Forest Service
Economic Development Administration
International Trade Administration
National Oceanic and Atmospheric Administration
Federal Energy Regulatory Commission
Agency for Healthcare Research and Quality
Centers for Disease Control and Prevention
Children and Families Administration
Food and Drug Administration
Indian Health Service
National Institutes of Health
Coast Guard
Fish and Wildlife Service
Land Management Bureau
Drug Enforcement Administration
National Endowment for the Humanities
Federal Aviation Administration
Federal Railroad Administration
Pipeline and Hazardous Materials Safety Administration
Comptroller of the Currency
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
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Federal Deposit Insurance Corporation.
Correcting amendments.
The Federal Deposit Insurance Corporation (FDIC) published a document in the
Effective August 12, 2022.
Alys V. Brown, Attorney, Legal Division, 202-898-3565,
This document augments the corrections to parts 338 (Fair Housing) and 343 (Consumer Protection in Sales of Insurance) that the FDIC published in the
Aged, Banks, banking, Civil rights, Credit, Fair housing, Individuals with disabilities, Marital status discrimination, Mortgages, Religious discrimination, Reporting and recordkeeping requirements, Savings associations, Sex discrimination, Signs and symbols.
Banks, banking, Consumer protection, Insurance, Savings associations.
For the reasons stated in the preamble, the FDIC corrects 12 CFR parts 338 and 343 by making the following correcting amendments:
12 U.S.C. 1817, 1818, 1819, 1820(b), 2801
12 U.S.C. 1819 (Seventh and Tenth); 12 U.S.C. 1831x.
Federal Aviation Administration (FAA), DOT.
Final rule; correction.
This action corrects a final rule published by the FAA in the
Effective date 0901 UTC, September 8, 2022. The Director of the Federal Register approves this incorporation by reference action under 1 CFR part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.
FAA Order 7400.11F, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
Colby Abbott, Rules and Regulations Group, Office of Policy, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783.
The FAA published a final rule (87 FR 38916; June 30, 2022), amending Jet Routes J-19, J-20, J-52, J-98, J-134, and J-231, RNAV route Q-176, and VHF Omnidirectional Range (VOR) Federal airways V-210, V-234, V-350, and V-507; and establishing RNAV routes T-418 and T-431 due to the planned decommissioning of the VOR portion of the Liberal, KS (LBL), VOR/Tactical Air Navigation (VORTAC) navigational aid (NAVAID). Subsequent to publication, the FAA determined that the KENTO, NM, route point was inadvertently identified as a WP, in error. This rule corrects that error by changing all references to the KENTO, NM, WP to the KENTO, NM, Fix. This is an editorial change only to match the FAA's aeronautical database information and does not alter the alignment of the affected Air Traffic Service (ATS) routes, Q-176 and T-431.
Jet Routes are published in paragraph 2004, RNAV Q-routes are published in paragraph 2006, VOR Federal airways are published in paragraph 6010(a), and United States RNAV T-routes are published in paragraph 6011 of FAA Order JO 7400.11F, dated August 10, 2021, and effective September 15, 2021, which is incorporated by reference in 14 CFR 71.1. The ATS routes listed in this document will be published subsequently in FAA Order JO 7400.11.
Accordingly, pursuant to the authority delegated to me, all references to the KENTO, NM, WP reflected in Docket No. FAA-2022-0025, as published in the
1. In FR Doc. 2022-13844, appearing on page 38917, in the first column, at line 19, correct “KENTO, NM, WP” to read “KENTO, NM, Fix.”
2. In FR Doc. 2022-13844, appearing on page 38918, in the first column, at line 10, correct “KENTO, NM, WP” to read “KENTO, NM, Fix.”
3. In FR Doc. 2022-13844, appearing on page 38918, in the third column, at lines 53, correct “KENTO, NM, WP” to read “KENTO, NM, FIX.”
4. In FR Doc. 2022-13844, appearing on page 38919, in the third column, at line 22, correct “KENTO, NM, WP” to read “KENTO, NM, FIX.”
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule; correction.
The FAA is correcting a final rule that appeared in the
Effective 0901 UTC, September 8, 2022. The Director of the Federal Register approves this incorporation by reference under 1 CFR part 51, subject to the annual revision of FAA Order JO 7400.11, Airspace Designations and Reporting Points, and publication of conforming amendments.
Nathan A. Chaffman, Federal Aviation Administration, Western Service Center, Operations Support Group, 2200 S 216th Street, Des Moines, WA 98198; telephone (206) 231-3460.
The FAA published a final rule in the
The Class E5 airspace designation is published in paragraph 6005 of FAA Order JO 7400.11F, dated August 10, 2021, and effective September 15, 2021, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in FAA Order JO 7400.11.
Accordingly, pursuant to the authority delegated to the FAA, “Modification of Class E Airspace; Coeur D'Alene—Pappy Boyington Field, ID”, published in the
That airspace extending upward from 700 feet above the surface within a 4.4-mile radius of the Coeur D'Alene—Pappy Boyington Field, and within 2.2 miles each side of the 193° bearing from the airport extending from the 4.4-mile radius to 9 miles south of the airport, and that airspace 4.4 miles each side of the 251° bearing from the Coeur D'Alene—Pappy Boyington Field extending from the 4.4-mile radius to 16 miles west of the airport and that airspace 1.8 miles west and 4 miles east of the 013° bearing from the Coeur D'Alene—Pappy Boyington Field extending from the 4.4-mile radius to 8.5 miles northeast from the airport.
Federal Aviation Administration (FAA), DOT.
Final rule; correction.
The FAA is correcting a final rule published in the
Effective date 0901 UTC, September 8, 2022. The Director of the Federal Register approves this incorporation by reference action under 1 CFR part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.
FAA Order 7400.11F, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
Paul Gallant, Rules and Regulations Group, Office of Policy, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783.
The FAA published a final rule in the
United States RNAV routes are published in paragraph 6011 are published in paragraph 6011 of FAA Order JO 7400.11F, dated August 10, 2021, and effective September 15, 2021, which is incorporated by reference in 14 CFR 71.1. The RNAV route listed in this document will be published subsequently in FAA Order JO 7400.11.
Accordingly, pursuant to the authority delegated to me, reference to the ZEBUV, AK, WP, published in the
Federal Aviation Administration (FAA), DOT.
Final rule; correction.
The FAA is correcting a final rule that published in the
Effective date 0901 UTC, September 8, 2022. The Director of the Federal Register approves this incorporation by reference action under 1 CFR part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.
FAA Order 7400.11F, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
Paul Gallant, Rules and Regulations Group, Office of Policy, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783.
The FAA published a final rule in the
United States RNAV routes are published in paragraph 6011 are published in paragraph 6011 of FAA Order JO 7400.11F, dated August 10, 2021, and effective September 15, 2021, which is incorporated by reference in 14 CFR 71.1. The RNAV route listed in this document will be published subsequently in FAA Order JO 7400.11.
Accordingly, pursuant to the authority delegated to me, reference to the RAYMD, AK, WP, published in the
Federal Communications Commission.
Final rule.
In this document the Media Bureau (Bureau) of the Federal Communications Commission (Commission or FCC) adopts changes to its public inspection file rules to reinstate the text of an explanatory note that was inadvertently deleted from the Code of Federal Regulations. The note clarified that Class D FM stations, or stations whose programming is wholly “Instructional,” are exempt from the requirement to maintain issues and programs lists in their public inspection file. Reinstatement of this explanatory text will provide clarity to regulatees as to their public inspection file obligations.
Effective September 12, 2022.
Albert Shuldiner, Chief, Media Bureau, Audio Division, (202) 418-2721; Alexander Sanjenis, Assistant Division Chief, Media Bureau, Audio Division, (202) 418-2779.
This is a summary of the Media Bureau's Order (Order), MB Docket No. 22-240; DA 22-662, adopted and released on June 22, 2022. The full text of this document will be available via the FCC's Electronic Comment Filing System (ECFS),
This document does not contain any new or modified information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13, see 44 U.S.C. 3507.
Therefore, it does not contain any new or modified information collection burdens for small business concerns with fewer than 25 employees, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4).
The Bureau will send a copy of this Order to Congress and the Government Accountability Office (GAO) pursuant to the Congressional Review Act, 5 U.S.C. 801(a)(1)(A).
1.
2. Section 73.3527 outlines the online public inspection file obligations of noncommercial educational stations. Section 73.3527(e)(8) states that “nonexempt noncommercial education broadcast stations” are required to maintain in their online public inspection files a quarterly “list of programs that have provided the station's most significant treatment of community issues during the preceding three month period.” However, the Rule does not define “nonexempt” or provide any explanation of which stations are exempt from this requirement.
3. Prior to the adoption of § 73.3527, the Commission had clarified that Class D FM stations are exempt from the requirement that stations maintain in their public files a list of programs addressing problems in the station's community, FCC 76-234, 41 FR 12424-01 (Mar. 25, 1976) (1976 R&O). Although the Commission required that NCE stations place in their public files such lists, the Commission codified in a Note to its Rules that “[e]xempt licensees include those offering wholly instructional programming and those operating under Class D, 10-watt authorizations.” In 1984, the Commission revisited the requirement for stations to maintain issues/programs lists, FCC 84-294, 49 FR 33658-01 (Aug. 24, 1984) (1984 R&O). The 1984 R&O again noted that Class D FM stations are exempt from the issues/programs lists requirements due to the limited nature of the service they provide. Although the Commission's order highlighted the exemption for Class D FM stations, the actual text of the new § 73.3527 inadvertently omitted that exemption.
4. Subsequently, the Mass Media Bureau issued an order in 1985 noting that the exemption was inadvertently omitted from the text of § 73.3527 but that Class D FM stations remained exempt from the requirement to maintain program lists (1985 Bureau Order). Accordingly, a Note 2 to § 73.3527 was added: “For purposes of paragraph (a)(7) of this section, exempt applicants, permittees or licensees include those whose existing or prospective facilities are Class D FM stations or whose programming is wholly `Instructional' ” (Class D Note). This revised version of § 73.3527 was published in the
5. In 1988, the Commission again adopted an order, FCC 88-52, 53 FR 15224 (Apr. 28, 1988), revising the retention of issues/programs lists in § 73.3527(a)(7) (1988 Order). The 1988 Order revised the rule to make it consistent with a change made to the companion rule for commercial stations. The 1987 NPRM that preceded that order did not propose any change to the Class D exemption; nor did the 1988 Order discuss any such change. However, the Class D Note did not appear in the 1988 edition of the CFR, nor in any subsequent edition.
6. Compounding the confusion created by the apparent inadvertent deletion of the Class D Note following the 1988 Order, the Bureau issued a Forfeiture Order in 2009, DA 09-590, (UMW) where it specifically rejected an argument that Class D FM stations are exempt from the issues/programs list requirement of § 73.3527. Although UMW correctly states that the Commission did indeed make Class D FM stations exempt in the 1976 R&O, it incorrectly held that the Commission did not intend to continue that exemption in effect when it adopted § 73.3527. UMW did not address the 1985 Bureau Order, which clarified that Class D FM stations are exempt from § 73.3527, nor did it explain what stations are considered exempt from the issues/programs list requirement.
7.
8. We find that notice and comment procedures are unnecessary under the good cause exception of the Administrative Procedure Act because re-codifying the inadvertently deleted text of the deleted Class D Note merely restores an exemption to § 73.3527 that the Commission established and has never sought to change in subsequent rulemaking actions. Consequently, we find notice and comment procedures are unnecessary for this action.
9. Finally, we disavow the Bureau's holding in UMW. As discussed above, the 1985 Bureau Order clearly states that Class D FM stations were meant to be exempted from the issues/programs lists requirement of § 73.3527, and no subsequent Commission decision changed that requirement. The removal of the Class D Note from § 73.3527 was not done pursuant to a Commission action, but rather through apparent inadvertence. Therefore, that exemption is still valid, and UMW provides an example of the importance of reflecting this exemption within the text of § 73.3527(e)(8).
10.
11.
12.
13. Accordingly,
14.
15.
16.
Communications equipment, Radio, Reporting and recordkeeping requirements, Television.
For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 73 as follows:
47 U.S.C. 154, 155, 301, 303, 307, 309, 310, 334, 336, 339.
(e) * * *
(8) * * * For the purposes of this section, exempt applicants, permittees, or licensees include those whose existing or prospective facilities are Class D FM stations or whose programming is wholly “Instructional.”
Federal Communications Commission.
Final rule; announcement of effective date.
The Federal Communications Commission (Commission) announces that the Office of Management and Budget (OMB) has approved, for a period of three years, the new information collection associated with the Commission's
The amendment to 47 CFR 95.2309, published at 84 FR 34792, July 19, 2019, is effective August 12, 2022.
Hugh Van Tuyl, Office of Engineering and Technology, at (202) 418-7506, or email:
For additional information concerning the Paperwork Reduction Act information collection requirements, contact Nicole Ongele at (202) 418-2991 or
This document announces that, on November 4, 2019, OMB approved, for a period of three years, the information collection requirements relating to the White Space Database rules contained in the Commission's
As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the FCC is notifying the public that it received final OMB approval on November 4, 2019, for the information collection requirements contained in the Commission's rules in 47 CFR part 95.
Under 5 CFR part 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number.
No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current, valid OMB Control Number. The OMB Control Number is 3060-0953.
The foregoing notice is required by the Paperwork Reduction Act of 1995, Public Law 104-13, October 1, 1995, and 44 U.S.C. 3507.
The total annual reporting burdens and costs for the respondents are as follows:
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to adopt a new airworthiness directive (AD) for Airbus Helicopters Model SA-365N, SA-365N1, AS-365N2, AS 365 N3, EC 155B, and EC155B1 helicopters. This proposed AD was prompted by reports of the cockpit doors failing to open after ditching with inflated floats on certain helicopters equipped with an emergency flotation system (EFS). This proposed AD would require revising the existing Rotorcraft Flight Manual (RFM) for your helicopter, installing placards, and depending on your model helicopter, modification of the jettisoning system, as specified in a European Union Aviation Safety Agency (EASA) AD, which is proposed for incorporation by reference (IBR). The FAA is proposing this AD to address the unsafe condition on these products.
The FAA must receive comments on this proposed AD by September 26, 2022.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For EASA material that is proposed for IBR in this NPRM, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
You may examine the AD docket at
Darren Gassetto, Aerospace Engineer, COS Program Management Section, Operational Safety Branch, Compliance & Airworthiness Division, FAA, 1600 Stewart Ave., 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 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 Darren Gassetto, Aerospace Engineer, COS Program Management Section, Operational Safety Branch, Compliance & Airworthiness Division, FAA, 1600 Stewart Ave., Suite 410, Westbury, NY 11590; telephone (516) 228-7323; email
EASA, which is the Technical Agent for the Member States of the European Union, has issued a series of ADs, with the most recent being EASA AD 2021-0101R1, dated February 25, 2022 (EASA AD 2021-0101R1), to correct an unsafe condition for Airbus Helicopters (AH), formerly Eurocopter, Eurocopter France, Aerospatiale, Sud Aviation, Model SA
EASA initially issued EASA AD 2021-0041, dated January 28, 2021 (EASA AD 2021-0041), for certain Model SA 365 N, SA 365 N1, AS 365 N2, AS 365 N3, EC 155 B, and EC 155 B1 helicopters, which required modifying the jettisoning system by installing an external handle on the jettison system of the pilot and co-pilot doors on certain Model SA/AS 365 helicopters, installing external instruction placards on the left-hand (LH) and right-hand (RH) side of the helicopter, and amending the RFM. EASA later issued EASA AD 2021-0101, dated April 12, 2021 (EASA AD 2021-0101), which superseded EASA AD 2021-0041, to also address Model AS 365 helicopters with the Airbus Helicopters Forward Looking InfraRed (AH FLIR) system installed.
EASA AD 2021-0101R1 retains the requirements of EASA AD 2021-0101 and extends the compliance time for Model SA 365 N, SA 365 N1, AS 365 N2, and AS 365 N3 helicopters, if equipped with the fixed parts of the AH FLIR system installation and that are not equipped with an EFS with a certain cabin layout where the passage between cabin and cockpit is smaller than a Type 4 passage (as defined in EASA AD 2021-0101R1); except helicopters that have Airbus Helicopters modification (AH MOD) MC90B73 embodied in production.
This proposed AD was prompted by reports of failure of the cockpit doors to open after ditching with inflated floats on certain helicopters equipped with an EFS. EASA advises emergency evacuation was only possible by jettisoning the hinged doors from the inside or by accessing the emergency exits in the cabin. EASA further advises that the passage from the cockpit to the cabin may be impaired on helicopters with certain interior layouts.
The FAA is proposing this AD to prevent cockpit doors failing to open during an emergency evacuation after an emergency ditching with inflated floats, which could result in the prevention of incapacitated occupants exiting the helicopter during an emergency from the outside by external rescuers. See EASA AD 2021-0101R1 for additional background information.
EASA AD 2021-0101R1 requires amending the RFM; installing placards on the LH and RH side of the helicopter; and for certain helicopters, modifying the jettison system by installing an external handle on the jettison system of the pilot and co-pilot doors.
This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
The FAA reviewed Airbus Helicopters Alert Service Bulletin (ASB) No. AS365-52.00.27, Revision 1, dated June 4, 2021 (AS365-52.00.27, Rev 1), which specifies procedures for installing labels (placards) on the pilot and co-pilot doors. AS365-52.00.27, Rev 1, also specifies procedures for installing an external handle on the jettison system.
The FAA also reviewed Airbus Helicopters ASB No. AS365-52.00.29, Revision 1, dated February 9, 2022, ASB No. AS365-52.00.29, Revision 0, dated February 10, 2021, and ASB No. EC155-52A033, Revision 0, dated September 30, 2020. This service information specifies procedures for installing labels (placards) on the pilot and co-pilot doors.
The FAA also reviewed Airbus Helicopters Flight Manual (FM) SA 365 N Supplement, SUP.10.4, Normal Revision (NR) 7, date code 20-40; Airbus Helicopters FM SA 365 N1 Supplement, SUP.10.4, NR 9, date code 20-40; Airbus Helicopters FM AS 365 N2 Supplement, SUP.14, NR 6, date code 20-40; Airbus Helicopters FM AS 365 N3 Supplement, SUP.14, NR 12, date code 20-28; Airbus Helicopters FM EC 155 B Supplement, SUP.14, NR 7, date code 20-11; and Airbus Helicopters FM EC 155 B1 Supplement, SUP.14, NR 8, date code 20-11. This service information provides updated procedures for ditching and emergency evacuation.
These helicopters have been approved by EASA and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with the European Union, EASA has notified the FAA about the unsafe condition described in its AD. The FAA is proposing this AD after evaluating all known relevant information and determining that the unsafe condition described previously is likely to exist or develop on other helicopters of these same type designs.
This proposed AD would require accomplishing the actions specified in EASA AD 2021-0101R1, described previously, as incorporated by reference, except for any differences identified as exceptions in the regulatory text of this proposed AD and except as discussed under “Differences Between this Proposed AD and EASA AD 2021-0101R1.”
This proposed AD would also require revising the existing RFM for your helicopter by updating the normal procedures section. Incorporating the RFM revision may be performed by the owner/operator (pilot) holding at least a private pilot certificate, and must be entered into the aircraft records showing compliance with this AD in accordance with 14 CFR 43.9(a) and 14 CFR 91.417(a)(2)(v). The record must be maintained as required by 14 CFR 91.417, 121.380, or 135.439.
In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA developed a process to use some civil aviation authority (CAA) ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has been coordinating this process with manufacturers and CAAs. As a result, the FAA proposes to incorporate EASA AD 2021-0101R1 by reference in the FAA final rule. This proposed AD would, therefore, require compliance with EASA AD 2021-0101R1 in its entirety through that incorporation, except for any differences identified as exceptions in the regulatory text of this proposed AD. Using common terms that are the same as the heading of a particular section in EASA AD 2021-0101R1 does not mean that operators need comply only with that section. For example, where the AD requirement refers to “all required actions and compliance times,” compliance with this AD requirement is not limited to the section titled “Required Action(s) and Compliance Time(s)” in EASA AD 2021-0101R1. Service information referenced in EASA AD 2021-0101R1 for compliance will be available at
EASA AD 2021-0101R1 allows using Airbus Helicopters ASB No. AS365-52.00.27, original issue, dated November 17, 2020 (including Erratum to ASB AS365-52.00.27, original issue, dated January 21, 2021); whereas this proposed AD would not. This proposed AD would require using Airbus Helicopters ASB No. AS365-52.00.27, Revision 1, dated June 4, 2021, instead.
EASA AD 2021-0101R1 requires operators to “inform all flight crews” of revisions to the RFM, and thereafter to “operate the helicopter accordingly.” However, this proposed AD would not specifically require those actions. FAA regulations mandate compliance with only the operating limitations section of the flight manual. The flight manual changes required by this proposed AD would apply to the emergency procedures and normal procedures sections of the existing RFM for your helicopter. Furthermore, compliance with such requirements in an AD is impracticable to demonstrate or track on an ongoing basis; therefore, a requirement to operate the aircraft in such a manner is unenforceable. Nonetheless, the FAA recommends that flight crews of the helicopters listed in the applicability operate in accordance with the revised emergency procedures and normal procedures proposed by this AD.
This proposed AD would allow the owner/operator (pilot) holding at least a private pilot certificate to revise the existing RFM for your helicopter and do the logbook entry, where as EASA AD 2021-0101R1 does not specify this. This proposed AD would require these actions to be entered into the aircraft records showing compliance with this AD in accordance with 14 CFR 43.9(a) and 14 CFR 91.417(a)(2)(v). The record must be maintained as required by 14 CFR 91.417, 121.380, or 135.439.
For certain helicopters, this proposed AD would require revising section 4.1, Normal Procedures, of the existing RFM for your helicopter to add a check to the RH and LH Cockpit Door Jettison Handles, whereas EASA AD 2021-0101R1 does not require that action.
The FAA estimates that this AD, if adopted as proposed, would affect 40 helicopters of U.S. Registry. Labor rates are estimated at $85 per work-hour. Based on these numbers, the FAA estimates the following costs to comply with this proposed AD.
Revising the existing RFM for your helicopter would take about 0.25 work-hour for an estimated cost of $21 per helicopter and $840 for the U.S. fleet.
Installing placards on the pilot and co-pilot doors would take about 1 work-hour and parts would cost up to about $138 for an estimated cost of up to $223 per helicopter.
For helicopters with the AH FLIR system installed, installing placards on the pilot and co-pilot doors would take about 0.5 work-hour and parts would cost about $52 for an estimated cost of $95 per helicopter.
If required, installing an external handle on the jettison system would take about 7 work-hours and parts would cost about $1,328 for an estimated cost of $1,923 per helicopter and $51,921 for the U.S. fleet (27 helicopters).
The FAA has included all known costs in its cost estimate. According to the manufacturer, however, some of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected operators.
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 September 26, 2022.
None.
This AD applies to all Airbus Helicopters Model SA-365N, SA-365N1, AS-365N2, AS 365 N3, EC 155B, and EC155B1 helicopters, certificated in any category.
Joint Aircraft Service Component (JASC) Codes: 1100, Placards and Markings; and 5210, Passenger/Crew Doors.
This AD was prompted by reports of failure of the cockpit doors to open after ditching with inflated floats on certain helicopters equipped with an emergency flotation system (EFS). The FAA is issuing this AD to inform external rescuers that the cockpit door jettison function needs to be utilized to successfully egress incapacitated flight crew from the cockpit during an emergency when the EFS is activated. This unsafe condition, if not addressed, could result in incapacitated occupants not being able to exit the helicopter after an emergency ditching with inflated floats.
Comply with this AD within the compliance times specified, unless already done.
Except as specified in paragraph (h) of this AD: Comply with all required actions and compliance times specified in, and in accordance with, European Union Aviation
(1) Where EASA AD 2021-0101R1 refers to effective dates “11 February 2021 [the effective date of EASA AD 2021-0041]” and “26 April 2021 [the effective date of the original issue of this AD],” this AD requires using the effective date of this AD.
(2) Where paragraph (1) of EASA AD 2021-0101R1 specifies to “inform all flight crews and, thereafter, operate the helicopter accordingly,” this AD does not require those actions.
(3) The action required by paragraph (1) of EASA AD 2021-0101R1 may be performed by the owner/operator (pilot) holding at least a private pilot certificate, and must be entered into the aircraft records showing compliance with this AD in accordance with 14 CFR 43.9(a) and 14 CFR 91.417(a)(2)(v). The record must be maintained as required by 14 CFR 91.417, 121.380, or 135.439.
(4) Where paragraph (2) of EASA AD 2021-0101R1 specifies to “modify the helicopter in accordance with the instructions of Section 3 of the applicable ASB,” for this AD, replace that text with, “modify the helicopter in accordance with Section 3.B. in the Accomplishment Instructions of the applicable ASB.”
(5) Where EASA AD 2021-0101R1 refers to “ASB AS365-52.00.27” and “AH ASB AS365-52.00.27 original issue dated 17 November 2020 (including Erratum to ASB AS365-52.00.27 original issue dated 21 January 2021),” this AD requires replacing each instance of that text with “Airbus Helicopters Alert Service Bulletin No. AS365-52.00.27, Revision 1, dated June 4, 2021.”
(6) Where the service information referenced in paragraph (2) of EASA AD 2021-0101R1 specifies discarding parts, this AD requires removing those parts from service.
(7) Where the service information referenced in paragraph (2) of EASA AD 2021-0101R1 specifies to use tooling, this AD allows the use of equivalent tooling.
(8) Where the service information referenced in paragraph (2) of EASA AD 2021-0101R1 specifies parking the helicopter in a hangar or maintenance hangar, this AD does not require those actions.
(9) This AD does not mandate compliance with the “Remarks” section of EASA AD 2021-0101R1.
(1) For Group 2 helicopters as defined in EASA AD 2021-0101R1, concurrently with accomplishing the actions specified in paragraph (1) of EASA AD 2021-0101R1, revise the existing RFM for your helicopter by adding the following text at the end of section 4.1, Normal Procedures: “right and left hand Cockpit Door Jettison Handles are properly closed and secured.”
(2) The action required by paragraph (i)(1) of this AD may be performed by the owner/operator (pilot) holding at least a private pilot certificate, and must be entered into the aircraft records showing compliance with this AD in accordance with 14 CFR 43.9(a) and 14 CFR 91.417(a)(2)(v). The record must be maintained as required by 14 CFR 91.417, 121.380, or 135.439.
(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)(2) 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 EASA AD 2021-0101R1, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
(2) For more information about this AD, contact Darren Gassetto, Aerospace Engineer, COS Program Management Section, Operational Safety Branch, Compliance & Airworthiness Division, FAA, 1600 Stewart Ave., Suite 410, Westbury, NY 11590; telephone (516) 228-7323; email
(3) For Airbus Helicopters service information identified in this AD, contact Airbus Helicopters, 2701 North Forum Drive, Grand Prairie, TX 75052; telephone (972) 641-0000 or (800) 232-0323; fax (972) 641-3775; or at
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to adopt a new airworthiness directive (AD) for certain De Havilland Aircraft of Canada Limited Model DHC-8-402 airplanes. This proposed AD was prompted by an investigation that found that the actual operating temperatures within the integrated flight cabinet (IFC) were significantly higher than anticipated during certification. This proposed AD would require a design change to improve the integrated flight cabinet (IFC) cooling capacity. The FAA is proposing this AD to address the unsafe condition on these products.
The FAA must receive comments on this proposed AD by September 26, 2022.
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 De Havilland Aircraft of Canada Limited, Dash 8 Series Customer Response Centre, 5800 Explorer Drive, Mississauga, Ontario, Canada, L4W 5K9; telephone North America (toll-free): +1 855-310-1013, Direct: +1 647-277-5820; email
You may examine the AD docket at
Gabriel Kim, Aerospace Engineer, Mechanical Systems and Administrative Services Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7300; 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 Gabriel Kim, Aerospace Engineer, Mechanical Systems and Administrative Services Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7300; email
Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued TCCA AD CF-2022-09, dated March 3, 2022 (TCCA AD CF-2022-09) (also referred to after this as the Mandatory Continuing Airworthiness Information, or the MCAI), to correct an unsafe condition for certain De Havilland Aircraft of Canada Limited (formerly Bombardier Inc.) model DHC-8-401 and -402 airplanes. You may examine the MCAI in the AD docket at
This proposed AD was prompted by an investigation that found that the actual operating temperatures within the IFC were significantly higher than anticipated during certification. Consequently, the reliability of the IFC module does not meet safety objectives. The FAA is proposing this AD to address the high operating temperatures within the IFC, which could lead to uncontrolled autopilot pitch trim servo runaway and failure of the stall warning and stick pusher, resulting in reduced controllability of the airplane. See the MCAI for additional background information.
De Havilland Aircraft of Canada Limited has issued Service Bulletin 84-21-24, Revision B, dated October 13, 2021. This service information describes procedures for a modification to improve the integrated flight cabinet (IFC) cooling capacity. The tasks include reworking the forward and aft avionics rack side panels, removing the piccolo tube assemblies, doing a general visual inspection for contamination of the IFCs and avionics rack, cleaning any contamination found, installing and routing new cooling ducts, and installing two new extraction plenums in the avionics rack cooling system.
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 product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to the FAA's bilateral agreement with the State of Design Authority, the FAA has been notified of the unsafe condition described in the MCAI and service information referenced above. The FAA is proposing this AD because the FAA evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop on other products of the same type design.
This proposed AD would require accomplishing the actions specified in the service information already described.
TCCA AD CF-2022-09 states that the AD applies to Model DHC-8-401 and -402 airplanes, serial numbers 4095 through 4633. However, all airplanes with serial numbers 4095 through 4633 are Model DHC-8-402 airplanes. No Model DHC-8-401 airplanes are affected by the unsafe condition identified in this proposed AD. Therefore, this proposed AD does not refer to Model DHC-8-401 airplanes in the applicability.
The FAA estimates that this AD, if adopted as proposed, would affect 56 airplanes of U.S. registry. The FAA estimates the following costs to comply with this proposed AD:
The FAA has included all known costs in its cost estimate. According to the manufacturer, however, some or all of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected operators.
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 September 26, 2022.
None.
This AD applies to De Havilland Aircraft of Canada Limited (formerly Bombardier Inc.) Model DHC-8-402 airplanes, certificated in any category, serial numbers 4095 through 4633 inclusive.
Air Transport Association (ATA) of America Code 21, Air Conditioning System.
This AD was prompted by an investigation that found that the actual operating temperatures within the integrated flight cabinet (IFC) were significantly higher than anticipated during the certification. Consequently, the reliability of the IFC module does not meet safety objectives. The FAA is issuing this AD to address the high operating temperatures within the IFC, which could lead to uncontrolled autopilot pitch trim servo runaway and failure of the stall warning and stick pusher, resulting in reduced controllability of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Within 8,000 flight hours or 48 months, whichever occurs first, from the effective date of this AD, do a modification to improve the integrated flight cabinet (IFC) cooling capacity, in accordance with the Accomplishment Instructions of De Havilland Aircraft of Canada Limited Service Bulletin 84-21-24, Revision B, dated Oct 13, 2021.
This paragraph provides credit for actions required by paragraph (g) of this AD, if those actions were performed before the effective date of this AD using De Havilland Aircraft of Canada Limited Service Bulletin 84-21-24, Revision A, dated August 20, 2021.
The following provisions also apply to this AD:
(1)
(2)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) TCCA AD CF-2022-09, dated March 3, 2022, for related information. This MCAI may be found in the AD docket on the internet at
(2) For more information about this AD, contact Gabriel Kim, Aerospace Engineer, Mechanical Systems and Administrative Services Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7300; email
(3) For service information identified in this AD, contact De Havilland Aircraft of Canada Limited, Dash 8 Series Customer Response Centre, 5800 Explorer Drive,
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to adopt a new airworthiness directive (AD) for certain Bombardier, Inc., Model BD-700-1A10 and BD-700-1A11 airplanes. This proposed AD was prompted by reports of the passenger door failing to dampen during opening at regularly scheduled maintenance checks, causing the door to open more rapidly than normal. An investigation found that a contributing factor was erroneous aircraft maintenance manual (AMM) procedures. This proposed AD would prohibit using certain versions of certain aircraft maintenance manual (AMM) tasks for the passenger door. The FAA is proposing this AD to address the unsafe condition on these products.
The FAA must receive comments on this proposed AD by September 26, 2022.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
You may examine the AD docket at
Chirayu Gupta, Aerospace Engineer, Mechanical Systems and Administrative Services Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7300; 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 Chirayu Gupta, Aerospace Engineer, Mechanical Systems and Administrative Services Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7300; email
Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued TCCA AD CF-2021-41, dated November 24, 2021 (TCCA AD CF-2021-41) (also referred to after this as the MCAI), to correct an unsafe condition for certain Bombardier, Inc., Model BD-700-1A10 and BD-700-1A11 airplanes. You may examine the MCAI in the AD docket at
This proposed AD was prompted reports of the passenger door failing to dampen during opening at regularly scheduled maintenance checks, causing the door to open more rapidly than normal. An investigation found that a contributing factor was erroneous AMM procedures. The AMM tasks related to passenger door maintenance have since been corrected, and only versions of these tasks dated May 19, 2021, or later have the correct procedures. The FAA is proposing this AD to prevent rapid opening of the passenger door, which can result in damage to the door and consequent injury to maintenance personnel. See the MCAI for additional background information.
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to the FAA's bilateral agreement with the State of Design Authority, the FAA has been notified of the unsafe condition described in the MCAI and service information referenced above. The FAA is proposing this AD because the FAA evaluated all the relevant information and determined the unsafe condition
This proposed AD would prohibit using versions issued prior to May 19, 2021 of certain AMM tasks for the passenger door.
The FAA estimates that this proposed AD affects 408 airplanes of U.S. registry. The FAA estimates the following costs to comply with this proposed AD:
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 September 26, 2022.
None.
This AD applies to Bombardier, Inc., Model BD-700-1A10 and BD-700-1A11 airplanes, certificated in any category, serial numbers (S/Ns) 9002 through 9998 inclusive, and S/Ns 60001 through 60045 inclusive.
Air Transport Association (ATA) of America Code 52, Doors.
This AD was prompted by reports of the passenger door failing to dampen during opening at regularly scheduled maintenance checks, causing the door to open more rapidly than normal. An investigation found that a contributing factor was erroneous aircraft maintenance manual (AMM) procedures. The FAA is issuing this AD to prevent rapid opening of the passenger door, which can result in damage to the door and consequent injury to maintenance personnel.
Comply with this AD within the compliance times specified, unless already done.
As of 30 days after the effective date of this AD, when performing the maintenance tasks identified in figure 1 to paragraph (g) of this AD, do not use any version of any task identified in figure 1 to paragraph (g) of this AD that was issued prior to May 19, 2021.
The following provisions also apply to this AD:
(1)
(2)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) TCCA AD CF-2021-41, dated November 24, 2021; for related information. This MCAI may be found in the AD docket at
(2) For more information about this AD, contact Chirayu Gupta, Aerospace Engineer, Mechanical Systems and Administrative Services Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7300; email
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to amend the Class E airspace at Bloomfield, IA. The FAA is proposing this action as the result of an airspace review as part of the decommissioning of the Bloomfield non-directional beacon (NDB).
Comments must be received on or before September 26, 2022.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590; telephone (202) 366-9826, or (800) 647-5527. You must identify FAA Docket No. FAA-2022-0773/Airspace Docket No. 22-ACE-14 at the beginning of your comments. You may also submit comments through the internet at
FAA Order JO 7400.11F, Airspace Designations and Reporting Points, and subsequent amendments can be viewed
Jeffrey Claypool, Federal Aviation Administration, Operations Support Group, Central Service Center, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone (817) 222-5711.
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 would amend the Class E airspace extending upward from 700 feet above the surface at Bloomfield Municipal Airport, Bloomfield, IA, to support instrument flight rule operations at this airport.
Interested parties are invited to participate in 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 and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2022-0773/Airspace Docket No. 22-ACE-14.” 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 notice may be changed in light of the comments received. 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 JO 7400.11F, Airspace Designations and Reporting Points, dated August 10, 2021, and effective September 15, 2021. FAA Order JO 7400.11F is publicly available as listed in the
The FAA is proposing an amendment to 14 CFR part 71 by amending the Class E airspace extending upward from 700 feet at Bloomfield Municipal Airport, Bloomfield, IA, by removing the Bloomfield NDB and the associated extension from the airspace legal description.
This action is necessary due to an airspace review as part of the decommissioning of the Bloomfield NDB.
Class E airspace designations are published in paragraph 6005 of FAA Order JO 7400.11F, dated August 10, 2021, and effective September 15, 2021, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in FAA Order JO 7400.11.
FAA Order JO 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. 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 rule, when promulgated, would 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).
Accordingly, pursuant to the authority delegated to me, 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 6.3-mile radius of Bloomfield Municipal Airport.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to establish Class D airspace for Craig Field, Selma, AL, as a new air traffic control tower will service the airport. This action would also amend Class E airspace extending upward from 700 feet above the surface by updating the radius and geographic coordinates of the airport. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations in the area.
Comments must be received on or before September 26, 2022.
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 Docket No. FAA-2022-0922; Airspace Docket No. 22-ASO-15 at the beginning of your comments. You may also submit comments through the internet at
FAA Order JO 7400.11F, Airspace Designations and Reporting Points, and subsequent amendments can be viewed on-line 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 would establish and amend airspace in Selma, AL, 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-2022-0922 and Airspace Docket No. 22-ASO-15) 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-2022-0922; Airspace Docket No. 22-ASO-015”. 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 JO 7400.11F, Airspace Designations and Reporting Points, dated August 10, 2021, and effective September 15, 2021. FAA Order JO 7400.11F is publicly available as listed in the
The FAA proposes an amendment to Title 14 CFR part 71 to establish Class D airspace in Selma, AL, as a new air traffic control tower will service Craig Field Airport. Also, Class E airspace extending upward from 700 feet above the surface would be amended for Craig Field Airport, as an airspace evaluation determined the radius required an increase to 10.2 miles (formerly 7
Class D and Class E airspace designations are published in Paragraphs 5000, and 6005, respectively, of FAA Order JO 7400.11F, dated August 10, 2021, and effective September 15, 2021, which is incorporated by reference in 14 CFR 71.1. The Class D and E airspace designations listed in this document will be published subsequently in FAA Order JO 7400.11F.
FAA Order JO 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 the surface up to and including 3,000 feet MSL, within a 4.3-mile radius of Craig Field Airport, and within 1.2 miles each side of the 146° bearing, extending from the 4.3-mile radius to 6.3 miles southeast of the airport; and within 1-mile each side of the 326° bearing, extending from the 4.3-mile radius to 6.3 miles northwest of the airport. This Class D airspace area is effective during the specific days and times established in advance by a Notice to Air Missions. The effective days and times will thereafter be continuously published in the Chart Supplement.
That airspace extending upward from 700 feet above the surface within a 10.2-mile radius of Craig Field Airport.
Federal Energy Regulatory Commission, Department of Energy.
Notice of proposed rulemaking.
The Federal Energy Regulatory Commission (Commission) proposes to add a requirement that all entities communicating with the Commission or other specified organizations related to a matter subject to the jurisdiction of the Commission submit accurate and factual information and not submit false or misleading information or omit material information. An entity is shielded from violation of the regulation if it has exercised due diligence to prevent such occurrences.
Comments are due October 11, 2022.
Comments, identified by docket number, may be filed in the following ways. Electronic filing through
•
• For those unable to file electronically, comments may be filed by U.S. Postal Service mail or by hand (including courier) delivery.
○
○
Gabe Sterling, Legal Information Office of Enforcement, Division of Investigations, Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, (202) 502-8891,
Andrea Cerbin, Legal Information Office of Enforcement, Division of Investigations, Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, (202) 502-8362,
1. Pursuant to sections 206, 215, 307, and 309 of the Federal Power Act (FPA),
2. A variety of current Commission regulations prohibit, in defined circumstances, inaccurate communications to the Commission and other organizations upon which the Commission relies to carry out its statutory obligations in the Commission-jurisdictional electric, natural gas, and oil industries and markets. However, these existing requirements cover only certain communications and impose a patchwork of different standards of care for such communications.
3. The Commission relies extensively upon the accuracy of information provided to it and to other organizations for effective decision making. Reliance on inaccurate information inhibits the Commission's regulatory oversight and could lead to substantial harm, whether it is communicated to the Commission or to the other organizations upon which the Commission relies to assist it to carry out its regulatory responsibilities. We are concerned that the Commission has no explicit requirement that communications related to a matter subject to the jurisdiction of the Commission be accurate or even that they not include intentional misrepresentations.
4. We believe that a broadly applicable duty of candor will improve the Commission's ability to effectively oversee jurisdictional markets by ensuring the Commission and organizations upon which the Commission relies base decisions on accurate information. Effective Commission oversight depends on entities' use of due diligence to reduce the possibility that false or inaccurate information is communicated to the Commission and other organizations upon which it relies. Further, intentional or reckless communication of false or inaccurate information is always unacceptable.
5. All persons appearing before the Commission and entities communicating with organizations regulated by the Commission should know that truthfulness is expected and required, that communications should be made following due diligence, and that communications should never be intentionally or recklessly misleading. However, we understand that there is a balance between ensuring accurate communications and the burden required to ensure that accuracy. By adopting a flexible standard, “due diligence,” and limiting the relevant communications to specific recipients related to matters subject to the jurisdiction of the Commission, we expect that such additional burdens, if any, would be minimal.
6. We seek comment on all aspects of the proposed rule, including specifically the following: the need for a broad duty of candor rule; whether 18 CFR 35.41(b) provides a reasonable foundation for the proposed expanded duty of candor rule; the Commission's authority for the proposed rule; whether there are categories of entities or individuals that should be exempted from the duty of candor; the scope of the communications covered by the rule; and whether the regulation properly identifies all organizations who assist the Commission to carry out its statutory obligations and communications to whom should be subject to a duty of candor.
7. Among the existing patchwork of Commission requirements imposing a duty of candor applicable to some Commission-regulated entities and markets is 18 CFR 35.41(b), which applies only to “Sellers” in electric markets, defined as a person who has either obtained or applied for market-based rate authority under the auspices of the FPA.
8. The Commission has adopted various regulations imposing a duty of candor for specific types of communications, and the vast majority of these regulations involve communications to the Commission or Commission staff. In each instance, the controlling regulation was adopted as part of specific regulatory requirements or procedures rather than as a broad requirement applicable to all of the Commission's oversight responsibilities, including areas where the Commission relies on other organizations to assist it in exercising its authorities. This history, discussed in the paragraphs to follow, has resulted in a limited set of requirements that may fail to ensure that the Commission can make decisions based on accurate information.
9. For many decades, the Commission's governing statutes and adopted regulations have required that certain submissions to it be made under oath and penalty of perjury. For example, FPA 304 requires that entities submit periodic or annual reports under oath,
10. While the authorities referenced above require submissions to be made under oath, other regulations impose differing obligations for communications. For example, the Commission has interpreted 18 CFR 157.5 to require applicants under NGA 7 seeking pipeline certificates of public convenience and necessity to disclose “fully and forthrightly . . . all information relevant to the application.”
11. The Commission also has adopted amendments to blanket sales certificates “to ensure the integrity of the natural gas market.”
12. For individuals, the Commission's Rules of Practice and Procedure impose a duty of candor on those appearing before it: “A person appearing before the Commission or the presiding officer must conform to the standards of ethical conduct required of practitioners before the Courts of the United States.”
13. Under 18 CFR 1c.1(a)(2) and 1c.2(a)(2), it is unlawful, in connection with jurisdictional natural gas and electric transactions, “[t]o make any untrue statement of a material fact or to omit to state a material fact necessary in order to make the statements made, in the light of the circumstances under which they were made, not
14. Federal law, in fact, contemplates criminal sanctions for intentionally false statements made to any branch of the United States Government, including the Commission. Under 18 U.S.C. 1001(a), individuals who “in any matter within the jurisdiction of the Government . . . make any materially false, fictitious, or fraudulent statement or representation” can be fined or imprisoned for up to five years. However, the Commission has no authority to prosecute such violations.
15. Taken as a whole, these statutory and regulatory provisions create obligations for candor in various communications made to or before the Commission in a variety of circumstances. But these obligations are individually limited.
16. We believe that existing § 35.41(b) can form the basis for a broader rule that applies to a wider range of communications in the Commission's regulation of the electric, natural gas, and oil industries and markets.
17. In the aftermath of the Western Energy Crisis, the Commission found that dishonest and abusive practices by Sellers with market-based rate authority led to unjust and unreasonable rates.
18. The duty of candor adopted in 18 CFR 35.41(b) has been upheld by the courts. For example, in
19. Although § 35.41(b) has been an effective tool to ensure the accuracy of communications by Sellers (
20. As the above discussion demonstrates, the Commission has adopted a variety of duties of candor regarding communications made to it as well as to other entities, but it has not adopted a standardized requirement affecting all types of communications related to matters subject to the jurisdiction of the Commission.
21. Moreover, for many communications made to the Commission, and organizations upon which the Commission relies in carrying out its statutory responsibilities, there is no explicit requirement that such
22. Similarly, absent a restriction contained in a tariff provision, there may be no explicit requirement of candor for various important communications fundamental to the functioning of a market that produces just and reasonable rates: for example, communications from shippers to interstate pipelines, from transmission customers to transmission utilities, from transmission utilities to independent system operators (ISOs) or regional transmission organizations (RTOs), and from wholesale demand response participants to ISOs, RTOs, or transmission providers. Even intentional miscommunications may not be explicitly prohibited by our regulations, unless made pursuant to a violation of the Commission's Anti-Manipulation Rule under part 1c of the Commission's regulations.
23. The Commission proposes to adopt a new part 1d within title 18 of the Code of Federal Regulations to require that entities ensure the accuracy of communications related to a matter subject to the Commission's jurisdiction when communicating with the following entities: the Commission, Commission-approved market monitors, Commission-approved RTOs, Commission-approved ISOs, jurisdictional transmission or transportation providers, or the Electric Reliability Organization and its associated Regional Entities. Ensuring the accuracy of such communications will increase confidence in Commission-jurisdictional industries and markets and will improve the Commission's ability to meet its statutory responsibilities. The integrity and effectiveness of the Commission's regulatory oversight and decision-making authority rely on and require accuracy in communications to each of these entities.
24. To this end, the Commission proposes to adopt a requirement that every entity must provide accurate and factual information and not submit false or misleading information, or omit material information, in any communication with the Commission or with a range of other organizations including Commission-approved market monitors, Commission-approved RTOs and ISOs, as well as jurisdictional transmission or transportation providers, or the Electric Reliability Organization and its associated Regional Entities, where such communication relates to a matter subject to the jurisdiction of the Commission, unless the entity exercises due diligence to prevent such occurrences.
25. In the following sections, we discuss: (A) why a broad duty of candor requirement is needed to protect Commission-jurisdictional industries and markets; (B) the Commission's, Sellers', and the courts' favorable experience with application of 18 CFR 35.41(b); (C) the statutory authorities supporting the proposed rule; and (D) interpretive guidance for the proposed rule and how it will be applied.
26. It is indisputable that communications related to matters subject to the jurisdiction of the Commission should be complete, honest, and accurate in order for the Commission to effectively carry out its regulatory responsibilities. The Commission, and equally the organizations upon which the Commission relies to carry out its statutory responsibilities, need complete, honest, and accurate information to make important policy and economic decisions affecting the fairness, competitiveness, and reliability of markets. Submission of false or misleading information, or omission of material information—whether intentionally or reckless—could lead the Commission to reach decisions that it otherwise would not have made, such as erroneously approving or denying (1) requests to construct and operate infrastructure projects, (2) applications for merger or consolidation of jurisdictional electric facilities, (3) applications for market-based rate authority, or (4) requests to revise tariff provisions. Likewise, submission of false or misleading information, or omission of material information could inhibit the Commission's ability to ensure that the rates, terms, and conditions of service of natural gas and oil pipelines and public utilities are just and reasonable and not unduly discriminatory or preferential. Similarly, it could lead the Commission or its staff to close an investigation that should continue, or to adopt policies that are ineffective. The submission of false or misleading information, or omission of material information could lead an ISO or RTO to make decisions that jeopardize competition, fairness, and reliability of electric markets, and that potentially harm market participants and cause them to lose confidence that markets are working fairly and producing results consistent with market rules and fundamentals. False information could also result in an interstate gas pipeline misallocating capacity.
27. We recognize that communications in markets as large, complex, and active as those the Commission regulates will sometimes include inadvertent errors or oversights. Identifying and punishing all mistaken communications, or expending undue resources to prevent every error, is both impractical and unnecessary.
28. We believe, therefore, that a balance must be struck between the need for accurate information and the burden of ensuring the accuracy of that information. Based on the Commission's experience with its existing regulations (especially 18 CFR 35.41(b)), we believe that a duty of candor should apply to: (1) all entities, including both organizations and individuals; (2) communications to the Commission and to certain other specified organizations that administer, participate in, or operate markets and facilities subject to the Commission's jurisdiction; and (3) communications related to a matter subject to the jurisdiction of the Commission. However, no entity should be penalized or otherwise sanctioned for inaccurate communications where due diligence has been exercised to ensure the communications' accuracy.
29. We believe that the duty of candor rule proposed herein will provide clarity that benefits the industries and markets the Commission regulates. If an entity communicates with the Commission or one of the other specified organizations identified in the regulation, it will know or be on notice that it must exercise due diligence in all its communications related to a matter subject to the jurisdiction of the Commission.
30. Notwithstanding the potential adoption of this proposed regulation, we are not proposing to remove other duties of candor from our existing regulations. Those duties of candor and that proposed here are not inconsistent. Further, we note that the proposed rule, if adopted, would not impose a general affirmative duty of disclosure, but would apply to communications whether they are voluntary or required.
