCSA-2014-0300; FMCSA-2014-0301; FMCSA-2014-0304; FMCSA-2014-0305; FMCSA-2015-0055; FMCSA-2015-0350; FMCSA-2016-0024; FMCSA-2016-0213; FMCSA-2016-0377; FMCSA-2017-0014; FMCSA-2017-0019; FMCSA-2018-0018; FMCSA-2018-0208; FMCSA-2018-0209; FMCSA-2019-0004; FMCSA-2019-0005; FMCSA-2019-0011), indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so that FMCSA can contact you if there are questions regarding your submission.
To submit your comment online, go to
If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8
FMCSA will consider all comments and material received during the comment period.
To view comments go to
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, including any personal information the commenter provides, to
Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption from the FMCSRs for no longer than a 5-year period if it finds such exemption would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved absent such exemption. The statute also allows the Agency to renew exemptions at the end of the 5-year period. FMCSA grants medical exemptions from the FMCSRs for a 2-year period to align with the maximum duration of a driver's medical certification.
The physical qualification standard for drivers regarding vision found in 49 CFR 391.41(b)(10) states that a person is physically qualified to drive a CMV if that person has distant visual acuity of at least 20/40 (Snellen) in each eye without corrective lenses or visual acuity separately corrected to 20/40
The 59 individuals listed in this notice have requested renewal of their exemptions from the vision standard in § 391.41(b)(10), in accordance with FMCSA procedures. Accordingly, FMCSA has evaluated these applications for renewal on their merits and decided to extend each exemption for a renewable 2-year period.
Interested parties or organizations possessing information that would otherwise show that any, or all, of these drivers are not currently achieving the statutory level of safety should immediately notify FMCSA. The Agency will evaluate any adverse evidence submitted and, if safety is being compromised or if continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315(b), FMCSA will take immediate steps to revoke the exemption of a driver.
In accordance with 49 U.S.C. 31136(e) and 31315(b), each of the 59 applicants has satisfied the renewal conditions for obtaining an exemption from the vision standard (see 63 FR 66226, 64 FR 16517, 65 FR 66286, 66 FR 13825, 66 FR 17994, 68 FR 13360, 68 FR 15037, 68 FR 19598, 68 FR 33570, 68 FR 37197, 68 FR 48989, 69 FR 33997, 69 FR 53493, 69 FR 61292, 69 FR 62742, 70 FR 2701, 70 FR 12265, 70 FR 14747, 70 FR 16887, 70 FR 25878, 70 FR 30999, 70 FR 42615, 70 FR 46567, 71 FR 62148, 71 FR 63379, 72 FR 184, 72 FR 1051, 72 FR 8417, 72 FR 11425, 72 FR 11426, 72 FR 12665, 72 FR 28093, 72 FR 36099, 72 FR 40359, 72 FR 40360, 73 FR 35197, 73 FR 48275, 73 FR 61925, 73 FR 75803, 73 FR 78423, 74 FR 6209, 74 FR 8302, 74 FR 9329, 74 FR 11991, 74 FR 15586, 74 FR 19267, 74 FR 20253, 74 FR 26466, 74 FR 28094, 74 FR 34074, 74 FR 34632, 75 FR 44051, 75 FR 77492, 75 FR 77942, 75 FR 77949, 75 FR 79083, 76 FR 4413, 76 FR 5425, 76 FR 9856, 76 FR 11215, 76 FR 15360, 76 FR 17483, 76 FR 20076, 76 FR 21796, 76 FR 29022, 76 FR 29026, 76 FR 32016, 76 FR 37173, 76 FR 44082, 76 FR 44653, 76 FR 49531, 77 FR 46153, 77 FR 60008, 77 FR 68202, 77 FR 70534, 77 FR 71671, 77 FR 74734, 78 FR 797, 78 FR 800, 78 FR 9772, 78 FR 12815, 78 FR 12822, 78 FR 16035, 78 FR 16762, 78 FR 18667, 78 FR 22596, 78 FR 22602, 78 FR 24798, 78 FR 27281, 78 FR 30954, 78 FR 32703, 78 FR 34143, 78 FR 41188, 78 FR 46407, 78 FR 51268, 78 FR 52602, 78 FR 57679, 78 FR 64274, 78 FR 77778, 79 FR 4531, 79 FR 18392, 79 FR 29498, 79 FR 35212, 79 FR 41737, 79 FR 