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Federal Aviation Administration (FAA), DOT.
Final rule.
The FAA is adopting a new airworthiness directive (AD) for certain Diamond Aircraft Industries GmbH (DAI) Model DA 42, DA 42 NG, and DA 42 M-NG airplanes. This AD is prompted by mandatory continuing airworthiness information (MCAI) issued by the aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as a loose rudder T-yoke axle nut. This AD requires replacing the rudder T-yoke axle with an improved rudder T-yoke axle. The FAA is issuing this AD to address the unsafe condition on these products.
This AD is effective December 14, 2022.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of December 14, 2022.
• For service information identified in this final rule, contact Diamond Aircraft Industries GmbH, N.A. Otto-Straße 5, A-2700 Wiener Neustadt, Austria; phone: +43 2622 26700; fax: +43 2622 26780; email:
• You may view this service information at the FAA, Airworthiness Products Section, Operational Safety Branch, 901 Locust, Kansas City, MO 64106. For information on the availability of this material at the FAA, call (817) 222-5110. It is also available at
Penelope Trease, Aviation Safety Engineer, General Aviation & Rotorcraft Section, International Validation Branch, FAA, 26805 E 68th Avenue, Denver, CO 80249; phone: (303) 342-1094; email:
The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain serial-numbered DAI Model DA 42, DA 42 NG, and DA 42 M-NG airplanes. The NPRM published in the
Occurrences were reported of finding a loose rudder T-yoke axle nut on DA 42 aeroplanes.
This condition, if not detected and corrected, could lead to vertical movement of the axle, possibly resulting in reduced rudder control of the aeroplane.
To address this potential unsafe condition, DAI issued the applicable MSB [Mandatory Service Bulletin], providing instructions to inspect for correct installation of the self-locking nut to the affected part.
For the reason described above, this [EASA] AD requires repetitive inspections for correct installation of the self-locking nut to the affected part and, depending on findings, accomplishment of applicable corrective action(s) and replacement of the self-locking nut. This [EASA] AD also provides an optional terminating action for the repetitive inspections.
You may examine the MCAI in the AD docket at
In the NPRM, the FAA proposed to require replacing the rudder T-yoke axle with an improved rudder T-yoke axle. The FAA is issuing this AD to prevent movement of the T-yoke axle. The unsafe condition, if not addressed, could result in reduced control of the airplane.
The FAA received one comment from DAI. The following presents the comment received on the NPRM and the FAA's response to the comment.
DAI requested that the FAA revise the NPRM to include recently published Diamond Aircraft Mandatory Service Bulletin DAI MSB 42-143 and MSB 42NG-086, dated December 23, 2021 (issued as one document), and explained this service bulletin further rectifies the unsafe condition of the movement of the T-yoke axle by specifying instructions to apply torque seal marks to the head of the T-yoke axle and to the self-locking nut. DAI further explained that the temporary revision of the aircraft maintenance manual (AMM) specifies visual inspection of these torque seal marks during every annual inspection. According to DAI, the additional visual inspection of the torque seal marks incorporated in Diamond Aircraft Mandatory Service Bulletin DAI MSB 42-143 and MSB 42NG-086, dated December 23, 2021, replaces the “Inspection of Rudder T-yoke axle Nut for Looseness” section of Diamond Aircraft Mandatory Service Bulletin DAI MSB 42-137/1 and MSB 42NG-079/1, dated December 11, 2021 (issued as one document), that was previously mandated by EASA AD 2019-0302.
The FAA disagrees. In the NPRM, the FAA did not propose to require the
These products have been approved by the aviation authority of another country and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with this State of Design Authority, it has notified the FAA of the unsafe condition described in the MCAI and service information referenced above. The FAA reviewed the relevant data, considered the comment received, and determined that air safety requires adopting this AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on these products. This AD is adopted as proposed in the NPRM.
The FAA reviewed Diamond Aircraft Recommended Service Bulletin DAI RSB 42-139 and DAI RSB 42NG-081, dated October 21, 2019 (issued as one document), published with DAI Work Instruction WI-RSB 42-139 and WI-RSB 42NG-081, Revision 1, dated October 24, 2019 (issued as one document) attached. The service bulletin specifies complying with the work instruction, which contains procedures for replacing the rudder T-yoke axle with an improved (additional retaining pin) rudder T-yoke axle. 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 MCAI applies to the Model DA 42 M airplane, and this AD does not because it does not have an FAA type certificate.
The MCAI requires repetitively inspecting the self-locking nut until the rudder T-yoke axle is replaced with improved part number (P/N) D60-5320-00-32. This AD requires installing rudder T-yoke axle P/N D60-5320-00-32 and does not have an inspection requirement.
The FAA estimates that this AD affects 193 airplanes of U.S. registry. The FAA estimates that it would take about 6 work-hours to replace the rudder T-yoke axle and require parts costing $166. The average labor rate is $85 per work-hour. Based on these figures, the FAA estimates the cost of this AD on U.S. operators to be $130,468 or $676 per airplane.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This AD will not have federalism implications under Executive Order 13132. This AD will 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 that this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Will not affect intrastate aviation in Alaska, and
(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This airworthiness directive (AD) is effective December 14, 2022.
None.
This AD applies to Diamond Aircraft Industries GmbH Model DA 42, DA 42 NG, and DA 42 M-NG airplanes, serial numbers 42.004 through 42.391, 42.394 through 42.396, 42.399 through 42.402, 42.405 through 42.416, 42.427, 42.AC001 through 42.AC135, 42.AC137 through 42.AC145, 42.AC148, 42.AC150 through 42.AC152, 42.MN001 through 42.MN034, 42.MN037 through 42MN042, 42.MN050 through 42.MN055, 42.MN057, 42.MN058, 42.MN100 through 42.MN103, 42.N001 through 42.N067, 42.N100 through 42.N250, 42.N300 through 42.N381, 42.N391, 42.NC001 through 42.NC004, and 42.NC006 through 42.NC008, certificated in any category.
Joint Aircraft System Component (JASC) Code 5320, Fuselage Miscellaneous Structure.
This AD was prompted by mandatory continuing airworthiness information (MCAI) issued by the aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as a loose rudder T-yoke axle nut. The FAA is issuing this AD to prevent movement of the T-yoke axle. The unsafe condition, if not addressed, could result in reduced control of the airplane.
Comply with this AD within the compliance times specified, unless already done.
(1) Within 100 hours time-in-service after the effective date of this AD or 12 months after the effective date of this AD, whichever
(2) As of the effective date of this AD, do not install rudder T-yoke axle P/N LN 9037-M6x90 on any airplane.
(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 certification office, send it to the attention of the person identified in paragraph (i)(1) and email to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(1) For more information about this AD, contact Penelope Trease, Aviation Safety Engineer, General Aviation & Rotorcraft Section, International Validation Branch, FAA, 26805 E 68th Avenue, Denver, CO 80249; phone: (303) 342-1094; email:
(2) Refer to European Union Aviation Safety Agency (EASA) AD 2019-0302, dated December 13, 2019, for related information. This EASA AD may be found in the AD docket at
(1) The Director of the Federal Register approved the incorporation by reference of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.
(i) Diamond Aircraft Recommended Service Bulletin DAI RSB 42-139 and DAI RSB 42NG-081, dated October 21, 2019 (issued as one document), published with DAI Work Instruction WI-RSB 42-139 and WI-RSB 42NG-081, Revision 1, dated October 24, 2019 (issued as one document) attached.
(ii) [Reserved]
(3) For service information identified in this AD, contact Diamond Aircraft Industries GmbH, N.A. Otto-Straße 5, A-2700 Wiener Neustadt, Austria; phone: +43 2622 26700; fax: +43 2622 26780; email:
(4) You may view this service information at the FAA, Airworthiness Products Section, Operational Safety Branch, 901 Locust, Kansas City, MO 64106. For information on the availability of this material at the FAA, call (817) 222-5110.
(5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email:
Federal Aviation Administration (FAA), DOT.
Final rule.
The FAA is adopting a new airworthiness directive (AD) for certain Airbus Canada Limited Partnership Model BD-500-1A10 and BD-500-1A11 airplanes. This AD was prompted by reports that the engine feed pressure switches were installed with no secondary locking mechanism and can become loose and cause a fuel leak. This AD requires initial and repetitive inspections at the engine feed pressure switch locations and installation of a flange adaptor with lockwire to terminate the repetitive inspections, as specified in a Transport Canada Civil Aviation (TCCA) AD, which is incorporated by reference. The FAA is issuing this AD to address the unsafe condition on these products.
This AD is effective December 14, 2022.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of December 14, 2022.
• For material incorporated by reference in this AD, contact TCCA, Transport Canada National Aircraft Certification, 159 Cleopatra Drive, Nepean, Ontario K1A 0N5, Canada; telephone 888-663-3639; email
• You may view this material at the FAA, Airworthiness Products Section, Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195. It is also available in the AD docket at
Joseph Catanzaro, Aerospace Engineer, Airframe and Propulsion Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7366; email
The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Airbus Canada Limited Partnership Model BD-500-1A10 and BD-500-1A11 airplanes. The NPRM published in the
In the NPRM, the FAA proposed to require initial and repetitive inspections at the engine feed pressure switch locations and installation of a flange adaptor with lockwire to terminate the repetitive inspections, as specified in TCCA AD CF-2021-50. The FAA is issuing this AD to address the unsafe condition on these products.
You may examine the MCAI in the AD docket at
The FAA received no comments on the NPRM or on the determination of the cost to the public.
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 this State of Design Authority, it has notified the FAA of the unsafe condition described in the MCAI referenced above. The FAA reviewed the relevant data and determined that air safety requires adopting this AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on this product. Except for minor editorial changes, this AD is adopted as proposed in the NPRM. None of the changes will increase the economic burden on any operator.
TCCA AD CF-2021-50 specifies procedures for repetitive general visual inspections of the torque identification stripes, torquing of the fuel pressure switches, and installation of lockwire at the two alternating current (AC) boost pump cartridges; repetitive general visual inspections of the torque identification stripes and torquing of the fuel pressure switches at the two engine feed pressure switches; and installation of a new flange adaptor and lockwire, which terminates the repetitive inspections. 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 estimates that this AD affects 60 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:
The FAA estimates the following costs to do any necessary on-condition actions that would be required based on the results of any required actions. The FAA has no way of determining the number of aircraft that might need these on-condition action:
The FAA has included all known costs in its cost estimate. According to the manufacturer, however, some or all of the costs of this 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.
This AD will not have federalism implications under Executive Order 13132. This AD will 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 that this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Will not affect intrastate aviation in Alaska, and
(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This airworthiness directive (AD) is effective December 14, 2022.
None.
This AD applies to Airbus Canada Limited Partnership Model BD-500-1A10 and BD-500-1A11 airplanes, certificated in any category, as identified in Transport Canada Civil Aviation (TCCA) AD CF-2021-50, dated December 21, 2021 (TCCA AD CF-2021-50).
Air Transport Association (ATA) of America Code 28, Fuel.
This AD was prompted by reports that the engine feed pressure switches were installed with no secondary locking mechanism and can become loose and cause a fuel leak. The FAA is issuing this AD to address the absence of a secondary locking feature (lockwire) on the fuel pressure switches, which may allow them to become loose and allow fuel to leak in the affected areas, creating a fire hazard.
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, TCCA AD CF-2021-50.
(1) Where TCCA AD CF-2021-50 refers to hours air time, this AD requires using flight hours.
(2) Where TCCA AD CF-2021-50 refers to its effective date, or 14 July 2021, the effective date of TCCA AD CF-2021-21, this AD requires using the effective date of this AD.
The following provisions also apply to this AD:
(1)
(2)
For more information about this AD, contact Joseph Catanzaro, Aerospace Engineer, Airframe and Propulsion Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7366; email
(1) The Director of the Federal Register approved the incorporation by reference of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise.
(i) Transport Canada Civil Aviation (TCCA) AD CF-2021-50, dated December 21, 2021.
(ii) [Reserved]
(3) For TCCA AD CF-2021-50, contact TCCA, Transport Canada National Aircraft Certification, 159 Cleopatra Drive, Nepean, Ontario K1A 0N5, Canada; telephone 888-663-3639; email
(4) You may view this material at the FAA, Airworthiness Products Section, Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.
(5) You may view this material that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
The FAA is superseding Airworthiness Directive (AD) 2000-20-15, which applied to certain Airbus SAS Model A300 and A300-600 series airplanes. AD 2000-20-15 required a high frequency eddy current (HFEC) inspection to detect cracking of the rear fittings of fuselage frame FR40 at stringer 27, and repetitive inspections or repair, as applicable. In lieu of accomplishing the repetitive inspections, AD 2000-20-15 provided a modification that would allow the inspection to be deferred for a certain period of time. This AD was prompted by cracking of the rear fittings of fuselage frame FR40 at stringer 27, and a determination that reduced compliance times are necessary. This AD removes airplanes from the applicability, and continues to require the actions in AD 2000-20-15, but at reduced compliance times, as specified in a European Union Aviation Safety Agency (EASA) AD, which is incorporated by reference. The FAA is issuing this AD to address the unsafe condition on these products.
This AD is effective December 14, 2022.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of December 14, 2022.
• For material incorporated by reference in this AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
• You may view this material at the FAA, Airworthiness Products Section, Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195. It is also available in the AD docket at
Dan Rodina, Aerospace Engineer, Large
The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2000-20-15, Amendment 39-11926 (65 FR 60349, October 11, 2000) (AD 2000-20-15). AD 2000-20-15 applied to certain Airbus SAS Model A300 and A300-600 series airplanes. AD 2000-20-15 required a HFEC inspection to detect cracking of the rear fittings of fuselage frame FR40 at stringer 27, and repetitive inspections or repair, as applicable. In lieu of accomplishing the repetitive inspections, AD 2000-20-15 provides a modification that would allow the inspection to be deferred for a certain period of time. The FAA issued AD 2000-20-15 to address fatigue cracking of the rear fittings of fuselage frame FR40 at stringer 27, which could result in reduced structural integrity of the airplane.
The NPRM published in the
You may examine the MCAI in the AD docket at
In the NPRM, the FAA proposed to continue to require the actions in AD 2000-20-15, but at reduced compliance times, as specified in EASA AD 2021-0288, dated December 21, 2021. The NPRM also proposed to remove airplanes from the applicability, as specified in EASA AD 2021-0288. The FAA is issuing this AD to address the unsafe condition on these products.
The FAA received comments from the Air Line Pilots Association, International (ALPA), and FedEx Express, who supported the NPRM without change.
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 this State of Design Authority, it has notified the FAA of the unsafe condition described in the MCAI referenced above. The FAA reviewed the relevant data, considered the comment[s] received, and determined that air safety requires adopting this AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on this product. Except for minor editorial changes, this AD is adopted as proposed in the NPRM. None of the changes will increase the economic burden on any operator.
EASA AD 2021-0288 specifies procedures for repetitive inspections of the rear fittings of fuselage frame FR40 at stringer 27 for cracking, and repair of any cracking. 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 estimates that this AD affects 67 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:
The FAA estimates the following costs to do any necessary repair based on the results of any required inspection. The FAA has no way of determining the number of aircraft that might need this repair:
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.
This AD will not have federalism implications under Executive Order 13132. This AD will 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 that this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Will not affect intrastate aviation in Alaska, and
(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This airworthiness directive (AD) is effective December 14, 2022.
This AD replaces AD 2000-20-15, Amendment 39-11926 (65 FR 60349, October 11, 2000) (AD 2000-20-15).
This AD applies to Airbus SAS airplanes identified in paragraphs (c)(1) through (4) of this AD, certificated in any category, as specified in European Union Aviation Safety Agency (EASA) AD 2021-0288, dated December 21, 2021 (EASA AD 2021-0288).
(1) Model A300 B2-1C, B2K-3C, B2-203, B4-2C, B4-103, and B4-203 airplanes.
(2) Model A300 B4-603 and B4-622 airplanes.
(3) Model A300 B4-605R and B4-622R airplanes.
(4) Model A300 F4-605R airplanes.
Air Transport Association (ATA) of America Code 53, Fuselage.
This AD was prompted by cracking of the rear fittings of fuselage frame FR40 at stringer 27, and a determination that reduced compliance times are necessary. The FAA is issuing this AD to address fatigue cracking of the rear fittings of fuselage frame FR40 at stringer 27, which could result in reduced structural integrity of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Except as specified in paragraphs (h) and (i) of this AD: Comply with all required actions and compliance times specified in, and in accordance with, EASA AD 2021-0288.
(1) Where paragraph (1) of EASA AD 2021-0288 specifies, for certain conditions, using the compliance time and repetitive intervals “in the applicable SB,” and where “the applicable SB” specifies that the “1st inspection will be done within [a specified number of flight cycles] after receipt of the Service Bulletin,” this AD requires compliance within the specified number of flight cycles after the effective date of this AD.
(2) Where EASA AD 2021-0288 refers to its effective date, this AD requires using the effective date of this AD.
(3) The “Remarks” section of EASA AD 2021-0288 does not apply to this AD.
Although the service information referenced in EASA AD 2021-0288 specifies to submit certain information to the manufacturer, this AD does not include that requirement.
The following provisions also apply to this AD:
(1)
(2)
For more information about this AD, contact Dan Rodina, Aerospace Engineer, Large Aircraft Section, FAA, International Validation Branch, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3225; email
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise.
(3) The following service information was approved for IBR on December 14, 2022.
(i) European Union Aviation Safety Agency (EASA) AD 2021-0288, dated December 21, 2021.
(ii) [Reserved]
(4) For EASA AD 2021-0288, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
(5) You may view this material at the FAA, Airworthiness Products Section, Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.
(6) You may view this material that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email
Federal Aviation Administration (FAA), DOT.
Final rule; correction.
This action corrects a final rule published by the FAA in the
Effective date 0901 UTC, December 29, 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 7400.11G, 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 in the
This is an editorial change only to match the FAA NASR database information and does not alter the alignment of the affected T-464 route.
United States Area Navigation Routes are published in paragraph 6011 of FAA Order JO 7400.11G, dated August 19, 2022, and effective September 15, 2022, which is incorporated by reference in 14 CFR 71.1. The RNAV T-route listed in this document will be published subsequently in FAA Order JO 7400.11.
Accordingly, pursuant to the authority delegated to me, references to the TONOC, WI, WP that is reflected in Docket No. FAA-2022-0243, as published in the
Drug Enforcement Administration, Department of Justice.
Final rule.
This final rule adopts, without change, an interim final rule with request for comments published in the
The effective date of this rule is December 9, 2022.
Terrence L. Boos, Ph.D., Chief, Drug and Chemical Evaluation Section, Diversion Control Division, Drug Enforcement Administration; Telephone: (571) 362-3249.
Under the Controlled Substances Act (CSA), as amended in 2015 by the Improving Regulatory Transparency for New Medical Therapies Act (Pub. L. 114-89), when the Drug Enforcement Administration (DEA) receives notification from the Department of Health and Human Services (HHS) that the Secretary has approved a certain new drug and HHS recommends control in the CSA schedule II-V, DEA is required to issue an interim final rule (IFR), with opportunity for public comment and to request a hearing, controlling the drug within a specified 90-day timeframe and subsequently to issue a final rule. 21 U.S.C. 811(j). When controlling a drug pursuant to subsection (j), DEA must apply the scheduling criteria of 21 U.S.C. 811 (b) through (d) and 812(b). 21 U.S.C. 811(j)(3).
On March 18, 2022, DEA received notification that FDA approved, on that same date, a new drug application for ZTALMY (ganaxolone oral suspension) for the treatment of seizures associated with cyclin-dependent kinase-like 5 deficiency disorder in patients two years or older. In addition, on March 14, 2022, HHS recommended that DEA place ganaxolone and its salts in schedule V of the CSA. On June 1, 2022, DEA, pursuant to 21 U.S.C. 811(j), published an IFR in the
The IFR referenced two supporting documents and stated they were available for viewing on the electronic docket. Specifically, the two documents cited are as follows: (1) HHS's March 2022 scientific and medical evaluation and scheduling recommendation (HHS Eight-Factor analysis), and (2) DEA's May 2022 Eight-Factor analysis. DEA has discovered that these documents were not posted to the electronic docket. However, they were available for viewing at DEA headquarters. Upon publication of this final rule, DEA will post to the docket DEA's and HHS's analyses that should have accompanied the IFR.
The IFR provided an opportunity for interested persons to submit comments, as well as file a request for a hearing or waiver of a hearing, on or before July 1, 2022. DEA did not receive any comments or requests for a hearing or
As indicated above, ganaxolone has been a schedule V controlled substance by virtue of an IFR issued by DEA in June 2022. Thus, this final rule does not alter the regulatory requirements applicable to handlers of ganaxolone that have been in place since that time. Nonetheless, for informational purposes, we restate here those requirements. Ganaxolone is subject to the CSA's schedule V regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, dispensing, importing, exporting, research, and conduct of instructional activities and chemical analysis with, and possession involving schedule V substances, including the following:
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This final rule, without change, affirms the amendment made by the IFR that is already in effect. Section 553 of the Administrative Procedure Act (5 U.S.C. 553) generally requires notice and comment for rulemakings. However, 21 U.S.C. 811(j) provides that in cases where a certain new drug is (1) approved by HHS, under section 505(c) of the Federal Food, Drug, and Cosmetic Act, and (2) HHS recommends control in CSA schedule II-V, DEA shall issue an IFR scheduling the drug within 90 days. Additionally, subsection (j) specifies that the rulemaking shall become immediately effective as an IFR without requiring DEA to demonstrate good cause. DEA issued an IFR on June 1, 2022, and solicited public comments on that rule. Subsection (j) further provides that after giving interested persons the opportunity to comment and to request a hearing, the Attorney General, as delegated to the Administrator of DEA, shall issue a final rule in accordance with the scheduling criteria of 21 U.S.C. 811(b) through (d) and 812(b). As stated above, DEA did not receive any comments or requests for a hearing or waiver of a hearing. DEA is now issuing the final rule in accordance with subsection (j).
In accordance with 21 U.S.C. 811(a) and (j), this scheduling action is subject to formal rulemaking procedures performed “on the record after opportunity for a hearing,” which are conducted pursuant to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth the procedures and criteria for scheduling a drug or other substance. Such actions are exempt from review by the Office of Management and Budget (OMB) pursuant to section 3(d)(1) of Executive Order (E.O.) 12866 and the principles reaffirmed in E.O. 13563.
This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.
This rulemaking does not have federalism implications warranting the application of E.O. 13132. The rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
This rule does not have tribal implications warranting the application of E.O. 13175. It does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to rules that are subject to notice and comment under section 553(b) of the APA. As noted in the above discussion regarding the applicability of the APA, DEA was not required to publish a general notice of proposed rulemaking. Consequently, the RFA does not apply to this final rule.
In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 1501
This rule is not a major rule as defined by the Congressional Review Act (CRA), 5 U.S.C. 804. However, pursuant to the CRA, DEA is submitting a copy of this final rule to both Houses of Congress and to the Comptroller General.
Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements.
Accordingly, the interim final rule amending 21 CFR part 1308, which published on June 1, 2022 (87 FR 32991), is adopted as a final rule without change.
This document of the Drug Enforcement Administration was signed on November 1, 2022, by Administrator Anne Milgram. That document with the original signature and date is maintained by DEA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DEA Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of DEA. This administrative process in no way alters the legal effect of this document upon publication in the
Drug Enforcement Administration, Department of Justice.
Final rule.
The Drug Enforcement Administration (DEA) is establishing a specific listing and DEA Chemical Control Number for
Effective date November 9, 2022.
Terrence L. Boos, Drug and Chemical Evaluation Section, Diversion Control Division, Drug Enforcement Administration; Telephone: (571) 362-3249.
The Controlled Substances Act (CSA) and the Drug Enforcement Administration's (DEA) implementing regulations give the Attorney General, as delegated to the Administrator of DEA (Administrator), the authority to specify, by regulation, a chemical as a “list I chemical.”
In addition, the United States is a Party to the 1988 United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances (1988 Convention), December 20, 1988, 1582 U.N.T.S. 95. Under Article 12 of the 1988 Convention, when the United States receives notification that a chemical has been added to Table I or Table II of the 1988 Convention, the United States is required to take measures it deems appropriate to monitor the manufacture and distribution of that chemical within the United States and to prevent its diversion, including measures related to international trade.
In a letter dated May 27, 2022, the United Nations Office on Drugs and Crime, in accordance with Article 12, paragraph 6 of the 1988 Convention, informed the Permanent Mission of the United States of America to the United Nations (Vienna) that the Commission on Narcotic Drugs (CND) decided to place the chemical 1-boc-4-AP in Table I of the 1988 Convention (CND Dec/65/5) at its 65th Session on March 16, 2022.
As discussed above, this rule does not affect the continuing status of 1-boc-4-AP as a list I chemical in any way. This action, as an administrative matter, merely establishes a separate, specific listing for 1-boc-4-AP in list I of the CSA and assigns a DEA chemical control number for the substance. This action will allow DEA to effectively monitor regulated transactions of 1-boc-4-AP, including the manufacture, distribution, importation, or exportation of 1-boc-4-AP, and to provide accurate reporting to the International Narcotics Control Board.
Pursuant to the final rule published on April 15, 2020,
Since even a small amount of 1-boc-4-AP can potentially yield a significant amount of controlled substances, DEA believes that the continued regulation of chemical mixtures containing any amount of 1-boc-4-AP as a list I chemical is necessary to prevent its illicit extraction, isolation, and use. 1-boc-4-AP is already subject to domestic control under list I as a carbamate of
DEA has implemented an application process to exempt certain chemical mixtures from the requirements of the CSA and its implementing regulations.
The listing of 1-boc-4-AP as a list I chemical continues to subject handlers (manufacturers, distributors, importers, and exporters) and proposed handlers to all of the regulatory controls and administrative, civil, and criminal actions applicable to the manufacture, distribution, importation, and exportation of a list I chemical. Since May 15, 2020, persons handling 1-boc-4-AP, including regulated chemical mixtures containing 1-boc-4-AP, have been required to comply with list I chemical regulations, including the following:
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An agency may find good cause to exempt a rule from certain provisions of the Administrative Procedure Act (APA) (5 U.S.C. 553), including notice of proposed rulemaking and the opportunity for public comment, if it is determined to be unnecessary, impracticable, or contrary to the public interest.
As discussed above, 1-boc-4-AP is currently and continues to be regulated as a list I chemical as a carbamate of
Pursuant to 5 U.S.C. 553(b)(3)(B), DEA finds that notice and comment rulemaking is unnecessary and that good cause exists to dispense with these procedures. The addition of a separate listing for 1-boc-4-AP and its DEA chemical control number in the list of list I chemicals in 21 CFR 1310.02(a) makes no substantive difference in the status of this chemical as a list I chemical, but instead is “a minor or merely technical amendment in which the public is not particularly interested.”
In addition, because 1-boc-4-AP is already subject to domestic control under list I as a carbamate of
This rule was developed in accordance with the principles of Executive Orders (E.O.) 12866 and 13563. This rule is not a significant regulatory action under E.O. 12866. 1-boc-4-AP is already regulated as a list I chemical in the United States, as a carbamate of the list I chemical
This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.
This rulemaking does not have federalism implications warranting the application of E.O. 13132. The rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government.
This rule does not have tribal implications warranting the application of E.O. 13175. It does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to rules that are subject to notice and comment under section 553(b) of the APA or other laws. As noted in the above section regarding the applicability of the APA, DEA determined that there is good cause to exempt this final rule from notice and comment. Consequently, the RFA does not apply.
In accordance with the UMRA, 2 U.S.C. 1501
The action does not impose a new collection of information requirement under the Paperwork Reduction Act, 44 U.S.C. 3501-3521. This action will not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
This final rule is not a major rule as defined by the Congressional Review Act (CRA), 5 U.S.C. 804. However, pursuant to the CRA, DEA is submitting a copy of this final rule to both Houses of Congress and to the Comptroller General.
Administrative practice and procedure, Drug traffic control, Exports, Imports, Reporting and recordkeeping requirements.
Accordingly, for the reasons set forth in the preamble, DEA amends 21 CFR part 1310 as follows:
21 U.S.C. 802, 827(h), 830, 871(b), 890.
(a) * * *
(38) [Reserved]
The addition reads as follows:
(g) * * *
(1) * * *
(iii) 1-boc-4-AP (
(c) * * *
This document of the Drug Enforcement Administration was signed on November 1, 2022, by Administrator Anne Milgram. That document with the original signature and date is maintained by DEA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DEA Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of DEA. This administrative process in no way alters the legal effect of this document upon publication in the
Federal Highway Administration (FHWA), U.S. Department of Transportation (DOT).
Final rule.
On November 16, 2020, FHWA published an interim final rule (IFR) amending FHWA's regulations to allow States the ability to use the Indefinite Delivery and Indefinite Quantity (ID/IQ) method of contracting, including job order contracting (JOC), on Federal-aid highway projects, under certain circumstances, on a permanent basis. This action adopts the IFR with a few minor changes and technical amendments. Most provisions from the IFR remain unchanged. This action also restores a missing provision inadvertently removed during an earlier, unrelated rulemaking.
This final rule is effective December 9, 2022.
Mr. James DeSanto, Office of Preconstruction, Construction, and Pavements,
This document, as well as the IFR, advance notice of proposed rulemaking, supporting materials, and all comments received may be viewed online through the Federal eRulemaking portal at:
The ID/IQ method of contracting allows a project owner to procure an unknown quantity of supplies or services for a fixed time. As described in FHWA's IFR, 85 FR 72919 (Nov. 16, 2020), government agencies use this method when they cannot determine, above a specified minimum, the precise quantities of supplies or services that they will require during the contract period. Contracting agencies use other names for these and similar types of contracts, including JOC contracts, master contracts, on-call contracts, area-wide contracts, continuing contracts, design-build push-button contracts, push-button contracts, stand-by contracts, and task order contracts.
With the publication of FHWA's IFR, FHWA operationalized the ID/IQ method of contracting, including JOC, for Federal-aid construction projects. Previously, this contracting technique was only authorized on an experimental basis under FHWA's Special Experimental Project No. 14 (SEP-14). Allowing ID/IQ contracting on a permanent basis provides benefits to State departments of transportation (State DOT) and other contracting agencies, including expediting project delivery, increasing administrative efficiency, reducing project costs, and increasing flexibility for State DOTs to use Federal-aid funds on certain projects. Additional discussion on State DOT and local public agency experience with ID/IQ contracting under FHWA's SEP-14 program, as well as FHWA's previous steps to operationalize ID/IQ contracting, is provided in the IFR.
On November 16, 2020, FHWA published its IFR in the
The following discussion summarizes the comments submitted to the docket on the IFR, notes where and why FHWA has made changes in the final rule, and explains why certain recommendations or suggestions have not been incorporated into the final rule.
In general, most commenters supported the rule. Comments generally
The San Diego Association of Governments (SANDAG) expressed support for the IFR. SANDAG cited its previous experience with ID/IQ contracting under the SEP-14 program and stated the method achieved quicker project delivery; reduced design, procurement, and construction costs; and provided a more efficient and flexible contracting method to address changing field conditions. FHWA appreciates these comments and finds no substantive response is needed.
The Delaware Department of Transportation (Delaware DOT) expressed overall support for the IFR. It explained that it generally favors less Federal requirements with more deference to State and local agencies. The Delaware DOT explained that its use of multiple-award ID/IQ contracts enables it to deliver relatively small projects very quickly, thereby benefitting the public significantly earlier than traditional procurement methods. Delaware DOT also cited reduced staff costs and efforts related to administration of ID/IQ projects, which also enables project costs to be reasonably managed. FHWA appreciates these comments and finds no substantive response is needed.