31. Providing inaccurate information to entities not named in the proposed regulation is also potentially problematic and may be actionable under other statutes and regulations in certain circumstances (
32. We propose to adopt a duty of candor rule that is based upon the existing duty of candor rule in 18 CFR 35.41(b). Since adoption of the Market Behavior Rules twenty years ago, the accuracy of communications by Sellers has improved substantially. While § 35.41(b) is likely not the only reason for this improvement, we believe that Sellers understand the regulation and generally attempt to comply with it. The Commission now has an abundance of experience and precedent applying § 35.41(b), which has been upheld in court as described above. We intend for this experience to inform the application of this proposed new rule, which is substantially similar in form and function, albeit broader in application.
33. Although the Commission's focus in adopting § 35.41(b) was Sellers with market-based rate authority, we find that the rule's underlying rationale—that the Commission cannot rely on market mechanisms to generate just and reasonable outcomes if those mechanisms have been undermined by inaccurate information—applies more broadly.
34. In fact, implicit in any Commission order is the presumption that representations made to the Commission and others are complete, accurate, and free of fraud, deception, or misrepresentation. Similarly, actions taken by market participants are taken with the understanding that the underlying information provided to them is accurate. One court described § 35.41 as aimed at “ensur[ing] the integrity and smooth functioning of the markets.”
35. The Commission has broad statutory authority, described below, to issue rules and regulations to allow it to effectively perform its regulatory functions. This authority includes the power to require accurate communications from those who choose to engage in Commission-jurisdictional markets or who communicate to the Commission about those markets. The Commission has previously implemented specific duty of candor regulations under this broad authority and it similarly has the authority to adopt a more generally applicable duty of candor.
36. The Commission has the statutory obligation under such statutes as the FPA, NGA, ICA, NGPA, and the Administrative Procedure Act to ensure that wholesale rates, and rules or practices directly affecting such rates, are just and reasonable,
37. The following authorities support the Commission's issuance of the proposed regulation:
• FPA 206, NGA 5, and ICA 13 and 15. As was the case with our adoption of 18 CFR 35.41, we believe that FPA 206 and the parallel provisions in the NGA and ICA provide a basis for adoption of the proposed regulation because information in our markets must be accurate to ensure that wholesale rates, and rules or practices directly affecting such rates are just and reasonable.
• FPA 307, NGA 14, and ICA 12(1)(a). Section 307 of the FPA and parallel section 14 of the NGA permit the Commission to obtain information needed to conduct investigations. Section 12(1)(a) of the ICA similarly permits the Commission to obtain information about the management and business of oil pipelines. Given the Commission's authority to obtain information, it follows that the Commission should be entitled to receive accurate information.
• FPA 309, NGA 16, NGPA 501(a), and Department of Energy Organization Act 402(a)(2) and 402(h). These sections give broad authority to the Commission to adopt regulations that are necessary or proper to effectuate its regulatory obligations. The Commission and the markets it regulates cannot function properly without the submission of accurate information.
• FPA 215. Section 215 conveys to the Commission, the Electric Reliability Organization, and Regional Entities the duties to obtain information and act upon that information. These obligations cannot be fulfilled without
• NGPA 311(c). Section 311(c) permits the Commission to prescribe terms and conditions to transportation authorizations under NGPA 311. One such condition can be to require that section 311 pipelines provide accurate information in their submissions to the Commission.
• ICA 1(5)(a). Transportation charges must be just and reasonable and charges based upon incorrect information are not just and reasonable.
38. We welcome comments on the Commission's authority to implement the proposed regulation.
39. To facilitate comment on the proposed regulation, we provide the following clarifications and expand upon some aspects of the proposed regulation. We welcome comments and requests for further clarification, as needed, on these points.
40. The proposed regulation utilizes the term “entity” because we believe that covered communications (
41. Further, we intend to interpret the term “communication” broadly, including informal and formal communications, verbal or written, and via any method that may be used for transmission. We also intend to interpret the term “Commission” under this provision to include communications to Commission staff. Communications to the other listed entities include communications to individuals employed or acting on behalf of those entities, including agents and contractors of the covered entities.
42. The proposed regulation applies to communications that relate to a matter subject to the jurisdiction of the Commission. Communications that are tangential or unrelated to matters subject to the jurisdiction of the Commission are not covered by the proposed regulation. For example, the proposed regulation typically would not apply to communications about contracts for general services with jurisdictional entities or employee/employer disputes within a jurisdictional entity.
43. The exercise of due diligence would be a defense to an alleged violation of the proposed regulation. The concept of due diligence is well developed in the context of duties of candor and the Commission and courts have precedent applying this defense.
44. We recognize that the best-intentioned entities may, and occasionally will, inadvertently provide inaccurate information. Even where due diligence cannot be demonstrated, it is not the Commission's intention to investigate or penalize all potential violations of the proposed regulation. As a general matter, we do not intend to penalize inadvertent errors, especially those of limited scope and impact. The Commission retains discretion not to pursue enforcement actions in such instances and will exercise that discretion, as appropriate, in implementing the proposed regulation, as the Commission does with all other Commission regulations.
45. Regulations of the Office and Management and Budget (OMB) implementing the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 through 3520) require Federal agencies to obtain approval from the OMB before conducting or sponsoring certain collections of information requirements imposed by agency rule.
46. The Commission is required to prepare an Environmental Assessment
47. The Regulatory Flexibility Act of 1980 (RFA)
48. Although this NOPR applies to many types of entities, including small entities, the burden associated with proposed regulation should be minimal. We expect that almost all entities regularly communicate with the Commission and jurisdictional actors with accuracy and honesty. We also believe that such communications already regularly occur with due diligence exercised and, thus, there should be no new burdens associated with the proposed rule on small entities. Further, due diligence for a small entity will often be different than for an entity with more resources and the proposed regulation accommodates these differences in resources. Therefore, the proposed regulation does not appear to pose a significant change to small entities.
49. The Commission invites interested persons to submit comments on the matters and issues proposed in this notice to be adopted, including any related matters or alternative proposals that commenters may wish to discuss. Comments are due October 11, 2022. Comments must refer to Docket No. RM22-20-000, and must include the commenter's name, the organization they represent, if applicable, and address in their comments. All comments will be placed in the Commission's public files and may be viewed, printed, or downloaded remotely as described in the Document Availability section below. Commenters on this proposal are not required to serve copies of their comments on other commenters.
50. The Commission encourages comments to be filed electronically via the eFiling link on the Commission's website at
51. Commenters that are not able to file comments electronically may file an original of their comment by USPS mail or by courier-or other delivery services. For submission sent via USPS only, filings should be mailed to: Federal Energy Regulatory Commission, Office of the Secretary, 888 First Street NE, Washington, DC 20426. Submission of filings other than by USPS should be delivered to: Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, MD 20852.
52. In addition to publishing the full text of this document in the
53. 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.
User assistance is available for eLibrary and the Commission's website during normal business hours from the Commission's Online Support at 202-502-6652 (toll free at 1-866-208-3676) or email at
Administrative practice and procedure.
By direction of the Commission.
Commissioner Danly is dissenting with a separate statement attached.
In consideration of the foregoing, the Commission proposes to add part 1d to title 18 of the
42 U.S.C. 7101-7352; 5 U.S.C. Ch. 5; E.O. 12009, 42 FR 46267, 3 CFR, 1978 Comp., p. 142.
Any entity must provide accurate and factual information and not submit false or misleading information, or omit material information, in any communication with the Commission, Commission-approved market monitors, Commission-approved regional transmission organizations, Commission-approved independent system operators, jurisdictional transmission or transportation providers, or the Electric Reliability Organization and its associated Regional Entities, where such communication relates to a matter subject to the jurisdiction of the Commission, unless the entity exercises due diligence to prevent such occurrences.
The following appendix will not appear in the Code of Federal Regulations.
DANLY, Commissioner,
1. I dissent from this notice of proposed rulemaking seeking to extend the duty of candor—which currently applies to “Sellers” in electric markets
2. Much of what the Commission and our jurisdictional entities routinely do involves “ `matter[s] of political, social, or other concern to the community' or . . . `is a subject of general interest and of value and concern to the public.' ”
3. The obvious question in response is what is the harm in simply extending the existing duty of candor? Would it not seem to make sense that people should tell the truth when conducting Commission-related activities? Is it not true that no court has held the existing duty of candor unlawful?
4. The proposed duty of candor provides that:
Any entity must provide accurate and factual information and not submit false or misleading information, or omit material information, in any communication with the Commission, Commission-approved market monitors, Commission-approved regional transmission organizations, Commission-approved independent system operators, jurisdictional transmission or transportation providers, or the Electric Reliability Organization and its associated Regional Entities, where such communication relates to a matter subject to the jurisdiction of the Commission, unless the entity exercises due diligence to prevent such occurrences.
5. So, for example, under the plain language of this provision, the Commission could find a violation of the duty of candor if a landowner (“entity”) exaggerates a complaint (“submit[s] . . . misleading information”) in an email to the pipeline developer with a right-of-way on her land (“in any communication with . . . jurisdictional transmission or transportation providers”). What if the landowner is angry about construction noise and says something like “I've never heard such a racket,” but in fact she had heard such a racket at a Poison concert in 1988? Absurd? Yes. Duty of candor violation? Also, yes.
6. In a recent generic proceeding, a commenter called claims made in a petition for rulemaking “largely defamatory.”
7. Commission enforcement of such violations may be unlikely, but the language the majority uses to reassure the public is quite alarming and amounts to “just trust us”:
[I]t is not the Commission's
So, are we to understand that it is the Commission's intention to penalize
8. In his concurrence in
[T]he pervasiveness of false statements, made for better or for worse motives, made thoughtlessly or deliberately, made with or without accompanying harm, provides a weapon to a government broadly empowered to prosecute falsity without more. And those who are unpopular may fear that the government will use that weapon selectively . . . .
9. Given the absence of limiting principles, this “duty of candor” risks “broadly empowering” the Commission to turn itself into a Ministry of Truth, policing the truth or falsity of an enormous sweep of communications. The rule is drafted so broadly that enforcement staff are likely subject to it. I am sure the subjects of investigations will appreciate this commitment to integrity.
10. Experience with the existing duty of candor suggests that promises of prosecutorial discretion are in the eye of the beholder, or in this case, the prosecutor. In practice, the Office of Enforcement frequently finds duty of candor violations when it finds any manipulative act or tariff violation. If a company is charged with violating an RTO tariff, duty of candor allegations appear almost automatic.
11. There is a sad irony to this rulemaking. The actual “candor” of communications within the industry will suffer. Employees at one utility (“transmission organization”) will hesitate to call or email counterparts at another utility (“transmission organization”) without first seeking the advice of counsel to make sure they have done their “due diligence” before engaging in “any communication.” This will deter cooperation within the industry and is not likely to be good for anyone.
12. There remain a few obvious questions: What about penalties? The NOPR says nothing about what sanctions the Commission plans to impose for this new class of violation. Presumably, it will be left to the Commission's discretion under its penalty guidelines
13. As usual, I strongly encourage anyone with the inclination or an interest in this proceeding to comment on the issues it raises.
14. In particular, I ask for comments on the fundamental question whether the proposed duty of candor creates Constitutional due process concerns because it is impermissibly vague. What conduct, exactly, is prohibited? Is there any way to cure the void-for-vagueness concerns?
15. How would a “due diligence” safe harbor work for members of the public, like the concert-going landowner who, in her communications with one of the listed entities, may be “prone to hyperbole”? Will the proposal chill public engagement with FERC and the listed jurisdictional entities? Should the Office of Public Participation offer sessions on how to qualify for the safe harbor when members of the public engage with RTOs and Utilities? I particularly encourage consumer advocates to comment on what the implications of this rule might be.
16. Further, does the Commission have the statutory authority to extend the duty of candor as far as proposed? Does the Commission's interest in protecting the integrity of its proceedings really extend to “any entity” in “any communication” “relate[d] to a matter subject to the jurisdiction of the Commission” with the rule's range of listed entities?
17. It may be possible to narrow the proposed duty of candor so that it would not grant the Commission such sweeping enforcement powers. I solicit comment on whether an intent or materiality requirement would allay concerns that the rule will impermissibly encompass core First Amendment protected speech.
18. Another irony: the Commission may be unlikely to get much candor from the regulated community in response to this NOPR. Most companies will be reticent to file comments in opposition to a proposed rule of candor. But voicing opposition to an impermissibly vague and broad rule that exposes a company to sweeping liability does not mean that the company supports lying to the Commission. They should not be hesitant. I strongly encourage industry comments and would be particularly interested in any experience with the application of the current duty of candor to the extent any entity is at liberty to discuss them. I also welcome a thorough analysis of our existing caselaw to fully judge how the existing duty of candor has been applied.
19. I look forward to reviewing the full record. My hope is that it will be sufficient to persuade the majority not to finalize this rule. We do not need rules for everything, especially when they are as problematically vague and broad as the proposal here.
For these reasons, I respectfully dissent.
Coast Guard, DHS.
Notice of proposed rulemaking.
The Coast Guard proposes to change how the CSX Transportation railroad drawbridge across Bay St. Louis, mile 0.5, Bay St. Louis, MS will operate. The bridge will continue to open according to the drawbridge regulations but the bridge tender will operate this bridge from a remote location at the CSX railroad terminal in Mobile, Alabama. We invite your comments on this proposed rulemaking.
Comments and relate material must reach the Coast Guard on or before October 11, 2022.
You may submit comments identified by docket number USCG-2022-0299 using Federal Decision Making Portal at
See the “Public Participation and Request for Comments” portion of the
If you have questions on this proposed rule, call or email Douglas Blakemore, Eighth Coast Guard District Bridge Administration Branch Chief at (504) 671-2128 or
The CSX Transportation railroad drawbridge crosses Bay St. Louis, mile 0.5, Bay St. Louis, MS. The bridge will continue to open according to the drawbridge regulations but the bridge tender will operate this bridge from a remote location at the CSX railroad terminal in Mobile, AL. This bridge has a 13 foot vertical clearance at mean high water, an unlimited vertical clearance in the open to vessel position and a 100′ horizontal clearance. The bridge operates according to 33 CFR 117.5.
CSX Transportation has requested to operate this bridge remotely from their railroad terminal in Mobile, AL. A copy of the bridge owners request can be found at
This NPRM will run simultaneously with a Test Deviation; under the same name and docket number. Both documents can be found at
This CSX drawbridge is located on Bay St. Louis, mile 0.5, Bay St. Louis, MS. It has a vertical clearance of 13′ in the closed to vessel position. The bridge operates according to 33 CFR 117.5. Bay St. Louis is used by commercial tows, barges and recreational vessel. The bridge opens for vessels about six times per day and vessels that do not need the bridge to open may pass.
33 CFR 117.42 sets Coast Guard drawbridge regulations. This regulation authorizes the Coast Guard District Commander to approve operations from a remote site. The bridge opens on signal for the passage of vessels in accordance with 33 CFR 117.5. This proposed rule will not change the operating schedule nor will it change how to request or signal for the bridge to open. Mariners requiring an opening may do so by contacting the CSX remote control center on Channels 13/16 or by the phone number posted at the bridge.
This proposed rule requires CSX to have the capability, including resources and manpower to return the operator to the bridge location following any of the below situations:
(1) Any component of the remote operations system fails and prevents the remote operator from being able to visually identify vessels, communicate with vessels, detect vessels immediately underneath the bridge or visually identify trains approaching the bridge.
(2) CSX fails to meet Federal Railway Administration (FRA) or any other government agency safety requirements; and.
(3) At the direction of the District Commander
We developed this proposed rule after considering numerous statutes and Executive Orders related to rulemaking. Below we summarize our analyses based on these statutes and Executive Orders.
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 NPRM has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM 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 certifies under 5 U.S.C. 605(b) that this proposed rule would 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 IV.A above this proposed rule would not have a significant economic impact on any vessel owner or operator.
If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this proposed rule would have a significant economic impact on it, please submit a comment (see
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 proposed 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
This proposed rule would call 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 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 proposed 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 proposed rule does not have tribal implications under Executive Order 13175 (Consultation and Coordination with Indian Tribal Governments) because it would 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. If you believe this proposed rule has implications for federalism or Indian tribes, please contact the person listed in the
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 proposed rule will not result in such an expenditure, we do discuss the effects of this proposed rule elsewhere in this preamble.
We have analyzed this rulemaking 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 proposed rule promulgates the operating regulations or procedures for drawbridges. Normally such actions are 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 rulemaking. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.
We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.
We accept anonymous comments. Comments we post to
Bridges.
For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 117 as follows:
33 U.S.C. 499; 33 CFR 1.05-1; DHS Delegation No. 0170.1.
(a) The draw of the CSX Transportation Railroad bridge, mile 0.5 Bay St. Louis, MS shall be remotely operated by the bridge tender at CSX's bridge remote control center in Mobile, Alabama and shall open promptly and fully when signaled to open. Vessels can contact the CSX bridge tender via VHF-FM channel 13 or 16 or by telephone at the number displayed on the signs posted at the bridge to request an opening of the draw.
(b) CSX will return the tender to the bridge location within 3 hours following any of the below situations:
(1) Any component of the remote operations system fails and prevents the remote operator from being able to visually identify vessels, communicate with vessels, detect vessels immediately underneath the bridge or visually identify trains approaching the bridge;
(2) CSX fails to meet Federal Railway Administration (FRA) or any other government agency safety requirements;
(3) Anytime at the direction of the District Commander.
Environmental Protection Agency (EPA).
Proposed rule; notice of data availability; request for comment; extending the comment period.
The U.S. Environmental Protection Agency (EPA) is issuing a notice of data availability (NODA) and extending the comment period for proposed amendments to the National Emissions Standards for Hazardous Air Pollutants (NESHAP) for Gasoline Distribution facilities and the Standards of Performance for Bulk Gasoline Terminals and proposed New Source Performance Standards (NSPS). The original proposed rule was published on June 10, 2022, with a 60-day public comment period closing August 9, 2022. With this notification, EPA is extending the public comment period for an additional 30 days, until September 12, 2022.
The comment period for the proposed rule published June 10, 2022, at 87 FR 35608, is extended. Comments should be received by September 12, 2022.
EPA has established a docket for this action under Docket ID No. EPA-HQ-OAR-2020-0371. Follow the detailed instructions provided under
Mr. Neil Feinberg, Sector Policies and Programs Division (E143-01), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711; telephone number: (919) 541-2214; fax number: (919) 541-0516; and email address:
The source categories subject to the June 10, 2022, proposal are Gasoline Distribution regulated under 40 CFR part 63, subparts R and BBBBBB and Petroleum Transportation and Marketing regulated under 40 CFR part 60, subpart XX. The EPA proposed revised requirements for loading operations, storage vessels and equipment leaks at bulk gasoline terminals and pipeline breakout stations at major sources of hazardous air pollutant emissions under the NESHAP for the major source gasoline distribution facilities (part 63, subpart R). The EPA also proposed revised requirements for loading operations, storage vessels and equipment leaks at area source bulk gasoline terminals, bulk gasoline plants, pipeline breakout stations, and pipeline pumping stations under the NESHAP for the area source gasoline distribution facilities (part 63, subpart BBBBBB). The sources affected by the proposed NSPS (part 60, subpart XXa) are loading operations and equipment leaks at bulk gasoline terminals that commenced construction or modification after June 10, 2022; emissions from storage vessels are covered under a separate NSPS (part 60, subpart Kb), which was not proposed to be amended.
On July 25, 2022, Our Children's Earth Foundation (“OCE”) requested an extension of the comment deadline for 30 to 45 days to review the proposed rules and supporting information included in the docket. OCE outlined several instances where they believed information appeared to be missing in the rulemaking docket. The EPA reviewed the rulemaking docket and concluded that, in most cases, the docket record was complete. However, we realized that we inadvertently omitted enforcement reports relied on for the proposed lower explosive limits (LEL) monitoring requirements included for internal floating roof storage vessels in that major and area source NESHAP. Following this request from OCE, EPA has decided to provide this notice of data availability (NODA) and comment period reopening to provide to notice and time for commenters to fully review the proposed rulemaking, including the additional information on LEL
Environmental Protection Agency (EPA).
Proposed rule; correction.
The U.S. Environmental Protection Agency (EPA) published a document in the
The public comment period for the proposed rule published in the
For questions about this action, contact Donna Lee Jones, Metals and Inorganic Chemicals Group, Sector Policies and Programs Division (D243-02), Environmental Protection Agency, Research Triangle Park, North Carolina 27711; telephone number: (919) 541-5251 fax number: (919) 541-3207 email address:
In the
1. On page 41639, in the second column, correct the
2. On page 41639, in the second column, correct the
3. On page 41639, in the third column, in the
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of availability of proposed fishery management plan amendment; request for comments.
The Mid-Atlantic Fishery Management Council has submitted Amendment 22 to the Summer Flounder, Scup, and Black Sea Bass Fishery Management Plan to NMFS. Amendment 22 proposes revisions to the summer flounder, scup, and black sea bass commercial and recreational allocation percentages. This action would also add the option for future modifications to the commercial/recreational allocation and transfer provisions to be considered through a framework action. Amendment 22 is intended to address the allocation-related impacts of the revised recreational catch and landings data provided by the Marine Recreational Information Program.
Public comments must be received on or before October 11, 2022.
You may submit comments on this document, identified by NOAA-NMFS-2022-0079, by the following method:
•
Copies of Amendment 22, including the Environmental Assessment, the Regulatory Impact Review, and the Initial Regulatory Flexibility Analysis (EA/RIR/IRFA) prepared in support of this action are available from Dr. Christopher M. Moore, Executive Director, Mid-Atlantic Fishery Management Council, Suite 201, 800 North State Street, Dover, DE 19901. The supporting documents are also accessible via the internet at:
Emily Keiley, Fishery Policy Analyst, (978) 281-9116, or email:
The Magnuson-Stevens Fishery Conservation and Management Act requires that each Regional Fishery Management Council transmit any amendment it prepares to NMFS for review and approval, disapproval, or partial approval. The Magnuson-Stevens Act also requires that NMFS, upon receiving an amendment and associated regulations deemed necessary by the Council to implement the amendment, immediately publish notification in the
The Mid-Atlantic Fishery Management Council (Council) and the Atlantic States Marine Fisheries Commission (Commission) cooperatively manage the summer flounder, scup, and black sea bass fisheries. The Summer Flounder, Scup, and Black Sea Bass Fishery Management Plan (FMP) outlines the allocation of quota, for each species, between the commercial and recreational fisheries. This joint amendment reevaluates and proposes to revise the commercial and recreational sector allocations in the Summer Flounder, Scup, and Black Sea Bass FMP. This action was initiated in part to address the allocation-related impacts of the revised recreational catch and landings data provided by the Marine Recreational Information Program (MRIP). Specifically, this amendment considers:
1. Modifying the current allocations between the commercial and recreational sectors for summer flounder, scup, and black sea bass;
2. Adding an option to transfer a portion of the allowable landings each year between the commercial and recreational sectors, in either direction, based on the needs of each sector; and
3. Adding the option for future additional modifications to the commercial/recreational allocation and/or transfer provisions to be considered through an FMP addendum/framework action, as opposed to an amendment.
Amendment 22 would change the commercial and recreational allocations for summer flounder, scup, and black sea bass. The current commercial and recreational allocations for all three species were set in the mid-1990s based on historical proportions of landings (for summer flounder and black sea bass) and catch (for scup) from each sector. Recent changes in how recreational catch is estimated by MRIP resulted in a revised time series of recreational data going back to the 1980s. This created a mismatch between the data that were used to set the allocations and the data currently used in management for setting catch limits. Changes to commercial catch data have also been made since the allocations were established. The allocation changes proposed in this amendment seek to ensure that the best available data is used to determine commercial and recreational sector allocations.
Amendment 22 includes a range of allocation alternatives, with options that would have maintained the current allocations and a variety of options to revise the allocations based on updated data using the same or modified “base years” (the time periods used to set the current allocations). The Council and Board ultimately voted to revise the allocations using the original base years updated with new data. This approach allows for consideration of fishery characteristics in years prior to influence by the commercial/recreational allocations, while also using the best scientific information available to understand the fisheries in those base years.
For all three species, these changes result in a shift in allocation from the commercial to the recreational sector. However, because the summer flounder and black sea bass fisheries will be transitioning from landings-based to catch-based allocations, the current and revised allocations for those species are not directly comparable. The proposed commercial and recreational sector allocations are shown in Table 1.
The Council and Board considered, but did not recommend, an option to “phase in” the allocation changes over a period of time. A phase-in period was deemed unnecessary given the relatively small magnitude of allocation changes.
The Council and Board also approved an option to allow future changes to commercial/recreational allocations, annual quota transfers, and other measures addressed in the amendment to be made through framework actions.
They also considered, but did not recommend, an option to allow transfers of annual quota between the commercial and recreational sectors at this time.
The Magnuson-Stevens Fishery Conservation and Management Act allows us to approve, partially approve, or disapprove measures recommended by the Council in an amendment based on whether the measures are consistent with the fishery management plan, plan amendment, the Magnuson-Stevens Act and its National Standards, and other applicable law. As such, we are seeking comment on whether measures in the Commercial/Recreational Allocation Amendment are consistent with the Summer Flounder, Scup, and Black Sea Bass FMP, the Magnuson-Stevens Act and its National Standards, and other applicable law. Public comments on this amendment and its incorporated documents may be submitted through the end of the comment period stated in this notification of availability.
A proposed rule to implement the amendment, including draft regulatory text, will also be published in the
Comments received after that date will not be considered in the decision to approve or disapprove the amendment.
16 U.S.C. 1801
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding; whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; ways to enhance the quality, utility and clarity of the information to be collected; and ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Comments regarding this information collection received by September 12, 2022will be considered. Written comments and recommendations for the proposed information collection should be submitted within 30 days of the publication of this notice on the following website
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
Forest Service, Agriculture (USDA).
Notice of meeting.
The Trinity County Resource Advisory Committee (RAC) will hold two public meetings in September 2022 according to the details shown below. 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 (FACA). 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 Shasta Trinity National Forest, consistent with the Federal Lands Recreation Enhancement Act. General information and meeting details can be found at the following website:
The meetings will be held on the following dates/times:
• September 12, 2022, 4:30 p.m.-6:30 p.m., Pacific Daylight Time; and
• September 19, 2022, 4:30 p.m.-6:30 p.m., Pacific Daylight Time.
All RAC meetings are subject to cancellation. For status of the meeting prior to attendance, please contact the person listed under
The meetings are open to the public and will be held virtually via telephone and/or video conference. Virtual meeting participation details can be found on the website listed under
Written comments may be submitted as described under
Monique Rea, RAC Coordinator, by phone at 916-580-5651 or via email at
Individuals who use telecommunication devices for the deaf and hard of hearing (TDD) may call the Federal Relay Service (FRS) at 1-800-877-8339, 24 hours a day, every day of the year, including holidays.
The meeting agenda will include:
1. Roll call;
2. Comments from the Designated Federal Official (DFO);
3. Review, discuss and approve minutes from previous RAC Meeting;
4. Review, disscuss, and vote on project proposals;
5. RAC Funding;
6. Public comment period; and
7. Closing comments from the DFO.
The meetings are 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 make a request in writing at least three days prior to the meeting date to be scheduled on the agenda for a particular meeting. 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 Monique Rea, RAC Coordinator, 360 Main Street, Weaverville, California 96093; or by email to
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 (
Equal opportunity practices in accordance with USDA's policies will be followed in all appointments to the Committee. To ensure that the recommendations of the Committee have taken in account the needs of the diverse groups served by USDA, membership shall include to the extent possible, individuals with demonstrated ability to represent minorities, women, and person with disabilities. USDA is an equal opportunity provider, employer, and lender.
Forest Service, Agriculture (USDA).
Notice of meeting.
The Shasta County Resource Advisory Committee (RAC) will hold a public meeting according to the details shown below. 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 (FACA). 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 Shasta-Trinity National Forest within Trinity County, consistent with the Federal Lands Recreation Enhancement Act. RAC information and virtual meeting information can be found at the following website:
The virtual meeting will be held on August 24, 2022, 9:30 a.m.-11:30 a.m., Pacific 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 is open to the public and will be held virtually via telephone and/or video conference. Virtual meeting participation details can be found on the website listed under
Written comments may be submitted as described under
Monique Rea, RAC Coordinator, by phone at 916-580-5651 or via email
Individuals who use telecommunication devices for the deaf and hard of hearing (TDD) may call the Federal Relay Service (FRS) at 1-800-877-8339, 24 hours per day, every day of the year, including holidays.
The meeting agenda will include:
1. Roll call;
2. Comments from the Designated Federal Official (DFO
3. RAC project updates;
4. Funding;
5. Discuss, recommend, approve projects;
6. Public comment period; and
7. Closing comments from the DFO.
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 at least three days prior to the meeting date, 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 Monique Rea, RAC Coordinator, 360 Main Street, Weaverville, California 96093; or by email to
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 (
Equal opportunity practices in accordance with USDA's policies will be followed in all appointments to the Committee. To ensure that the recommendations of the Committee have taken in account the needs of the diverse groups served by USDA, membership shall include to the extent possible, individuals with demonstrated ability to represent minorities, women, and person with disabilities. USDA is an equal opportunity provider, employer, and lender.
Forest Service, Agriculture (USDA).
Notice of meeting.
The Missouri River Resource Advisory Committee (RAC) will hold a public meeting according to the details shown below. 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 (FACA). 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 Helena-Lewis and Clark National Forest, consistent with the Federal Lands Recreation Enhancement Act. General information and meeting details can be found at the following website:
The meeting will be held on September 8, 2022, 7:00 p.m.-8:00 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 is open to the public and will be held virtually via telephone and/or video conference. Virtual meeting participation details can be found on the website listed under
Written comments may be submitted as described under
Molly Ryan, Designated Federal Officer (DFO), by phone at 406-949-9766 or email at
Individuals who use telecommunication devices for the deaf and hard of hearing (TDD) may call the Federal Relay Service (FRS) at 1-800-877-8339, 24 hours a day, every day of the year, including holidays.
The meeting agenda will include:
1. Review recreation fee proposal for Ear Mountain Cabin;
2. Review member status/reappointment logistics;
3. Approve meeting minutes;
4. Schedule the next meeting; and
5. Review slideshow of completed projects that have benefited from Title II funds the Missouri River RAC has allocated.
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 make a request in writing at least three days prior to the meeting date 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 Elizabeth Casselli, 1220 38th Street North, Great Falls, MT 59405; or by email to
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 (
Equal opportunity practices in accordance with USDA's policies will be followed in all appointments to the Committee. To ensure that the recommendations of the Committee have taken in account the needs of the diverse groups served by USDA, membership shall include to the extent possible, individuals with demonstrated ability to represent minorities, women, and person with disabilities. USDA is an equal opportunity provider, employer, and lender.
Forest Service, Agriculture (USDA).
Notice of meeting.
The Trinity County Resource Advisory Committee (RAC) will hold a public meeting according to the details shown below. 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 (FACA). The purpose of the committee is to improve
The meeting will be held on August 22, 2022, 4:30 p.m.-6:30 p.m., Pacific 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 is open to the public and will be held virtually via telephone and/or video conference. Virtual meeting participation details can be found on the website listed under
Written comments may be submitted as described under
Monique Rea, RAC Coordinator, by phone at 916-580-5651 or via email at
Individuals who use telecommunication devices for the deaf and hard of hearing (TDD) may call the Federal Relay Service (FRS) at 1-800-877-8339, 24 hours per day, every day of the year, including holidays.
The meeting agenda will include:
1. Roll call;
2. Comments from the Designated Federal Official (DFO);
3. Approve minutes from last meeting;
4. Discuss, recommend, approve projects;
5. Public comment period; and
6. Closing comments from the DFO.
The meeting is open to the public. The agenda will include time for individuals to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing at least 3 days prior to the meeting date, 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 Monique Rea, RAC Coordinator, 360 Main Street, Weaverville, California 96093; or by email to
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 (
Equal opportunity practices in accordance with USDA's policies will be followed in all appointments to the Committee. To ensure that the recommendations of the Committee have taken in account the needs of the diverse groups served by USDA, membership shall include to the extent possible, individuals with demonstrated ability to represent minorities, women, and person with disabilities. USDA is an equal opportunity provider, employer, and lender.
Forest Service, Agriculture (USDA).
Solicitation of nominations for members.
The Forest Service, The United States Department of Agriculture (USDA) is seeking nominations for the Secure Rural School Resource Advisory Committees (SRS RACs) pursuant the Secure Rural Schools and Community Self-Determination Act (the Act) and the Federal Advisory Committee Act (FACA). Additional information on the SRS RACs can be found by visiting the SRS RACs website at:
Written nominations must be received November 10, 2022. A completed application packet includes the nominee's name, resume, and completed
See
Brianna Gallegos, National Partnership Coordinator, National Partnership Office, USDA Forest Service, Yates Building, 1400 Independence Avenue, Mailstop #1158, Washington, DC 20250 or by email to
In accordance with the provisions of FACA, the Secretary of Agriculture is seeking nominations for the purpose of improving collaborative relationships among people who use and care for National Forests and provide advice and recommendations to the Forest Service concerning projects and funding consistent with Title II. The duties of SRS RACs include monitoring projects, advising the Secretary on the progress and results of monitoring efforts, and making recommendations to the Forest Service for any appropriate changes or adjustments to the projects being monitored by the SRS RACs.
The SRS RACs will be comprised of 15 members approved by the Secretary of Agriculture (or designee) where each will serve a 4-year term. SRS RACs memberships will be balanced in terms of the points of view represented and
(1) Five persons who represent:
(a) Organized Labor or Non-Timber Forest Product Harvester Groups;
(b) Developed Outdoor Recreation, Off-Highway Vehicle Users, or Commercial Recreation Activities;
(c) Energy and Mineral Development, or Commercial or Recreational Fishing Groups;
(d) Commercial Timber Industry; and
(e) Federal Grazing Permit or Other Land Use Permit Holders, or Representative of Non-Industrial Private Forest Land Owners, within the area for which the committee is organized.
(2) Five persons who represent:
(a) Nationally or Regionally Recognized Environmental Organizations;
(b) Regionally or Locally Recognized Environmental Organizations;
(c) Dispersed Recreational Activities;
(d) Archaeology and History; and
(e) Nationally or Regionally Recognized Wild Horse and Burro Interest, Wildlife Hunting Organizations, or Watershed Associations.
(3) Five persons who represent:
(a) State Elected Office holder;
(b) County or Local Elected Office holder;
(c) American Indian Tribes within or adjacent to the area for which the committee is organized;
(d) Area School Officials or Teachers; and
(e) Affected Public-at-Large.
If a vacancy arises, the Designated Federal Officer (DFO) may consider recommending to the Secretary (or designee) to fill the vacancy as soon as it occurs with a candidate from the applicant pool provided an appropriate candidate is available. In accordance with the Act, members of the SRS RAC shall serve without compensation. SRS RAC members and replacements may be allowed travel expenses and per diem for attendance at committee meetings, subject to approval of the DFO responsible for administrative support to the SRS RAC.
The appointment of members to the SRS RACs will be made by the Secretary of Agriculture (or designee).
The public is invited to submit nominations for membership on the SRS RACs, either as a self-nomination or a nomination of any qualified and interested person. Any individual or organization may nominate one or more qualified persons to represent the interest areas listed above. To be considered for membership, nominees must:
1. Be a resident of the State in which the SRS RAC has jurisdiction;
2. Identify what interest group they would represent and how they are qualified to represent that interest group;
3. Provide a cover letter stating why they want to serve on the SRS RAC and what they can contribute;
4. Provide a resume showing their past experience in working successfully as part of a group working on forest management activities;
5. Complete
Nominations and completed applications for SRS RACs should be sent to the appropriate Forest Service Regional Offices listed below:
Jeffery Miller, Northern Regional Coordinator, Forest Service, 26 Fort Missoula Road, Missoula, Montana 59804, (406) 329-3576.
Jace Ratzlaff, Rocky Mountain Regional Coordinator, Forest Service, 1617 Cole Blvd., Building 17, Lakewood, Colorado 80401, (719) 469-1254.
Jonathan Word, Southwestern Regional Coordinator, Forest Service, 333 Broadway SE, Albuquerque, New Mexico 87102, (505) 842-3241.
Don Jaques, Intermountain Regional Coordinator (Idaho/Utah/Nevada), Forest Service, 355 North Vernal Avenue, Vernal, UT 84078 (435) 781-5119.
Paul Wade, Pacific Southwest Regional Coordinator, Forest Service, 1323 Club Drive, Vallejo, California 94592, (707) 562-9010.
Yewah Lau, Pacific Northwest Regional Office, Forest Service, 295142 Highway 101 South, Quilcene, Washington 98379, (360) 981-9101.
Sheila Holified, Southern Regional Coordinator, Forest Service, 1720 Peachtree Road, Northwest, Atlanta, Georgia 30309, (205) 517-9033.
David Scozzafave, Eastern Regional Coordinator, Forest Service, 626 East Wisconsin Avenue, Milwaukee, Wisconsin 53202, (414) 297-3602.
Kevin Hood, Alaska Regional Coordinator, Forest Service, 709 West 9th Street, Room 561C, Juneau, Alaska 99801-1807, (907) 586-7829.
Equal opportunity practices in accordance with USDA's policies will be followed in all appointments to the Committee. To ensure that the recommendations of the Committee have taken in account the needs of the diverse groups served by USDA, membership shall include to the extent possible, individuals with demonstrated ability to represent minorities, women, and person with disabilities. USDA is an equal opportunity provider, employer, and lender.
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.
Forest Service, Agriculture (USDA).
Notice of meeting.
The Black Hills National Forest Advisory Board (NFAB) will hold a public meeting according to the details shown below. The committee is authorized under the Forest and Rangeland Renewable Resources Planning Act of 1974, the National Forest Management Act of 1976, the Federal Public Lands Recreation Enhancement Act, and operates in compliance with the Federal Advisory Committee Act (FACA). The purpose of the committee is to provide advice and recommendations on a broad range of forest issues such as forest plan revisions or amendments, forest health including fire, insect and disease, travel management, forest monitoring and evaluation, recreation fees, and site specific projects having forest-wide implications. General information can be found at the following website:
The meeting will be held on September 21, 2022, 1:00 p.m.-4:30 p.m., Mountain Daylight Time.
All commmittee meetings are subject to cancellation. For status of the meeting prior to attendance, please contact the person listed under
This meeting is open to the public and will be held at the U.S. Forest Service, Mystic Ranger District Office, 8221 Mount Rushmore Road, Rapid City, South Dakota 57702. Virtual meeting participation details can be found on the website listed under
Written comments may be submitted as described under
Scott Jacobson, Committee Coordinator, by phone at 605-440-1409 or email at
Individuals who use telecommunication devices for the deaf and hard of hearing (TDD) may call the Federal Relay Service (FRS) at 1-800-877-8339, 24 hours a day, every day of the year, including holidays.
The meeting agenda will include:
1. Annual Ethics Training;
2. Black Hills National Forest Overview;
3. Getting to know your BHNF Leadership; and
4. Elect Chair/Vice Chair.
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 make a request in writing by at least three days before the meeting 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 Scott Jacobson, NFAB Committee Coordinator, Mystic Ranger District Office, 8221 Mount Rushmore Road, Rapid City, South Dakota 57702; or by email to
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.
Equal opportunity practices in accordance with USDA's policies will be followed in all appointments to the Committee. To ensure that the recommendations of the Committee have taken in account the needs of the diverse groups served by USDA, membership shall include to the extent possible, individuals with demonstrated ability to represent minorities, women, and person with disabilities. USDA is an equal opportunity provider, employer, and lender.
Persons with disabilities who require alternative means of communication for program information (
Forest Service, Agriculture (USDA).
Notice of meeting.
The Shasta County Resource Advisory Committee (RAC) will hold two public meetings in September 2022 according to the details shown below. 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 (FACA). 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 Shasta-Trinity National Forest within Trinity County, consistent with the Federal Lands Recreation Enhancement Act. RAC information and virtual meeting information can be found at the following website:
The meetings will be held on the following dates/times:
• September 14, 2022, 9:30 a.m.-11:30 a.m., Pacific Daylight Time, and
• September 21, 2022, 9:30 a.m.-11:30 a.m., Pacific Daylight Time.
All RAC meetings are subject to cancellation. For status of the meetings prior to attendance, please contact the person listed under
The meetings are open to the public and will be held virtually via telephone and/or video conference. Virtual meeting participation details can be found on the website listed under
Written comments may be submitted as described under
Monique Rea, RAC Coordinator, by phone at 916-580-5651 or via email at
Individuals who use telecommunication devices for the deaf and hard of hearing (TDD) may call the Federal Relay Service (FRS) at 1-800-877-8339, 24 hours per day, every day of the year, including holidays.
The meeting agenda will include:
1. Roll call;
2. Comments from the Designated Federal Official (DFO);
3. RAC project updates;
4. Funding;
5. Elect Chair;
6. Discuss, recommend, approve projects;
7. Public comment period; and
8. Closing comments from the DFO.
The meetings are 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 at least three days prior to the meeting dates, to be scheduled on the agenda for a particular meeting. 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 Monique Rea, RAC Coordinator, 360 Main Street, Weaverville, California 96093; or by email to
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 (
Equal opportunity practices in accordance with USDA's policies will be followed in all appointments to the Committee. To ensure that the recommendations of the Committee have taken in account the needs of the diverse groups served by USDA, membership shall include to the extent possible, individuals with demonstrated ability to represent minorities, women, and person with disabilities. USDA is an equal opportunity provider, employer, and lender.
Commission on Civil Rights.
Notice; revision of virtual meeting platform and additional meeting information.
The Commission on Civil Rights is holding a meeting of the Tennessee Advisory Committee on Wednesday, August 24, 2022, at 12 p.m. (CT). This notice revises the meeting date and virtual meeting information. The notice is in the
Victoria Moreno, (434) 515-0204,
Replace Webex virtual details as follows:
Join via phone: 800-360-9505 USA Toll Free; Access Code: 2763 908 5121#.
United States Commission on Civil Rights.
Notice of Commission public business meeting.
Friday, August 19, 2022, 10:00 a.m. EST.
Meeting to take place virtually and is open to the public via livestream on the Commission's YouTube page:
Angelia Rorison: 202-376-8371;
In accordance with the Government in Sunshine Act (5 U.S.C. 552b), the Commission on Civil Rights is holding a meeting to discuss the Commission's business for the month. This business meeting is open to the public. Computer assisted real-time transcription (CART) will be provided. The web link to access CART (in English) on Friday, August 19, 2022, is
Economic Development Administration, Department of Commerce.
Notice and opportunity for public comment.
The Economic Development Administration (EDA) has received petitions for certification of eligibility to apply for Trade Adjustment Assistance from the firms listed below. Accordingly, EDA has initiated investigations to determine whether increased imports into the United States of articles like or directly competitive with those produced by each of the firms contributed importantly to the total or partial separation of the firms' workers, or threat thereof, and to a decrease in sales or production of each petitioning firm.
Any party having a substantial interest in these proceedings may request a public hearing on the matter. A written request for a hearing must be submitted to the Trade Adjustment Assistance Division, Room 71030, Economic Development Administration, U.S. Department of Commerce, Washington, DC 20230, no later than ten (10) calendar days following publication of this notice. These petitions are received pursuant to section 251 of the Trade Act of 1974, as amended.
Please follow the requirements set forth in EDA's regulations at 13 CFR 315.8 for procedures to request a public hearing. The Catalog of Federal Domestic Assistance official number and title for the program under which these petitions are submitted is 11.313, Trade Adjustment Assistance for Firms.
International Trade Administration, Department of Commerce.
Extension of solicitation of nominations for membership in the Renewable Energy and Energy Efficiency Advisory Committee.
As announced in the June 15, 2022
All nominations for immediate consideration for appointment must be received by 5:00 p.m. Eastern Daylight Time (EDT) on August 25, 2022. After that date, ITA may continue to accept nominations under this notice to fill any vacancies that may arise.
Nominations may be emailed to
Cora Dickson, Office of Energy & Environmental Industries; phone 202-482-6083; email
The Committee shall consist of approximately 35 members appointed by the Secretary in accordance with applicable Department of Commerce guidance and based on their ability to carry out the objectives of the Committee. Members shall represent U.S. companies, U.S. trade associations, U.S. private sector organizations, and civil society groups with activities focused on the export competitiveness of U.S. renewable energy and energy efficiency goods and services. The Committee shall also represent the range of company or organizational roles in the development of renewable energy and energy efficiency projects, including, for example, project developers, technology integrators, financial institutions, and manufacturers. Members of the Committee are selected, in accordance with applicable Department of Commerce guidelines, based on their ability to carry out the objectives of the Committee as set forth in the Charter and in a manner that ensures that the Committee is balanced in terms of points of view, industry subsector, geography, and company size. The diverse membership of the Committee assures perspectives reflecting the full breadth of the Committee's responsibilities, and, where possible, the Department of Commerce will also consider the ethnic, racial, and gender diversity and various abilities of the United States population.
Members serve at the pleasure of the Secretary from the date of appointment to the Committee to the date on which the Committee's charter terminates. Members serve in a representative capacity presenting the views and interests of a U.S. entity or U.S. organization, as well as their particular subsector; they are, therefore, not Special Government Employees.
Members of the Committee must not be registered as foreign agents under the Foreign Agents Registration Act. No member may represent a company that is majority owned or controlled by a foreign government entity (or foreign government entities). Members of the Committee will not be compensated for their services or reimbursed for their travel expenses.
If you are interested in applying or nominating someone else to become a member of the Committee, please provide the following information:
(1) Sponsor letter on the company's, trade association's or organization's letterhead containing the name, title, and relevant contact information (including phone and email address) of the individual who is applying or being nominated;
(2) An affirmative statement that the nominee will be able to meet the expected time commitments of Committee work. Committee work includes
• attending in-person committee meetings roughly four times per year (lasting one day each),
• undertaking additional work outside of full committee meetings including subcommittee conference calls or meetings as needed, and
• frequently drafting, preparing, or commenting on proposed recommendations to be evaluated at Committee meetings;
(3) Short biography of nominee, including credentials;
(4) Brief description of the company, trade association, or organization to be represented and its business activities; company size (number of employees and annual sales); and export markets served;
(5) An affirmative statement that the nominee meets all Committee eligibility requirements.
Please do not send company, trade association, or organization brochures or any other information.
See the
Nominees selected for appointment to the Committee will be notified by email.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meeting.
The New England Fishery Management Council (Council) is scheduling a public meeting of its Groundfish Advisory Panel to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). This meeting will be held in-person without a webinar option. Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.
This meeting will be held on Wednesday, August 31, 2022, at 8:30 a.m.
The meeting will be held at the Hilton Garden Inn, 100 Boardman Street, Boston, MA 02129; phone: (617) 567-6789.
Thomas A. Nies, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492.
The Groundfish Advisory Panel will discuss development of draft Framework Adjustment 65 specifications and measures: status determination criteria, rebuilding plans for Gulf of Maine (GOM) cod and Southern New England/Mid-Atlantic (SNE/MA) winter flounder, FY2023-FY2024 US/CA total allowable catches, FY2023-FY2024 specifications: Georges Bank (GB) yellowtail flounder and GB cod (including a catch target for the recreational fishery), FY2023-FY2025 specifications for 14 stocks, additional measures to promote stock rebuilding for GB cod, GOM cod and SNE/MA winter flounder, and revised acceptable biological catch (ABC) control rules, in consultation with the Scientific and Statistical Committee. They will also discuss Amendment 23 progress on development of metrics. The advisory panel will also discuss the development of a draft white paper on potential approaches to allocate “Georges Bank cod” to the recreational fishery delivered in 2022 to inform the 2023 priorities discussion as well as discuss possible groundfish priorities for 2023. The panel will make recommendations to the Groundfish Committee, as appropriate, and discuss other business, as necessary.
Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during these meetings. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at (978) 465-0492, at least 5 days prior to the date. This meeting will be recorded. Consistent with 16 U.S.C. 1852, a copy of the recording is available upon request.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public meeting.
The New England Fishery Management Council (Council) is scheduling a public meeting of its Groundfish Recreational Advisory Panel to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). This meeting will be held in-person without a webinar option. Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.
This meeting will be held on Wednesday, August 31, 2022, at 1:30 p.m.
The meeting will be held at the Hilton Garden Inn, 100 Boardman Street, Boston, MA 02129; phone: (617) 567-6789.
Thomas A. Nies, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492.
The Groundfish Recreational Advisory Panel will discuss development of draft Framework Adjustment 65 specifications and measures: status determination criteria, rebuilding plans for Gulf of Maine (GOM) cod and Southern New England/Mid-Atlantic (SNE/MA) winter flounder, FY2023-FY2024 US/CA total allowable catches, FY2023-FY2024 specifications: Georges Bank (GB) yellowtail flounder and GB cod (including a catch target for the recreational fishery), FY2023-FY2025 specifications for 14 stocks, additional measures to promote stock rebuilding for GB cod, GOM cod and SNE/MA winter flounder, and revised acceptable biological catch (ABC) control rules, in consultation with the Scientific and Statistical Committee. The Panel will also discuss the development of a draft white paper on potential approaches to allocate “Georges Bank cod” to the recreational fishery delivered in 2022 to inform the 2023 priorities discussion as well as possible groundfish priorities for 2023. They will discuss and provide input to the Groundfish Committee on updating NOAA's National Saltwater Recreational Fisheries Policy. They will also make recommendations to the Groundfish Committee, as appropriate, and discuss other business, as necessary.
Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during these meetings. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at (978) 465-0492, at least 5 days prior to the date. This meeting will be recorded. Consistent with 16 U.S.C. 1852, a copy of the recording is available upon request.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; receipt of application.
Notice is hereby given that the Chicago Zoological Society (Michael J. Adkesson, D.V.M., Responsible Party), 3300 South Golf Road, Brookfield, Illinois 60513, has applied in due form for a permit to import and export marine mammal parts for scientific research.
Written, telefaxed, or email comments must be received on or before September 12, 2022.
The application and related documents are available for review by selecting “Records Open for Public Comment” from the “Features” box on the Applications and Permits for Protected Species (APPS) home page,
Written comments on this application should be submitted via email to
Those individuals requesting a public hearing should submit a written request via email to
Jennifer Skidmore or Shasta McClenahan, Ph.D., (301) 427-8401.
The subject permit is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361
The applicant proposes to import and export marine mammal parts from South American fur seals (
In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321
Concurrent with the publication of this notice in the
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meeting.