46153, 79 FR 47175, 79 FR 56102, 79 FR 65759, 79 FR 65760, 79 FR 69985, 79 FR 73686, 80 FR 603, 80 FR 2473, 80 FR 3305, 80 FR 3308, 80 FR 6162, 80 FR 8927, 80 FR 13070, 80 FR 14220, 80 FR 14223, 80 FR 15859, 80 FR 15863, 80 FR 16500, 80 FR 16502, 80 FR 18693, 80 FR 20562, 80 FR 22773, 80 FR 25766, 80 FR 25768, 80 FR 31957, 80 FR 33007, 80 FR 33011, 80 FR 36395, 80 FR 36398, 80 FR 41547, 80 FR 44185, 80 FR 44188, 80 FR 45573, 80 FR 62161, 80 FR 67481, 81 FR 14190, 81 FR 21655, 81 FR 39100, 81 FR 66718, 81 FR 80161, 81 FR 81230, 81 FR 90050, 81 FR 96165, 81 FR 96180, 82 FR 13043, 82 FR 13045, 82 FR 13048, 82 FR 13187, 82 FR 15277, 82 FR 17736, 82 FR 18949, 82 FR 18956, 82 FR 22379, 82 FR 23712, 82 FR 26224, 82 FR 32919, 82 FR 33542, 82 FR 35043, 82 FR 37499, 82 FR 47295, 83 FR 2306, 83 FR 15195, 83 FR 28325, 83 FR 34661, 83 FR 40638, 83 FR 53727, 83 FR 60954, 84 FR 2305, 84 FR 2311, 84 FR 2314, 84 FR 2323, 84 FR 2326, 84 FR 2328, 84 FR 5550, 84 FR 10389, 84 FR 12665, 84 FR 16320, 84 FR 16327, 84 FR 16336, 84 FR 21393, 84 FR 21397, 84 FR 21401, 84 FR 33801, 84 FR 47045, 84 FR 47057, 84 FR 52166). They have submitted evidence showing that the vision in the better eye continues to meet the requirement specified at § 391.41(b)(10) and that the vision impairment is stable. In addition, a review of each record of safety while driving with the respective vision deficiencies over the past 2 years indicates each applicant continues to meet the vision exemption requirements. These factors provide an adequate basis for predicting each driver's ability to continue to drive safely in interstate commerce. Therefore, FMCSA concludes that extending the exemption for each renewal applicant for a period of 2 years is likely to achieve a level of safety equal to that existing without the exemption.
In accordance with 49 U.S.C. 31136(e) and 31315(b), the following groups of drivers received renewed exemptions in the month of August and are discussed below. As of August 8, 2021, and in accordance with 49 U.S.C. 31136(e) and 31315(b), the following 51 individuals have satisfied the renewal conditions for obtaining an exemption from the vision requirement in the FMCSRs for interstate CMV drivers (63 FR 66226, 64 FR 16517, 65 FR 66286, 66 FR 13825, 66 FR 17994, 68 FR 13360, 68 FR 15037, 68 FR 19598, 68 FR 33570, 69 FR 33997, 69 FR 53493, 69 FR 61292, 69 FR 62742, 70 FR 2701, 70 FR 12265, 70 FR 14747, 70 FR 16887, 70 FR 25878, 71 FR 62148, 71 FR 63379, 72 FR 184, 72 FR 1051, 72 FR 8417, 72 FR 11425, 72 FR 11426, 72 FR 12665, 72 FR 28093, 72 FR 36099, 73 FR 35197, 73 FR 48275, 73 FR 61925, 73 FR 75803, 73 FR 78423, 74 FR 6209, 74 FR 8302, 74 FR 9329, 74 FR 11991, 74 FR 15586, 74 FR 19267, 74 FR 20253, 74 FR 26466, 74 FR 28094, 75 FR 44051, 75 FR 77492, 75 FR 77942, 75 FR 77949, 75 FR 79083, 76 FR 4413, 76 FR 5425, 76 FR 9856, 76 FR 11215, 76 FR 15360, 76 FR 17483, 76 FR 20076, 76 FR 21796, 76 FR 29022, 76 FR 29026, 76 FR 32016, 76 FR 37173, 76 FR 44082, 77 FR 46153, 77 FR 60008, 77 FR 68202, 77 FR 70534, 77 FR 71671, 77 FR 74734, 78 FR 797, 78 FR 800, 78 FR 9772, 78 FR 12815, 78 FR 12822, 78 FR 16035, 78 FR 16762, 78 FR 18667, 78 FR 22596, 78 FR 22602, 78 FR 24798, 78 FR 27281, 78 FR 30954, 78 FR 32703, 78 FR 41188, 78 FR 46407, 78 FR 51268, 78 FR 57679, 78 FR 64274, 78 FR 77778, 79 FR 18392, 79 FR 29498, 79 FR 35212, 79 FR 41737, 79 FR 46153, 79 FR 47175, 79 FR 56102, 79 FR 65759, 79 FR 65760, 79 FR 69985, 79 FR 73686, 80 FR 603, 80 FR 2473, 80 FR 3305, 80 FR 3308, 80 FR 6162, 80 FR 8927, 80 FR 13070, 80 FR 14220, 80 FR 14223, 80 FR 15859, 80 FR 15863, 80 FR 16500, 80 FR 16502, 80 FR 18693, 80 FR 20562, 80 FR 22773, 80 FR 25766, 80 FR 25768, 80 FR 31957, 80 FR 33007, 80 FR 33011, 80 FR 36395, 80 FR 36398, 80 FR 45573, 80 FR 67481, 