Gordian, a company in Greenville, South Carolina, expressed its support for fully operationalizing ID/IQ contracting, including JOC. In addition, Gordian shared its views on industry best practices and was responsive to FHWA's questions in the IFR, as discussed in later sections of this notice.
In the IFR, FHWA asked a series of questions about cost and time savings based on the use of the ID/IQ contracting method. FHWA received a few responsive comments which generally noted that cost savings would be realized, and that ID/IQ contracting may reduce procurement cycle time. FHWA received little additional data that was not considered in its original analysis. Some of the State DOT commenters explained that they did not yet have enough experience and data with this contracting to provide answers.
Among the few responsive comments, Gordian provided examples of Federal-aid projects saving between 5 and 20 percent relative to other contracting methods. Gordian also maintained that using ID/IQ may reduce procurement cycle time for straightforward construction projects by as much as 90 percent.
In addition, the Pennsylvania Department of Transportation (PennDOT) explained that it does not have experience with ID/IQ contracting to date but anticipates ID/IQ would reduce project or construction costs over the life of the contract. It also expects that over time the prices associated with ID/IQ contracts may be slightly lower than traditional contracts due to the anticipation of consistent work for contractors and the ease of assigning unanticipated or emergency work.
FHWA agrees with the responsive comments that ID/IQ contracting is likely to reduce project costs and expedite project delivery of certain highway projects. FHWA did not receive sufficient new data to warrant revising its analysis of cost savings from operationalizing ID/IQ contracting on a permanent basis provided under the IFR.
The Idaho Transportation Department inquired about licensing and bonding of ID/IQ projects, specifically whether licensing and bonding requirements should consider the value of the “master agreement” (ID/IQ contract) or the value of the work order.
In general, FHWA's contracting regulations do not specify the process or provide requirements for furnishing performance bonds on Federal-aid projects. In general, contracting agencies may use their own procedures and requirements for bonding, insurance, prequalification, qualification, or licensing of contractors on Federal-aid projects as long as those procedures do not restrict competition (23 CFR 635.110(b)). For example, an agency may choose to adjust its requirements to facilitate more small business participation. The revision in 23 CFR 635.110(f) in the IFR simply clarifies that the general requirement also applies to ID/IQ contracting. FHWA has considered the comment and believes no further revision to this section is necessary.
The Michigan Department of Transportation recommended that the requirement for FHWA Division Administrator prior approval of addenda be delegated to State DOTs. FHWA believes this approval as set forth in the IFR is consistent with similar requirements for other contracting methods and is subject to the statutory assumption provisions under 23 U.S.C. 106(c). FHWA has considered this comment and believes FHWA divisions and State DOTs may incorporate project-specific approval actions related to ID/IQ contracting into their agreements under 23 U.S.C. 106(c)(3), thus, no further revision to the rule is required.
In the IFR, FHWA added § 635.114(m) requiring ID/IQ contracts be awarded in accordance with the solicitation document. FHWA revised this section in a manner consistent with other contracting methods, recognizing that contracting agencies desire flexibility when configuring their ID/IQ solicitations and contracts. While FHWA did not receive public comments specifically addressing the amendment to the regulation in the IFR at § 635.114(m), and FHWA is not making any changes to that section, FHWA recommends that contracting agencies ensure their ID/IQ solicitation documents contain adequate provisions, where appropriate, to address analyzing bids for unbalancing or extreme variations within bids as compared to the engineer's estimate.
In FHWA's construction manager/general contractor (CM/GC) final rule, published in the
While these changes were not included in the previous IFR for this rulemaking, FHWA has determined that
The Oregon Department of Transportation (Oregon DOT) raised questions seeking clarification on contractual terms used in the IFR. The Oregon DOT asked if FHWA intended the term “contract” as used throughout the rule, and specifically in § 635.604(a)(6), to mean the ID/IQ contract, or the work order. The Oregon DOT argued that an ID/IQ contract is a “master contract” or an “agreement-to-agree” and that the work order is an actual contract, thereby clouding the understanding of optional contract extensions in §§ 635.604(a)(6)(i) through (iii).
The IFR provides a definition of the term ID/IQ contract, which includes defining it as “the principal contract between the contracting agency and the contractor.” In addition, the definition of ID/IQ contract also contains common names used by agencies around the Nation, one of which is “master contract.” Also, the IFR provides a definition of work order, stating it “means the contract document issued for a definite scope of work under an ID/IQ contract.”
Throughout the rule, FHWA has attempted to consistently use the terms above to clearly convey our meaning. FHWA appreciates the points raised and has carefully considered the comments. While FHWA disagrees that the definitions of ID/IQ contract and work order are insufficient, we acknowledge that the use of the undefined term related to optional contract extensions has the potential to cause confusion. As discussed below, FHWA has modified §§ 635.604(a)(6)(i) and 635.604(a)(6)(ii) to consistently refer to optional contract extensions.
The IFR includes a provision in § 635.604(a)(3)(ii) addressing methods to adjust prices when optional contract extensions are included in an ID/IQ contract and solicitation. While FHWA did not receive public comments to the docket on this topic, we believe additional clarification on this point in the preamble may assist contracting agencies when developing ID/IQ projects.
For clarification, as implied by the plain language, FHWA does not intend the phrase in § 635.604(a)(3)(ii), “specify the basis, such as a published index” to exclude alternatives other than a published index. FHWA views other methods, such as predetermining and publishing a fixed percentage in the solicitation, or requesting bidders supply an adjustment percentage with their bid, as transparent and objective means of adjusting prices for optional contract extensions, which may reasonably be used under this rule. FHWA is not making any revisions to the proposed regulatory text as a result of this clarification.
In FHWA's IFR, we asked commenters to address specific questions relating to the rule. Two of the questions related to this section of the regulation: one question asked about FHWA requiring estimated minimum and maximum quantities to be provided in both ID/IQ solicitations and contracts or requiring estimates for any other reason; another asked if FHWA should require agencies to specify the estimated minimum and maximum quantities that may be expected under each work order.
The Delaware DOT responded by opposing the requirement to specify estimated minimum and maximum quantities of services for ID/IQ contracts. They cited their success in bidding ID/IQ projects using an expected or approximate amount of work, while clearly noting in the contract document that issuing work orders is not guaranteed.
Gordian recommended against the requirement to specify estimated minimum and maximums, thereby providing flexibility to contracting agencies. Gordian explained that in its experience some agencies may elect to include this information, but in its opinion it is not necessary for successful implementation. Gordian suggested a more appropriate approach would be to require an estimated annual dollar value of work, on which contractors could base their initial bid.
The PennDOT commented that it does not recommend requiring estimated minimum and maximum quantities in ID/IQ solicitations and contracts but does recommend including a requirement for estimating minimum and maximum quantities expected in a work order.
The Vermont Agency of Transportation (VTrans) advised against requiring estimated minimum and maximum quantities in ID/IQ solicitations and contracts, citing the difficulty to program all Federal and State projects that may utilize ID/IQ contracting over a period of 5 years. The VTrans described such an exercise as speculative and unreliable. They further stated their process of using both line items and lump sum bidding on work orders has been efficient and thus recommended against requiring an estimate of minimum and maximum quantities expected for a work order.
FHWA appreciates the responses and has carefully considered the comments. FHWA agrees it is not necessary to mandate that contracting agencies specify the minimum and maximum quantity of services to be acquired under an ID/IQ contract. However, a reasonable estimate of quantities in the solicitation is necessary to serve as a basis for bidders to base their prices as well as serving as a basis for analyzing bids. For this reason, FHWA has modified this section accordingly to require a reasonable estimate of quantities in the solicitation. We also agree with the importance of clearly stating in the solicitation, when appropriate, that the estimate of quantities does not guarantee work orders will be issued. However, even if a minimum award provision is included in the solicitation or contract, § 635.604(a)(7), which remains unmodified under the final rule, provides that a contracting agency's payment to a contractor to satisfy a minimum award provision that is not supported by eligible work is not eligible for Federal-aid participation.
The IFR included two questions specific to the topic of multiple award ID/IQ contracts. One question solicited input on criteria to be used when issuing work orders under multiple-award contracts, while another question asked commenters to consider if typical cause and convenience termination clauses are sufficient to remove deficient contractors from consideration in a multiple award pool.
Several commenters cited contractor availability as a reasonable criterion to use when issuing work orders in a
The Delaware DOT also suggested a scenario where a contracting agency could bypass the low-cost contractor “if the second-lowest-cost contractor is within a close percentage of the low-cost contractor” and the agency believes doing so would be in the agency's and public's interest. In addition, Gordian recommended allowing work orders issued on multiple award ID/IQ contracts using the JOC method be issued on a rotating basis “so that the dollar value of assigned work is approximately equal.” The Oregon DOT asked if FHWA would accept a result where “the same few master contract holders being awarded all of the work orders, with some firms receiving few to no work orders over the life of the contract.” The PennDOT and Oregon DOT recommended competitive methods be used to issue work orders.
In response to these comments, FHWA believes non-competitive methods of issuing work orders on multiple award ID/IQ contracts (including JOC contracts), such as on a rotating basis, or using other factors not related to competition or contractor disqualification, are contrary to the statutory competitive bidding requirement set forth in 23 U.S.C. 112. FHWA acknowledges that low bidders may be successful in being offered and awarded most, if not all, work orders in a multiple award ID/IQ contract based upon analyses of bid prices and actual work order quantities. Consistent with statutory requirements, FHWA is maintaining the regulatory prohibition against rotating or other non-competitive issuance of work orders.
The Delaware DOT commented that typical cause and convenience termination clauses are sufficient to remove contractors from the pool of those to be considered when issuing work orders when those contractors are not meeting the terms of the contract. The Delaware DOT recommended this issue be deferred to State or local procedures. Gordian also supported providing flexibility to contracting agencies to use their own procedures and be able to suspend assigning work to a particular contractor for cause. The VTrans cited their process of providing contractors with post-construction evaluations and written warning of any significant issue that may lead to “off-ramping” a contractor, providing that contractor an opportunity to address deficiencies. FHWA acknowledges these comments and does not believe the regulatory text requires further revision.
The Oregon DOT made several comments requesting clarification on FHWA's contractual terms, including as they are used in § 635.604(a)(6)(ii) related to wage determinations in ID/IQ contracts. The Oregon DOT commented that while the IFR provides requirements for updating prevailing wage rates when optional contract extensions are executed, FHWA did not address requirements for prevailing wages applicable to the original term of an ID/IQ contract or “master contract.” FHWA has considered this comment and believes the issue is sufficiently addressed in the existing regulation at 23 CFR 635.117(f). Under that regulation, the appropriate wage rates are to be identified in the bidding documents, which must specify “that such rates are a part of the contract covering the project.” FHWA believes this applies to ID/IQ contracts just as it would be to other competitive procurements, subject to the requirements of 29 CFR 1.6, where a correct wage determination remains in effect for the term of a contract. In this context, the contract is the ID/IQ contract, not the individual work orders falling under the ID/IQ contract. FHWA does not believe the regulatory text requires further revision.
The Oregon DOT asked if wage rates “in effect on the date of the execution of a two-year contract extension of the master contract would apply to all work orders issued at any time during the two-year extension.” In the IFR, FHWA intended § 635.604(a)(6)(ii) to address this issue and agrees the prevailing wage determination cited in Oregon DOT's example would be in effect for all work orders issued during the term of the extension, unless and until a new optional contract extension is executed. As discussed above and further discussed in the Definitions section at 635.602, FHWA is further revising §§ 635.604(a)(6)(i) and 635.604(a)(6)(ii) to consistently refer to optional contract extensions.
In the IFR, FHWA requested comments about procedures that could be implemented to efficiently review and approve small preventative maintenance projects with limited scope in numerous locations. Several commenters shared best practices and suggestions. FHWA appreciates these responses, which are best suited for incorporation into future ID/IQ contracting guidance, summaries of peer exchanges, or technical assistance provided by FHWA. FHWA is not making changes to the regulation based on these comments.
The Delaware DOT commented about the number of FHWA approvals included in the IFR. In its opinion the number seems more than necessary. The Delaware DOT proposed FHWA Division Administrators approve a set of ID/IQ procedures, after which project-specific approvals would not be required. In response, FHWA believes the approvals set forth in the IFR are consistent with similar requirements in other contracting methods, and most are subject to the statutory assumption provisions under 23 U.S.C. 106(c). Notable exceptions to these assumption provisions include the approval of proposed ID/IQ procurement procedures under § 635.605(a) and the execution of formal project agreements under § 630.106. FHWA has considered the comment and believes FHWA division offices and State DOTs may incorporate project-specific approval actions related to ID/IQ contracting into their agreements under 23 U.S.C. 106(c)(3), similar to the approach with other contracting methods, and that no further revision to the rule is required.
In the IFR, FHWA asked the public to consider procedures that should be in place when using ID/IQ procedures within a design-build contract to ensure compliance with this subpart as well as 23 CFR part 636 and related requirements. FHWA received few responses to this question, with commenters indicating they did not have experience with combining the design-build method with ID/IQ contracting. Gordian recommended FHWA not mandate specific procedures. FHWA appreciates the responses and
FHWA has considered the impacts of this rule under E.O. 12866 (58 FR 51735, Oct. 4, 1993), Regulatory Planning and Review, as supplemented by E.O. 13563 (76 FR 3821, Jan. 21, 2011), Improving Regulation and Regulatory Review, and DOT's regulatory policies and procedures. The Office of Information and Regulatory Affairs within the Office of Management and Budget (OMB) has determined that this rulemaking is not a significant regulatory action under section 3(f) of E.O. 12866. Accordingly, OMB has not reviewed it under that E.O.
As described above, this rule adopts the IFR published by FHWA on November 16, 2020, with a few minor changes and technical amendments. Most provisions from the IFR remain unchanged. The IFR amended FHWA's regulations to allow States the ability to use the ID/IQ method of contracting, including JOC, on Federal-aid highway projects, under certain circumstances, on a permanent basis. This action also restores a minor provision in 23 CFR part 635 inadvertently removed during an earlier, unrelated rulemaking. As with the IFR, FHWA believes that the rule will provide cost savings for, and expedite project delivery of, certain highway projects.
FHWA did not receive many comments in response to questions about cost and time savings based on the use of the ID/IQ contracting method. Commenters generally believed that cost savings would be realized, and that procurement time would be reduced for certain projects but, provided little additional data that was not considered in FHWA's original analysis under the IFR. FHWA agrees with the responsive comments that ID/IQ contracting is likely to reduce project costs and expedite project delivery but did not receive sufficient new data to warrant revising its earlier analysis under the interim final rule where it anticipated a cost savings, measured in 2019 dollars, of $3.4 million per year at a 7 percent discount rate.
Pursuant to the Congressional Review Act (5 U.S.C. 801,
In compliance with the Regulatory Flexibility Act (Pub. L. 96-354, 5 U.S.C. 601-612), FHWA has evaluated the effects of this action on small entities and has determined that the action is not anticipated to have a significant economic impact on a substantial number of small entities. The amendment addresses obligation of Federal funds to States for Federal-aid highway projects. As such, it affects only States and States are not included in the definition of small entity set forth in 5 U.S.C. 601. Therefore, FHWA certifies that the action will not have a significant economic impact on a substantial number of small entities.
This rule would not impose unfunded mandates as defined by the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, 109 Stat. 48, March 22, 1995) as it will not result in the expenditure by State, local, Tribal governments, in the aggregate, or by the private sector, of $155 million or more in any 1 year (2 U.S.C. 1532
This action has been analyzed in accordance with the principles and criteria contained in E.O. 13132 dated August 4, 1999, and FHWA has determined that this action would not have a substantial direct effect or sufficient federalism implications on the States. FHWA has also determined that this action would not preempt any State law or regulation or affect the States' ability to discharge traditional State governmental functions.
Catalog of Federal Domestic Assistance Program Number 20.205, Highway Planning and Construction. The regulations implementing E.O. 12372 regarding intergovernmental consultation on Federal programs and activities apply to this program. Local entities should refer to the Catalog of Federal Domestic Assistance Program Number 20.205, Highway Planning and Construction, for further information.
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501,
FHWA has analyzed this action for the purpose of the National Environmental Policy Act of 1969, as amended (42 U.S.C. 4321
FHWA has analyzed this action under E.O. 13175, dated November 6, 2000, and believes that the action would not impose substantial direct compliance costs on Indian Tribal governments; and would not preempt Tribal laws. The rulemaking addresses obligations of Federal funds to States for Federal-aid highway projects and would not impose any direct compliance requirements on Indian Tribal governments. To the extent that Tribes utilize these regulations, they would be expected to derive the same benefits identified above. Therefore, a Tribal summary impact statement is not required.
E.O. 12898 requires that each Federal agency make achieving environmental justice part of its mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of its programs, policies, and activities on minorities and low-income populations. FHWA has determined that this final rule does not raise any environmental justice issues.
A regulation identification number (RIN) is assigned to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. The RIN number
Government contracts, Grant programs—transportation, Highway safety, Highways and roads, Reporting and recordkeeping requirements, Traffic regulations.
Grant programs—transportation, Highways and roads, Reporting and recordkeeping requirements.
For the reasons set out above, the interim final rule amending title 23 Code of Federal Regulations, parts 630 and 635, which was published at 85 FR 72919 on November 16, 2020, is adopted as final with the following changes:
Sections 1525 and 1303 of Pub. L. 112-141, Sec. 1503 of Pub. L. 109-59, 119 Stat. 1144; 23 U.S.C. 101 (note), 109, 112, 113, 114, 116, 119, 128, and 315; 31 U.S.C. 6505; 42 U.S.C. 3334, 4601
(p) * * *
(1) * * *
(vi) * * *
(A) A statement concerning scope and current status of the required services; and
(B) A statement which requires compliance with the Uniform Relocation and Real Property Acquisition Policies Act of 1970, as amended, and 23 CFR part 710.
(a) * * *
(3) * * *
(iii) Specify the estimated quantity or value of services the contracting agency anticipates it may acquire under the contract, either on an annual basis or over the entire initial term of the ID/IQ contract.
(6) * * *
(i) Prior to granting an optional contract extension of the ID/IQ contract, the contracting agency must receive concurrence from the Division Administrator.
(ii) For ID/IQ contracts where prevailing wages apply under 23 U.S.C. 113, the current prevailing wage rate determination as determined by the U.S. Department of Labor in effect on the date of the execution of the optional contract extension of the ID/IQ contract shall apply to work covered under the optional contract extension.
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is taking final action to approve updates to the Code of Federal Regulations delegation tables to reflect the current delegation status of New Source Performance Standards and National Emission Standards for Hazardous Air Pollutants in Arizona and California.
This rule is effective on December 9, 2022.
The EPA has established a docket for this action under Docket ID No. EPA-R09-OAR-2021-0962. All documents in the docket are listed at
Jeffrey Buss, EPA Region IX, (415) 947-4152,
Throughout this document, “we,” “us” and “our” refer to the EPA.
Through this document, the EPA is accomplishing the following objectives:
(1) Update the delegation tables in the Code of Federal Regulations, Title 40 (40 CFR), parts 60, 61 and 63 to provide an accurate listing of the delegated New Source Performance Standards (NSPS) and National Emission Standards for Hazardous Air Pollutants (NESHAP); and
(2) Clarify those authorities that the EPA retains and are not granted to state or local agencies as part of NSPS or NESHAP delegation.
This action will update the delegation tables in 40 CFR parts 60, 61 and 63, to allow easier access by the public to the status of delegations in various state or local jurisdictions. The updated delegation tables will include the delegations approved in response to recent requests, as well as those previously granted. The tables are shown at the end of this document.
Recent requests for delegation that have been incorporated into the updated 40 CFR parts 60, 61 and 63 tables are identified below. Each individual submittal identifies the specific NSPS and NESHAP for which delegation was requested. The requests have already been approved by letter and simply need to be included in the CFR tables.
Sections 111(c)(1) and 112(l) of the Clean Air Act, as amended in 1990, authorizes the Administrator to delegate his or her authority for implementing and enforcing standards in 40 CFR parts 60, 61 and 63.
Delegation grants a state or local agency the primary authority to implement and enforce federal standards. All required notifications and reports should be sent to the delegated state or local agency with a copy to EPA Region IX, as appropriate. Acceptance of delegation constitutes agreement by the state or local agency to follow 40 CFR parts 60, 61 and 63, and the EPA's test methods and continuous monitoring procedures.
In general, the EPA does not delegate to state or local agencies the authority to make decisions that are likely to be nationally significant or alter the stringency of the underlying standards. For a more detailed description of the authorities in 40 CFR parts 60 and 61 that are retained by the EPA,
As additional assurance of national consistency, state and local agencies must send to EPA Region IX Enforcement Division's Air Section Manager a copy of any written decisions made pursuant to the following delegated authorities:
• applicability determinations that state a source is not subject to a rule or requirement;
• approvals or determination of construction, reconstruction, or modification;
• minor or intermediate site-specific changes to test methods or monitoring requirements; or
• site-specific changes or waivers of performance testing requirements.
For decisions that require the EPA's review and approval (for example, major changes to monitoring requirements), the EPA intends to make determinations in a timely manner.
In some cases, the standards themselves specify that specific provisions cannot be delegated. State and local agencies should review each individual standard for this information.
The EPA retains independent authority to enforce the standards and regulations of 40 CFR parts 60, 61 and 63.
On March 31, 2022, the EPA published in the
The commenter notes that California had the worst air quality levels in the United States in 2020, followed by Arizona. Additionally, Arizona and California are the top two states for having the largest Native American population. Arizona has over 332,000 Native Americans and is home to the country's largest tribe, The Navajo Nation, and California has over 321,000 Native Americans. Although air pollution affects all residents living in California and Arizona, health disparities are prominent among certain vulnerable populations such as Indigenous communities.
The commenter recommends that the delegation tables should be updated regularly, and comprehensive and detailed guidelines should be added as well to assure there is no gray area in following rules to prevent increased air pollution in California and Arizona. Finally, the commenter notes that Tribal governments can play a crucial role in decreasing air pollutants and work with entities at the federal and state levels.
We thank the commenter for the comment. While the commenter supports the proposed rule, we want to address some of the commenter's specific remarks.
Sections 111(c)(1) and 112(l) of the Clean Air Act, as amended in 1990, authorizes the Administrator to delegate his or her authority for implementing and enforcing standards in 40 CFR parts 60, 61 and 63. Tribes may apply to the EPA for such authority and assume regulatory and program management responsibilities in Indian country through the treatment in a similar manner as a tribe as a state process. In Arizona, for example, the Gila River Indian Community Department of Environmental Quality has delegated authority for the NESHAP within its jurisdiction.
The EPA's planning documents underscore the importance of direct implementation in fulfilling the Agency's mission in Indian country. As stated in the Fiscal Year 2022-2026 EPA Strategic Plan, “Ensuring EPA direct implementation of federal environmental programs in Indian country is in keeping with the federal trust responsibility. When the Agency directly implements federal environmental programs the agency also advances environmental justice for federally recognized Tribes. EPA will continue its long commitment to assisting Tribes in building the capacity to receive delegated programs. In those instances when Tribal governments are authorized to implement federal programs, EPA supports Tribal governments' inclusion of environmental justice principles, community engagement, and decision-making processes.”
Additionally, the EPA consults with federally recognized tribes under
On April 11, 2022, the EPA received an email message from the Yolo-Solano Air Quality Management District (AQMD) regarding its delegations for various subparts in 40 CFR parts 60, 61 and 63. With respect to Part 60, Yolo-Solano AQMD pointed out that the current delegations tables do not show delegations for any subparts to it despite the copies they furnished of older published versions showing various subparts were in fact delegated to Yolo-Solano AQMD. While the email message did not reference our action to update the NSPS and NESHAP delegation tables, we did receive it during the public comment period and intend to address it in this final action as a comment.
We agree with the comment that the existing delegation tables for 40 Part 60 are incorrect for Yolo-Solano AQMD. It appears that a publishing error occurred approximately in 2009, which resulted in the Tuolumne County Air Pollution Control District (APCD), Ventura County APCD and the Yolo-Solano AQMD delegations being deleted and/or altered from the table for 40 CFR part 60. With respect to parts 61 and 63, we found no error in the delegation tables. We are correcting the delegation status table for Part 60 for the three districts through this final rule.
Section 553 of the APA, 5 U.S.C. 553(b)(3)(B), provides that, when an agency for good cause finds that notice and public procedure are impracticable, unnecessary, or contrary to the public interest, the agency may issue a rule without providing notice and an opportunity for public comment. The EPA has determined that there is good cause for correcting the tables for 40 CFR part 60 for Tuolumne County APCD, Ventura County APCD and Yolo-Solano AQMD without prior proposal and opportunity for comment because our action merely conforms the delegation table with actions taken by the EPA years ago and that remain in force. Thus, notice and public procedures are unnecessary. The EPA finds that this constitutes good cause under 5 U.S.C. 553(b)(3)(B).
This document serves to notify the public that the EPA is updating the 40 CFR parts 60, 61 and 63 tables for Arizona and California to codify recent delegations of NSPS and NESHAP as authorized under Sections 111(c)(1) and 112(1)(l) of the Clean Air Act.
Under the Clean Air Act, the Administrator is required to approve delegation requests that comply with the provisions of the Act and applicable federal regulations. 42 U.S.C. Sections 7410(c) and 7412(l). Thus, in reviewing delegation submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); and
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act.
In addition, the air districts did not evaluate environmental justice considerations as part of their delegation requests. There is no information in the record, however, inconsistent with the stated goals of E.O. 12898 (59 FR 7629, February 16, 1994) of achieving environmental justice for people of color, low-income populations, and indigenous peoples.
Furthermore, the delegation submissions are not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Environmental protection, Administrative practice and procedure, Air pollution control, Hazardous substances, Intergovernmental relations, Reporting and recordkeeping requirements.
For the reasons set out in the preamble, title 40, chapter I, of the Code of Federal Regulations is amended as follows:
42 U.S.C. 7401
The revisions read as follows:
(d) * * *
(1) * * *
(2) * * *
(i) * * *
(v) * * *
(vii) * * *
(ix) * * *
Nuclear Regulatory Commission.
Regulatory basis; request for comment.
The U.S. Nuclear Regulatory Commission (NRC) is requesting comment on a regulatory basis to support a rulemaking that would amend its regulations for nonemergency event notifications. The NRC is evaluating the current requirements and guidance for immediate notification of nonemergency events for operating nuclear power reactors and assessing whether the requirements present an unnecessary reporting burden. The regulatory basis contains an analysis of whether reporting requirements can be reduced or eliminated when they do not have a commensurate safety benefit.
Submit comments by January 9, 2023. Comments received after this date will be considered if it is practical to do so, but the NRC is able to ensure consideration only for comments received before this date.
You may submit comments by any of the following methods; however, the NRC encourages electronic comment submission through the Federal rulemaking website:
•
•
For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
George Tartal, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-0016; email:
Please refer to Docket ID NRC-2020-0036 (formerly Docket ID NRC-2018-0201 for the associated petition for rulemaking) when contacting the NRC about the availability of information for this action. You may obtain publicly available information related to this action by any of the following methods:
•
•
•
The NRC encourages electronic comment submission through the Federal rulemaking website (
The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.
To facilitate early stakeholder engagement in the rulemaking process, the NRC is requesting comment on a regulatory basis to support a rulemaking that would amend Section 50.72, “Immediate notification requirements for operating nuclear power reactors,” of Title 10 of the
The regulatory basis is developed as a precursor to a proposed rule and describes the NRC's preferred approach for resolving an issue raised in a petition for rulemaking (PRM), PRM-50-116, submitted by the Nuclear Energy Institute (NEI) on August 2, 2018. The petition requested the NRC to amend its regulations to remove all nonemergency notification requirements for operating nuclear power reactors. On August 12, 2021, the NRC published a notice in the
The regulatory basis recommends that the NRC pursue rulemaking to remove six of the nonemergency event notification requirements, clarify regulatory guidance for two of the requirements, and make no changes to the rest of the nonemergency event notification requirements. The NRC also recommends rulemaking to provide a voluntary, alternative method for submitting nonemergency event reports to the NRC.
The NRC will consider feedback received on the regulatory basis in the development of the planned proposed rule and will address written comments in that proposed rule.
The Cumulative Effects of Regulation (CER) describes the challenges that licensees or other impacted entities (such as State agency partners) may face while implementing new regulatory positions, programs, and requirements (
1. In light of any current or projected CER challenges, what should be a reasonable effective date, compliance date, or submittal date(s) from the time the final rule is published to the actual implementation of any new proposed requirements, including changes to programs, procedures, or the facility?
2. If current or projected CER challenges exist, what should be done to address this situation (
3. Do other regulatory actions (
4. Are there unintended consequences? Does the potential proposed action create conditions that would be contrary to the potential proposed action's purpose and objectives? If so, what are the consequences and how should they be addressed?
Please provide information on the costs and benefits of the potential proposed action. This information will be used to support additional regulatory analysis by the NRC.
The documents identified in the following table are available to interested persons through one or more of the following methods, as indicated.
The NRC may post documents related to this rulemaking activity to the Federal rulemaking website at
The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal agencies to write documents in a clear, concise, and well-organized manner. The NRC has written this document to be consistent with the Plain Writing Act as well as the Presidential Memorandum, “Plain Language in Government Writing,” published June 10, 1998 (63 FR 31885). The NRC requests comment on this document with respect to the clarity and effectiveness of the language used.
For the Nuclear Regulatory Commission.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to adopt a new airworthiness directive (AD) for certain Continental Aerospace
The FAA must receive comments on this NPRM by December 27, 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 Continental Aerospace Technologies GmbH, Platanenstrasse 14, 09356 Sankt Egidien, Germany; phone: +49 37204 696 0; email:
• You may view this service information at the FAA, Airworthiness Products Section, Operational Safety Branch, 1200 District Avenue, Burlington, MA 01803. For information on the availability of this material at the FAA, call (817) 222-5110.
Barbara Caufield, Aviation Safety Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: (781) 238-7146; 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 regulations.gov, including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this NPRM.
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 Barbara Caufield, Aviation Safety Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.
The European Union Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2021-0022, dated January 18, 2021 (referred to after this as “the MCAI”), to address an unsafe condition on certain Continental Aerospace Technologies GmbH (Type Certificate previously held by Technify Motors GmbH and Thielert Aircraft Engines GmbH) TAE 125-02-99 and TAE 125-02-114 model reciprocating engines. The MCAI states that the manufacturer has received reports of fractured main bearing studs. A fractured main bearing stud provides improper support to the crankshaft and increases crankshaft clearance, resulting in crankshaft sensor failures and potential crankshaft fracture. The manufacturer is investigating the root cause of main bearing stud failures. To address this unsafe condition, Continental Aerospace Technologies GmbH published service information to identify the serial numbers (S/Ns) of the affected engines and specify procedures for replacement of certain main bearing studs. The MCAI specifies actions to replace main bearing studs and specifies certain main bearing studs that are not to be installed onto any engine. This condition, if not addressed, could result in engine in-flight shutdown and forced landing, damage to the airplane, and injury to the occupants. The FAA is issuing this AD to address the unsafe condition.
You may examine the MCAI in the AD docket at
The FAA reviewed Continental Aerospace Technologies GmbH Service Bulletin (SB) CG 125-1027 P1, Revision 1, dated May 28, 2021. This service information identifies the S/Ns of the affected engines and specifies procedures for replacing the main bearing studs. The FAA also reviewed Continental Aerospace Technologies GmbH Repair Instruction RI-05-0017-04, Revision 4, dated April 1, 2021. This service information provides instructions for replacing the main bearing studs.
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
These products have been approved by the aviation authority of another country and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with this State of Design Authority, it has notified the FAA of the unsafe condition described in the MCAI and service information described above. The FAA is issuing this NPRM after determining that the unsafe condition described previously is likely to exist or develop on other products of these same type designs.