The New England Fishery Management Council (Council) is scheduling a joint public meeting of its Skate Committee and Advisory Panel via webinar to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.
This webinar will be held on Thursday, September 1, 2022, at 9 a.m.
Webinar registration URL information:
Thomas A. Nies, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492.
The Skate Committee and Advisory Panel will meet jointly to review and discuss, the 2022 Northeast Skate Complex Annual Monitoring Report (for FY 2021) including Plan Development Team work to improve methods for catch accounting, specifications, and in-season quota monitoring. They will also develop recommendations for 2023 Council management priorities regarding skates. This could include an action to address the NOAA Fisheries Draft Action Plan to Reduce Atlantic Sturgeon Bycatch in Federal Large Mesh Gillnet Fisheries. Other business may be discussed, as necessary.
Although non-emergency issues not contained on the agenda may come before this Council for discussion, those issues may not be the subject of formal action during this meeting. Council action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency. The public also should be aware that the meeting will be recorded. Consistent with 16 U.S.C. 1852, a copy of the recording is available upon request.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.
Consumer Financial Protection Bureau.
Notice and request for comment.
In accordance with the Paperwork Reduction Act of 1995 (PRA), the Consumer Financial Protection Bureau (CFPB or Bureau) requests the extension of the Office of Management and Budget's (OMB's) approval of the existing information collection titled “Privacy of Consumer Financial Information (Regulation P)” approved under OMB Control Number 3170-0010.
Written comments are encouraged and must be received on or before September 12, 2022 to be assured of consideration.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Documentation prepared in support of this information collection request is available at
Consumer Financial Protection Bureau.
Notice and request for comment.
In accordance with the Paperwork Reduction Act of 1995 (PRA), the Consumer Financial Protection Bureau (CFPB or Bureau) requests the extension of the Office of Management and Budget's (OMB's) approval of the existing information collection titled “Equal Credit Opportunity Act (Regulation B)” approved under OMB Control Number 3170-0013.
Written comments are encouraged and must be received on or before September 12, 2022 to be assured of consideration.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Documentation prepared in support of this information collection request is available at
The ECOA also prescribes creditors must inform applicants of decisions made on credit applications. Particularly where creditors make adverse actions on credit applications or existing accounts, creditors must inform consumers as to why the adverse action was taken such that credit applicants can challenge errors or learn how to become more creditworthy. Creditors must retain all application information for 25 months including notices that they sent, and any information related to adverse actions. The ECOA requires creditors who furnish applicant information to a consumer reporting agency to reflect participation of the applicant's spouse if the spouse is permitted to use or is contractually liable on the account.
Office of Postsecondary Education, Department of Education.
Notice.
The Department of Education (Department) is issuing a notice inviting applications (NIA) for fiscal year (FY) 2022 for the Postsecondary Success Program, Assistance Listing Number 84.116M. This notice relates to the approved information collection under OMB control number 1894-0006.
For the addresses for obtaining and submitting an application, please refer to our Common Instructions for Applicants to Department of Education Discretionary Grant Programs, published in the
Nemeka Mason, U.S. Department of Education, 400 Maryland Avenue SW, Room 2C102, Washington, DC 20202-4260. Telephone: (202) 453-5650. Email:
If you are deaf, hard of hearing, or have a speech disability and wish to access telecommunications relay services, please dial 7-1-1.
Nationally, the U.S. Census Bureau reports that nearly one in five Americans has some college education but no degree.
The pandemic has further exacerbated some of the college completion challenges that students face. As colleges pivoted to online instruction and students faced unprecedented and simultaneous health, family, and employment challenges, an estimated 1 million students left school. Many still have not returned.
Many institutions have engaged in institutional reform efforts or implemented evidence-based activities that helped to improve their students' rates of completion. For instance, corequisite remediation programs have helped students to stay enrolled and on track for completion by allowing them to earn credit while completing developmental education courses.
We believe the college completion funds available through this grant program will help to amplify the work already happening on campuses to improve retention and completion and reengage students who are close to completion, especially nontraditional students. Specifically, the Department encourages applicants that have already committed to evidence-based practices for reenrollment and retention, completion, and/or closing equity gaps to apply for this grant program. Wherever possible, institutions should note their participation in networks and communities of practice related to college completion efforts as evidence of the institution's commitment to this work and capacity both to conduct the work and to share it with partner institutions. We also urge applicant institutions to think carefully about opportunities to evaluate their strategies as rigorously as possible to ensure they produce high-quality information about the effectiveness of the intervention as the strength of the institution's proposed evaluation plan will be a key factor in reviewing the application, as detailed in the selection criteria. Additionally, subject to the availability of funding, successful applicants may be required to work with a Department technical assistance provider in carrying out project evaluations that will build evidence of effectiveness.
This priority is:
Projects that are designed to improve postsecondary student outcomes and that are supported by evidence that meets the conditions in the definition of “promising evidence” (as defined in 34 CFR 77.1(c)). In responding to this priority, applicants must identify one or more of the proposed activities (project components) that meet the promising evidence standard and include a logic model that demonstrates the relationship between such proposed activities and the relevant outcomes the project is designed to achieve.
This priority is:
Applications from community colleges (as defined in this notice).
(i) A randomized controlled trial employs random assignment of, for example, students, teachers, classrooms, or schools to receive the project component being evaluated (the treatment group) or not to receive the project component (the control group).
(ii) A regression discontinuity design study assigns the project component being evaluated using a measured variable (
(iii) A single-case design study uses observations of a single case (
(i) A practice guide prepared by What Works Clearinghouse (WWC) reporting a “strong evidence base” or “moderate evidence base” for the corresponding practice guide recommendation;
(ii) An intervention report prepared by the WWC reporting a “positive effect” or “potentially positive effect” on a relevant outcome with no reporting of a “negative effect” or “potentially negative effect” on a relevant outcome; or
(iii) A single study assessed by the Department, as appropriate, that—
(A) Is an experimental study, a quasi-experimental design study, or a well-
(B) Includes at least one statistically significant and positive (
Contingent upon the availability of funds and the quality of applications, we may make additional awards in subsequent years from the list of unfunded applications from this competition.
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• A “page” is 8.5′ x 11′, on one side only, with 1″ margins at the top, bottom, and both sides.
• Doublespace (no more than three lines per vertical inch) all text in the application narrative, including titles, headings, footnotes, quotations, references, and captions as well as all text in charts, tables, figures, and graphs.
• Use a font that is either 12 point or larger, and no smaller than 10 pitch (characters per inch).
• Use one of the following fonts: Times New Roman, Courier, Courier New, or Arial.
The recommended page limit does not apply to the cover sheet; the budget section, including the narrative budget justification; the assurances and certifications; or the one-page abstract. However, the recommended page limit does apply to all of the application narrative.
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(1) The Secretary considers the need for the proposed project.
(2) In determining the need for the proposed project, the Secretary considers the following factors:
(i) The magnitude or severity of the problem to be addressed by the proposed project. (Up to 10 points)
(ii) The extent to which the proposed project will provide services or otherwise address the needs of students at risk of educational failure. (Up to 5 points)
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(1) The Secretary considers the significance of the proposed project.
(2) In determining the significance of the proposed project, the Secretary considers the following factors:
(i) The likelihood that the proposed project will result in system change or improvement. (Up to 5 points)
(ii) The extent to which the proposed project is likely to build local capacity to provide, improve, or expand services that address the needs of the target population. (Up to 5 points)
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(1) The Secretary considers the quality of the design of the proposed project.
(2) In determining the quality of the design of the proposed project, the Secretary considers the extent to which the goals, objectives, and outcomes to be achieved by the proposed project are clearly specified and measurable. (Up to 5 points)
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(1) The Secretary considers the quality of the services to be provided by the proposed project.
(2) In determining the quality of the services to be provided by the proposed project, the Secretary considers the quality and sufficiency of strategies for ensuring equal access and treatment for eligible project participants who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability. (Up to 10 points)
(3) In addition, the Secretary considers the following factors:
(i) The extent to which the services to be provided by the proposed project are appropriate to the needs of the intended recipients or beneficiaries of those services. (Up to 10 points)
(ii) The likelihood that the services to be provided by the proposed project will lead to improvements in the skills necessary to gain employment. (Up to 10 points)
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(1) The Secretary considers the quality of the management plan for the proposed project.
(2) In determining the quality of the management plan for the proposed project, the Secretary considers the adequacy of the management plan to achieve the objectives of the proposed project on time and within budget, including clearly defined responsibilities, timelines, and milestones for accomplishing project tasks. (Up to 10 points)
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(1) The Secretary considers the quality of the evaluation to be conducted of the proposed project.
(2) In determining the quality of the evaluation, the Secretary considers the following factors:
(i) The extent to which the methods of evaluation are thorough, feasible, and appropriate to the goals, objectives, and outcomes of the proposed project. (Up to 5 points)
(ii) The extent to which the methods of evaluation include the use of objective performance measures that are clearly related to the intended outcomes of the project and will produce quantitative and qualitative data to the extent possible. (Up to 5 points)
(iii) The extent to which the methods of evaluation will, if well implemented, produce evidence about the project's effectiveness that would meet the What Works Clearinghouse standards with or without reservations as described in the What Works Clearinghouse Handbook (as defined in 34 CFR 77.1(c)). (Up to 20 points)
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In addition, in making a competitive grant award, the Secretary requires
A panel of non-Federal reviewers will review and score each application in accordance with the selection criteria. A rank order funding slate will be made from this review. Awards will be made in rank order according to the average score received from the peer review.
Before making awards, we will screen applications submitted in accordance with the requirements in this notice to determine whether applications have met eligibility and other requirements. This screening process may occur at various stages of the process; applicants that are determined to be ineligible will not receive a grant, regardless of peer reviewer scores or comments.
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Please note that, if the total value of your currently active grants, cooperative agreements, and procurement contracts from the Federal Government exceeds $10,000,000, the reporting requirements in 2 CFR part 200, Appendix XII, require you to report certain integrity information to FAPIIS semiannually. Please review the requirements in 2 CFR part 200, Appendix XII, if this grant plus all the other Federal funds you receive exceed $10,000,000.
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(a) Selecting recipients most likely to be successful in delivering results based on the program objectives through an objective process of evaluating Federal award applications (2 CFR 200.205);
(b) Prohibiting the purchase of certain telecommunication and video surveillance services or equipment in alignment with section 889 of the National Defense Authorization Act of 2019 (Pub. L. 115-232) (2 CFR 200.216);
(c) Providing a preference, to the extent permitted by law, to maximize use of goods, products, and materials produced in the United States (2 CFR 200.322); and
(d) Terminating agreements in whole or in part to the greatest extent authorized by law if an award no longer effectuates the program goals or agency priorities (2 CFR 200.340).
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If your application is not evaluated or not selected for funding, we notify you.
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We reference the regulations outlining the terms and conditions of an award in the
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(b) At the end of your project period, you must submit a final performance report, including financial information, as directed by the Secretary. If you receive a multiyear award, you must submit an annual performance report that provides the most current performance and financial expenditure information as directed by the Secretary under 34 CFR 75.118. The Secretary may also require more frequent performance reports under 34 CFR 75.720(c). For specific requirements on reporting, please go to
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(a) Number and percentage of stopped-out students who reenrolled at the institution.
(b) Number and percentage of stopped-out students who were served by the grant and who reengaged and earned a certificate, an associate degree, or a bachelor's degree.
(c) Number and percentage of currently enrolled students who were served by the grant and who were still
(d) Number and percentage of currently enrolled students who were served by the grant and who earned a certificate, an associate degree, or a bachelor's degree.
These measures constitute the Department's indicators of success for this program. Consequently, we advise an applicant for an award under this program to consider the operationalization of the measures in conceptualizing the approach and evaluation for its proposed project.
If funded, you will be required to collect and report data in your project's annual performance report (34 CFR 75.590).
You may also access documents of the Department published in the
Federal Student Aid (FSA), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing an extension without change of a currently approved collection.
Interested persons are invited to submit comments on or before October 11, 2022.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Beth Grebeldinger, (202) 377-4018.
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Office of Electricity, Department of Energy.
Notice of renewal.
Pursuant to the Federal Advisory Committee Act and following consultation with the Committee Management Secretariat, General Services Administration, notice is hereby given that the Electricity Advisory Committee's (EAC) charter has been renewed for a two-year period, beginning on August 5, 2022.
The Committee will provide advice and recommendations to the Assistant Secretary for Electricity on programs to modernize the Nation's electric power system.
Additionally, the renewal of the EAC has been determined to be essential to conduct Department of Energy business and to be in the public interest in connection with the performance of duties imposed upon the Department of Energy, by law and agreement. The Committee will continue to operate in accordance with the provisions of the Federal Advisory Committee Act, adhering to the rules and regulations in implementation of that Act.
Ms. Jayne Faith, Designated Federal Officer at (202) 586-5260; email:
This document of the Department of Energy was signed on August 5, 2022, by Miles Fernandez, Acting Committee Management Officer, 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
Office of Environmental Management, Department of Energy.
Extension of public comment period.
On July 8, 2022, a
DOE extends the public comment period to September 6, 2022. DOE will consider all comments submitted or postmarked by September 6, 2022. Comments submitted to DOE concerning the Draft Mercury Storage SEIS-II, prior to this announcement do not need to be resubmitted as a result of this extension of the comment period.
Additional information regarding the SEIS-II, the 2011 Mercury Storage EIS, 2013 Mercury Storage SEIS, and other related documents is available online at:
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Questions concerning the Draft Mercury Storage SEIS-II or the public hearing can be sent to Ms. Julia Donkin, NEPA Document Manager, Office of Environmental Management, U.S. Department of Energy, EM-4.22, 1000 Independence Avenue SW, Washington, DC 20585, (202) 586-5000, or to
• For general information concerning the DOE Office of Environmental Management NEPA process, please contact Mr. William Ostrum, Office of Environmental Management NEPA Compliance Officer, U.S. Department of Energy, EM-4.31, 1000 Independence Avenue SW, Washington, DC 20585, (202) 586-2513, or to
On July 8, 2022, DOE published in the
This document of the Department of Energy was signed on August 5, 2022, by William I. White Senior Advisor for Environmental Management, Office of Environmental Management, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.
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k. Pursuant to section 4.32(b)(7) of 18 CFR of the Commission's regulations, if any resource agency, Indian Tribe, or person believes that an additional scientific study should be conducted in order to form an adequate factual basis for a complete analysis of the application on its merit, the resource agency, Indian Tribe, or person must file a request for a study with the Commission not later than 60 days from the date of filing of the application, and serve a copy of the request on the applicant.
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The Commission strongly encourages electronic filing. Please file additional study requests and requests for cooperating agency status using the Commission's eFiling system at
m. This application is not ready for environmental analysis at this time.
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The Schoolfield Project is operated in run-of-river mode, which may be suspended during reservoir drawdown and refilling for inspection of the City of Danville, Virginia's water supply intakes, which occurs on an as needed basis. During normal operation, an instantaneous minimum flow of 300 cubic feet per second is released downstream. The minimum flow is typically provided as part of generation flows. Average annual generation at the project was 15,220 megawatt-hours from 2017-2020.
o. A copy of the application can be viewed on the Commission's website at
You may also register online at
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Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of the notice of ready for environmental analysis.
On January 3, 2022, Georgia Power filed an application for a new, major license for the 18-megawatt Lloyd Shoals Hydroelectric Project (Lloyd Shoals Project; FERC No. 2336). The Lloyd Shoals Project is located on the Ocmulgee River in Butts, Henry, Jasper, and Newton Counties, Georgia. The project does not occupy federal lands.
In accordance with the Commission's regulations, on May 26, 2022, Commission staff issued a notice that the project was ready for environmental analysis (REA Notice). Based on the information in the record, including comments filed on the REA Notice, staff does not anticipate that licensing the project would constitute a major federal action significantly affecting the quality of the human environment. Therefore, staff intends to prepare an Environmental Assessment (EA) on the application to relicense the Lloyd Shoals Project.
The EA will be issued and circulated for review by all interested parties. All comments filed on the EA will be analyzed by Commission staff and considered in the Commission's final licensing decision.
The application will be processed according to the following schedule. Revisions to the schedule may be made as appropriate.
Any questions regarding this notice may be directed to Navreet Deo at (202) 502-6304, or
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system (
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5 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:
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 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
The filings are accessible in the Commission's eLibrary system (
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), Establishing No-Discharge Zones (NDZs) under Clean Water Act Section 312 (EPA ICR number 1791.09, OMB Control Number 2040-0187) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR that is currently approved through August 31, 2022. Public comments were previously requested via the
Additional comments may be submitted on or before September 12, 2022.
Submit your comments, referencing Docket ID Number EPA-HQ-OW-2008-0150, online using
For additional delivery options and information about EPA's dockets, visit
Submit written comments and recommendations to OMB for the proposed information collection within 30 days of publication of this notice to
Kelsey Watts-FitzGerald, Oceans, Wetlands, and Communities Division, Office of Wetlands, Oceans, and Watersheds, 4504T, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: 202-566-0232; 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
In designated NDZs, discharge of both treated and untreated sewage from vessels is prohibited. A state is not required to designate an NDZ and therefore need only develop applications for waters where such a discharge prohibition has been deemed necessary and beneficial by the state. This ICR addresses the burden to state respondents to develop applications containing the necessary information, as well as the burden associated with the EPA's review of state applications. The information collection activities discussed in this ICR do not require the submission of any confidential information.
(B) Uniform National Discharge Standards (UNDS) NDZs and Review of Discharge Determination or Standard: CWA section 312(n)(7) and the implementing regulations in 40 CFR part 1700 identify the information that a state must submit to the EPA in the state's application to establish an NDZ for one or more discharges incidental to the normal operation of a vessel of the Armed Forces. A state may seek an NDZ designation for any incidental discharge subject to UNDS for which the EPA and Department of Defense (DoD) have promulgated national standards of performance and corresponding implementing regulations, respectively. In addition, CWA section 312(n)(5) provides that that the Governor of any state may petition the EPA and DoD to review any discharge determination or standard promulgated under CWA section 312(n) for vessels of the Armed Forces if there is significant new information that could reasonably result in a change to the discharge determination or standard. This ICR addresses the burden to a state respondent to develop applications for NDZs and requests for a review of a
Environmental Protection Agency (EPA).
Notice.
The Toxic Substances Control Act (TSCA) requires EPA to publish in the
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPPT-2022-0116, is available online at
This action provides information that is directed to the public in general.
This document lists the statements of findings made by EPA after review of submissions under TSCA section 5(a) that certain new chemical substances or significant new uses are not likely to present an unreasonable risk of injury to health or the environment. This document presents statements of findings made by EPA during the reporting period.
TSCA section 5(a)(3) requires EPA to review a submission under TSCA section 5(a) and make one of the following specific findings:
• The chemical substance or significant new use presents an unreasonable risk of injury to health or the environment;
• The information available to EPA is insufficient to permit a reasoned evaluation of the health and environmental effects of the chemical substance or significant new use;
• The information available to EPA is insufficient to permit a reasoned evaluation of the health and environmental effects and the chemical substance or significant new use may present an unreasonable risk of injury to health or the environment;
• The chemical substance is or will be produced in substantial quantities, and such substance either enters or may reasonably be anticipated to enter the environment in substantial quantities or there is or may be significant or substantial human exposure to the substance; or
• The chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment.
Under TSCA, the unreasonable risk findings must be made without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant under the conditions of use. The term “conditions of use” is defined in TSCA section 3 to mean “the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of.”
TSCA section 5(g) requires EPA to publish in the
Anyone who plans to manufacture (which includes import) a new chemical substance for a non-exempt commercial purpose and any manufacturer or processor wishing to engage in a use of a chemical substance designated by EPA as a significant new use must submit a notice to EPA at least 90 days before commencing manufacture of the new chemical substance or before engaging in the significant new use.
The submitter of a notice to EPA for which EPA has made a finding of “not likely to present an unreasonable risk of injury to health or the environment” may commence manufacture of the chemical substance or manufacture or processing for the significant new use
In this unit, EPA provides the following information (to the extent that such information is not claimed as Confidential Business Information (CBI)) on the PMNs, MCANs and SNUNs for which, during this period, EPA has made findings under TSCA section 5(a)(3)(C) that the new chemical substances or significant new uses are not likely to present an unreasonable risk of injury to health or the environment:
The following list provides the EPA case number assigned to the TSCA section 5(a) submission and the chemical identity (generic name if the specific name is claimed as CBI).
• J-21-0020, J-21-0021, J-21-0022, J-21-0023, J-21-0024, J-21-0025, CinderBio-1 (Generic Name).
• J-22-0009, J-22-0010, Genetically modified microorganism for the production of a chemical substance (Generic Name).
• P-21-0189, Fats and Glyceridic oils, algae; CASRN: 1353573-84-8.
• J-22-0011, Biofuel producing
• P-21-0176, Alkane dioic acid, bis (poly aromatic triazine) alkanoic ether phenoxy ester (Genetic Name).
To access EPA's decision document describing the basis of the “not likely to present an unreasonable risk” finding made by EPA under TSCA section 5(a)(3)(C), look up the specific case number at
Environmental Protection Agency (EPA).
Notice.
In accordance with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is issuing a notice of receipt of requests by registrants through 2022 Pesticide Registration Maintenance Fee responses to voluntarily cancel certain pesticide registrations. EPA intends to grant these requests at the close of the comment period for this announcement unless the Agency receives substantive comments within the comment period that would merit its further review of the requests, or unless the registrants withdraw its requests. If these requests are granted, any sale, distribution, or use of products listed in this notice will be permitted after the registrations have been cancelled only if such sale, distribution, or use is consistent with the terms as described in the final order.
Comments must be received on or before September 12, 2022.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2022-0544, through the
Submit written withdrawal request by mail to: Registration Division (7504M), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. ATTN: Brenda Minnema.
Brenda Minnema, Registration Division (7504M), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 566-2840; email address:
This action is directed to the public in general and may be of interest to a wide range of stakeholders including environmental, human health, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides.
1.
2.
This notice announces receipt by the Agency of requests from registrants to cancel 149 pesticide products registered under FIFRA section 3 (7 U.S.C. 136a) or section 24(c) (7 U.S.C. 136v(c)). These registrations are listed in sequence by registration number (or company number and 24(c) number) in Table 1 of this unit.
Unless the Agency determines that there are substantive comments that warrant further review of the requests or the registrants withdraw their requests, EPA intends to issue an order in the
Table 2 of this unit includes the names and addresses of record for all registrants of the products in Table 1 of this unit, in sequence by EPA company number. This number corresponds to the first part of the EPA registration numbers of the products listed in this unit.
FIFRA section 6(f)(1) (7 U.S.C. 136d(f)(1)) provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be canceled. FIFRA further provides that, before acting on the request, EPA must publish a notice of receipt of any such request in the
Registrants who choose to withdraw a request for cancellation should submit such withdrawal in writing to the person listed under
Existing stocks are those stocks of registered pesticide products that are currently in the United States and that were packaged, labeled, and released for shipment prior to the effective date of the cancellation action. Because the Agency has identified no significant potential risk concerns associated with these pesticide products, upon cancellation of the products identified in Table 1 of Unit II., EPA anticipates allowing registrants to sell and distribute existing stocks of these products until January 15, 2023, or the date of that the cancellation notice is published in the
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency has submitted the following information collection request (ICR) to
Additional comments may be submitted on or before September 12, 2022.
Submit your comments to EPA, referencing Docket ID No. EPA-HQ-OPPT-2014-0838, online using
Submit written comments and recommendations to OMB for the proposed information collection within 30 days of publication of this notice to
Katherine Sleasman, Regulatory Support Branch, Office of Chemical Safety and Pollution Prevention, 7101M, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone: (202) 566-1204; email:
Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the docket for this ICR. The docket can be viewed online at
Amended Notice:
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NESHAP for Inorganic Arsenic Emissions from Primary Copper Smelters (EPA ICR Number 1089.07, OMB Control Number 2060-0044), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently-approved through October 31, 2022. Public comments were previously requested, via the
Additional comments may be submitted on or before September 12, 2022.
Submit your comments, referencing Docket ID Number EPA-HQ-OAR-2022-0065, online using
For additional delivery options and information about EPA's dockets, visit
Submit written comments and recommendations to OMB for the proposed information collection within 30 days of publication of this notice to
Muntasir Ali, Sector Policies and Program Division (D243-05), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina, 27711; telephone number: (919) 541-0833; 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
Environmental Protection Agency (EPA).
Proposed action; determination with request for comments and notice of opportunity for public hearing.
The EPA is proposing to determine that the reduction in expenditures of recurrent non-Federal funds for the Hawaii Department of Health (HDOH) in support of its
Comments and/or requests for a public hearing must be received by the EPA at the address stated below on or before September 12, 2022 .
Submit your comments, identified by Docket ID No. EPA-R09-OAR-2022-0705 at
Asia Yeary, EPA Region IX, Pacific Islands Contact Office, Prince Kuhio Federal Building, 300 Ala Moana Blvd., Suite 5-152, Honolulu, HI 96850; phone at (808) 541-2726 or email at
Section 105 of the CAA provides grant funding to air pollution control agencies for the prevention and control of air pollution or implementation of national primary and secondary ambient air quality standards. In accordance with 40 CFR 35.145(a), the Regional Administrator may provide air pollution control agencies up to three-fifths of the approved costs of implementing programs for the prevention and control of air pollution. CAA section 105 grants require a cost share (also referred to as a match requirement) of 40%. Program activities relevant to the match consist of both recurring and non-recurring (unique, one-time only) expenses. In addition, air pollution control agencies must meet a maintenance of effort (MOE) requirement in accordance with section 105(c)(1) of the CAA, 42 U.S.C. 7405(c)(1).
The MOE provision requires that an eligible agency spend at least the same dollar level of funds as it did in the previous grant year for the costs of recurring activities. Specifically, section 105(c)(1) of the CAA provides that, “No agency shall receive any grant under this section during any fiscal year when its expenditures of non-Federal funds for recurrent expenditures for air pollution control programs will be less than its expenditures were for such programs during the preceding fiscal year.” However, pursuant to CAA section 105(c)(2), 42 U.S.C. 7405(c)(2), the EPA may still award a grant to an agency not meeting the requirements of section 42 U.S.C. 7405(c)(1), “. . . if the Administrator, after notice and opportunity for public hearing, determines that a reduction in expenditures is attributable to a non-selective reduction in the expenditures in the programs of all Executive branch agencies of the applicable unit of Government.” These statutory requirements are repeated in the EPA's implementing regulations at 40 CFR 35.140-35.148. The EPA issued a memorandum dated September 30, 2011, entitled “Updated Information for Determining a Non-Selective Reduction” with guidance to recipients on what constitutes a nonselective reduction. In consideration of the legislative history, the guidance clarified that a non-selective reduction does not necessarily mean that each executive branch agency needs to be reduced in equal proportion. However, it must be clear to the EPA, from the weight of evidence, that a recipient's CAA-related air program is not being disproportionately impacted or singled out for a reduction.
A section 105 grant recipient must submit a final federal financial report no later than 120 days from the close of its grant period that documents all of its federal and non-federal expenditures for the completed period. The recipient seeking an adjustment to its MOE for that period must provide the rationale and the documentation necessary to enable the EPA to determine that a nonselective reduction has occurred. In order to expedite that determination, the recipient must provide details of the budget action and the comparative fiscal impacts on all the jurisdiction's executive branch agencies, and the recipient's air program. The recipient needs to identify any executive branch agencies or programs that should be excepted from comparison and explain why. The recipient must provide evidence that the air program is not being singled out for a reduction or being disproportionately reduced. Documentation in key areas will be needed: budget data specific to the recipient's air program; and comparative budget data between the recipient's air program, the agency containing the air program, and the other executive branch agencies. The EPA may also request information from the recipient about how impacts on its program operations will affect its ability to meet its CAA obligations and requirements, and documentation that explains the cause of the reduction, such as legislative changes or the issuance of a new executive order.
In FY2021, the EPA awarded the HDOH $781,332, which represented approximately 29% of the HDOH budget. In FY2022, the EPA awarded the HDOH $884,194, which represented approximately 31% of the HDOH budget.
HDOH's final federal financial report for FY2021 indicated that HDOH's MOE level was $1,918,582. HDOH expects their FY2022 expenditures to be approximately $1,645,864, which indicates that HDOH's expenditures of non-federal funded recurring activities is not sufficient to meet the MOE requirements for FY2022 under section 105 of the CAA because it is not equal to or greater than the MOE for the previous fiscal year.
The EPA must make a determination (after notice and an opportunity for a public hearing) that the reduction in expenditures from 2021 to 2022 is attributable to a non-selective reduction in the expenditures in the programs of all executive branch agencies of Hawaii's State government.
The HDOH is a department organizationally within the Hawaii State government, which is the unit of government for CAA section 105(c)(2) purposes.
On July 5, 2022, the HDOH submitted a request to the EPA seeking a reduction for the required MOE for FY2022 due to a non-selective reduction in expenditures. The HDOH explained that it will be unable to meet its MOE
HDOH explained that the reduction is non-selective because the air program is not being disproportionately impacted or singled out as the reduction of expenditures due to increased vacancies and inability to replace staff is occurring throughout the State government, and not exclusively to the air program. Hawaii is currently experiencing one of the highest rates of out-migration of its work-age population. State agencies have lost staff and have struggled to hire new staff to replace them.
The vacancy data provided by Hawaii's Department of Human Resources Development (DHRD) and HDOH's Human Resources (HR) shown below supports the requested MOE reduction by demonstrating that a non-selective reduction in the expenditures of all executive branch agencies has occurred. The air program's vacancy rate increased by 3.23%, from 27.42% in 2021 to 30.65% in 2022 and the majority of HDOH's environmental programs' vacancy rates also increased anywhere from 1.69% to 30.95% during this same time frame. In line with the air program and the other environmental program vacancy increases, the vacancy rate for the entire HDOH (which contains the air program and other environmental programs) increased by 3.88% (from 17.38% to 21.25%) during this period. Overall statewide (executive branch agencies) position vacancy rates showed an even larger increase of 7.88% from 2021 to 2022. Trends in the HDOH and executive branch agency data show steady increases in vacancy rates with the largest increase occurring over the last year. The air program's vacancy rate increase of 3.23% is slightly smaller than the HDOH's increase of 3.88% and less than half of the executive branch agency increase of 7.88% over the past year.
The EPA proposes to find that the request for a reset of HDOH's MOE meets the requirements for a non-selective reduction under CAA section 105. The HDOH's reduction in personnel expenses and significant cut back on expenditures caused by the COVID-19 pandemic contributed to the reduction in expenditures.
The EPA proposes that the MOE for HDOH's FY2022 CAA section 105 grant be reduced to $1,645,864 to address the non-selective reduction of recurrent expenditures discussed above.
This notice constitutes a request for public comment and an opportunity for public hearing as required by the CAA. All written substantive comments received by September 12, 2022 on this proposal will be considered. The EPA will conduct a public hearing on this proposal only if a written request for such is received by the EPA by September 12, 2022. If no written request for a hearing is received or if the EPA determines that the issues raised are insubstantial, the EPA will proceed to reduce HDOH's MOE for FY2022.
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) will convene the Hazardous Waste Electronic System (e-Manifest) Advisory Board for a three (3) day virtual public meeting. The purpose of the meeting is for EPA to seek the Board's consultation and recommendations regarding the e-Manifest system (Meeting Theme:
This public meeting will be conducted virtually. Registration online is required to attend and/or provide oral public comment during this meeting. Please refer to the e-Manifest Advisory Board website at
Fred Jenkins, Designated Federal Officer (DFO), U.S. Environmental Protection Agency, Office of Resource Conservation and Recovery, email:
This meeting will be open to the public. The full agenda and meeting materials will be available in the docket for the meeting and at the e-Manifest Advisory Board website at
This action is directed to the public in general. This action may be of particular interest to persons who are or may be subject to the Hazardous Waste Electronic Manifest Establishment (e-Manifest) Act.
Information about the e-Manifest Advisory Board is available on the e-Manifest Advisory Board website,
The Hazardous Waste Electronic Manifest (e-Manifest) System Advisory Board is established in accordance with the provisions of the Hazardous Waste Electronic Manifest Establishment Act, 42 U.S.C. 6939g, and the Federal Advisory Committee Act (FACA), 5 U.S.C. App.2. The e-Manifest Advisory Board is in the public interest and supports the EPA in performing its duties and responsibilities. The Board shall meet annually to discuss, evaluate the effectiveness of, and provide recommendations about the system to the EPA Administrator.
The sole duty of the Advisory Board is to provide advice and recommendations to the EPA Administrator. As required by the e-Manifest Act, the e-Manifest Advisory Board is composed of nine (9) members. One (1) member is the EPA Administrator (or a designee), who serves as Chairperson of the Advisory Board. The rest of the committee is composed of:
• At least two (2) members who have expertise in information technology;
• At least three (3) members who have experience in using or represent users of the manifest system to track the transportation of hazardous waste under the e-Manifest Act;
• At least three (3) members who are state representatives responsible for processing manifests.
All members of the e-Manifest Advisory Board, except for the EPA Administrator, are appointed as Special Government Employees or Representatives.
EPA launched the e-Manifest system on June 30, 2018. e-Manifest provides those persons required to use a Resource Conservation and Recovery Act (RCRA) manifest under either federal or state law the option of using electronic manifests to track shipments of hazardous waste and to meet certain RCRA requirements. By enabling the transition from a paper-intensive process to an electronic system, EPA estimates e-Manifest will ultimately save state and industry users more than $50 million annually, once electronic manifests are widely adopted.
Since system inception through May 2022, EPA has received roughly 25 thousand electronic manifests (both fully electronic and hybrid manifests) out of a total of approximately 7 million manifests. Electronic manifests thus represent less than a half of a percent of manifests received by EPA. EPA seeks to dramatically increase this percentage.
EPA hosted two virtual public meetings on October 27, 2021, and November 3, 2021, to discuss how to increase electronic adoption and solicit feedback from stakeholders. The meetings described existing electronic manifest functionality and the feasibility of several options to increase use of electronic manifests. As a next step in this effort, EPA will convene its next public meeting of the e-Manifest System Advisory Board from October 4-6, 2022. The meeting will include discussion of the comments EPA received from the public meetings, as well as related policy and technical changes EPA is considering for the e-Manifest system to increase adoption of electronic manifests. The general purpose of this meeting is for the Board to advise the Agency on these potential changes.
The meeting background paper along with related supporting materials including the charge questions to the Advisory Board, the Advisory Board membership roster (
The e-Manifest Advisory Board will prepare meeting minutes summarizing its recommendations to EPA approximately ninety (90) days after the meeting. The meeting minutes will be posted on the e-Manifest Advisory Board website, or they may be obtained from the public docket at
To participate in the virtual public meeting, please follow the instructions in this section.
1.
Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Copyrighted material will not be posted without explicit permission of the copyright holder. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. Members of the public should also be aware that their personal contact information, if included in any written comments, may be posted on the internet at
The EPA will generally not consider comments or comment contents located outside of the primary submission (
2.
Federal Communications Commission.
Notice of public meeting.
In accordance with the Federal Advisory Committee Act, this notice advises interested persons that the Federal Communications Commission's (Commission) Communications Security, Reliability, and Interoperability Council (CSRIC) VIII will hold its fifth meeting on September 21, 2022 at 1 p.m. EDT.
September 21, 2022.
The Meeting will be held via conference call and available to the public via WebEx at
Suzon Cameron, Designated Federal Officer, Federal Communications Commission, Public Safety and Homeland Security Bureau, (202) 418-1916 or email:
The meeting on September 21, 2022, at 1 p.m. EDT, will be held electronically only and may be viewed live, by the public, at
The CSRIC is a Federal Advisory Committee that will provide recommendations to the Commission to improve the security, reliability, and interoperability of communications systems. On June 30, 2021, the Commission, pursuant to the Federal Advisory Committee Act, renewed the charter for CSRIC VII for a period of two years through June 29, 2023. The meeting on September 21, 2022, will be the fifth meeting of CSRIC VIII under the current charter. The Commission will provide audio and/or video coverage of the meeting over the internet from the FCC's web page at
Open captioning will be provided for this event. Other reasonable accommodations for people with disabilities are available upon request. Requests for such accommodations should be submitted via email to
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal Agencies to take this opportunity to comment on the following information collection. Pursuant to the Small Business Paperwork Relief Act of 2002, the FCC seeks specific comment on how it can further reduce the information collection burden for small business concerns with fewer than 25 employees.
Written comments and recommendations for the proposed information collection should be submitted on or before September 12, 2022.
Comments should be sent to
For additional information or copies of the information collection, contact Cathy Williams at (202) 418-2918. To view a copy of this information collection request (ICR) submitted to OMB: (1) go to the web page
The Commission may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
As part of its continuing effort to reduce paperwork burdens, as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the FCC invited the general public and other Federal Agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimates; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology. Pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4), the FCC seeks specific comment on how it might “further reduce the information collection burden for small business concerns with fewer than 25 employees.”
Federal Communications Commission.
Notice.
In this Public Notice, the Public Safety and Homeland Security Bureau (Bureau) seeks comment on the filings from the respective Departments of Transportation of the State of Florida and State of Georgia, and State of Maryland State Highway Administration, each requesting a waiver of the Commission's rules to operate roadside units (RSUs) with cellular vehicle to everything (C-V2X)-based technology in the upper 30 megahertz (5.895-5.925 GHz) portion of the 5.850-5.925 GHz (5.9 GHz) band under its Part 90 intelligent transportation system (ITS) license.
Federal Communications Commission, 45 L Street NE, Washington, DC 20554.
Comments are due on or before September 12, 2022 and reply comments are due on or before October 11, 2022.
Roberto Mussenden, Senior Attorney, Policy and Licensing Division, Public Safety and Homeland Security Bureau, at
This is a summary of the Commission's
(1) a certification that there are no existing ITS licensees authorized to operate within the same geographic area in which the waiver applicant seeks to operate, OR certification that the waiver applicant has coordinated with every existing ITS licensee licensed (in whole or part) within that same geographic area to ensure that the waiver applicant's C-V2X-based roadside unit operations will not interfere with any Dedicated Short Range Communications (DSRC)-based roadside units operating in the 5.895-5.925 GHz band;
(2) a certification that the waiver applicant's C-V2X operations will comply with the existing technical rules (
(3) a certification that the applicant's operations will be revised to the extent necessary to comply with any final rules that the Commission adopts for C-V2X operations; and
(4) a certification that the applicant's C-V2X operations will be limited to transportation and vehicle safety-related communications.
“If an ITS waiver applicant that seeks authority to operate C-V2X-based roadside units or on-board units in the 5.895-5.925 GHz band is unable to comply with the existing ITS technical rules found in 47 CFR 90.371-90.383 or 47 CFR 95.3167-95.3189, respectively, they should include in their general waiver request the certifications from the streamlined waiver process outlined in this PN that they are unable to meet, the specific existing rules that they are unable to comply with, along with a specific proposal of the technical specifications they seek to use instead, and an explanation of why a waiver is warranted under Section 1.925. To facilitate granting of qualifying waiver requests, and in light of the alternate technical specifications proposed in their waiver, we would generally expect the ITS waiver applicant to include a demonstration showing that their requested waiver would not cause a greater potential for interference to other users operating in the 5.895-5.925 GHz band than DSRC-based operations in this band, and otherwise to address how the public interest would be served by such a waiver under Section 1.925. Based on the proposed change in technical parameters, the waiver request should also address any conditions (
“The applicant for equipment certification should identify the specific technical requirements that the C-V2X equipment would meet, and explain how those specific technical requirements would be consistent with the associated waiver(s) granted for operation of C-V2X systems in the 5.895-5.925 GHz band. To the extent that the request for waiver of equipment authorization rules to authorize C-V2X-based roadside units or on-board units differs in any respect from the technical rules specified in the Part 90 or Part 95 waiver(s), the application for waiver may require more extensive review, consistent with current practice relating to waiver of equipment authorization rules.”
•
•
Filings can be sent by commercial courier or by the U.S. Postal Service. All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.
• Commercial deliveries (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9050 Junction Drive, Annapolis Junction, MD 20701.
• U.S. Postal Service First-Class, Express, and Priority mail must be addressed to 45 L Street NE, Washington, DC 20554.
• Effective March 19, 2020, and until further notice, the Commission no longer accepts any hand or messenger delivered filings. This is a temporary measure taken to help protect the health and safety of individuals, and to mitigate the transmission of COVID-19. See FCC Announces Closure of FCC Headquarters Open Window and Change in Hand-Delivery Policy, Public Notice, DA 20-304 (March 19, 2020).
• During the time the Commission's building is closed to the general public and until further notice, if more than one docket or rulemaking number appears in the caption of a proceeding, paper filers need not submit two additional copies for each additional docket or rulemaking number; an original and one copy are sufficient.
Board of Governors of the Federal Reserve System.
Notice of a modified system of records.
Pursuant to the provisions of the Privacy Act of 1974, notice is given that the Board of Governors of the Federal Reserve System (Board) proposes to modify an existing system of records, entitled BGFRS-37, “FRB—Electronic Applications.” This system enables bank holding companies (BHCs), savings and loan holding companies (SLHCs), state member banks, and foreign banks with operations in the United States, or other companies, and persons to submit an application or notice to the Federal Reserve System for approval or non-objection, as appropriate, to conduct certain transactions or engage in certain activities.
Comments must be received on or before September 12, 2022. This modified system of records will become effective September 12, 2022, without further notice, unless comments dictate otherwise.
The Office of Management and Budget (OMB), which has oversight responsibility under the Privacy Act, requires a 30-day period prior to publication in the
You may submit comments, identified by
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All public comments will be made available on the Board's website at
David B. Husband, Senior Counsel, (202) 530-6270,
The Board is modernizing the electronic applications system and its filing process by permitting external filers to file applications, notices, requests for determinations, and other applications-related inquiries submitted by filers electronically through a paperless application process. The Board is moving to a cloud-based system (Fed EZ File) for use by the Board and the Federal Reserve Banks, acting pursuant to authority delegated by the Board (collectively, “FRS”). FRS staff will use Fed EZ File to create, review, store, and retrieve information, including information obtained from individuals, financial institutions, and other business organizations, or their authorized representatives (collectively, “filers”), in connection with applications, notices, requests for determinations, and other applications-related inquiries submitted by filers to the FRS (collectively, “filings”). These transactions and activities include, for example, acquisitions by a BHC or SLHC, bank mergers, non-bank acquisitions or new activities, BHC or SLHC formations, financial holding company elections, branch establishments, changes in bank control, community development and public welfare investments, and the appointment of directors or senior executive officers by a BHC, SLHC, or bank. This system will also enable FRS staff to request additional information, view business and supervisory information from various entities as needed, act on the filing, and deliver official and related correspondence. FRS staff will also manually input paper-based filings received by the FRS into the EZ File system for the above purposes.
Accordingly, the Board is revising the SORN in order to incorporate the move to a new cloud-based system and generally update the SORN since its last revision. In particular, the Board is making changes to the purpose, authority, category of individuals, category of records, and the routine uses sections. The Board has clarified the intended purpose of the system and expanded the category of individuals to also include public commenters on filings more accurately. The Board has provided greater specificity to the category of records section by identifying in greater detail some of the information types included in typical filings.
The Board is also amending the system-specific routine use to permit the sharing of the information covered by this system of records with other financial institution regulatory agencies as necessary on a confidential basis consistent with explicit information sharing agreements, rather than for regulatory comment purposes only, because the Board works with those agencies on supervisory and regulatory matters beyond those focused on regulatory comments. The Board is also eliminating the reference to “thrift regulatory agencies” in the phrase “other bank and thrift regulatory agencies” as outdated because the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act, Pub. L. 111-203, 124 Stat. 1376 (2010)) dissolved the Office of Thrift Supervision and replacing “bank” with “financial institution.” Thus, the Board proposes to revise the system-specific routine use to read: “to disclose certain information to other financial institution regulatory agencies pursuant to explicit information sharing agreements.”
In the authority section, the Board is revising the list of authorities to include additional statutes and regulations that authorize the Board to receive filings from external parties and to reflect statutory changes since the SORN's last issuance in 2008. In particular, the Dodd-Frank Act was passed in 2010 and made substantial changes to banking laws and regulations, which affected the authorities for this system of records. For example, section 311 of Dodd-Frank transferred authority to supervise and regulate SLHCs from the Office of Thrift Supervision to the Board. Accordingly, the Board is adding the Home Owners' Loan Act, as well as the Board's implementing Regulations LL and MM, which authorize the Board to receive filings from SLHCs as authorities. Similarly, the Board is adding to the authorities section 167 of the Dodd-Frank Act and the Board's implementing Regulation YY, which required certain foreign banking organizations to create a U.S.
The Board is also revising the list of legal authorities to include those which were inadvertently omitted from or incorrectly cited in the previous SORN. This includes adding corrected references to the U.S. Code provisions corresponding to sections 9, 19, and 25 of the Federal Reserve Act, concerning state banks as members of the Federal Reserve System; bank reserves; and foreign branches of domestic banks, respectively. In addition, the Board is revising the legal authority section to include other statutory provisions under which the Board receives filings, including sections 23A and 23B of the Federal Reserve Act and the Board's implementing Regulation W, concerning depository institutions' relations and transactions with affiliates, and section 24A, concerning investments in bank premises. Further, the Board is revising the legal authorities to include sections 8, 18(c), 19, 32, and 44 of the Federal Deposit Insurance Act, concerning termination of insured depository institution status; bank merger transactions; participation in banking by individuals convicted of, or who have entered into a pretrial diversion or similar program for, certain crimes; changes in directors and senior executive officers of insured depository institution holding companies; and interstate bank mergers, respectively. The Board has also added references to other relevant authorizing banking statutes, such as the Foreign Bank Supervision Enhancement Act and the Depository Institution Management Interlocks Act.
The Board is also updating the contact information for the system manager, the record source categories, the system location information, and the policies and practices for storage, retrieval, and retention of records.
The Board is also making technical changes to BGFRS-37 consistent with the template laid out in OMB Circular No. A-108. Accordingly, the Board has made technical corrections and non-substantive language revisions to the following sections: “Policies and Practices for Storage of Records,” “Policies and Practices for Retrieval of Records,” “Policies and Practices for Retention and Disposal of Records,” “Administrative, Technical and Physical Safeguards,” “Record Access Procedures,” “Contesting Record Procedures,” and “Notification Procedures.” The Board has also created the following new sections: “Security Classification” and “History.”
BGFRS-37, “FRB—Electronic Applications.”
Unclassified.
Board of Governors of the Federal Reserve System, 20th Street and Constitution Avenue NW Washington, DC 20551. Some data will be hosted by third-party vendors, in government clouds managed by BOX in Nevada and California, Appian in Ohio, and OneSpan in Virginia and Ohio.
Vaishali Sack, Designated Agency Applications Official, Supervision and Regulation Division, Board of Governors of the Federal Reserve System, 20th Street and Constitution Avenue NW, Washington, DC 20551, 202-452-5221,
Sections 9, 19, 23A, 23B, 24A, 25, and 25A of the Federal Reserve Act (12 U.S.C. 321-338a, 461-506, 371c, 371c-1, 371(d), 601-605, and 611-631); the Change in Bank Control Act (12 U.S.C. 1817(j)); Sections 8, 18(c), 19, 32, and 44 of the Federal Deposit Insurance Act (12 U.S.C. 1818, 1828(c), 1829, 1831i, and 1831(u)); the Bank Holding Company Act of 1956 (12 U.S.C. 1841
These records are collected and maintained to assist the Board and the Federal Reserve Banks (collectively, “FRS”) in evaluating whether individuals, financial institutions, and other business organizations meet the applicable statutory and regulatory factors that are required to be considered in a particular filing.
Persons who are parties to regulatory filings submitted to the FRS, and public commenters to such submissions.
In connection with their role in filings, individuals provide information, which may include, but is not limited to the following: name (including former names and/or nicknames); contact information such as telephone number, email address, etc.; address (home, business, and/or mailing); citizenship information, including place and date of birth; and/or citizenship status; government-issued identification, such as driver's license number, Social Security number, passport number and/or alien registration number, and/or taxpayer identification number; occupation and employment history; financial and credit information (including credit history); education and professional credentials; information about compliance with applicable laws and regulations, criminal history, and involvement with court proceedings; and related organizations. In addition, submissions from members of the public may contain unsolicited personally identifiable information (“PII”) (such as bank account information or social security numbers) even though such PII is not required for the individual to provide comments or feedback.
The information is submitted by individual filers, certain employees, officers, directors, or shareholders of financial institutions or other business organizations, representatives of individual or institutional filers, Federal and state banking regulators, state insurance regulators, and members of the public. FRS staff may also provide information to obtain access to the system. FRS staff may also independently obtain information regarding filers from publicly available sources.
General routine uses A, B, C, D, G, I, and J apply to this system. These general routine uses are located at
Paper records are stored in locked file cabinets with access limited to staff with a need to know until the paper records have been scanned and stored electronically. Electronic records will be stored at the Board and by third-party vendors in FedRAMP approved government cloud storage solutions.
Records can be searched for and retrieved by authorized staff only, by every data field on a record, and by the contents of each record. Access to records is limited to those persons whose official duties require it.
Records are retained for 60 days within the system and then transferred to the Board's electronic recordkeeping system. Records are retained in the Board's electronic recordkeeping system for 15 years, then destroyed when no longer needed for reference.
The system has the ability to track individual user actions within the system. The audit and accountability controls are based on NIST and Board standards, which are based on applicable laws and regulations. The controls assist in detecting security violations and performance or other issues in the system. Access to the system is restricted to authorized users within the FRS who require access for official business purposes. Users are classified into different roles and common access and usage rights are established for each role. User roles are used to delineate between the different types of access requirements such that users are restricted to information that is required in the performance of their duties. Periodic assessments and reviews are conducted to determine whether users still require access, have the appropriate role, and whether there have been any unauthorized changes. Records are encrypted at rest and in transmission.