81 FR 14190, 81 FR 21655, 81 FR 39100, 81 FR 66718, 81 FR 80161, 81 FR 81230, 81 FR 90050, 81 FR 96165, 81 FR 96180, 82 FR 13043, 82 FR 13045, 82 FR 13048, 82 FR 13187, 82 FR 15277, 82 FR 17736, 82 FR 18949, 82 FR 18956, 82 FR 22379, 82 FR 23712, 82 FR 26224, 82 FR 32919, 82 FR 33542, 82 FR 37499, 83 FR 2306, 83 FR 15195, 83 FR 28325, 83 FR 34661, 83 FR 40638, 83 FR 53727, 83 FR 60954, 84 FR 2305, 84 FR 2311, 84 FR 2314, 84 FR 2323, 84 FR 2326, 84 FR 2328, 84 FR 5550, 84 FR 10389, 84 FR 12665, 84 FR 16320, 84 FR 16327, 84 FR 16336, 84 FR 21393, 84 FR 21397, 84 FR 21401, 84 FR 47057, 84 FR 52166):
The drivers were included in docket numbers FMCSA-1998-4334, FMCSA-2000-7918, FMCSA-2003-14504, FMCSA-2004-17984, FMCSA-2004-18885, FMCSA-2005-20027, FMCSA-2006-26066, FMCSA-2006-26653, FMCSA-2008-0106, FMCSA-2008-0340, FMCSA-2009-0086, FMCSA-2010-0385, FMCSA-2011-0010, FMCSA-2011-0102, FMCSA-2012-0279, FMCSA-2012-0337, FMCSA-2013-0022, FMCSA-2013-0027, FMCSA-2013-0028, FMCSA-2013-0169, FMCSA-2014-0004, FMCSA-2014-0006, FMCSA-2014-0008, FMCSA-2014-0298, FMCSA-2014-0300, FMCSA-2014-0301, FMCSA-2014-0304, FMCSA-2014-0305, FMCSA-2015-0350, FMCSA-2016-0024, FMCSA-2016-0213, FMCSA-2016-0377, FMCSA-2017-0014, FMCSA-2018-0018, FMCSA-2018-0208, FMCSA-2018-0209, FMCSA-2019-0004, and FMCSA-2019-0005. Their exemptions are applicable as of August 8, 2021 and will expire on August 8, 2023.
As of August 10, 2021, and in accordance with 49 U.S.C. 31136(e) and 31315(b), the following individual has satisfied the renewal conditions for obtaining an exemption from the vision requirement in the FMCSRs for interstate CMV drivers (70 FR 30999, 70 FR 46567, 72 FR 40359, 74 FR 34074, 76 FR 44653, 79 FR 4531, 80 FR 41547, 82 FR 32919, 84 FR 52166):
The driver was included in docket number FMCSA-2005-21254. The exemption is applicable as of August 10, 2021 and will expire on August 10, 2023.
As of August 15, 2021, and in accordance with 49 U.S.C. 31136(e) and 31315(b), the following three individuals have satisfied the renewal conditions for obtaining an exemption from the vision requirement in the FMCSRs for interstate CMV drivers (68 FR 37197, 68 FR 48989, 70 FR 42615, 72 FR 40360, 74 FR 34632, 76 FR 49531, 79 FR 4531, 80 FR 44185, 82 FR 32919, 84 FR 33801, 84 FR 47045, 84 FR 52166):
The drivers were included in docket numbers FMCSA-2003-15268 and FMCSA-2019-0011. Their exemptions are applicable as of August 15, 2021 and will expire on August 15, 2023.
As of August 23, 2021, and in accordance with 49 U.S.C. 31136(e) and 31315(b), the following individual has satisfied the renewal conditions for obtaining an exemption from the vision requirement in the FMCSRs for interstate CMV drivers (78 FR 34143, 78 FR 52602, 82 FR 32919, 84 FR 52166):
The driver was included in docket number FMCSA-2013-0029. The exemption is applicable as of August 23, 2021 and will expire on August 23, 2023.
As of August 25, 2021, and in accordance with 49 U.S.C. 31136(e) and 31315(b), the following two individuals have satisfied the renewal conditions for obtaining an exemption from the vision requirement in the FMCSRs for interstate CMV drivers (80 FR 44188, 80 FR 62161, 82 FR 32919, 84 FR 52166):
The drivers were included in docket number FMCSA-2015-0055. Their exemptions are applicable as of August 25, 2021 and will expire on August 25, 2023.
As of August 29, 2021, and in accordance with 49 U.S.C. 31136(e) and 31315(b), the following individual has satisfied the renewal conditions for obtaining an exemption from the vision requirement in the FMCSRs for interstate CMV drivers (82 FR 35043, 82 FR 47295, 84 FR 52166):
The driver was included in docket number FMCSA-2017-0019. The exemption is applicable as of August 29, 2021 and will expire on August 29, 2023.