This proposed AD would require the removal of certain main bearing studs
The FAA estimates that this AD, if adopted as proposed, would affect 92 engines installed on aircraft 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 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 December 27, 2022.
None.
This AD applies to Continental Aerospace Technologies GmbH (Type Certificate previously held by Technify Motors GmbH and Thielert Aircraft Engines GmbH) TAE 125-02-99 and TAE 125-02-114 model reciprocating engines with an engine serial number (S/N) identified in Models Affected, Continental Aerospace Technologies GmbH Service Bulletin (SB) CG 125-1027 P1, Revision 1, dated May 28, 2021.
Joint Aircraft System Component (JASC) Code 7200, Engine (Turbine/Turboprop).
This AD was prompted by manufacturer reports of fractured main bearing studs. The FAA is issuing this AD to prevent failure of the main bearing stud. The unsafe condition, if not addressed, could result in engine in-flight shutdown and forced landing, damage to the airplane, and injury to the occupants.
Comply with this AD within the compliance times specified, unless already done.
(1) For Group 1 and Group 2 engines, before exceeding the applicable compliance time in Table 1 to paragraph (g)(1) of this AD, remove all main bearing studs from service if one or more main bearing studs with part number (P/N) 05-7211-K009801 and batch number B180703/1, B184216/1, B184216/2, or B191277/1 are installed on the engine and replace with parts eligible for installation in accordance with Instructions, paragraphs 4.2 through 4.2.17 of Continental Aerospace Technologies GmbH Repair Instruction RI-05-0017-04, Revision 4, dated April 1, 2021 (Continental Aerospace Technologies GmbH RI-05-0017-04, Revision 4).
(2) For engines not installed on an airplane as of the effective date of this AD, before further flight, remove all main bearing studs if one or more main bearing studs with P/N 05-7211-K009801 and batch number B180703/1, B184216/1, B184216/2, or B191277/1 are installed on the engine and replace with parts eligible for installation in accordance with Instructions, paragraphs 4.2 through 4.2.17 of Continental Aerospace Technologies GmbH RI-05-0017-04, Revision 4.
After the effective date of this AD, do not install onto any engine a main bearing stud with P/N 05-7211-K009801 and batch number B180703/1, B184216/1, B184216/2, or B191277/1.
(1) For the purpose of this AD, Group 1 engines are affected engines installed on single-engine airplanes, with main bearing stud with P/N 05-7211-K009801 and batch number B180703/1, B184216/1, B184216/2, or B191277/1 installed on the engine, and affected engines installed on twin-engine airplanes, with main bearing stud with P/N 05-7211-K009801 and batch number B180703/1, B184216/1, B184216/2, or B191277/1 installed on both engines.
(2) For the purpose of this AD, Group 2 engines are affected engines installed on twin-engine airplanes, with main bearing stud with P/N 05-7211-K009801 and batch number B180703/1, B184216/1, B184216/2, or B191277/1 installed on only one engine.
(3) For the purpose of this AD, parts eligible for installation are any main bearing studs that do not have P/N 05-7211-K009801 and batch number B180703/1, B184216/1, B184216/2, or B191277/1.
The Manager, ECO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in § 39.19. In accordance with § 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in paragraph (k)(2) of this AD and email to:
(1) Refer to European Union Aviation Safety Agency (EASA) AD 2021-0022, dated January 18, 2021, for related information. This EASA AD may be found in the AD docket at
(2) For more information about this AD, contact Barbara Caufield, Aviation Safety Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: (781) 238-7146; email:
(1) The Director of the Federal Register approved the incorporation by reference of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.
(i) Continental Aerospace Technologies GmbH Service Bulletin CG 125-1027 P1, Revision 1, dated May 28, 2021.
(ii) Continental Aerospace Technologies GmbH Repair Instruction RI-05-0017-04, Revision 4, dated April 1, 2021.
(3) For Continental Aerospace Technologies GmbH service information identified in this AD, contact Continental Aerospace Technologies GmbH, Platanenstrasse 14, 09356 Sankt Egidien, Germany; phone: +49 37204 696 0; email:
(4) You may view this service information at the FAA, Airworthiness Products Section, Operational Safety Branch, 1200 District Avenue, Burlington, MA 01803. For information on the availability of this material at the FAA, call (817) 222-5110.
(5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email:
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to supersede Airworthiness Directive (AD) 2022-09-03, which applies to certain Airbus SAS Model A350-941 and -1041 airplanes. AD 2022-09-03 requires revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive airworthiness limitations. Since the FAA issued AD 2022-09-03, the FAA has determined that new or more restrictive airworthiness limitations are necessary. This proposed AD would continue to require the actions in AD 2022-09-03 and require revising the existing maintenance or inspection program, as applicable, to incorporate additional new or more restrictive airworthiness limitations, 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 December 27, 2022.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
• For 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 view this material at the FAA, Airworthiness Products Section, Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.
Dan Rodina, Aerospace Engineer, Large Aircraft Section, FAA, International Validation Branch, 2200 South 216th St., Des Moines, WA 98198; telephone 206-231-3225; 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 Dan Rodina, Aerospace Engineer, Large Aircraft Section, FAA, International Validation Branch, 2200 South 216th St., Des Moines, WA 98198; telephone 206-231-3225; email
The FAA issued AD 2022-09-03, Amendment 39-22023 (87 FR 29030, May 12, 2022) (AD 2022-09-03), which applies to certain Airbus SAS Model A350-941 and -1041 airplanes. AD 2022-09-03 requires revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive airworthiness limitations. The FAA issued AD 2022-09-03 to address the potential failure of certain life-limited parts, which could result in reduced structural integrity of the airplane.
Since the FAA issued AD 2022-09-03, the FAA has determined that additional new or more restrictive airworthiness limitations are necessary.
EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2022-0124, dated June 28, 2022 (EASA AD 2022-0124) (also referred to as the MCAI), to correct an unsafe condition for all Airbus SAS Model A350-941 and -1041 airplanes. EASA AD 2022-0124 superseded EASA AD 2021-0206 (which corresponds to FAA AD 2022-09-03).
Airplanes with an original airworthiness certificate or original export certificate of airworthiness issued after May 2, 2022 must comply with the airworthiness limitations specified as part of the approved type design and referenced on the type certificate data sheet; this proposed AD therefore does not include those airplanes in the applicability.
This proposed AD was prompted by a determination that new or more restrictive airworthiness limitations are necessary. The FAA is proposing this AD to address the potential failure of certain life-limited parts, which could result in reduced structural integrity of the airplane. See the MCAI for additional background information.
EASA AD 2022-0124 specifies new or more restrictive airworthiness limitations for airplane structures and safe life limits.
This proposed AD would also require EASA AD 2021-0206, dated September 15, 2021, which the Director of the Federal Register approved for incorporation by reference as of June 16, 2022 (87 FR 29030, May 12, 2022).
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
These products have been approved by the aviation authority of another country and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with the State of Design Authority, it has notified the FAA of the unsafe condition described in the MCAI described above. The FAA is issuing this NPRM after determining that the unsafe condition described previously is likely to exist or develop in other products of these same type designs.
This proposed AD would retain the requirements of AD 2022-09-03. This proposed AD would also require revising the existing maintenance or inspection program, as applicable, to incorporate additional new or more restrictive airworthiness limitations, which are specified in EASA AD 2022-0124 described previously, as proposed for incorporation by reference. Any differences with EASA AD 2022-0124 are identified as exceptions in the regulatory text of this AD.
This proposed AD would require revisions to certain operator maintenance documents to include new actions (
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 2022-0124 by reference in the FAA final rule. This proposed AD would, therefore, require compliance with EASA AD 2022-0124 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 2022-0124 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 2022-0124. Service information required by EASA AD 2022-0124 for compliance will be available at
The FAA's process of incorporating by reference MCAI ADs as the primary source of information for compliance with corresponding FAA ADs has been limited to certain MCAI ADs (primarily those with service bulletins as the primary source of information for accomplishing the actions required by the FAA AD). However, the FAA is now expanding the process to include MCAI ADs that require a change to airworthiness limitation documents, such as airworthiness limitation sections.
For these ADs that incorporate by reference an MCAI AD that changes airworthiness limitations, the FAA requirements are unchanged. Operators must revise the existing maintenance or inspection program, as applicable, to incorporate the information specified in the new airworthiness limitation document. The airworthiness limitations must be followed according to 14 CFR 91.403(c) and 91.409(e).
The previous format of the airworthiness limitation ADs included a paragraph that specified that no alternative actions (
The FAA estimates that this AD, if adopted as proposed, would affect 30 airplanes of U.S. registry. The FAA estimates the following costs to comply with this proposed AD:
The FAA estimates the total cost per operator for the retained actions from AD 2022-09-03 to be $7,650 (90 work-hours × $85 per work-hour).
The FAA has determined that revising the existing maintenance or inspection program takes an average of 90 work-hours per operator, although the agency recognizes that this number may vary from operator to operator. Since operators incorporate maintenance or inspection program changes for their affected fleet(s), the FAA has determined that a per-operator estimate is more accurate than a per-airplane estimate.
The FAA estimates the total cost per operator for the new proposed actions to be $7,650 (90 work-hours × $85 per work-hour).
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 December 27, 2022.
This AD replaces AD 2022-09-03, Amendment 39-22023 (87 FR 29030, May 12, 2022) (AD 2022-09-03).
This AD applies to Airbus SAS Model A350-941 and -1041 airplanes, certificated in any category, with an original airworthiness certificate or original export certificate of airworthiness issued on or before May 2, 2022.
Air Transport Association (ATA) of America Code 05, Time Limits/Maintenance Checks.
This AD was prompted by a determination that new or more restrictive airworthiness limitations are necessary. The FAA is issuing this AD to address the potential failure of certain life-limited parts, which could result in reduced structural integrity of the airplane.
Comply with this AD within the compliance times specified, unless already done.
This paragraph restates the requirements of paragraph (j) of AD 2022-09-03, with no changes. For airplanes with an original airworthiness certificate or original export certificate of airworthiness issued on or before June 30, 2021: 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 Agency (EASA) AD 2021-0206, dated September 15, 2021 (EASA AD 2021-0206). Accomplishing the revision of the existing maintenance or inspection program required by paragraph (j) of this AD terminates the requirements of this paragraph.
This paragraph restates the requirements of paragraph (k) of AD 2022-09-03, with no changes.
(1) Where EASA AD 2021-0206 refers to its effective date, this AD requires using June 16, 2022 (the effective date of AD 2022-09-03).
(2) The requirement specified in paragraph (1) of EASA AD 2021-0206 does not apply to this AD.
(3) Paragraph (2) of EASA AD 2021-0206 specifies revising “the approved AMP” within 12 months after its effective date, but this AD requires revising the existing maintenance or inspection program, as applicable, within 90 days after June 16, 2022 (the effective date of AD 2022-09-03).
(4) The initial compliance time for doing the tasks specified in paragraph (2) of EASA AD 2021-0206 is at the applicable “limitations” as incorporated by the requirements of paragraph (2) of EASA AD 2021-0206, or within 90 days after June 16, 2022 (the effective date of AD 2022-09-03), whichever occurs later.
(5) The provisions specified in paragraph (3) and (4) of EASA AD 2021-0206 do not apply to this AD.
(6) The “Remarks” section of EASA AD 2021-0206 does not apply to this AD.
This paragraph restates the requirements of paragraph (l) of AD 2022-09-03, with a new exception. Except as required by paragraph (j) of this AD, after the revision of the existing maintenance or inspection program has been accomplished as required by paragraph (g) of this AD, no alternative actions (
Except as specified in paragraph (k) of this AD: Comply with all required actions and compliance times specified in, and in accordance with, EASA AD 2022-0124, dated June 28, 2022 (EASA AD 2022-0124). Accomplishing the revision of the existing maintenance or inspection program required by this paragraph terminates the requirements of paragraph (g) of this AD.
(1) The requirement specified in paragraph (1) of EASA AD 2022-0124 does not apply to this AD.
(2) Paragraph (2) of EASA AD 2022-0124 specifies revising “the approved AMP” within 12 months after its effective date, but this AD requires revising the existing maintenance or inspection program, as applicable, within 90 days after the effective date of this AD.
(3) The initial compliance time for complying with the limitations specified in paragraph (2) of EASA AD 2022-0124 is at the applicable “limitations” as incorporated by the requirements of paragraph (2) of EASA AD 2022-0124, or within 90 days after the effective date of this AD, whichever occurs later.
(4) The provisions specified in paragraphs (3) and (4) of EASA AD 2022-0124 do not apply to this AD.
(5) The “Remarks” section of EASA AD 2022-0124 does not apply to this AD.
After the existing maintenance or inspection program has been revised as required by paragraph (j) of this AD, no alternative actions (
The following provisions also apply to this AD:
(1)
(2)
For more information about this AD, contact Dan Rodina, Aerospace Engineer, Large Aircraft Section, FAA, International Validation Branch, 2200 South 216th St., Des Moines, WA 98198; telephone 206-231-3225; email
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise.
(3) The following service information was approved for IBR on [DATE 35 DAYS AFTER PUBLICATION OF THE FINAL RULE].
(i) European Union Aviation Safety Agency (EASA) AD 2022-0124, dated June 28, 2022.
(ii) [Reserved]
(4) The following service information was approved for IBR on June 16, 2022 (87 FR 29030, May 12, 2022).
(i) European Union Aviation Agency (EASA) AD 2021-0206, dated September 15, 2021.
(ii) [Reserved]
(5) For EASA ADs 2021-0206 and 2022-0124, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
(6) You may view this service information at the FAA, Airworthiness Products Section, Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.
(7) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to adopt a new airworthiness directive (AD) for certain GE Aviation Czech s.r.o. (GEAC) M601E-11, M601E-11A, M601E-11AS, M601E-11S, and M601F model turboprop engines. This proposed AD was prompted by the exclusion of life limits for certain compressor cases and compressor drums from the airworthiness limitations section (ALS) of the engine maintenance manual (EMM). This proposed AD was also prompted by certain compressor cases that, following rework, were improperly re-identified and the engine logbook entries were not completed. This proposed AD would require recalculation of the consumed life for the affected compressor cases and compressor drums and, depending on the results of the recalculation, removal and replacement of the affected compressor case or compressor drum with a part eligible for installation. The FAA is proposing this AD to address the unsafe condition on these products.
The FAA must receive comments on this NPRM by December 27, 2022.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
• For GEAC material identified in this NPRM, contact GE Aviation Czech s.r.o., Beranových 65, 199 02 Praha 9, Letňany, Czech Republic; phone: +420 222 538 111.
• You may view this material at the FAA, Airworthiness Products Section, Operational Safety Branch, 1200 District Avenue, Burlington, MA 01803. For information on the availability of this material at the FAA, call (817) 222-5110.
Barbara Caufield, Aviation Safety Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: (781) 238-7146; 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 Barbara Caufield, Aviation Safety Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.
The European Union Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2021-0264, dated November 22, 2021 (referred to after this as “the MCAI”), to correct an unsafe condition on GEAC M601E, M601E-11, M601E-11A, M601E-11AS, M601E-11S, M601E-21, M601F and M601FS model turboprop engines. The MCAI states that the life limits for certain compressor cases and compressor drums were not published in the applicable ALS of the EMM for certain GEAC M601 model turboprop engines. The MCAI also states that following rework of certain compressor cases from part number (P/N) M601-154.6 to P/N M601-154.51, those compressor cases were improperly re-identified and the engine logbook entries were not completed, which could cause the compressor case to remain in service beyond its applicable life limit. This condition can lead to failure of an affected part, possibly resulting in engine mount failure and high energy debris release.
As a result of this unsafe condition, the MCAI specifies replacement of the affected parts and engine logbook correction. The MCAI also specifies conditions and clarifications for parts installation using GEAC Alert Service Bulletin ASB-M601F-72-30-00-0061 [01] and ASB-M601E-72-30-00-0110 [01], (single document; formatted as service bulletin identifier [revision number]), dated October 15, 2021.
You may examine the MCAI in the AD docket at
The FAA reviewed GEAC Alert Service Bulletin ASB-M601F-72-30-00-0061 [01] and ASB-M601E-72-30-00-0110 [01], (single document; formatted as service bulletin identifier
This ASB is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in
These products have been approved by the aviation authority of another country and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with this State of Design Authority, it has notified the FAA of the unsafe condition described in the MCAI and service information described above. The FAA is issuing this NPRM after determining that the unsafe condition described previously is likely to exist or develop on other products of the same type design.
This proposed AD would require recalculation of the consumed life for the affected compressor cases and compressor drums and, depending on the results of the recalculation, removal and replacement of the affected compressor case or compressor drum with a part eligible for installation.
EASA AD 2022-0034 includes an Engine Logbook Correction paragraph which specifies correction of the compressor case P/N, while this proposed AD does not include the Engine Logbook Correction paragraph.
EASA AD 2022-0034 applies to GEAC M601E, M601E-21, and M601FS model turboprop engines, and this AD does not because they do not have an FAA type certificate.
The FAA estimates that this AD, if adopted as proposed, would affect 7 engines installed on airplanes of U.S. registry.
The FAA estimates the following costs to comply with this proposed AD:
The FAA estimates the following costs to do any necessary replacements that would be required based on the recalculated consumed life of the affected parts. The agency has no way of determining the number of aircraft that might need these replacements:
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 December 27, 2022.
None.
This AD applies to GE Aviation Czech s.r.o. (GEAC) M601E-11, M601E-11A, M601E-11AS, M601E-11S, M601E-21, M601F, and M601FS model turboprop engines, with an installed compressor case part number (P/N) M601-154.51, which includes compressor cases identified as, or recorded in the engine logbook as P/N M601-154.6; or with an installed compressor drum having P/N M601-130.7 or P/N M601-134.7.
Joint Aircraft System Component (JASC) Code 7240, Turbine Engine Compressor Section.
This AD was prompted by the manufacturer's determination that the life limits for certain compressor cases and compressor drums were not published in the applicable airworthiness limitations section of the engine maintenance manual. Additionally, it was determined that following rework, certain compressor cases were improperly re-identified and the engine logbook entries were not completed. The FAA is issuing this AD to prevent the failure of the compressor case and compressor drum. The unsafe condition, if not addressed, could result in engine mount failure and high energy debris release.
Comply with this AD within the compliance times specified, unless already done.
(1) Within 90 days after the effective date of this AD, recalculate the consumed life of the affected compressor case and affected compressor drum in accordance with the formula and lifing coefficients in paragraph 2.B., Table 1 of the Accomplishment Instructions of GEAC Alert Service Bulletin ASB-M601F-72-30-00-0061 [01] ASB-M601E-72-30-00-0110 [01] (single document; formatted as service bulletin identifier [revision number]), dated October 15, 2021.
(2) For GEAC M601E-11, M601E-11A, and M601F model turboprop engines, before the recalculated consumed life of an affected compressor case exceeds 11,000 equivalent flight cycles (FCs), replace the compressor case with a compressor case eligible for installation.
(3) For GEAC M601E-11S and M601E-11AS model turboprop engines, before the recalculated consumed life of an affected compressor case exceeds 11,000 equivalent FCs, or within 12 months after the effective date of this AD, whichever occurs first, replace the compressor case with a compressor case eligible for installation.
(4) For all affected engines with an installed compressor drum having P/N M601-130.7 or M601-134.7, before the recalculated consumed life of the compressor drum exceeds 6,750 equivalent FCs, or within 12 months after the effective date of this AD, whichever occurs first, replace the compressor drum with a compressor drum eligible for installation.
(1) For the purpose of this AD, a “compressor case eligible for installation” is:
(i) For GEAC M601E-11, M601E-11A, and M601F model turboprop engines, an affected compressor case that is identified as P/N M601-154.51 with no reference to other P/N's and that does not have a recalculated consumed life that has exceeded its life limit, or a compressor case that is not P/N M601-154.51.
(ii) For GEAC M601E-11S and M601E-11AS model turboprop engines, a compressor case that is not P/N M601-154.51.
(2) For the purpose of this AD, a “compressor drum eligible for installation” is a compressor drum that is not P/N M601-130.7 or M601-134.7.
The Manager, ECO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in § 39.19. In accordance with § 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in paragraph (j)(2) of this AD and email to:
(1) Refer to European Union Aviation Safety Agency (EASA) AD 2021-0264, dated November 22, 2021, for related information. This EASA AD may be found in the AD docket at
(2) For more information about this AD, contact Barbara Caufield, Aviation Safety Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: (781) 238-7146; email:
(1) The Director of the Federal Register approved the incorporation by reference of the material listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.
(i) GE Aviation Czech Alert Service Bulletin ASB-M601F-72-30-00-0061 [01] and ASB-M601E-72-30-00-0110 [01], (single document; formatted as service bulletin identifier [revision number]), dated October 15, 2021.
(ii) Reserved.
(3) For GEAC service information identified in this AD, contact GE Aviation Czech s.r.o., Beranových 65, 199 02 Praha 9, Letňany, Czech Republic; phone: +420 222 538 111.
(4) You may view this material at the FAA, Airworthiness Products Section, Operational Safety Branch, 1200 District Avenue, Burlington, MA 01803. For information on the availability of this material at the FAA, call (817) 222-5110.
(5) You may view this material that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email:
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to adopt a new airworthiness directive (AD) for all The Boeing Company Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes. This proposed AD was prompted by an evaluation by the design approval holder (DAH) indicating that the skin lap splice at certain stringers is subject to widespread fatigue damage (WFD). This proposed AD would require an inspection for any repair at certain skin lap splices and depending on the configuration, repetitive inspections for buckling, wrinkling, bulging at affected skin lap splices and repair, repetitive inspections for cracking at affected locations common to fuselage skin on the left and right sides and repair, and alternative inspections and on-condition actions. The FAA is proposing this AD to address the unsafe condition on these products.
The FAA must receive comments on this proposed AD by December 27, 2022.
You may send comments, using the procedures found in 14 CFR
•
•
•
•
For service information identified in this NPRM, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; internet
You may examine the AD docket at
Willard Ashforth, Senior Aerospace Engineer, Airframe Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA 98198; phone: 206-231-3520; 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 Willard Ashforth, Senior Aerospace Engineer, Airframe Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA 98198; phone: 206-231-3520; email:
Fatigue damage can occur locally, in small areas or structural design details, or globally, in widespread areas. Multiple-site damage is widespread damage that occurs in a large structural element such as a single rivet line of a lap splice joining two large skin panels. Widespread damage can also occur in multiple elements such as adjacent frames or stringers. Multiple-site damage and multiple-element damage cracks are typically too small initially to be reliably detected with normal inspection methods. Without intervention, these cracks will grow, and eventually compromise the structural integrity of the airplane. This condition is known as WFD. It is associated with general degradation of large areas of structure with similar structural details and stress levels. As an airplane ages, WFD will likely occur, and will certainly occur if the airplane is operated long enough without any intervention.
An FAA final rule (“Aging Airplane Program: Widespread Fatigue Damage;” 75 FR 69746, November 15, 2010) became effective on January 14, 2011, and amended 14 CFR parts 25, 26, 121, and 129 (commonly known as the WFD rule). The WFD rule requires certain actions to prevent structural failure due to WFD throughout the operational life of certain existing transport category airplanes and all of these airplanes that will be certificated in the future. Design approval holders (DAHs) of existing and future airplanes subject to the WFD rule are required to establish a limit of validity (LOV) of the engineering data that support the structural maintenance program. Operators affected by the WFD rule may not fly an airplane beyond its LOV, unless an extended LOV is approved.
The WFD rule does not require identifying and developing maintenance actions if the DAHs can show that such actions are not necessary to prevent WFD before the airplane reaches the LOV. Many LOVs, however, do depend on accomplishment of future maintenance actions. As stated in the WFD rule, any maintenance actions necessary to reach the LOV will be mandated by airworthiness directives through separate rulemaking actions.
In the context of WFD, this action is necessary to enable DAHs to propose LOVs that allow operators the longest operational lives for their airplanes, and still ensure that WFD will not occur. This approach allows for an implementation strategy that provides flexibility to DAHs in determining the timing of service information development (with FAA approval), while providing operators with certainty regarding the LOV applicable to their airplanes.
The FAA has received reports indicating fuselage skin cracking found between stations (STA) 767 and STA 787, just below S-14R fuselage skin lap splice, where a lower skin panel buckle intersected the upper skin of the lap splice. Fuselage skin cracking was also found between just below S-14R between STA 747 and STA 767. Skin buckles, wrinkles, or bulges may be precursors to cracks at the potential affected fuselage longitudinal lap splice areas on all 737NG airplanes. Fatigue cracks initiated at multiple locations where linear anomalies were found in the clad layer of the lower skin. Areas of loose paint, discoloration, loose fasteners, lap joint separation, or disturbed sealant can be indicative of areas where skin buckles, wrinkles, or bulges have occurred. Such areas should
The FAA is issuing this NPRM after determining that the unsafe condition described previously is likely to exist or develop on other products of the same type design.
The FAA reviewed Boeing Special Attention Requirements Bulletin 737-53-1399 RB, dated May 20, 2022. This service information specifies procedures for a general visual inspection for any repair, any buckle, any wrinkle, any bulge, and any cracking at skin lap splice at stringers S-4 (Boeing Converted Freighter only), S-14 and S-24 (737-600 only). This service information also describes procedures, depending on the configuration, for repetitive detailed inspections for buckling, wrinkling, bulging at unrepaired areas of affected lap splices and repair; repetitive detailed, high frequency eddy current (HFEC), and ultrasonic (UT) inspections for cracking at affected locations common to fuselage skin on the left and right sides and repair; and alternative inspections and on-condition actions.
This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in
This proposed AD would require accomplishing the actions specified in the service information already described except for any differences identified as exceptions in the regulatory text of this proposed AD. For information on the procedures and compliance times, see this service information at
The FAA estimates that this AD, if adopted as proposed, would affect 2,462 airplanes of U.S. registry. The FAA estimates the following costs to comply with this proposed AD:
The FAA has received no definitive data on which to base the cost estimates for the on-condition repairs or for the alternative inspections and on-condition actions specified in 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 December 27, 2022
None.
This AD applies to all The Boeing Company Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes, certificated in any category.
Air Transport Association (ATA) of America Code 53, Fuselage.
This AD was prompted by an evaluation by the design approval holder (DAH) indicating that the skin lap splice at stringers S-4, S-14, and S-24 are subject to widespread fatigue damage (WFD). The FAA is issuing this AD to address cracks, skin buckles, wrinkles, and bulges at fuselage longitudinal lap splice areas at S-4, S-14 and S-24. This condition, if not addressed, could result in a large crack in the fuselage skin, which may result in the inability of a principal structural element to sustain limit load, which could result in reduced structural integrity of the airplane and lead to a decompression event.
Comply with this AD within the compliance times specified, unless already done.
Except as specified by paragraph (h) of this AD: At the applicable times specified in the “Compliance” paragraph of Boeing Special Attention Requirements Bulletin 737-53-1399 RB, dated May 20, 2022, do all applicable actions identified in, and in accordance with, the Accomplishment Instructions of Boeing Special Attention Requirements Bulletin 737-53-1399 RB, dated May 20, 2022.
(1) Where the Compliance Time columns of the tables in the “Compliance” paragraph of Boeing Special Attention Requirements Bulletin 737-53-1399 RB, dated May 20, 2022, use the phrase “the original issue date of Boeing Special Attention Requirements Bulletin 737-53-1399 RB,” this AD requires using “the effective date of this AD.”
(2) Where Boeing Special Attention Requirements Bulletin 737-53-1399 RB, dated May 20, 2022, specifies contacting Boeing for repair instructions or for alternative inspections: This AD requires doing the repair and doing the alternative inspections and applicable on-condition actions using a method approved in accordance with the procedures specified in paragraph (i) of this AD.
(1) The Manager, Seattle ACO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or responsible Flight Standards Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in paragraph (j)(1) of this AD. Information may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the responsible Flight Standards Office.
(3) An AMOC that provides an acceptable level of safety may be used for any repair, modification, or alteration required by this AD if it is approved by The Boeing Company Organization Designation Authorization (ODA) that has been authorized by the Manager, Seattle ACO Branch, FAA, to make those findings. To be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD.
(1) For more information about this AD, contact Willard Ashforth, Senior Aerospace Engineer, Airframe Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA 98198; phone: 206-231-3520; email:
(2) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; internet
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to amend Class D airspace, Class E surface airspace, and Class E airspace designated as an extension to a Class D surface area and Class E airspace extending upward from 700 feet above the surface at Athens/Ben Epps Airport, Athens, GA as a result of the biennial airspace evaluation. This action would eliminate the excess airspace remaining after the decommissioning of the Bulldog Non-Directional Beacon (NDB) and subsequent cancellation of the NDB Runway 27 approach to Athens/Ben Epps Airport effective October 15, 2015, as well as update the geographic coordinates for the airport and the point-of-origin. 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 December 27, 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-2022-1333; Airspace Docket No. 22-ASO-24 at the beginning of your comments. You may also submit comments through the internet at
FAA Order JO 7400.11G Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
Jennifer Ledford, Operations Support Group, Eastern Service Center, Federal Aviation Administration, 1701 Columbia Avenue, College Park, GA 30337; Telephone: (404) 305-5946.
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 airspace for Athens/Ben Epps Airport, Athens, GA, to support IFR operations in the area.
Interested persons are invited to comment on this proposed rulemaking
Communications should identify both docket numbers (Docket No. FAA-2022-1333 and Airspace Docket No. 22-ASO-24) 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-2022-1333; Airspace Docket No. 22-ASO-24.” The postcard will be dated/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 7400.11G, Airspace Designations and Reporting Points, dated August 19, 2022, and effective September 15, 2022. FAA Order JO 7400.11G is publicly available as listed in the
The FAA proposes an amendment to 14 CFR part 71 to amend Class D airspace for Athens/Ben Epps Airport by extending the airspace from a 4-mile radius to a 4.6-mile radius surrounding the airport, and by updating the airport's geographic coordinates to coincide with the FAA's database. Also, Class E surface airspace, extension to Class D airspace, and transition airspace would be amended for the above airport. Class E surface airspace for Athens/Ben Epps Airport would be amended by extending the airspace from a −4-mile radius to a 4.6-mile radius surrounding the airport. The Class E airspace used for an extension to Class D will be reduced from 3 miles to 2.4 miles on each side of the Athens Point of Origin 195° bearing extending from the 4.6-mile radius of the Athens/Ben Epps Airport to 7.6 miles south of the Point of Origin and will be reduced from 3 miles to 1.4 miles each side of the Athens Point of Origin 076° bearing extending from the 4.6-mile radius of the airport to 7 miles east of the Point of Origin. The Class E5 transition airspace extending upward from 700 feet above the surface would be amended to within a 7.7-mile radius of Athens/Ben Epps Airport (reduced from an 11.5-mile radius). This eliminates the excess airspace that remained after the decommissioning of the Bulldog (BJT) non-directional beacon (NDB) and subsequent cancellation of the NDB Rwy 27 approach, effective October 15, 2015 (80 FR 61978). In addition, this action would replace the outdated terms Airport/Facility Directory with the term Chart Supplement and Notice to Airmen with the term Notice to Air Missions, in the airspace descriptions. This action is replacing the VORTAC used for airspace definition with a point-of-origin.
Class D and E airspace designations are published in Paragraphs 5000, 6002, 6004, and 6005, respectively, of FAA Order JO 7400.11G, dated August 19, 2022, and effective September 15, 2022, which is incorporated by reference in 14 CFR 71.1. The Class D and 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 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 to and including 3,300 feet MSL within a 4.6-mile radius of the Athens/Ben Epps Airport. This Class D airspace area is effective during the specified dates and times established in advance by a Notice to Air Missions. The effective date and time will thereafter be continuously published in the Chart Supplement.