The Privacy Act allows individuals the right to access records maintained about them in a Board system of records. Your request for access must: (1) contain a statement that the request is made pursuant to the Privacy Act of 1974; (2) provide either the name of the Board system of records expected to contain the record requested or a concise description of the system of records; (3) provide the information necessary to verify your identity; and (4) provide any other information that may assist in the rapid identification of the record you seek.
The Board handles all Privacy Act requests as both a Privacy Act request and as a Freedom of Information Act request. The Board does not charge fees to a requestor seeking to access or amend his/her Privacy Act records.
You may submit your Privacy Act request to the: Secretary of the Board, Board of Governors of the Federal Reserve System, 20th Street and Constitution Avenue NW, Washington, DC 20551.
You may also submit your Privacy Act request electronically by filling out the required information at:
The Privacy Act allows individuals to seek amendment of information that is erroneous, irrelevant, untimely, or incomplete and is maintained in a system of records that pertains to them. To request an amendment to your record, you should clearly mark the request as a “Privacy Act Amendment Request.” You have the burden of proof for demonstrating the appropriateness of the requested amendment and you must provide relevant and convincing evidence in support of your request.
Your request for amendment must: (1) provide the name of the specific Board system of records containing the record you seek to amend; (2) identify the specific portion of the record you seek to amend; (3) describe the nature of and reasons for each requested amendment; (4) explain why you believe the record is not accurate, relevant, timely, or complete; and (5) unless you have already done so in a related Privacy Act request for access or amendment, provide the necessary information to verify your identity.
Same as “Access procedures” above. You may also follow this procedure in order to request an accounting of previous disclosures of records pertaining to you as provided for by 5 U.S.C. 5I(c).
Certain portions of this system of records may be exempt from 5 U.S.C. 552a(c)(3),I),I)(1), (e)(4)(G), (H), and (I), and (f) of the Privacy Act pursuant to 5 U.S.C. 552a(k)(2).
This SORN was previously published in the
Board of Governors of the Federal Reserve System.
Office of Government-wide Policy, General Services Administration (GSA).
Publication of GSA Bulletin FMR G-08.
GSA has issued FMR Bulletin G-08, which temporarily waives the annual mail management reporting requirements of large Federal agencies as mandated by FMR §§ 102-192.85-102-192.105. This FMR Bulletin G-08 is available at
August 12, 2022.
For clarification of content, contact Michael DeMale, Office of Asset and Transportation, GSA, at email
Federal agencies must comply with FMR part 102-192, authorized by 44 U.S.C. 2901-2906, when developing and administering Federal agency mail programs. However, in February 2018, in response to two Office of Management and Budget (OMB) Memorandums (M-17-26
This FMR Bulletin G-08 rescinds and replaces FMR Bulletin G-07 by extending the temporary waiver of the annual mail management reporting requirement as mandated by FMR §§ 102-192.85-102-192.105.
Agency for Healthcare Research and Quality, HHS.
Notice.
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) re-approve the proposed information collection project “The Systematic Review Data Repository (SRDR) Platform”.
Comments on this notice must be received by October 11, 2022.
Written comments should be submitted to: Doris Lefkowitz, Reports Clearance Officer, AHRQ, by email at
Copies of the proposed collection plans, data collection instruments, and specific details on the estimated burden can be obtained from the AHRQ Reports Clearance Officer.
Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at
Since 1997, the AHRQ Evidence-based Practice Center (EPC) Program has been reviewing relevant scientific information on a wide spectrum of clinical and health services topics to produce various types of evidence reports. A majority of these evidence reports are systematic reviews (SRs), which are used as evidence bases for clinical practice guidelines, research agendas, healthcare coverage, and other health related policies. Performing SRs is costly in time, labor, and money. Moreover, there is an increasing expectation of quicker turnaround in producing SRs to accommodate the fast moving pace of innovations and new scientific discoveries in healthcare. Some SRs overlap or are duplicated; independent teams of SR producers often extract data from the same studies, resulting in replication of work. Current methodology makes it difficult to harness and reuse previous work when updating SRs.
In an effort to reduce the economic burden of conducting SRs, the EPC program undertook development of a collaborative, Web-based repository of systematic review data called the Systematic Review Data Repository (SRDR). The OMB Control Number for this data collection is 0935-0244, which was last approved by OMB on October 16, 2019.
This resource serves as both an archive and data extraction tool, shared among organizations and individuals producing SRs worldwide, enabling the creation of a central database of SR data. This database is collaboratively vetted, freely accessible, and integrates seamlessly with reviewers' existing workflows, with the ultimate goal of facilitating the efficient generation and update of evidence reviews, and thus speeding and improving evidence-based policy-making with regards to health care.
Note that the SRDR system was upgraded during the last period of OMB clearance and is now designated as SRDR+. We will use the term “SRDR platform” to collectively denote the various upgraded iterations of the platform.
The SRDR project aims to achieve the following goals:
(1) Create online easy-to-use Web-based tools for conducting systematic reviews to facilitate extraction of data from primary studies;
(2) Develop an open-access searchable archive of key questions addressed in systematic reviews;
(3) Maintain a public repository of primary study data including provision of technical support for repository users; and
(4) Develop a process for making summary data from systematic reviews digitally shareable to end-users.
This study is being conducted by AHRQ through its contractor, Brown University, pursuant to AHRQ's statutory authority to conduct and support research on healthcare and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness and value of healthcare services, including database development. 42 U.S.C. 299a(a)(1) and (8).
To achieve the goals of this project the following data collections are being implemented:
(1) Collect registration information on SRs from SR producers who will populate the SRDR platform.
The SRDR platform now uses a two-tiered categorization of users, and collection of registration data will depend on the type of user. “Contributors” are SR producers who use the SRDR platform as a tool to support production of the SR and share scientific data from their SRs. Registration data will be collected from these users. “General public” users only view scientific data publicly available in the SRDR platform. No data will be collected from these users. The “Commentator” category of users that were referenced in the last OMB clearance period has been eliminated in the updated system since no users have signed up to be commentators.
All Contributors undergo a simple self-registration process by providing a password and an email address. Provision of username and institution information by registrants is now optional in the updated system. Collection of registration data from Contributors is required due to the technical nature of using the SRDR platform both as a database and a tool for assisting in the production of a SR, including providing comments in the various sections of a particular project on the SRDR platform. In addition, provision of an email address and institution information allows the administrators of the SRDR platform to
User registration will be used for administrative purposes only including communication between SRDR platform administrators and registrant users. This type of information will not be made publicly available.
Exhibit 1 shows the estimated annualized burden hours for the respondents' time to participate/use the SRDR platform. In 2020, 1,029 users registered as Contributors. Registration will take approximately 1.5 minutes or 0.025 hours per user. We thus calculate the total burden hours required for registration for all users annually is 25.73 hours.
Exhibit 2 shows the estimated cost burden associated with the respondents' time to participate/use the SRDR platform. The total cost burden to respondents is estimated at an average of $ 1,126.97 annually.
In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, comments on AHRQ's information collection are requested with regard to any of the following: (a) whether the proposed collection of information is necessary for the proper performance of AHRQ's health care research and health care information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of information; (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 upon the respondents, including the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.
Agency for Healthcare Research and Quality (AHRQ), HHS.
Request for Supplemental Evidence and Data Submissions.
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on
Jenae Benns, Telephone: 301-427-1496 or Email:
The Agency for Healthcare Research and Quality has commissioned the Evidence-based Practice Center (EPC) Program to complete a review of the evidence for
The EPC Program is dedicated to identifying as many studies as possible that are relevant to the questions for each of its reviews. In order to do so, we are supplementing the usual manual and electronic database searches of the literature by requesting information from the public (
This is to notify the public that the EPC Program would find the following information on Cervical Degenerative Disease Treatment helpful:
A list of completed studies that your organization has sponsored for this indication. In the list, please
Description of whether the above studies constitute
Your contribution is very beneficial to the Program. Materials submitted must be publicly available or able to be made public. Materials that are considered confidential; marketing materials; study types not included in the review; or information on indications not included in the review cannot be used by the EPC Program. This is a voluntary request for information, and all costs for complying with this request must be borne by the submitter.
The draft of this review will be posted on AHRQ's EPC Program website and available for public comment for a period of 4 weeks. If you would like to be notified when the draft is posted, please sign up for the email list at:
The systematic review will answer the following questions. This information is provided as background. AHRQ is not requesting that the public provide answers to these questions.
KQ1. In patients with radiographic spinal cord compression and no cervical spondylotic myelopathy, what are the comparative effectiveness and harms of surgery compared to non-operative treatment or no treatment?
KQ2. In patients with radiographic spinal cord compression and mild to severe myelopathy, what is the effectiveness and harms of surgery versus non-operative treatment or no treatment? How do the effectiveness and harms vary by level of severity of myelopathy at the time of surgery?
KQ3. In patients with cervical degenerative disease, what are the comparative effectiveness and harms of surgical compared to non-operative treatment?
KQ4. In patients with cervical degenerative disease, what are the comparative effectiveness and harms of therapies added on to surgery (pre- or post-operative) compared with the same surgery alone?
KQ5. In patients with cervical radiculopathy due to cervical degenerative disease, what are the comparative effectiveness and harms of posterior versus anterior surgery?
KQ6. In patients with cervical degenerative disease, what are the comparative effectiveness and harms of posterior versus anterior surgery in patients with greater than or equal to three level disease?
KQ7. In patients with cervical spondylotic myelopathy due to cervical degenerative disease, what are the comparative effectiveness and harms of cervical laminectomy and fusion compared to cervical laminoplasty in patients?
KQ8. In patients with cervical spondylotic radiculopathy or myelopathy at one or two levels, what are the comparative effectiveness and harms of cervical arthroplasty compared to anterior cervical discectomy and fusion?
KQ9. In patients undergoing anterior cervical discectomy and fusion, what are the comparative effectiveness and harms of surgery based on interbody graft material or device type?
KQ10. In patients with pseudarthrosis after prior anterior cervical fusion surgery, what are the comparative effectiveness and harms of posterior approaches compared to revision anterior arthrodesis?
KQ11. In patients with cervical spondylotic myelopathy, what is the prognostic utility of preoperative magnetic resonance imaging (MRI) findings for neurologic recovery after surgery?
KQ12. What is the sensitivity and specificity of imaging assessment for identifying symptomatic pseudarthrosis after prior cervical fusion surgery?
KQ13. In patients with cervical spondylotic myelopathy, what are the comparative effectiveness and harms of intraoperative neuromonitoring (
* For purposes of these key questions, we are focusing on symptomatic cervical degenerative disc disease; with the exception of Key Question 1, evaluation and management of asymptomatic disease is beyond the scope of this review.
CQ1. What is the prevalence of cervical degenerative disease with spinal cord compression in asymptomatic patients?
CQ2. What is the natural history of untreated spinal cord compression in patients with cervical degenerative disease?
In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled “Evaluation Reporting Template for National and State Tobacco Control Program” to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on October 13, 2021 to obtain comments from the public and affected agencies. CDC did not receive comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.
CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:
(a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to be collected;
(d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
(e) Assess information collection costs.
To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570. Comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Evaluation Reporting Template for National and State Tobacco Control Program—New—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).
CDC's Office on Smoking and Health (OSH) created the National and State Tobacco Control Program (NTCP) in 1999 to encourage coordinated, national efforts to reduce tobacco-related diseases and deaths. The NTCP provides funding and technical support to state and territorial health departments. NTCP funds 50 states, Washington DC, Puerto Rico, and Guam. NTCP-funded programs are working to eliminate exposure to secondhand smoke, promote quitting among adults and youth, prevent initiation among youth and young adults, and identify and eliminate tobacco-related disparities. To reach these goals, the programs implement state and community interventions, mass-reach health communication interventions, tobacco use and dependence treatment interventions, and conduct surveillance and evaluation.
This information collection project supports the NTCP tobacco program managers, administrators, and evaluators by specifying which information should be included in their annual evaluation reports. Furthermore, the information collected via this form will allow OSH to monitor and evaluate program performance, document facilitators and barriers, lessons learned and promising practices, establish processes to support continuous program improvement and development, and assess the effectiveness and outcomes of the NTCP.
Information will be collected electronically using an Excel spreadsheet tool titled “Evaluation Reporting Template for National and State Tobacco Control Program” (ERT). The collection of this information is part of a federal reporting requirement for funds received by NTCP recipients. The information collection form will consolidate information necessary for evaluation of the NTCP.
The data collected through the Evaluation Reporting Template for National and State Tobacco Control Program (ERT) was compared to all other potential evaluation data sources and designed not to duplicate any information collected in other tools. Although other NTCP data collection tools are currently in use to collect data for NTCP (Monitoring and Reporting System for the National Tobacco Control Program; OMB Control No. 0920-1097, Exp. 04/30/2023), these existing data collection tools are focused on financial and programmatic management, program implementation, and performance measurement. By contrast, the ERT will collect process and outcome evaluation findings resulting from individual evaluations designed by each NTCP recipient. Findings will include contextual factors, indicators, lessons learned, and information about health inequities and health disparities.
Recipients will use the ERT for National and State Tobacco Control Program to report information to CDC about their Tobacco Control Program evaluation findings. Each recipient will submit an Evaluation Report template annually. OMB approval is requested for three years. Intended respondents include 53 cooperative agreement recipients. The estimated burden per response is eight hours for each Annual Evaluation Report. The total estimated annualized burden is 424 hours.
In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled “Evaluation of the Chronic Disease Self-Management Program in the US Affiliated Pacific Islands” to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on April 16, 2021 to obtain comments from the public and affected agencies. CDC did not receive comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.
CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:
(a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to be collected;
(d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
(e) Assess information collection costs.
To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570. Comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Evaluation of the Chronic Disease Self-Management Program (CDSMP) in the US Affiliated Pacific Islands (OMB Control No. 0920-1265)—Reinstatement—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).
NCCDPHP plans to evaluate the implementation of Stanford University's Chronic Disease Self-Management Program (CDSMP) in the US Affiliated Pacific Islands (USAPIs). These jurisdictions include American Samoa, Guam, the Commonwealth of the Northern Mariana Islands, the Republic of Palau, the Republic of the Marshall Islands, and the Federated States of Micronesia. Stanford University's Chronic Disease Self-Management Program (CDSMP) is a six-week series of workshops for people with arthritis, diabetes, lung disease, cancer, and other health problems. The workshops focus on helping participants learn strategies to manage chronic disease, including techniques to deal with problems such as frustration, fatigue, pain and isolation; appropriate exercise for maintaining and improving strength, flexibility, and endurance; and appropriate use of medications among others. Proven benefits of CDSMP include decreased pain and health distress, increased energy, increased physical activity, better communication with health care providers, and increased confidence in managing chronic disease. The program will be offered repeatedly over the course of three years. This new request is for three years, which will cover repeated data collection.
The purpose of the evaluation is to understand: (1) how CDSMP is being implemented in the region; (2) to identify barriers and facilitators to implementation; (3) to monitor fidelity to Stanford University's model and document adaptations to the curriculum; and (4) to understand the self-reported effects of the program on program participants. Because this is the first time CDSMP is being implemented in the USAPIs, we do not know if the intervention, which has proven to improve health outcomes in many ethnic groups within the United States, will lead to improved health outcomes for these communities.
CDC requests OMB approval for an estimated 63 annual burden hours. There are no costs to respondents other than their time to participate.
Estimated Annualized Burden Hours
In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled “Project Firstline Partner Reporting, the assessment of performance and progress data on a new infection control program for frontline healthcare personnel” to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on April 8, 2022, to obtain comments from the public and affected agencies. CDC received three comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.
CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:
(a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to be collected;
(d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
(e) Assess information collection costs.
To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570. Comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Project Firstline (PFL) Partner Reporting—New—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).
The goal of the Project Firstline (PFL) Partner Reporting project is to collect performance/progress information from PFL national partner organizations to inform development of tailored infection prevention and control (IPC) communications and trainings and resources designed for frontline healthcare personnel (HCP). PFL is a new program and as such, collection of performance/progress data is critical for successful program implementation and ongoing improvement. Gathering data from PFL partners will provide crucial insights into the diverse needs of HCP, gaps in existing CDC training resources, and will help CDC understand the reach and impact of the PFL initiative. Having this information will allow CDC and partners to monitor progress towards desired outcomes while improving PFL outreach and programming based on lessons learned. The PFL collaborative network, data-driven training and education programs, and targeted messaging through digital platforms will help drive behavior change—enhancing the readiness of the nation's frontlines to respond to the current COVID-19 pandemic and future disease outbreaks.
To fulfill the data requested by CDC for training activities, partner organizations ask training participants to complete registration for activities and/or evaluations at the end of trainings, and data from these sources are then aggregated and submitted to CDC along with descriptive information about the training topic and approach. The partner organizations also collect and submit data on communications activities occurring through email, social media, websites, and podcasts to promote the trainings. The total estimated annualized burden is 502 hours.
In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled “National Environmental Assessment Reporting System (NEARS)” to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on April 08, 2022, to obtain comments from the public and affected agencies. CDC received one comment related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.
CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:
(a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to be collected;
(d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
(e) Assess information collection costs.
To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570. Comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
National Environmental Assessment Reporting System (NEARS) (OMB Control No. 0920-0980, Exp. 08/31/2022)—Revision—National Center for Environmental Health (NCEH), Centers for Disease Control and Prevention (CDC).
CDC is requesting a three-year Paperwork Reduction Act (PRA) clearance for the National Environmental Assessment Reporting System (NEARS) to collect data from foodborne illness outbreak environmental assessments routinely conducted by local, state, territorial, or tribal food safety programs during outbreak investigations. Prior to the development of NEARS, environmental assessment data were not collected at the national level. The data reported through this surveillance system provides timely information on the causes of outbreaks, including environmental factors associated with outbreaks, and are essential to environmental public health regulators' efforts to respond more effectively to outbreaks and prevent future, similar outbreaks. This surveillance system was specifically designed to link to CDC's National Outbreak Reporting System (NORS) (OMB Control No. 0920-1304, Exp. 09/30/2023), a disease (
While conducting environmental assessments during outbreak investigations is routine for food safety program officials, reporting information from the environmental assessments to CDC is not routine. Local, state, federal, territorial, and tribal food safety programs are the primary respondents for this data collection. One official from each participating program will report environmental assessment data on outbreaks. These programs are typically located in public health or agriculture agencies. In the U.S., there are approximately 3,000 such agencies.
Not every program of the approximate 3,000 programs will register for NEARS and respond every year. Currently, 34 programs have entered outbreak data into NEARS. We expect up to 10 additional programs will register to participate in NEARS over the next three years, to reach a maximum of 44 reporting programs.
It is not possible to determine exactly how many outbreaks will occur in the future, nor where they will occur. Over the past six years, we received 1,261 reports to NEARS, with the highest number of 307 reports in 2018, and a yearly average of 210 reports. Based on these reporting trends, we estimate that each participating program will report up to seven foodborne illness outbreaks per year; therefore, up to 308 outbreaks may be reported annually to NEARS for the duration of the next PRA clearance.
The activities associated with NEARS that require a burden estimate consist of registration, training, observing, data recording, and data reporting events. Food safety programs interested in participating in NEARS must first register to use the system. The anticipation of 10 new programs over the next three years is rounded to three new programs per year. Therefore, the total estimated annual burden associated with registration is one hour (10 minutes per hour × three registrations = 0.5 hours rounded to one hour).
The next activity is the training for the food safety program personnel participating in NEARS. These staff will be encouraged to attend a Microsoft Teams/Zoom Meeting (
Although not a requirement, food safety program personnel participating in NEARS will also be encouraged to complete CDC's Environmental Assessment Training Series (EATS). This e-Learning course provides training to staff on how to use a systems approach in foodborne illness outbreak environmental assessments. Participants acquire in-depth skills and knowledge to investigate foodborne illness outbreaks as a member of a larger outbreak response team, identify an outbreak's environmental causes, and recommend appropriate control measures. The course is presented in the context of a simulated virtual environment where participants can interact and practice the skills being learned. We estimate the burden of this training to be a maximum of 10 hours. Respondents will only take this training one time. Assuming a maximum participation of up to 10 new programs and approximately five staff being trained at each program, the estimated burden associated with this training is 500 hours (10 hours × 10 entities × five staff per entity).
Data reporting activities for NEARS will be done once at each establishment involved in the outbreak. Information collection activities for NEARS consist of the following: NEARS data reporting and NEARS manager interview.
For each outbreak, the respondent (one official from each participating program) will spend around 30 minutes recording environmental assessment data on pen and paper. Assuming a maximum number of 308 outbreaks, the estimated annual burden is 150 hours (30 minutes per outbreak × 300 outbreaks) for recording observations.
The manager interview will be conducted on pen and paper at each establishment associated with an outbreak. The respondents for this activity are the retail food managers of the outbreak establishments. Manager interviews are a routine part of outbreak investigations; however, food safety program personnel participating in NEARS conduct a structured interview and will thus conduct their interviews slightly differently than they would if they were not participating in NEARS. For this reason, we have presented the burden for this interview separately. Most outbreaks are associated with only one establishment; however, some are associated with multiple establishments. We estimate that a maximum of four manager interviews will be conducted per outbreak (n = 4 × 308 = 1,232). Each interview and data reporting will take about 20 minutes. The estimated annual burden is 411 hours (20 minutes × 1,232 manager interviews).
Entering data into the NEARS Data Reporting Form (web entry) is combined for both the environmental assessment and the manager interviews and is expected to take approximately 40 minutes, for a total of 205 burden hours (40 minutes × 308 outbreaks).
As part of this Revision information collection request (ICR), the requested changes to the NEARS Data Recording Form (paper form) include an update to the definitions for contributing factors based on national workgroup recommendations. In addition, one question was added to obtain a measure of the community's social vulnerability in the census tract where the food establishment is located. The social vulnerability index (SVI) will be added to the NEARS Data Reporting Form (web entry) as a change request in the next fiscal year. These form modifications are not anticipated to change the time burden per response.
Due to the anticipated increase in reporting sites from 34 to 44 registered food safety programs with each reporting up to seven outbreaks each year, the total estimated annual burden for this information collection is 1,371 hours. This reflects an increase in time burden of 21 hours over the previously approved 1,350 hours. The total number of respondents is 1,951 per year. This reflects an increase of 51 respondents over the previously approved 1,900 respondents. There are no costs to the respondents other than their time.
In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled “Well-Integrated Screening and Evaluation for Women Across the Nation (WISEWOMAN) Reporting System” to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on June 2, 2022 to obtain comments from the public and affected agencies. CDC received no comment(s) related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.
CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:
(a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to be collected;
(d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
(e) Assess information collection costs.
To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570. Comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Well-Integrated Screening and Evaluation for Women Across the Nation (WISEWOMAN) Reporting System (OMB Control No. 0920-0612, Exp. 08/31/2022)—Extension—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).
The WISEWOMAN program, sponsored by the CDC, provides services to low income, uninsured, or underinsured women aged 40-64. WISEWOMAN is designed to prevent, detect, and control hypertension and other cardiovascular disease (CVD) risk factors through healthy behavior support services which are tailored for individual and group behavior change. The WISEWOMAN program provides services to women who are jointly enrolled in the National Breast and Cervical Cancer Early Detection Program (NBCCEDP), which is also sponsored by CDC.
The WISEWOMAN program is administered by state health departments and tribal programs. In 2018, new five-year cooperative agreements were awarded under Funding Opportunity Announcement DP18-1816, subject to the availability of funds. CDC collects two types of information from WISEWOMAN awardees. The WISEWOMAN awardee submits an electronic data file to CDC twice per year. The Minimum Data Elements (MDE) file contains data using a unique identifier with client-level information about cardiovascular disease risk factors and types of healthy behavior support services for participants served by the program. The estimated burden per response for the MDE file is 24 hours. In addition, each WISEWOMAN awardee submits an Annual Progress Report to CDC, which provides a narrative summary of the awardee's objectives and the activities undertaken to meet program goals. The estimated burden per response for the Annual Progress Report is 16 hours.
There are no changes to the information collection. CDC will continue to use the information collected from WISEWOMAN awardees to support program monitoring and improvement activities, evaluation, and assessment of program outcomes. The overall program evaluation helps to demonstrate program accomplishments and strengthen the evidence for implementing strategies that improve engagement of underserved populations. The information reported to CDC can also help to determine whether the identified strategies and associated activities can be implemented at various levels within a state or tribal organization. Evaluation is also designed to demonstrate how WISEWOMAN can obtain cardiovascular disease health outcome data on at-risk populations, promote public education about cardiovascular disease risk-factors, and improve the availability of healthy behavior support services for under-served women.
OMB approval is requested for two years. Participation in this information collection is required as a condition of cooperative agreement funding. There are no costs to respondents other than their time. The total estimated annualized burden hours are 2,240.
In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled “National HIV Behavioral Surveillance System (NHBS)” to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on May 13, 2022 to obtain comments from the public and affected agencies. CDC did not receive comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.
CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:
(a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to be collected;
(d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
(e) Assess information collection costs.
To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570. Comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
National HIV Behavioral Surveillance System (NHBS) (OMB Control No. 0920-0770, Exp. 01/31/2023)—Revision—National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).
The purpose of this data collection is to monitor behaviors of persons at high risk for infection that are related to Human Immunodeficiency Virus (HIV) transmission and prevention in the United States. The primary objectives of the NHBS are to obtain data from samples of persons at risk to: (a) describe the prevalence and trends in risk behaviors; (b) describe the prevalence of and trends in HIV testing and HIV infection; (c) describe the prevalence of and trends in use of HIV prevention services; and (d) identify met and unmet needs for HIV prevention services in order to inform health departments, community based organizations, community planning groups and other stakeholders.
By describing and monitoring the HIV risk behaviors, HIV seroprevalence and incidence, and HIV prevention experiences of persons at highest risk for HIV infection, NHBS provides an important data source for evaluating progress towards national public health initiatives, such as reducing new infections, increasing the use of condoms, and targeting populations at high risk.
The Centers for Disease Control and Prevention requests approval for a three-year Revision of this information collection. Data are collected through in-person interviews conducted with persons systematically selected from 20 Metropolitan Statistical Areas (MSAs) throughout the United States; these 20 MSAs are chosen based on highest number of HIV infections diagnosed. Persons at risk for HIV infection to be interviewed for NHBS include men who have sex with men (MSM), persons who inject drugs (PWID), and heterosexually active persons at increased risk of HIV infection (HET). A brief screening interview will be used to determine eligibility for participation in the behavioral assessment.
The data from the behavioral assessment will provide estimates of: (1) behavior related to the risk of HIV and other sexually transmitted diseases; (2) prior testing for HIV; and (3) use of HIV prevention services.
All persons interviewed will also be offered an HIV test and will participate in a pre-test counseling session. No other federal agency systematically collects this type of information from persons at risk for HIV infection. These data have substantial impact on prevention program development and monitoring at the local, state, and national levels. CDC estimates that NHBS will involve, per year, in up to 20 MSAs, eligibility screening for 125 persons and eligibility screening plus the behavioral assessment with 500 eligible respondents, resulting in a total of 30,000 eligible survey respondents and 7,500 ineligible screened persons during a three-year period. Data collection will rotate such that interviews will be conducted among one group per year: MSM in Year 1, PWID in Year 2, and HET in Year 3. The type of data collected for each group will vary slightly due to different sampling methods and risk characteristics of the group.
Participation of respondents is voluntary and there is no cost to the respondents other than their time. CDC requests OMB approval for an estimated 6,600 annual burden hours.
In notice document 2022-16791, appearing on pages 48033 through 48034 in the issue of Friday, August 5, 2022, make the following corrections:
1. On page 48034, in the table, on the third row, in the second cell, “LifeSet Team
Supervisors” should appear below “LifeSet Specialists”.
2. On the same page, in the same table, remove the fourth row including the text “LifeSet Team Supervisors”.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Submit written comments (including recommendations) on the collection of information by September 12, 2022.
To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to
Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
FDA's guidance document entitled “Medical Device Accessories—Describing Accessories and Classification Pathways”
The FDA Reauthorization Act of 2017 (FDARA) (Pub. L. 115-52) changed how FDA regulates medical device accessories. Specifically, section 707 of FDARA added section 513(f)(6) to the statute and requires that FDA, upon request, classify existing and new accessories notwithstanding the classification of any other device with which such accessory is intended to be used. This means that the classification of an accessory may not be the same as its parent device, depending on the risks of the accessory when used as intended and the level of regulatory controls necessary for reasonable assurance of safety and effectiveness of the accessory. Until an accessory is distinctly classified, its existing classification will continue to apply. This provision does not preclude a manufacturer from submitting a De Novo request for an accessory.
Depending on an accessory's regulatory history, there are different submission types, tracking mechanisms, and deadlines:
(1) Existing accessory types are those that have been identified in a classification regulation or granted marketing authorization as part of a 510(k), premarket approval application (PMA), or De Novo request (approved under OMB control numbers 0910-0120, 0910-0231, and 0910-0844, respectively). Manufacturers with marketing authorization for an existing accessory may request appropriate classification through a new stand-alone premarket submission (Existing Accessory Request). Upon request, FDA is required to meet with a manufacturer or importer to discuss the appropriate classification of an existing accessory prior to submitting a written request. Existing Accessory Requests will be initially tracked as “Q-submissions” (approved under OMB control number 0910-0756). FDA has a statutory deadline of 85 calendar days to respond to an Existing Accessory Request.
(2) New accessory types are those that have not been granted marketing authorization as part of a 510(k), PMA,
For both Existing and New Accessory Requests, manufacturers must request proper classification of their accessory in the submission and include draft special controls, if requesting classification into class II. The processes that we use to classify an accessory will be like those used for De Novo requests. If FDA grants the Accessory Request, FDA must issue an order establishing a new classification regulation for the accessory type. If FDA denies the Accessory Request, FDA must issue a letter with a detailed description and justification for our determination.
In the
FDA estimates the burden of this collection of information as follows:
Based on an evaluation of the information collection, we have reduced the estimated number of existing requests from 15 to 10, and we have reduced the estimated number of new requests from 10 to 5. This adjustment results in an overall reduction to the information collection by 10 responses and 400 hours annually. We believe these adjustments more accurately reflect the current number of requests associated with medical device accessory classifications.
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 (GFI) #110 (VICH GL16(R1)) entitled “Effectiveness of Anthelmintics: Specific Recommendations for Porcines (Revision 1).” This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This revision clarifies the definition of adequate infection in individual animals, updates considerations for field studies, and makes additional clarifying changes.
Submit either electronic or written comments on the draft guidance by October 11, 2022 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
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 guidance to the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Aimée Phillippi-Taylor, Center for Veterinary Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl, Rockville, MD 20855, 240-402-0601,
FDA is announcing the availability of a draft GFI #110 (VICH GL16(R1)) entitled “Effectiveness of Anthelmintics: Specific Recommendations for Porcines (Revision 1).” It should be read in conjunction with GFI #90 (VICH GL7) entitled “Effectiveness of Anthelmintics: General Recommendations,” which should be referred to for discussion of broad aspects for providing pivotal data to demonstrate product anthelmintic effectiveness. The purpose of this guidance is: (1) to be more specific for certain specific porcine issues not discussed in GFI #90 (VICH GL7); (2) to highlight differences with GFI #90 (VICH GL7) on effectiveness data recommendations; and (3) to give explanations for disparities with GFI #90 (VICH GL7). This revision clarifies the definition of adequate infection in individual animals, updates considerations for field studies, and makes additional clarifying changes.
FDA has participated in efforts to enhance international harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify, and then reduce, differences in technical requirements for drug development among regulatory agencies in different countries. FDA has actively participated in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use to develop harmonized technical requirements for the approval of human pharmaceutical and biological products among the European Union, Japan, and the United States. The VICH is a parallel initiative for veterinary medicinal products. The VICH is concerned with developing harmonized technical requirements for the approval of veterinary medicinal products in the European Union, Japan, and the United States, and includes input from both regulatory and industry representatives.
The VICH Steering Committee is composed of member representatives from the European Commission and European Medicines Agency; AnimalhealthEurope; FDA—Center for Veterinary Medicine; U.S. Department of Agriculture—Center for Veterinary Biologics; the U.S. Animal Health Institute; the Japanese Ministry of Agriculture, Forestry and Fisheries; and the Japanese Veterinary Products Association. There are 10 observers to the VICH Steering Committee: One representative from government and one representative from industry of Australia, New Zealand, Canada, South Africa, and the United Kingdom. The World Organisation for Animal Health is an associate member of the VICH. The VICH Secretariat, which coordinates the preparation of documentation, is provided by HealthforAnimals.
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 “Effectiveness of Anthelmintics: Specific Recommendations for Porcines (Revision 1).” 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 OMB under the PRA. The collections of information in 21 CFR part 514 have been approved under OMB Control Number 0910-0032.
Persons with access to the internet may obtain the draft guidance at
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 (GFI) #90 (VICH GL7(R1)) entitled “Effectiveness of Anthelmintics: General Recommendations (Revision 1).” This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The objective of this draft guidance is to provide study design recommendations that will facilitate the universal acceptance of the generated effectiveness data to fulfill the national/regional requirements for anthelmintic drugs in animal species. This revision updates data analysis and isolate characterization recommendations, outlines how to approach new indications, and makes additional clarifying changes.
Submit either electronic or written comments on the draft guidance by October 11, 2022 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 guidance to the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Aimée Phillippi-Taylor, Center for Veterinary Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0601,
FDA is announcing the availability of a draft guidance for industry GFI #90 (VICH GL7(R1)) entitled “Effectiveness of Anthelmintics: General Recommendations (Revision 1).” The objective of this guidance is to provide study design recommendations that will facilitate the universal acceptance of the generated effectiveness data to fulfill the national/regional requirements for anthelmintic drugs in animal species. This revision updates data analysis and isolate characterization recommendations, outlines how to approach new indications, and makes additional clarifying changes.
FDA has participated in efforts to enhance international harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify, and then
The VICH Steering Committee is composed of member representatives from the European Commission and European Medicines Agency; AnimalhealthEurope; FDA—Center for Veterinary Medicine and U.S. Department of Agriculture—Center for Veterinary Biologics; the U.S. Animal Health Institute; the Japanese Ministry of Agriculture, Forestry and Fisheries; and the Japanese Veterinary Products Association. There are 10 observers to the VICH Steering Committee: One representative from government and one representative from industry of Australia, New Zealand, Canada, South Africa, and the United Kingdom. The World Organisation for Animal Health is an associate member of the VICH. The VICH Secretariat, which coordinates the preparation of documentation, is provided by HealthforAnimals.
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 “Effectiveness of Anthelmintics: General Recommendations (Revision 1).” 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 OMB under the PRA. The collections of information in 21 CFR part 514 have been approved under OMB control number 0910-0032.
Persons with access to the internet may obtain the draft guidance at
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 (GFI) #109 (VICH GL15(R1)) entitled “Effectiveness of Anthelmintics: Specific Recommendations for Equines (Revision 1).” This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This revision clarifies the definition of adequate infection in individual animals, updates considerations for field studies, and makes additional clarifying changes.
Submit either electronic or written comments on the draft guidance by October 11, 2022 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
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 guidance to the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Aimée Phillippi-Taylor, Center for Veterinary Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl, Rockville, MD 20855, 240-402-0601,
FDA is announcing the availability of a draft GFI #109 (VICH GL15(R1)) entitled “Effectiveness of Anthelmintics: Specific Recommendations for Equines (Revision 1).” It should be read in conjunction with GFI #90 (VICH GL7), “Effectiveness of Anthelmintics: General Recommendations,” which should be referred to for discussion of broad aspects for providing pivotal data to demonstrate product anthelmintic effectiveness. The purpose of this guidance is: (1) to be more specific for certain specific equine issues not discussed in GFI #90 (VICH GL7); (2) to highlight differences with GFI #90 (VICH GL7) on effectiveness data recommendations; and (3) to give explanations for disparities with GFI #90 (VICH GL7). This revision clarifies the definition of adequate infection in individual animals, updates considerations for field studies, and makes additional clarifying changes.
FDA has participated in efforts to enhance international harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify, and then reduce, differences in technical requirements for drug development among regulatory agencies in different countries.
FDA has actively participated in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use to develop harmonized technical requirements for the approval of human pharmaceutical and biological products among the European Union, Japan, and the United States. The VICH is a parallel initiative for veterinary medicinal products. The VICH is concerned with developing harmonized technical requirements for the approval of veterinary medicinal products in the European Union, Japan, and the United States, and includes input from both regulatory and industry representatives.
The VICH Steering Committee is composed of member representatives from the European Commission and European Medicines Agency; AnimalhealthEurope; FDA—Center for Veterinary Medicine and U.S. Department of Agriculture—Center for Veterinary Biologics; the U.S. Animal Health Institute; the Japanese Ministry of Agriculture, Forestry and Fisheries; and the Japanese Veterinary Products Association.
There are 10 observers to the VICH Steering Committee: One representative from government and one representative from industry of Australia, New Zealand, Canada, South Africa, and the United Kingdom. The World Organisation for Animal Health is an associate member of the VICH. The VICH Secretariat, which coordinates the preparation of documentation, is provided by HealthforAnimals.
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 “Effectiveness of Anthelmintics: Specific Recommendations for Equines (Revision 1).” 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 OMB under the PRA. The collections of information in 21 CFR part 514 have been approved under OMB control number 0910-0032.
Persons with access to the internet may obtain the draft guidance at
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 (GFI) #113 (VICH GL20(R1)) entitled “Effectiveness of Anthelmintics: Specific Recommendations for Felines (Revision 1).” This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This revision clarifies the definition of adequate infection in individual animals, updates considerations for field studies, and makes additional clarifying changes.
Submit either electronic or written comments on the draft guidance by October 11, 2022 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 guidance to the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Aimée Phillippi-Taylor, Center for Veterinary Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl, Rockville, MD 20855, 240-402-0601,
FDA is announcing the availability of a draft GFI #113 (VICH GL20(R1)) entitled “Effectiveness of Anthelmintics: Specific Recommendations for Felines (Revision 1).” It should be read in conjunction with GFI #90 (VICH GL7), “Effectiveness of Anthelmintics: General Recommendations,” which should be referred to for discussion of broad aspects for providing pivotal data to demonstrate product anthelmintic effectiveness. The purpose of this guidance is: (1) to be more specific for certain specific feline issues not discussed in GFI #90 (VICH GL7); (2) to highlight differences with GFI #90 (VICH GL7) on effectiveness data recommendations; and (3) to give explanations for disparities with GFI #90 (VICH GL7). This revision clarifies the definition of adequate infection in individual animals, updates considerations for field studies, and makes additional clarifying changes.
FDA has participated in efforts to enhance international harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify, and then reduce, differences in technical requirements for drug development among regulatory agencies in different countries.
FDA has actively participated in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use to develop harmonized technical requirements for the approval of human pharmaceutical and biological products among the European Union, Japan, and the United States. The VICH is a parallel initiative for veterinary medicinal products. The VICH is concerned with developing harmonized technical
The VICH Steering Committee is composed of member representatives from the European Commission and European Medicines Agency; AnimalhealthEurope; FDA—Center for Veterinary Medicine and U.S. Department of Agriculture—Center for Veterinary Biologics; the U.S. Animal Health Institute; the Japanese Ministry of Agriculture, Forestry and Fisheries; and the Japanese Veterinary Products Association.
There are 10 observers to the VICH Steering Committee: One representative from government and one representative from industry of Australia, New Zealand, Canada, South Africa, and the United Kingdom. The World Organisation for Animal Health is an associate member of the VICH. The VICH Secretariat, which coordinates the preparation of documentation, is provided by HealthforAnimals.
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 “Effectiveness of Anthelmintics: Specific Recommendations for Felines (Revision 1).” 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 OMB under the PRA. The collections of information in 21 CFR part 514 have been approved under OMB control number 0910-0032.
Persons with access to the internet may obtain the draft guidance at
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 GFI #114 (VICH GL21(R1)) entitled “Effectiveness of Anthelmintics: Specific Recommendations for Chickens—Gallus gallus (Revision 1).” This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This revision clarifies the definition of adequate infection in individual animals, updates considerations for field studies, and makes additional clarifying changes. This revision clarifies the definition of adequate infection in individual animals, updates considerations for field studies, and makes additional clarifying changes.
Submit either electronic or written comments on the draft guidance by October 11, 2022 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 guidance to the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Aimée Phillippi-Taylor, Center for Veterinary Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0601,
FDA is announcing the availability of a draft guidance for industry GFI #114 (VICH GL21(R1)) entitled “Effectiveness of Anthelmintics: Specific Recommendations for Chickens—Gallus gallus (Revision 1).” It should be read in conjunction with GFI #90 (VICH GL7), “Effectiveness of Anthelmintics: General Recommendations,” which should be referred to for discussion of broad aspects for providing pivotal data to demonstrate product anthelmintic effectiveness. The purpose of this guidance is to: (1) be more specific for certain specific chicken issues not discussed in GFI #90 (VICH GL7); (2) highlight differences with GFI #90 (VICH GL7) on effectiveness data recommendations; and (3) give explanations for disparities with GFI #90 (VICH GL7). This revision clarifies the definition of adequate infection in individual animals, updates considerations for field studies, and makes additional clarifying changes.
FDA has participated in efforts to enhance international harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify, and then reduce, differences in technical requirements for drug development among regulatory agencies in different countries.
FDA has actively participated in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use to develop harmonized technical requirements for the approval of human pharmaceutical and biological products among the European Union, Japan, and the United States. The VICH is a parallel initiative for veterinary medicinal products. The VICH is concerned with developing harmonized technical requirements for the approval of veterinary medicinal products in the European Union, Japan, and the United States, and includes input from both regulatory and industry representatives.
The VICH Steering Committee is composed of member representatives from the European Commission and European Medicines Agency; AnimalhealthEurope; FDA—Center for Veterinary Medicine and U.S. Department of Agriculture—Center for Veterinary Biologics; the U.S. Animal Health Institute; the Japanese Ministry of Agriculture, Forestry and Fisheries; and the Japanese Veterinary Products Association.
There are 10 observers to the VICH Steering Committee: One representative from government and one representative from industry of Australia, New Zealand, Canada, South Africa, and the United Kingdom. The World Organisation for Animal Health is an associate member of the VICH. The VICH Secretariat, which coordinates the preparation of documentation, is provided by HealthforAnimals.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21CFR 10.115). This draft guidance, when finalized, will represent the current thinking of FDA on “Effectiveness of Anthelmintics: Specific Recommendations for Chickens—Gallus gallus (Revision 1).” 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 OMB under the PRA. The collections of information in 21 CFR part 514 have been approved under OMB Control No. 0910-0032.
Persons with access to the internet may obtain the draft guidance at
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 GFI #96 (VICH GL13(R1)) entitled “Effectiveness of Anthelmintics: Specific Recommendations for Ovines (Revision 1).” This draft guidance has been developed for veterinary use by the
Submit either electronic or written comments on the draft guidance by October 11, 2022 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 guidance to the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Aimée Phillippi-Taylor, Center for Veterinary Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl, Rockville, MD 20855, 240-402-0601,
FDA is announcing the availability of a draft guidance for industry GFI #96 (VICH GL13(R1)) entitled “Effectiveness of Anthelmintics: Specific Recommendations for Ovines (Revision 1).” It should be read in conjunction with GFI #90 (VICH GL7), “Effectiveness of Anthelmintics: General Recommendations,” which should be referred to for discussion of broad aspects for providing pivotal data to demonstrate product anthelmintic effectiveness. The purpose of this guidance is: (1) to be more specific for certain specific ovine issues not discussed in GFI #90 (VICH GL7); (2) to highlight differences with GFI #90 (VICH GL7) on effectiveness data recommendations; and (3) to give explanations for disparities with GFI #90 (VICH GL7). This revision clarifies the definition of adequate infection in individual animals, updates considerations for field studies, and makes additional clarifying changes.
FDA has participated in efforts to enhance international harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify, and then reduce, differences in technical requirements for drug development among regulatory agencies in different countries.
FDA has actively participated in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use to develop harmonized technical requirements for the approval of human pharmaceutical and biological products among the European Union, Japan, and the United States. The VICH is a parallel initiative for veterinary medicinal products. The VICH is concerned with developing harmonized technical requirements for the approval of veterinary medicinal products in the European Union, Japan, and the United States, and includes input from both regulatory and industry representatives.
The VICH Steering Committee is composed of member representatives from the European Commission and European Medicines Agency;
There are 10 observers to the VICH Steering Committee: One representative from government and one representative from industry of Australia, New Zealand, Canada, South Africa, and the United Kingdom. The World Organisation for Animal Health is an associate member of the VICH. The VICH Secretariat, which coordinates the preparation of documentation, is provided by HealthforAnimals.
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 “Effectiveness of Anthelmintics: Specific Recommendations for Ovines (Revision 1).” 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 OMB under the PRA. The collections of information in 21 CFR part 514 have been approved under OMB Control Number 0910-0032.
Persons with access to the internet may obtain the draft guidance at
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 GFI #111 (VICH GL19(R1)) entitled “Effectiveness of Anthelmintics: Specific Recommendations for Canines (Revision 1).” This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This revision clarifies the definition of adequate infection in individual animals, updates considerations for field studies, and makes additional clarifying changes.
Submit either electronic or written comments on the draft guidance by October 11, 2022 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 guidance to the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Aimée Phillippi-Taylor, Center for Veterinary Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0601,
FDA is announcing the availability of a draft guidance for industry GFI #111 (VICH GL19(R1)) entitled “Effectiveness of Anthelmintics: Specific Recommendations for Canines (Revision 1).” It should be read in conjunction with GFI #90 (VICH GL7), “Effectiveness of Anthelmintics: General Recommendations,” which should be referred to for discussion of broad aspects for providing pivotal data to demonstrate product anthelmintic effectiveness. The purpose of this guidance is: (1) to be more specific for certain specific canine issues not discussed in GFI #90 (VICH GL7); (2) to highlight differences with GFI #90 (VICH GL7) on effectiveness data recommendations; and (3) to give explanations for disparities with GFI #90 (VICH GL7). This revision clarifies the definition of adequate infection in individual animals, updates considerations for field studies, and makes additional clarifying changes.
FDA has participated in efforts to enhance international harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify, and then reduce, differences in technical requirements for drug development among regulatory agencies in different countries.
FDA has actively participated in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use to develop harmonized technical requirements for the approval of human pharmaceutical and biological products among the European Union, Japan, and the United States. The VICH is a parallel initiative for veterinary medicinal products. The VICH is concerned with developing harmonized technical requirements for the approval of veterinary medicinal products in the European Union, Japan, and the United States, and includes input from both regulatory and industry representatives.
The VICH Steering Committee is composed of member representatives from the European Commission and European Medicines Agency; AnimalhealthEurope; FDA—Center for Veterinary Medicine and U.S. Department of Agriculture—Center for Veterinary Biologics; the U.S. Animal Health Institute; the Japanese Ministry of Agriculture, Forestry and Fisheries; and the Japanese Veterinary Products Association.
There are 10 observers to the VICH Steering Committee: one representative from government and one representative from industry of Australia, New Zealand, Canada, South Africa, and the United Kingdom. The World Organisation for Animal Health is an associate member of the VICH. The VICH Secretariat, which coordinates the preparation of documentation, is provided by HealthforAnimals.
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 “Effectiveness of Anthelmintics: Specific Recommendations for Canines (Revision 1).” 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 OMB under the PRA. The collections of information in 21 CFR part 514 have been approved under OMB control number 0910-0032.
Persons with access to the internet may obtain the draft guidance at
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 (GFI) #95 (VICH GL12(R1)) entitled “Effectiveness of Anthelmintics: Specific Recommendations for Bovines (Revision 1).” This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This revision clarifies the definition of adequate infection in individual animals, updates considerations for field studies, and makes additional clarifying changes.
Submit either electronic or written comments on the draft guidance by October 11, 2022 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 guidance to the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Aimée Phillippi-Taylor, Center for Veterinary Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0601,
FDA is announcing the availability of a draft GFI #95 (VICH GL12(R1)) entitled “Effectiveness of Anthelmintics: Specific Recommendations for Bovines (Revision 1).” It should be read in conjunction with GFI #90 (VICH GL7), “Effectiveness of Anthelmintics: General Recommendations,” which should be referred to for discussion of broad aspects for providing pivotal data to demonstrate product anthelmintic effectiveness. The purpose of this guidance is: (1) to be more specific for certain specific bovine issues not discussed in GFI #90 (VICH GL7); (2) to highlight differences with GFI #90 (VICH GL7) on effectiveness data recommendations; and (3) to give explanations for disparities with GFI #90 (VICH GL7). This revision clarifies the definition of adequate infection in individual animals, updates considerations for field studies, and makes additional clarifying changes.
FDA has participated in efforts to enhance international harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify, and then reduce, differences in technical requirements for drug development among regulatory agencies in different countries. FDA has actively participated in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use to develop harmonized technical requirements for the approval of human pharmaceutical and biological products among the European Union, Japan, and the United States. The VICH is a parallel initiative for veterinary medicinal products. The VICH is concerned with developing harmonized technical requirements for the approval of veterinary medicinal products in the European Union, Japan, and the United States, and includes input from both regulatory and industry representatives.
The VICH Steering Committee is composed of member representatives from the European Commission and European Medicines Agency; AnimalhealthEurope; FDA—Center for Veterinary Medicine; U.S. Department of Agriculture—Center for Veterinary Biologics; the U.S. Animal Health Institute; the Japanese Ministry of Agriculture, Forestry and Fisheries; and the Japanese Veterinary Products Association. There are 10 observers to the VICH Steering Committee: one representative from government and one representative from industry of Australia, New Zealand, Canada, South Africa, and the United Kingdom. The World Organisation for Animal Health is an associate member of the VICH. The VICH Secretariat, which coordinates the
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 “Effectiveness of Anthelmintics: Specific Recommendations for Bovines (Revision 1).” 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 OMB under the PRA. The collections of information in 21 CFR part 514 have been approved under OMB Control Number 0910-0032.
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 we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Submit written comments (including recommendations) on the collection of information by September 12, 2022.
To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to
Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Under sections 501(c) and 502(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351(c) and 352(a)), nonsterile devices that are labeled as sterile but are in interstate transit to a facility to be sterilized are adulterated and misbranded. FDA regulations at § 801.150(e) (21 CFR 801.150(e)) establish a control mechanism by which firms may manufacture and label medical devices as sterile at one establishment and ship the devices in interstate commerce for sterilization at another establishment, a practice that facilitates the processing of devices and is economically necessary for some firms.