The exemptions are extended subject to the following conditions: (1) Each driver must undergo an annual physical examination (a) by an ophthalmologist or optometrist who attests that the vision in the better eye continues to meet the requirements in 49 CFR 391.41(b)(10), and (b) by a certified medical examiner (ME), as defined by § 390.5, who attests that the driver is otherwise physically qualified under § 391.41; (2) each driver must provide a copy of the ophthalmologist's or optometrist's report to the ME at the time of the annual medical examination; and (3) each driver must provide a copy of the annual medical certification to the employer for retention in the driver's qualification file or keep a copy of his/her driver's qualification if he/her is self-employed. The driver must also have a copy of the exemption when driving, for presentation to a duly authorized Federal, State, or local enforcement official. The exemption will be rescinded if: (1) The person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained before it was granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315(b).
During the period the exemption is in effect, no State shall enforce any law or regulation that conflicts with this exemption with respect to a person operating under the exemption.
Based upon its evaluation of the 59 exemption applications, FMCSA renews the exemptions of the aforementioned drivers from the vision requirement in § 391.41(b)(10), subject to the requirements cited above. In accordance with 49 U.S.C. 31136(e) and 31315(b), each exemption will be valid for two years unless revoked earlier by FMCSA.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Receipt of petition.
Volvo Group North America, LLC (“Volvo”), has determined that certain Model Year (MY) 2015-2021 Volvo VHA, VHD, VNL, VNM, and VNR class 8 trucks and truck-tractors do not fully comply with Federal Motor Vehicle Safety Standard (FMVSS) No. 101,
Send comments on or before July 28, 2021.
Interested persons are invited to submit written data, views, and arguments on this petition. Comments must refer to the docket and notice number cited in the title of this notice and submitted by any of the following methods:
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• Comments may also be faxed to (202) 493-2251.
Comments must be written in the English language and be no greater than 15 pages in length, although there is no limit to the length of necessary attachments to the comments. If comments are submitted in hard copy form, please ensure that two copies are provided. If you wish to receive confirmation that the comments you have submitted by mail were received, please enclose a stamped, self-addressed postcard with the comments. Note that all comments received will be posted without change to
All comments and supporting materials received before the close of business on the closing date indicated above will be filed in the docket and will be considered. All comments and supporting materials received after the closing date will also be filed and will be considered to the fullest extent possible.
When the petition is granted or denied, notice of the decision will also be published in the
All comments, background documentation, and supporting materials submitted to the docket may be viewed by anyone at the address and times given above. The documents may also be viewed on the internet at
DOT's complete Privacy Act Statement is available for review in a
Neil Dold, General Engineer, NHTSA, Office of Vehicle Safety Compliance, 202-366-7352,
Volvo has determined that certain Volvo VHA, VHD, VNL, VNM, and VNR class 8 trucks and truck-tractors, do not fully comply with the requirements of paragraph S5.2.8 of FMVSS No. 101,
This notice of receipt of Volvo's petition is published under 49 U.S.C. 30118 and 30120 and does not represent any Agency decision or other exercise of judgment concerning the merits of the petition.
Approximately 72,239 Volvo VAH, VHD, VNL, VNM, and VNR class 8 trucks and truck-tractors manufactured between December 16, 2014, and December 21, 2020, are potentially involved.
Volvo explains that the noncompliance is that the subject vehicles are equipped with a steering-wheel-mounted automatic vehicle speed system control switch (cruise control) that is not properly identified and, therefore, does not comply with paragraph S5.2.8 of FMVSS No. 101.
Paragraph S5.2.8 of FMVSS No. 101 includes the requirements relevant to this petition. Each control for an automatic vehicle speed system (cruise control) and each control for heating and air conditioning systems must have identification provided for each function of each such system.
The following views and arguments presented in this section, “V. Summary of Volvo's Petition,” are the views and arguments provided by Volvo. They have not been evaluated by the Agency and do not reflect the views of the Agency. Volvo describes the subject noncompliance and contends that the noncompliance is inconsequential as it relates to motor vehicle safety.
In support of its petition, Volvo submitted the following reasoning:
1. The cruise on and off button is just to the right of the switch in question. Considering the proximity of the switch to the cruise control on-and-off and cancel-and-resume buttons, the switch's function is self-explanatory.
2. This type of switch is commonly used for this function.
3. The function of the switch is explained in the operator's manual.
4. There are no warranty claims, consumer complaints, field reports, property damage or death and injury notices associated with the subject noncompliance.