That airspace extending upward from the surface within a 4.6-mile radius of the Athens/Ben Epps Airport. This Class E airspace area is effective during the specific dates and times established in advance by a Notice to Air Missions. The effective date and time will thereafter be continuously published in the Chart Supplement.
That airspace extending upward from the surface within 2.4 miles on each side of the Athens Point of Origin 195° bearing extending from the 4.6-mile radius of the Athens/Ben Epps Airport to 7.6 miles south of the Point of Origin, and within 1.4 miles each side of the Athens Point of Origin 076° bearing extending from the 4.6-mile radius of the airport to 7 miles east of the Point of Origin. This Class E airspace area is effective during the specific dates and times established in advance by a Notice to Air Missions. The effective date and time will thereafter be continuously published in the Chart Supplement.
That airspace extending upward from 700 feet above the surface within a 7.7-mile radius of Athens/Ben Epps Airport.
Consumer Product Safety Commission.
Notice of proposed rulemaking; notice of opportunity for oral presentation of comments.
The U.S. Consumer Product Safety Commission (Commission or CPSC) has determined preliminarily that there is an unreasonable risk of injury and death associated with entrapment hazards from adult portable bed rails (APBRs). To address these risks, the Commission proposes a rule under the Consumer Product Safety Act (CPSA) to require that APBRs meet the requirements of the applicable voluntary standard on APBRs, with modifications. The Commission is providing an opportunity for interested parties to present written and oral comments on this notice of proposed rulemaking (NPR). Like written comments, any oral comments will be part of the rulemaking record.
Other comments, identified by Docket No. CPSC-2013-0022, may be submitted by any of the following methods:
Vineed Dayal, Directorate for Engineering Sciences, Office of Hazard Identification and Reduction, Consumer Product Safety Commission, National Product Testing and Evaluation Center, 5 Research Place, Rockville, MD 20850; telephone: 301-987-2292;
In 2013, the CPSC received two requests to initiate proceedings under the CPSA to address an unreasonable risk of injury associated with APBRs. Gloria Black, the National Consumer
The CPSC docketed the requests as a single petition: Petition CP 13-1, Petition Requesting a Ban or Standard on APBRs under the CPSA. On June 4, 2013, the Commission published a notice in the
On April 28, 2015, the Commission voted again to defer a decision on the petition to allow the ASTM voluntary standard development process to continue. Throughout this period, staff participated in the ASTM F15.70 subcommittee to develop the voluntary standard for APBRs. In August 2017, ASTM published the voluntary standard, ASTM F3186-17,
On July 15, 2020, staff provided the Commission a briefing package on its review of ASTM F3186-17 (Staff's 2020 briefing package).
On March 9, 2022, staff provided to the Commission another briefing package on ASTM F3186-17 (Staff's 2022 briefing package).
On March 16, 2022, the Commission voted to grant Petition CP 13-1 and directed staff to proceed with this NPR. In this proposed rule, the Commission preliminarily determines that APBRs pose an unreasonable risk of injuries and deaths associated with entrapment hazards.
This proposed rulemaking is authorized by the CPSA. 15 U.S.C. 2051-2084. Section 7(a) of the CPSA authorizes the Commission to promulgate a mandatory consumer product safety standard that sets forth performance or labeling requirements for a consumer product, if such requirements are reasonably necessary to prevent or reduce an unreasonable risk of injury. 15 U.S.C. 2056(a). Section 9 of the CPSA specifies the procedure that the Commission must follow to issue a consumer product safety standard under section 7 of the CPSA. In accordance with section 9, the Commission is commencing this rulemaking by issuing an NPR.
According to section 9(f)(1) of the CPSA, before promulgating a consumer product safety rule, the Commission must consider, and make appropriate findings to be included in the rule, on the following issues:
• The degree and nature of the risk of injury that the rule is designed to eliminate or reduce;
• The approximate number of consumer products subject to the rule;
• The need of the public for the products subject to the rule and the probable effect the rule will have on utility, cost, or availability of such products; and
• The means to achieve the objective of the rule while minimizing adverse effects on competition, manufacturing, and commercial practices.
Under section 9(f)(3) of the CPSA, to issue a final rule, the Commission must find that the rule is “reasonably necessary to eliminate or reduce an unreasonable risk of injury associated with such product” and that issuing the rule is in the public interest.
• The voluntary standard is not likely to eliminate or adequately reduce the risk of injury,
• Substantial compliance with the voluntary standard is unlikely.
There are several types of bed rails available to consumers under CPSC jurisdiction.
Although similar in design, these products may have different functions. Some are meant to keep the occupant from rolling out of bed, and others are intended to assist an occupant in getting in and out of bed or repositioning on the bed surface. Some of these products can serve both functions. Because of the similarity in design and means of attachment to the side of the bed, products intended for both types of uses can have the same potential entrapment hazards, as discussed in section III of this preamble.
In September and October 2021, CPSC staff conducted an online search that identified 12 firms supplying 65 distinct APBR models. Retail prices for the identified APBR models ranged from $38 to $275. Based on an interview with one APBR manufacturer's representative and market information from the identified APBR models, staff estimates that in 2021, the mean retail price is $50 per APBR; total market revenues are approximately $9 million; and the number of APBRs sold that year was approximately 180,000 units.
CPSC staff summarized the data on deaths and injuries involving APBRs (Tab A: Division of Hazard Analysis: Directorate for Epidemiology (EPHA)). Staff reviewed Consumer Product Safety Risk Management System (CPSRMS) injury cases and National Electronic Injury Surveillance System (NEISS) injury cases that occurred in the period from January 1, 2003, through December 31, 2021.
Staff identified a total of 332 incident reports for the period January 2003 to December 2021. Of these, 310 were reports of fatalities, and 22 were reports of nonfatal incidents. Most of the
The remaining incidents were extracted from various sources including newspaper clippings, consumer reports, and manufacturer and retailer reports to CPSC. These documents contain limited information on incident scenarios. The age range of victims in the 305 fatal incidents for which age was reported was 14 to 103 years. More than 75 percent of the incident victims were age 70 or older, and almost 80 percent of the reported fatalities involved victims ages 70 or older. Table 1 below presents the distribution of these APBR incidents by age.
Table 2 details the distribution of these APBR-related incidents by gender. Approximately 70 percent of all incident victims and incident fatalities were female.
Approximately 50 percent of all APBR-related incidents and fatalities occurred at home. Other commonly reported locations included nursing homes, assisted living facilities, and residential institutions, for example.
The majority of reports, 58 percent, indicated that the victim suffered from at least one underlying medical condition. Almost 34 percent were reported to have more than one medical condition. Table 4 below summarizes the most common underlying medical conditions reported.
Between January 2003 and December 2021, there were an estimated 79,500 injuries related to adult bed rails treated in hospital emergency departments (EDs) across the United States. There appeared to be a statistically significant increasing trend in injuries during this period. Staff's review showed that in the vast majority of NEISS cases, there was insufficient information available in the case narrative to determine whether the bed rail product involved was specifically an adult portable bed rail, or just a regular adult bed rail; only one case narrative specifies the product involved as an adult portable bed rail. Hence, the estimates presented in Table 5, which provides an overview of the estimated number of adult bed rail-related injuries per year, may be an overestimate. An estimated injury rate per 100,000 population has also been calculated, based on estimates of population ages 13 and older provided by the U.S. Census Bureau.
The vast majority (88 percent) of patients were treated and released or examined and released without treatment, while approximately 11 percent were hospitalized or held for observation. There was only one NEISS case that involved a death; the remaining 1,945 involving nonfatal injuries. This one NEISS case involving a death is separate from any of the CPSRMS incidents, and it was unclear what specific type of product was involved.
Staff from CPSC's Directorate for Health Sciences (HS) and from the Human Factors Division of the Directorate for Engineering Sciences (ESHF) (Tabs B and C of Staff's NPR briefing package) reviewed the incident
• More than 75 percent of the victims were age 70 or older.
• More than 80 percent of the reported fatalities involved victims ages 70 or older.
• Fifty-eight percent of victims suffered from at least one underlying medical condition.
• Almost 34 percent of victims were reported to have more than one medical condition.
Staff grouped the hazard types into four categories based on the bed rail's role in the incident. The categories are listed in order of highest to lowest frequency.
• Rail entrapment: There were 286 incidents related to rail entrapment. This category includes incidents in which the victim was caught, stuck, wedged, or trapped between the mattress/bed and the bed rail, between bed rail bars, between a commode and rail, between the floor and rail, between the night table and rail, or between a dresser and rail. Based on the narratives, the most frequently injured body parts were the neck and head. This category includes 284 fatalities and two nonfatal injuries from entrapment or wedging between the bed rail and mattress.
•
•
•
Rail entrapment, the most common hazard pattern among all reported incidents, accounted for more than 90 percent (284 of 310) of the fatal incidents. A review of the In-Depth Investigations (IDIs)
Of the 310 fatal incidents, approximately 34 percent reported the victim to have multiple medical conditions, and approximately 58 percent of incidents reported at least one underlying medical condition. The vast majority of nonfatal incident reports (all reports except one) did not list any underlying medical condition. Preexisting chronic medical conditions or disorders included Alzheimer's disease, dementia, and other mental limitations; Parkinson's disease; cerebral palsy; multiple sclerosis; Lesch-Nyhan syndrome;
CPSC staff identified falls as the second most common hazard pattern associated with APBRs, accounting for 25 incidents (8 percent), 23 of which resulted in fatality. Staff found that most falls associated with APBRs involve the victim falling against or striking the APBR, but these incident reports usually have limited details. Therefore, the APBRs might have played an incidental role in some of these cases. A minority of fall-related incidents, according to staff's review, involved the victim deliberately climbing over the APBR.
To issue a final rule under section 9(f)(3) of the CPSA if a voluntary standard addressing the risk of injury has been adopted and implemented, the Commission must find that:
• The voluntary standard is not likely to eliminate or adequately reduce the risk of injury,
• Substantial compliance with the voluntary standard is unlikely.
Based on staff's review of ASTM F3186-17, the Commission has preliminarily determined that the voluntary standard is not likely to eliminate or adequately reduce the unreasonable risk of injury associated with entrapments on APBRs. In addition, based on several rounds of testing of APBRs, conducted by staff as discussed below, the Commission has preliminarily determined that substantial compliance with the voluntary standard is also unlikely. Accordingly, in this rule, the Commission proposes to incorporate by reference ASTM F3186-17, with modifications, to address the entrapment hazards associated with APBRs. CPSC staff's assessment of the provisions of ASTM F3186-17 are summarized below.
ASTM F3186-17 establishes performance requirements for APBRs, including requirements for resistance to entrapment, marking and labeling, and instructional literature. Section 3.1.1 of ASTM F3186-17 defines “adult portable bed rail” as:
[A]n adjacent type bed rail, grab bar, assistive bar, transfer aid, cane or rail (henceforth identified as the product or products) intended by the manufacturer to be installed on, against, or adjacent to an adult bed. The product may vary in lengths (for example, full, half, or partial rails, grab bar or handle or transfer post or pole), and is intended by the manufacturer to aid the bed occupant in moving on the bed surface, in entering or exiting the bed, to minimize the possibility of falling out of bed, or for other similar purposes. This includes similar products that are likely to be used for these purposes even if this is not explicitly stated by the manufacturer. However, the standard does not address all products that might be so used, for example, a chair.
ASTM F3186—17 (section 3.1.2) defines “adjacent type bed rail” as:
[A] portable bed rail or related product in which the guard portion (portion that an adult would contact when rolling toward the mattress edge) is essentially a vertical plane or pole that is positioned against the side of the mattress.
The Commission preliminarily determines that these definitions are appropriate for evaluating APBRs that: (1) are installed or used along the side of a bed and intended to reduce the risk of falling from the bed; (2) assist the consumer in repositioning in the bed; or (3) assist the consumer in transitioning into or out of the bed.
Section 5 of ASTM F3186-17 sets out general requirements. Section 5.1 requires that there will be no hazardous sharp points or edges. Section 5.2 states that any exposed parts shall be smooth and free from rough edges. Section 5.3 requires that products covered by the standard that are installed on a bed that articulates (
General requirements mandating smooth edges on exposed parts improve safety by preventing potential lacerations or skin injuries from APBRs. In addition, testing APBR products on articulating beds allows assessment of openings that could potentially lead to entrapment when the bed is adjusted from the flat position to the articulated position.
In addition to the general requirements, several performance requirements in ASTM F3186-17 are intended to address the risk of injury associated with APBRs. These include requirements for assembly, structural integrity, retention system performance, and fall and entrapment prevention.
Staff identified 284 fatal incidents related to rail entrapment. This hazard pattern is the most prevalent among the incidents, accounting for more than 90 percent of all fatal incidents. Effectively addressing the entrapment hazard associated with APBRs depends upon, among other things, consumers assembling and installing the product properly. ASTM F3186-17 includes performance requirements intended to improve the likelihood that the APBR will be assembled and installed properly. For example:
• Section 6.1 sets forth a requirement for products to include a retention system, which maintains the installed product in position without requiring readjustment of the components. This retention system must be permanently attached to the APBR once it has been assembled and must not be removable without the use of a tool.
• Section 6.2 includes structural integrity requirements that call for the product to be tested without changing dimensions.
• Section 6.5 requires that structural components and retention system components must not be capable of being misassembled, which the standard defines as the APBR being assembled in a way that appears functional but would not meet the retention system (section 6.1), structural integrity (6.2), entrapment (6.3), or openings (6.4) requirements.
The requirement that retention systems be permanently attached to the APBR once it has been assembled, and removable only with a tool, reduces the likelihood that consumers will misplace the retention system, and increases the likelihood that consumers, including secondary users, will continue to use the retention system. The requirement that structural and retention system components not be misassembled reduces the risk of injury or death that could arise from the consumer omitting key parts of the APBR (
Falls were the second most common hazard pattern in the incident data, accounting for 25 incidents (8 percent). Staff found that most falls associated with APBRs involve the victim falling against or striking the APBR, but these incident reports usually have limited details. Therefore, the APBRs might have played an incidental role in some of these cases. If the fall was triggered by the APBR becoming dislodged, or its position shifted, then these incidents potentially may be addressed by the voluntary standard's structural integrity testing and the requirement of a permanently attached retention system to maintain the installed product in position. For example, section 6.2 of ASTM F3186-17 includes a “structural integrity” requirement that calls for the installed APBR to extend at least 4 inches above the top of the thickest recommended mattress. This minimum height requirement for APBRs may address some fall incidents by limiting the ability of consumers to climb over these products. However, some fall-related incidents involved the victim deliberately climbing over the APBR and this requirement may not prevent such consumers from falling over the bed rail.
Staff identified entrapment as the most prevalent hazard pattern among the incidents. In accordance with the entrapment test methods specified in section 8 of the standard, section 6.3 of ASTM F3186-17 requires products to be tested to assess the potential for entrapment in four different zones. These zones represent four of the seven sectors identified by the FDA in its 2006 guidance document, Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment (FDA, 2006), as potential areas of entrapment in hospital bed systems.
Section 8.4 defines the four entrapment zones tested under ASTM F3186-17, which are (1) within the product; (2) between rail support(s) and the bed mattress, when applicable, under the product; (3) between the product and the mattress; and (4) between the underside of the end of the product and the mattress. Entrapment testing to ASTM F3186-17 is performed using the anthropometric “entrapment test probe,” which is the cone and cylinder tool described in the 2006 FDA guidance document (section 7.2). In addition, some entrapment zones require using a force gauge to test the force applied on the test probe (section 7.3). Table 6 below, describes the four entrapment zones, with illustrations from the 2006 FDA guidance document of sample entrapments within each of these zones.
Staff's review of the rail entrapment incidents, test requirements, and test methods showed that most of the reported entrapment fatalities involved one of the four zones listed above. Specifically, staff could determine the entrapment location of 214 of the 284 fatal incidents, and all but six of these cases occurred in one of the four zones of entrapment tested in ASTM F3186-17, as shown in Table 7 below. Based on this analysis, it is likely that most of the 70 incidents for which there was insufficient information to identify the location of the entrapment also involved one of these four zones.
Staff's evaluation that rail entrapments predominantly occur in Zones 1 through 4 is also consistent with the FDA's finding that these four zones accounted for about 80 percent of hospital bed rail entrapment events reported to the FDA. FDA's recommended dimensional limits for these zones and the anthropometric test probe, serve as the basis for the entrapment requirements of ASTM F3186-17. CPSC's review indicates that the performance requirements in the standard, which are based on identified entrapment patterns and related anthropometric data, would effectively address the entrapment hazard patterns related to APBRs with proposed modifications, as discussed in section V. of this preamble.
Section 9.1 of ASTM F3186-17 specifies that the labeling on the APBR and its retail packaging must be marked with the type and size of beds and mattresses, including the mattress thickness range for which the APBR is intended. In addition, the labeling and retail packaging on the APBR must state the appropriate distance between an installed APBR and the headboard or footboard of the bed. The space between the APBR and headboard or footboard is considered Zone 6 under the 2006 FDA guidance document. ASTM F3186-17 requires the consumer to correctly install the APBR at the specified distance from the headboard or footboard to prevent entrapment. This hazard is addressed by requiring labeling on the APBR to state the appropriate distance between an installed APBR and the headboard or footboard of the bed. Section 9.1 also specifies that all on-product labels must be permanent.
Section 9.2 establishes requirements for warning statements that must appear on the APBR and its retail packaging, instructions, and digital or print advertising. The warning statements must be easy to understand, and any other labels or written instructions provided along with the required statements cannot contradict or confuse the meaning of the required warnings or otherwise be misleading.
Section 11 specifies requirements for instructional literature that must accompany APBRs. The instructions provided must be easy to read and understand; include assembly, installation, maintenance, cleaning, operation, and adjustment instructions and warnings, where applicable; include drawings or diagrams to provide a better understanding of set up and operation of the product; include drawings that depict all the entrapment zones; and include all warning statements specified in section 9.2, including warnings about product damage or misalignment.
Although requirements for labeling, warning, and instructional requirements are less effective at reducing hazards than product designs that directly address known hazards, these requirements in the standard improve safety by addressing risks that may not be eliminated through design.
For the reasons discussed in section V. of this preamble, the Commission preliminarily determines that the voluntary standard is not likely to eliminate or adequately reduce the unreasonable risk of injury associated with entrapments on APBRs. Accordingly, the Commission is proposing to adopt the voluntary standard with specified modifications necessary to improve safety and adequately reduce the unreasonable risk of injury associated with entrapment on APBRs.
Staff conducted two rounds of market compliance testing to ASTM F3186-17: the first round in 2018 and 2019, the second round in 2021. In both rounds, no APBRs met all requirements of ASTM F3186-17. All products failed at least one critical mechanical requirement, such as retention strap performance, structural integrity, and entrapment. As described in Tabs C and D of the Staff's NPR briefing package, an APBR that fails any one mechanical performance requirement could result in a fatal entrapment. Furthermore, all products failed the labeling, warning, and instructional requirements. This section discusses market compliance with ASTM F3186-17.
From 2018 through 2019, CPSC's Directorate for Laboratory Sciences, Division of Mechanical Engineering staff tested 35 randomly selected APBR models for compliance with ASTM F3186-17, which became effective in August 2017. APBRs were purchased in 2018. Staff tested the products to determine if they conformed to the general requirements and the performance requirements of the standard. Staff also tested conformance with the labeling, warning, and instructional literature requirements. Staff found that none of the 35 sampled products conformed to the voluntary standard. Staff assessment showed that market compliance with the standard was low when staff purchased the samples in 2018, after the standard had become effective. However, due to the lack of compliant labeling, staff could not confirm all the manufacture dates for the products to compare them to the standard's effective date. As shown in Table 8 below, compliance varied by section of the standard. Overall, 33 APBR models did not meet the entrapment performance requirements, and none of the 35 models met the labeling, warnings, or instructional literature requirements.
Of the 35 APBR models staff tested, 33 failed at least one of the entrapment requirements for the four different zones in and around the APBR. In other words, 94 percent of samples had at least one major zone where a body part could be entrapped. Furthermore, many samples failed the entrapment requirements in multiple zones: 14 failed the Zone 1 entrapment requirement; 27 failed Zone 2; 11 failed Zone 3; and 6 failed Zone 4.
Staff's testing also revealed high failure rates in several other sections, including the retention system requirements (28 of 35 samples), and structural integrity requirements (15 of 35 samples). These types of failures indicate that the product may not stay rigidly in place after installation and will not adequately support the consumer during normal use conditions, such as leaning against the product. Not meeting these requirements thus significantly increases the likelihood of entrapment and fall hazards.
Retention system failures occurred when components were not permanently attached to the product, the retention strap permanently deflected or detached during the free-end pull test,
All 35 models failed the labeling, warning, and instructional literature requirements. None of the 35 models fully met the following requirements: section 9.1 for retail packaging and product labels; section 9.2, which specifies that warning statements must appear on the product, its retail package, and its instructions; and section 11's requirement to include instructional literature with required warning statements. None of the samples adequately instructed consumers how to safely install the APBRs; nor did the samples adequately inform consumers of the known hazards related to APBRs. Detailed testing results are provided in Appendix A of the Staff's NPR briefing package.
In 2021, CPSC staff conducted a second round of product testing to ASTM F3186-17 to determine if the additional time and outreach efforts by staff since 2018 was sufficient for manufacturers to increase their overall level of compliance to the standard. A representative total of 17 APBR products were selected and procured for testing: these included all eight APBR models that staff identified as new to the market since the 2018 analysis, and nine additional, randomly selected models from the remaining models available in the market. The nine randomly selected models were products previously identified as available in the 2018 analysis, and were included to account for any undisclosed changes to the models that may have improved their compliance to the voluntary standard.
The 2021 testing, like the 2018 analysis, was designed to assess overall compliance to the voluntary standard, with a focus on certain sections including Retention Systems, Structural Integrity, Entrapment, Openings, Misassembled Products, Warning Statements, and Instructional Literature. All 17 samples failed at least one of these performance requirements. Detailed testing results are provided in Appendix B of the Staff's NPR briefing package. Because testing of a sample was stopped after it failed to meet at least one performance requirement, the data collected may not account for all the potential nonconformities for each product.
Additionally, none of the 17 models met the labeling, warnings, and instructional literature requirements. As shown in Table 9 below, the failure modes of this analysis are similar to those in the 2018 analysis, indicating little-to-no changes in the market over this time.
CPSC has issued five public notices regarding APBRs that did not comply with ASTM F3186-17. In April 2021, CPSC warned consumers to stop using three models of APBRs manufactured by Bed Handles, Inc., because the products pose an entrapment hazard.
In December 2021, CPSC announced voluntary recalls of APBRs manufactured by three firms, due to the
• Drive DeVilbiss Healthcare (496,100 units, 2 deaths);
• Compass Health Brands (104,900 units, 3 deaths); and
• Essential Medical Supply, Inc. (272,000 units, 1 death).
In June 2022, CPSC warned consumers to stop using 10 models of APBRs manufactured and sold by Mobility Transfer Systems, Inc. from 1992 to 2021, and by Metal Tubing USA, Inc. in 2021 and 2022. Three entrapment deaths involving one model have occurred.
As discussed in section V. of this preamble, the Commission preliminarily determines that, without additional modifications, the voluntary standard is insufficient to eliminate or adequately reduce the unreasonable risk of injury of entrapments on APBRs. Moreover, based on staff's test results showing that there is no market compliance with the voluntary standard, the Commission preliminarily determines that substantial compliance to a voluntary adult portable bed rail safety standard is unlikely. Accordingly, the Commission proposes to incorporate by reference, ASTM F3186-17 with modifications, to require APBR manufacturers to comply with the mandatory standard and thereby improve safety.
The Commission preliminarily determines that ASTM F3186-17, with modifications to improve safety, would likely address all known product hazard modes associated with APBRs, and particularly entrapment. These modifications are as follows:
• Provide additional definitions for product “assembly” and “installation” to ensure their consistent and differentiated use throughout the document;
• Include recommendations for manufacturers to take into account the range of mattress thicknesses to ensure safe use of the product by the consumer and provide testers with additional guidance for selecting the mattress thickness during the test setup;
• Address inconsistencies with stated dimensions to ensure consistent dimensional tolerances;
• Provide additional clarity for Zone 1 and 2 test setup and methods;
• Provide additional guidance for identifying potential Zone 2 openings;
• Update the requirements for Zone 3 testing for consistency; and
• Make grammatical and editorial corrections.
Proposed § 1270.1 provides that new part 1270 establishes a consumer product safety standard for APBRs manufactured after 30 days after publication of the final rule in the
Proposed § 1270.2 sets forth the requirements for APBRs that are required in addition to those required by ASTM F3186-17. Section 1270.2(a) would require each APBR to comply with all applicable provisions of ASTM F3186-17 with the following changes as set forth in § 1270(b):
The Commission proposes to add the following new definitions to ASTM F3186-17.
• Section 3.1.8:
• Section 3.1.9:
• Section 3.1.10:
These proposed definitions are intended to differentiate between “assembly” and “installation” so manufacturers can ensure products meet the requirements of sections 6.1.3 and 9.2.7, as discussed below. Although “installation component” is used throughout the voluntary standard, it was not explained. The new proposed definition helps clarify the location of warnings from section 9.2.7.
The Commission proposes to revise sections 6.1.3 and 9.2.7 with the definitions provided in proposed sections 3.1.8, 3.1.9 and 3.1.10 as follows:
• Section 6.1.3: Revise “Permanently attached retention system components shall not be able to be removed without the use of a tool after initial installation” by changing “initial installation” to “initial assembly.”
Staff's review shows that making the retention system permanent during product assembly ensures that retention system integrity is maintained, even if the product is reinstalled after initial assembly. Retention systems are a critical component for reducing known product hazards. Removable retention systems are known to lead to entrapment hazards. The additional definitions make clear that retention system should remain attached to the product and should not be compromised after initial assembly and between uninstallation, and reinstallation of the product.
• Section 9.2.7: Revise “At least one conspicuous component of the product must be labeled with the following entrapment warning” by changing “conspicuous component” to “installation component.”
Staff's review demonstrates that this warning is intended to draw attention to the installation component and to encourage its use. The installation component is commonly located under the mattress during use, and therefore, the warning would not be “conspicuous” when in the manufacturer's recommended use position. Requiring the warning to be on a “conspicuous component” most likely would not permit the warning to be placed on an installation component. The proposed language would instead draw attention to the installation component. Furthermore, the warning required by section 9.2.6, which also discusses entrapment hazards and keeping the product tight against the mattress, is required to be placed on an installation component rather than on a conspicuous component.
The Commission proposes to clarify the following sections of ASTM F3186-17:
• § 6.5.1: Revise “Any structural components and retention system components of a product covered by this specification that require consumer assembly shall not be able to be misassembled when evaluated to 6.5.2” to “Any structural components and retention system components of a product covered by this specification that require consumer assembly or adjustment, or components that may be removed by the consumer without the use of a tool, shall not be able to be misassembled when evaluated to 6.5.2.”
This revision clarifies that disassembly with the use of a tool is not considered as “misassembly” under section 6.5.
Section 6.5.2: Revise “Determining Misassembled Product: A product covered by this specification shall be considered misasssembled if it appears to be functional under any condition and it does not meet the requirements of 6.1-6.4.”
This editorial change corrects the misspelling of “misasssembled” to “misassembled.”
Staff's review shows that mattress thickness is a known variable that may cause some APBR product designs to have hazardous entrapment zones. Accordingly, to improve the safety of APBRs, the ASTM F3186-17 requirements should provide additional guidance on what thickness of mattress to use for testing APBR products. The following proposed new sections address this issue:
• Section 6.2.1.1: If the manufacturer does not recommend a specific applicable range of mattress heights or thicknesses, the test personnel shall choose a mattress that provides the most severe condition per test requirement. If the product has adjustable settings, and the manufacturer does not recommend orienting or adjusting features on the product in a specific manner, the testers shall adjust the product to the most severe condition per test requirement.
Defining a range of recommended mattress thicknesses provides consumers with necessary information for safe use of the product. If no mattress thickness is recommended, consumers may incorrectly assume safe use with any mattress thickness. Similarly, products may come with many types of adjustable settings. If appropriate setting recommendations are not provided, consumers may incorrectly assume all settings are safe. This requirement does not supersede misassembly requirements in section 6.5 but is proposed to be applied in addition to those requirements.
• Section 7.1.3: Mattress thickness ranges used for testing may be up to 1.5 in (38 mm) larger or smaller than the range specified by the manufacturer. If the manufacturer does not recommend a particular range of mattress heights, the testers shall choose a mattress that provides the most severe condition per test requirement. NOTE *: Proposed Mattress Type Clarification: The technology and consumer preferences for bedding are highly variable and continuously changing. Therefore, they cannot be reasonably accounted for within this standard. Test facilities and personnel should consider current bedding trends and all types of mattresses that may foreseeably be used with the product when making a test mattress selection.
Because mattress types are constantly changing, the proposed language in sections 6.2.1.1 and 7.1.3 informs manufacturers and testers to be aware of the types and variability of mattresses consumers may be using with these products and test accordingly. Consumers cannot be expected to be able to consistently measure mattress thickness, nor to purchase a new mattress for proper compatibility with a bed rail. Additionally, consumers are likely to follow nominal thickness descriptors of their mattresses which may vary from actual specifications. This additional range proposed for testing in new proposed section 7.1.3 may be up to 1.5 in (38 mm) larger or smaller than the range specified by the manufacturer, will increase safety by accounting for foreseeable reasonable differences between nominal and actual mattress thicknesses.
• Section 7.2:
To update outdated references, this section is proposed to be changed to state that the FDA guidance may be found at
The Commission is proposing revisions to test for Zone 3 entrapment hazards
• Section 6.3.3: Zone 3—Revise “The highest point on the cylinder of the test probe (see 7.2) shall not pass completely below the horizontal uncompressed plane of the mattress when tested according to 8.4.5.” Add at the end of the sentence “. . .when tested in accordance with section 8.4.5, the horizontal centerline on the face of the 4.7 in (120 mm) end of the test probe (see 7.2) shall be above the highest point of the uncompressed mattress.”
• Section 8.4.5.4: Revise “Turn the cone until the centerline on the face of the 4.7 in (119.38 mm) end is horizontal and let the cone sink into the space by its own weight. (1) If the line on the face of the 4.7 in (120 mm) end of the cone is above the surface of the mattress highest point of the uncompressed mattress, as shown in Figure 4a, the space passes the test. (2) If the line on the face of the 4.7 in (120 mm) end of the cone is at or below the surface of the mattress, the space fails the test.” Instead of the “below the surface of the mattress” insert “below the highest point of the uncompressed mattress, as shown in Figure 4b.”
• Section 8.4.5.4. Add the following proposed figures (Figure 4a and Figure 4b) for reference for Zone 3 test:
CPSC staff's review showed that the Zone 3 entrapment performance requirement in section 6.3.3 is redundant due to the failure criteria described in the associated test method, section 8.4.5.4. To ensure consistency, proposed revisions to these sections more accurately describe the test method for the highest level of safety and are also more consistent with the FDA guidance document referenced in the standard. In addition, the Figures 4a and 4b are proposed to assist testers in visualizing the test criteria.
• Section 6.4.1 Revise the measurements in “Holes or slots that extend entirely through a wall section of any rigid material less than
Staff's review showed that the measurement references in 6.4.1 were not accurate or consistent throughout the section, or the referenced Figure 2. The proposed change to this section fixes those issues and harmonizes the requirements with other established ASTM standards that have similar requirements such as ASTM F2085 (Children's Portable Bed Rails), codified under 16 CFR part 1224.
To make the current language and test method in ASTM F816-17 section 8.4.4 for Zone 2 entrapment testing (
• Section 8.4. NOTE 1: Revise “The tests described in this section are identical to those described in the referenced FDA Guidance Document and in the NSA video” to “The tests described in this section are similar to those described in the referenced FDA Guidance Document.”