Under § 801.150(e)(1), manufacturers and sterilizers may sign an agreement containing the following: (1) contact information of the firms involved and the identification of the signature authority of the shipper and receiver, (2) instructions for maintaining accountability of the number of units in each shipment, (3) acknowledgment that the devices that are nonsterile are being shipped for further processing, and (4) specifications for sterilization processing. This agreement allows the manufacturer to ship misbranded products to be sterilized without initiating regulatory action and provides FDA with a means to protect consumers from use of nonsterile products. During routine plant inspections, FDA normally reviews agreements that must be kept for 2 years after final shipment or delivery of devices (see § 801.150(a)(2)). The respondents to this collection of information are device manufacturers and contract sterilizers. FDA's estimate of the reporting burden is based on data obtained from industry in recent years. It is estimated that each of the firms subject to this requirement prepares an average of 37.5 written agreements each year. This estimate varies greatly, from 1 to 218, because some firms provide sterilization services on a part-time basis for only 1 customer, while others are large facilities with many customers. The average time required to prepare each written agreement is estimated to be 4 hours. This estimate varies depending on whether the agreement is the initial agreement or an annual renewal, on the format each firm elects to use, and on the length of time required to reach agreement. The estimate applies only to those portions of the written agreement that pertain to the requirements imposed by this regulation. The written agreement generally also includes contractual agreements that are a usual and customary business practice. The recordkeeping requirements of § 801.150(a)(2) consist of making copies and maintaining the records required under the third-party disclosure section of this collection.
In the
FDA estimates the burden of this collection of information as follows:
Our estimated burden for the information collection reflects an overall increase of 27,778 hours and a corresponding increase of 6,175 responses/records. We attribute this adjustment to an increase in the number of submissions we received over the last few years.
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 GFI #97 (VICH GL14(R1)) entitled “Effectiveness of Anthelmintics: Specific Recommendations for Caprines (Revision 1).” This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This revision clarifies the definition of adequate infection in individual animals, updates considerations for field studies, and makes additional clarifying changes.
Submit either electronic or written comments on the draft guidance by October 11, 2022 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 guidance to the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Aimée Phillippi-Taylor, Center for Veterinary Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl, Rockville, MD 20855, 240-402-0601,
FDA is announcing the availability of a draft guidance for industry GFI #97 (VICH GL14(R1)) entitled “Effectiveness of Anthelmintics: Specific Recommendations for Caprines (Revision 1).” It should be read in conjunction with GFI #90 (VICH GL7), “Effectiveness of Anthelmintics: General Recommendations,” which should be referred to for discussion of broad aspects for providing pivotal data to demonstrate product anthelmintic effectiveness. The purpose of this guidance is: (1) to be more specific for certain specific caprine issues not discussed in GFI #90 (VICH GL7); (2) to highlight differences with the GFI #90 (VICH GL7) on effectiveness data recommendations; and (3) to give explanations for disparities with the GFI #90 (VICH GL7). This revision clarifies the definition of adequate infection in individual animals, updates considerations for field studies, and makes additional clarifying changes.
FDA has participated in efforts to enhance international harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify, and then reduce, differences in technical requirements for drug development among regulatory agencies in different countries.
FDA has actively participated in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use to develop harmonized technical requirements for the approval of human pharmaceutical and biological products among the European Union, Japan, and the United States. The VICH is a parallel initiative for veterinary medicinal products. The VICH is concerned with developing harmonized technical requirements for the approval of veterinary medicinal products in the European Union, Japan, and the United States, and includes input from both regulatory and industry representatives.
The VICH Steering Committee is composed of member representatives from the European Commission and European Medicines Agency; AnimalhealthEurope; FDA—Center for Veterinary Medicine and U.S. Department of Agriculture—Center for Veterinary Biologics; the U.S. Animal Health Institute; the Japanese Ministry of Agriculture, Forestry and Fisheries; and the Japanese Veterinary Products Association.
There are 10 observers to the VICH Steering Committee: one representative from government and one representative from industry of Australia, New Zealand, Canada, South Africa, and the United Kingdom. The World Organisation for Animal Health is an associate member of the VICH. The VICH Secretariat, which coordinates the preparation of documentation, is provided by HealthforAnimals.
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 “Effectiveness of Anthelmintics: Specific Recommendations for Caprines (Revision 1).” 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 OMB under the PRA. The collections of information in 21 CFR part 514 have been approved under OMB Control Number 0910-0032.
Persons with access to the internet may obtain the draft guidance at
The Indian Health Service (IHS) is accepting applications for a cooperative agreement for the Healthy Lifestyles in Youth (HLY) Program. This program is authorized under the Snyder Act, 25 U.S.C. 13; and the Transfer Act, 42 U.S.C. 2001(a). This program is described in the Assistance Listings located at
This program promotes healthy lifestyles for American Indian and
The purpose of this program is to support the IHS mission to improve the health of AI/AN youth through health promotion and health education programs. The goal of this IHS cooperative agreement is to address healthy lifestyle development and emphasize nutrition and physical activity for AI/AN children and youth 7 through 11 years of age. To do this, the awardee must meet the following objectives:
• Collaborate with selected Native American Boys and Girls Club sites, via a grant application process;
• Provide health and physical education programs;
• Help youth achieve and maintain healthy lifestyles through participation in fitness programs;
• Help youth acquire a range of physical skills; and
• Help youth develop a sense of teamwork and cooperation.
These early intervention strategies provide evidence based opportunities to reduce and/or halt the increasing trend of obesity and diabetes among youth and young adults. Native Boys and Girls Clubs that develop a health promotion program that includes the TRAIL curriculum may help curtail the effects of unhealthy eating behaviors and lack of physical activity that can lead to obesity, diabetes, and other chronic diseases later in life. The TRAIL curriculum was developed to provide information on good nutrition and to promote physical activity among youth participating in Native American Boys and Girls Clubs. The TRAIL curriculum is a 3-month (12 lessons) program that provides youth with a comprehensive understanding of healthy lifestyles in order to prevent diabetes. Woven throughout the program are self-esteem and prevention activities. Participants draw from Tribal traditions and history to learn about nutrition, healthy food choices, media influences, and the impact of diabetes. The TRAIL curriculum emphasizes the importance of teamwork and community service. Members engage in service projects to improve healthy lifestyles in their communities, including starting community gardens to connect youth to their food source and organizing community-wide physical fitness events.
The overall results show improvement in participant knowledge of diabetes, health, and healthy food choices, as well as improved levels of fitness and physical activity. To date, this cooperative agreement has funded over 95 Native American Boys and Girls Club sites that have established and implemented this curriculum project and have served over 22,144 AI/AN youth. Program test scores each year consistently indicate: (a) increased knowledge about diabetes; (b) increased physical activity; and, (c) increased ability to identify healthier food options (post-intervention scores vs. pre-intervention test scores). Program physical activity logs show participating AI/AN youth collectively perform approximately 20,000 hours of physical activity each year. Boys and Girls Clubs also report annually on the service projects that are carried out by TRAIL participants in their local communities.
Boys and Girl Club sites that are located outside of Tribal communities are not eligible.
The Boys and Girls Club sites selected by the awardee may use IHS grant funds to provide services to eligible IHS beneficiaries only. The awardee will: provide technical consultation; train; monitor; evaluate; and provide funds to support these activities.
1. Develop a written plan for the planning, implementation, and evaluation of this project to include overseeing at least 98 sites, as agreed upon with the IHS. The local evaluation effort should include local evidence-based practice (EBP) fidelity data and how data will integrate with the National Evaluation Frame. Complete this task within 30 days of the award date and obtain approval by the IHS.
2. Develop selection criteria for additional sites as well as announce, evaluate, and select new sites. Sites must submit documentation verifying that they serve only AI/AN youth from eligible IHS beneficiaries, as a requirement for selection by the awardee. Conduct a start-up planning meeting with new sites within 2 months of each site's initial selection and award.
3. Plan and conduct an orientation and training meeting for new sites within 2 months of selection. Submit agenda, training goals and objectives, and participant list to IHS within 1 month of completion of each orientation session.
4. Update TRAIL curriculum as needed/directed and implement use. Document any specific changes to the curriculum and note expected impacts on implementation, data collection and outcomes.
5. Develop, in consultation with the IHS, the implementation and technical assistance plan for the coordination of the selected Boys and Girls Club sites. Submit criteria to the IHS for approval.
6. Each site will implement the TRAIL program, emphasizing healthy behaviors, such as physical activity and nutrition. Each program plan will also include a parent component describing approaches for involving the families of participants.
7. Each site will implement Physical Activity Strength and Endurance Challenges 3 times, 6 to 8 weeks apart. Physical activity data will be collected and summarized.
8. Awardee will promote and facilitate local, state, and national partnerships for the purpose of establishing or enhancing program support that involves increasing physical activity and good nutrition for the tribally-managed Boys and Girls Club sites. This includes, but is not limited to, establishing other partners such as American Indian-Alaska Native Program Branch (AI-ANPB) of Head Start Programs, Wings of America, United National Indian Tribal Youth, Inc. (UNITY), Tribal colleges, BGCA, Tribal organizations, local community health providers, and other private organizations as appropriate.
9. Awardee will continue to implement current evaluation processes in consultation for the TRAIL project. At a minimum, the evaluation will include:
a. training attendance (gender, age, grade level);
b. pre- and post- tests to assess participant knowledge;
c. monthly activity logs from each site on the physical activity portion of their program. Daily data to be collected includes the date, number of minutes of physical activity, and number of children participating; and
d. information/log on parent and family participation in education and activity programs, community involvement and partnerships.
10. Submit collated and summarized data to the IHS. Work with the IHS in
11. Provide ongoing technical support to the sites for the duration of the initiative. Provide training and technical assistance in all forms,
12. Provide technical assistance to the sites in developing a written work plan, with measurable goals, objectives and activities that adheres to the terms and conditions of the cooperative agreement.
13. Establish a formal agreement with Native American Boys and Girls Club sites, involving funding assistance and technical support to ensure clubs successfully implement the TRAIL program.
14. Submit to the IHS a written work plan and report describing each site's demographics, information on the number of youth in the eligible age range in the catchment area, the number that attend the Boys and Girls Clubs regularly, and the number served by this project, goals, objectives, activities, partnerships, and proposed outcomes.
15. Provide the IHS written quarterly reports on the evaluation outcomes, activity reports at each site, any parent involvement activities and other participation, description of the community partnerships, and other activities as appropriate. Conduct quarterly conference calls with IHS to review project status.
The total funding identified for the first budget year, starting in fiscal year (FY) 2022, is approximately $1,250,000. The funding available for competing and subsequent continuation awards issued under this announcement is subject to the availability of appropriations and budgetary priorities of the Agency. The IHS is under no obligation to make awards that are selected for funding under this announcement.
One award will be issued under this program announcement.
The project period is for 5 years.
Cooperative agreements awarded by the Department of Health and Human Services (HHS) are administered under the same policies as grants. However, the funding agency, IHS, is anticipated to have substantial programmatic involvement in the project during the entire period of performance. Below is a detailed description of the level of involvement required of the IHS.
(1) Identify a core group of IHS staff to work with the awardee in providing technical assistance and guidance.
(2) Meet with the awardee to review awardee work plan and provide guidance on implementation, program evaluation, and data collection strategy and tools.
(3) Participate in quarterly conference calls. Work with the awardee to display the results of this project by publishing on shared websites as well as in jointly authored publications.
(4) Use the evidence-based program(s), framework(s), and data collection requirement(s) to develop a National Logic Model and Evaluation Plan to collect national program aggregate and local EBP fidelity data.
To be eligible for this funding opportunity an applicant must be an organization with extensive experience developing and managing youth programs, health advocacy and education, and outreach related to AI/AN health care on a national scale.
The program office will notify any applicants deemed ineligible.
Please refer to Section IV.2 (Application and Submission Information/Subsection 2, Content and Form of Application Submission) for additional proof of applicant status documents required, such as Tribal Resolutions, proof of nonprofit status, etc.
The IHS does not require matching funds or cost sharing for grants or cooperative agreements.
Applications with budget requests that exceed the highest dollar amount outlined under Section II Award Information, Estimated Funds Available, or exceed the period of performance outlined under Section II Award Information, Period of Performance, are considered not responsive and will not be reviewed. The Division of Grants Management (DGM) will notify the applicant.
The following documentation is required (if applicable):
The DGM must receive an official, signed Tribal Resolution prior to issuing a Notice of Award (NoA) to any Tribe or Tribal organization selected for funding. An applicant that is proposing a project affecting another Indian Tribe must include resolutions from all affected Tribes to be served. However, if an official signed Tribal Resolution cannot be submitted with the application prior to the application deadline date, a draft Tribal Resolution must be submitted with the application by the deadline date in order for the application to be considered complete and eligible for review. The draft Tribal Resolution is not in lieu of the required signed resolution but is acceptable until a signed resolution is received. If an application without a signed Tribal Resolution is selected for funding, the applicant will be contacted by the Grants Management Specialist (GMS) listed in this funding announcement and given 90 days to submit an official signed Tribal Resolution to the GMS. If the signed Tribal Resolution is not received within 90 days, the award will be forfeited.
Tribes organized with a governing structure other than a Tribal council may submit an equivalent document commensurate with their governing organization.
Organizations claiming nonprofit status must submit a current copy of the 501(c)(3) Certificate with the application.
The application package and detailed instructions for this announcement are available at
Please direct questions regarding the application process to
Mandatory documents for all applicants include:
• Application forms:
1. SF-424, Application for Federal Assistance.
2. SF-424A, Budget Information—Non-Construction Programs.
3. SF-424B, Assurances—Non-Construction Programs.
4. Project Abstract Summary form.
• Project Narrative (not to exceed 25 pages). See Section IV.2.A, Project Narrative for instructions.
• Budget Justification/Narrative (not to exceed 5 pages). See Section IV.2.B, Budget Narrative for instructions.
• Tribal Resolution(s) as described in Section III, Eligibility.
• 501(c)(3) Certificate, if applicable.
• Biographical sketches for all Key Personnel.
• Contractor/Consultant resumes or qualifications and scope of work.
• Disclosure of Lobbying Activities (SF-LLL), if applicant conducts reportable lobbying.
• Certification Regarding Lobbying (GG-Lobbying Form).
• Copy of current Negotiated Indirect Cost (IDC) rate agreement (required in order to receive IDC).
• Documentation of current Office of Management and Budget (OMB) Financial Audit (if applicable).
Acceptable forms of documentation include:
1. Email confirmation from Federal Audit Clearinghouse (FAC) that audits were submitted; or
2. Face sheets from audit reports. Applicants can find these on the FAC website at
All Federal public policies apply to IHS grants and cooperative agreements. Pursuant to 45 CFR 80.3(d), an individual shall not be deemed subjected to discrimination by reason of their exclusion from benefits limited by Federal law to individuals eligible for benefits and services from the IHS. See
This narrative should be a separate document that is no more than 25 pages and must: (1) have consecutively numbered pages; (2) use black font 12 points or larger (applicants may use 10 point font for tables); (3) be single-spaced; and (4) be formatted to fit standard letter paper (8
Be sure to succinctly answer all questions listed under the evaluation criteria (refer to Section V.1, Evaluation Criteria) and place all responses and required information in the correct section noted below or they will not be considered or scored. If the narrative exceeds the overall page limit, the application will be considered not responsive and will not be reviewed. The 25-page limit for the project narrative does not include the work plan, standard forms, Tribal Resolutions, budget, budget narratives, and/or other items. Page limits for each section within the project narrative are guidelines, not hard limits.
There are three parts to the narrative: Part 1—Introduction and Need for Assistance; Part 2—Work Plan; and Part 3—Organizational Capabilities. See below for additional details about what must be included in the narrative. The page limits below are for each narrative and budget submitted.
Please provide a description of the need for assistance with offering this program. Applicant should demonstrate knowledge of: health concerns for AI/AN youth; health promotion activities in Tribal communities such as BGCA; and working with Tribes and Tribal organizations.
This section should demonstrate the soundness and effectiveness of the proposal. The work plan should be designed to describe how and when the sites will be selected; describe how the sites will be trained on the curriculum and provided technical assistance; and describe how sites will be supported for a physical activity program with the equipment and participant incentives.
Describe the plan for collecting data, monitoring, and assuring quality and quantity of data and the plan for evaluating and reporting program results.
Describe the broader capacity of the organization to complete the project outlined in the work plan, including: (1) identification and bios for key personnel responsible for completing tasks; (2) description of the structure of the organization and chain of responsibility for successful completion of the project outline in the work plan; (3) description of financial and project management capacity, including information regarding similarly sized projects in scope and financial assistance as well as other grants and projects successfully completed; (4) description of national experience in providing administrative and support services to Tribal youth organizations, education agencies and other Tribal programs for the benefit of AI/AN children and youth and Tribal communities (indicate experience in national partnerships or national support efforts on behalf of AI/AN communities especially as it pertains to health concerns); (5) description of equipment and space available for use during the proposed project; and (6) description of specialized experience working with Native Boys and Girls Club sites and the TRAIL curriculum program.
Provide a budget narrative that explains the amounts requested for each line item of the budget from the SF-424A (Budget Information for Non-Construction Programs) for the first year of the project. The applicant can submit with the budget narrative a more detailed spreadsheet than is provided by the SF-424A (the spreadsheet will not be considered part of the budget narrative). The budget narrative should specifically describe how each item will support the achievement of proposed objectives. Be very careful about showing how each item in the “Other” category is justified. For subsequent budget years (see Multi-Year Project Requirements in Section V.1, Application Review Information, Evaluation Criteria), the additional pages should highlight the changes from the first year or clearly indicate that there are no substantive budget changes during the period of performance. Do
Applications must be submitted through
If technical challenges arise and assistance is required with the application process, contact
The IHS will not acknowledge receipt of applications.
Executive Order 12372 requiring intergovernmental review is not applicable to this program.
• Pre-award costs are not allowable.
• The available funds are inclusive of direct and indirect costs.
• Only one cooperative agreement may be awarded per applicant.
All applications must be submitted via
If you cannot submit an application through
If the DGM approves your waiver request, you will receive a confirmation of approval email containing submission instructions. You must include a copy of the written approval with the application submitted to the DGM. Applications that do not include a copy of the signed waiver from the Deputy Director of the DGM will not be reviewed. The Grants Management Officer of the DGM will notify the applicant via email of this decision. Applications submitted under waiver must be received by the DGM no later than 5:00 p.m. Eastern Time on the Application Deadline Date. Late applications will not be accepted for processing. Applicants that do not register for both the System for Award Management (SAM) and
Please be aware of the following:
• Please search for the application package in
• If you experience technical challenges while submitting your application, please contact
• Upon contacting
• Applicants are strongly encouraged not to wait until the deadline date to begin the application process through
• Please follow the instructions on
• Applicants must comply with any page limits described in this funding announcement.
• After submitting the application, you will receive an automatic acknowledgment from
Organizations that are not registered with SAM must access the SAM online registration through the SAM home page at
Your
Check your organization's
Check your
The Federal Funding Accountability and Transparency Act of 2006, as amended (“Transparency Act”), requires all HHS awardees to report information on sub-awards. Accordingly, all IHS awardees must notify potential first-tier sub-awardees that no entity may receive a first-tier sub-award unless the entity has provided its UEI number to the prime awardee organization. This requirement ensures the use of a universal identifier to enhance the quality of information available to the public pursuant to the Transparency Act.
Additional information on implementing the Transparency Act, including the specific requirements for SAM, are available on the DGM Grants Management, Policy Topics web page at
Possible points assigned to each section are noted in parentheses. The project narrative and budget narrative should include only the first year of activities; information for multi-year projects should be included as a separate document. See “Multi-year Project Requirements” at the end of this section for more information. The project narrative should be written in a
This section should demonstrate knowledge of health concerns and issues regarding AI/AN youth, health promotion activities in Tribal communities, and working with Tribes and Tribal organizations.
This section should demonstrate a sound and effective annual work plan that will support accomplishment of deliverables and milestones of the TRAIL project. The work plan should be designed to:
a. Describe how and when the sites will be selected.
b. Describe how the sites will be trained on the curriculum and provided technical assistance.
c. Describe the plan for collecting data, monitoring, and assuring quality and quantity of data.
d. Describe the plan for evaluating and reporting.
e. Describe how sites will be supported for a physical activity program.
This section should outline the broader capacity of the organization to complete the project outlined in the work plan. It includes the identification of personnel responsible for completing tasks and the chain of responsibility for successful completion of the project outline in the work plan. The section should:
a. Describe the structure of the organization.
b. Describe the ability of the organization to manage the proposed project and include information regarding similarly sized projects in scope and financial assistance as well as other grants and projects successfully completed.
c. Describe what equipment (
d. List and provide bios for key personnel who will work on the project. The section should demonstrate knowledge in:
i. Financial and project management.
ii. Nationwide experience in providing administrative and support services to Tribal youth organizations, education agencies and other Tribal programs for the benefit of children and youth.
iii. AI/AN youth and Tribal communities and indicate experience in national partnerships or national support efforts on behalf of AI/AN communities especially as it pertains to health concerns.
iv. Experience working with Tribal Boys and Girls Club sites and the TRAIL curriculum program.
v. Local and national evaluation, including data collection and analysis
This section should provide a clear estimate of the project program costs and justification for expenses for the entire cooperative agreement period. The budget and budget justification should be consistent with the tasks identified in the work plan.
a. Categorical budget (Form SF-424A, Budget Information Non Construction Programs) completed for the first budget period.
b. Narrative justification for all costs, explaining why each line item is necessary or relevant to the proposed project. Include sufficient details to facilitate the determination of cost allow ability.
c. Indication of any special start-up costs.
d. Budget justification should include a description of the planned costs and how they relate to or support the proposed project activities.
Applications must include a brief project narrative and budget (one additional page per year) addressing the developmental plans for each additional year of the project. This attachment will not count as part of the project narrative or the budget narrative. This narrative should include discussion regarding the meaningful use of program implementation, process, and fidelity data.
Additional documents can be uploaded as Other Attachments in
• Work plan, logic model, and/or timeline for proposed objectives.
• Position descriptions for key staff.
• Resumes of key staff that reflect current duties.
• Consultant or contractor proposed scope of work and letter of commitment (if applicable).
• Current Indirect Cost Rate Agreement.
• Map of area identifying project location(s).
• Additional documents to support narrative (
Each application will be prescreened for eligibility and completeness as outlined in the funding announcement. Applications that meet the eligibility criteria shall be reviewed for merit by the Objective Review Committee (ORC) based on evaluation criteria. Incomplete applications and applications that are not responsive to the administrative thresholds (budget limit, period of performance limit) will not be referred to the ORC and will not be funded. The program office will notify the applicant of this determination.
Applicants must address all program requirements and provide all required documentation.
All applicants will receive an Executive Summary Statement from the IHS Division of Diabetes Treatment and Prevention within 30 days of the conclusion of the ORC outlining the strengths and weaknesses of their application. The summary statement will be sent to the Authorizing Official identified on the face page (SF-424) of the application.
The NoA is the authorizing document for which funds are dispersed to the approved entities and reflects the amount of Federal funds awarded, the purpose of the award, the terms and conditions of the award, the effective date of the award, the budget period, and period of performance. Each entity approved for funding must have a user account in GrantSolutions in order to retrieve the NoA. Please see the Agency Contacts list in Section VII for the systems contact information.
Approved applications not funded due to lack of available funds will be held for 1 year. If funding becomes available during the course of the year, the application may be reconsidered.
Awards issued under this announcement are subject to, and are administered in accordance with, the following regulations and policies:
A. The criteria as outlined in this program announcement.
B. Administrative Regulations for Grants:
• Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards currently in effect or implemented during the period of award, other Department regulations and policies in effect at the time of award, and applicable statutory provisions. At the time of publication, this includes 45 CFR part 75, at
• Please review all HHS regulatory provisions for Termination at 45 CFR 75.372, at
C. Grants Policy:
• HHS Grants Policy Statement, Revised January 2007, at
D. Cost Principles:
• Uniform Administrative Requirements for HHS Awards, “Cost Principles,” at 45 CFR part 75 subpart E.
E. Audit Requirements:
• Uniform Administrative Requirements for HHS Awards, “Audit Requirements,” at 45 CFR part 75 subpart F.
F. As of August 13, 2020, 2 CFR 200 was updated to include a prohibition on certain telecommunications and video surveillance services or equipment. This prohibition is described in 2 CFR 200.216. This will also be described in the terms and conditions of every IHS grant and cooperative agreement awarded on or after August 13, 2020.
This section applies to all awardees that request reimbursement of IDC in their application budget. In accordance with HHS Grants Policy Statement, Part II-27, the IHS requires applicants to obtain a current IDC rate agreement and submit it to the DGM prior to the DGM issuing an award. The rate agreement must be prepared in accordance with the applicable cost principles and guidance as provided by the cognizant agency or office. A current rate covers the applicable grant activities under the current award's budget period. If the current rate agreement is not on file with the DGM at the time of award, the IDC portion of the budget will be restricted. The restrictions remain in place until the current rate agreement is provided to the DGM.
Per 45 CFR 75.414(f) Indirect (F&A) costs, “any non-Federal entity (NFE) [
Electing to charge a de minimis rate of 10 percent only applies to applicants that have never received an approved negotiated indirect cost rate from HHS or another cognizant Federal agency. Applicants awaiting approval of their indirect cost proposal may request the 10 percent de minimis rate. When the applicant chooses this method, costs included in the indirect cost pool must not be charged as direct costs to the grant.
Available funds are inclusive of direct and appropriate indirect costs. Approved indirect funds are awarded as part of the award amount, and no additional funds will be provided.
Generally, IDC rates for IHS awardees are negotiated with the Division of Cost Allocation at
The awardee must submit required reports consistent with the applicable deadlines. Failure to submit required reports within the time allowed may result in suspension or termination of an active grant, withholding of additional awards for the project, or other enforcement actions such as withholding of payments or converting to the reimbursement method of payment. Continued failure to submit required reports may result in the imposition of special award provisions and/or the non-funding or non-award of other eligible projects or activities. This requirement applies whether the delinquency is attributable to the failure of the awardee organization or the individual responsible for preparation of the reports. Per DGM policy, all reports must be submitted electronically by attaching them as a “Grant Note” in GrantSolutions. Personnel responsible for submitting reports will be required to obtain a login and password for GrantSolutions. Please use the form under the Recipient User section of
Download the Recipient User Account Request Form, fill it out completely, and submit it as described on the web page and in the form.
The reporting requirements for this program are noted below.
Program progress reports are required annually. The progress reports are due within 30 days after the reporting period ends (specific dates will be listed in the NoA Terms and Conditions). These reports must include a brief comparison of actual accomplishments to the goals established for the period, a summary of progress to date or, if applicable, provide sound justification for the lack of progress, and other pertinent information as required. A final report must be submitted within 90 days of expiration of the period of performance.
Federal Financial Reports are due 30 days after the end of each budget period, and a final report is due 90 days after the end of the period of performance. Awardees are responsible and accountable for reporting accurate information on all required reports: the Progress Reports and the Federal Financial Report.
The BGCA defines impact as the contribution a Club makes to the attitudes, skills, values, and behaviors of Club members that enables them to succeed in adulthood. BGCA has designed a model called Formula for Impact—a roadmap for Clubs to help ensure that members achieve BGCA's priority outcomes of Academic Success, Good Character and Citizenship, and Healthy Lifestyles. These priority outcomes are achieved through the
The National Youth Outcomes Initiative (NYOI) is an online data management tool that is designed to collect data from Clubs, compile that information, and provides reports on impact back to Clubs and BGCA. The NYOI was developed via the National Commission on Impact's National Outcomes Database and Reporting Tool. One of the priority outcomes tracked through NYOI is Healthy Lifestyles. The indicators measured under this outcome go hand-in-hand with the indicators measured throughout the TRAIL program. In addition, the Good Character and Citizenship indicators support the TRAIL program requirement of participants engaging with their community and community health partners.
Healthy Lifestyles Indicators:
Good Character and Citizenship Indicators:
NYOI also measures Club members' engagement in the following physical activities:
• Number of days per week they participate in physical activity during their free time;
• Number of days per week they participate in physical activity during school physical education class;
• Number of days per week they participate in physical activity at the Club;
• Daily fruit and vegetable intake;
• Number of sugar sweetened drinks consumed per day;
• Alcohol, drug, and tobacco use and abuse;
• Sexual activity and condom use;
• Demographic information including gender, age, and grade level of AI/AN youth participants;
• Pre- and Post-tests to assess participant knowledge; and
• Quarterly progress reports to capture program implementation tasks and feedback received from youth participants, family members, and community members.
This award may be subject to the Transparency Act sub-award and executive compensation reporting requirements of 2 CFR part 170.
The Transparency Act requires the OMB to establish a single searchable database, accessible to the public, with information on financial assistance awards made by Federal agencies. The Transparency Act also includes a requirement for awardees of Federal grants to report information about first-tier sub-awards and executive compensation under Federal assistance awards.
The IHS has implemented a Term of Award into all IHS Standard Terms and Conditions, NoAs, and funding announcements regarding the FSRS reporting requirement. This IHS Term of Award is applicable to all IHS grant and cooperative agreements issued on or after October 1, 2010, with a $25,000 sub-award obligation threshold met for any specific reporting period.
For the full IHS award term implementing this requirement and additional award applicability information, visit the DGM Grants Management website at
Should you successfully compete for an award, recipients of Federal financial assistance (FFA) from HHS must administer their programs in compliance with Federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see
• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting your legal obligation to take reasonable steps to ensure meaningful access to your programs or activities by limited English proficiency individuals, see
• For information on your specific legal obligations for serving qualified individuals with disabilities, including reasonable modifications and making services accessible to them, see
• HHS funded health and education programs must be administered in an environment free of sexual harassment. See
• For guidance on administering your program in compliance with applicable Federal religious nondiscrimination laws and applicable Federal conscience protection and associated anti-discrimination laws, see
The IHS is required to review and consider any information about the applicant that is in the FAPIIS at
As required by 45 CFR part 75 Appendix XII of the Uniform Guidance, NFEs are required to disclose in FAPIIS any information about criminal, civil, and administrative proceedings, and/or affirm that there is no new information to provide. This applies to NFEs that receive Federal awards (currently active grants, cooperative agreements, and procurement contracts) greater than $10,000,000 for any period of time during the period of performance of an award/project.
As required by 2 CFR part 200 of the Uniform Guidance, and the HHS implementing regulations at 45 CFR part 75, the IHS must require an NFE or an applicant for a Federal award to disclose, in a timely manner, in writing to the IHS or pass-through entity all violations of Federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the Federal award. All applicants and awardees must disclose in writing, in a timely manner, to the IHS and to the HHS Office of Inspector General all information related to violations of Federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the Federal award. 45 CFR 75.113.
Disclosures must be sent in writing to:
Failure to make required disclosures can result in any of the remedies described in 45 CFR 75.371 Remedies for noncompliance, including suspension or debarment (see 2 CFR part 180 and 2 CFR part 376).
1. Questions on the programmatic issues may be directed to: Ms. Carmen Licavoli Hardin, Acting Director, Indian Health Service, Division of Diabetes Treatment and Prevention, 5600 Fishers Lane, Mail Stop: 08N34A&B, Rockville, MD 20897,
2. Questions on grants management and fiscal matters may be directed to: Donald Gooding, Senior Grants Management Specialist, Indian Health Service, Division of Grants Management, 5600 Fishers Lane, Mail Stop: 09E70, Rockville, MD 20857,
3. Questions on systems matters may be directed to: Paul Gettys, Deputy Director, Indian Health Service, Division of Grants Management, 5600 Fishers Lane, Mail Stop: 09E70, Rockville, MD 20857,
The Public Health Service strongly encourages all grant, cooperative agreement, and contract awardees to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of the facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the HHS mission to protect and advance the physical and mental health of the American people.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Advisory Council for Human Genome Research.
The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend as well as those who need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The meeting will be videocast and can be accessed from
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.
Any interested person may file written comments with the committee within 15 days after the meeting 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.
In the interest of security, NIH has procedures at
Information is also available on the Institute's/Center's home page:
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Information is also available on the Institute's/Center's home page:
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Information is also available on the Institute's/Center's home page:
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Information is also available on the Institute's/Center's home page:
National Institutes of Health, HHS.
Notice.
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institute of General Medical Sciences (NIGMS), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.
To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Dr. Ming Lei, Director, Division for Research Capacity Building NIGMS, NIH, 45 Center Drive, Room 2AS44C, MSC-6200, Bethesda, Maryland 20892 or call non-toll-free number (301) 827-5323 or email your request, including your address to:
Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) 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) Ways to enhance quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
OMB approval is requested for three years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 841.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
U.S. Coast Guard, Department of Homeland Security.
Request for applications.
The U.S. Coast Guard is accepting applications to fill eight vacancies on the National Chemical Transportation Safety Advisory Committee (Committee). This Committee advises the Secretary of Homeland Security, through the Commandant of the U.S. Coast Guard, on matters relating to the safe and secure marine transportation of hazardous materials.
Completed applications must reach the U.S. Coast Guard on or before September 12, 2022.
Applications must be emailed to
Lieutenant Ethan Beard, Alternate Designated Federal Officer of the National Chemical Transportation Safety Advisory Committee; telephone 202-372-1419 or email at
The National Chemical Transportation Safety Advisory Committee was established on December 4, 2018, by section 601 of the
The Committee is statutorily required to meet at least once a year; however, it typically holds meetings at least twice a year. Meetings are held at a location selected by the U.S. Coast Guard. All members serve at their own expense and receive no salary or other compensation from the Federal Government. Members will not be reimbursed for travel in accordance with the Committee's charter.
In this solicitation for Committee members, applicants will be considered for eight (8) positions to represent the following entities:
• Chemical manufacturing entities;
• Entities related to marine handling or transportation of chemicals;
• Vessel design and construction entities;
• Marine safety or security entities; and
• Marine environmental protection entities.
Each member of the Committee must have particular expertise, knowledge, and experience on matters related to the
In order for the Department to fully leverage broad-ranging experience and education, the National Chemical Transportation Safety Advisory Committee must be diverse with regard to professional and technical expertise. The Department is committed to pursuing opportunities, consistent with applicable law, to compose a committee that reflects the diversity of the nation's people.
If you are interested in applying to become a member of the Committee, email your application to
Coast Guard, DHS.
Notice.
The Coast Guard announces that it is removing the conditions of entry on vessels arriving from the country of Cote d'Ivoire. Based on the results of the most recent country visit, the Coast Guard has determined that Cote d'Ivoire is now substantially implementing the International Ship and Port Facility Security Code and has effective anti-terrorism measures in place.
The policy announced in this notice is effective August 2, 2022
For information about this document call or email J.J. Hudson, Chief, Office of International and Domestic Port Security, United States Coast Guard, telephone 202-372-1173,
The authority for this notice is 5 U.S.C. 552(a) (“Administrative Procedure Act”), 46 U.S.C. 70110 (“Maritime Transportation Security Act of 2002”), and Department of Homeland Security Delegation No. 00170.1, Revision No. 01.3 (II)(97.f). As delegated, section 70110(a) authorizes the Coast Guard to impose conditions of entry on vessels arriving in U.S. waters from ports that the Coast Guard has not found to maintain effective anti-terrorism measures.
In 2011, the Coast Guard determined that effective anti-terrorism measures were not in place in the ports of Cote d'Ivoire. Accordingly, conditions of entry were imposed on vessels arriving from Cote d'Ivoire. Based on recent assessments, the Coast Guard has determined that Cote d'Ivoire is maintaining effective anti-terrorism measures, and the Coast Guard is, accordingly, removing the conditions of entry announced in previously published Notices. With this notice, the current list of countries assessed and not maintaining effective anti-terrorism measures is as follows: Cambodia, Cameroon, Comoros, Djibouti, Equatorial Guinea, The Gambia, Guinea-Bissau, Iran, Iraq, Libya, Madagascar, Micronesia, Nauru, Nigeria, Republic of Seychelles, Sao Tome and Principe, Syria, Timor-Leste, Venezuela, and Yemen. The current Port Security Advisory is available at:
Office of General Counsel, HUD.
Notice, correction.
On May 19, 2022, HUD published a notice in the
Applicable: August 12, 2022.
John Hartung, Director, Policy, Risk Analysis & Lender Relations Division, Office of Residential Care Facilities, Office of Healthcare Programs, Office of Housing, Department of Housing and Urban Development, 1222 Spruce Street, St. Louis, MO 63103-2836; telephone: 314-418-5238 (this is not a toll-free number). Persons with hearing or speech impairments may access this number through TTY by calling the toll-free Federal Information Relay Service at 800-877-8339 (this is a toll-free number).
On May 19, 2022 (87 FR 30510) (FR Doc. 2022-10539), HUD issued a public notice announcing proposed mortgage insurance premium (MIP) changes to an earlier October 2, 2015, notice, for certain commitments issued or reissued beginning October 1, 2022.
The May 19, 2022, notice contained a chart that incorrectly listed current upfront capitalized MIP basis points for 232 NC/SR Healthcare Facilities w/o LIHTC, 232 NC/SR Healthcare Facilities with LIHTC, 223(d) Operating Loss Loan for Healthcare Facilities, 241(a) Supp. Loan for Healthcare Facilities w/o LIHTC, 241(a) Supp. Loan for Healthcare Facilities with LIHTC, 242 Hospitals, and 241(a) Supplemental Loans for Hospitals as each being 100. Under the October 2, 2015, notice, the correct current up front capitalized MIP basis points for each of these categories is, respectively, 77, 45, 95, 72, 45, 70,
In the
Fish and Wildlife Service, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the U.S. Fish and Wildlife Service (Service), are proposing a new information collection in use without Office of Management and Budget (OMB) approval.
Interested persons are invited to submit comments on or before October 11, 2022.
Send your comments on the information collection request (ICR) by one of the following methods (reference Office of Management and Budget (OMB) Control Number 1018—Bison in the subject line of your comment):
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To request additional information about this ICR, contact Madonna L. Baucum, Service Information Collection Clearance Officer, by email at
In accordance with the Paperwork Reduction Act (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
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.
• National Wildlife Refuge System Administration Act (16 U.S.C. 668dd and 668ee; as amended);
• American Indian Religious Freedom Act (Pub. L. 95-341);
• Indian Self-Determination and Education Assistance Act (Pub. L. 93-638, as amended);
• Surplus Range Animals (50 CFR 30.1);
• Disposition of Surplus Range Animals (50 CFR 30.2);
• Native American Policy of the U.S. Fish and Wildlife Service (510 FW 1);
• Fenced Animal Management policy (701 FW 8); and
• Collections, Donations, and Disposals policy (701 FW 5).
In 2020, the U.S. Department of the Interior (DOI) Bison Working Group published the
The
Periodic reduction in the size of Service bison herds is required to remain within the ecological carrying capacity of Service lands. Live bison capture and removal assists in the restoration of bison to Tribal lands, supports the efforts of States and other conservation organizations, and ensures that the ecological needs of other species are met on limited-size refuges. To support maximum conservation of genetic diversity within and across Service herds, selection of young bison available for donation is coordinated across all refuges. From the surplus bison made available for donation from refuges, requests will be prioritized for bison restoration and conservation purposes.
We propose Form 3-2555, “Bison Donations Request Form,” to request surplus bison. Respondents will generally be from Tribal governments and intertribal organizations, although we do expect to receive a small number of requests from States and private sector organizations (nonprofit and educational/research organizations). The request form provides details governing the protocol and collects the following information:
• Name of requesting Tribe, intertribal organization, State, or private sector organization.
• Documentation that the proposed project or program meets the definition of a conservation herd.
• Demonstration of the educational contribution of the donation to increasing public knowledge and appreciation of the wildlife values of bison (for educational and research organizations only).
• Total number (or percentage of total donation request) of bison and purpose of request:
• Signature of requesting Tribe, intertribal organization, State, or private sector organization official.
In addition to completion of Form 3-2555, recipients of donated bison must inform the Service of the destination State for donated bison no fewer than 30 days prior to a scheduled bison capture operation, to allow the Service time to meet interstate transport regulatory testing requirements. Recipients of donated bison must also inform the Service of the destination physical address for donated bison no fewer than 10 days prior to scheduled bison loadout, to facilitate timely completion of required interstate veterinary permit applications and veterinary inspection certificates.
The public may request a copy of the proposed Form 3-2555 by sending a request to the Service Information Collection Clearance Officer (see
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
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, permit renewals, and/or permit amendments to conduct activities intended to enhance the propagation or survival of endangered species under the Endangered Species Act of 1973, as amended. 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 written data or comments on the applications by September 12, 2022.
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Karen Marlowe, Permit Coordinator, 404-679-7097 (telephone),
We invite review and comment from the public and local, State, Tribal, and Federal agencies on applications we have received for permits to conduct certain activities with endangered and threatened species under section 10(a)(1)(A) of 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 take endangered or threatened species while engaging in activities that are conducted for scientific purposes that promote recovery of species or for enhancement of propagation or survival of species. These activities often include the capture and collection of species, which would result in prohibited take if a permit were not issued. 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.
Proposed activities in the following permit requests are for the recovery and enhancement of propagation or survival of the species in the wild. The ESA requires that we invite public comment before issuing these permits. Accordingly, we invite local, State, Tribal, and Federal agencies and the public to submit written data, views, or arguments with respect to these applications. The comments and recommendations that will be most useful and likely to influence agency decisions are those supported by quantitative information or studies.
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.
We publish this notice under section 10(c) of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
Bureau of Land Management, Interior.
Notice of availability.
In accordance with the National Environmental Policy Act (NEPA) of 1969, as amended, and the Federal Land Policy and Management Act of 1976, as amended, the Bureau of Land Management (BLM) has prepared a final environmental impact statement (EIS) for the Whitewater River Groundwater Replenishment Facility Project (Project), and by this notice is announcing the availability of the final EIS for a 30-day review period.
The BLM will issue a final decision on the proposal a minimum of 30 days after the date that the Environmental Protection Agency (EPA) publishes its notice of availability (NOA) in the
You may review the final EIS at
Brandon G. Anderson, BLM Project Manager, telephone: (760) 422-9120; email:
Persons who use telecommunication devices for the deaf may call the Federal Relay Service (FRS) at 1-800-877-8339 to contact the BLM during normal business hours. The FRS is available 24 hours a day, 7 days a week, to leave a message or question. You will receive a reply during normal business hours.
The Coachella Valley Water District (CVWD) seeks a right-of-way (ROW) grant from the BLM for its existing groundwater replenishment facility in North Palm Springs that is partially located on public lands managed by the BLM. The existing facility consists of water control berms, intake structures, conveyance structures, and 19 infiltration ponds over approximately 690 acres of BLM-managed public lands. The facility also includes 1,480 acres of lands held by CVWD. No new construction and no change in operations are proposed. The change in volume represents CVWD's request that the BLM analyze environmental impacts for the full annual capacity of the facility, instead of the anticipated water allotments, as was done for the previous grant. The change in acreage represents CVWD's request to authorize the use of public lands for water control berms upstream of its intake structure.
The Proposed Action (Alternative 1) is the BLM Preferred Alternative and would authorize the facility in its existing configuration, which has the ability to infiltrate up to 511,000 acre-feet per year, representing the maximum physical capacity of the facility. In addition to the Proposed Action, the final EIS considers a no action alternative and three action alternatives. Alternative 2 (Partial Implementation) would authorize only the area of public lands on which the water control structures upstream of the intake are located. Alternative 3 (Reduced Volume) would authorize the same facility as described under Alternative 1 but would limit annual infiltration volume to 220,000 acre-feet per year. Alternative 4 (Land Disposal) would authorize the sale or exchange of the public lands within the project footprint and would authorize the facility operation on public lands for a period of 10 years, sufficient to implement the disposal. Alternative 5 (No Action) would not authorize those portions of the facility that are located on public lands. Those portions would be removed, and the public lands rehabilitated.
The BLM is the lead agency under NEPA and will make Federal decisions regarding the ROW for the Project. The U.S. Fish and Wildlife Service is a Cooperating Agency and will issue a Biological Opinion for the project. The U.S. Bureau of Indian Affairs, Agua Caliente Band of Cahuilla Indians, Desert Water Agency, and Metropolitan Water District of Southern California are Cooperating Agencies in this environmental review, but do not have direct permitting roles in the project.
On June 11, 2021, the BLM published a draft EIS for a 45-day review period. The BLM received nine comments during the public comment process. Issues raised included: concerns for ground water quality and quantity, impacts to listed species, and feasibility of mitigation measures. These issues are addressed in the response to comments and final EIS analysis.
The BLM utilized and coordinated the NEPA process to help fulfill the public involvement process under the National Historic Preservation Act (54 U.S.C. 306108), as provided in 36 CFR 800.2(d)(3).
Bureau of Land Management, Interior.
Notice of public meetings.
In accordance with the Federal Land Policy and Management Act and the Federal Advisory Committee Act of 1972, the U.S. Department of the Interior, Bureau of Land Management (BLM) Western Oregon Resource Advisory Council (RAC) will meet as follows.
The Western Oregon RAC will meet on September 22, 2022; and October 11 and 13, 2022. Each meeting will begin at 9 a.m. The September 22 and October 11 meetings will adjourn at approximately 4 p.m. The October 13 meeting will adjourn at approximately 3 p.m.
The meetings will be virtual meetings held over the Zoom platform. Please register at least one day in advance of the meetings. Register for the September meeting here:
Register for the October meetings here:
Kyle Sullivan, Public Affairs Specialist, Medford District, 3040 Biddle Road, Medford, OR 97504; phone: (541) 618-2340; email:
The 15-member Western Oregon RAC advises the Secretary of the Interior, through the BLM, on a variety of public land issues across public lands in Western Oregon, including the Coos Bay, Medford, Northwest Oregon, and Roseburg Districts and part of the Lakeview District. Topics of discussion for these meetings include Secure Rural Schools Title II funding, recreation, recreation fee proposals, fire management, land use planning, invasive species management, timber management, travel management, wilderness, cultural resource management, and other issues as appropriate. The September meeting will provide an administrative orientation for new RAC members and discuss the Secure Rural School Title II funding process. The October meetings will focus on the review and recommendation of projects proposed for funding under the Title II of the Secure Rural Schools legislation.
The meetings are open to the public, and public comment periods will be held at 3 p.m. on September 22, at 3:30 p.m. on October 11, and at 2 p.m. on October 13. Depending on the number of persons wishing to comment and the time available, time allotted for individual oral comments may be limited. The public may present written comments to the Western Oregon RAC. Comments can also be emailed to
Please make requests in advance for sign language interpreter services, assistive listening devices, or other reasonable accommodations. We ask that you contact the person listed in the (see
Individuals in the United States who are deaf, blind, hard of hearing, or have a speech disability may dial 711 (TTY, TDD, or TeleBraille) to access telecommunications relay services. Individuals outside the United States should use the relay services offered within their country to make international calls to the point-of-contact in the United States.
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.
Detailed minutes for the RAC meetings will be maintained in the Medford District Office and will be available for public inspection and reproduction during regular business hours within 30 days following the meeting. Previous minutes, membership information, and upcoming agendas are available at:
Bureau of Land Management, Interior.
Notice of call for nominations.
The purpose of this notice is to solicit public nominations for three positions on the National Wild Horse and Burro Advisory Board (Board) that will become vacant on October 9, 2022. The Board provides advice concerning the management, protection, and control of wild free-roaming horses and burros on public lands administered by the Department of the Interior, through the Bureau of Land Management (BLM), and the Department of Agriculture, through the U.S. Forest Service.
Nominations must be post marked or submitted to the following addresses no later than September 12, 2022.
All mail sent via the U.S. Postal Service should be addressed as follows:
Wild Horses and Burro Division, U.S. Department of the Interior, Bureau of Land Management, Attn: Dorothea Boothe, HQ-260, 9828 31st Avenue; Phoenix, AZ 85051.
All packages that are sent via FedEx or UPS should be addressed as follows:
U.S. Department of the Interior, Bureau of Land Management, Wild Horse and Burro Division, Attn: Dorothea Boothe, 9828 31st Avenue, Phoenix, AZ 85051. Please consider emailing PDF documents to Ms. Boothe at
Dorothea Boothe, Wild Horse and Burro Program Coordinator, telephone: (602) 906-5543, email:
Members of the Board serve without compensation; however, while away from their homes or regular places of business, Board and subcommittee members engaged in Board or subcommittee business, approved by the Designated Federal Officer (DFO), may be allowed travel expenses, including per diem in lieu of subsistence under 5 U.S.C. 5703, in the same manner as persons employed intermittently in government service. Nominations for a term of 3 years are needed to represent the following categories of interest:
• Humane Advocacy;
• Livestock Management; and
• Wildlife Management.
The Board will meet one to four times annually. The DFO may call additional meetings in connection with special needs for advice. Individuals may nominate themselves or others. Any individual or organization may nominate one or more persons to serve on the Board.
Nominations should include a resume providing adequate description of the nominee's qualifications, including information that would enable the Departments of the Interior and Agriculture to make an informed decision regarding meeting the membership requirements of the Board and permit the Departments to contact a potential member. Nominations are to be sent to the address listed in the
As appropriate, certain Board members may be appointed as special Government employees (SGEs). Please be aware that applicants selected to serve as SGEs will be required, prior to appointment, to file a Confidential Financial Disclosure Report in order to avoid involvement in real or apparent conflicts of interest. You may find a copy of the Confidential Financial Disclosure Report at the following
Membership Selection: Individuals shall qualify to serve on the Board because of their education, training, or experience that enables them to give informed and objective advice regarding the interest they represent. They should demonstrate experience or knowledge of the area of their expertise and a commitment to collaborate in seeking solutions to resource management issues. The Board is structured to provide fair membership and balance, both geographic and interest specific, in terms of the functions to be performed and points of view to be represented. Members are selected with the objective of providing representative counsel and advice about public land and resource planning. No person is to be denied an opportunity to serve because of race, age, sex, sexual orientation, religion, or national origin.