Volvo concludes that the subject noncompliance is inconsequential as it relates to motor vehicle safety and that its petition to be exempted from providing notification of the noncompliance, as required by 49
NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and 30120(h)) that permit manufacturers to file petitions for a determination of inconsequentiality allow NHTSA to exempt manufacturers only from the duties found in sections 30118 and 30120, respectively, to notify owners, purchasers, and dealers of a defect or noncompliance and to remedy the defect or noncompliance. Therefore, any decision on this petition only applies to the subject trucks and truck-tractors that Volvo no longer controlled at the time it determined that the noncompliance existed. However, any decision on this petition does not relieve equipment distributors and dealers of the prohibitions on the sale, offer for sale, or introduction or delivery for introduction into interstate commerce of the noncompliant trucks and truck-tractors under their control after Volvo notified them that the subject noncompliance existed.
Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).
Notice of a new system of records.
In accordance with the Privacy Act of 1974, the Department of Transportation (DOT) proposes a new system of records titled “Entry-Level Driver Training Provider Registry” (TPR). This system of records will allow DOT to collect and maintain registered training provider information and entry-level driver training certification information. The information in the system will be used to establish training provider accounts, act as a central repository for entry level-driver training (ELDT) certification information and transmit that information to State Driver Licensing Agencies (SDLAs).
Comments on the system will be accepted on or before 30 days from the date of publication of this notice. The system will be effective 30 days after publication of this notice. Routine uses will be effective at that time.
You may submit comments, identified by docket number OST-2021-0037 by one of the following methods:
All submissions received must include the agency name and docket number OST-2021-0037. All comments received will be posted without change to
For general and privacy questions, please contact: Karyn Gorman, Acting Departmental Chief Privacy Officer, Department of Transportation, S-81, Washington, DC 20590, Email:
In accordance with the Privacy Act of 1974, the Department of Transportation is proposing a new system of records titled “Department of Transportation (DOT)/Federal Motor Carrier Safety Administration (FMCSA)—012, Entry-Level Driver Training Provider Registry” (TPR). This system will collect information related to registered training providers and entry level-driver training (ELDT) certification information pertaining to individual applicants for commercial driver's licenses (CDLs) or certain endorsements. The Moving Ahead for Progress in the 21st Century Act (MAP-21) requires DOT to regulate ELDT (Pub. L. 112-141, section 32304, 126 Stat. 405, 791 (July 6, 2012)). MAP-21 modified 49 U.C 31305 by adding paragraph (c), which required FMCSA to issue ELDT regulations addressing the knowledge and skills that an individual must acquire before obtaining a CDL or specified endorsement for the first time. MAP-21 also required training providers to demonstrate, by providing certification information, that the individual meets the ELDT requirements. Section 32304(a) allows the Secretary to establish the process by which a training provider must provide certification information. These ELDT regulations are currently located in 49 CFR part 380. The TPR is the tool that training providers and SDLAs will use to meet the ELDT requirements.
Training providers, as defined in 49 CFR 380.605, wishing to provide ELDT must be listed on the TPR. Training providers include, but are not limited to, training schools, educational institutions, rural electric cooperatives, motor carriers, State/local governments, school districts, joint labor management programs, owner-operators, and individuals. To be listed on the TPR, a training provider must certify that it meets the applicable eligibility requirements listed in 49 CFR 380.703(a), including completion of FMCSA's registration process. Registration is accomplished by accessing FMCSA's TPR website and electronically transmitting a completed Training Provider Registration Form (TPRF) affirming, under penalties of perjury, that the provider will teach the FMCSA-prescribed curriculum that is appropriate for the CDL class or endorsement. When a provider meets the applicable requirements, FMCSA will issue the provider a unique TPR number and, as applicable, add the provider's information to the TPR website. The information maintained in the system of records on training providers, some of whom are individuals, includes, but is not limited to, the training entity's legal name, location, phone number, website address, and the type of ELDT offered. Except as noted below, this information will be located on the publicly available portion of the TPR website, which will allow driver-trainees to locate and contact registered training providers. In addition, FMCSA may use the training providers' contact information to communicate with them regarding their registration information on the TPR, or to initiate an audit or investigation of the training provider pursuant to 49 CFR 380.703(a)(6) and 380.719(a)(5). FMCSA acknowledges that some training providers, including those who provide ELDT only for their own employees or prospective employees, may wish to keep their contact information private and therefore not have it publicly displayed on the TPR website. Accordingly, training providers who do not intend to make their services available to all driver-trainee applicants can elect not to include their contact information in the public listing that appears on the TPR website; however, these training providers will be publicly identified by name, city, and State. This option will be made available at the time of initial registration and can be changed anytime the provider so chooses.
The system of records will also serve as a central repository of driver-trainee ELDT certification information.