Although the FDA guidance document is the source of the entrapment test methodologies, there are several differences in the proposed standard and the FDA guidance document. In addition, the NSA video is not available.
• Section 8.4.3.4: Revise “If the test probe does not pull through freely attach the force gauge and exert a 22.5 lbf (100 N) pulling force to the 2.4 in (60 mm) cylindrical end of the entrapment test tool perpendicular to the plane of the opening in both directions. If the 4.7 in (120 mm) end of the cone does not enter any of the openings, this space passes the test. If the 4.7 in (120 mm) end of the test probe cone does enter and pass through any of the openings, this space fails the test” to “If the test probe does not pull through freely attach the force gauge and exert a 22.5 lbf (100 N) pulling force along the axis of the cone, perpendicular to the 2.4 in (60 mm) cylindrical end of the entrapment test tool. If the 4.7 in (120 mm) end of the cone does not enter any
As explained by CPSC staff, the intent of this test is to determine if both the 2.4 in and 4.7 in portions of the test probe cone can enter or pass through any Zone 1 opening under the required force. This would mean that a body part can be entrapped, and a hazard is present. Furthermore, applying the force perpendicular to the opening may have multiple interpretations and may not always emulate the known hazard of head or limb entrapment. Applying the pull force perpendicular to the 2.4 in cylindrical end of the cone better represents these known hazards when compared to a pull force applied perpendicular to the face of the rail.
• Section 8.4.4.3: Revise “Insert the 2.4 in (60 mm) end of the cone perpendicular to the opening from the longitudinal centerline of the mattress” to “Insert the 2.4 in (60 mm) end of the cone into the opening.” Slide the cone into the opening until it is in full contact with the product. The mattress shall only be compressed by the weight of the cone.
The intent of this requirement is to address entrapment hazards associated with bed rails and head entrapment in Zone 2 by ensuring that the test probe cannot pass through any openings in the entrapment zone. This criterion is based on the FDA guidance document, which includes a dimension of 120 mm (4.75 in), encompassing the 5th percentile female head breadth. This dimension is represented by the 4.7 in portion of the test probe, and it should be applied in any orientation in which the head may be entrapped. The removed language may have led test personnel to unnecessarily restrict orientations to which the probe is applied.
• Section 8.4.4.4: Revise “Using the force gauge, exert a 22.5 lbf (100 N) pulling force to the 2.4 in (60 mm) cylindrical end of cone in both directions perpendicular to the rail” to “If the test probe does not pull through freely, use the force gauge to exert a 22.5 lbf (100 N) pulling force along the axis of the cone, perpendicular to the 2.4 in (60 mm) cylindrical end of cone.”
The intent of this test is to determine if both the 2.4 in and 4.7 in portions of the test probe cone can enter or pass through the Zone 2 opening under the required force. This would mean that a body part can be entrapped, and a hazard is present. Applying the pull force perpendicular to the 2.4 in cylindrical end of the cone represents these known hazards better when compared to a pull force applied perpendicular to the face of the rail, and also reduces ambiguity.
In addition, to take in account bed rails that have significant overhang, the NPR proposes to add new section 8.4.4.5.
• Section 8.4.4.5: If a horizontal section of the rail greater than 4.7 in (120 mm) exists along the bottom of the rail, that section must also meet the Zone 2 requirements.
Bed rails that have significant overhanging elements that would allow the passage of the head in a manner consistent with identified Zone 2 entrapment hazards were not considered during the development of the APBR testing procedure, but the overhang could potentially result in a similar entrapment. Thus, the requirements and test methods for these types of openings should be consistent with the Zone 2 requirements as reflected in the proposed language.
Section 8.6.3 of ASTM F3186-17 currently requires that “a 50 lbf force (222.5 N) force to be applied to the free end of the retention system in the horizontal direction,” without adequately defining the term “free end”. By adding a note to the end of section 8.6.3., to explain the location of the “free end” will clarify the test method for testers and make it more repeatable. Accordingly, the Commission proposes to add the following note:
• Section 8.6.3 NOTE ***: The “free end” is defined as the location on the retention system that is designed to produce a counter force; it may be a single distinct point or a location on a loop.
• Section 9.1.1.3: Revise “That the product is to be used only with the type and size of mattress and bed, including the range of thickness of mattresses specified by the manufacturer of the product. If beds with head or footboards are allowed, the distance between the head or footboard and the placement of the product shall be indicated to be either <2.4 in (60 mm) or >12.5 in (318 mm)” to remove “either <2.4 in (60 mm) or” from the last sentence.
This proposed change addresses an inconsistency between section 9.1.1.3, which states that products may be installed <2.4 in or >12.5 in away from head or footboards, and section 9.2.6, which states that products must be installed at least 12.5 in from headboards or footboards.
• Section 9.2.5: Revise the warning statement: Each product's retail package and instructions shall include the following warning statements:
This proposed change is a grammatical edit and brings the warning language into alignment with similar language used in section 9.2.6.
• Section 11.1.1.3: Revise “In addition to contacting the manufacturer directly, consumers should report
This proposed change is a grammatical edit.
The CPSC is proposing an anti-stockpiling provision to prevent firms from manufacturing large quantities of non-compliant APBRs before the rule takes effect and seeks comment on this provision. This section would make it a prohibited act for manufacturers and importers to manufacture or import APBRs that do not comply with the requirements of this part in any 1-month period between the date of publication of the final rule and the effective date of the final rule at a rate that is greater than 105 percent of the rate at which they manufactured or imported APBRs during the base period for the manufacturer or importer. The proposed base period for APBRs would be the calendar month with the median manufacturing or import volume within the last 13 months immediately preceding the month of promulgation of a final rule.
The findings required by section 9 of the CPSA are discussed throughout this preamble and set forth in § 1270.4 of the proposed rule.
Pursuant to section 9(c) of the Consumer Product Safety Act, publication of a proposed rule must include a preliminary regulatory analysis containing:
• A preliminary description of the potential benefits and potential costs of the proposed rule, including any benefits or costs that cannot be quantified in monetary terms, and an identification of those likely to receive the benefits and bear the costs.
• A discussion of why a relevant voluntary safety standard would not eliminate or adequately reduce the risk of injury addressed by the proposed rule.
• A description of any reasonable alternatives to the proposed rule, together with a summary description of their potential costs and benefits and why such alternatives should not be published as a proposed rule.
CPSC's preliminary assessment of the potential benefits and costs show that the annualized present value of the potential societal costs of the proposed rule is $298.11 million. If 92 percent of deaths caused by entrapment are addressed by the proposed rule, there are potential annual benefits of $266.99 million. CPSC also assessed lower efficacy rates of the proposed rule which showed the quantifiable benefits of the proposed rule in the range of $66.75 million (assuming a 25% efficacy rate) to $200.24 million per year (assuming a 75% efficacy rate). The costs associated with the proposed requirements to prevent the hazards associated with APBRs are expected to be $2.01 million per year. On a per product basis, the benefits of the proposed rule are estimated between $110.59 per APBR (25%) and $331.78 per APBR (75%), and the costs are estimated at $3.34 per APBR. All these amounts are in 2021 dollars using a discount rate of 3 percent. Staff's analysis is based is based on incident reports for entrapments, only. Although APBRs may have been involved in other deaths or injuries, such as falls, those incidents are not considered in the benefit cost analysis because there are limited details involving such incidents, and it is unclear whether these incidents would be prevented by the proposed rule.
The potential benefits and costs of the proposed rule are discussed in Tab G of the Staff's NPR briefing package. The most common hazard pattern among all reported incidents is rail entrapment, accounting for more than 90 percent (284 of 310) of the fatal incidents. For the preliminary regulatory analysis, staff chose the period of 2010 through 2019 to base its rates of fatalities per product because it was the most recent 10-year window where all or nearly all incidents have been reported. Staff identified 158 deaths from entrapment that occurred from 2010 through 2019. This number accounts for 92 percent of observed death incidents; the remaining 8 percent were caused by underlying incidents that may or may not be prevented by the proposed rule. To forecast entrapment deaths into the future, staff used death rates per million APBRs in conjunction with its forecast of APBRs in use throughout the study period. Staff assumed deaths would stay the same as the average rates observed between 2010 to 2019: 31.9 deaths per million APBRs. Staff forecasted APBRs in use using the population breakdown by age of APBR users, adjusted for population demographics and the growth of home healthcare spending.
To estimate the societal costs of entrapment deaths, staff applied the value of statistical life (VSL). VSL is an estimate used in benefit-cost analysis to place a value on reductions in the likelihood of premature deaths. The VSL does not place a value on individual lives, but rather, it represents an extrapolated estimate, based on the rate at which individuals trade money for small changes in mortality risk. This is a “willingness to pay” methodology that attempts to measure how much individuals are willing to pay for a small reduction in their own mortality risks, or how much additional compensation they would require to accept slightly higher mortality risks. For this analysis, staff applied estimates of the VSL developed by the U.S. Environmental Protection Agency (EPA). The EPA estimate of the VSL, when adjusted for inflation, is $10.5 million in 2021 dollars. Staff multiplied the VSL by the number of forecasted deaths throughout the study period to calculate societal costs of deaths from entrapment in the absence of the proposed rule.
CPSC staff assumes that the number of firms and APBR models in use will tend to be stable in future years around the values in 2022: 12 firms and 65 models. The market for APBRs is expected to grow at an average rate of 2.01 percent between 2024 and 2053 as a result of an aging U.S. population. Assuming the rates of incidents per million APBRs stays constant, an industry of this size would result in an average of 32 deaths from entrapment per year. At a value of a statistical life (VSL) of $10.5 million (2021 dollars), the annualized present value of the potential costs of the proposed rule is $298.11 million.
Staff did not include injuries in its benefit-cost assessment because for many incidents involving injuries, there is not sufficient information to determine whether they would be prevented by the proposed rule. However, staff has quantified and monetized the injuries in a sensitivity analysis as a potential upper limit to assess the benefits of this proposed rule. The requirements of the proposed rule are expected to address 92 percent of deaths caused by entrapment. However, staff also assessed potential benefits under three scenarios derived from this baseline efficacy, estimating benefits at: 75 percent, 50 percent, and 25 percent of their potential value.
At these rates under varying conservative assumptions (
Table 11 compares the benefits and costs on a per-unit basis, to add a marginal value perspective.
Staff's regulatory assessment of the costs of the proposed rule assumed that 100 percent of manufacturers will fully redesign their APBR models to comply with ASTM F3186-17, with modifications. Like the benefits estimation, the time span of the cost analysis covers a 30-year period that starts in 2024, which is the expected year of implementation of the rule. This cost analysis presents all cost estimates in 2021 dollars. This cost analysis also discounts costs in the future and uses a 3 percent discount rate to estimate their present value.
The cost of implementing an APBR fix to address entrapment hazards includes the costs manufacturers incur to redesign existing models and produce new designs to comply with ASTM F3186-17, as well as any additional cost of producing the APBR that is associated with its redesign. Manufacturers incur design costs that include redesigning existing APBR models, and designing APBR models in the future, to comply with the ASTM F3186 as modified. Manufacturers would likely incur expenditures in design labor, design production, design validation, and compliance testing. Staff's review indicates that once existing models have been redesigned with a working solution, new models can adapt the solution at a minimal cost.
Manufacturers can transfer some, or all, of the increased production cost to consumers through price increases. In the first year, staff expects producer manufacturing costs to increase by $5.40 per APBR, of which $4.00 per APBR is expected to be passed on to the consumer in the form of higher prices. At the margins, some producers may exit the market because their increased marginal costs now exceed the increase in market price. Likewise, a fraction of consumers would now probably be excluded from the market because the increased market price exceeds their personal price threshold for purchasing an APBR. Deadweight loss is the measure of the losses faced by marginal producers and consumers who are forced out of the market due to the new requirements of the proposed rule. For this analysis, staff estimated deadweight loss for each year the proposed rule is expected to have an impact on marginal cost and market price. Table 12 summarizes the cost of the proposed rule:
A major source of uncertainty is the omission of nonfatal entrapment injuries in the benefits assessment. This may result in a significant under-estimation of the benefits of the proposed rule. In its sensitivity analysis, staff included the benefits of averting all nonfatal injuries reported in NEISS, despite the uncertainty of whether these incidents would be in-scope of this proposed rule. These estimates serve as the theoretical upper bound of benefits from the proposed rule.
Staff used NEISS incidents and the Injury Cost Model (ICM) to extrapolate and generate national estimates for injuries from entrapment treated in EDs and other settings. The ICM calculated that there were 125,121 nonfatal injuries from entrapment in the United States from 2010 to 2019. Of this total, 79,563 were treated in an outpatient setting (
To forecast injuries from entrapment into the future, staff used injury rates per million APBRs in conjunction its forecast of APBRs in use throughout the study period. Staff assumed injuries would stay the same as the average rates observed between 2010 to 2019: 1,293.6 hospital admissions per million APBRs in use; 7,902.2 ED admissions per million APBRs in use; and 16,059.7 doctor/clinic visits per million APBRs in use. Staff forecasted APBRs in use based on the population breakdown by age of APBR users, adjusted for population demographics and the growth of home healthcare spending. Staff estimated the societal costs of nonfatal injuries using the ICM. The ICM estimates that the costs (in 2021 dollars) associated with nonfatal entrapment injuries using the quality adjusted life years are: $15,270 for injuries treated at the doctor's office/clinic; $28,849 for injuries treated in the ED; and $280,832 for injuries that result in hospital admission.
Table 13 below displays metrics for the benefits and costs of the proposed rule. The table displays net benefits (difference between benefits and costs) and the benefit-cost ratio (benefits divided by costs) to assess the cost-benefit relationship. The table displays these metrics using annualized benefits for the three scenarios: 75 percent, 50 percent, and 25 percent. These metrics show the proposed rule's benefits well exceed costs in each scenario.
Table 13 displays metrics for benefits, with nonfatal injuries included, and costs of the proposed rule.
Table 14 compares the benefits, with nonfatal injuries included, to costs on a per-unit basis.
Based on staff's evaluation of ASTM F3186-17, the Commission preliminarily determines that the voluntary standard is not likely to eliminate or adequately reduce the unreasonable risk of injury associated with entrapments on APBRs. Further, as discussed in section II of this preamble, and Tabs C and D of the staff NPR briefing package, staff collected sample populations of APBR models and tested them, first in 2018 through 2019, and then again in 2021. In each instance, all
CPSC staff also conducted informal interviews with five firms in January and February 2018, to determine if the firms were familiar with the ASTM standard, if they believed their products conformed to the standard, and if they believed other suppliers would conform to the standard. Four firms indicated they were familiar with the standard; one thought that their products already conformed; two indicated some modifications were required to bring their products into compliance; and two expressed uncertainty whether they would put warning labels required by the voluntary standard on their product. One firm expressed concern that if they applied the required warnings to their product and competitors did not, then consumers would believe their products were more hazardous than competing APBRs without warning labels, causing the firm to lose market share.
Accordingly, CPSC testing and informal interviews show that there is no substantial industry compliance with the voluntary standard at this time. Furthermore, substantial future industry compliance appears unlikely because firms have had several years to comply with the voluntary standard and, despite repeated outreach and testing, no APBRs are known to comply with all the requirements in the standard.
The Commission considered six alternatives to the proposed rule: (1) take no regulatory action; (2) conduct a recall of APBRs instead of promulgating a final rule; (3) conduct an educational campaign; (4) ban APBRs from the market entirely; (5) require enhanced safety warnings for APBRs; and (6) a later effective date. The Commission preliminarily finds that none of these alternatives would adequately address the hazards associated with APBRs.
If the Commission opted to take no regulatory action, the industry foreseeably would continue to fail to address the entrapment hazards associated with APBRs, and consumers would remain at risk. The estimated $298.11 million average annualized societal costs would continue to be incurred by consumers in the form of deaths and injuries. For this reason, the Commission does not find this alternative would address the unreasonable risk of injury associated with APBRs.
The Commission could seek to recall APBRs in use that present a substantial product hazard. With this alternative, manufacturers would continue to not comply with the voluntary standard and would not incur any costs to modify or test APBRs to comply with the proposed rule. However, recalls only apply to an individual manufacturers and sellers of APBRs, and do not extend to similar products that fall within the scope of ASTM 3186-17 and present the same hazards. In addition, recalls occur only after consumers have purchased and used such products and may have been killed or injured due to exposure to the hazard. Finally, recalls cannot directly prevent unsafe products from entering the market. Therefore, much of the estimated $298.11 million average annualized societal costs would continue to be incurred by consumers in the form of deaths and injuries. For these reasons, the Commission does not find this alternative would address the unreasonable risk of injury associated with APBRs.
The Commission could issue news releases or use other information and marketing techniques to warn consumers about entrapment hazards associated with APBRs, instead of issuing a mandatory rule. Information and marketing campaigns, in conjunction with CPSC recall actions, may reduce the number of injuries and societal costs associated with APBR entrapment hazards. However, education campaigns and recalls are not likely to adequately reduce the risk of injury from the entrapment hazard. As noted above, CPSC has issued recall announcements for APBRs in the past, and these have not adequately addressed the entrapment hazard. Furthermore, recalls and associated education campaigns occur only after consumers have been exposed to the hazard and potentially suffered injury or death due as the result. Therefore, the Commission does not find this alternative would adequately address the unreasonable risk of injury associated with APBRs.
The Commission could ban APBRs sold as consumer products. However, in considering this alternative, the Commission must weigh both quantifiable and unquantifiable factors of the utility of APBR use to consumers. APBRs provide benefits to users, including mobility, ease of access to beds, and the potential for at-home care. Considering both the quantifiable and unquantifiable costs and benefits, the net benefit of this alternative is likely less than that of the proposed rule. However, the Commission seeks comments on whether the proposed adoption of the modified ASTM standard sufficiently addresses the hazard and whether a ban is warranted, and if so, what the impact of a ban would be on consumers (
The Commission could require enhanced safety warnings on APBRs. Warning labels on APBRs have not produced the desired results of reducing entrapment injuries and deaths. Safety warnings that rely on consumers to alter their behavior to avoid the hazard are less effective than designing the hazard out of the product or guarding the consumer from the hazard. Accordingly, the Commission preliminarily finds that warnings alone would not adequately address the unreasonable risk of injury associated with APBRs. Although warnings and instructions have limited effectiveness, the labeling, warning, and instructional literature requirements of ASTM F3186-17 do beneficially address the risk of injuries and deaths associated with APBRs and CPSC proposes that they be adopted with modifications set forth in the proposed rule.
The Commission could issue the new rule with an introduction time greater than the 30 days recommended in this proposed rule. APBRs that present an unreasonable risk of death or injury from entrapment would continue to enter the marketplace during that time. Delaying the benefits of the rule likely results in higher social costs, in exchange for limited benefits to producers, who would still be required to revise their APBR products. Furthermore, manufacturers of APBRs have long had notice of the requirements of ASTM F3186-17 and, as staff investigation confirms, are familiar with the core requirements of the proposed rule. For this reason, staff does not recommend this alternative.
Whenever an agency publishes an NPR, section 603 of the Regulatory Flexibility Act (RFA), 5 U.S.C. 601-612, requires agencies to prepare an initial regulatory flexibility analysis (IRFA), unless the head of the agency certifies that the rule will not have a significant
(1) a description of why action by the agency is being considered;
(2) a succinct statement of the objectives of, and legal basis for, the proposed rule;
(3) a description and, where feasible, an estimate of the number of small entities to which the proposed rule will apply;
(4) a description of the projected reporting, recordkeeping, and other compliance requirements of the proposed rule, including an estimate of the classes of small entities which will be subject to the requirement and the type of professional skills necessary for preparation of the report or record; and
(5) an identification, to the extent practicable, of all relevant Federal rules which may duplicate, overlap, or conflict with the proposed rule.
The IRFA must also describe any significant alternatives to the proposed rule that would accomplish the stated objectives and that minimize any significant economic impact on small entities. Staff's initial regulatory flexibility analysis is provided in Tab H of Staff's NPR briefing package.
The purpose of the proposed rule is to reduce deaths and injuries resulting from entrapment on APBRs. CPSC staff identified 310 fatal injuries associated with APBR hazards in years 2003 through 2021. Although staff's assessment with ASTM F3186-17 shows that, with modifications, it would adequately reduce the unreasonable risk of injury associated with APBRs, there is no compliance with the voluntary standard. Accordingly, the Commission preliminarily finds that a mandatory rule is reasonably necessary to reduce the unreasonable risk of injury of entrapment hazards from APBRs.
The Commission proposes this rule to reduce the risk of death and injury associated with APBRs. The proposed rule is promulgated under the authority in sections 7 and 9 of the CPSA.
The proposed rule would apply to all manufacturers and importers of APBRs. Staff identified seven U.S. APBR manufacturers that meet the SBA criteria for small businesses. Importers of APBRs could be wholesale or retail distributers. Staff identified one U.S. APBR firm in these categories that could be considered a small business.
The proposed rule would establish a performance requirement for APBRs and test procedures that suppliers would have to meet to sell APBRs in the United States. Specifically, the NPR would require APBRs sold in the United States to comply with the ASTM F3186-17 standard, with the proposed modifications. CPSC expects most APBR manufacturers, including those considered small by SBA standards, would incur costs associated with bringing their APBRs into compliance with the proposed rule, as well as costs related to testing and issuing a General Certificate of Conformity (GCC).
In accordance with section 14 of the CPSA, manufacturers would have to issue a GCC for each APBR model, certifying that the model complies with the proposed rule. According to section 14 of the CPSA, GCCs must be based on a test of each product, or a reasonable testing program; and GCCs must be provided to all distributors or retailers of the product. The manufacturer would have to comply with 16 CFR part 1110 concerning the content of the GCC, retention of the associated records, and all other applicable requirements.
CPSC has not identified any other Federal rules that duplicate, overlap, or conflict with the proposed rule.
Generally, CPSC considers an impact to be potentially significant if it exceeds 1 percent of firm's gross revenue. Staff identified seven APBR manufacturers that meet SBA size standards for small businesses. Staff applied both the per-model and per-unit costs to each manufacturer's number of models and estimated unit sales in 2021. Staff found that the initial cost to comply with the proposed rule exceeds one percent of reported annual revenue for three of the seven manufacturers identified as small businesses. For these three APBR manufacturers, the economic impact of the proposed rule is expected to be significant. As discussed in Tab G of Staff's NPR Briefing Package, to achieve compliance with the proposed rule's performance requirements, APBR suppliers would incur costs from redesigning, retooling, and testing. Staff estimates this cost to be $42,239 per model in the first year. Staff estimates the additional production cost for labor and material to be $10.01 per unit produced in the first year, of which $7.74 is expected to be passed on to the consumer.
Staff identified one possible importer of APBRs from foreign suppliers that would be considered small businesses based on SBA size standards. Small importers would be adversely impacted by the proposed rule if its foreign supplier withdrew from the U.S. market, rather than incur the cost of compliance. Small importers would also be adversely impacted if foreign manufacturers failed to provide a GCC and the importers had to perform their own testing for compliance. If sales of APBRs are a substantial source of the importer's business, and the importer cannot find an alternative supplier of APBRs, the economic impact on these firms may be significant. However, staff estimates the U.S. APBR market will grow at annual rate of approximately 2.01 percent over the next 20 years. It is unlikely that foreign manufacturers would exit a market growing at this rate. APBR importers also import other medical equipment, devices, and supplies. For these firms, any decline in APBR sales and revenue may be partially or fully offset by increasing sales and revenues of these other products. Small importers would be responsible for issuing a GCC certifying that their APBRs comply with the rule's requirements. However, importers may issue GCCs based upon certifications provided by or testing performed by their suppliers. Based on an estimated $4,532 per model for testing, the impact on small importers whose suppliers provide GCCs is unlikely to be significant.
The Commission proposes to incorporate by reference ASTM F3186-17,
In accordance with the OFR regulations, section IV. of this preamble summarizes the major provisions of ASTM F3186-17 that the Commission proposes to incorporate by reference into 16 CFR part 1270. The standard
Generally, the Commission's regulations are considered to have little or no potential for affecting the human environment, and environmental assessments and impact statements are not usually required. See 16 CFR 1021.5(a). The proposed rule is not expected to have an adverse impact on the environment and is considered to fall within the “categorical exclusion” for the purposes of the National Environmental Policy Act. 16 CFR 1021.5(c).
Executive Order (E.O.) 12988, Civil Justice Reform (Feb. 5, 1996), directs agencies to specify the preemptive effect of a rule in the regulation. 61 FR 4729 (Feb. 7, 1996). The proposed regulation for APBRs is issued under authority of the CPSA. 15 U.S.C. 2051-2089. Section 26 of the CPSA provides that “whenever a consumer product safety standard under this Act is in effect and applies to a risk of injury associated with a consumer product, no State or political subdivision of a State shall have any authority either to establish or to continue in effect any provision of a safety standard or regulation which prescribes any requirements as to the performance, composition, contents, design, finish, construction, packaging or labeling of such product which are designed to deal with the same risk of injury associated with such consumer product, unless such requirements are identical to the requirements of the Federal Standard.”
States or political subdivisions of a state may apply for an exemption from preemption regarding a consumer product safety standard, and the Commission may issue a rule granting the exemption if it finds that the state or local standard: (1) provides a significantly higher degree of protection from the risk of injury or illness than the CPSA standard, and (2) does not unduly burden interstate commerce.
This proposed rule contains information collection requirements that are subject to public comment and review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA). 44 U.S.C. 3501-3520. We describe the provisions in this section of the document with an estimate of the annual reporting burden. Our estimate includes the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.
Staff estimates the burden of this collection of information as follows in Table 15:
Our estimate is based on the following. There are 12 known entities supplying APBRs to the U.S. market. On average, each entity supplies six APBR models to the market. All 12 entities are assumed to already use labels on both their products and packaging. However, none of the APBR models tested comply with ASTM F3186-17 labeling and informational requirements. CPSC therefore expects all entities will need to make modifications to their existing labels. The estimated time required to make these modifications is about eight hours per model. Each entity supplies an average of six different APBR models. Therefore, the estimated burden associated with labels is 576 hours (12 entities × 6 models per entity × 8 hours per model = 576 hours). We estimate the hourly compensation for the time required to create and update labels is $35.25 (U.S. Bureau of Labor Statistics, “Employer Costs for Employee Compensation,” March 2022, total compensation for all sales and office workers in goods-producing private industries:
The proposed rule would also require instructions to be supplied with the product. Under the OMB's regulations (5 CFR 1320.3(b)(2)), the time, effort, and financial resources necessary to comply with a collection of information that would be incurred by persons in the “normal course of their activities” are excluded from a burden estimate, where an agency demonstrates that the disclosure activities required to comply are “usual and customary.” APBRs require installation on an existing bed, which implies instructions for proper use, fit, and position on a bed, as well as cleaning are necessary. While many APBR entities already provide some instructional material, CPSC expects all will need to make some modifications to existing material. The estimated time to modify the instructional material is 24 hours per model. Each entity supplies an average of six different APBR models. Therefore, the estimated burden associated with instructional literature is 1,728 hours (12 entities × 6 models per entity × 24 hours per model). We estimate the hourly compensation for the time required to create and update instructional material is $35.25 (U.S. Bureau of Labor Statistics, “Employer Costs for Employee Compensation,” March 2022), total compensation for all sales and office workers in goods-producing private industries:
Based on this analysis, the proposed standard for APBRs would impose a burden to industry of 2,304 hours, at an estimated cost of $81,216 annually ($20,304 + $60.912). Existing APBR entities would incur these costs in the first year following the proposed rule's effective date. In subsequent years, costs could be less, depending on the number of new APBR models introduced by existing entities and/or by entities entering the APBR market. As required under the PRA (44 U.S.C. 3507(d)), CPSC has submitted the information collection requirements of this proposed rule to the OMB for review. Interested persons are requested to submit comments regarding information collection by December 9, 2022, to the Office of Information and Regulatory Affairs, OMB as described under the
Section 14(a) of the CPSA requires that products subject to a consumer product safety rule under the CPSA, or to a similar rule, ban, standard or regulation under any other act enforced by the Commission, must be certified as complying with all applicable CPSC-enforced requirements. 15 U.S.C. 2063(a). A final rule on APBRs would subject them to this requirement.
The Administrative Procedure Act (APA) generally requires that the effective date of a rule be at least 30 days after publication of a final rule. 5 U.S.C. 553(d). Section 9(g)(1) of the CPSA states that a consumer product safety rule shall specify the date such rule is to take effect, and that the effective date must be at least 30 days after promulgation but cannot exceed 180 days from the date a rule is promulgated, unless the Commission finds, for good cause shown, that a later effective date is in the public interest and publishes its reasons for such finding.
If finalized, the Commission proposes an effective date of 30 days after publication of the final rule. ASTM F3186-17 has been in existence since August 2017, and agency staff has conducted outreach efforts to make firms aware of the requirements of the standard. Accordingly, manufacturers already are familiar with ASTM F3186-17 and should be ready and able to comply with the requirements included in the proposed rule. Therefore, the Commission preliminarily finds a 30-day effective date following publication of the rule in the
We invite all interested persons to submit comments on any aspect of the proposed rule. Specifically, the Commission seeks comments on the following:
• Information regarding any analysis and/or tests done on APBRs in relation to the risks of injury or death they present;
• Information regarding any potential costs or benefits of the proposed rule that were not included the foregoing preliminary regulatory analysis;
• Information regarding the number of small businesses impacted by the proposed rule and the magnitude of the impacts of the proposed rule;
• The testing procedures and methods of the proposed rule and whether they sufficiently reduce the risk associated with APBRs, or whether other measures are necessary and information demonstrating how these measures address the identified risks;
• Potential alternatives to APBRs if they are banned, and the impact that a ban on APBRs would have on consumers (
• Any qualitative or quantitative evidence concerning the utility that APBRs have for consumers relative to alternative products that might be used as substitutes in the event APBRs are banned; and
• The appropriateness of the 30-day effective date, and a quantification of how a 30-day effective date would affect the benefits and costs of the proposed rule.
Section 9 of the CPSA requires the Commission to provide interested parties “an opportunity for oral presentation of data, views, or arguments.” 15 U.S.C. 2058(d)(2). The Commission must keep a transcript of such oral presentations.
Section 9(d)(1) of the CPSA requires the Commission to promulgate a final consumer product safety rule within 60 days of publishing a proposed rule. 15 U.S.C. 2058(d)(1). Otherwise, the Commission must withdraw the proposed rule if it determines that the rule is not reasonably necessary to eliminate or reduce an unreasonable risk of injury associated with the product or is not in the public interest.
The Commission finds that there is good cause to extend the 60-day period for this rulemaking. Under both the APA and the CPSA, the Commission must provide an opportunity for interested parties to submit written comments on a proposed rule. 5 U.S.C. 553; 15 U.S.C. 2058(d)(2). The
These factors make it impractical for the Commission to issue a final rule within 60 days of this proposed rule. Moreover, issuing a final rule within 60 days of the NPR may limit commenters' ability to provide useful input on the rule, and CPSC's ability to evaluate and take that information into consideration in developing a final rule. Accordingly, the Commission finds that there is good cause to extend the 60-day period for promulgating the final rule after publication of the proposed rule.
Administrative practice and procedure, Consumer protection, Incorporation by reference, Adult portable bed rails.
15 U.S.C. 2056, 15 U.S.C 2058, and 5 U.S.C. 553.
This part 1270 establishes a consumer product safety standard for adult portable bed rails manufactured after [DATE 30 DAYS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER].