Pursuant to Section 7 of the Wild Free-Roaming Horses and Burros Act, members of the Board cannot be employed by the State or Federal Government.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined to institute a modification proceeding in the above-captioned investigation.
Megan M. Valentine, Esq., Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 708-2301. Copies of non-confidential documents filed in connection with this investigation may be viewed on the Commission's electronic docket (EDIS) at
On February 11, 2020, the Commission instituted this investigation based on a complaint filed by Sonos, Inc. (“Sonos”) of Santa Barbara, California. 85 FR 7783 (Feb. 11, 2020). The complaint alleges violations of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337) (“section 337”), based on the importation into the United States, the sale for importation, or the sale within the United States after importation of certain audio players and controllers, components thereof, and products containing the same by reason of infringement of certain claims of U.S. Patent Nos. 9,195,258 (“the '258 patent”); 10,209,953 (“the '953 patent”); 8,588,949 (“the '949 patent”); 9,219,959 (“the '959 patent”); and 10,439,896 (“the '896 patent”).
On September 21, 2020, the Commission terminated the investigation as to Alphabet based on withdrawal of the allegations in the complaint directed to Alphabet. Order No. 18 (Sept. 1, 2020),
On August 13, 2021, the presiding Chief Administrative Law Judge (“CALJ”) issued an initial determination (“ID”) finding a violation of section 337 with respect to the following claims of the asserted patents: claims 17, 21, 24, and 26 of the '258 patent; claims 7, 14, and 22-24 of the '953 patent; claim 10 of the '959 patent; claims 1, 2, and 5 of the '949 patent; and claims 1, 5, 6, and 12 of the '896 patent.
On November 19, 2021, the Commission determined to review the ID in part with respect to the ID's analysis of whether the products accused of infringing the '258 and '953 patents are articles that infringe at the time of importation. 86 FR 67492 (Nov. 26, 2021). The Commission also determined to correct two typographical errors on pages 24 and 84 of the ID.
On January 6, 2022, the Commission terminated the investigation with a finding of a violation of section 337 with respect to claims 17, 21, 24, and 26 of the '258 patent; claims 7, 14, and 22-24 of the '953 patent; claim 10 of the '959 patent; claims 1, 2, and 5 of the '949 patent; and claims 1, 5, 6, and 12 of the '896 patent. 87 FR 1784-85 (Jan. 12, 2022). The Commission issued a limited exclusion order (“LEO”) and a cease and desist order (“CDO”) against Google.
On January 27, 2022, Sonos filed a petition with the U.S. Court of Appeals for the Federal Circuit seeking review of the Commission's finding that one or more redesign products that Google submitted for adjudication with respect to each asserted patent are non-infringing.
On July 14, 2022, Google filed a petition for modification of the LEO and CDO, pursuant to Commission Rule 210.76(a), 19 CFR 210.76(a). Google alleges that its Pixel smartphones, tablets, laptops, and other “controllers” installed with an allegedly new Device Utility app do not infringe any of claims
The Commission has determined that Google's petition complies with the requirements for institution of a modification proceeding pursuant to Commission Rule 210.76. Accordingly, the Commission has determined to institute a modification proceeding and has delegated the proceeding to the CALJ. The presiding CALJ shall submit a recommended determination within six (6) months after publication of notice of this Order in the
The Commission vote for this determination took place on August 8, 2022.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in Part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
On the basis of the record
The Commission instituted these reviews on January 3, 2022 (87 FR 119) and determined on April 8, 2022, that it would conduct expedited reviews (87 FR 38780, June 29, 2022).
The Commission made these determinations pursuant to section 751(c) of the Act (19 U.S.C. 1675(c)). It completed and filed its determinations in these reviews on August 8, 2022. The views of the Commission are contained in USITC Publication 5341 (August 2022), entitled
By order of the Commission.
On the basis of the record
The Commission instituted these reviews on June 1, 2021 (86 FR 29286) and determined on September 7, 2021 that it would conduct full reviews (86 FR 52180, September 20, 2021). Notice of the scheduling of the Commission's reviews and of a public hearing to be held in connection therewith was given by posting copies of the notice in the Office of the Secretary, U.S. International Trade Commission, Washington, DC, and by publishing the notice in the
The Commission made these determinations pursuant to section 751(c) of the Act (19 U.S.C. 1675(c)). It completed and filed its determinations in these reviews on August 9, 2022. The views of the Commission are contained in USITC Publication 5339 (August 2022), entitled
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled
Katherine M. Hiner, Acting Secretary to the Commission, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-2000. The public version of the
The Commission has received a complaint and a submission pursuant to § 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of Purple Innovation, LLC on August 5, 2022. The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of pillows and seat cushions, components thereof, and packaging thereof. The complainant names as respondents: Bedmate-U Co., Ltd. of Korea; Chuang Fan Handicraft Co., Ltd of China; Dongguan Bounce Technology Co., Ltd. of China; Dongguan Jingrui Silicon Technology Co., Ltd. of China; Foshan Dirani Design Furniture Co., Ltd. of China; Global Ocean Trading Co., Ltd. of China; Guang An Shi Lin Chen Zai Sheng Wuzi Co. Ltd. of China; Guang Zhou Wen Jie Shang Mao Youxian Gongsi Co., Ltd. of China; Guangzhou Episilon Import and Export Co., Ltd. of China; Guangzhoushi Baixiangguo Keji Youxian Gongsi Co., Ltd. of China; Haircrafters LLC of Chattanooga, TN; Hangzhou Lishang Import & Export Co., Ltd. of China; Hangzhou Lydia Sports Goods Co., Ltd. of China; Hebei Zeyong Technology Co., Ltd. of China; Henson Holdings, LLC d.b.a. SelectSoma of Lafayette. LA; Hetaibao of China; Hubei Sheng Bingyi Dianzi Keji Youxian Gongsi Co. Ltd. of China; Kaifeng Shi Long Ting Qu Chen Yi Shangmao Youxian Gongsi Co., Ltd. of China; Lankao Junchang Electronic Commerce Co., Ltd. of China; Lei Lei Wang of China; Liu Lin Xian Xu Bin Dian Zi Chan Pin Dian of China; Nanchang Shirong Bao Er Guanggao Youxian Gongsi Co., Ltd. of China; Ningbo Bolian Import & Export Co., Ltd. of China; Ningbo Minzhou Import & Export Co., Ltd. of China; Ruian Ketai Commodity Co. Ltd. of China; Ruian Xiu Yuan Guoji MaoYi Youxian Gongsi Co., Ltd. of China; Shandong Jiu Hui Xinxi Keji Youxian Gongsi Co., Ltd. of China; Shanxi Chao Ma Xun Keji Youxian Gongsi Co., Ltd. of China; Shenzhen Baibaikang Technology Co., Ltd. of China; Shenzhen Leadfar Industry Co., Ltd. of China; Shenzhen Shi Chi Yang Wang Luo Ji Shu Youxian Gongsi Co., Ltd. of China; Shenzhen Shi Mai Rui Ke Dianzi Shangwu Co. Ltd. of China; Shenzhen Shi Xin Shangpin Dianzi Shangwu Youxian Gongsi Co., Ltd. of China; Shenzhen Shi Yan Huang Chu Hai Keji Youxian Gongsi Co., Ltd. of China; Shenzhen Shi Yuxiang Meirong Yongju Youxian Gongsi Co. Ltd. of China; Shenzhen Tianrun Material Co., Ltd. of China; Wuhan Chenkuxuan Technology Co., Ltd. of China; Xiao Dawei of China; Xiao Xiao Pi Fa Shang Mao You Xian Ze Ren Gongsi Co. of China; YaRu Wang of China; Yiwu Youru E-commerce Co., Ltd. of China; Zhejiang Xinhui Import & Export Co., Ltd. of China; and Zhou Meng Bo of China. The complainant requests that the Commission issue a limited exclusion order and cease and desist orders and impose a bond upon respondents' alleged infringing articles during the 60-day Presidential review period pursuant to 19 U.S.C. 1337(j).
Proposed respondents, other interested parties, and members of the public are invited to file comments on any public interest issues raised by the complaint or § 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.
In particular, the Commission is interested in comments that:
(i) explain how the articles potentially subject to the requested remedial orders are used in the United States;
(ii) identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders;
(iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;
(iv) indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and
(v) explain how the requested remedial orders would impact United States consumers.
Written submissions on the public interest must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the
Persons filing written submissions must file the original document electronically on or before the deadlines stated above. Submissions should refer to the docket number (“Docket No. 3633”) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of §§ 201.10 and 210.8(c) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)).
By order of the Commission.
Drug Enforcement Administration, Justice.
Notice of application.
Cambridge Isotope Laboratories has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to
Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before September 12, 2022. Such persons may also file a written request for a hearing on the application on or before September 12, 2022.
The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to
In accordance with 21 CFR 1301.34(a), this is notice that on July 18, 2022, Cambridge Isotope Laboratories, 50 Frontage Road, Andover, Massachusetts 01810-5413, 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 substances for preparation of analytical standards and formulations. In reference to drug codes 7370 (Tetrahydrocannabinols), the company plans to import a synthetic Tetrahydrocannabinol. No other activities for these drug codes are authorized for this registration.
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.
Drug Enforcement Administration, Justice.
Notice of application.
Galephar Pharmaceutical Research, Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to
Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before September 12, 2022. Such persons may also file a written request for a hearing on the application on or before September 12, 2022.
The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to
In accordance with 21 CFR 1301.34(a), this is notice that on July 28, 2022, Galephar Pharmaceutical Research, Inc., 100 Carr 198 Industrial Park, Juncos, Puerto Rico 00777-3873, applied to be registered as
The company plans to import the listed controlled substance in finished dosage form for analytical purpose only. No other activity for this drug code is authorized for this registration.
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.
Notice of availability; request for comments.
The Department of Labor (DOL) is submitting this Chief Evaluation Office (CEO)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.
The OMB will consider all written comments that the agency receives on or before September 12, 2022.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Nicole Bouchet by telephone at 202-693-0213, or by email at
The Chief Evaluation Office of DOL seeks approval of this generic clearance to allow DOL to conduct a variety of formative data collections. Under this generic clearance, DOL would engage in a variety of formative data collections with researchers, practitioners, technical assistance providers, service providers and potential participants throughout the field to fulfill the following goals: (1) inform the development of DOL research, (2) maintain a research agenda that is rigorous and relevant, (3) ensure that research products are as current as possible and (4) inform the provision of technical assistance. DOL envisions using a variety of techniques including semi-structured discussions, focus groups, surveys, and telephone or in-person interviews in order to reach these goals. The findings from this data collection can inform and support future and current research but that are not highly systematic or intended to be statistically representative or otherwise generalizable. For additional substantive information about this ICR, see the related notice published in the
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless the OMB approves it and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid OMB Control Number.
DOL seeks PRA authorization for this information collection for three (3) years. OMB authorization for an ICR cannot be for more than three (3) years without renewal. The DOL notes that information collection requirements submitted to the OMB for existing ICRs receive a month-to-month extension while they undergo review.
National Endowment for the Humanities; National Foundation on the Arts and the Humanities.
Notice of meeting.
The National Endowment for the Humanities (NEH) will hold seven meetings, by videoconference, of the Humanities Panel, a federal advisory committee, during September 2022. The purpose of the meetings is for panel review, discussion, evaluation, and recommendation of applications for financial assistance under the National Foundation on the Arts and the Humanities Act of 1965.
See
Elizabeth Voyatzis, Committee Management Officer, 400 7th Street SW, Room 4060, Washington, DC 20506; (202) 606-8322;
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C. App.), notice is hereby given of the following meetings:
This video meeting will discuss applications on the topic of U.S. History, for the Digital Projects for the Public: Prototyping Grants program, submitted to the Division of Public Programs.
This video meeting will discuss applications on the topic of Computational Analysis, for the Digital Humanities Advancement Grants program, submitted to the Office of Digital Humanities.
This video meeting will discuss applications on the topic of International Topics, for the Digital Projects for the Public: Prototyping Grants program, submitted to the Division of Public Programs.
This video meeting will discuss applications on the topic of U.S. History, for the Digital Projects for the Public: Prototyping Grants program, submitted to the Division of Public Programs.
This video meeting will discuss applications on the topic of Public Humanities, for the Digital Humanities Advancement Grants program, submitted to the Office of Digital Humanities.
This video meeting will discuss applications on the topic of U.S. History, for the Digital Projects for the Public: Prototyping Grants program, submitted to the Division of Public Programs.
This video meeting will discuss applications on the topic of U.S. History, for the Digital Projects for the Public: Prototyping Grants program, submitted to the Division of Public Programs.
Because these meetings will include review of personal and/or proprietary financial and commercial information given in confidence to the agency by grant applicants, the meetings will be closed to the public pursuant to sections 552b(c)(4) and 552b(c)(6) of Title 5, U.S.C., as amended. I have made this determination pursuant to the authority granted me by the Chairman's Delegation of Authority to Close Advisory Committee Meetings dated April 15, 2016.
In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science Foundation (NSF) announces the following meeting:
Weeks of August 15, 22, 29, September 5, 12, 19, 2022. The schedule for Commission meetings is subject to change on short notice. 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 (
Public.
Members of the public may request to receive the information in these notices 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
There are no meetings scheduled for the week of August 15, 2022.
There are no meetings scheduled for the week of August 22, 2022.
There are no meetings scheduled for the week of August 29, 2022.
There are no meetings scheduled for the week of September 5, 2022.
There are no meetings scheduled for the week of September 12, 2022.
There are no meetings scheduled for the week of September 19, 2022.
For more information or to verify the status of meetings, contact Wesley Held at 301-287-3591 or via 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.
Office of Personnel Management, Healthcare and Insurance.
Notice of new system of records.
In accordance with the Privacy Act of 1974, the Office of Personnel Management (OPM) proposes to publish a new system of records titled “OPM/Central-27, FEHB Disputed Claims and Complaints Records.” This system of records contains information about enrollees or their family members who have submitted a request to OPM for its review of healthcare claim denials made by Federal Employees Health Benefits (FEHB) plans. This system of records also contains records related to complaints received by OPM about the FEHB Program, Carriers, or plans. This newly established system of records will be included in OPM's inventory of record systems.
Please submit comments on or before September 12, 2022. This new system of records is effective upon publication in today's
You may submit written comments through the Federal Rulemaking Portal:
For general questions, please contact Dyan Dyttmer, 202-606-1412. For privacy questions, please contact Kellie Cosgrove Riley, Chief Privacy Officer, 202-360-6065, or
In accordance with the Privacy Act of 1974, 5 U.S.C 552a, the Office of Personnel Management proposes to establish a new system of records titled “OPM/Central-27, FEHB Disputed Claims and Complaints Records.” Established in 1960 through the Federal Employees Health Benefits Act of 1959, 5 U.S.C. 8901
OPM receives, stores, and processes requests from individuals covered by FEHB plans (or their authorized representatives) to review healthcare claim denials made by FEHB plans. As part of this review, OPM gathers records related to the denied claim from the covered individual (or authorized representatives) and the FEHB Carrier. OPM may also submit records to an Independent Medical Reviewer to obtain an advisory opinion from an independent healthcare professional. OPM issues a written decision regarding the disputed claim; if OPM reverses the denied healthcare claim, in whole or in part, the FEHB Carrier is required to comply with OPM's decision. This system of records includes the request for review, all records related to the review, correspondence, and OPM's decision.
OPM also receives complaints about the FEHB Program, Carriers, or plans. These complaints may come from a variety of sources including FEHB-covered individuals,
The records in this new system of records to date have been included in the OPM/Central-1 Civil Service Retirement and Insurance system of records (OPM/Central-1). However, OPM's organizational structure and its retirement and insurance programs have evolved over time and OPM has determined that OPM/Central-1 no longer provides the public with the most informative notice regarding the system of records, nor adequately facilitates individuals' ability to exercise their rights under the Privacy Act and OPM's ability to respond effectively. Accordingly, OPM is in the process of regrouping the records currently contained in OPM/Central-1 and publishing corresponding systems of records notices. Additional systems of records notices related to other record sets currently encompassed in OPM/Central-1 have been previously published or will be published in the future.
FEHB disputed claims and complaints records will now be maintained in the system of records known as OPM/Central-27, FEHB Disputed Claims and Complaints Records. This newly established system of records will be included in OPM's inventory of records systems. In accordance with 5 U.S.C. 552a(r), OPM has provided a report of this system of records to the Office of Management and Budget and to Congress.
FEHB Disputed Claims and Complaints Records, OPM/Central-27
Unclassified.
Healthcare and Insurance, Office of Personnel Management, 1900 E Street NW, Suite 3400, Washington, DC 20415 is responsible for this system of records. The electronic records in this system are maintained at OPM's data center in Macon, Georgia.
Associate Director, Healthcare and Insurance, Office of Personnel Management, 1900 E St NW, Washington, DC 20415.
5 U.S.C. Chapter 89, Health Insurance; 5 CFR part 890 (health insurance generally); 5 CFR 890.105 and § 890.107 (regarding OPM's review of denied claims and judicial review of OPM's final action); and 5 CFR 890.114 (regarding complaints related to surprise billing).
The purpose of this system of records is to collect, process, review, maintain, and make decisions concerning disputed healthcare claims for individuals covered by FEHB plans; collect, process, review, maintain, and respond to complaints regarding the FEHB Program, Carriers, and plans;
a. Enrollees (defined in 5 CFR 890.101) and their family members who have filed an FEHB disputed claim.
b. Individuals who have submitted a complaint to OPM about the FEHB Program, Carriers, or plans.
a. Name;
b. Date of birth;
c. Home address;
d. Email address;
e. Telephone number;
f. Health plan name and member ID;
g. Dates of service under appeal;
h. All materials submitted by the individual or duly authorized representative related to the disputed claim, including written correspondence and emails;
i. Explanation of benefits, including advanced explanation of benefits;
j. Good Faith Estimate of charges;
k. Notice and Consent Documents related to the No Surprises Act;
l. Reconsideration determination related to the disputed claim from the FEHB Carrier and any related correspondence;
m. Bills related to the disputed claim;
n. Medical records related to the disputed claim;
o. Response from the FEHB Carrier to OPM regarding the disputed claim;
p. Advisory opinion from the Independent Medical Reviewer;
q. Copy of OPM's final disposition of the claim and any other agency correspondence;
r. System-generated reports or documents;
s. All materials submitted to OPM related to a complaint submitted to OPM about the FEHB Program, Carriers, or plans;
t. All materials generated by OPM in reviewing a complaint submitted to OPM about the FEHB Program, Carriers, or plans; and
u. Any response generated by OPM to a complaint submitted to OPM about the FEHB Program, Carriers, or plans.
The records in this system related to disputed claims are obtained from individuals covered by FEHB plans or their duly authorized representatives, FEHB Carriers, and Independent Medical Reviewers. The records in this system related to complaints are obtained from a variety of sources including FEHB-covered individuals, health care providers, Congressional and White House inquiries, tribal entities, the Department of Health and Human Services and other Federal, State, or local agencies.
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 OPM as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:
a. To the Department of Justice, including Offices of the U.S. Attorneys; another Federal agency conducting litigation or in proceedings before any court, adjudicative, or administrative body; another party in litigation before a court, adjudicative, or administrative body; or to a court, adjudicative, or administrative body. Such disclosure is permitted only when it is relevant or necessary to the litigation or proceeding and one of the following is a party to the litigation or has an interest in such litigation:
(1) OPM, or any component thereof;
(2) Any employee or former employee of OPM in his or her official capacity;
(3) Any employee or former employee of OPM in his or her individual capacity where the Department of Justice or OPM has agreed to represent the employee;
(4) The United States, a Federal agency, or another party in litigation before a court, adjudicative, or administrative body, upon the OPM General Counsel's approval, pursuant to 5 CFR part 295 or otherwise.
b. To the appropriate Federal, State, or local agency responsible for investigating, prosecuting, enforcing, or implementing a statute, rule, regulation, or order, when a record, either on its face or in conjunction with other information, indicates or is relevant to a violation or potential violation of civil or criminal law or regulation.
c. To a member of Congress from the record of an individual in response to an inquiry made at the request of the individual to whom the record pertains.
d. To the National Archives and Records Administration (NARA) for records management inspections being conducted under the authority of 44 U.S.C. 2904 and 2906.
e. To appropriate agencies, entities, and persons when (1) OPM suspects or has confirmed that there has been a breach of the system of records,· (2) OPM has determined that as a result of the suspected or confirmed breach there is a risk of harm to individuals, OPM (including its information systems, programs, and operations), the Federal Government, or national security; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with OPM's efforts to respond to the suspected or confirmed breach or to prevent, minimize, or remedy such harm.
f. To another Federal agency or Federal entity, when OPM determines that information from this system of records is reasonably necessary to assist the recipient agency or entity in (1) responding to a suspected or confirmed breach or (2) preventing, minimizing, or remedying the risk of harm to individuals, the recipient agency or entity (including its information systems, programs, and operations), the Federal Government, or national security, resulting from a suspected or confirmed breach.
g. To contractors, grantees, experts, consultants, or volunteers performing or working on a contract, service, grant, cooperative agreement, or other assignment for OPM when necessary to accomplish an agency function related to this system of records. Individuals provided information under this routine use are subject to the same Privacy Act requirements and limitations on disclosure as are applicable to OPM employees.
h. To FEHB Carriers for the purpose of obtaining complete records held by the plan regarding the claim or claims in dispute, obtaining responsive information relating to a complaint related to the Carrier or its FEHB plan, or providing OPM's decision regarding the disputed claim review or OPM's response regarding a complaint.
i. To an Independent Medical Reviewer for the purpose of obtaining an advisory opinion from the Reviewer regarding the claim or claims in dispute.
j. To an individual or entity submitting a complaint to OPM about the FEHB Program, Carriers, or plans, a response or report of outcome related to the complaint.
The electronic records in this system of records are maintained in an
These records are retrieved primarily by the name of the individual, FEHB health plan name, date of birth and/or claim number of the individual to whom they pertain but may be retrieved by any personal identifier.
The disputed claims and complaints records are subject to the NARA-approved records schedule NC1-146-77-01 INS 4(b) relating to Healthcare and Insurance claims correspondence, correspondence with individuals or carriers' representatives on the interpretation of contracts, and settlement of Federal employee claims under health benefits and life insurance plans.
Records in this system are protected from unauthorized access and misuse through various administrative, technical, and physical security measures. OPM security measures are in compliance with the Federal Information Security Modernization Act of 2014 (Pub. L. 113-203), associated OMB policies, and applicable standards and guidance from the National Institute of Standards and Technology (NIST). Transmission of the data feed from FEHB Carriers and Independent Medical Reviewers to this system is encrypted in compliance with NIST Federal Information Processing Standards Publication 197.
Individuals seeking notification of and access to their records in this system of records may do so by submitting a request in writing to the Office of Personnel Management, Office of Privacy and Information Management—FOIA, 1900 E Street NW, Washington, DC 20415-7900 or by emailing
1. Full name, including any former name.
2. Date of birth.
3. FDC Control Number, if known.
4. Reasonable specification of the requested information.
5. The address to which the information should be sent.
6. Signature.
Individuals requesting access must also comply with OPM's Privacy Act regulations regarding verification of identity and access to records (5 CFR 297). Medical or psychological records may also be subject to 5 CFR 297.205.
Individuals wishing to request amendment of their records in this system of records may do so by writing to the to the Office of Personnel Management, Office of Privacy and Information Management—FOIA, 1900 E Street NW, Room 5415, Washington, DC 20415-7900 or by emailing
1. Full name, including any former name.
2. Date of birth.
3. Name and address of employing agency or retirement system.
4. Precise identification of the information to be amended.
5. Signature.
Individuals requesting amendment of their records must also comply with OPM's Privacy Act regulations regarding verification of identity and access to records (5 CFR 297). OPM may refer amendment requests to other entities when those entities are the original source of the record.
See “Record Access Procedures.”
None.
OPM/Central-1, Civil Service Retirement and Insurance Records, 73 FR 15013 (March 20, 2008), 80 FR 74815 (November 30, 2015).
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (“PRA”) (44 U.S.C. 3501
Rule 17Ad-17 requires certain transfer agents and broker-dealers to make two searches for the correct address of lost securityholders using an information database without charge to the lost securityholders. In addition, paying agents are required to attempt to notify lost payees at least once. In addition, the entities also are required to maintain records relating to the searches and notifications.
The Commission staff estimates that the rule applies to approximately 496 broker dealers and transfer agents, and 3,113 paying agent entities, including carrying firms, transfer agents, indenture trustees, custodians, and approximately 10% of issuers. The Commission staff estimates that the total annual burden for searches is approximately 183,813 hours and the total annual burden for paying agent notifications is approximately 38,913 hours. In addition, approximately 5,968 burden hours are associated with recordkeeping, representing an annual burden of 4,411 hours for the broker-dealers and transfer agents, and 1,557 for paying agents. The Commission staff estimates that the aggregate annual burden is therefore approximately 228,694 hours (183,813 + 38,913 + 5,968).
In addition, the Commission staff estimates that covered entities will incur costs of approximately $6,617,298 annually, primarily as payment to third party data base providers that will search for the missing securityholders.
The retention period for the recordkeeping requirement under Rule 17Ad-17 is not less than three years following the date the notice is submitted. The recordkeeping requirement under this rule is mandatory to assist the Commission in monitoring compliance with the rule. This rule does not involve the collection of confidential information.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
The public may view background documentation for this information collection at the following website: >
Dated: August 8, 2022.
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (“PRA”) (44 U.S.C. 3501
Rule 19b-4(e) permits a self-regulatory organization (“SRO”) to list and trade a new derivative securities product without submitting a proposed rule change pursuant to Section 19(b) of the Act (15 U.S.C. 78s(b)), so long as such product meets the criteria of Rule 19b-4(e) under the Act. However, in order for the Commission to maintain an accurate record of all new derivative securities products traded on the SROs, Rule 19b-4(e) requires an SRO to file a summary form, Form 19b-4(e), to notify the Commission when the SRO begins trading a new derivative securities product that is not required to be submitted as a proposed rule change to the Commission. Form 19b-4(e) should be submitted within five business days after an SRO begins trading a new derivative securities product that is not required to be submitted as a proposed rule change. In addition, Rule 19b-4(e) requires an SRO to maintain, on-site, a copy of Form 19b-4(e) for a prescribed period of time.
This collection of information is designed to allow the Commission to maintain an accurate record of all new derivative securities products traded on the SROs that are not deemed to be proposed rule changes and to determine whether an SRO has properly availed itself of the permission granted by Rule 19b-4(e). The Commission reviews SRO compliance with Rule 19b-4(e) through its routine inspections of the SROs.
The respondents to the collection of information are SROs (as defined by the Act), all of which are national securities exchanges. As of April 8, 2022 there were 24 entities registered as national securities exchanges with the Commission. The Commission receives an average total of 2,331 responses per year, which corresponds to an estimated annual hour burden of approximately 2,331 hours (2,331 responses × 1 hour per response). At an average hourly cost of $72, the aggregate related internal cost of compliance for Rule 19b-4(e) is approximately $167,832 per year (2,331 burden hours multiplied by $72/hour).
Compliance with Rule 19b-4(e) is mandatory. Information received in response to Rule 19b-4(e) shall not be kept confidential; the information collected is public information.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
The public may view background documentation for this information collection at the following website,
On April 21, 2022, MEMX LLC (“MEMX” or the “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange proposes to adopt new Chapters 16-29 into its rulebook to govern MEMX Options. In addition, the Exchange proposes to add rule text to existing Chapters 2 (Members of the Exchange) and 8 (Discipline) so that those chapters take into account the new options rule set. MEMX Options will operate an electronic trading system for options (the “System”) that will provide for the electronic display and execution of orders, which the Exchange intends to operate “in a manner similar to that of other options exchanges.”
The proposed rules relating to qualification and participation on MEMX Options are set forth in proposed Chapters 17 and 22. These rules are substantively identical to the corresponding rules of Cboe BZX Options, with the only differences being internal references and other minor technical differences.
MEMX will have only one type of member, referred to as an “Options Member,” which must be a registered broker-dealer.
An Options Member that represents customer orders as an agent on MEMX Options and those that conduct proprietary trading as principal other than in the capacity of a market maker are referred to as Options Order Entry Firms (“OEFs”). OEFs may only transact business with Public Customers if they are members of FINRA.
In addition, an Options Member can seek to register with the Exchange as an Options Market Maker to make markets in specific classes of options it chooses in advance (“appointed classes”) where it would have certain rights and bear certain responsibilities beyond those of other Options Members.
Furthermore, existing Exchange Rules applicable to the MEMX equities market contained in Chapters 1 through 15 of the Exchange Rules will apply to Options Members unless a specific Exchange Rule applicable to MEMX Options (
Chapter 16.1 sets forth the defined terms used in Chapters 16 to 29 relating to the trading of options contracts on the Exchange. Each of the terms defined in Rule 16.1 is either identical or substantially similar to definitions in Cboe BZX Rule 16.1. A complete list of the defined terms is set forth in the filing.
The Exchange states that MEMX Options will leverage the Exchange's current technology, including its customer connectivity, messaging protocols, quotation and execution engine, order router, data feeds, and network infrastructure.
MEMX Options will not have a physical trading floor. All trading interest entered into the System will be automatically executable. Orders entered into the System will be displayed anonymously.
Like the Exchange's equities facility, MEMX Options will maintain a price/time allocation model across all participants rather than differentiating between participants. As such, MEMX Options will execute all trading interest at the best price level within the System before executing trading interest at the next best price.
MEMX will be a member of the Options Price Reporting Authority (“OPRA”) and will disseminate its quotations in accordance with Rule 602 of Regulation NMS.
The Exchange will become an exchange member of the Options Clearing Corporation (“OCC”). The System will be linked to OCC for the Exchange to transmit locked-in trades for clearance and settlement.
The Time-in-Force designations are identical to the same Time-in-Force designations available on Cboe BZX Options, except that Cboe BZX Options rules describe Time-in-Force designations as applicable only to limit orders on Cboe BZX Options, whereas the Exchange has proposed allowing such designations to be placed on both Limit Orders and Market Orders.
MEMX Options will offer “bulk message” functionality whereby Market Makers will be able to use a single electronic message to enter, modify, or cancel up to a specified number of bids and offers.
Additionally, the Exchange may delay the commencement of trading in any class of options in the interests of a fair and orderly market.
In the filing, the Exchange explains that it proposes a simplified opening procedures because for a successful opening process to function, MEMX believes an exchange needs a critical mass of liquidity from market participants in order to price and execute opening transactions.
Subject to the exceptions contained in Rule 27.2(b), the System will ensure that an order will not be executed at a price that trades through another options exchange. Any order entered with a price that would lock or cross a Protected Quotation that is not eligible for either routing or the price adjust process as defined in Rule 21.1(i) will be cancelled.
The Exchange explains that the routing functionality for MEMX Options is designed to operate much like the routing functionality for the Exchange's equities market, in that the Exchange “offers a simple routing service to facilitate compliance with applicable regulations and does not currently offer other complex routing strategies.”
The Exchange will use its existing affiliated routing broker-dealer, MEMX Execution Services LLC (“MEMX Execution Services”), to route orders solely on behalf of MEMX Options.
Use of routing services, including routing using MEMX Execution Services, is optional. Users that do not want to use routing services provided by the Exchange must designate orders as not available for routing.
To mitigate the financial and regulatory risks associated with providing Users with access to away options exchanges, MEMX has implemented certain tests to comply with market access requirements under Rule 15c3-5.
Rule 21.16 sets forth a Risk Monitor Mechanism that will offer Users a choice between a “passive” risk counter
When the System determines that a specified parameter has reached the User's pre-defined risk limit and instructions, the Risk Monitor Mechanism will effectuate a User's pre-determined action from among the following options: (i) cancel or reject such User's orders or quotes in all series of the applicable underlying(s) and cancel or reject any additional orders or quotes from the User in the applicable underlying(s) until the counting program is reset; or (ii) suspend all of a User's resting orders or quotes in all series of the applicable underlying(s) and cancel or reject any additional orders or quotes from the User in the applicable underlying(s) until the Exchange is instructed to reinstate such bids and offers. A User may also engage the Risk Monitor Mechanism to cancel resting bids and offers, as well as subsequent orders as set forth in Rule 22.10 (“mass cancellation”) or to suspend all resting bids and offers until the Exchange is instructed to reinstate such bids and offers (“mass suspension”). When a User's resting orders or quotes have been suspended and the User instructs the Exchange to reinstate all such bids and offers, each reinstated order or quote shall receive a new timestamp reflecting the time it was re-posted to the MEMX Options Book.
The Risk Monitor Mechanism's “passive” functionality is substantially similar to that offered on Cboe BZX Options, except that Cboe BZX Options' rule does not permit Users to designate a Custom Group Limit to track risk parameters across a customized group of orders, nor does Cboe BZX Options permit Users to choose to suspend, rather than cancel or reject, resting interest when a risk limit has been reached or to engage the Risk Monitor Mechanism for mass suspension as an alternative to mass cancellation.
Cboe BZX Options rules do not presently contain a similar version of MEMX Option's proposed “active” Risk Monitor Mechanism functionality. As described above, in the “active” version, the System will increment the active risk counter associated with a defined parameter when the relevant activity occurs, and the System will decrement the active risk counter upon positive confirmation from the User via an electronic instruction that the User has acknowledged a change in the active risk counter. The User will be able to specify the value by which each parameter increments and decrements in the active risk counter. The proposed active risk counter will therefore enable a User to interact with the Risk Monitor Mechanism dynamically such that the User may actively acknowledge executions and decrement the counting program by a specified amount as such executions occur (or at any time), rather than waiting until a risk limit is reached or the User otherwise sends a specific instruction to the Exchange to completely reset the counting program. In the filing, the Exchange provides several examples to demonstrate how both the passive and active risk counters will operate.
In addition to the Risk Monitor Mechanism functionality, the Exchange also will offer additional price protection mechanisms and risk controls that relate to certain standard or Exchange-established parameters based on order type and market conditions.
The Exchange represents that it will participate in the Linkage Plan, and therefore will be required to comply with the obligations of participants under the Plan.
The Exchange explains that Chapter 27 (Options Order Protection and Locked and Crossed Markets Rules) is designed to conform to the requirements of the Plan, and the rules in that chapter are substantively identical to the rules of Cboe BZX Options.
The Exchange proposes to adopt operational and member conducts rules for MEMX Options that are substantively identical to the rules of Cboe BZX Options regarding: (i) exercises and deliveries;
Before commencing operations, MEMX Options will become a member of the Options Price Reporting Authority (“OPRA”), the Options Linkage Authority (“OLA”), the Options Regulatory Surveillance Authority (“ORSA”), and the Options Listing Procedures Plan (“OLPP”).
The Exchange represents that it will leverage many of the structures it established to operate a national securities exchange for trading equities in compliance with Section 6 of the Act.
Consistent with the Exchange's existing regulatory structure, the Exchange's Chief Regulatory Officer will have general supervision of the regulatory operations of MEMX Options, including responsibility for overseeing the surveillance, examination, and enforcement functions and for administering all regulatory services agreements applicable to MEMX Options.
The Exchange's existing rules governing members will apply to Options Members and their associated persons. The Exchange's existing rules provide that members, a term that includes Options Members, agree to be regulated by the Exchange as a condition of effecting securities transactions on the Exchange's trading facilities.
As it does with equities trading, the Exchange will perform automated surveillance of trading on MEMX Options for the purpose of maintaining a fair and orderly market at all times, and it will monitor MEMX Options to identify unusual trading patterns and determine whether particular trading activity requires further regulatory investigation.
Additionally, the Exchange will oversee the process for determining and implementing trade halts, identifying and responding to unusual market conditions, and administering the Exchange's process for identifying and remediating “obvious errors” by and among its Options Members.
The Commission approved the Exchange's Minor Rule Violation Plan (“MRVP”) in 2020.
In connection with MEMX Options, the Exchange is amending its MRVP and Exchange Rule 8.15, Interpretation and Policy .01, to include Rule 25.3 (Penalty for Minor Rule Violations). Rule 25.3 contains provisions addressing the following: (i) position limit and exercise limit violations; (ii) violations regarding the failure to accurately report position and account information; (iii) Market Maker quoting obligations; (iv) violations regarding expiring exercise declarations; (v) violations relating to the failure to respond to the Exchange's requests for the submission of trade data; and (vi) violations relating to noncompliance with the Consolidated Audit Trail Compliance Rule requirements. The Exchange further states that the rules included in proposed Rule 25.3 are the same as the rules included in the MRVPs of other options exchanges.
The Exchange represents that, upon implementation, it will include the enumerated options trading rule violations in the Exchange's standard quarterly report of actions taken on minor rule violations under the MRVP.
In addition to the new rules for MEMX Options, the Exchange also proposes to amend certain of its existing rules in order to reflect the Exchange's proposed operation of MEMX Options. First, the Exchange is amending paragraph (d) of Interpretations and Policies .01 to Rule 2.5 (Restrictions), which generally requires each member to register at least two Principals with the Exchange subject to certain exceptions described therein, to provide that such paragraph (d) shall not apply to a member that solely conducts business on the Exchange as an Options Member, however, Options Members must comply with the registration requirements set forth in proposed Rule 17.2(g).
The Exchange also is deleting the word “equities” in the first sentence of Rule 2.7 (Revocation of Membership or Association with a Member), which currently provides that members or associated persons of members may effect approved equities securities transactions on the Exchange's trading facilities only so long as they possess all the qualifications set forth in the Exchange Rules.
The Exchange proposes to modify Rule 2.11(a)(6), which states that MEMX Execution Services shall maintain an error account for the purpose of addressing positions that are the result of an execution or executions that are not clearly erroneous under Rule 11.15 and result from a technical or systems issue at MEMX Execution Services, the Exchange, a routing destination, or a non-affiliate third-party routing broker that affects one or more orders (“Error Positions”). The proposed change to Rule 2.11(a)(6) adds a reference to the comparable provision in Rule 20.6 that governs review and resolution of options transactions that may qualify as obvious errors.
After careful review, the Commission finds that the Exchange's proposal is consistent with the requirements of the Act and the rules and regulations thereunder applicable to a national securities exchange.
As detailed above, MEMX Options' proposed rules are substantially similar to those of other exchanges, especially Cboe BZX, though the Exchange is not proposing to adopt certain optional features offered by other exchanges so that its trading platform at launch will, as the Exchange described it, have “a simplified suite of conventional order types and functionality that is designed to provide for an efficient, robust, and transparent order matching process.”
As described above, only Options Members, and their Sponsored Participants,
The Commission finds that the rules applicable to qualification, registration, member operations, and use of MEMX Options, which are substantially similar to those of other options exchanges, are consistent with the Act, including Sections 6(b)(1), (2), and (6) thereof, in that they provide the Exchange with the capacity to regulate access to and conduct on MEMX Options and enforce the federal securities laws among persons using its facilities, provide that registered broker-dealers can become members and have access to MEMX Options, and ensure that Options Members and their associated persons can be appropriately disciplined for violations of the Act, the rules and regulations thereunder, and Exchange rules.
With respect to Market Maker members, the Commission finds that the proposed Market Maker qualification requirements, which also are substantially similar to those of other options exchanges, are consistent with the Act. The Commission further finds that the Options Market Maker participation requirements are consistent with the Act. Market makers receive certain benefits for carrying out their responsibilities. For example, a broker-dealer or other lender may extend “good faith” credit to a member of a national securities exchange or registered broker-dealer to finance its activities as a market maker or specialist.
The functionalities and features of MEMX Options' market structure and trading system are based on functionalities and features currently used and previously approved for other options exchanges. Among other things, the rules are reasonably designed to provide for a simple, orderly opening process for an exchange that only trades multiply listed options, as well as an orderly re-opening process following the conclusion of a trading halt. Further, the rules provide for the electronic display and execution of orders in traditional price/time priority. MEMX Options will utilize only two order types (limit orders and market orders) and offer a limited suite of order handling instructions, all of which are well-established in both the equities and options markets. These proposed execution priority rules and order types are consistent with the Act, in particular Section 6(b)(5) of the Act, in that, among other things, they are designed to promote just and equitable principles of trade and are not designed to permit unfair discrimination between customers, issuers, brokers, or dealers.
MEMX also is requiring a one-second exposure period in order to execute as principal orders represented as agent, which is the same standard required by other exchanges. This exposure requirement should facilitate the prompt execution of orders while continuing to provide members with an opportunity to compete for exposed bids and offers.
MEMX listing standards for options traded on MEMX Options are substantively identical to those currently utilized by other exchanges. MEMX will join the Options Listings Procedures Plan and will list and trade options already listed on other options exchanges. The Commission finds that the Exchange's proposed listing standards are consistent with the Act, including Section 6(b)(5), in that they are designed to protect investors and the public interest and promote just and equitable principles of trade. As explained below, MEMX's operation of MEMX Options is conditioned on MEMX joining and participating in the OLPP. The Exchange has represented that it will join the OLPP and will become an exchange member of OCC.
Further, MEMX proposes operational rules that are substantively identical to the rules of other options exchanges, such as Cboe BZX, including rules
And, as described above, in those cases where MEMX Options' proposed rules vary from current functionality on other options exchanges, many of those variations are because MEMX proposes a more streamlined system and is not proposing to introduce those optional features.
As such, the Commission finds that the proposed functionalities and features of MEMX Options' overall structure and trading operations are consistent with the Act, and in particular, with Section 6(b)(5) of the Act, which requires an exchange's rules, among other things, be designed to promote just and equitable principles of trade, to remove impediments to and perfect the mechanism of a free and open market and a national market system, and, in general, to protect investors and the public interest, and are not designed to permit unfair discrimination between customers, issuers, brokers, or dealers.
The MEMX Options rules are designed to comply with applicable federal securities laws and regulations and the obligations of the Linkage Plan. Specifically, the rules are designed to ensure that an order is not executed at a price that would trade through another options exchange. In this regard, the Commission notes that MEMX Options is required under Rule 608(c) of Regulation NMS
Before commencing operations, MEMX represents that it will become a participant in the Linkage Plan.
As discussed above, MEMX Options will offer Users an optional mechanism to establish certain risk control parameters and limits. The “passive” functionality is substantially similar to that offered on Cboe BZX Options, except that MEMX Options will permit Users to track risk parameters across a customized group of orders and will permit Users to choose to suspend, rather than cancel or reject, resting interest when a risk limit has been reached.
In addition to the Risk Monitor Mechanism, the Exchange will offer additional price protection mechanisms and risk controls. These controls are substantially similar to those offered on Cboe BZX, with slight modifications to align with the Exchange's proposed streamlined market opening procedures and fewer available order types and instructions on MEMX Options. Also, whereas the drill-through price protection mechanism offered on Cboe BZX executes an incoming order to a determined “Drill-Through Price” and then displays the remainder of the order on Cboe BZX Options at that price for a brief period of time, the Exchange proposes to cancel the remainder of an incoming order after executing the order.
The Commission believes that the proposed risk protections for MEMX Options are reasonably designed to provide liquidity providers with protections to help them manage risk and efficiently use capital when trading options. These protections are in addition to, and do not take the place of, members' required market access controls, vigilant oversight of trading and algorithms, and overall risk management. For example, these mechanisms are intended to provide market makers and other liquidity providers with optional supplemental tools as an additional layer of protection to assist them in managing risk and utilizing available capital in leveraged options securities. To the extent they achieve that intended objective, liquidity providers should be able to provide additional liquidity to the market at potentially improved prices, thus benefitting investors.
While most of these protections are substantively similar to those available on other options markets, some of the differences discussed above are designed to offer market participants additional flexibility when using the Risk Monitor Mechanism in a manner consistent with the functionality and scope of protections that the Risk Monitor Mechanism provides. Accordingly, the Commission finds that the proposed risk controls for MEMX Options are consistent with the Act in that they are designed to, among other things, promote just and equitable principles of trade and protect investors and the public interest.
The Exchange represents that it will become a participant in the various applicable multiparty plans for options
The Exchange represents that it will leverage the structures it currently maintains to operate and oversee its equities trading facility, which involve the following three elements: (i) the Exchange will join the existing options industry agreements pursuant to Section 17(d) of the Act,
Also, as explained above, consistent with the Exchange's existing regulatory structure, the Exchange's Chief Regulatory Officer will have general supervision of the regulatory operations of MEMX Options, including responsibility for overseeing the surveillance, examination, and enforcement functions and for administering all regulatory services agreements applicable to MEMX Options. Similarly, the Exchange's existing Regulatory Oversight Committee will be responsible for overseeing the adequacy and effectiveness of Exchange's regulatory and self-regulatory organization responsibilities, including those applicable to MEMX Options.
As it does with equities, the Exchange will perform automated surveillance of trading on MEMX Options for the purpose of maintaining a fair and orderly market at all times. As it does with its equities trading facility, the Exchange will monitor MEMX Options to identify unusual trading patterns and determine whether particular trading activity requires further regulatory investigation by FINRA.
In addition, the Exchange will oversee the process for determining and implementing trade halts, identifying and responding to unusual market conditions, and administering the Exchange's process for identifying and remediating “obvious errors” by and among its Options Members. The proposed rules in Chapter 20 (Regulation of Trading on MEMX Options) regarding halts, unusual market conditions, extraordinary market volatility, obvious errors, and audit trail are substantively identical to the rules of Cboe BZX Options.
Based on the foregoing, the Commission finds that the Exchange's proposed rules and regulatory structure with respect to MEMX Options are consistent with the requirements of the Act, in particular with Section 6(b)(1) of the Act, which requires an exchange to be so organized and have the capacity to be able to carry out the purposes of the Act and to comply, and to enforce compliance by its members and persons associated with its members, with the Act and the rules and regulations thereunder, and the rules of the Exchange, and with Sections 6(b)(6) and 6(b)(7) of the Act, which require an Exchange to provide fair procedures for the disciplining of members and persons associated with members. The Commission further believes that it is consistent with the Act to allow the Exchange to contract with FINRA to perform functions relating to the regulation and discipline of members and the regulation of MEMX Options.
The Commission finds that the amended MRVP is consistent with Sections 6(b)(1), 6(b)(5), and 6(b)(6) of the Act, which require, in part, that an exchange have the capacity to enforce compliance with, and provide appropriate discipline for, violations of the rules of the Exchange and the federal securities laws. As existing MEMX Rule 8.15 will continue to offer procedural rights to a person sanctioned for a violation listed in proposed MEMX Options Rule 25.3, the Commission believes that the Exchange's rules provide a fair procedure for the disciplining of members and associated persons, consistent with Section 6(b)(7) of the Act.
In approving the proposed change to the Exchange's MRVP, the Commission in no way minimizes the importance of compliance with the Exchange's rules and all other rules subject to the imposition of fines under the Exchange's MRVP. The Commission believes that the violation of any SRO rules, as well as the federal securities laws, is a serious matter. However, the Exchange's MRVP provides a reasonable means of addressing rule violations that do not rise to the level of requiring formal disciplinary proceedings, while providing flexibility in handling certain violations. The Commission expects that the Exchange will continue to conduct surveillance with due diligence and make a determination based on its findings, on a case-by-case basis, whether a fine of more or less than the recommended amount is appropriate for a violation under the Exchange's MRVP or whether a violation requires a formal disciplinary action.
Section 11(a)(1) of the Act
In a letter to the Commission, the Exchange requests that the Commission concur with the Exchange's conclusion that Options Members that enter orders into the System satisfy the requirements of Rule 11a2-2(T).
The Rule's first requirement is that orders for covered accounts be transmitted from off the exchange floor. In the context of automated trading systems, the Commission has found that the off-floor transmission requirement is met if a covered account order is transmitted from a remote location directly to an exchange's floor by electronic means.
Second, the Rule requires that the member and any associated person not participate in the execution of its order after the order has been transmitted. MEMX represented that at no time following the submission of an order is an Options Member or an associated person of the Options Member able to acquire control or influence over the result or timing of the order's execution.
Third, Rule 11a2-2(T) requires that the order be executed by an exchange member who is unaffiliated with the member initiating the order. The Commission has stated that this requirement is satisfied when automated exchange facilities, such as the MEMX Options trading system are used, as long as the design of these systems ensures that members do not possess any special or unique trading advantages in handling their orders after transmitting them to the exchange.
Fourth, in the case of a transaction effected for an account with respect to which the initiating member or an associated person thereof exercises investment discretion, neither the initiating member nor any associated person thereof may retain any compensation in connection with effecting the transaction, unless the person authorized to transact business for the account has expressly provided otherwise by written contract referring to Section 11(a) of the Act and Rule 11a2-2(T) thereunder.
The Exchange proposes to incorporate by reference as MEMX Options Rules certain rules of Cboe Exchange (“Cboe”), the New York Stock Exchange (“NYSE”), and FINRA.
Using its authority under Section 36 of the Act, the Commission previously exempted certain SROs from the requirement to file proposed rule changes under Section 19(b) of the Act.
The Commission is granting the Exchange's request for exemption, pursuant to Section 36 of the Act, from the rule filing requirements of Section 19(b) of the Act with respect to the rules that the Exchange proposes to incorporate by reference into MEMX Options Rules. The Commission believes that this exemption is appropriate in the public interest and consistent with the protection of investors because it will promote more efficient use of Commission and SRO resources by avoiding duplicative rule filings based on simultaneous changes to identical rule text sought by more than one SRO. Consequently, the Commission grants the Exchange's exemption request for MEMX Options. This exemption is conditioned upon the Exchange providing written notice to Options Members whenever Cboe, NYSE, or FINRA proposes to change a rule that MEMX Options has incorporated by reference.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether Amendment No. 1 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.
The Commission finds good cause to approve the proposed rule change prior to the 30th day after the date of publication of Amendment No. 1 in the
The Commission finds that Amendment No.1 raises no novel regulatory issues and is reasonably designed to perfect the mechanism of a free and open market and the national market system, protect investors and the public interest, and not be unfairly discriminatory, or impose an unnecessary or inappropriate burden on competition. The Amendment makes minor and non-material clarifying and conforming changes and makes additional representations that each provide more clarity on the application of the MEMX Options rules and the commencement of operation of MEMX Options. Accordingly, pursuant to Section 19(b)(2) of the Act,
Although the Commission's approval of the proposed rule change is final, and the proposed rules are therefore effective, it is further ordered that the operation of MEMX Options is conditioned on the satisfaction of the requirements below:
A.