Each ELDT training provider is responsible for collecting certain information from its driver trainees, to include the driver-trainee's name, permit or driver license number, State of licensure, license class and/or endorsements, the type of training completed (
The Department is proposing three routine uses for this system of records tied directly to the purpose of the system. The first routine use would allow the provision of the training provider's legal name, location, phone number, website address, and the type of ELDT offered, to members of the public to allow entry-level drivers the necessary information to locate a provider in his or her locality. The second proposed routine use would allow the transmission of a driver's ELDT certification information in response to mandatory queries made by SDLAs (and third-party skills testers authorized by the SDLA) prior to conducting the applicable skills test. This routine use will allow CDL skills examiners to verify the driver's eligibility to take the required test(s) as outlined in the ELDT regulations. The third proposed routine use would allow the transmission of a driver's ELDT certification information in response to mandatory queries made by SDLAs prior to conducting the knowledge test for the H endorsement. This routine use will allow SDLAs to verify the driver's eligibility to take the test.
FMCSA has also included DOT General Routine Uses, to the extent they are compatible with the purposes of this System. As recognized by the Office of Management and Budget (OMB) in its Privacy Act Implementation Guidance and Responsibilities (65 FR 19746 (July 9, 1975)), the routine uses include proper and necessary uses of information in the system, even if such uses occur infrequently. FMCSA has included in this notice routine uses for disclosures to law enforcement when the record, on its face, indicates a violation of law, to DOJ for litigation purposes, or when necessary in investigating or responding to a breach of this system or other agencies' systems. DOT may disclose to Federal, State, local, or foreign agency information relevant to law enforcement, litigation, and proceedings before any court or adjudicative or administrative body. OMB has long recognized that these types of routine uses are “proper and necessary” uses of information and qualify as compatible with agency systems (65 FR 19476, April 11, 2000). In addition, OMB Memorandum M-17-12, directed agencies to include routine uses that will permit sharing of information when needed to investigate, respond to, and mitigate a breach of a Federal information system. DOT also has included routine uses that permit sharing with the National Archives and Records Administration when necessary for an inspection, to any federal government agency engaged in audit or oversight related to this system, or when DOT determines that the disclosure will detect, prevent, or mitigate terrorism activity. These types of disclosures are necessary and proper uses of information in this system because they further DOT's obligation to fulfil its records management and program management responsibilities by facilitating accountability to agencies charged with oversight in these areas, and DOT's obligation under Intelligence Reform and Terrorism Prevention Act of 2004, Public Law 108-456, and Executive Order 13388 (Oct. 25, 2005) to share information necessary and relevant to detect, prevent, disrupt, preempt, or mitigate the effects of terrorist activities against the territory, people, and interests of the United States.
The Privacy Act (5 U.S.C. 552a) governs the means by which the federal government agencies collect, maintain, use, and disseminate individuals' records. The Privacy Act applies to information that is maintained in a “system of records.” A “system of records” is a group of any records under the control of an agency from which information is retrieved by the name of an individual or by some identifying number, symbol, or other identifying particular assigned to the individual. The Privacy Act extends rights and protections to individuals who are U.S. citizens and lawful permanent residents. Additionally, the Judicial Redress Act (JRA) provides a covered person with a statutory right to make requests for access and amendment to covered records, as defined by the JRA, along with judicial review for denials of such requests. In addition, the JRA prohibits disclosures of covered records, except as otherwise permitted by the Privacy Act.
Below is the description of the Training Provider Registry System of Records. In accordance with
DOT/FMCSA 012—Entry-Level Driver Training Provider Registry (TPR).
Unclassified.
Records are maintained in a FedRAMP-certified third-party cloud environment. The contracts are maintained by DOT at 1200 New Jersey Avenue SE, Washington, DC 20590.
System Manager, Commercial Driver License Division, Office of Safety Programs, FMCSA, U.S. Department of Transportation, 1200 New Jersey Avenue SE, Washington, DC 20590.
Moving Ahead for Progress in the 21st Century Act (MAP-21) (Pub. L. 112-141, section 32304, 126 Stat. 405, 791 (July 6, 2012)).
The purpose of the system is to (1) collect and maintain information on training providers listed on the TPR; (2) collect and maintain certification
Categories of individuals within this system include: Entry-level drivers and training providers operating as individuals (
Categories of records in the system include:
Training Provider Information:
ELDT Certification Information:
Training providers submit both records about themselves and of driver-trainees who complete required entry-level driver training.
In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act, all or a portion of the records or information contained in this system may be disclosed outside DOT as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:
1. To the public, the training provider's legal name, location, phone number, website address, and the type of ELDT offered to allow entry-level drivers the necessary information to locate a provider in his or her locality.
2. To SDLAs, including third-party skills test examiners authorized by the State, the driver's training record, for verification that an applicant seeking a Class A or Class B CDL, and/or a P or S endorsement, has completed the required ELDT before administering requisite skills test(s) to the individual.
3. To SDLAs, the driver's training record, for verification that an applicant seeking a H endorsement has completed the required ELDT before administering the knowledge test for that endorsement.
1. In the event that a system of records maintained by DOT to carry out its functions indicates a violation or potential violation of law, whether civil, criminal or regulatory in nature, and whether arising by general statute or particular program pursuant thereto, the relevant records in the system of records may be referred, as a routine use, to the appropriate agency, whether Federal, State, local or foreign, charged with the responsibility of investigating or prosecuting such violation or charged with enforcing or implementing the statute, or rule, regulation, or order issued pursuant thereto.