(a) Except as provided in paragraph (b) of this section, each adult portable bed rail must comply with all applicable provisions of ASTM F3186-17,
(b) Comply with the ASTM F3186-17 standard with the following changes:
(1) In addition to complying with section 3.1.7 of ASTM F3186-17, each adult portable bed rail must comply with the following:
(i)
(ii)
(iii)
(2) Instead of complying with section 6.1.3 of ASTM F3186-17, comply with the following:
(i) Under section 6.1.3, permanently attached retention system components shall not be able to be removed without the use of a tool after initial assembly.
(ii) [Reserved]
(3) In addition to complying with section 6.2.1 of ASTM F3186-17, comply with the following:
(i) Under section 6.2.1.1, if the manufacturer does not recommend a specific applicable range of mattress heights or thicknesses, the test personnel shall choose a mattress that provides the most severe condition per test requirement. If the product has adjustable settings, and the manufacturer does not recommend orienting or adjusting features on the product in a specific manner, the testers shall adjust the product to the most severe condition per test requirement.
(ii) [Reserved]
(4) Instead of complying with section 6.3.3 of ASTM F3186-17, comply with the following:
(i)
(ii) [Reserved]
(5) Instead of complying with section 6.4.1 of ASTM F3186-17, comply with the following:
(i) Under section 6.4.1, holes or slots that extend entirely through a wall section of any rigid material less than 0.375 in (9.53 mm) thick and admit a 0.210 in (5.33 mm) diameter rod shall also admit a 0.375 in (9.53 mm) diameter rod. Holes or slots that are between 0.210 in (5.33 mm) and 0.375 in (9.53 mm) and have a wall thickness less than 0.375 in (9.53 mm) but are limited in depth to 0.375 in (9.53 mm) maximum by another rigid surface shall be permissible (see Opening Example in Figure 2 of ASTM F3186-17).
(ii) [Reserved]
(6) Instead of complying with section 6.5.1 of ASTM F3186-17, comply with the following:
(i) Under section 6.5.1, any structural components and retention system components of a product covered by this specification that require consumer assembly or adjustment, or components that may be removed by the consumer without the use of a tool, shall not be able to be misassembled when evaluated to 6.5.2.
(ii) [Reserved]
(7) Instead of complying with section 6.5.2 of ASTM F3186-17, comply with the following:
(i)
(ii) [Reserved]
(8) In addition to complying with section 7.1 of ASTM F3186-17, comply with the following:
(i) Under section 7.1.3, mattress thickness ranges used for testing may be up to 1.5 in (38 mm) larger or smaller than the range specified by the manufacturer. If the manufacturer does not recommend a particular range of mattress heights, the testers shall choose
The technology and consumer preferences for bedding are highly variable and continuously changing. Therefore, they cannot be reasonably accounted for within this standard. Test facilities and personnel should consider current bedding trends and all types of mattresses that may foreseeably be used with the product when making a test mattress selection.
(ii) [Reserved]
(9) In addition to complying with section 7.2 of ASTM F3186-17, comply with the following:
(i)
(ii) [Reserved]
(10) Instead of complying with Note 1 in section 8.4 of ASTM F3186-17, comply with the following:
The tests described in this section are similar to those described in the referenced FDA Guidance Document.
(11) Instead of complying with section 8.4.3.4 of ASTM F3186-17, comply with the following:
(i) Under section 8.4.3.4, if the test probe does not pull through, freely attach the force gauge and exert a 22.5 lbf (100 N) pulling force along the axis of the cone, perpendicular to the 2.4 in (60 mm) cylindrical end of the entrapment test tool. If the 4.7 in (120 mm) end of the cone does not enter any of the openings, this space passes the test. If the 4.7 in (120 mm) end of the test probe cone does enter any of the openings, this space fails the test.
(ii) [Reserved]
(12) Instead of complying with section 8.4.4.3 of ASTM F3186-17, comply with the following:
(i) Under section 8.4.4.3, insert the 2.4 in (60 mm) end of the cone perpendicular into the opening. Slide the cone into the opening until it is in full contact with the product. The mattress shall only be compressed by the weight of the cone.
(ii) [Reserved]
(13) Instead of complying with section 8.4.4.4 of ASTM F3186-17, comply with the following:
(i) Under section 8.4.4.4, if the test probe does not pull through freely use the force gauge to exert a 22.5 lbf (100 N) pulling force along the axis of the cone, perpendicular to the 2.4 in (60 mm) cylindrical end of cone.
(ii) Under section 8.4.4.5, if a horizontal section of the rail greater than 4.7 in exists along the bottom of the rail, that section must also meet the Zone 2 requirements.
(14) Instead of complying with section 8.4.5.4 of ASTM F3186-17, comply with the following:
(i) Under section 8.4.5.4, turn the cone until the line on the face of the 4.7 in (120 mm) end is horizontal and let the cone sink into the space by its own weight.
(A) If the line on the face of the 4.7 in (120 mm) end of the cone is above the highest point of the uncompressed mattress, as shown in Figure 1 to paragraph (b)(14) of this section, the space passes the test.
(B) If the line on the face of the 4.7 in (120 mm) end of the cone is at or below the highest point of the uncompressed mattress, as shown in Figure 1 to paragraph (b)(14) of this section, the space fails the test.
(ii) [Reserved]
(15) In addition to complying with section 8.6.3 of ASTM F3186-17, define “free end” in a note as follows:
The “free end” is defined as the location on the retention system that is designed to produce a counter force; it may be a single distinct point or a location on a loop.
(16) Instead of complying with section 9.1.1.3 of ASTM F3186-17, comply with the following:
(i) Under section 9.1.1.3, that the product is to be used only with the type and size of mattress and bed, including the range of thickness of mattresses, specified by the manufacturer of the product. If beds with head or footboards
(ii) [Reserved]
(17) Instead of complying with section 9.2.5 of ASTM F3186-17, comply with the following:
(i) Under section 9.2.5, each product's retail package and instructions shall include the warning statements in Figure 2 to paragraph (b)(17)(i) of this section.
(ii) [Reserved]
(18) Instead of complying with section 9.2.7 of ASTM F3186-17, comply with the following:
(i) Under section 9.2.7, at least one installation component of the product must be labeled with the entrapment warning in Figure 3 to paragraph (b)(18)(i).
(ii) [Reserved]
(19) Instead of complying with section 11.1.1.3 of ASTM F3186-17, comply with the following:
(i) Under section 11.1.1.3, in addition to contacting the manufacturer directly, consumers should report problems to the CPSC at its website
(ii) [Reserved]
(a)
(b)
(a)
(b)
(c)
(d)
(2) The cost of compliance to address entrapment hazards includes the costs manufacturers incur to redesign existing models and produce new designs to comply with the mandatory standard, as well as the cost of producing the redesigned APBR. Manufacturers would
(e)
(2) The Commission considered alternatives to the proposed rule to minimize impacts on competition and manufacturing including:
(i) Take no regulatory action;
(ii) Conduct a recall of APBRs instead of promulgating a final rule;
(iii) Conduct an educational campaign;
(iv) Require enhanced safety warnings; and
(v) Longer effective date.
(3) However, the Commission determines preliminarily that none of these alternatives would adequately reduce the risk of deaths and injuries associated with APBR entrapment that the proposed rule addresses.
(f)
(g)
(h)
(1) The Commission preliminarily determines that the voluntary standard is not likely to eliminate or adequately reduce the unreasonable risk of injury associated with entrapments on APBRs. Accordingly, the Commission is proposing to adopt the voluntary standard with specified modifications necessary to improve safety and adequately reduce the unreasonable risk of injury associated with entrapment on APBRs. Entrapment is the most prevalent hazard pattern among the deaths and injuries associated with APBRs. The entrapment test methods specified in the voluntary standard require products to be tested to assess the potential for entrapment in four different zones. These zones were identified by the FDA in its 2006 guidance document, Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment (FDA, 2006) and used in the voluntary standard, as potential areas of entrapment for APBRs. The FDA's guidance is based on recommendations from the Hospital Bed Safety Workgroup (HBSW), which was formed in 1999 to address reports of patient entrapment. The voluntary standard specifies the FDA probe to test entrapment zones. The probe design is based on the anthropometric dimensions of key body parts, including the head, neck, and chest of at-risk adults. The four entrapment zones required to be tested are:
(i) Within the product;
(ii) Between rail support(s) and the bed mattress, when applicable, under the product;
(iii) Between the product and the mattress; and
(iv) Between the underside of the end of the product and the mattress.
(2) Most of the reported entrapment fatalities involved one of the four zones listed. In 214 out of 284 fatal incidents, the entrapment location was identified and all but six of these cases occurred in one of the four zones of entrapment tested in ASTM F3186-17. Based on this analysis, it is likely that most of the 70 incidents for which there was insufficient information to identify the location of the entrapment also involved one of these four zones.
(3) The Commission preliminarily determines that modifications to the voluntary standard are needed to improve safety. Such modifications include: provide additional definitions for product assembly and installation to ensure their consistent and differentiated use throughout the standard; add recommendations for manufacturers to take into account the range of mattress thicknesses to ensure safe use of the product by the consumer and provide testers with additional guidance for selecting the mattress thickness during the test setup; address inconsistencies with stated dimensions to ensure consistent dimensional tolerances; provide additional clarity for Zone 1 and 2 test setup and methods; provide additional guidance for identifying potential Zone 2 openings; update the requirements for Zone 3 testing consistency; and correct grammatical errors.
(4) The Commission preliminarily determines that substantial compliance with the voluntary standard is unlikely. CPSC conducted two rounds of market compliance testing to ASTM F3186-17: the first round in 2018 and 2019, the second round in 2021. In both rounds of market compliance testing, no APBRs met all requirements of ASTM F3186-17. All products failed at least one critical mechanical requirement, such as retention strap performance, structural integrity, and entrapment and all products failed the labeling, warning, and instructional requirements.
(i)
(2) The requirements of the proposed rule, with modifications, are expected to address 92 percent of deaths caused by entrapment and produce estimated benefits of $266.99 million. Benefits were assessed under three more conservative scenarios derived from this baseline efficacy, estimating benefits at: 75 percent, 50 percent, and 25 percent of their potential value. Even under the most conservative assumption that only one quarter, or 25 percent of the potential benefits are achieved, the net benefits greatly exceed the costs of the rule. The annualized benefits of the proposed rule are estimated as follows: at 75 percent—$200.24 million, 50 percent-$133.49 million, and 25 percent-$66.75 million, respectively. The estimated annualized costs associated with the proposed requirements to prevent APBR hazards is $2.01 million. This results in net quantifiable net benefits of $198.23 million, $131.48 million, and $64.74 million on an annualized basis. On a per product basis, the benefits of the proposed rule are estimated between $331.78 per APBR (75%), $221.19 (50%), and $110.59 per APBR (25%), and the costs are $3.34 per APBR. All these amounts are in 2021 dollars using a discount rate of 3 percent.
(3) Injuries from entrapment and other hazards on APBRs are not included in the benefit-cost assessment because for many incidents involving injuries, there is not sufficient information to determine whether they would fall under the scope of this proposed rule. However, the injuries are quantified in a sensitivity analysis as a potential upper limit to assess the benefits of this proposed rule. The sensitivity analysis used NEISS incidents and the Injury Cost Model (ICM) to extrapolate and generate national estimates for injuries from entrapment treated in an ED or other settings. The ICM calculated that the aggregate number of nonfatal injuries in the United States from entrapment from 2010 to 2019 was 125,121. Staff estimated that from the total of these injuries, 79,563 were treated in an outpatient setting (
(j)
(i) Take no regulatory action;
(ii) Conduct a recall of APBRs instead of promulgating a final rule;
(iii) Conduct an educational campaign;
(iv) Ban APBRs from the market entirely;
(v) Require enhanced safety warnings; and
(vi) Longer effective date.
(4) Although most of these alternatives may be a less burdensome alternative to the proposed rule, the Commission determines preliminarily that none of the less burdensome alternatives would adequately reduce the risk of deaths and injuries associated with APBRs that is addressed in the proposed rule.
Internal Revenue Service (IRS), Treasury.
Correction to a notice of proposed rulemaking and notice of public hearing.
This document contains a correction to a notice of proposed rulemaking and notice of public hearing (REG-100719-21) published in the
Written or electronic comments are being accepted and must be received by December 19, 2022. Requests to speak and outlines of topics to be discussed at the public hearing scheduled for January 9, 2023, at 10:00 a.m. EST must be received by December 19, 2022.
Commenters are strongly encouraged to submit public comments electronically. Submit electronic submissions via the Federal eRulemaking Portal at
Concerning the proposed regulation, Carolyn M. Lee at (202) 317-6845; concerning cost methodology, Michael A. Weber at (202) 808-9738; and concerning submission of comments, the hearing, and the access code to attend the hearing by telephone, Regina Johnson, 202-317-6901 (not toll-free numbers) or
The proposed regulations and notice of public hearing subject to this correction are under section 9701 of Title 31 of the United States Code.
Accordingly, the notice of proposed rulemaking and notice of public hearing (REG-100719-21) that is the subject of FR Doc. 2022-21458, published on October 5, 2022 (87 FR 60357), is corrected to read as follows:
1. On page 60358, in the first column, under the caption
2. On page 60360, in the first column, the fifth and sixth lines from the top of the column, the language “
3. On page 60360, in the third column, the last line in the table in the second paragraph showing the estimated costs for direct labor and benefits by year, the language“1,673,217” is corrected to read “$1,673,217.”
4. On page 60361, in the first column, the third line in the table preceding the first paragraph, the language “2,674,248” is corrected to read “$2,674,248.”
5. On page 60361, in the third column, the fifth and sixth lines from the top of the last paragraph, the language “such requirements that” is corrected to read “the requirements and”.
6. On page 60362, in the second column, under the caption Comments and Public Hearing, in the second full paragraph, the language “December 16, 2022” is corrected to read “January 9, 2023;” and the language “December 5, 2022” is corrected to read “December 19, 2022.”
Alcohol and Tobacco Tax and Trade Bureau, Treasury.
Advance notice of proposed rulemaking.
The Alcohol and Tobacco Tax and Trade Bureau (TTB) is seeking public comment on TTB's trade practice regulations related to the Federal Alcohol Administration Act's exclusive outlet, tied house, commercial bribery, and consignment sales prohibitions. President Biden's Executive Order 14036 (“Promoting Competition in the American Economy”), the Department of the Treasury's related February 2022 report (“Competition in the Markets for Beer, Wine, and Spirits”), and public comments related to that report have raised questions about whether these regulations could be improved. To assist the agency in formulating potential proposals to amend the regulations, TTB invites comments on the issues described in this document.
Comments must be received on or before March 9, 2023.
You may electronically submit comments to TTB on this advance notice of proposed rulemaking, and view copies of this document, its supporting materials, and any comments TTB receives on it within Docket No. TTB-2022-0011 as posted at
Christopher Forster-Smith, Regulations and Rulings Division, Alcohol and Tobacco Tax and Trade Bureau, 1310 G Street NW, Box 12, Washington, DC 20005; telephone 202-453-1039 ext. 150.
Section 105 of the Federal Alcohol Administration Act (FAA Act) prohibits producers, wholesalers, and importers of distilled spirits, wine, or malt beverages (
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TTB administers these FAA Act provisions pursuant to section 1111(d) of the Homeland Security Act of 2002, as codified at 6 U.S.C. 531(d). In addition, the Secretary of the Treasury (the Secretary) has delegated certain administrative and enforcement authorities to TTB through Treasury Order 120-01.
TTB has promulgated regulations at 27 CFR part 6 (“Tied-House”) specifying the practices that are means to induce under section 105(b) of the FAA Act, criteria for determining whether a practice is a violation of section 105(b) of the FAA Act, and exceptions to section 105(b)(3) of the FAA Act. TTB has promulgated regulations at 27 CFR part 8 (“Exclusive Outlets”) specifying arrangements which are exclusive outlets under section 105(a) of the FAA Act and criteria for determining whether a practice is a violation of section 105(a) of the FAA Act. TTB has promulgated regulations at 27 CFR part 10 (“Commercial Bribery”) specifying practices which may result in violations of section 105(c) of the FAA Act and criteria for determining whether a practice is a violation of section 105(c) of the FAA Act. TTB has promulgated regulations at 27 CFR part 11 (“Consignment Sales”) specifying arrangements which are consignment sales under section 105(d) of the FAA Act and containing guidelines concerning returns or exchanges of distilled spirits, wine and malt beverages from a retailer or wholesaler.
On July 9, 2021, President Biden issued an Executive Order titled “Promoting Competition in the American Economy.” See E.O. 14036, 86 FR 36987 (July 14, 2021). Section 5(j) directed the Secretary, in consultation with the Attorney General and the Chair of the Federal Trade Commission (FTC), to submit a report within 120 days “assessing the current market structure and conditions of competition [for beer, wine, and spirits], including an assessment of any threats to competition and barriers to new entrants[.]” The Order provided that the report should address unlawful trade practices that hinder smaller and independent businesses or new entrants from distributing their products; patterns of consolidation in production, distribution, or retail markets; and “any unnecessary trade practice regulations of matters such as bottle sizes, permitting, or labeling that may unnecessarily inhibit competition[.]”
Further, section 5(k) of the Order directed the Secretary, through the TTB Administrator, to consider within 240 days: (1) Initiating a rulemaking to update TTB's trade practice regulations; (2) revising or rescinding any regulations that “unnecessarily inhibit competition;” and (3) “reducing any barriers that impede market access for smaller and independent brewers, winemakers, and distilleries.”
On July 28, 2021, the Department of the Treasury (Treasury) issued a Request for Information (RFI) soliciting input from the public and industry regarding the current market structure and conditions of competition in the American markets for beer, wine, and spirits, including an assessment of any threats to competition and barriers to new entrants. See Notice No. 204, 86 FR 40678. Treasury received 827 public comments in response to this RFI (RFI Comments), including numerous comments addressing the exclusive outlet, tied house, commercial bribery, and consignment sales prohibitions.
On February 9, 2022, Treasury, in consultation with the U.S. Department of Justice and the Federal Trade Commission, released a report titled “Competition in the Markets for Beer, Wine, and Spirits” (Report). The Report analyzes the markets for beer, wine, and spirits and, while finding significant growth over the last several decades in the number of small and “craft” producers of beer, wine, and spirits, the Report also finds significant concentration in certain markets. In addition, the Report analyzes the burden that complex regulations place on small businesses and new market entrants. To help address the competitive challenges in the beer, wine, and spirits marketplace, the Report identifies several recommendations, including evaluating trade practice enforcement policies, and reform of post-Prohibition era regulations that hinder small firms and new entrants from accessing the marketplace. The Report also recommends that TTB consider rulemaking to update its trade practice regulations under the FAA Act with an eye to giving a green light to practices that are essentially harmless and inherently procompetitive.
TTB has not revised the trade practice regulations in over 20 years and recognizes that the regulations may not take into account current marketplace realities. Accordingly, in this advance notice of proposed rulemaking, TTB invites comments on updating the trade practice regulations listed in the Background section above (
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TTB invites comments as to how it might update the regulations with respect to which practices place or have the potential to place retailer independence at risk, as well as which activities would result in exclusion under these parts. TTB also invites comments on whether it should clarify or alter the definition of exclusion in terms of “purchasing less” of a competitor's product, as provided in the regulations. See,
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In addition to the specific requests for comments above, TTB is interested in receiving comments on any other issue or concern related to TTB's trade practice regulations.
As noted above, Treasury requested comments on, among other topics, the issue of trade practices in its recently published RFI regarding the current market structure and conditions of competition in the American markets for beer, wine, and spirits. Treasury received a number of comments on trade practices in response to that RFI, and TTB will consider those comments for the purposes of this advance notice of proposed rulemaking as well.
TTB requests comments from industry members, consumers, and anyone interested in whether TTB should proceed with regulatory initiatives concerning the issues described above in this document. Please submit your comments by the closing date shown above in this document.
You may submit comments on this proposal as an individual or on behalf of a business or other organization via the
All submitted comments and attachments are part of the rulemaking record and are subject to public disclosure. Do not enclose any material in your comments that you consider confidential or that is inappropriate for disclosure.
TTB will post, and you may view, copies of this document, its supporting materials, and any comments TTB receives about this proposal within the related
Please contact TTB's Regulations and Rulings Division by email using the web form available at
Christopher Forster-Smith of the Regulations and Rulings Division drafted this advanced notice of proposed rulemaking. Other TTB staff also participated in its development.
Postal Service
Proposed rule.
The Postal Service is proposing to amend
Submit comments on or before December 9, 2022.
Mail or deliver written comments to the manager, Product Classification, U.S. Postal Service, 475 L'Enfant Plaza SW, Room 4446, Washington, DC 20260-5015. If sending comments by email, include the name and address of the commenter and send to
All submitted comments and attachments are part of the public record and subject to disclosure. Do not enclose any material in your comments that you consider to be confidential or inappropriate for public disclosure.
You may inspect and photocopy all written comments, by appointment only, at USPS® Headquarters Library, 475 L'Enfant Plaza SW, 11th Floor North, Washington, DC 20260. These records are available for review on Monday through Friday, 9 a.m.-4 p.m., by calling 202-268-2906.
Starlene Blackwood at (901) 681-4475 or Garry Rodriguez at (202) 268-7281.
Ancillary service endorsements provide an option for mailers to instruct the Postal Service on how to treat their mail if it is determined to be undeliverable-as-addressed and to request address correction services. Address corrections are currently available in four available formats: a returned mailpiece with the new address or reason for nondelivery attached; PS Form 3547
Participating Full-Service and Seamless Acceptance mailers receive ACS notices at no charge. As a result, notices provided to mailers in this format has far exceeded the volume of returned mail and PS Forms 3547 and 3579 requested and generated from undeliverable Full-Service and Seamless Acceptance mail.
The Postal Service is proposing to remove the option to request PS Forms 3547,
Full Service and Seamless Acceptance mailers and publishers that desire address correction information from undeliverable as addressed (UAA) mail will be required to receive address correction notices electronically via ACS. Those mailers that apply the ancillary service endorsement “Address Service Requested” or “Change Service Requested” to their mail, and Periodical publishers will receive ACS notices via the Data Distribution Dashboard from the Business Customer Gateway or by enrolling in the Electronic Product Fulfillment (EPF) secure website at
The Postal Service is proposing to implement this change effective July 9, 2023. However, mailers that currently request manual address corrections via PS Form 3547 or PS Form 3579 may begin to request ACS immediately. We believe this proposed revision will provide customers with more efficient and less costly address correction notices.
Although exempt from the notice and comment requirements of the Administrative Procedure Act (5 U.S.C. 553(b), (c)) regarding proposed rulemaking by 39 U.S.C. 410(a), the Postal Service invites public comment on the following proposed revisions to
We will publish an appropriate amendment to 39 CFR part 111 to reflect these changes.
Administrative practice and procedure, Postal Service.
Accordingly, 39 CFR part 111 is proposed to be amended as follows:
5 U.S.C. 552(a); 13 U.S.C. 301-307; 18 U.S.C. 1692-1737; 39 U.S.C. 101, 401-404, 414, 416, 3001-3018, 3201-3220, 3401-3406, 3621, 3622, 3626, 3629, 3631-3633, 3641, 3681-3685, and 5001.
Mailers can access OneCode ACS using an Intelligent Mail barcode, which contains a valid Service Type Identifier indicating the ancillary service requested; a numeric Mailer ID; and the Serial Number, a unique numeric mailpiece identifier (Keyline equivalent). This option is available for letters and flat size pieces mailed as First-Class Mail, USPS Marketing Mail, and Periodicals. Address Service, Change Service and Return Service Ancillary Services are available for letters and flat-sized mail pieces mailed as First-Class Mail, USPS Marketing Mail, and Bound Printed Matter (BPM), by choosing the appropriate ACS Service Type Identifier in the Intelligent Mail barcode. USPS Marketing Mail and Bound Printed Matter pieces with ACS using an Intelligent Mail barcode require the use of a printed on-piece endorsement. ACS mailers are encouraged to use the “Electronic Service Requested” text endorsement. Other printed endorsements are not required to request ancillary services in conjunction with an Intelligent Mail barcode used on First-Class Mail or Periodicals mailpieces, and their use may produce unintended results. Full-Service and Seamless Acceptance mailers that desire separate address corrections using Address Service and Change Service ancillary services must request ACS and will receive the ACS notices through Full Service. See 705.23.5.2 for additional standards. For other mailers, in order to receive requested ACS information, mailers must notify the NCSC, ACS Department in Memphis, TN, in writing, seven days prior to mailing to establish a method for ACS notice fulfillment and to arrange for payment of electronic or automated address correction fees. Mailpieces must meet the following specifications:
Mailers presenting mailpieces (except for those noted below) that qualify for the full-service Intelligent Mail option will receive automated address correction notices electronically when the pieces are encoded with Intelligent Mail barcodes with “Address Service Requested” or “Change Service Requested” under standards for OneCode ACS and under the following conditions:
a. Mailpieces must include the appropriate ACS service type ID in the Intelligent Mail barcode to match the ancillary service requested. See 507.1.5 for mail disposition and address correction combinations by class of mail.
b. Complimentary ACS ancillary service address correction notices for mailpieces in full-service mailings are available for:
1. First-Class Mail letters and flats, provided at no charge (printed endorsement not required for letters).
2. Periodicals letters and flats, provided at no charge (printed endorsement not required).
3. USPS Marketing Mail letters and flats or BPM flats, provided at no charge. USPS Marketing Mail and BPM pieces must include a printed on-piece endorsement in addition to encoding the ACS ancillary service request into
c. Mailers must use the ACS address correction information provided by USPS to update their address records to receive notices without paying additional fees. Beginning July 9, 2023, address corrections will only be provided electronically in the Business Customer Gateway under Mailing Reports utilizing the Data Distribution and Informed Visibility Dashboard
d. A new Service Type Identifier (STID) Table will be published on PostalPro removing all STID references for manual corrections when mailers present qualifying Full-Service mail.
Environmental Protection Agency (EPA).
Proposed rule.
On March 22, 2021, the State of Colorado submitted State Implementation Plan (SIP) revisions related to attainment of the 2008 8-hour ozone National Ambient Air Quality Standards (NAAQS) for the Denver Metro/North Front Range (DMNFR) Serious nonattainment area by the applicable attainment date of July 20, 2021. The Environmental Protection Agency (EPA) proposes to approve the majority of the submittal, including base and future year emission inventories, a reasonable further progress (RFP) demonstration, a reasonably available control measures (RACM) analysis, a motor vehicle inspection and maintenance (I/M) program, a nonattainment new source review (NNSR) program, 2020 motor vehicle emissions budgets (MVEBs) and transportation controls, a clean fuel fleet program, and revisions to Colorado Air Quality Control Commission (Commission or AQCC) regulations for the control of ozone via ozone precursors and control of hydrocarbons via oil and gas emissions. The EPA is also proposing to approve portions of the reasonably available control technology (RACT) analyses and revisions from submissions made on May 13, 2020; May 18, 2021; and May 20, 2022. Finally, the EPA proposes to approve revisions from submissions made on May 14, 2018, May 13, 2020, and May 20, 2022 that were conditionally approved on May 13, 2022. This action is being taken in accordance with the Clean Air Act (CAA).
Written comments must be received on or before December 9, 2022.
Submit your comments, identified by Docket ID No. EPA-R08-OAR-2022-0632, to the Federal Rulemaking Portal:
Abby Fulton, Air and Radiation Division, EPA, Region 8, Mailcode 8ARD-IO, 1595 Wynkoop Street, Denver, Colorado 80202-1129, telephone number: (303) 312-6563, email address:
Throughout this document wherever “we,” “us,” or “our” is used, we mean the EPA.
The information presented in this document is organized as follows:
As explained below, the EPA is proposing various actions on Colorado's proposed SIP revisions that were submitted on May 13, 2020, March 22, 2021, May 18, 2021, and May 20, 2022. Specifically, we are proposing to approve portions of Colorado's Serious attainment plan for the 2008 8-hour ozone NAAQS. In addition, we propose to approve the MVEBs and revisions to Regulation Number 7 (Reg. 7) contained in the State's submittal. We also propose to approve all other aspects of the submittal, except for the RACT submission for certain sources and enhanced monitoring, which we will be acting on at a later date, and for the attainment demonstration and contingency measures. We are also proposing to approve revisions to Colorado Regulation Number 21 (Reg. 21) from the State's May 13, 2020 submittal, and to Reg. 7 from the State's May 18, 2021 submittal. Finally, we are proposing to approve the Reg. 7 revisions from the State's May 14, 2018, May 13, 2020, and May 20, 2022
The basis for our proposed action is discussed in this proposed rulemaking. Technical information that we rely upon in this proposal is in the docket, which is available at
On March 12, 2008, the EPA revised both the primary and secondary NAAQS for ozone to a level of 0.075 parts per million (ppm) (based on the annual fourth-highest daily maximum 8-hour average concentration, averaged over 3 years), to provide increased protection of public health and the environment.
On May 4, 2016, the EPA published its determination that the Denver Area, among other areas, had failed to attain the 2008 8-hour ozone NAAQS by the attainment deadline, and that it was accordingly reclassified to Moderate ozone nonattainment status.
We are proposing to take action on Colorado SIP submittals made on five different dates:
This submittal contains amendments to Reg. 7, sections XII (Volatile Organic Compound Emissions from Oil and Gas Operations) and XVIII (Natural Gas-Actuated Pneumatic Controllers Associated with Oil and Gas Operations) to meet RACT for oil and gas sources covered by the EPA's 2016 Oil and Gas Control Techniques Guidelines (CTG).
On this date the State submitted two SIP revisions. One of the submittals includes a full reorganization of Reg. 7 into parts A-E, amends oil and gas storage tank requirements, updates RACT requirements for major sources of volatile organic compounds (VOC) and nitrogen oxides (NO
The second submittal contains new Reg. 21 to limit the VOC content in consumer products and in architectural and industrial maintenance (AIM) coatings manufactured, distributed, or sold in the DMNFR Area. Specifically, the Commission adopted VOC standards in the Ozone Transport Commission (OTC) AIM coatings model rule phase 2 (2014) and VOC standards in the OTC consumer products model rule phase 4 (2013). Reg. 21 includes definitions, exemptions, labeling, and recordkeeping provisions based on the OTC model rules.
This submittal contains the State's Serious ozone attainment plan and revisions to Reg. 7 to include RACT requirements in Colorado's ozone SIP for 50 tons per year (tpy) major sources of VOC and/or NO
The state regulations included with this submittal contain mostly state-only revisions that have not been submitted for inclusion in the SIP. Portions of these regulations submitted as SIP revisions include typographical, grammatical, and formatting corrections to the outline of Reg. 7 and part E (combustion equipment at major source RACT).
On this date the State submitted three SIP revisions. One of the submittals contains amendments that were mostly state-only and not submitted as SIP revisions. The SIP revisions adopted by the AQCC on Feb. 19, 2021 include updates to definitions in Reg. 7, part D, section III (natural gas-actuated pneumatic controllers associated with oil and gas operations).
Another submittal contains amendments to Reg. 7 that establish categorical RACT requirements for major sources of NO
The third submittal contains revisions concerning RACT requirements for oil and gas sources. Specifically, on Dec. 17, 2021 the AQCC adopted revisions to Reg. 7, part D, section I for performance or manufacturer testing for combustion equipment used to control emissions from storage vessels and wet seal centrifugal compressors as to which we proposed conditional approval. We are now proposing approval of those revisions.
The CAA requires that states meet certain procedural requirements before submitting SIP revisions to the EPA, including the requirement that states adopt SIP revisions after reasonable notice and public hearing.