B.
C.
D.
It is further ordered, pursuant to Section 36 of the Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
Cboe BYX Exchange, Inc. (the “Exchange” or “BYX”) proposes to amend its fee schedule. The text of the proposed rule change is provided in Exhibit 5.
The text of the proposed rule change is also available on the Exchange's website (
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend its Fee Schedule by (i) introducing a Non-Displayed Add Volume Tier under Footnote 1 (Add/Remove Volume Tiers) and (ii) amending the criteria of the Step-Up Tier under Footnote 2. The Exchange proposes to implement these changes effective August 1, 2022.
The Exchange first notes that it operates in a highly competitive market in which market participants can readily direct order flow to competing venues if they deem fee levels at a particular venue to be excessive or incentives to be insufficient. More specifically, the Exchange is only one of 16 registered equities exchanges, as well as a number of alternative trading systems and other off-exchange venues that do not have similar self-regulatory responsibilities under the Securities
Currently, the Exchange offers various Add/Remove Volume Tiers under footnote 1 of the Fee Schedule, which offer various enhanced rebates and reduced fees for reaching certain, incrementally more challenging volume-based thresholds. These tiers are available to Members whose orders yield fee codes B,
The proposed Non-Displayed Add Volume Tier is designed to incentivize overall order flow, particularly by offering a reduced fee for non-displayed orders that achieve the volume-based criteria. The Exchange also believes that the proposed fee associated with the proposed Non-Displayed Add Volume Tier is commensurate with the tier's criteria. Further, the proposed Non-Displayed Add Volume Tier will provide non-displayed liquidity providing Members on the Exchange incentives to contribute to a deeper, more liquid market, which in turn, provides additional execution opportunities for all Members. The Exchange believes that this benefits all Members by enhancing overall market quality and contributing towards a robust and well-balanced market ecosystem. The Exchange notes that the proposed Non-Displayed Add Volume Tier will be available to all Members.
The Exchange also proposes to revise the criteria of the Step-Up Tier under Footnote 2 of the Fee Schedule. Currently, the Step-Up Tier offers a reduced fee of $0.0014 to Members whose orders yield fee codes, B,
• Member has a combined Step-Up Auction ADV and Step-Up ADAV from April 2022 (as compared to June 2021) greater than or equal to 3,000,000 (as compared to 2,000,000); and Member has a combined Auction ADV and ADAV greater than or equal to 0.25% of TCV.
The Exchange believes the proposed change continues to incentivize increased overall order flow to the Exchange, albeit with slightly modified criteria, which may contribute to a deeper, more liquid market to the benefit of all market participants by creating a more robust and well-balanced market ecosystem. Additionally, the Exchange believes the proposed lower reduced fee of $0.0012 is commensurate with the revised criteria as Members are still required to increase the amount of liquidity they provide on the Exchange, thereby contributing to a deeper and more liquid market, which benefits all market participants. Furthermore, the proposed Step-Up Tier continues to be available to all Members and provide Members an opportunity to receive a reduced fee, albeit using a slightly modified criteria.
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
The Exchange believes that the proposed Non-Displayed Add Volume Tier and the proposed changes to the Step-Up Tier are reasonable, equitable and not unfairly discriminatory because each tier, as proposed, will be available to all Members and provide Members an opportunity to receive a reduced fee. As noted above, the Exchange operates in a highly competitive market. The Exchange is only one of 16 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 rates and tiered pricing structures to that of the Exchange, including schedules of rebates and fees that apply based upon members achieving certain volume thresholds. Specifically, the Exchange notes that relative volume-based incentives and discounts have been widely adopted by exchanges,
In particular, the Exchange believes the proposed Non-Displayed Add Volume Tier is reasonable because it provides an additional opportunity for Members to receive a discounted rate by reaching the proposed threshold by means of liquidity adding non-displayed orders. The Exchange believes that adopting a Non-Displayed Add Volume Tier based on a Member's non-displayed liquidity adding orders will encourage non-displayed liquidity providing Members to provide for a deeper, more liquid market, and, as a result, increased execution opportunities at improved price levels and, thus, overall order flow. The Exchange similarly believes that the proposed revised Step-Up Tier is reasonable because it continues to provide a discounted rate (albeit at a lower amount), which is commensurate with the revised criteria. The Exchange believes that removing the first requirement from the first prong of criteria while simultaneously updating the baseline month from June 2021 to April 2022 and increasing the growth amount continues to provide a reasonable means to achieve a reduced fee while contributing towards a deeper and more liquid market. The Exchange believes that the proposed Non-Displayed Add Volume Tier and proposed revised Step-Up Tier continue to benefit all Members by contributing towards a robust and well-balanced market ecosystem. Increased overall order flow benefits all investors by deepening the Exchange's liquidity pool, providing greater execution incentives and opportunities, offering additional flexibility for all investors to enjoy cost savings, supporting the quality of price discovery, promoting market transparency and improving investor protection.
The Exchange believes the proposed Non-Displayed Add Volume Tier and the proposed revisions to the Step-Up Tier represent an equitable allocation of fees and are not unfairly discriminatory because all Members continue to be eligible for those tiers, would have the opportunity to meet a tier's criteria, and would receive the proposed reduced fee if such criteria is met. Without having a view of activity on other market and off-exchange venues, the Exchange has no way of knowing whether this proposed rule change would definitely result in any Members qualifying for the proposed tiers. While the Exchange has no way of predicting with certainty how the proposed tiers will impact Member activity, the Exchange anticipates that at least one Member will be able to satisfy the criteria for the proposed Non-Displayed Add Volume Tier and ten Members will be able to satisfy the proposed criteria for the Step-Up Tier. The Exchange also notes that the proposed changes will not adversely impact any Member's ability to qualify for other reduced fee or enhanced rebate tiers. Should a Member not meet the proposed criteria under the proposed or modified tier, the Member will merely not receive that corresponding reduced fee. The Exchange believes that the proposed addition of the Non-Displayed Add Volume Tier and the proposed changes to the Step-Up Tier will benefit all market participants by incentivizing additional hidden liquidity and, thus, deeper more liquid markets as well as increased execution opportunities. Particularly, the proposals are designed to incentivize liquidity, which further contributes to a deeper, more liquid market and provide even more execution opportunities for active market participants at improved prices. This overall increase in activity deepens the Exchange's liquidity pool, offers additional cost savings, supports the quality of price discovery, promotes market transparency and improves market quality, for all investors.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. Rather, as discussed above, the Exchange believes that the proposed change would encourage the submission of additional order flow to a public exchange, thereby promoting market depth, execution incentives and enhanced execution opportunities, as well as price discovery and transparency for all Members. As a result, the Exchange believes that the proposed changes further the Commission's goal in adopting Regulation NMS of fostering competition among orders, which promotes “more efficient pricing of individual stocks for all types of orders, large and small.”
The Exchange believes the proposed rule change does not impose any burden on intramarket competition that is not necessary or appropriate in furtherance of the purposes of the Act. Particularly, the proposed tier changes will apply to all Members equally, in that all Members will be eligible for the Non-Displayed Add Volume Tier and all Members will continue to be eligible for the Step-Up Tier. In addition, all Members will have a reasonable opportunity to meet the tiers' criteria and will receive the reduced fee on their qualifying orders if such criteria are met. The Exchange does not believe the proposed changes burden competition, but rather, enhance competition as they
Next, the Exchange believes the proposed rule change does not impose any burden on intermarket competition that is not necessary or appropriate in furtherance of the purposes of the Act. As previously discussed, the Exchange operates in a highly competitive market. Members have numerous alternative venues that they may participate on and direct their order flow, including other equities exchanges, off-exchange venues, and alternative trading systems. Additionally, the Exchange represents a small percentage of the overall market. Based on publicly available information, no single equities exchange has more than 16% of the market share.
The Exchange neither solicited nor received comments on the proposed rule change.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
KS Railroad (KS), a noncarrier and division of KINKISHARYO International, L.L.C. (KII), has filed a verified notice of exemption pursuant to 49 CFR 1150.31 to operate on 1,173 feet, three inches of railroad track inside an existing industrial facility owned by KII in Piscataway, N.J. (the Line). The Line has no mileposts.
According to the verified notice, the Line is currently operated by KII as
KS certifies that its annual projected revenues as a result of the transaction will not exceed those that would qualify it as a Class III carrier and will not exceed $5 million. KS states that no interchange commitments are being imposed on KS's operation.
The transaction may be consummated on or after August 27, 2022, the effective date of the exemption (30 days after the verified notice was filed).
If the verified notice contains false or misleading information, the exemption is void ab initio. Petitions to revoke the exemption under 49 U.S.C. 10502(d) may be filed at any time. The filing of a petition to revoke will not automatically stay the effectiveness of the exemption. Petitions for stay must be filed no later than August 19, 2022 (at least seven days before the exemption becomes effective).
All pleadings, referring to Docket No. FD 36618, must be filed with the Surface Transportation Board either via e-filing on the Board's website or in writing addressed to 395 E Street SW, Washington, DC 20423-0001. In addition, a copy of each pleading must be served on KS's representative, Eric M. Hocky, Clark Hill PLC, Two Commerce Square, 2001 Market St., Suite 2620, Philadelphia, PA 19103.
According to KS, this action is categorically excluded from environmental review under 49 CFR 1105.6(c) and from historic preservation reporting requirements under 49 CFR 1105.8(b).
Board decisions and notices are available at
By the Board, Mai T. Dinh, Director, Office of Proceedings.
Federal Aviation Administration (FAA), Transportation DOT.
Notice of request to release airport improvement program property.
Notice is being given that the FAA is considering a request from the City and County of Spokane, Washington to waive the Airport Improvement Program property requirements for approximately 108 acres of airport property located at Spokane International Airport, Spokane, Washington.
Comments are due within 30 days of the date of the publication of this notice in the
Mandi M. Lesauis, Program Specialist, Seattle Airports District Office,
The subject properties are located in the northeast section of the airport. This release will allow the City and County of Spokane to sell 108 acres of Parcel 1 to developers for storage warehouses, transportation/logistics warehouses with minor office spaces for light industrial or commercial business. There will be proceeds generated from the proposed release of this property for capital improvements at the airport. The City and County of Spokane, Washington will receive not less than fair market value for the property and the revenue generated from the sale will be used for airport purposes. It has been determined through study that the subject partial parcel will not be needed for aeronautical purposes.
Federal Railroad Administration (FRA), Department of Transportation (DOT).
Notice of availability and request for comments.
This document provides the public with notice that, on August 2, 2022, the Port Authority Trans-Hudson (PATH) submitted a request for amendment (RFA) to its FRA-approved Positive Train Control Safety Plan (PTCSP). As this RFA may involve a request for FRA's approval of proposed material modifications to an FRA-certified positive train control (PTC) system, FRA is publishing this notice and inviting public comment on the railroad's RFA to its PTCSP.
FRA will consider comments received by September 1, 2022. FRA may consider comments received after that date to the extent practicable and without delaying implementation of valuable or necessary modifications to a PTC system.
Gabe Neal, Staff Director, Signal, Train Control, and Crossings Division, telephone: 816-516-7168, email:
In general, Title 49 United States Code (U.S.C.) section 20157(h) requires FRA to certify that a host railroad's PTC system complies with Title 49 Code of Federal Regulations (CFR) part 236, subpart I, before the technology may be operated in revenue service. Before making
Under 49 CFR 236.1021(e), FRA's regulations provide that FRA will publish a notice in the
Interested parties are invited to comment on PATH's RFA to its PTCSP by submitting written comments or data. During FRA's review of this railroad's RFA, FRA will consider any comments or data submitted within the timeline specified in this notice and to the extent practicable, without delaying implementation of valuable or necessary modifications to a PTC system.
In accordance with 49 CFR 211.3, FRA solicits comments from the public to better inform its decisions. DOT posts these comments, without edit, including any personal information the commenter provides, to
Issued in Washington, DC.
Federal Railroad Administration (FRA), Department of Transportation (DOT).
Notice of availability and request for comments.
This document provides the public with notice that, on July 29, 2022, the Southern California Regional Rail Authority (Metrolink) submitted a request for amendment (RFA) to its FRA-approved Positive Train Control Safety Plan (PTCSP). As this RFA may involve a request for FRA's approval of proposed material modifications to an FRA-certified positive train control (PTC) system, FRA is publishing this notice and inviting public comment on the railroad's RFA to its PTCSP.
FRA will consider comments received by September 1, 2022. FRA may consider comments received after that date to the extent practicable and without delaying implementation of valuable or necessary modifications to a PTC system.
Gabe Neal, Staff Director, Signal, Train Control, and Crossings Division, telephone: 816-516-7168, email:
In general, title 49 United States Code (U.S.C.) section 20157(h) requires FRA to certify that a host railroad's PTC system complies with title 49 Code of Federal Regulations (CFR) part 236, subpart I, before the technology may be operated in revenue service. Before making certain changes to an FRA-certified PTC system or the associated FRA-approved PTCSP, a host railroad must submit, and obtain FRA's approval of, an RFA to its PTCSP under 49 CFR 236.1021.
Under 49 CFR 236.1021(e), FRA's regulations provide that FRA will publish a notice in the
Interested parties are invited to comment on Metrolink's RFA to its PTCSP by submitting written comments or data. During FRA's review of this railroad's RFA, FRA will consider any comments or data submitted within the timeline specified in this notice and to the extent practicable, without delaying implementation of valuable or necessary modifications to a PTC system.
In accordance with 49 CFR 211.3, FRA solicits comments from the public to better inform its decisions. DOT posts these comments, without edit, including any personal information the commenter provides, to
Issued in Washington, DC.
Pipeline and Hazardous Materials Safety Administration (PHMSA), Department of Transportation (DOT).
Notice.
PHMSA is issuing this notice to serve process and inform all persons who currently hold explosive approvals for certain jet perforating guns of the process necessary for maintaining, modifying, upgrading/up-classing, or terminating these approvals.
Ms. Harpreet Singh, Chief, Energetic Materials Branch, Sciences and Engineering Division, Office of Hazardous Materials Safety, (202) 366-4535, PHMSA, 1200 New Jersey Ave. SE, Washington, DC 20590.
In November 2020, PHMSA issued the HM-219C
In the HM-219C rulemaking, PHMSA noted the major differences between the AESC/IME JPG 2017 standard and the previous 2008 standard, such as:
• The 1.4D (UN0494) JPG classifications have been removed.
• The 1.1D (UN0124) JPG classifications are issued with a note that the approved 1.1D perforating gun system can be transported as 1.4D in accordance with Special Provision (SP) 114 (49 CFR 172.102). This SP allows for JPGs classified as 1.1D explosives to be reclassified as 1.4D explosives for transportation if certain conditions are met.
• The 1.1D (NA0124) and 1.4D (NA0494) “with detonator” JPG classifications have been removed. Such JPG systems are now subject to testing in accordance with 49 CFR 173.56(b) prior to approval.
• The JPG Kodiak
Since publication of the HM-219C final rule in November 2020, PHMSA has identified approximately 773 current explosive (EX) approvals that are assigned to one of the four identification numbers—UN0124, UN0494, NA0124, and NA0494—impacted by the AESC/IME JPG 2017 standard.
Today's notice is primarily intended to serve as a notice of proposed termination in accordance with 49 CFR 105.35(a)(3) and 107.713(b)(1) and (c), and to reach all EX approval holders who have not yet submitted a request to maintain, modify, upgrade/up-class, or terminate their current approval.
PHMSA is providing the following options to current holders of an EX approval affected by this requirement. Affected EX approval-holders may take the appropriate actions as explained in the table below.
The approximately 773 EX approvals are held by over 100 separate companies. Because of the AESC/IME JPG 2017 Standard, existing approvals for the four affected UN/NA ID numbers—UN0124, UN0494, NA0124, and NA0494—must be modified in accordance with 49 CFR 107.713(a)(1) to reflect whether EX approval holders have met the requirements of the standard.
EX approval holders have until September 12, 2022, to provide a written response to PHMSA either to request that PHMSA maintain, modify, upgrade/upclass, or terminate their approval(s) or to otherwise show cause as to why their approval(s) should not be terminated, in accordance with 49 CFR 107.713(c)(1). Approvals for which PHMSA does not receive a request by September 12, 2022, are subject to the following:
Requests may be submitted to PHMSA via email at
The names of EX approval holders who have not yet submitted a request to maintain, modify, upgrade/up-class, or terminate their current approval(s) are provided in Table 3. This table accurately reflects the population of holders as of July 1, 2022.
Department of Transportation (DOT), Office of the Secretary (OST).
Notice and request for comments.
In compliance with the Paperwork Reduction Act of 1995, the Department of Transportation's Office of the Secretary (OST) invites the general public, industry and other governmental parties to comment on the Foreign Air Carrier Application for Statement of Authorization. The pre-existing information collection request previously approved by the Office of Management and Budget (OMB) expired on July 31, 2022.
Written comments should be submitted by October 2, 2022.
Darren Jaffe, (202) 366-2512, Office of International Aviation, U.S. Department of Transportation, 1200 New Jersey Avenue SE, Room W86-441, Washington, DC 20590. Office hours are from 9 a.m. to 5:30 p.m., Monday through Friday, except Federal holidays.
You may submit a comment to Docket No. DOT-OST-2013-0074 through one of the following methods:
If you wish to receive confirmation of receipt of your written comments, please include a self-addressed, stamped postcard with the following statement: “Comments on Docket No. DOT-OST-2013-0074. The Docket Clerk will date stamp the postcard prior to returning it to you via the U.S. mail. Please note that due to delays in the delivery of U.S. mail to Federal offices in Washington, DC, we recommend that persons consider an alternative method (internet, fax, or professional delivery service) to submit comments to the docket and to ensure their timely receipt at U.S. DOT.
Foreign carriers will also have to provide evidence that their homeland government will afford reciprocity to U.S. carriers seeking authority for the similar fifth-, sixth- and seventh-freedom operations. Carriers may cite certifications submitted by carriers from the same homeland if that homeland issued such certification within the preceding six-month period. Approximately 100 carriers from roughly 30 distinct homelands use OST Form 4540 to apply for statements of authorization annually. We estimate that one foreign carrier from any given homeland will expend roughly 4 hours every six-months to obtain certification from its homeland governments.
We have no empirical data to indicate how much time is required for a person to complete OST Form 4540; however, anecdotal evidence reveals that respondents spend thirty (30) minutes or less completing the form and brief justification. In some cases, respondents spend a limited amount of time, less than ten (10) minutes, reviewing the form before sending it via facsimile or email to the Department. In the interest of providing a conservative estimate so as to not understate the burden hours, we estimate the hour burden for completing OST Form 4540 as thirty (30) minutes.
All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
Office of the Comptroller of the Currency (OCC), Treasury.
Notice and request for comment.
The OCC, as part of its continuing effort to reduce paperwork and respondent burden, invites comment on a continuing information collection as required by the Paperwork Reduction Act of 1995 (PRA). In accordance with the requirements of the PRA, the OCC may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. The OCC is soliciting comment concerning renewal of its information collection titled, “Financial Management Policies—Interest Rate Risk,” which is applicable only to Federal savings associations.
Comments must be submitted on or before October 11, 2022.
Commenters are encouraged to submit comments by email, if possible. You may submit comments by any of the following methods:
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Following the close of this notice's 60-day comment period, the OCC will publish a second notice with a 30-day comment period. You may review comments and other related materials that pertain to this information collection beginning on the date of publication of the second notice for this collection by the method set forth in the next bullet.
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• For assistance in navigating
Shaquita Merritt, OCC Clearance Officer, (202) 649-5490 or, for persons who are deaf or hearing impaired, TTY, (202) 649-5597, Chief Counsel's Office, Office of the Comptroller of the Currency, 400 7th Street SW, Suite 3E-218, Washington, DC 20219.
Under the PRA (44 U.S.C. 3501
(a) Whether the collections of information are necessary for the proper performance of the OCC's functions, including whether the information has practical utility;
(b) The accuracy of the OCC's estimates of the burden of the information collections, including the validity of the methodology and assumptions used;
(c) Ways to enhance the quality, utility, and clarity of the information to be collected;
(d) Ways to minimize the burden of information collections on respondents, including through the use of automated collection techniques or other forms of information technology; and
(e) Estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.
August 18, 2022, 12:00 p.m. to 2:00 p.m., Eastern time.
This meeting will be accessible via conference call and via Zoom Meeting and Screenshare. Any interested person may call (i) 1-929-205-6099 (US Toll) or 1-669-900-6833 (US Toll) or (ii) 1-877-853-5247 (US Toll Free) or 1-888-788-0099 (US Toll Free), Meeting ID: 994 9030 9143, to listen and participate in this meeting. The website to participate via Zoom Meeting and Screenshare is
This meeting will be open to the public.
The Unified Carrier Registration Plan Education and Training Subcommittee (the “Subcommittee”) will continue its work
The Subcommittee Chair will welcome attendees, call the meeting to order, call roll for the Subcommittee, confirm whether a quorum is present, and facilitate self-introductions.
The UCR Executive Director will verify the publication of the meeting notice on the UCR website and distribution to the UCR contact list via email followed by the subsequent publication of the notice in the
The Subcommittee Agenda will be reviewed, and the Subcommittee will consider adoption.
Draft minutes from the June 23, 2022, Subcommittee meeting via teleconference will be reviewed. The Subcommittee will consider action to approve.
The Subcommittee Chair will provide an update on the Roadside Enforcement Module that describes the steps a roadside law enforcement officer would use to enforce UCR.
The Subcommittee Chair will discuss the UCR E-Certificate and review questions assigned to Subcommittee members.
The UCR Chief Staff Executive will discuss the UCR Volunteer Training Module.
The Subcommittee Chair will call for any other items Subcommittee members would like to discuss.
The Subcommittee Chair will adjourn the meeting.
The agenda will be available no later than 5:00 p.m. Eastern time, August 10, 2022 at:
Elizabeth Leaman, Chair, Unified Carrier Registration Plan Board of Directors, (617) 305-3783,
Securities and Exchange Commission.
Proposed rule.
The Securities and Exchange Commission (“Commission”) is re-proposing amendments to a rule under the Securities Exchange Act of 1934 (“Act” or “Exchange Act”) that exempts certain registered brokers or dealers from membership in a registered national securities association (“Association”). The re-proposed amendments would replace the rule's
Comments should be received on or before September 27, 2022.
Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
Studies, memoranda, or other substantive items may be added by the Commission or staff to the comment file during this rulemaking. A notification of the inclusion in the comment file of any such materials will be made available on the Commission's website. To ensure direct electronic receipt of such notifications, sign up through the “Stay Connected” option at
Michael Bradley, Assistant Director, at (202) 551-5594; David Michehl, Special Counsel, at (202) 551-5627; Nicholas Shwayri, Special Counsel, at (202) 551-5667; Vince Vuong, Special Counsel, at (202) 551-3742; or Mark Sater, Attorney-Advisor, at (202) 551-4729, Division of Trading and Markets, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-7010.
Section 15(b)(8) of the Act
The securities markets have evolved dramatically in the forty-plus years since the Commission adopted Rule 15b9-1. During that span, the securities markets have transformed from being floor-based to being mostly electronic, and registered dealers have emerged that engage in significant, computer-based, cross-market proprietary trading activity. Several proprietary trading firms that are registered dealers and exchange members are not members of an Association, in reliance on Rule 15b9-1. These firms may effect significant securities transaction volume elsewhere than on an exchange of which they are a member but are not subject to Association oversight.
Self-regulatory organization (“SRO”)
As a result, when broker-dealer firms that are not FINRA members effect securities transactions otherwise than on an exchange of which they are a member, such as off-exchange or on exchanges where they are not a member (collectively referred to herein as “off-member-exchange”),
In addition, SROs retain responsibility for regulatory oversight under the RSAs; however, RSAs are voluntary, privately negotiated agreements that can expire or be terminated, and accordingly, these agreements may not in the future provide the stability of FINRA oversight. Further, the Commission, of course, may bring enforcement actions, including pursuant to referrals made by SROs, to
The Commission adopted Rule 15b9-1 several decades ago so that an exchange member's limited proprietary trading activity ancillary to its exchange activity—which, at that time, typically was a floor business conducted on a single national securities exchange—would not necessitate Association membership in addition to exchange membership.
The evolution of the markets—since Rule 15b9-1 was adopted and since the Commission's proposed changes to Rule 15b9-1 in 2015—presents a need to realign Rule 15b9-1 with the current market so that the regulatory scheme more appropriately effectuates Exchange Act principles regarding complementary exchange SRO and Association oversight in today's market, including Section 15(b)(9)'s mandate that any exemption from Section 15(b)(8) be consistent with the public interest and protection of investors. Accordingly, the Commission is re-proposing amendments to Rule 15b9-1 that would rescind the
Self-regulation is a longstanding, key component of U.S. securities industry regulation.
This framework is embodied by several Exchange Act statutory provisions. When the Exchange Act was adopted in 1934, the exchanges were the only SROs and were charged with regulating the activities of their broker-dealer members. Congress soon recognized, however, that the benefit of exchange regulation could be undermined by the absence of a
Additional statutory provisions contemplate coordination of broker-dealer oversight among SROs. Section 19(g)(1) of the Exchange Act requires every SRO to examine for and enforce compliance by its members and associated persons with the Exchange Act, the rules and regulations thereunder, and the SRO's own rules, unless the SRO is relieved of this responsibility pursuant to Section 17(d) or Section 19(g)(2) of the Act.
FINRA, however, is primarily responsible for exercising SRO oversight over broker-dealers' off-member-exchange securities trading activities, such as when broker-dealers effect securities transactions across markets that include exchanges where they are not a member or the off-exchange market.
In addition, FINRA has rules that support a comprehensive public transparency regime with respect to off-exchange securities transactions. One element of this regime is the requirement that FINRA members report to FINRA all OTC Equity Security trades
In contrast to FINRA, the regulatory focus of national securities exchanges, which are also SROs, is generally on trading by their members on their respective exchanges.
In addition, exchanges have entered into 17d-2 plans that allocate to FINRA examination and enforcement responsibility relating to compliance by common members with Federal securities laws, Commission rules, and common exchange and FINRA rules, allowing the exchanges to focus on trading on their own markets. For example, under a 17d-2 plan for the allocation of regulatory responsibility relating to Regulation NMS rules, FINRA is responsible for overseeing and enforcing compliance with certain Regulation NMS rules by common members of FINRA and any exchange participant in the agreement, while each exchange retains responsibility for surveillance and enforcement with respect to trading activities or practices
In addition to regulatory coordination that occurs through 17d-2 plans and RSAs, SROs also coordinate regulatory efforts through forums provided by the Intermarket Surveillance Group (“ISG”). The ISG, created in 1981, is an international group of exchanges, market centers, and regulators that perform market surveillance in their respective jurisdictions.
The Commission originally adopted Rule 15b8-1 in 1965 (renumbered to Rule 15b9-1 in 1983 and generally referred to herein as Rule 15b9-1) to allow exchange specialists and other floor members to receive a portion of the commissions paid on occasional off-exchange transactions referred to other broker-dealers, up to a nominal amount.
Since that time, the securities markets have undergone a substantial transformation that has been driven primarily by rapid and ongoing evolution of technologies for generating, routing, and executing orders, and the impact of regulatory changes.
In fact, the large-scale proprietary trading that occurs in the securities markets today is not confined to equities and options. For example, there is significant automated proprietary trading in U.S. Treasury securities, which are not traded on any national securities exchange.
The Commission estimates that, as of the end of 2021, there were 66 firms that were Commission-registered broker-dealers and exchange members but not FINRA members, and that there were 65 such firms as of April 2022.
Several of these firms—both single-exchange and multiple-exchange members—engage in cross-market and off-exchange proprietary securities trading. These firms account for a significant portion of off-exchange securities trading volume and initiate a significant number of securities transactions on exchanges other than exchanges to which they belong as a member.
For example, of the estimated 66 broker-dealers that were exchange members but not FINRA members as of the end of 2021, 47 initiated orders in listed equities in September 2021 that were executed on or off an exchange.
Of the estimated 65 broker-dealers that were exchange members but not FINRA members as of April 2022, 43 initiated orders in listed equities in April 2022 that were executed on or off an exchange.
There is also a high degree of concentration of this volume among a subset of the identified firms. In this regard, the Commission estimates that, as of September 2021, 13 of the 47 identified firms that initiated orders in listed equities then accounted for approximately 9.3% of total off-exchange listed equities volume executed in September 2021 and 94% of the off-exchange listed equities transaction volume attributable to the 47 identified firms that month.
The Commission also estimates that, as of April 2022, 12 of the 43 identified firms that initiated orders in listed equities then accounted for approximately 4.25% of total off-exchange listed equities volume executed in April 2022 and 91.6% of the off-exchange listed equities transaction volume attributable to the 43 identified firms that month.
With respect to trading in U.S. Treasury securities, all of which occurs off-exchange,
Due to the evolution of the securities markets since Rule 15b9-1 was adopted, the Commission preliminarily believes that the rule's effect has become dislodged from the rule's intended purpose. The underlying presumption built into Rule 15b9-1's
Indeed, as reflected by the figures set forth above, some dealer firms are able to engage in substantial proprietary securities trading activity elsewhere than their member exchange(s) without becoming FINRA members, in reliance on Rule 15b9-1. These firms are not all subject to the same set of rules and interpretations, which can vary between exchanges. Importantly, FINRA has the expertise regarding off-exchange trading, but under the current regulatory structure underpinning Rule 15b9-1, for non-FINRA members that trade off-exchange and are members of different exchanges, FINRA applies the rules of the different exchanges using the exchanges' interpretations of those rules. This can result in different interpretations and FINRA registration would promote consistent interpretations and efficiencies in enforcement and regulation with respect to this growing part of the market. The rise in electronic proprietary trading and an increasingly fragmented market where trading takes place across many active markets have put pressure on the status quo and presented a need for there to be more consistent regulation of such trading. As a result, the Commission preliminarily believes that the exemption from FINRA oversight provided by Rule 15b9-1 should be limited.
In particular, there are Federal securities laws, Commission rules, and SRO rules that prohibit various forms of improper activity by broker-dealers.
In this regard, exchange SROs and FINRA are able to perform cross-market surveillance of trading activity in NMS and OTC securities using the Consolidated Audit Trail (“CAT”) data.
Exchange SROs and FINRA also have entered into 17d-2 plans
The Commission therefore understands FINRA's cross-market regulatory program for equities and options relies on RSAs insofar as it covers broker-dealers that are not FINRA members.
Further, the continued availability of the Rule 15b9-1 exemption from Association membership detracts from FINRA's off-exchange securities transaction reporting regime, and in particular, TRACE reporting for U.S. Treasury securities transactions. The “covered ATS” U.S. Treasury security volumes set forth above may not capture
Accordingly, the Commission is proposing to update Rule 15b9-1 such that proprietary trading firms that are registered broker-dealers generally must join FINRA, pursuant to Section 15(b)(8) of the Act, if they effect securities transactions otherwise than on an exchange of which they are a member. The Commission preliminarily believes that amending Rule 15b9-1 so that broker-dealer proprietary trading firms generally would be required to join FINRA if they trade elsewhere than on an exchange where they are a member would address the above-described issues by subjecting such firms to FINRA's direct, membership-based jurisdiction and rules, including FINRA's TRACE reporting regime for U.S. Treasury security transactions. This would be consistent with the Exchange Act's statutory framework for complementary exchange SRO and Association oversight of broker-dealer trading activity, in which Section 15(b)(8) requires broker-dealers to join an Association if they effect securities transactions elsewhere than an exchange where they are a member. Amending Rule 15b9-1 in this way also would modernize the rule in a manner that is consistent with how proprietary trading occurs today and that promotes Section 15(b)(9)'s requirement that any exemption from Section 15(b)(8) be consistent with the public interest and protection of investors. The Commission believes that direct, membership-based FINRA oversight over and the application of FINRA's securities transaction reporting requirements to firms that effect off-member-exchange securities transactions would create more effective SRO oversight over their off-member-exchange securities trading activity and therefore promote the protection of investors and the public interest.
As discussed above,
The Commission requests comment on all aspects of the foregoing background discussion as well as, in particular, on the following questions:
1. Is the Commission's estimate of the number of broker-dealers that are exchange members but not FINRA members still accurate as of the time of publication of this re-proposal? Is it too high or too low? Are there broker-dealers that were not FINRA members as of April 2022 that have since joined FINRA? Please explain.
2. Are the Commission's estimates of the securities transaction volumes attributable to non-FINRA member broker-dealers accurate? If not, why are they inaccurate? Are there any uncertainties associated with such estimates?
3. Do exchange SROs directly exercise their SRO authority with respect to off-member-exchange securities trading activity by their members? If so, how have exchange SROs exercised their authority in this regard? In particular, how, if at all, have exchange SROs sought to exercise SRO authority over off-member-exchange securities trading activity conducted by their broker-dealer members that are not FINRA members? Have exchange SROs sought to exercise authority over U.S. Treasury securities trading activity by their members? Please explain and provide examples, if possible.
4. Do RSAs or other cooperative arrangements among SROs cover the
5. Is the Commission's understanding correct that FINRA's cross-market regulatory program for equities and options is based on RSAs insofar as it covers broker-dealers that are not FINRA members? If not, how are broker-dealers that are not FINRA members covered?
The Commission previously proposed to amend Rule 15b9-1 in March 2015.
As a general matter, the result under the amended version of Rule 15b9-1 being proposed today would be the same as under the 2015 Proposal: a broker or dealer would be required to join an Association if it effects transactions in securities elsewhere than on an exchange to which it belongs as a member, unless it can rely upon one of the amended rule's narrow exceptions.
As noted above, Rule 15b9-1 currently exempts any broker or dealer from membership in an Association if it is a member of a national securities exchange, carries no customer accounts, and has annual gross income of no more than $1,000 that is derived from purchases or sales of securities effected otherwise than on an exchange of which it is a member.
The Commission is proposing to eliminate the
As in the 2015 Proposal, today the Commission is re-proposing to delete paragraphs (a)(3) and (b) from Rule
Some commenters on the 2015 Proposal questioned the necessity and appropriateness of the expanded FINRA oversight that would result from the then-proposed elimination of the
The Commission continues to believe, however, that in today's market the
Rule 15b9-1's stasis notwithstanding the market's transformation has led to a misalignment in the complementary regulatory structure contemplated by Congress since FINRA does not have direct, membership-based jurisdiction over off-member-exchange securities trading activity by broker-dealers that are not FINRA members. The Exchange Act established the concept of an Association as the regulator of such trading activity,
Contrary to certain commenters' suggestion that FINRA oversight of proprietary trading firms is not necessary since they do not carry customer accounts, FINRA has established a regulatory regime for broker-dealers that effect off-member-exchange securities transactions that applies to FINRA members regardless of whether they handle customer orders or carry customer accounts. For example, FINRA has developed a detailed set of rules in core areas such as trading practices,
In addition, an Association's regulatory responsibility, like exchange SROs', includes an obligation to monitor for operational and regulatory issues, as well as issues relating to market disruptions.
Moreover, contrary to commenters' assertions, the Commission does not preliminarily believe that exchange oversight alone would be more effective at remedying the above-described issues than direct FINRA oversight of off-member-exchange securities trading activity through the Association membership envisioned by Congress, or that FINRA membership would result in duplicative regulation for broker-dealer proprietary trading firms. The imposition of FINRA rules on such firms would require them to report their U.S. Treasury securities transactions under FINRA's TRACE reporting regime. It also would require that such firms be identified in off-exchange NMS stock transaction reports to FINRA's TRFs,
Some commenters on the 2015 Proposal also contended that the availability of CAT data would mitigate the need to subject proprietary trading firms to FINRA SRO oversight.
As is discussed in more detail in the Economic Analysis, firms that must become FINRA members would become subject to the fees charged by FINRA to all of its member firms. FINRA charges each member firm certain regulatory fees designed to recover the costs to FINRA of the supervision and regulation of members, including performing examinations, financial monitoring, and policy, rulemaking, interpretive, and enforcement activities.
Shortly after the Commission published the 2015 Proposal, FINRA issued a Regulatory Notice proposing to amend the TAF such that it would not apply to transactions by a proprietary trading firm effected on exchanges of which the firm is a member.
On March 28, 2022, the Commission proposed changes to the definition of “dealer” and “government securities dealer,” within the meaning of Sections 3(a)(5) and 3(a)(44) of the Exchange Act, respectively.
The Commission requests comment on all aspects of the proposed elimination of the
6. Are there exchange floor members that currently rely on the $1,000
7. Should the Commission retain the
8. Instead of eliminating the proprietary trading exclusion, should the Commission retain a modified version of it? If so, how should it be modified and why? How could the proprietary trading exclusion be modified such that there is appropriate and comprehensive SRO oversight of firms that trade securities otherwise than on an exchange of which they are member and that trading activity? For example, could the proprietary trading exclusion be modified such that a firm's reliance on it is contingent on the firm reporting its off-exchange securities transactions to the appropriate FINRA facility or TRACE? Would this suffice to enable the Commission to achieve the goals expressed herein, despite not providing FINRA with direct regulatory oversight of the firms?
9. If the
10. To what extent do dealer firms that are not FINRA members and that trade securities otherwise than on an exchange of which they are a member rely on the proprietary trading exclusion? Where, other than an exchange where they are a member, do they typically effect securities transactions? On ATSs? Off-exchange otherwise than on an ATS? Another exchange where they are not a member? In what sort of dealer activity do these firms engage? For example, do they typically provide liquidity or make markets? Do they typically remove liquidity? Do they engage in other types of trading activities?
11. If the
12. Do commenters agree that some exchange member dealer firms trade proprietarily in U.S. Treasury securities as well as exchange-traded securities, and are not FINRA members in reliance on the proprietary trading exclusion? If the
13. Do commenters believe that most exchange member dealer firms that effect proprietary securities transactions otherwise than on an exchange of which they are member would need to join FINRA as a result of the elimination of the
14. How do exchange SROs currently surveil or regulate their members' securities trading activity and conduct elsewhere than the exchange? Do exchange SRO efforts in this regard mitigate any need to rescind the
15. Are there concerns regarding how the TAF would apply to proprietary trading broker-dealer firms?
16. Are there concerns regarding the applicability of certain FINRA rules to solely proprietary trading broker-dealers, as opposed to those who face customers? Which rules, and why? Are there benefits to applying FINRA rules to these broker-dealers?
The Commission is proposing to add to Rule 15b9-1 a new paragraph (c) that would set forth two narrow circumstances in which a broker or dealer could continue to be exempt from Section 15(b)(8)'s Association
In paragraph (c)(1) of Rule 15b9-1, the Commission proposes to provide an exemption from Association membership if a broker or dealer that meets the criteria of paragraphs (a) and (b) of the rule effects transactions in securities otherwise than on a national securities exchange of which it is a member that result solely from orders that are routed by a national securities exchange of which it is a member to comply with Rule 611 of Regulation NMS
The ITS Plan required each participant to provide electronic access to its displayed best bid and offer, and provided an electronic mechanism for routing orders, called commitments to trade, to access those displayed prices.
Today, Rule 611 of Regulation NMS requires trading centers, such as national securities exchanges, to establish, maintain, and enforce written policies and procedures reasonably designed to prevent trade-throughs in exchange-listed stocks, subject to certain exceptions.
The proposed rule would continue to accommodate securities transactions away from a broker's or dealer's member exchange(s) that are to comply with these regulatory requirements. An exchange member may at times seek to effect a securities transaction on that exchange at a price that would trade through a protected quotation displayed on another trading center, such as another exchange or FINRA's ADF. In such a case, the exchange may route the member's order (if the exchange does not reject it), through a routing broker-dealer, to that other trading center to access the protected quotation. Moreover, if, for example, an ATS were to display a protected quotation on FINRA's ADF, absent the proposed exemption, a broker or dealer would have to join FINRA in order to have access to all protected quotations, even if the broker or dealer already is a member of every exchange on which it effects securities transactions.
In essence, a broker or dealer may, as a necessary part of its business trading on exchanges of which it is a member and in light of today's market structure, effect securities transactions elsewhere than an exchange where it is a member solely as a consequence of routing by its member exchange(s) to comply with the requirements of Rule 611 of Regulation NMS or the Options Linkage Plan. The proposed rule would not require Association membership as a result of such transactions. On the contrary, it
The Commission also believes that it would be consistent with the protection of investors and the public interest to permit reliance on this exemption only where the routing is performed by a national securities exchange of which the broker or dealer is a member. This limitation would help ensure that the broker's or dealer's member exchange has visibility into these routing transactions and thus is better able to provide effective SRO oversight of its member's activity that is related to its trading on the exchange and may not be overseen by another SRO if the member is exempt from Association membership under amended Rule 15b9-1.
A commenter on the 2015 Proposal sought clarity as to whether the exemption would apply to routing broker-dealers that are affiliated with national securities exchanges that are used by exchanges to conduct routing to other trading centers.
The Commission requests comment on all aspects of the proposed routing exemption in amended Rule 15b9-1. In particular, the Commission seeks responses to the following questions:
17. What are commenters' views on the proposed routing exemption? How, if at all, should the proposed routing exemption be modified?
18. Is the scope of the proposed routing exemption sufficient to provide relief for all securities transactions effected elsewhere than on an exchange of which a broker or dealer is a member that might be effected to comply with Rule 611 of Regulation NMS and the Options Linkage Plan? If not, how should it be changed?
19. Should the proposed routing exemption be broadened to cover transactions beyond those that are to comply with Rule 611 of Regulation NMS and the Options Linkage Plan? If so, what types of additional transactions should be covered and why? For example, should the proposed routing exemption be broadened such that it covers routing by an exchange for any purpose and pursuant to any of the exchange's available routing functionalities? Should the proposed routing exemption be narrowed so that it does not cover transactions to comply with Rule 611 or the Options Linkage Plan? Should the proposed routing exemption be eliminated in its entirety?
20. Are there other off-exchange transactions that a broker or dealer might effect in order to comply with regulatory requirements? If so, please describe those transactions and the relevant regulatory requirements. Should there be an exemption in amended Rule 15b9-1 that applies to any such transactions?
21. Should the proposed routing exemption also cover broker-dealer routing to access protected quotations without using the member exchange's routing mechanisms? Why or why not?
22. As discussed above, the Commission preliminarily believes that
In paragraph (c)(2) of amended Rule 15b9-1, the Commission proposes to provide an exemption from Association membership if a broker or dealer that meets the criteria of paragraphs (a) and (b) of the rule effects transactions in securities otherwise than on a national securities exchange of which it is a member, with or through another registered broker or dealer, that are solely for the purpose of executing the stock leg of a stock-option order.
The Commission understands that there are firms that trade stock-option orders whose business is focused on one or more options exchanges of which they are a member, and whose trading elsewhere is primarily to effect the execution of stock orders to facilitate their stock-option order business. In the Commission's preliminary view, these firms' stock trading activity is for a limited purpose and ancillary to their primary business handling stock-option orders on an options exchange of which they are member. As discussed below, there is a close link between the stock component transaction of a stock-option order and the relevant options exchange. As such, the proposed rule would permit these types of firms to continue their stock-option order trading business without being required to join stock exchanges or an Association solely in order to effect the execution of the stock legs of stock-option orders that they handle.
As noted above, the Commission estimates that, in 2021, 50 of the 66 firms identified as registered broker-dealers and exchange members but not FINRA members initiated options order executions.
Options exchanges define the term “stock-option order” in their rules.
Relying on the options exchange's definition also should enhance an exchange's ability to monitor whether its members are appropriately relying on the proposed exemption and thereby enhance its ability to provide effective SRO oversight of its members' stock-option order trading activity. Under options exchange rules, an exchange member submitting a stock-option order to the exchange must designate to the exchange one or more specific broker-dealers: (i) that are not affiliated with the exchange; (ii) with which the exchange member has entered into a brokerage agreement; (iii) that the exchange has identified as having connectivity to electronically communicate the stock components of stock-option orders to stock trading venues; and (iv) to which the exchange will electronically communicate the stock component of the stock-option order on behalf of the member.
The Commission preliminarily believes that the exchange's oversight capabilities will be further enhanced, consistent with the public interest and protection of investors, by requiring written policies and procedures in connection with the stock-option exemption in proposed paragraph (c)(2) of the amended rule. This requirement would help facilitate exchange SRO supervision of brokers and dealers relying on the stock-option order exemption because it would provide an efficient and effective way for the relevant options exchange to assess compliance with the proposed exemption. Moreover, the Commission preliminarily believes that requiring brokers and dealers to develop written policies and procedures would provide sufficient flexibility to accommodate potentially varying business models of brokers and dealers that effect stock-option orders and may seek to rely on this exemption.
Such written policies and procedures must be reasonably designed to ensure and demonstrate that the broker's or dealer's securities transactions elsewhere than on an exchange of which it is a member are solely for the purpose of executing the stock leg of a stock-option order. Accordingly, a broker or dealer seeking to rely upon the proposed stock-option order exemption must establish, maintain, and enforce written policies and procedures reasonably designed to ensure and demonstrate that such transactions are solely for the purpose of executing the stock leg of a stock-option order. For example, the broker or dealer could maintain documentation that demonstrates its compliance with the stock-option order requirements of any options exchange of which it is a member and where it effects the execution of stock-option orders. Indeed, in addition to the Commission, the options exchange of which the broker or dealer is a member and where the stock-option order is handled would be able to enforce compliance with the stock-option order exemption. In the context of routine examinations of its members, the options exchange generally would review the adequacy of its members' written policies and procedures and assess whether its members' off-member-exchange transactions comply with those written policies and procedures as well as the terms of the exemption itself, as set forth in amended Rule 15b9-1.
Finally, a broker or dealer seeking to rely on the stock-option order exemption would be required to preserve a copy of its policies and procedures in a manner consistent with Rule 17a-4 under the Exchange Act until three years after the date the policies and procedures are replaced with updated policies and procedures.
The Commission requests comment on all aspects of the proposed stock-option order exemption in Rule 15b9-1. In particular, the Commission seeks responses to the following questions:
23. Is the proposed stock-option order exemption necessary and appropriate? Why or why not? How, if at all, should this proposed exemption be modified?
24. Is the scope of the proposed stock-option order exemption sufficient to provide for all off-member-exchange transactions that might be effected by a broker or dealer as a necessary component of handling stock-option orders? If not, how should it be changed?
25. Should the proposed stock-option order exemption be broadened to cover transactions beyond those necessary to complete stock-option orders? If so, what types of additional transactions should be covered and why? Should the proposed exemption be narrowed in some way? Should the proposed stock-option order exemption be eliminated in its entirety?
26. Is the Commission's understanding correct that all stock-option orders must be QCTs? If not, what types of stock-option orders are not required to be QCTs? Should they be covered by the proposed exemption?
27. The proposed stock-option order exemption is limited to transactions
28. Stock transactions effected in reliance on the exemption would still be subject to required transaction reporting. Would such reliance impede required transaction reporting in any way?
29. As proposed, the stock-option order exemption would cover stock-option orders with one stock leg and any number of options legs. Is this appropriate? Should the proposed stock-option order exemption be limited to two-leg stock-option orders where one leg is a stock and the other leg is an option? Why or why not? Do firms execute stock-option orders that contain multiple stock legs? If so, should the stock legs of such stock-option orders be covered by the proposed exemption?
As discussed above, the Commission adopted Rule 15b9-1 so that an exchange member's limited trading activity ancillary to its floor business on a single national securities exchange would not necessitate Association membership in addition to exchange membership.
Unlike today's proposed amendments, the 2015 Proposal would have provided an exemption from Association membership for a dealer that is an exchange member, carries no customer accounts, conducts business on the floor of a national securities exchange, and effects transactions off the exchange, for the dealer's own account with or through another registered broker or dealer, that are solely for the purpose of hedging the risks of its floor-based activity.
Some commenters supported the proposed hedging exemption in the 2015 Proposal, but suggested that the exemption should not be limited to a dealer operating solely on a physical exchange floor, and also should cover off-member-exchange hedging transactions by dealers that trade electronically on their member exchange(s).
Commenters more broadly suggested that the 2015 Proposal did not adequately consider options market makers or their hedging needs.
The Commission requests comment on its re-proposed approach of not providing a hedging exemption in amended Rule 15b9-1. In particular, the Commission seeks responses to the following questions:
30. Should the Commission adopt a hedging exemption outside the context of the proposed stock-option order exemption? Why or why not? Would it be apparent whether a securities transaction is for hedging purposes?
31. Should the Commission adopt a hedging exemption (in addition to the proposed stock-option order exemption) that applies to a dealer that is a member of multiple exchanges? Why or why not? Should the Commission allow firms to rely on any such exemption only if they effect hedging transactions in securities on exchanges where they are not a member (
32. Should the Commission adopt a hedging exemption that covers off-member-exchange transactions to hedge on-member-exchange electronic transactions and physical exchange floor transactions, just on-member-exchange physical exchange floor transactions or just on-member-exchange electronic transactions? Why would one of these possible approaches be preferable to another? Under each possible approach, how difficult would it be to discern what off-member-exchange securities transactions by electronic trading firms are for hedging purposes? The Commission specifically seeks data that demonstrates the extent to which exchange member dealer firms trade elsewhere than on their member exchange(s) in order to hedge the risks of their trading activities on their member exchange(s).
33. Are there non-floor-based exchange members that today focus their business activities on a single exchange? Are there floor-based exchange members that today focus their business activities on a single exchange? If so, what is the nature of each firm's business activities?
34. Should the Commission adopt a hedging exemption in the amended rule that requires a dealer seeking to rely on the exemption to establish, maintain, and enforce written policies and procedures reasonably designed to ensure and demonstrate that its off-member-exchange hedging transactions reduce or otherwise mitigate the risks of the financial exposure the dealer incurs as a result of its on-member-exchange activity? Why or why not? What would be the costs of establishing, maintaining, and enforcing the policies and procedures, and any related record-keeping requirements? How are such costs determined? Please provide evidence of the nature, timing, and extent of such costs. Would such costs deter dealers from relying on the hedging exemption? Are there more efficient and effective alternatives to a policies and procedures approach? If so, what are they? Please describe in detail.