2a. Routine Use for Disclosure for Use in Litigation. It shall be a routine use of the records in this system of records to disclose them to the Department of Justice or other federal agency conducting litigation when—(a) DOT, or any agency thereof, or (b) Any employee of DOT or any agency thereof, in his/her official capacity, or (c) Any employee of DOT or any agency thereof, in his/her individual capacity where the Department of Justice has agreed to represent the employee, or (d) The United States or any agency thereof, where DOT determines that litigation is likely to affect the United States, is a party to litigation or has an interest in such litigation, and the use of such records by the Department of Justice or other federal agency conducting the litigation is deemed by DOT to be relevant and necessary in the litigation, provided, however, that in each case, DOT determines that disclosure of the records in the litigation is a use of the information contained in the records that is compatible with the purpose for which the records were collected.
2b. Routine Use for Agency Disclosure in Other Proceedings. It shall be a routine use of records in this system to disclose them in proceedings before any court or adjudicative or administrative body before which DOT or any agency thereof, appears, when—(a) DOT, or any agency thereof, or (b) Any employee of DOT or any agency thereof in his/her official capacity, or (c) Any employee of DOT or any agency thereof in his/her individual capacity where DOT has agreed to represent the employee, or (d) The United States or any agency thereof, where DOT determines that the proceeding is likely to affect the United States, is a party to the proceeding or has an interest in such proceeding, and DOT determines that use of such records is relevant and necessary in the proceeding, provided, however, that in each case, DOT determines that disclosure of the records in the proceeding is a use of the information contained in the records that is compatible with the purpose for which the records were collected.
3. Disclosure may be made to a Congressional office from the record of an individual in response to an inquiry from the Congressional office made at the request of that individual. In such cases, however, the Congressional office does not have greater rights to records than the individual. Thus, the disclosure may be withheld from delivery to the individual where the file contains investigative or actual information or other materials which are being used, or are expected to be used, to support prosecution or fines against the individual for violations of a statute, or of regulations of the Department based on statutory authority. No such limitations apply to records requested for Congressional oversight or legislative purposes; release is authorized under 49 CFR 10.35(9).
4. One or more records from a system of records may be disclosed routinely to the National Archives and Records Administration (NARA) in records management inspections being conducted under the authority of 44 U.S.C. 2904 and 2906.
5. DOT may make available to another agency or instrumentality of any government jurisdiction, including State and local governments, listings of names from any system of records in DOT for use in law enforcement activities, either civil or criminal, or to expose fraudulent claims, regardless of the stated purpose for the collection of the information in the system of records. These enforcement activities are generally referred to as matching programs because two lists of names are checked for match using automated assistance. This routine use is advisory in nature and does not offer unrestricted access to systems of records for such law enforcement and related antifraud activities. Each request will be
6. DOT may disclose records from this system, as a routine use, to appropriate agencies, entities, and persons when (1) DOT suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (2) DOT has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by DOT or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with DOT's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
7. DOT may disclose records from this system, as a routine use, to the Office of Government Information Services for the purpose of (a) resolving disputes between FOIA requesters and federal agencies and (b) reviewing agencies' policies, procedures, and compliance in order to recommend policy changes to Congress and the President.
8. DOT may disclose records from the system, as a routine use, to contractors and their agents, experts, consultants, and others performing or working on a contract, service, cooperative agreement, or other assignment for DOT, when necessary to accomplish an agency function related to this system of records.
9. DOT may disclose records from this system, as a routine use, to an agency, organization, or individual for the purpose of performing audit or oversight operations related to this system of records, but only such records as are necessary and relevant to the audit or oversight activity. This routine use does not apply to intra-agency sharing authorized under Section (b)(1) of the Privacy Act.
10. DOT may disclose from this system, as a routine use, records consisting of, or relating to, terrorism information (6 U.S.C. 485(a)(5)), homeland security information (6 U.S.C. 482(f)(1)), or Law enforcement information (Guideline 2 Report attached to White House Memorandum, “Information Sharing Environment”, November 22, 2006) to a Federal, State, local, tribal, territorial, foreign government and/or multinational agency, either in response to its request or upon the initiative of the Component, for purposes of sharing such information as is necessary and relevant for the agencies to detect, prevent, disrupt, preempt, and mitigate the effects of terrorist activities against the territory, people, and interests of the United States of America, as contemplated by the Intelligence Reform and Terrorism Prevention Act of 2004 (Pub. L. 108-458) and Executive Order 13388 (October 25, 2005).
Records in this system are stored electronically on a contractor-maintained cloud storage service.
Records of training providers may be retrieved by the following data elements: Training provider's name, location, city, state, type of CDL training offered, and training provider number. Records of driver-trainees may be retrieved by the following data elements: CDL holder's name, license number, and commercial learner's permit number.