For the May 13, 2020 (part D, oil and gas) submittal, the AQCC provided notice in the Colorado Register on October 10, 2019
For the May 13, 2020 (Reg. 21) submittal, the AQCC provided notice in the Colorado Register on May 10, 2019
For the March 22, 2021 submittal, the AQCC provided notice in the Colorado Register on October 10, 2020
For the May 18, 2021 submittal, the AQCC provided notice in the Colorado Register on July 10, 2020
For the May 20, 2022 submittal (part D, Definitions) the AQCC provided notice in the Colorado Register on January 10, 2021
For the May 20, 2022 submittal (Misc. Metals and Process Heater) the AQCC provided notice in the Colorado Register on May 10, 2021
For the May 20, 2022 submittal (part D, Oil and Gas) the AQCC provided notice in the Colorado Register on October 10, 2021
Accordingly, we propose to find that Colorado met the CAA's procedural requirements for reasonable notice and public hearing.
CAA section 182 outlines SIP requirements applicable to ozone nonattainment areas in each classification category. A Serious area classification triggers requirements for state submissions described in the EPA's regulations implementing the 2008 8-hour ozone NAAQS.
Colorado submitted SIP revisions to the EPA on March 22, 2021, to meet the requirements of a Serious area classification for the DMNFR Area. Colorado's proposed SIP revisions consist of the parts listed below.
• 8-Hour Ozone Attainment Plan (OAP), which includes monitoring information, emission inventories, an RFP demonstration, an attainment demonstration using photochemical grid modeling, a RACT analysis, a RACM analysis, a motor vehicle emissions I/M program, NNSR program certification, contingency measures, MVEBs for transportation conformity, and a clean fuel fleet program.
• Revisions to Reg. 7.
CAA section 172(c)(3), requires that each SIP include a “comprehensive, accurate, current inventory of actual emissions from all sources of the relevant pollutant or pollutants in [the] area.” The accounting required by this section provides a “base year” inventory that serves as the starting point for
Colorado's DMNFR Serious area attainment plan includes a 2011 base year inventory, a 2017 milestone year inventory, and a 2020 attainment year inventory. The inventories catalog NO
The 2011 base year inventory was included as part of the Moderate area SIP submittal and approved as part of our July 3, 2018 action.
The 2017 milestone year emissions inventories are in tons per summer day and represent the most current available data, as of the time of submission, for emissions estimates for an average episode day during the peak summer ozone season of June through September. This includes actual data for the oil and gas sector and stationary sources in addition to newer data from updated regional transportation demand models used by the two Metropolitan Planning Organizations in the DMNFR Area.
The 2020 inventory is in tons per summer day and represents emissions estimates for an average episode day during the peak summer ozone season (June through September). The 2020 inventory for VOC and NO
The 2017 milestone year and 2020 attainment emission inventories were developed using EPA-approved emissions models, methodology, and guidelines for stationary, mobile, and area emission sources.
The 2017 emissions inventories for power plants (also referred to as electric generating units) and other point sources were developed using Colorado Air Pollutant Emission Notice (APEN) reported data for each year, as specified in Tables 16 and 17 of the OAP. Area sources include many categories of emissions, such as coatings, household and personal care products, pesticides, and sealants. The 2017 area source emissions inventory is included in Table 18 of the OAP. The inventory was based on the EPA's 2014 National Emissions Inventory (NEI) and was derived from the 2014 NEI based on county population projections from the Colorado State Demography Office. The EPA finds that these sources (including those in the oil and gas sector) were adequately accounted for in the emissions inventory. The methodology used to calculate emissions for each respective category was consistent with recommendations and explanations in relevant EPA guidance,
Projected future emissions in 2020 were based on anticipated growth, technological advancements, and expected emissions controls that were to be implemented by the 2020 ozone season. The 2020 oil and gas emission inventory was based on 2017 actual site-specific emissions and 2018 APEN reported data, including technology and production and projected 2020 emissions and production. The 2020 emissions inventory for EGUs was developed based on Colorado APEN reported data for 2018 and is specified in Table 28 of the OAP. The future year inventory for other point sources beyond EGUs is based on 2018 APEN data. The 2020 area source inventory is provided in Table 30 of the OAP and was grown from the EPA's 2014 NEI based on county population projections from the State Demography Office. Reductions from implementation of Colorado AQCC Reg. 21 were then applied.
Table 1 shows the emissions by source category from the 2011 base year, 2017 milestone year, and 2020 attainment year emission inventories.
Details of Colorado's emissions inventory development are in Colorado's supporting TSD.
CAA section 182(b)(1) and the EPA's 2008 Ozone Implementation Rule
As noted above, the CAA section 182(b)(1) requirement for a 15% RFP demonstration applies to ozone nonattainment areas classified Moderate and above. In addition, Serious ozone nonattainment areas are subject to the CAA section 182(c)(2)(B) requirement to submit SIP revisions showing a 9% reduction of VOC
We reviewed the State's 9% RFP submittal for consistency with the requirements of the CAA and EPA regulations and guidance. To demonstrate compliance with RFP requirements, the State compared its 2017 milestone VOC inventory against its projected 2020 VOC emissions inventory and demonstrated that the projected 2020 emissions of VOC were at least 9% below the 2011 base year inventory. Colorado projected an 11.7% reduction in VOC emissions from 2017-2020.
Section 172(c)(1) of the CAA requires that SIPs for nonattainment areas “provide for the implementation of all reasonably available control measures as expeditiously as practicable (including such reductions in emissions from existing sources in the area as may be obtained through the adoption, at a minimum, of reasonably available control technology).” The EPA has defined “reasonably available control technology” (RACT) as “[t]he lowest emissions limitation that a particular source is capable of meeting by the application of control technology that is reasonably available considering technological and economic feasibility.”
For a Moderate, Serious, or Severe area a major stationary source is one that emits, or has the potential to emit, 100, 50, or 25 tpy or more, respectively, of VOCs or NO
On reclassification to Serious status, the DMNFR Area was required to implement RACT as expeditiously as practicable, but no later than August 3, 2020 for RACT needed for demonstrating attainment and July 20, 2021 for RACT not needed for demonstrating attainment.
As part of its May 31, 2017 Moderate ozone attainment plan, the Division conducted RACT analyses to demonstrate that the RACT requirements for CTG and major sources in the DMNFR Area had been fulfilled. The Division conducted these RACT analyses for VOC and NO
In July 2018, the Commission adopted categorical RACT requirements for combustion equipment at major sources under the Moderate classification that the Commission had determined in 2016 were not addressed by SIP RACT requirements. In November 2019, the Commission adopted SIP requirements to include provisions that implement RACT for major sources of VOC and NO
In December 2019, the Commission adopted additional RACT requirements for major sources of VOC and NO
The RACT submissions that we are now proposing to approve include those that we have not previously acted on that are addressing RACT for several non-CTG VOC and NO
In preparing its RACT determinations, Colorado reviewed source permits, consulted with Division permitting and enforcement staff involved with each source, and consulted with the sources themselves.
We are proposing action on the RACT demonstrations for certain additional VOC CTG, non-CTG VOC, and NO
Table 3 contains the CTGs, EPA reference document, and the corresponding sections of Reg. 7 that fulfill the applicable RACT requirements for the EPA-issued CTGs. Colorado's Reg. 7 contains SIP approved and submitted revisions (see section V.I. of this document); we propose to find that these revisions meet RACT requirements for the sources listed in Table 3.
We have reviewed the emission limitations and control requirements for the above sources and compared them against the EPA's CTG documents and available technical information in CTG dockets. The EPA has also evaluated the submitted rules and has determined that they are consistent with the CAA, the EPA's regulations, and the EPA's policies. Based on the information in the record, we propose to find that the corresponding sections in Reg. 7 provide for the lowest emission limitation through application of control techniques that are reasonably available considering technological and economic feasibility. Therefore, we propose to find that the control requirements for oil and gas sources and certain miscellaneous metal coatings are RACT for affected sources in the DMNFR Area under the 2008 8-hour ozone NAAQS.
In Colorado's TSDs for Reasonably Available Control Technology for Major Sources, dated December 14, 2020,
We have reviewed the emission limitations and control requirements for the source categories in Table 4 and compared them to the EPA's regulations, ACT documents, available technical information, and guidelines. The EPA has also evaluated the submitted rules and has determined that they are consistent with the CAA, the EPA's regulations, and the EPA's policies. For more information, see the EPA TSD prepared in conjunction with this action. Based on the information in the record, we propose to find that the corresponding sections in Reg. 7 provide for the lowest emission limitation through application of control techniques that are reasonably available considering technological and economic feasibility. Therefore, we propose to find that the control requirements for the source categories identified in Table 4 are RACT for all affected sources in the DMNFR Area under the 2008 8-hour ozone NAAQS.
States are not required to adopt RACT limits for source categories for which no sources exist in a nonattainment area, and can submit a negative declaration to that effect. The EPA approved the majority of the State's negative declarations on July 3, 2018.
CAA section 172(c)(1) of the CAA requires that states adopt “all reasonably available control measures [RACM] as expeditiously as practicable.” The EPA interprets the CAA RACM provision to require a demonstration that: (1) The state has adopted all reasonable measures (including RACT) to meet RFP requirements and to demonstrate attainment as expeditiously as possible; and (2) no additional measures that are reasonably available will advance the attainment date or contribute to RFP for the area.
Colorado previously evaluated potentially available control measures for RACM purposes with their 2008 Moderate ozone attainment plan. The EPA approved the State's RACM analysis on July 3, 2018.
The State's RACM review took place in the context of a series of state actions that had the effect of reducing emissions. Since the base year of 2011, Colorado has adopted oil and gas regulations;
As part of the RACM analysis, CDPHE examined emission reduction measures
After reviewing possible measures, Colorado determined that all reasonably available control measures necessary to demonstrate attainment are currently being implemented. Table 47 of Colorado's OAP lists control measures included in Colorado's SIP as they relate to the State's 2017 and 2020 emission inventories, photochemical modeling in the attainment demonstration, and weight of evidence analysis.
Emission measures that were evaluated but determined not to be RACM are discussed in chapter 7.5 of the OAP. Colorado used the following criteria to determine whether measures were considered RACM:
• Necessary to demonstrate attainment;
• Technologically or economically feasible;
• Implemented successfully in other Serious nonattainment areas;
• Could be implemented by May 1, 2020; and
• Could qualify as SIP measures by being quantifiable, enforceable, permanent, and surplus.
Emission reduction measures evaluated for RACM were broken into various categories: oil and gas, mobile source inspection and maintenance, fuels, transportation, local government policies, outreach, land use, and other. Table 54 of the OAP summarizes the measures evaluated and Colorado's RACM determination for each measure. Colorado also reviewed the EPA's Menu of Control Measures for NAAQS Implementation
In its analysis, Colorado evaluated all source categories that could contribute meaningful emission reductions, and identified and evaluated an extensive list of potential control measures. To determine reasonableness and availability, the State considered the time needed to develop and adopt regulations, and the time it would take to see the benefit from these measures. The EPA has reviewed the RACM analysis and finds that there are no additional RACM that would have advanced the Serious area attainment date of 2021 for the DMNFR Area.
As a Serious ozone nonattainment area, pursuant to CAA section 182(c)(3), Colorado was required to implement an enhanced I/M program in the DMNFR Area.
The AIR program and Reg. 11 were expanded into portions of Larimer and Weld counties as “state only” requirements in the Colorado 2009 Legislative session, with the passage of Senate Bill 09-003. The startup date of the I/M program in these two counties was November 1, 2010. The purpose of this expansion of the AIR program and Reg. 11 into portions of Larimer and Weld counties was to further reduce vehicle emissions of NO
The most recent federally approved revisions to the Reg. 11 enhanced I/M program were adopted by the AQCC in May 2017. The revisions consisted of:
• Inclusion of OBD I/M pass/fail results as a qualifying consideration in the remote sensing clean screen low emitter index,
• Clarification of details of tailpipe and OBD inspection procedures and OBD readiness criteria, and
• Establishing authority to fail vehicles exhibiting evidence of OBD fraud.
These revisions were approved by EPA on February 7, 2019.
On July 15, 2022, Colorado submitted supplemental modeling of the State's I/M program for comparison against the applicable Enhanced I/M performance standard requirements in 40 CFR part 51, subpart S. Colorado used the latest approved version of the EPA's mobile source emissions model, MOVES3.0.3 (released January 2022), for the comparative analysis. Demonstration of program equivalency to the enhanced I/M program standard was conducted in accordance with the EPA's published I/M performance standard modeling guidance, MOVES3 technical guidance, and additional technical guidance from the EPA as necessary.
To demonstrate that the Colorado enhanced I/M program meets the enhanced program performance standard described in 40 CFR 51.351(i), the Colorado program must be modeled to show that, on the proper analysis date, it obtains the same or lower emissions reductions as the federal model enhanced program. The state program may provide reductions of NAAQS relevant pollutants equivalent to the reductions expected from the model program to within ±0.02 grams per mile for the area's total vehicle miles travelled on a July weekday in the attainment date year. Colorado's supplemental demonstration shows that the state's I/M program meets the applicable enhanced I/M performance standard requirements for the 2008 ozone NAAQS.
Based on our review and as discussed above we find that Colorado has a Vehicle I/M Program that meets the performance standard for Enhanced I/M, and we therefore propose approval of this portion of the OAP.
As a Serious ozone nonattainment area, Colorado was required to implement an NNSR program. Applicable NNSR requirements for ozone nonattainment areas are described in CAA section 182 and further defined in 40 CFR part 51, subpart I (Review of New Sources and Modifications). Under these requirements, new major sources and major modifications at existing sources must achieve the lowest achievable emission rate (LAER) and obtain emission offsets in an amount based on the specific ozone nonattainment classification. The emission offset ratio required for Serious ozone nonattainment areas is 1.2 to 1.
The Colorado SIP includes Regulation 3, part D, section V.A. (Concerning Major Stationary Source New Source Review and Prevention of Significant Deterioration, Requirements Applicable to Nonattainment Areas).
Section 176(c) of the CAA establishes a requirement known as “Transportation Conformity,” under which federal agencies must ensure that actions they support or fund will conform to the applicable SIP. Conformity to a SIP means that transportation activities will not produce new air quality violations, worsen existing violations, or delay timely attainment of the NAAQS.
Additionally, CAA section 182(c)(5) requires that states, every three years, submit a demonstration for Serious nonattainment areas that current aggregate VMT, aggregate vehicle emissions, congestion levels, and other relevant traffic-related and vehicle emissions-related factors (collectively “relevant parameters”) are consistent with those used for the area's ozone attainment demonstration.
Colorado derived the MVEBs for NO
These MVEBs are consistent with, and clearly related to, the emissions inventory and the control measures in the SIP, and satisfy the criteria at 40 CFR 93.118(e)(4). Therefore, we propose approval of the MVEBs as reflected in Table 6. This proposed approval applies to the Northern Subarea and Southern Subarea MVEBs as well as the Total Nonattainment Area MVEBs. The transportation conformity subareas are defined in chapter 11, section 11.2 of the OAP and are listed below.
• The Northern Subarea is the area denoted by the ozone nonattainment area north of the Boulder County northern boundary and extended through southern Weld County to the Morgan County line. This area includes the North Front Range MPO's (NFRMPO) regional planning area as well as part of the Upper Front Range Transportation Planning Region (TPR) in Larimer and Weld counties.
• The Southern Subarea is the area denoted by the ozone nonattainment area south of the Boulder County northern boundary and extended through southern Weld County to the Morgan County line. This area includes the nonattainment portion of the Denver Regional Council of Governments (DRCOG) regional planning area and the southern Weld County portion of the Upper Front Range TPR.
• Both subareas are further described in the OAP in Figure 20, “8-hour Ozone Nonattainment Area Subareas.”
In addition to proposing approval of the MVEBs, we also propose to approve the process described in chapter 11, section 11.2.3 in the OAP for the use of the Total Nonattainment Area MVEBs or the subarea MVEBs for the respective MPOs to determine transportation conformity for their respective RTP. As described in section 11.2.3 of Colorado's OAP, the OAP identifies subarea MVEBs for DRCOG and the NFRMPO. These SIP-identified subarea MVEBs allow either MPO to make independent conformity determinations for the applicable subarea MVEBs whose frequency and timing needs for conformity determinations differ. As noted in section 11.2.3, DRCOG and the NFRMPO may switch from using the Total Nonattainment Area MVEBs to using the subarea MVEBs for determining conformity. To switch to use of the subarea MVEBs (or to subsequently switch back to use of the Total Nonattainment Area MVEBs) DRCOG and the NFRMPO must use the process described in the DMNFR OAP in section 11.2.3.
Regarding transportation control requirements, as described in section 11.3 of the OAP, MVEBs are evaluated on a regular basis by the MPOs through their conformity process. Based on the most recent conformity determinations for the northern and the southern subregions, Colorado's demonstration shows that both areas were meeting the current emissions budgets established in the 2008 Moderate area Ozone SIP, and that they are expected be able to meet the proposed budgets for the 2008 Serious area Ozone SIP in future conformity determinations. The EPA finds that the transportation control measures as described in section 11.3 of the OAP meet CAA requirements. We therefore propose to approve this section of the OAP.
Sections 182(c)(4) and 241-246 of the CAA provide that states with ozone nonattainment areas classified as Serious, Severe, or Extreme must implement a federally enforceable program to require certain centrally fueled fleet operators to include a specified percentage of clean-fuel vehicles (CFV) in their new fleet purchases to reduce emissions of ozone precursors, or else to engage in a state-managed credit trading scheme with other fleet operators who purchase CFV in excess to requirements. Section 182(c)(4) of the Act also allows states subject to the clean-fuel fleet program requirements to develop substitute programs to achieve equivalent reductions to those achieved by the default program requirements for the covered nonattainment area, and to submit them to the EPA for approval.
In the OAP, Colorado cited an EPA determination
The EPA amended the Clean Fuel Fleet standards in 40 CFR part 88 in 2021 to address the fact that current emissions standards for engines and vehicles are either more stringent than or equivalent to the Clean Fuel Fleet standards.
Because 2004 model year Heavy Duty Diesel and Tier II and III vehicle standards meet or exceed the CFV LEV standards, we propose to find that Colorado meets the Federal Clean Fuel Fleet Program requirements, and to approve that portion of the submittal that addresses the requirements of section 182(c)(4) of the CAA.
This section describes revisions to Colorado Regs. 7 and 21 submitted as a part of the SIP, including emission control requirements for oil and gas operations; turbines, process heaters, and other combustion equipment, foam manufacturing; architectural coatings and consumer products. The revisions also establish RACT requirements for emission points at certain CTGs and major sources of VOC and NO
Colorado's Reg. 7, entitled “Control of Ozone via Ozone Precursors and Control of Hydrocarbons via Oil and Gas Emissions,” contains general RACT requirements as well as specific emission limits applicable to various industries. The EPA approved the repeal and re-promulgation of Reg. 7 in 1981,
In February 2021, the EPA approved Reg. 7 revisions in sections I (Applicability), IX (Surface Coating Operations), X (Use of Cleaning Solvents), XIII (Graphics Arts and Printing), XVI (Controls of Emissions from Stationary and Portable Engines and Other Combustion Equipment in the 8-Hour Ozone Control Area), and XIX (Control of Emissions from Specific Major Sources of VOC and/or NO
In November 2021, the EPA approved submitted revisions to sections II (general provisions), XII (Volatile Organic Compound Emissions from Oil and Gas Operations), and XVIII (emissions from natural gas-actuated pneumatic controllers located at or upstream of natural gas processing plants) of Reg. 7 from State submissions in 2018 and 2019.
Most recently, in May 2022, the EPA conditionally approved AQCC regulations of ozone precursor and hydrocarbon emissions from oil and gas operations in sections XII.J.1 of Reg. 7 from the State's May 14, 2018 submittal and part D, sections I.D., I.E., I.F., and I.J.1. of Reg. 7 from the State's May 13, 2020 submission.
Colorado submitted new regulation number 21 (Reg. 21) on May 13, 2020, and revised Reg. 7 revisions with the OAP on March 22, 2021, and subsequent revisions on May 18, 2021 and May 20, 2022. The 2020 submittal includes new Reg. 21, which establishes VOC content limits in architectural coatings and consumer products. The 2022 revisions in Reg. 7, part C, section I.O and part E, sections II.A., III.B., and V. address RACT for major sources with VOC and/or NO
As noted above, Colorado designated various parts of Reg. 7 and Reg. 21 “State Only” and in Reg. 7, section I.A.1.c and Reg. 21, section I.A.2. indicated that sections designated State Only are not federally enforceable. The EPA concludes that provisions designated State Only have not been submitted for EPA approval, but for informational purposes. Hence, the EPA is not proposing to act on the portions of Regs. 7 or 21 designated State Only, and this proposed rule does not discuss them further except as relevant to discussion of the portions of the regulation that Colorado intended to be federally enforceable.
The EPA proposes to approve the changes made to Reg. 21 with Colorado's May 13, 2020 submission.
Part A of Reg. 21 establishes new rules for limiting VOC emissions from consumer products as of May 1, 2020. “Consumer products,” as defined in section VI.GG., “means a chemically formulated product used by household and institutional consumers including, but not limited to, detergents; cleaning compounds; polishes; floor finishes; cosmetics; personal care products; home, lawn, and garden products; disinfectants; sanitizers; aerosol paints; automotive specialty products; and aerosol adhesives. Consumer product does not include other paint products, furniture coatings, or architectural coatings.”
Table 1 in section II establishes VOC content limits for manufacturing, selling, suppling, offering for sale, and distributing consumer products. Additional standards in section II include labeling, certification, and VOC limit applicability requirements for consumer products. Section II.J. includes a list of chemicals that consumer products cannot contain. Section II.K. includes a list of consumer products that cannot contain trichloroethylene in a combined amount greater than 0.01 percent by weight. Table 1 in Part A includes the VOC content limits for consumer products manufactured on or after May 1, 2020.
Section III of part A contains container labeling requirements, including a requirement for clear display of dates that products were manufactured or date codes representing the date of manufacture on containers or packages; special purpose spray adhesive classification requirements; and dilution ratios for non-aerosol floor wax strippers. Sections III.E and F. include label display requirements for energized electrical cleaner and zinc rich primers. Under section III.F aerosol adhesives, adhesive removers, electronic cleaners, electrical cleaners, energized electrical cleaners, and content products must include the product category, applicable VOC standard for the product as a percentage by weight, and the applicable substrate and/or application for special purpose spray adhesives on labels.
Section IV contains reporting requirements to demonstrate compliance with the applicability and standards requirements in part A. These include maintaining records necessary to demonstrate exemptions under section I.B and of the para-dichlorobenzene content of solid air freshener, insecticide, or toilet/urinal care consumer products. Records must be maintained for a minimum of three years and made available to the Division upon request. Section IV.D. includes a list of information that must be reported to the Division within 90 days of written notice. This information includes the names and contact information of responsible parties, consumer product brand names for each product label and category, Colorado sales in pounds per year, and the net percent by weight of total product.
Section V includes test methods that should be used to determine compliance with the requirements in part A (CARB Method 310 or through calculation of the VOC content from records of the amounts of constituents used to make the product) and whether a product is a liquid or solid (ASTM D4359-90(2000)e). Section VI contains a list of definitions used throughout part A. We propose to find that the provisions in part A are consistent with CAA requirements, and that they strengthen the SIP. We therefore propose to approve the revisions in part. A.
Part B of Reg. 21 establishes new rules for limiting VOC emissions from architectural or industrial maintenance (AIM) coatings as of May 1, 2020. Architectural coating, as defined in section VI.F., “means a coating to be applied to stationary structures or their appurtenances at the site of installation, to portable buildings at the site of installation, to pavements, or to curbs. Architectural coating does not include
Section I contains the applicability requirements. The rules apply to people who sell, supply, offer for sale, distribute for sale, or manufacture for sale AIM coatings in the 8-hour ozone control area. Section I.B. includes a number of exemptions from the requirements in section B including AIM coatings that are manufactured in Colorado solely for shipment and use outside of Colorado; aerosol coating products, and AIM coatings that are sold in containers with a volume of one liter or less.
Table 1 in section II establishes VOC content limits for manufacturing, blending, suppling, selling, offering for sale, and soliciting for application AIM coatings. Section III of part B includes container labeling requirements including clearly displaying dates that products were manufactured or date codes representing the date of manufacture on containers, a statement of the manufacturer's recommendation regarding thinning of the coating, and the VOC content in grams per liter of coating. Section III.D. includes a list of statements that should be displayed on container labels, such as “for industrial use only,” “for blocking stains,” “high gloss,” and “for metal substrates only.”
Section IV contains a list of information that must be reported to the Division within 180 days of written notice to demonstrate compliance with part B requirements. This information includes the names and mailing address of manufacturers, the names of the coatings products as they appear on the labels and the application coating categories, the VOC content in gram per liter as determined in accordance with section V, and the density of the products in pounds per gallon.
Section V includes test methods that should be used to determine compliance with the requirements in part B. Section V.A. describes the process for determining the VOC content of a coating. Section VI. contains a list of definitions used throughout part B. We propose to find that the provisions in part B are consistent with CAA requirements, and that they strengthen the SIP. We therefore propose to approve the revisions in part B.
The EPA proposes to approve the following changes made to Reg. 7 with Colorado's March 22, 2021 submission.
Section I of part C contains rules for surface coating operations. In this submittal, the Commission expanded Section I.O wood furniture surface coating requirements to the surface coatings of other wood products such as doors, door casings, and decorative wood accents. The provisions apply to other wood products coating operations with uncontrolled actual emissions greater than or equal to 50 tpy located in the DMNFR Area. A detailed evaluation of section I is in the TSD for this action. We propose to find that the provisions in part C are consistent with CAA and RACT requirements, and that they strengthen the SIP. We therefore propose to approve the revisions in part. C.
Section II of part E contains rules for the control of emissions from stationary and portable combustion equipment in the DMNFR Area. The revisions in art E include RACT requirements for 50 tpy major sources of VOC and/or NO
Section II.A.4.a.(iv) expands categorical boiler RACT requirements for 50-100 MMBtu/hr boilers at 50 tpy major sources to comply with a 0.1 lb/MMBtu NO
Section II.A.4.b.(i)(A) was revised to reference NSPS KKKK NO
A detailed evaluation of section II is in the TSD for this action. We propose to find that the provisions in section II are consistent with CAA and RACT requirements, and that they strengthen the SIP. We therefore propose to approve the revisions in part E, section II.
Section V of part E contains new rules for the control of emissions from foam manufacturing in the DMNFR Area as of January 27, 2020. Foam manufacturing operation, as defined in section V.A.3.e., “means any expanded polystyrene (EPS) production line, or portion of a production line, which processes raw EPS bead into final molded EPS product. Production line processes include, but are not limited to pre-expansion, aging (pre-puff), and molding. The manufacturing process ends after the product exits the EPS mold. `Foam manufacturing operation' also means any production line processing methylene diphenyl diisocyanate (MDI), resins, and various hardeners and thickeners into foam products and which results in VOC emissions into the atmosphere. The manufacturing process ends after the product exits the drying tunnel.” Section V.A.3. includes a list of definitions used in section V.
Section V.A.4. establishes emission limits for foam manufacturing operations. Operators must limit VOC emissions from foam manufacturing to 3.0 lbs per 100 lbs of total material processed, averaged monthly, or must control VOC emissions from foam
A detailed evaluation of section V is in the TSD for this action. We propose to find that the provisions in section V are consistent with CAA and RACT requirements, and that they strengthen the SIP. We therefore propose to approve the revisions in part E, section V.
The majority of the changes to Reg. 7 from the May 18, 2021 submittal are state-only and therefore have not been submitted for inclusion in the SIP. The SIP revisions from this submittal include editorial revisions to the outline of the regulation and numbering changes to part E, section I.D.4., SIP controls for existing natural gas fired RICE. The revisions are clerical in nature and do not affect the substance of the requirements. Therefore, we propose to approve the changes.
The EPA proposes to approve the changes made to Reg. 7 with Colorado's May 20, 2022 miscellaneous metals and process heaters submittal.
Section I of part C contains rules for surface coating operations. The Commission has previously adopted requirements for metal surface coatings based on recommendations in EPA's Control of Volatile Organic Emissions from Existing Stationary Sources—Volume VI: Surface Coating of Miscellaneous Metal Parts and Products (1978), including VOC content limits, work practices, and recordkeeping requirements. In 2008, however, the EPA published a subsequent metal coating CTG, Control Techniques Guidelines for Miscellaneous Metal and Plastic Parts Coatings (Metal Coating CTG), which recommends expanding the coatings VOC content limits from four to fifty, including work practices, application methods, and recordkeeping. Therefore, in response to EPA's concern with Colorado's existing metal parts coating requirements as based on EPA's 1978 CTG, the Commission revised the metal surface coating requirements in part C, section I to correspond to the recommendations in the 2008 Metal Coating CTG.
The revised section I.L., Manufactured Metal Parts and Metal Products, applies to sources where actual emissions are greater than or equal to 6.8 kilograms (15 lbs) per day and 1.4 kilograms (3 lbs) per hour. Starting January 1, 2022, section I.L requirements applied to metal parts and product surface coating units at facilities where total actual VOC emissions from all metal parts and products surface coating operations are greater than or equal to 2.7 tons per 12-month rolling period, before consideration of controls.
Revised section I.L.1.b. removes a number of exemptions for surface coatings of various metal parts and products: automobiles and light-duty trucks, metal cans, flat metal sheets and strips in the form of rolls or coils, large appliances, magnet wire for use in electrical machinery, and metal furniture. Section I.L.b.(iii) adds categories for which section I.L. does not apply, including certain sources regulated by NSPS and sources that must comply with other sections of the SIP. Section I.L.2.b. includes new requirements for surface coating of manufactured metal parts or metal products facilities and operations. Section I.L.2.b.(i) requires that VOC emissions from coatings and thinners be reduced with an emission control system having a control efficiency of 90% or greater. Additionally, products must comply with the VOC content limits established in Tables 1 and 2 of section I.L.2.b. A number of new definitions were added to section I.L.1.c.
Sections I.L.3. and I.L.4. include application methods and work practice standards that owners and operators must use and follow. These include the use of high-volume low-pressure spray, roller coat, and airless spray; storing all VOC containing coatings, thinners, coating related waste materials, cleaning materials, and used shop towels in closed containers; and minimizing VOC emissions from cleaning of application, storage, mixing, and conveying equipment by cleaning equipment without atomizing the cleaning solvent and capturing spent solvent in closed containers section I.L.5. contains recordkeeping requirements to demonstrate compliance with section I.L. Records must be maintained for a minimum of five years and made available to the Division upon request.
A detailed review of section I.L. is in the TSD for this action. We propose to find that the provisions in section I.L. are consistent with CAA requirements, represent RACT for the emission limits in Table 2 “Metal Parts and Products VOC Content Limits” and Table 7 “Metal Parts and Products VOC Emission Rate Limits” of the 2008 Miscellaneous Metal Parts and Products CTG, and that they strengthen the SIP. We therefore propose to approve the revisions in part C, section I.
Section II of part E contains rules for the control of emissions from stationary and portable combustion equipment in the 8-hour ozone control area. The Commission revised this section of Reg. 7 to include provisions in the SIP that require the implementation of RACT for process heaters at major sources of NO
Table 2 in section II.A.4.g. contains NO
A detailed evaluation of section II is in the TSD for this action. We propose to find that the provisions in section II
The majority of the changes to Reg. 7 from the State's May 20, 2022 part D definitions submittal are state-only and therefore have not been submitted for inclusion in the SIP. The SIP revisions from this submittal include revisions to definitions included in Reg. 7, part D, section III for natural gas-actuated pneumatic controllers associated with oil and gas operations. The revisions to definitions associated with pneumatic controllers reflect more accurate and appropriate technical definitions and do not affect the substance of the requirements. Therefore, we propose to approve the changes.