35. Would current exchange surveillance and enforcement mechanisms be effective to monitor off-member-exchange trades that would be executed pursuant to a possible hedging exemption? Could this be accomplished through 17d-2 plans and RSAs? Please explain. Would exchanges otherwise have the ability to assess dealers' compliance with a hedging exemption? If not, should the Commission require additional reporting by registered broker-dealers acting as an agent for dealers relying on a hedging exemption? Please explain.
36. Should the Commission adopt a hedging exemption that is subject to quantitative limits on the volume of hedging transactions that a firm may execute in reliance on such an exemption? Could qualitative or quantitative requirements assist in identifying off-member-exchange activity that is solely for the purpose of hedging? Please explain.
37. Should the Commission adopt a hedging exemption that requires the exchange member to retain records demonstrating how each off-member-exchange transaction complies with its policies and procedures? Why or why not? What would be the associated costs, and what is the basis for those costs? Would the cost associated with recordkeeping on a transaction-by-transaction basis be overly burdensome, impractical, or unnecessary?
38. Should the Commission adopt a hedging exemption that requires dealers to make a certification in connection with their reliance on the hedging exemption? Why or why not? If a certification should be required, what would be the key elements thereof? How frequently should the certification be made? Who should make it? What qualifications, if any, to such certification might be appropriate? For example, should firms be required to certify that they have a reasonable basis to believe that they are in compliance with a hedging exemption? Or should they be required to make such a certification to the best of their knowledge? Is there a different standard that would be appropriate? Should the certification be made in conjunction with an internal compliance review? If so, what type of internal compliance review should be conducted?
39. Would not adopting a hedging exemption affect liquidity on any national securities exchange?
The Commission recognizes that firms may need time to comply with any amended Rule 15b9-1 if adopted. In particular, they may need time to become a member of an Association. As noted previously, FINRA is currently the only Association. To become a FINRA member, a broker or dealer must complete FINRA's New Member Application and participate in a pre-membership interview.
Alternatively, broker-dealer firms that currently rely on Rule 15b9-1 and carry no customer accounts may choose to adjust their business model or
The Commission preliminarily believes that one year after publication in the
40. Would one year after publication of any final rule in the
41. Would one year after publication of any final rule in the
42. How long is the registration process with FINRA typically? How long would it take FINRA to process new membership applications from firms that join FINRA as a result of the proposed amendments, considering that many such firms may submit applications close in time to each other? Please include the estimated time to prepare the application as well as the estimated time for FINRA to process the application.
43. How long does it typically take to complete the application process with a national securities exchange? Please include the estimated time to prepare the application as well as the estimated time for an exchange to process the application.
44. To the extent a firm intends to rely on one or more of the exemptions in the amended rule, how long would it take such firm to make the required systems changes to comply? Are there other steps that would need to be taken to achieve compliance? If so, what is the estimated time to accomplish those steps? How long would it take a firm to establish the policies and procedures that would be necessary to rely on the stock-option order exemption?
45. To the extent a firm intends to adjust its business model or organizational structure such that it effects securities transactions only on an exchange of which it is a member, how long would it take such firm to make such an adjustment? What systems or other changes would be required?
The Commission seeks comment on all aspects of the proposed amendments to Rule 15b9-1. Commenters should, when possible, provide the Commission with data to support their views. Commenters suggesting alternative approaches should provide comprehensive proposals, including any conditions or limitations that they believe should apply, the reasons for their suggested approaches, and their analysis regarding why their suggested approaches would satisfy the objectives of the proposed amendments.
46. The Commission requests comment generally on whether the proposed amendments to Rule 15b9-1 are appropriate. How, if at all, should the proposed amendments be modified? Should either of the proposed exemptions from Association membership set forth in proposed paragraphs (c)(1) and (c)(2) of the amended rule be eliminated? If so, why? For example, should the Commission maintain the proposed routing exemption, but not maintain the proposed stock-option order exemption? Why or why not? Should the Commission maintain the proposed stock-option order exemption, but not the routing exemption? Why or why not?
47. Should the Commission eliminate Rule15b9-1 in its entirety, such that there is no exemption from Section 15(b)(8) of the Act? Broker-dealers would then be statutorily required by Section 15(b)(8) of the Act, without exception, to join an Association if they effect securities transactions otherwise than on an exchange where they are a member. In other words, a broker-dealer that effects transactions in securities otherwise than on an exchange of which it is a member would have to join FINRA even if its transactions result solely from orders that are routed by an exchange of which it is a member to comply with order protection requirements or are solely for the purpose of executing the stock leg of a stock-option order. What would be the benefits or drawbacks of eliminating Rule 15b9-1 in its entirety? Please explain.
48. Should the Commission amend Rule 15b9-1 to capture only those broker-dealers that are exchange members but not FINRA members that account for the high degree of concentration of off-exchange listed equities volume? For example, the Commission estimates that, as of September 2021, 13 of the 47 identified firms that initiated orders in listed equities then accounted for approximately 94% of the off-exchange listed equities transaction volume attributable to the 47 identified firms that month. If so, what methodology should be used to select the most significant firms?
49. Other than the proposed routing exemption and stock-option order
50. How might dealers that currently rely on Rule 15b9-1's
51. Reliance on Rule 15b9-1 is currently self-effecting (
52. If the Commission were to eliminate Rule 15b9-1 altogether, how many broker-dealers would: (i) effect securities transactions only on national securities exchanges of which they are already member; (ii) become members of additional national securities exchanges such that they are not required to join an Association; and/or (iii) become members of an Association?
53 Would the proposed amendments have an effect on market liquidity? If so, please estimate that effect. Would there be any deleterious impacts on market quality? Would there be positive impacts on market liquidity or market quality more broadly?
54. Should the Commission allow broker-dealers that are a member of an exchange and conduct off-exchange trading activity to remain exempt from membership in an Association? If so, why? Should the level of off-exchange activity affect the ability of a firm to be exempt from Association membership? Why or why not?
55. Does the CAT plan mitigate the need for the proposed amendments to Rule 15b9-1? If so, how? Would it be appropriate and feasible to modify CAT reporting to accomplish any of the goals of amended Rule 15b9-1?
56. Do existing 17d-2 plans and RSAs among SROs mitigate the need for the proposed amendments to Rule 15b9-1? If so, how? Do commenters agree that RSAs are subject to change and may not in the future provide the stability of FINRA oversight? How frequently are RSAs typically renegotiated?
57. Is Association membership an efficient or effective approach for the regulation of firms that trade across multiple exchanges but do not trade off-exchange? Are there more effective alternatives?
58. Under the proposed amendments to Rule 15b9-1, a broker-dealer that does not effect securities transactions off an exchange, but currently effects securities transactions on an exchange of which it is not a member, would be required either to join an Association or become a member of each exchange where it effects securities transactions, unless its exchange trading is covered by an exemption in the proposed amended rule. Should the proposed amendments be revised to provide an exemption from Section 15(b)(8) of the Act to permit such a firm, with no off-exchange trading, to remain exempt from membership in an Association and continue trading on exchanges of which it is not a member even if that trading activity would not satisfy one of the proposed exemptions in the amended rule? Should any such approach be based on certain conditions being met, such as any exchange of which the firm is a member entering into appropriate contractual or self-regulatory responsibility sharing arrangements such that an exchange SRO is in a position to effectively surveil all of the trading activities of that firm?
59. If the proposed rule amendments are adopted, proprietary trading broker-dealers that are not currently FINRA members may join FINRA. Would this affect FINRA's governance or its performance of its regulatory or supervisory functions?
60. Are there other changes the Commission should make to Rule 15b9-1? If so, why? What specifically should be changed and how? How would any such changes better achieve the stated goals of the proposal?
The Commission is proposing to amend Rule 15b9-1 to re-align it with today's market so that the regulatory scheme more appropriately effectuates Exchange Act principles regarding complementary exchange SRO and Association oversight. Currently, a broker or dealer may engage in unlimited proprietary trading in the off-exchange market without becoming a member of an Association, so long as its proprietary trading activity is conducted with or through another registered broker or dealer.
However, the Exchange Act's statutory framework places SRO oversight responsibility with an Association for trading that occurs elsewhere than on an exchange to which a broker or dealer belongs as a member.
In the case of U.S. Treasury securities and other fixed income securities (other than municipal bonds)
The Exchange Act presents exchange SROs and Associations as complements, providing for member-based supervision both on and off-exchange. The proposed amendments would rescind the
The Commission discusses below a number of economic effects that are likely to result from the proposed amendments.
The Exchange Act governs the way in which the U.S. securities markets and its brokers and dealers operate. Section 3(a)(4)(A) of the Act generally defines a “broker” broadly as “any person engaged in the business of effecting transactions in securities for the account of others.”
Generally, any broker-dealer that wants to interact directly on a securities exchange must register with the Commission as a broker-dealer before applying to gain direct access to the exchange.
Most brokers and dealers are small, with 66% of brokers and dealers employing 15 or fewer associated persons and only 10% of brokers and dealers employing over 100 associated persons.
The Commission has identified 65 firms that, as of April 2022, were Commission registered broker-dealers and exchange members, but not members of FINRA, that may be required to either join an Association or change their trading practices under the proposed amendments.
In September 2021, there were 66 registered broker-dealers that were exchange members but not FINRA members.
FINRA members are required to report transactions in TRACE-eligible securities. Market participants can gain real-time access to TRACE through market vendors, for most TRACE-eligible securities, with a few exceptions including U.S. Treasury securities.
In September 2021, of the 66 non-FINRA member firms, 47 initiated equity orders that were not executed on an exchange, accounting for $789 billion (approximately 9.8%) in off-exchange traded dollar volume in listed equities.
There is significant diversity in the business models of non-FINRA member firms. Some non-FINRA member firms may limit their equity trading to a single exchange, while others trade on multiple venues including off-exchange venues such as ATSs. Some firms are significant contributors to both off-exchange and exchange volume. Because CAT requires reporting of all NMS stock trades, including off-exchange trades, FINRA and the Commission are able to quantify the aggregate off-exchange activity of non-FINRA member firms.
Off-exchange equity trading occurs across many trading venues. In quarter 3 of 2021, 32 ATSs actively traded NMS stocks, comprising 9.6% of NMS stock share volume. Furthermore, 187 named
While some non-FINRA member firms trade actively off-exchange, some of these firms also supply and demand liquidity actively on multiple equity and options exchanges. Table 1 below shows the executed dollar volume in listed equities by trading venue type during September 2021 and April 2022 for the non-FINRA member firms. Table 2 below shows the executed dollar volume, number of trades, and number of contracts in options during September 2021 and April 2022 for the non-FINRA member firms.
Table 1 shows that the majority of non-FINRA member firms executed listed equity orders (approximately 75%) on exchanges where the firm was a registered member. However, they also transacted on exchanges where the firm was not a member in addition to trading off-exchange. Table 2 shows the number of non-FINRA member firms that also executed trades in the options market and the total dollar, trades, and contract volume. In September 2021, forty-two non-FINRA member firms and nine of the 13 largest firms executed trades on options exchanges. Eight of the nine largest firms executed trades on seven or more options exchanges. In April 2022, 35 non-FINRA member firms and nine of the 12 largest firms executed trades on options exchanges.
The surveillance and regulation of each broker or dealer is partially dependent upon its individual SRO membership status. Each SRO is required to examine for and enforce compliance by its members and associated persons with the Exchange Act, the rules and regulations thereunder, and the SRO's own rules, including, for exchange SROs, the rules on the trading that occurs on the exchange it oversees. Because of this, SROs that oversee an exchange generally possess expertise in regulating members who specialize in trading on their exchange and in using the order types that may be unique or specialized within the exchange. This expertise complements the expertise of an Association in supervising cross-exchange and off-exchange trading activity.
While all exchanges are SROs and have access to CAT data covering trading activity by their members both on and off exchanges, currently nearly all equity activity and much options activity of non-FINRA member broker-dealers is surveilled by FINRA through the RSAs with exchange SROs. However, RSAs are voluntary, privately negotiated agreements that can expire or be terminated, and accordingly, these agreements may not in the future provide the consistency and stability of direct FINRA oversight. U.S. Treasury security trading and other fixed income trading,
Some exchanges serve as DEA for certain of their members.
All registered brokers and dealers are required to join an Association unless they effect transactions in securities solely on a national securities exchange of which they are a member or are
The existing Association, FINRA, serves crucial functions in the current regulatory structure.
Additionally, despite the fact that FINRA does not have the authority to monitor non-FINRA member firms that are not covered by RSA or 17d-2 plans that include these services, the Commission understands that FINRA operates a cross-market regulatory program that covers 100% of equity trades and 45% of option trading.
Currently, some non-FINRA member firms transact heavily in the course of normal business activities within venues regulated by SROs of which they are not members. This activity is not limited to equities; non-FINRA member firms play a large role in U.S. Treasury securities markets as well.
This is very different from when Rule 15b9-1 was first adopted. The Act provides for regulation of exchange trading by the exchanges themselves; it further generally provides for supervision of off-exchange trading by an Association.
SRO rules require their members to report CAT data daily.
Because non-FINRA member firms are not required to join an Association if they qualify for an exemption, they are not required to pay the costs of Association membership, which could be significant, especially for non-FINRA member firms with substantial trading activity. FINRA members currently pay fees associated with FINRA membership including the annual Gross Income Assessment (GIA), the annual personnel assessment; and the TAF and Section 3 fees.
The FINRA Section 3 fee is the second of two primary FINRA fees (the other being TAF) that are assessed upon each off-exchange sale by or through a FINRA member. Under Section 31 of the Act,
The market for liquidity provision on equity exchanges is competitive. In September 2021 across all exchanges, each equity security had between 1 to 47 registered market makers providing liquidity. The median equity security had 3 registered market makers, and 75% of securities had 2 or more registered market makers. Twenty-five percent of equity securities had 6 or more registered market makers. Additionally, while the number of market makers provides a good indication as to the number of firms in the business of providing liquidity, it does not necessarily indicate whether each market maker is an active competitor. However, the Commission believes that many market makers actively compete to provide liquidity.
As stated above, non-FINRA member firms do not have the same regulatory costs as FINRA member firms, which may give non-FINRA member firms a competitive advantage in providing liquidity. As such, non-FINRA member firms may be able to provide liquidity at a lower cost than FINRA member firms given that non-FINRA member firms have a lower variable cost, all else equal, for trading compared to FINRA member firms.
The Commission believes that non-FINRA member firms are active participants in the market to provide liquidity in off-exchange markets. The Commission estimates that non-FINRA member firms account for between 4.6% and 9.8% of off-exchange dollar volume in equities. Additionally, nearly 10% of all non-FINRA member equity trading activity occurs in off-exchange markets. In U.S. Treasury securities markets, non-FINRA member firms trading activity that is reported by covered ATSs account for 2.5% of all transaction volume.
In addition to the specific, individual benefits and costs discussed below, the Commission expects the amendments may have varying effects on efficiency, competition, and capital formation. These effects are described in this section. The proposal may result in improved efficiency of capital allocation. To the extent that liquidity provision changes as a result of the proposal, market efficiency might be impacted. Additionally, the proposal would have mixed effects on competition to provide liquidity, as current non-FINRA member firms may be less likely to provide liquidity but current FINRA members may be more likely to provide liquidity. The Commission believes that the amendments would not likely have a meaningful effect on capital formation.
Although non-FINRA member firms could seek to comply with the amendments in multiple ways, each route could involve changes to firms' business models. Some non-FINRA member firms may limit their trading to exchanges of which they are members, and the Commission believes that some may not trade off-exchange other than to comply with Rule 611 of Regulation NMS or the Options Linkage Plan,
The changes non-FINRA member firms make to their business model to comply with the amendments may affect competition in the equity and U.S. Treasury securities markets, particularly for off-exchange liquidity provision. Non-FINRA member firms may be less willing to compete to provide liquidity off-exchange, decreasing off-exchange liquidity. For example, non-FINRA member firms may choose to cease their off-exchange activity rather than join an Association—although it is likely that firms that trade heavily in the off-exchange market may find it more costly to cease their off-exchange activity than to join an Association.
The Commission preliminarily believes that requiring membership in an Association, consistent with Rule 15b9-1, could facilitate an appropriate level of oversight. The Commission also recognizes that the loss of liquidity provision in off-exchange trading may impose costs on investors in the form of higher trading costs than they would otherwise realize. These effects may differ across asset classes. In the case of non-FINRA member broker-dealers trading U.S. Treasury securities, costs to join an Association include the costs of establishing TRACE reporting. Depending on the firm's activity level in that market, firms may be more likely to withdraw from that market if their anticipated profit levels from U.S. Treasury securities trading do not justify the additional reporting requirements. The impact on liquidity in U.S. Treasury securities markets is not likely to significantly impact investor costs to trade these securities because U.S. Treasury securities are generally very liquid and competition to provide this liquidity is robust. If some non-FINRA member broker-dealers stop competing in the market to provide this liquidity, other broker-dealers are likely to increase their activity in this market, but the Commission acknowledges that if liquidity decreases, investor costs to trade U.S. Treasury securities could increase.
Additionally, the removal of liquidity from the market could either improve or degrade execution quality on off-exchange markets.
In response to the 2015 Proposal, several commenters expressed liquidity concerns.
Changes in business models for non-FINRA member firms may affect market quality on exchanges as well. In addition to trading extensively in the off-exchange market, many non-FINRA member firms are among the most active participants on exchanges. Business model changes by these firms may lead to less exchange liquidity for several reasons. First, non-FINRA member firms that choose not to join an Association would no longer be able to rely on the rule and trade indirectly on exchanges of which they are not members, unless they comply with the routing or stock-options order exemptions.
The Commission believes that the amendments are not likely to have an economically meaningful effect on direct capital formation, which is the assignment of financial resources to meet the funding requirements of a profitable capital project, in this case, the provision of liquidity to financial markets. However, the Commission believes that the changes in allocation of regulatory fees and direct FINRA supervision within the off-exchange market may result in improved efficiency of capital allocation by the financial industry. The proposed amendments may reduce the capital commitment of non-FINRA member firms to liquidity provision. In response, it is possible that current member firms may choose to commit additional capital to liquidity provision when the trading environment has more uniform regulatory requirements. The Commission believes that this may lead to an overall increased commitment of liquidity both to exchanges and the off-exchange market. This increased commitment is likely to have some positive effects on capital market efficiency, such as lower quoted spreads on exchanges. In addition to lowering immediate execution costs on exchanges, lower exchange quoted spreads are likely to reduce transaction costs off-exchange as well, because off-exchange trades are typically priced with reference to quoted exchange prices.
The Commission believes these effects are not likely to be significant because the market to provide liquidity is very competitive. These markets are served by a number of liquidity providers with different business strategies and a strategic change by relatively few competitors is unlikely to disturb liquidity provision overall.
The proposed amendments may impact competition to provide liquidity by increasing the regulatory cost for current non-FINRA member firms. Currently, non-FINRA member firms do not bear the costs associated with FINRA membership. As such, FINRA member firms bear a number of costs not borne by non-FINRA member firms including a number of regulatory fees and indirect costs that are assessed or imposed upon member firms.
The existing differential regulatory cost burdens of FINRA member firms and non-FINRA member firms may have consequences with respect to market quality both for exchange-based and off-exchange trading. For example, because non-FINRA member firms, all else equal, currently face lower variable costs of trading compared to member firms, non-FINRA member firms may be able to provide liquidity at a lower cost than member firms. It may also reduce direct execution costs (such as quoted and effective spreads) for both exchange and off-exchange trades, the latter of which are normally derivatively priced with reference to prevailing exchange quotes. The differential regulatory burden, however, may also reduce depth at best prices because a member firm may not be able to trade profitably at a price established by a non-FINRA member firm that faces lower regulatory costs. Lower liquidity at best exchange prices implies greater price effect of trades, which may increase trading costs, particularly for large orders. For example, if the best price on an exchange is associated with 100 shares of depth, a 200 share order will exhaust depth at the best price and the second 100 share lot may execute at an inferior price.
Currently, FINRA is the only Association.
To be registered as a new Association, in addition to requirements that parallel the requirements to be a national securities exchange, a new Association must “[b]y reason of the number and geographical distribution of its members and the scope of their transactions” be able to carry out the purposes of Section 15A.
The ability to form an Association is characterized by barriers to entry. The proposed amendments include a one-year implementation period, which may provide a significant time constraint to form a new Association. A new Association would likely incur significant fixed costs to create the infrastructure needed to perform the surveillance and oversight requirements imposed on Associations by statute and regulation. It may also incur substantial costs, including personnel, training, travel, and other costs to provide for effective surveillance and supervision of the off-exchange equity and U.S. Treasury securities markets. Indeed, the only existing Association, FINRA, has resources that enable it to surveil and supervise the off-exchange market.
The amendments may increase barriers to entry and thus affect the potential for competition among regulators of off-exchange markets. Currently, the primary barrier to entry is the high fixed cost involved in forming and operating an Association. As proposed, the amendments bring nearly all off-exchange trading under the jurisdiction of an Association, including the trading of firms that currently are not members of an Association (non-FINRA member firms). If these firms join the only existing Association, FINRA, any newly-formed Association may have increased difficulty attracting the members needed to support the high fixed costs associated with forming an Association because every broker or dealer that participates in the off-exchange market would already be a FINRA member. This increased difficulty results because many firms may be reluctant to change Associations, either because of the costs to change compliance infrastructures or uncertainty in the regulatory environment of the new Association. Thus, if the amendments result in more firms becoming members of the FINRA, a new Association could face increased difficulties attracting members in the future. If the new Association is introduced after implementation of the rule, these stated effects would become more likely as the current non-FINRA member firms would have already joined FINRA.
The proposed amendments may create incentives to start a competing Association. The amendments, as proposed, could cause a number of firms with similar business models and substantial off-exchange volume to concurrently contemplate Association membership. This may provide the incentive to create a new Association and tailor it to the specific business models of these firms. If a competing Association limited the scope of its members or operations, it might not have to duplicate all of the surveillance and supervision functions required to be provided by an Association that does not have those limits. This may lower the costs of forming an Association and alter the barriers to entry.
When the Commission previously considered these amendments, some commenters expressed their concern about a concentration of regulatory oversight.
The existence of multiple Associations might provide benefits to the market as a whole. If a new Association could provide high quality services to members with a lower fee structure, all Associations would have
Competition among Associations could also entail substantial costs. If the market for Associations is characterized by economies of scale, aggregate costs for the same level of regulation would be higher in a market with two Associations than in a market with a single Association. These additional costs would ultimately be borne by the broker and dealer members of either Association, and could be passed on to investors. Second, Associations might compete on the basis of providing “light touch” regulation, in essence surveilling less and providing less supervision. As a result, the quality of market supervision might decrease, although the Commission does itself oversee self-regulatory organizations, such as Associations, and accordingly, would not permit a “race to the bottom.”
This section discusses costs and benefits of the amendments. While the Commission has attempted, where possible, to provide estimated quantifiable ranges, both costs and benefits are difficult to quantify for this proposal for a number of reasons.
The overall benefits of the amendments relate to more stable and uniform surveillance of off-exchange activity by the direct, membership-based Association oversight to oversee such activity. As such, the benefits the Commission anticipates from the amendments are largely qualitative and by their nature difficult to measure quantitatively.
The amendments would induce initial, ongoing and indirect costs which would be similarly difficult to measure for a variety of reasons. First, market participants are heterogeneous in their type, existing exchange memberships, and activity level in the off-exchange market. Consequently, compliance costs would vary across firms in a number of dimensions. Second, estimating costs is complicated by the fact that non-FINRA member firms can comply with the proposal in a number of ways, and presumably each would choose to seek compliance in the manner that minimizes the sum of its direct costs (related to joining and maintaining memberships in additional SROs) and indirect costs (which include forgone opportunities to trade profitably and costs associated with revising business strategies). Furthermore, some firms are likely to remain exempt but the Commission lacks data to identify those firms with certainty.
As discussed above,
The Commission believes that the amendments to Rule 15b9-1 would improve supervision of non-FINRA member firms. FINRA, currently the only Association, has substantial experience and expertise from overseeing a large number of brokers and dealers that trade off-exchange or across exchanges. This makes FINRA's potential regulation of non-FINRA member firms with off-exchange or cross-market trading activity particularly efficient.
In addition, the amendments, as proposed, would enhance the supervision and enforcement for equities and options beyond the benefits from the CAT NMS Plan.
The benefits of the proposed amendments would be pronounced in the U.S. Treasury securities markets. A significant amount of volume in U.S. Treasury securities markets comes from broker-dealers that may be newly required to become FINRA members as a result of the proposed amendments.
The Commission believes that the proposed amendments could have similar or additional benefits for other TRACE reported securities, should current non-FINRA member firms also trade in such securities. However, the Commission lacks the information necessary to discern the degree of any such benefits because, as noted above, the Commission does not have any data or other information available, unlike with U.S. Treasury securities, to determine how many non-FINRA member firms, if any, actively trade in these securities or to predict how many additional trades would be reported under the proposal.
While current members of an Association would not be directly affected by this rule, they would benefit by having a more level playing field in reporting trades in the U.S. Treasury securities markets. With more uniform regulatory requirements, firms may compete more equitably to supply liquidity both on exchanges and in the off-exchange market.
Although fewer firms will be able to rely on the proposed narrower exemptions, the proposed narrower exemptions would continue to provide benefits for non-FINRA members as well as other market participants. These exemptions would continue to provide cost savings for non-FINRA members as they would continue to not be required to join FINRA and thus avoid the costs of doing so. Additionally, the routing exemption would facilitate regulatory compliance designed to improve market quality.
The amendments, by narrowing the existing exemption, would result in brokers and dealers that no longer qualify for the exemption having to comply with Section 15(b)(8) by either limiting their trading to exchanges of which they are members, joining an Association or abiding by one of the stated exemptions. Under the amendments, therefore, non-FINRA member firms that choose to continue any off-member-exchange activity will be faced with choices that would involve corresponding costs. For example, non-FINRA member firms may incur costs related to membership in an Association or costs necessitated by additional exchange memberships. Additionally, some non-FINRA member firms may incur the costs of losing the benefits of trading in the off-member-exchange market if they decide not to join an Association. There could also be indirect costs associated with the proposed amendments, depending on if a non-FINRA member chooses to join an Association or not.
Most of the direct costs incurred in joining an Association and maintaining membership therein are dependent on firm characteristics and activity level. Furthermore, the Commission believes that some non-FINRA member firms may comply by ceasing their off-member-exchange trading activity, avoiding many of these costs but forgoing the opportunity to trade profitably in some venues. If all 12 of the non-FINRA member firms that have significant off-member-exchange trading activities in equities were to join FINRA, the median aggregate cost of the amendment for these firms would be about $95,000 in implementation costs and median ongoing aggregate annual costs of about $2.7 million.
Based on discussions with FINRA,
The fees associated with a FINRA membership application can vary. As an initial matter, the application fee to join FINRA is tier-based according to the number of registered persons associated with the applicant. This one-time application fee ranges from $7,500 to $55,000.
In addition to the application fees and data reporting costs, the Commission has taken into account the cost of legal and other advising necessary for effectively completing the application to be a member of FINRA. Some firms may choose to perform this legal work internally while others may use outside counsel for the initial membership application. In making this choice, non-FINRA member firms would likely take into account factors, such as the size and resources of the firm, the complexity of the firm's business model, and whether the firm previously used outside counsel to register with any exchanges. Based on conversations with industry participants that assist with FINRA membership, for non-FINRA member firms that choose to employ outside counsel to assist with their FINRA membership application, the cost of such counsel ranges from approximately $40,000 to $125,000, with a midpoint of $82,500. Factors affecting the specific costs of a particular firm include the number of associated persons, the level of complexity or uniqueness of the firm's business plan, and whether the firm has previously completed exchange membership applications with similar requirements.
With respect to ongoing costs, three components of such costs are any ongoing fees associated with FINRA membership, costs of legal work relating to FINRA membership, and costs associated with additional compliance activities. The ongoing membership-related fees associated with FINRA membership include the annual GIA; and the TAF and Section 3 fees, among others.
With certain assumptions, the Commission attempted to estimate direct compliance costs that a non-FINRA member firm is likely to face to comply with the amendments. The estimate applies to the 12 non-FINRA member firms that have significant off-member-exchange trading activities; smaller firms should face lower costs compared to these 12 firms because they have less revenue and trading volume that would be subject to GIA, TAF and Section 3 fees. Though non-FINRA member firms may already indirectly bear some of these costs as they may be passed through by FINRA member counterparties. Ongoing annual cost estimates (one time and annual) are broken down in Table 2.
The annual GIA generally requires members to pay a percentage of the member firm's total annual revenue based on a graduated scale.
The magnitude of the TAF depends on the transaction volume of a FINRA member that is covered by the TAF as described in the FINRA By-Laws.
Some off-exchange trading that non-FINRA member firms engage in currently may no longer be profitable when TAF is incurred. Consequently, non-FINRA member firms may reduce their trading both on exchanges and off-exchange after joining an Association.
In May of 2015, FINRA issued a Regulatory Notice proposing to amend the TAF such that it would not apply to transactions by a proprietary trading firm effected on exchanges of which the firm is a member, to coincide with originally proposed changes to 15b9-1.
In addition to the TAF, non-FINRA member firms that choose to join FINRA may incur additional Section 3 fees. Using data on off-exchange trading during September 2021, the Commission estimated that Section 3 fees incurred by the 12 large non-FINRA member firms due to their off-exchange trading would have an average incurred Section 3 fee of $4,541,719.31 annually, with a median incurred Section 3 fee of $2,150,069.99.
Ongoing compliance costs would depend on the business circumstances of each firm and the types of issues that could arise. As in the case of the initial membership, some non-FINRA member firms may choose to conduct ongoing compliance activities in-house while others may seek to outsource this work.
FINRA members may also be required to pay the median Personnel Assessment.
The Commission estimates that the median ongoing cost for non-FINRA member firms would be $2,742,664. However, as discussed above, these costs could vary. The Section 3 fees which make up a large portion of these costs are likely to be overestimated for reasons stated above. Additionally, the TAF is likely to be underestimated.
In addition to the cost estimates discussed above, the Commission recognizes that both non-FINRA member firms and SROs would incur other direct and indirect costs because of the increased regulatory requirements of the amendments. Specifically, there would be compliance costs associated with regulation by FINRA.
Two commenters on the 2015 Proposal submitted estimates for the cost of becoming FINRA members.
One commenter was concerned that FINRA's membership fees would only rise with no competitive forces to restrain the increase of such fees.
Additionally, to the extent that a firm trades fixed income securities, they would also have implementation and ongoing costs associated with TRACE reporting. The Commission believes that four non-FINRA member firms have significant trading activities in U.S. Treasury securities markets. The Commission estimates that these firms will each have an initial cost of $2,025, associated with setting up systems for TRACE reporting. This cost includes the Direct Circuit Connectivity Fee for TRACE reporting through Nasdaq, in which Nasdaq facilitates the reporting to TRACE. FINRA does not charge a Transaction Reporting Fee for trading activity in U.S. Treasury securities markets.
Non-FINRA member firms must be members of all exchanges upon which they transact business if they decide not to join an Association. With limited exceptions for some excluded activity, some non-FINRA member firms may choose to join additional exchanges to be excluded from the requirement to become a member of an Association. Alternatively, these firms may cease trading on exchanges of which they are not members.
Based on discussions with FINRA and industry participants, the Commission understands that completing a membership application with an additional exchange is generally less complicated and time consuming than completing a membership application with FINRA. Consequently, the Commission believes that the compliance burden on non-FINRA member firms for joining an additional exchange is likely to be significantly less than that of joining FINRA as those non-FINRA member firms that choose to join an additional exchange are likely able to perform this work internally, given that they are already members of at least one exchange, and that such work should take less time than the time required to complete an application with FINRA. However, the aggregate cost of joining multiple exchanges would likely be more costly than the cost of joining FINRA.
In addition to the legal burden, non-FINRA member firms joining additional exchanges as a result of the proposed amendments would incur membership and related fees. To the extent that non-FINRA member firms choose to become members of additional exchanges, the fees associated with such memberships would vary depending on the type of access sought and the exchanges of which non-FINRA member firms choose to become members.
The Commission also believes that the exchange membership fees that would apply to non-FINRA member firms joining such exchanges would be those fees that apply to either introducing brokers or dealers or proprietary trading firms. This assumption is consistent with the fact that any brokers or dealers carrying customer accounts could not qualify for the current exemption of Rule 15b9-1. Thus, any exchange membership fees that apply to firms that provide clearing services or conduct a public business would not apply to non-FINRA member firms.
Furthermore, because all non-FINRA member firms are members of at least one exchange,
To obtain estimates of the cost of joining additional exchanges, the Commission reviewed the membership-related fee structures of all twenty-four national securities exchanges. In assuming that the potential burden of joining additional exchanges would likely be less than that of joining FINRA, the Commission assumes that the costs imposed on non-FINRA member firms by the amendments would be membership fees, and not costs relating to trading, such as trading permit fees and connectivity fees. The Commission recognizes that membership alone in an exchange may not guarantee the ability to trade because many exchanges charge fees for trading rights, ports, various degrees of connectivity, and floor access and equipment, should those be desired. The fees associated with trading on an exchange are not the result of the amendments because, under the amendments, a non-FINRA member firm could continue to trade through another broker or dealer on an exchange as long as that non-FINRA member firm is a member of every exchange on which it trades or is a member of FINRA. In other words, the amendments themselves do not impose the cost of connectivity and related fees, but only the costs associated with membership on exchanges on which non-FINRA member firms could trade. To the extent, therefore, that non-FINRA member firms continue to trade through other brokers or dealers in a manner consistent with how they currently operate, the amendments impose only the costs associated with membership.
To arrive at estimates of the cost of joining additional exchanges, the Commission aggregated any fees associated with a firm's initial application to an exchange (“initial fee”) and separately aggregated the fees associated with any monthly or annual membership costs to obtain a separate annual cost (“annual fee”). Based on these aggregations, the Commission obtained a range for both the initial fee and the annual fee across exchanges. The initial fee is as low as $0 for some exchanges. Most exchanges have an
Regarding monthly or annual membership fees, most exchanges' ongoing monthly or annual membership fees generally range from $1,500 to $7,200.
Non-FINRA member firms that choose not to join an Association but wish to continue to trade off-exchange (or on exchanges of which they are not members) must do so in a manner that conforms to the routing or stock-option order exemptions. To rely on the stock-option order exemption, the proposal would require non-FINRA member firms to establish, maintain, and enforce policies and procedures as discussed above.
In addition to possibly incurring costs related to joining exchanges, non-FINRA member firms that choose not to join an Association would lose the benefits of trading in off-member-exchange markets. As mentioned above, non-FINRA member firms are significant participants in off-exchange activity. Much of this trading is attributed to 12 non-FINRA member firms, and the activity level across those firms varies widely. The Commission estimates that those 12 non-FINRA member firms executed $744 billion in off-exchange volume in September of 2021, while the remaining non-FINRA member firms executed $46 billion. The Commission cannot estimate the likelihood of these firms choosing to cease off-exchange activity rather than joining an Association. One commenter echoed these concerns when it stated that non-members may “curtail all off-exchange trading” if the high costs of FINRA membership outweigh the profits.
Finally, those firms that choose not to join an Association would be limited in their ability to route their own transactions to comply with the requirements of Regulation NMS and the Options Linkage Plan.
The Commission could provide an exemption from Association membership if a dealer that meets the criteria of paragraphs (a) and (b) of the rule, conducts business on the floor of a single exchange, and its trading elsewhere is proprietary and solely for the purpose of hedging its floor-based exchange trading activity on its member exchange. The hedging exemption could be limited to firms that trade on the floor of a national securities exchange. Specifically, the alternative would provide that a dealer that conducts
The Commission believes that this alternative could provide a limited exemption from Association membership that is consistent with the original design of Rule 15b9-1's exclusion for proprietary trading. Today, few dealers limit their quoting and other non-hedging trading activities to a particular exchange. Under this alternative, the registered dealers among this group that limit their primary trading business to a single exchange floor may continue to hedge the risk of that business by effecting securities transactions on another exchange or in the off-exchange market that are solely for the purpose of hedging the dealers' on-exchange activity, without such transactions triggering a requirement to join an Association.
The Commission also believes that this alternative approach, and in particular the limitation of its coverage to dealers that engage in floor trading and are a member of only a single exchange, could be consistent with the public interest and the protection of investors. A dealer's hedging activity resulting from its trading activity on multiple exchanges of which the dealer is a member presents cross-market surveillance concerns as previously discussed, and therefore FINRA would be in the best position to conduct regulatory oversight to the extent that the dealer's hedging transactions take place elsewhere than on exchanges of which it is a member. By contrast, so long as a dealer's hedging activity results from floor trading activity that is confined to a single exchange of which the dealer is a member, that exchange could be able to adequately supervise the hedging activities of the dealer, consistent with the public interest and protection of investors.
In addition, requiring written policies and procedures, as described above, would facilitate exchange supervision of dealers relying on such floor member hedging exemption, as it could provide an efficient and effective way for the relevant exchange to assess compliance with the proposed exemption. This could further serve the public interest and help protect investors.
Because the alternative hedging exemption for floor traders is intended to allow a dealer to reduce or otherwise mitigate its risk, such as position risk, incurred in connection with its exchange-based dealer activities, it would be limited to transactions for the dealer's own account. In addition, because the dealer would not itself be a member of any other national securities exchange on which hedging transactions may be effected, or of an Association, such transactions would need to be conducted with or through another registered broker or dealer that is a member of such other national securities exchange or a member of an Association (or of both).
However, the Commission believes that this alternative exemption would currently apply to very few and as little as zero non-FINRA member firms. Given that so few non-FINRA member firms would qualify for the exemption, the Commission believes that there is little value in including such an exemption. Additionally, by including the exemption the Commission believes that unforeseen circumstances could allow for firms to take advantage of the exemption in the future in ways that are not consistent with the original intent of the exemption, much like firms currently rely on Rule 15b9-1 in ways that are not consistent with the original intent.
The amendments, in accordance with Section 15(b)(8), preclude any firm that is not a member of an Association from trading on exchanges of which it is not a member.
In considering the Exchange Membership Alternative, the Commission weighed whether the same issue of off-exchange activity not being subject to effective regulatory oversight that exists when a non-FINRA member firm trades off-exchange is present when a member or non-FINRA member firm trades on an exchange of which it is not a member (through a member of that exchange). The Commission continues to believe that the amendments adequately address the issue of establishing effective oversight of off-exchange activity and that the more onerous Exchange Membership Alternative would not provide any additional regulatory benefit beyond the benefits the amendments provide for several reasons. First, while some exchanges may lack specialized regulatory personnel to directly surveil their members' trading off-exchange, FINRA has these resources to surveil the activity of member firms both on exchanges and off-exchange. Accordingly, requiring member firms to also become members of each exchange on which they effect transactions, including indirectly, would be unnecessarily duplicative because FINRA already has the resources necessary to surveil the activity of a member firm trading on an exchange of which it is not a member. In addition, while some exchanges do not have a specialized rule set to govern their members' activity in the off-exchange market, FINRA's rules are often consistent with the trading rules of exchanges on which members transact.
The Exchange Membership Alternative might have required firms to become members of more SROs than required under the proposed amendments, which would impose additional costs. In particular, some non-FINRA member firms that would become member firms under the proposed amendments would also need to become members of additional exchanges or cease trading on those exchanges. In addition, some current
The Commission considered retaining the $1,000
The Commission could eliminate Rule 15b9-1 altogether, leaving no exemption from Section 15(b)(8) of the Act. This would cause all current non-FINRA member firms that effect off-member-exchange securities transactions to be required by Section 15(b)(8) to join FINRA, which could improve FINRA's ability to surveil activity of member firms both on and off exchange, as well as investigate potentially violative behavior. Though, the Commission believes that such violative behavior by such firms may be easily identifiable under the proposed amendments, due to the fact that the proposed exemptions are narrow. However, eliminating the exemption for firms that would qualify for the routing exemption or the stock-option order exemption may prove to unnecessarily increase the costs for such firms. The Commission also believes that the routing exemption and stock-option order exemption will provide important avenues for providing liquidity and, therefore, eliminating the exemptions may drive these firms from the market and lead to a reduction in liquidity and market quality.
The Commission requests comment on all aspects of this Economic Analysis, including whether the analysis has: (1) identified all benefits and costs, including all effects on efficiency, competition, and capital formation; (2) given due consideration to each benefit and cost, including each effect on efficiency, competition, and capital formation; and (3) identified and considered reasonable alternatives to the proposed rule amendments. We request and encourage any interested person to submit comments regarding the proposed rules, our analysis of the potential effects of the proposed amendments, and other matters that may have an effect on the proposed rules. We request that commenters identify sources of data and information as well as provide data and information to assist us in analyzing the economic consequences of the proposed rules and proposed amendments. We also are interested in comments on the qualitative benefits and costs we have identified and any benefits and costs we may have overlooked. In addition to our general request for comments on the Economic Analysis associated with the proposed rules and proposed amendments, we request specific comment on certain aspects of the proposal:
61.
• Is the Commission's description of the current activity levels of non-FINRA member firms accurate? If not, can you provide additional data to better describe non-FINRA member firms' activity levels?
• Is there information or data on the trading activity level of non-FINRA member firms, in TRACE reportable securities other than U.S. Treasury securities? If so, please provide data.
62.
• Is the Commission's description of current market oversight accurate? Why or why not?
63.
• Would the proposed amendment improve regulatory oversight of current non-FINRA member firms? If not, is there currently adequate oversight of non-FINRA member firms?
• Would improved regulatory oversight improve market quality in financial markets?
• Would the proposed rules improve transparency for non-FINRA member firms that have significant trading activities in U.S. Treasury securities markets?
• Are there significant limitations, beyond those discussed above, in the economic analysis of the effect on regulatory supervision?
64.
• Will some non-FINRA member firms change their business practices, including ceasing to trade securities, as opposed to joining an Association as a result of the proposed amendments? Why or why not?
• Will some non-FINRA member firms join each exchange on which they trade as opposed to joining an Association as a result of the proposed amendments? Why or why not?
• Will the proposed amendments lead to a reduction of liquidity as a result of non-FINRA member firms changing their business practices as due to the proposed amendments? Why or why not?
65.
• Could the proposed amendments provide a strong enough incentive for the creation of a second Association? Why or why not? Do you believe that there are barriers to entry that would prevent a second Association from being formed?
66.
• Would the proposed amendments create a more level regulatory playing field for FINRA member firms relative to non-FINRA member firms?
67.
• Would the proposed amendments decrease competitive advantages and reduce costs borne by the investing public through increased price discovery? Why or why not?
68.
• Has the proposal accurately described the costs to non-FINRA member firms? Why or why not?
• Has the proposal accurately estimated the fees assessed by FINRA? If not, can you provide estimates?
• In 2015 FINRA proposed amendments to the TAF in response to a previous Commission proposal to amend the 15b9-1 exemption. If the proposed FINRA amendments are adopted, how would this change the economic effects?
69.
• Do you believe that the economic effects of each of the provided
• Are there other alternatives?
• How many non-FINRA members would qualify for a floor trading hedging exemption? Is zero accurate?
Certain provisions of the proposed amendments to Rule 15b9-1 contain “collection of information requirements” within the meaning of the Paperwork Reduction Act of 1995 (“PRA”).
The proposed amendments to Rule 15b9-1 include a collection of information within the meaning of the PRA for brokers or dealers relying on the stock-option order exemption under the amended rule. The stock-option order exemption under the amendments to Rule 15b9-1 would permit a qualifying broker or dealer to effect securities transactions otherwise than on an exchange where it is a member, with or through another broker or dealer, that are solely for the purpose of executing the stock leg of a stock-option order. Brokers or dealers relying on this exemption would be required to establish, maintain, and enforce written policies and procedures reasonably designed to ensure and demonstrate that such transactions are solely for the purpose of executing the stock leg of a stock-option order. In addition, such brokers or dealers would be required to preserve a copy of their policies and procedures in a manner consistent with Rule 17a-4 until three years after the date the policies and procedures are replaced with updated policies and procedures.
The policies and procedures required under amended Rule 15b9-1 would be used by the Commission and SROs to understand how brokers and dealers relying on the exemption evaluate whether the securities transactions that they effect elsewhere than an exchange where they are a member are solely for the purpose of executing the stock leg of a stock-option order and, more generally, how such brokers and dealers are complying with the requirements of the exemption and Rule 15b9-1. These policies and procedures would be used generally by the Commission as part of its ongoing efforts to monitor and enforce compliance with the federal securities laws, including Section 15(b)(8) of the Act and Rule 15b9-1 thereunder. In addition, SROs may use the information to monitor and enforce compliance by their members with applicable SRO rules and the federal securities laws.
The Commission believes that a small number of brokers or dealers would rely on the stock-option order exemption. The Commission estimates that, based on publicly available information reviewed covering the end of April 2022, there are approximately 65 brokers-dealers registered with the Commission that are currently a member of an exchange but not a member of an Association. The Commission believes that some, but not all, of these brokers-dealers would likely choose to avail themselves of the stock-option order exemption, because not all of them handle stock-option orders or, for those that do handle stock-option orders, they may effect the execution of stock leg components of those orders on exchanges where they are a member. The Commission estimates that seven firms could potentially rely on the stock-option order exemption and would therefore be required to comply with the policies and procedures requirement.
The Commission estimates that the one-time, initial burden for a broker or dealer to establish written policies and procedures as required under amended Rule 15b9-1 would be approximately 8 hours.
The Commission estimates that the initial, first year burden associated with amended Rule 15b9-1 would be 56 hours per broker or dealer, which corresponds to an initial aggregate burden of 392 hours.
All of the collection of information discussed above would be mandatory.
To the extent that the Commission receives confidential information pursuant to the collection of information, such information will be kept confidential, subject to the provisions of applicable law.
Brokers or dealers seeking to take advantage of the stock-option order exemption would be required to preserve a copy of their policies and procedures in a manner consistent with Rule 17a-4
Pursuant to 44 U.S.C. 3506(c)(2)(B), the Commission solicits comment to:
70. Evaluate whether the proposed collection of information is necessary for the proper performance of our functions, including whether the information shall have practical utility;
71. Evaluate the accuracy of our estimate of the burden of the proposed collection of information;
72. Determine whether there are ways to enhance the quality, utility, and clarity of the information to be collected; and
73. Evaluate whether there are ways to minimize the burden of collection of information on those who are to respond, including through the use of automated collection techniques or other forms of information technology.
Persons submitting comments on the collection of information requirements should direct them to the Office of Management and Budget, Attention: Desk Officer for the Securities and Exchange Commission, Office of Information and Regulatory Affairs, Washington, DC 20503, and should also send a copy of their comments to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090, with reference to File Number S7-05-15. Requests for materials submitted to OMB by the Commission with regard to this collection of information should be in writing, with reference to File Number S7-05-15 and be submitted to the Securities and Exchange Commission, Office of FOIA/PA Services, 100 F Street NE, Washington, DC 20549-2736. As OMB is required to make a decision concerning the collections of information between 30 and 60 days after publication, a comment to OMB is best assured of having its full effect if OMB receives it within 30 days of publication.
For purposes of the Small Business Regulatory Enforcement Fairness Act of 1996, (“SBREFA”),
Section 3(a) of the Regulatory Flexibility Act of 1980
The Commission examined recent FOCUS data for the 3,528 active brokers and dealers overseen by the Commission, including 3,454 brokers and dealers that are FINRA members and the 65 non-FINRA member firms as of April 2022 and estimates that not more than four of the affected entities have net capital of $500,000 or less and are not affiliates of larger organizations. The Commission oversees approximately 3,528 brokers and dealers, of which 740 have net capital of $500,000 or less and are not affiliates of larger organizations.
The Commission requests comment on all aspects of the foregoing certification as well as, in particular, on the following questions:
74. We solicit comment as to whether the proposed amendments could have impacts on small entities that have not been considered. We request that commenters describe the nature of any impacts on small entities and provide empirical data to support the extent of such effect, including the magnitude of any economic impact the proposed amendments would have on small entities.
75. Do commenters believe that the proposed amendments would have a significant economic impact on a substantial number of small entities? If so, how should the Commission alter the proposed amendments to lessen the impact on these entities?
Such comments will be placed in the same public file as comments on the proposed amendments to Rule 15b9-1. Persons wishing to submit written comments should refer to the instructions for submitting comments in the front of this release.
The Exchange Act, 15 U.S.C. 78a
Brokers, Dealers, Registration, Securities.
For the reasons set out in the preamble, the Commission proposes to amend Title 17, Chapter II of the Code of Federal Regulations as follows:
15 U.S.C. 77c, 77d, 77g, 77j, 77s, 77z-2, 77z-3, 77eee, 77ggg, 77nnn, 77sss, 77ttt, 78c, 78c-3, 78c-5, 78d, 78e, 78f, 78g, 78i, 78j, 78j-1, 78k, 78k-1, 78
Any broker or dealer required by section 15(b)(8) of the Act (15 U.S.C. 78o(b)(8)) to become a member of a registered national securities association shall be exempt from such requirement if it:
(a) Is a member of a national securities exchange;
(b) Carries no customer accounts; and
(c) Effects transactions in securities solely on a national securities exchange of which it is a member, except that with respect to this paragraph (c):
(1) A broker or dealer may effect transactions in securities otherwise than on a national securities exchange of which the broker or dealer is a member that result solely from orders that are routed by a national securities exchange of which the broker or dealer is a member to comply with 17 CFR 242.611 or the Options Order Protection and Locked/Crossed Market Plan; or
(2) A broker or dealer may effect transactions in securities otherwise than on a national securities exchange of which the broker or dealer is a member, with or through another registered broker or dealer, that are solely for the purpose of executing the stock leg of a stock-option order. A broker or dealer seeking to rely on this exception shall establish, maintain and enforce written policies and procedures reasonably designed to ensure and demonstrate that such transactions are solely for the purpose of executing the stock leg of a stock-option order. Such broker or dealer shall preserve a copy of its policies and procedures in a manner consistent with 17 CFR 240.17a-4 until three years after the date the policies and procedures are replaced with updated policies and procedures.
By the Commission.