FMCSA proposes to maintain training records of individual drivers for 60 years or until notified that the driver is deceased. This retention period is consistent with other CDL driver records maintained by SDLAs. FMCSA proposes to maintain training provider registration information for 60 years. This retention period is consistent with the proposed record scheduled for training records of individuals and allows FMCSA to maintain a complete and accurate history. The records schedule for the TPR records is currently being developed and will be submitted for approval by the National Archives and Records Administration (NARA). All records maintained in the system of records will not be disposed of and will be treated as permanent records until the schedule is approved by NARA.
Records in this system are safeguarded in accordance with applicable rules and policies, including all applicable DOT automated systems security and access policies. Appropriate controls have been imposed to minimize the risk of compromising the information that is being stored and ensuring confidentiality of communications using tools such as encryption, authentication of sending parties, and compartmentalizing databases; and employing auditing software. TPR data is encrypted at rest and in transit. Access to records in this system is limited to those individuals who have a need to know the information for the performance of their official duties and who have appropriate clearances or permissions. All personnel with access to data are screened through background investigations commensurate with the level of access required to perform their duties.
Individuals seeking access to and notification of any record contained in this system of records, or seeking to contest its content, may submit a request to the System Manager in writing in writing to the address provided under “System Manager and Address.” Individuals may also search the public docket at
When seeking records about yourself from this system of records or any other Departmental system of records your request must conform with the Privacy Act regulations set forth in 49 CFR part 10. You must sign your request, and your signature must either be notarized or submitted under 28 U.S.C. 1746, a law that permits statements to be made under penalty of perjury as a substitute for notarization. While no specific form is required, you should provide the following:
• An explanation of why you believe the Department would have information on you;
• Identify which component(s) of the Department you believe may have the information about you;
• Specify when you believe the records would have been created;
• Provide any other information that will help the FOIA staff determine which DOT component agency may have responsive records; and
If your request is seeking records pertaining to another living individual, you must include a statement from that individual certifying his/her agreement for you to access his/her records. Without this bulleted information, the Department may not be able to conduct an effective search, and your request may be denied due to lack of specificity or lack of compliance with applicable regulations.
FMCSA depends upon training providers to submit data as accurately as possible. If a driver finds inaccurate information pertaining to ELDT Certification Information in the TPR, or inaccurate information was transmitted to the SDLA, drivers must contact the training provider that conducted the training to request that corrections be submitted to the TRP as appropriate. Once the corrections have been made, the training provider should resubmit the Training Certification Information form to the TPR, noting the corrections made. Upon receipt of the updated certification, the TPR will automatically retain a record of the information. In the event the driver-trainee wishes to obtain the revised training certification information, they will need to contact the training provider that conducted the training.
If a training provider discovers that information contained in the TPR is inaccurate, the training provider may make corrections by accessing their TPR account on the TPR and submitting an updated Training Provider Registration form (OMB Control number 2126-0028).
Individuals seeking to contest the content of any record pertaining to him or her in this system may also contact the System Manager following the Privacy Act procedures in 49 CFR part 10, subpart E, Correction of Records. Written requests for correction must conform with the Privacy Act regulations set forth in 49 CFR part 10. You must sign your request, and your signature must either be notarized or submitted under 28 U.S.C. 1746, a law that permits statements to be made under penalty of perjury as a substitute for notarization. While no specific form is required, you may obtain forms for this purpose from the FMCSA Freedom of Information Act Officer
Individuals seeking to contest the content of any record pertaining to him or her in the system may contact the System Manager following the procedures described in “Record Access Procedures” above.
None.
None.
Issued in Washington, DC.
Departmental Offices, U.S. Department of the Treasury.
Notice.
The Department of the Treasury will submit the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on this request.
Comments must be received on or before July 28, 2021.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Copies of the submissions may be obtained from Molly Stasko by emailing
The reports covered by this information collection will be reviewed by the U.S. Department of the Treasury and may be used for compliance, civil penalty, and enforcement purposes by the agency.
44 U.S.C. 3501
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Benefits Administration, 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
Maribel Aponte, Office of Enterprise and Integration, Data Governance Analytics (008), 1717 H Street NW, Washington, DC 20006, (202) 266-4688 or email
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.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Benefits Administration (VBA), 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
Maribel Aponte, Office of Enterprise and Integration, Data Governance Analytics (008), 1717 H Street NW, Washington, DC 20006, (202) 266-4688 or email
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.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Benefits Administration, 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
Maribel Aponte, Office of Enterprise and Integration, Data Governance Analytics (008), 1717 H Street NW, Washington, DC 20006, (202) 266-4688 or email
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.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Insert Administration name, 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
Maribel Aponte, Office of Enterprise and Integration, Data Governance Analytics (008), 1717 H Street NW, Washington, DC 20006, (202) 266-4688 or email
The
By direction of the Secretary.