In November 2021, the EPA approved the majority of revisions to Colorado's regulations for oil and gas operations from State submissions in 2018 and 2020
The revisions from the May 20, 2022 part D, Oil and Gas submittal are consistent with the commitments in the letter
We propose to approve the majority of the OAP submittal from the State of Colorado for the DMNFR Area submitted on March 22, 2021. (In this rule we are not proposing any action on the submitted attainment demonstration, enhanced monitoring, or contingency measures.) Specifically, we propose to approve:
• Milestone and future year emissions inventories;
• RFP demonstration;
• Demonstration of RACT for oil and natural gas industry VOC CTG sources;
• Demonstration of RACT for certain miscellaneous metal parts coatings VOC CTG sources;
• Demonstration of RACT for certain VOC and NO
• Demonstration of RACM implementation;
• Motor vehicle I/M program;
• NNSR program; and
• MVEBs.
We also propose to approve SIP revisions to Reg. 21 submitted by the State on May 13, 2020 and to Reg. 7 submitted by the State on March 22, 2021, May 18, 2021, and May 20, 2022 as shown in Table 7. We are proposing to approve Colorado's determination that the above rules constitute RACT for the specific categories addressed in Tables 3 and 4. A comprehensive summary of the revisions in Colorado's Regs. 7 and 21 organized by the EPA's proposed rule action and submittal dates are provided in the Table 7.
Under section 110(l) of the CAA, the EPA cannot approve a SIP revision if the revision would interfere with any applicable requirement concerning attainment and reasonable further progress toward attainment of the NAAQS, or any other applicable requirement of the Act. In addition, section 110(l) requires that each revision to an implementation plan submitted by a state be adopted by the state after reasonable notice and public hearing.
The Colorado SIP revisions that the EPA is proposing to approve do not interfere with any applicable requirements of the Act. The Reg. 7 revisions submitted by the State are intended to strengthen the SIP and to serve as RACT for certain sources for the Colorado ozone SIP. Colorado's submittals provide adequate evidence that the revisions were adopted after reasonable public notices and hearings. Therefore, CAA section 110(l) requirements are satisfied.
Executive Order 12898
To identify potential environmental burdens and susceptible populations in the DMNFR Area, a screening analysis was conducted using the EJSCREEN
As to all vulnerable groups within the DMNFR Area, as explained below we believe that this action will be beneficial and will tend to reduce impacts. When the EPA establishes a new or revised NAAQS, the CAA requires the EPA to designate all areas of the U.S. as either nonattainment, attainment, or unclassifiable. If an area is designated nonattainment for a NAAQS, the state must develop a plan outlining how the area will attain and maintain the standard by reducing air pollutant emissions. In this action we are proposing to approve the majority of the State's OAP submittal for the DMNFR Area and state rules as meeting RACT and satisfying other CAA requirements. The EPA has defined RACT as the lowest emission limitation that a particular source is capable of meeting by the application of control technology that is reasonably available considering technological and economic feasibility. Approval of these rules into the SIP will establish federally enforceable requirements that may reduce emissions from operations in the area. These requirements will contribute to the increased protection of those residing, working, attending school, or otherwise present in those areas, and we propose to determine that this rule, if finalized, will not have disproportionately high or adverse human health or environmental effects on communities with environmental justice concerns.
In this document, the EPA is proposing to include regulatory text in an EPA final rule that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference Colorado AQCC Regulation 7 pertaining to the control of ozone via ozone precursors and control of hydrocarbons vial oil and gas emissions and Regulation 21 pertaining to Control of Volatile Organic Compounds from Consumer Products and Architectural and Industrial Maintenance Coatings discussed in section VI of this preamble.
The EPA has made, and will continue to make, these materials generally available through
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely proposes to approve state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. The proposed rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Environmental protection, Air pollution control, Carbon monoxide, Greenhouse gases, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
42 U.S.C. 7401
Office of the Secretary, Department of Health and Human Services (HHS).
Proposed rule.
This proposed rule would adopt updated versions of the retail pharmacy standards for electronic transactions adopted under the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). These updated versions would be modifications to the currently adopted standards for the following retail pharmacy transactions: health care claims or equivalent encounter information; eligibility for a health plan; referral certification and authorization; and coordination of benefits. The proposed rule would also broaden the applicability of the Medicaid pharmacy subrogation transaction to all health plans. To that end, the rule would rename and revise the definition of the transaction and adopt an updated standard, which would be a modification for state Medicaid agencies and an initial standard for all other health plans.
To be assured consideration, comments must be received at one of the addresses provided below, January 9, 2023.
In commenting, please refer to file code CMS-0056-P.
Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed):
1.
2.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
For information on viewing public comments, see the beginning of the
Geanelle G. Herring, (410) 786-4466, Beth A. Karpiak, (312) 353-1351, or Christopher S. Wilson, (410) 786-3178.
This rule proposes to adopt modifications to standards for electronic retail pharmacy transactions and a subrogation standard adopted under the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), and to broaden the applicability of the HIPAA subrogation transaction.
The rule proposes to modify the currently adopted retail pharmacy standards and adopt a new standard. These proposals would provide improvements such as more robust data exchange, improved coordination of benefits, and expanded financial fields that would avoid the need to manually enter free text, split claims, or prepare and submit a paper Universal Claim Form.
But for a small modification to the requirement for the use of a particular data field, adopted in 2020, the presently adopted pharmacy standards were finalized in 2009. Since then, the National Committee on Vital and Health Statistics (NCVHS) has recommended that HHS publish a proposed rule adopting more recent standards to address evolving industry changing business needs. Consistent with NCVHS recommendations and collaborative industry and stakeholder input, we believe the updated retail pharmacy standards we propose here are sufficiently mature for adoption and that covered entities are ready to implement them.
Sections 1171
The provisions in this proposed ruled would adopt the NCPDP Telecommunication Standard Implementation Guide, Version F6 (Version F6) and equivalent NCPDP Batch Standard Implementation Guide, Version 15 (Version 15); and NCPDP Batch Standard Pharmacy Subrogation Implementation Guide, Version 10, for non-Medicaid health plans. These updated standards would replace the currently adopted NCPDP Telecommunication Standard Implementation Guide, Version D, Release 0 (Version D.0) and the equivalent NCPDP Batch Standard Implementation Guide, Version 1, Release 2 (Version 1.2); and NCPDP Batch Standard Medicaid Subrogation Implementation Guide, Version 3.0, Release 0.
Industry stakeholders report that Version F6 would bring much needed upgrades over Version D.0, such as improvements to the information attached to controlled substance claims, including refinement to the quantity prescribed field. This change would enable refills to be distinguished from multiple dispensing events for a single fill, which would increase patient safety. Version F6 provides more specific fields to differentiate various types of fees, including taxes, regulatory fees, and medication administration fees. Finally, Version F6 increases the dollar amount field length and would simplify coverage under prescription benefits of new innovative drug therapies priced at, or in excess of, $1 million. The current adopted Version D.0 does not support this business need.
The current Medicaid Subrogation Implementation Guide Version 3.0 (Version 3.0) was adopted to support federal and state requirements for state Medicaid agencies to seek reimbursement from the correct responsible health plan. However, industry stakeholders reported that there is a need to expand the use of the subrogation transaction beyond Medicaid agencies, and noted that the use of a subrogation standard that would apply to other payers would be a positive step for the industry. Whereas HIPAA regulations currently require only Medicaid agencies to use Version 3.0 in conducting the Medicaid pharmacy subrogation transaction, all health plans would be required to use the Pharmacy Subrogation Implementation Guide for Batch Standard, Version 10, to transmit pharmacy subrogation transactions, which would allow better tracking of subrogation efforts and results across all health plans, and support cost containment efforts.
Should these proposals be adopted as proposed, it would require covered entities to comply 24 months after the effective date of the final rule. Small health plans would have 36 months after the effective date of the final rule to comply.
We estimate that the overall cost for pharmacies, pharmacy benefit plans, and chain drug stores to move to the updated versions of the pharmacy standards and the initial adoption of the pharmacy subrogation transaction standard would be approximately $386.3 million. The cost estimate is based on the need for technical development, implementation, testing, initial training, and a 24-month compliance timeframe. We believe that HIPAA covered entities or their contracted vendors have already largely invested in the hardware, software, and connectivity necessary to conduct the transactions with the updated versions of the pharmacy standards.
This background discussion presents a history of statutory provisions and regulations that are relevant for purposes of this proposed rule.
Congress addressed the need for a consistent framework for electronic transactions and other administrative simplification issues in HIPAA (Pub. L. 104-191, enacted on August 21, 1996). Through subtitle F of title II of HIPAA, Congress added to title XI of the Act a new Part C, titled “Administrative Simplification,” which required the Secretary of the Department of Health and Human Services (the Secretary) to adopt standards for certain transactions to enable health information to be exchanged more efficiently and to achieve greater uniformity in the transmission of health information. For purposes of this and later discussion in this proposed rule, we sometimes refer to this statute as the “original” HIPAA.
Section 1172(a) of the Act states that “[a]ny standard adopted under [HIPAA] shall apply, in whole or in part, to . . . (1) A health plan. (2) A health care clearinghouse. (3) A health care provider who transmits any health information in electronic form in connection with a [HIPAA transaction],” which are collectively referred to as “covered entities.” Generally, section 1172 of the Act requires any standard adopted under HIPAA to be developed, adopted, or modified by a standard setting organization (SSO). In adopting a standard, the Secretary must rely upon recommendations of the NCVHS, in consultation with the organizations referred to in section 1172(c)(3)(B) of the Act, and appropriate federal and state agencies and private organizations.
Section 1172(b) of the Act requires that a standard adopted under HIPAA be consistent with the objective of reducing the administrative costs of providing and paying for health care. The transaction standards adopted under HIPAA enable financial and administrative electronic data interchange (EDI) using a common structure, as opposed to the many varied, often proprietary, transaction formats on which industry had previously relied and that, due to lack of uniformity, engendered administrative burden. Section 1173(g)(1) of the Act, which was added by section 1104(b) of the Patient Protection and Affordable Care Act, further addresses the goal of uniformity by requiring the Secretary to adopt a single set of operating rules for each
Section 1173(a) of the Act requires that the Secretary adopt standards for financial and administrative transactions, and data elements for those transactions, to enable health information to be exchanged electronically. The original HIPAA provisions require the Secretary to adopt standards for the following transactions: health claims or equivalent encounter information; health claims attachments; enrollment and disenrollment in a health plan; eligibility for a health plan; health care payment and remittance advice; health plan premium payments; first report of injury; health claim status; and referral certification and authorization. The Patient Protection and Affordable Care Act (Pub. L. 111-148) additionally required the Secretary to develop standards for electronic funds transfers transactions. Section 1173(a)(1)(B) of the Act requires the Secretary to adopt standards for any other financial and administrative transactions the Secretary determines appropriate. Section 1173(a)(4) of the Act requires that the standards and operating rules, to the extent feasible and appropriate: enable determination of an individual's eligibility and financial responsibility for specific services prior to or at the point of care; be comprehensive, requiring minimal augmentation by paper or other communications; provide for timely acknowledgment, response, and status reporting that supports a transparent claims and denial management process; describe all data elements in unambiguous terms, require that such data elements be required or conditioned upon set terms in other fields, and generally prohibit additional conditions; and reduce clerical burden on patients and providers.
Section 1174 of the Act requires the Secretary to review the adopted standards and adopt modifications to them, including additions to the standards, as appropriate, but not more frequently than once every 12 months, unless the Secretary determines that the modification is necessary in order to permit compliance with the standard.
Section 1175(a) of the Act prohibits health plans from refusing to conduct a transaction as a standard transaction. Section 1175(a)(3) of the Act also prohibits health plans from delaying the transaction or adversely affecting or attempting to adversely affect a person or the transaction itself on the grounds that the transaction is in standard format. Section 1175(b) of the Act provides for a compliance date not later than 24 months after the date on which an initial standard or implementation specification is adopted for all covered entities except small health plans, which must comply not later than 36 months after such adoption. If the Secretary adopts a modification to a HIPAA standard or implementation specification, the compliance date for the modification may not be earlier than 180 days following the date of the adoption of the modification. The Secretary must consider the time needed to comply due to the nature and extent of the modification when determining compliance dates, and may extend the time for compliance for small health plans if he deems it appropriate.
Sections 1176 and 1177 of the Act establish civil money penalties (CMPs) and criminal penalties to which covered entities may be subject for violations of HIPAA Administrative Simplification rules. HHS administers the CMPs under section 1176 of the Act and the U.S. Department of Justice administers the criminal penalties under section 1177 of the Act. Section 1176(b) sets out limitations on the Secretary's authority and provides the Secretary certain discretion with respect to imposing CMPs. This section provides that no CMPs may be imposed with respect to an act if a penalty has been imposed under section 1177 with respect to such act. This section also generally precludes the Secretary from imposing a CMP for a violation corrected during the 30-day period beginning when an individual knew or, by exercising reasonable diligence, would have known that the failure to comply occurred.
In the August 17, 2000
Since initially adopting the HIPAA standards in the Transactions and Code Sets final rule, we have adopted a number of modifications to them. The most extensive modifications were adopted in a final rule titled “Health Insurance Reform; Modifications to the Health Insurance Portability and Accountability Act (HIPAA) Electronic Transaction Standards” in the January 16, 2009
In the Transactions and Code Sets final rule, we defined the terms “modification” and “maintenance.” We explained that when a change is substantial enough to justify publication of a new version of an implementation specification, such change is considered a modification and must be adopted by the Secretary through regulation (65 FR 50322). Conversely, maintenance describes the activities necessary to support the use of a standard, including technical corrections to an implementation specification. Maintenance changes are typically corrections that are obvious to readers of the implementation guides, not controversial, and essential to implementation (68 FR 8388, February 20, 2003). Maintenance changes to Version D.0 were identified by the industry, balloted and approved through the NCPDP, and are contained in the NCPDP Version D.0 Editorial. In an October 13, 2010
In a final rule titled “Administrative Simplification: Modification of the Requirements for the Use of Health Insurance Portability and Accountability Act of 1996 (HIPAA) National Council for Prescription Drug Programs (NCPDP) D.0 Standard,” published in the January 24, 2020
In that rulemaking, the Secretary noted that the NCPDP had issued a subsequent publication, the October 2017 Telecommunication Standard Implementation Guide, Version F2 (Version F2), that, among many other unrelated changes, revised the situational circumstances to specify an even broader use of the Quantity Prescribed (460-ET) field. The change described the field as “required only if the claim is for a controlled substance or for other products as required by law; otherwise, not available for use.” We explained that we chose not to adopt Version F2 at that time because, given the public health emergency caused by the opioid crisis and the urgent need to find ways to yield data and information to help combat it, we believed it was more appropriate to take a narrow, targeted approach while taking additional time to further evaluate the impact of a new version change on covered entities.
The law generally requires at section 1172(c) that any standard adopted under HIPAA be developed, adopted, or modified by an SSO. Section 1171 of the Act defines an SSO as an SSO accredited by the American National Standards Institute (ANSI), including the NCPDP (the SSO applicable to this proposed rule) that develops standards for information transactions, data, or any standard that is necessary to, or will facilitate the implementation of, Administrative Simplification. Information about the NCPDP's balloting process, the process by which it vets and approves the standards it develops and any changes thereto, is available on its website,
In the Transactions and Code Sets final rule, the Secretary adopted procedures to maintain and modify existing, and adopt new, HIPAA standards and established a new organization type called the “Designated Standard Maintenance Organization” (DSMO). Regulations at 45 CFR 162.910 provide that the Secretary may designate as a DSMO an organization that agrees to conduct, to the satisfaction of the Secretary, the functions of maintaining the adopted standard, and receiving and processing requests for adopting a new standard or modifying an adopted standard. In an August 17, 2000 notice titled “Health Insurance Reform: Announcement of Designated Standard Maintenance Organizations” (65 FR 50373), the Secretary designated the following six DSMOs: X12, NCPDP, Health Level Seven, the National Uniform Billing Committee (NUBC), the National Uniform Claim Committee (NUCC), and the Dental Content Committee (DCC) of the American Dental Association.
In general, HIPAA requires the Secretary to adopt standards that have been developed by an SSO. The process for adopting a new standard or a modification to an existing standard is described in the Transactions and Code Sets final rule (65 FR 50344) and implemented at § 162.910. Under § 162.910, the Secretary considers recommendations for proposed modifications to existing standards or a proposed new standard if the recommendations are developed through a process that provides for: open public access; coordination with other DSMOs; an appeals process for the requestor of the proposal or the DSMO that participated in the review and analysis if either of the preceding were dissatisfied with the decision on the request; an expedited process to address HIPAA content needs identified within the industry; and submission of the recommendation to the NCVHS.
Any entity may submit change requests with a documented business case to support its recommendation to the DSMO. The DSMO receives and manages those change requests, including reviewing them and notifying the SSO of its recommendation for approval or rejection. If the changes are recommended for approval, the DSMO also notifies the NCVHS and suggests that a recommendation for adoption be made to the Secretary.
The foregoing processes were followed with respect to the modifications and new standard proposed in this rule, and stemmed from the following change requests the NCPDP submitted to the DSMO: (1) DSMO request 1201 requested replacing the adopted NCPDP Telecommunication Standard Implementation Guide, Version D.0 and the equivalent Batch Standard Implementation Guide Version 1.2 with updated versions, the NCPDP Telecommunication Standard Implementation Guide, Version F2 and the equivalent Batch Standard Implementation Guide, Version 15; (2) DSMO request 1202 requested replacing the adopted NCPDP Batch Standard Medicaid Subrogation Implementation Guide, Version 3.0, for use by Medicaid agencies, with the NCPDP Batch Standard Subrogation Implementation Guide, Version 10, for use by all health plans; and (3) DSMO request 1208 updated DSMO request 1201 requested adopting an updated version of the NCPDP Telecommunication Standard Implementation Guide, Version F6 instead of Version F2.
The NCVHS was established by statute in 1949; it serves as an advisory committee to the Secretary and is statutorily conferred a significant role in the Secretary's adoption and modification of HIPAA standards. In 2018, the NCVHS conducted two days of hearings seeking the input of health care providers, health plans, clearinghouses, vendors, and interested stakeholders regarding the NCPDP Telecommunication Standard, Version F2, as a potential replacement for NCPDP Version D.0, and the equivalent Batch Standard Implementation Guide, Version 15, as a potential replacement for Version 1.2. Testimony was also presented in support of replacing the NCPDP Batch Standard Medicaid Subrogation Implementation Guide, Version 3.0, with the Batch Standard Subrogation Implementation Guide, Version 10. In addition to the NCPDP, organizations submitting testimony
In a letter
During the March 24, 2020 NCVHS full committee meeting, there was a hearing to discuss Change Request 1208 regarding the NCPDP Telecommunication Standard, Version F6, as a potential update to the NCVHS 2018 recommendation to the Secretary to adopt Version F2. During the hearing, the NCPDP noted that several key Version F2 limitations had been resolved by Telecommunication Standard Implementation Guide, Version F6. Significantly, with respect to the number of digits in the dollar field, Version F2 would not support dollar fields of $1 million or more. To that point, since receipt of the NCVHS's May 17, 2018 recommendation, several new drugs priced at, or in excess of, $1 million have entered the market and researchers and analysts anticipate that over the next several years dozens of new drugs priced similarly or higher may enter the market, while hundreds more likely high-priced therapies, including for gene therapies that target certain cancers and rare diseases, are under development. To meet emerging business needs, the NCPDP updated the Telecommunication Standard to support dollar fields equal to, or in excess of, $1 million and made other updates, including enhancements to improve coordination of benefits processes, prescriber validation fields, plan benefit transparency, codification of clinical and patient data, harmonization with related standards, and controlled substance reporting, that necessitated the new version, F6. The transcript and testimony from the March 24, 2020 full committee meeting is available at
In a letter dated April 22, 2020,
Should they be finalized as proposed herein, the NCPDP Telecommunication Standard Implementation Guide, Version F6 (Version F6) and equivalent NCPDP Batch Standard Implementation Guide, Version 15 (Version 15) would replace the currently adopted NCPDP Telecommunication Standard Implementation Guide, Version D, Release 0 (Version D.0) and the equivalent NCPDP Batch Standard Implementation Guide, Version 1, Release 2 (Version 1.2). Version F6 includes a number of changes from Version D.0 that alter the use or structure of data fields, insert new data segments, and add new functionality. Adopting Version F6 to replace Version D.0 would constitute a HIPAA modification.
We are proposing to adopt modifications to the current HIPAA retail pharmacy standards for the following transactions: health care claims or equivalent encounter information; eligibility for a health plan; referral certification and authorization; and coordination of benefits. Covered entities conducting the following HIPAA transactions would be required to use Version F6:
• Health care claims or equivalent encounter information (§ 162.1101).
++ Retail pharmacy drug claims.
++ Retail pharmacy supplies and professional claims.
• Eligibility for a health plan (§ 162.1201).
++ Retail pharmacy drugs.
• Referral certification and authorization (§ 162.1301).
++ Retail pharmacy drugs.
• Coordination of benefits (§ 162.1801).
In its April 22, 2020 letter to the Secretary, the NCVHS considered industry testimony and recommended that HHS propose to replace Version D.0 with Version F6 as the HIPAA standard for retail pharmacy transactions. Testifiers at the March 2020 NCVHS full committee meeting advocated for HHS to adopt updated versions of the retail pharmacy standards to better accommodate business requirements that have changed significantly for covered entities since 2009 when Version D.0 was adopted, and also since Version F2 was approved. The NCVHS recommendation, and industry testimony from both the May 2018 hearing and the March 2020 full committee meeting, highlighted the benefits Version F6 would provide over Version D.0, to include benefits introduced in Version F2 that are incorporated into Version F6:
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As discussed in section I. of this proposed rule, in the Modification of Version D.0 Requirements final rule (85 FR 4236), we adopted the requirements that the Quantity Prescribed (460-ET) field in Version D.0 must be treated as a required field where the transmission is for a Schedule II drug in any of the following three HIPAA transactions: (1) health care claims or equivalent encounter information; (2) referral certification and authorization; and (3) coordination of benefits. Version F6 requires the use of the 460-ET field for all controlled substances. Therefore, we would no longer need to explicitly require its situational use, and we would revise the regulation text at §§ 162.1102(d), 162.1302(d), and 162.1802(d) accordingly.
Batch mode can be used for processing large volumes of transactions. For example, a retail pharmacy that has several locations can send one batch mode transaction, containing multiple claims collected over time from the various locations, to an entity with which it has contracted, or otherwise to a centralized entity, that will route each claim in the transaction to the appropriate payer. The NCPDP Batch Standard, Version 15, better supports retail pharmacy batch mode transactions than the currently adopted Version 1.2 because it was developed in coordination with F6 and includes the same benefits as Version F6, but in batch mode, including the updates that improve coordination of benefits processes, prescriber validation fields, plan benefit transparency, codification of clinical and patient data, harmonization with related standards, and controlled substance reporting.
In sum, we believe adopting Version F6 and its equivalent Batch Standard, Version 15 to replace Version D.0 and Version 1.2 would result in greater interoperability for entities exchanging prescription information, improve patient care, provide better data for drug utilization monitoring, and reduce provider burden. Because Version F6 and Version 15 would better support the business needs of the industry than Version D.0 and Version 1.2, we propose to adopt them as the standards for the following retail pharmacy transactions: health care claims or equivalent encounter information; eligibility for a health plan; referral certification and authorization; and coordination of benefits. We would revise §§ 162.1102, 162.1202, 162.1302, and 162.1802 accordingly.
We solicit comments regarding our proposal to adopt Version F6 to replace Version D.0 and Version 15 to replace Version 1.2.
In the 2009 Modifications final rule, we adopted the Batch Standard Medicaid Subrogation Implementation Guide, Version 3.0, Release 0 (Version 3.0) as the standard for the Medicaid pharmacy subrogation transaction. In that rule, we discussed that state Medicaid agencies sometimes pay claims for which a third party may be legally responsible, and where the state is required to seek recovery. This can occur when the Medicaid agency is not aware of the existence of other coverage, though there are also specific circumstances in which states are required by federal law to pay claims and then seek reimbursement afterward. For the full discussion, refer to 74 FR 3296.
Because we are proposing to broaden the scope of the subrogation transaction to apply to all health plans, not just state Medicaid agencies, we are proposing to revise the definition of the transaction. The Medicaid pharmacy subrogation transaction is defined at § 162.1901 as the transmission of a claim from a Medicaid agency to a payer for the purpose of seeking reimbursement from the responsible health plan for a pharmacy claim the state has paid on behalf of a Medicaid recipient. We are proposing to change the name of the transaction at § 162.1901 to the “Pharmacy subrogation transaction” and define the transaction as the transmission of a request for reimbursement of a pharmacy claim from a health plan that paid the claim, for which it did not have payment responsibility, to the health plan responsible for the claim.
There are a few notable differences between the current and proposed transaction definitions. First, the current definition defines the transaction such that it only applies to state Medicaid agencies, in their role as health plans, as the sender of the transaction. Because we are proposing to broaden the scope of the transaction to apply to all health plans, not just state Medicaid agencies, the Pharmacy subrogation transaction definition would specify that the sender of the transaction is “a health plan that paid the claim” instead of a “Medicaid agency.” In addition, the current definition identifies that the sender of the transaction is requesting “reimbursement for a pharmacy claim the state has paid on behalf of a Medicaid recipient.” To align this aspect of the current definition with the broadened scope that would apply to all health plans, the proposed definition identifies that the sender health plan has paid a claim “for which it did not have payment responsibility.”
Second, the current definition identifies a pharmacy subrogation transaction as the “transmission of a claim.” The proposed definition would specify that a pharmacy subrogation transaction is the transmission of a “request for reimbursement of a pharmacy claim.” We use the term “claim” in a specific way with regard to the HIPAA transaction defined at 45 CFR 162.1101 to describe a provider's request to obtain payment from a health plan. We never intended that the subrogation transaction be defined as a “claim” in the strict sense of the word. We believe replacing “claim” with “request for reimbursement” would clarify that the purpose of a pharmacy subrogation transaction is to transmit request to be reimbursed for a claim rather than to transmit a claim.
We are proposing that the current definition of the Medicaid pharmacy subrogation transaction would remain in the regulatory text at § 162.1901(a) and the proposed definition of the Pharmacy subrogation transaction would be added at § 162.1901(b). The Medicaid pharmacy subrogation transaction would continue to apply until the compliance date of the Pharmacy subrogation transaction, in accordance with the proposed compliance dates discussed in section III.C.2. of this proposed rule. Then, beginning on the compliance date for the Pharmacy subrogation transaction, the Medicaid pharmacy subrogation transaction would no longer be in effect and all covered entities would be required to comply with the proposed standard for the Pharmacy subrogation transaction.
As discussed previously, the current HIPAA standard, Version 3.0, for the Medicaid pharmacy subrogation transaction, only applies to state Medicaid agencies seeking reimbursement from health plans responsible for paying pharmacy claims. The standard does not address business needs for other payers, such as Medicare Part D, state assistance programs, or private health plans that would seek similar reimbursement. Section 1173(a)(2) of the Act lists financial and administrative transactions for which the Secretary is required to adopt standards. The Pharmacy subrogation transaction is not a named transaction in section 1173(a)(2) of the Act, but section 1172(a)(1)(B) of the Act authorizes the Secretary to adopt standards for other financial and administrative transactions as the Secretary determines appropriate, consistent with the goals of improving the operation of the health care system and reducing administrative costs. Adopting a standard for a broader subrogation transaction that would apply to all health plans, not just Medicaid agencies, would facilitate the efficiency and effectiveness of data exchange and transaction processes for all payers involved in post-payment of pharmacy claims and would support greater payment accuracy across the industry.
At the NCVHS March 2018 hearing,
We are proposing to replace the NCPDP Batch Standard Medicaid Subrogation Implementation Guide, Version 3.0, Release 0, with the NCPDP Batch Standard Pharmacy Subrogation Implementation Guide, Version 10 as the standard for Pharmacy subrogation transactions at § 162.1902(b). For state Medicaid agencies, this proposal would be a modification from Version 3.0. While Version 10 is called the “Pharmacy Subrogation Implementation Guide” rather than the “Medicaid Subrogation Implementation Guide,” Version 10 still applies to subrogation transactions originating from Medicaid agencies and preserves the data elements in Version 3.0 except in the following instances, the purpose of which is to accommodate non-Medicaid plans' use of the modified standard:
• The Medicaid Agency Number definition is changed to accommodate use of the field by Medicaid and non-Medicaid health plans.
• The Medicaid Subrogation Internal Control Number/Transaction Control Number field, which is designated as “not used” in Version 3.0. is replaced with the required use of the Reconciliation ID field.
• The Medicaid Paid Amount field, which is designated as “not used” in Version 3.0, is replaced with the required use of the Subrogation Amount Requested field.
• The Medicaid ID Number field, which is a required field in Version 3.0, is changed to a situational field that is only required when one of the health plans involved in the transaction is a Medicaid agency.
While state Medicaid agencies would be required to implement these changes in order to comply with Version 10, the changes would be de minimis and state Medicaid agencies' use of the modified standard would essentially be the same as their use of the current standard.
We solicit comments on our proposal related to the adoption of Version 10.
Section 1175(b)(2) of the Act addresses the timeframe for compliance with modified standards. The section provides that the Secretary must set the compliance date for a modification at such time as the Secretary determines appropriate, taking into account the time needed to comply due to the nature and extent of the modification. However, the compliance date may not be sooner than 180 days after the effective date of the final rule. In the discussion later in this rule, we explain why we are proposing that all covered entities would need to be in compliance with Version F6 and its equivalent Batch Standard Version 15 for retail pharmacy transactions 24 months after the effective date of the final rule, which we would reflect in §§ 162.1102, 162.1202, 162.1302, and 162.1802.
In its April 22, 2020 recommendation letter to the Secretary, discussed in section I.C.3. of this proposed rule, the NCVHS, upon consideration of industry feedback, recommended the following implementation timelines and dates for Version F6 and Version 15:
• Provide a 3-year pre-implementation window following publication of the final rule, allowing (but not requiring) industry use beginning at the end of the three years.
• Allow both Versions D.0 and F6 to be used for an 8-month period after the 3-year pre-implementation window, which the NCVHS suggested would enable an effective live-testing and transition period.
• Require full compliance by the end of the third year, that is, exclusive use of Version F6, after the 8-month period.
After carefully considering the NCVHS's recommended implementation timelines and dates, for the following reasons we are not proposing a 3-year pre-implementation compliance window or an 8-month transition period. While industry feedback on which the NCVHS relied to make its recommendations did include some discussion on specific changes necessary to implement Version F6 (for example, the expansion of the financial fields), the majority of feedback was not specific to Version F6, but, rather, concerned general challenges that would be associated with implementing any standard modification. For example, feedback related to concerns about general budget constraints, as well as compliance dates that conflict with other pharmacy industry priorities such as the immunization season or times of year where prescription benefits plans typically experience heavy new member enrollment. In addition, several industry stakeholders, including the NCPDP, stated that they were not aware of any significant implementation barriers specific to Version F6. In its May 17, 2018 letter industry testimony asserted, and the NCVHS agreed, that the process to implement Version F6 would be similar to the process necessary to implement Version F2.
Additionally, the proposed modification, to move from Version D.0 to Version F6, pertains only to retail pharmacy transactions. That is different in scope, for example, from the modifications finalized in the 2009 Modifications final rule (74 FR 3296), which affected all of the then-current HIPAA transactions. There, we implemented an extended compliance date for the modified standards in response to the numerous comments advocating for it given the extensive changes in Versions 5010 and D.0 from Versions 4010 and 5.1, which commenters asserted necessitated a coordinated implementation and testing schedule. Given that the scope of the modification in this proposed rule is limited to just retail pharmacy transactions, we believe the industry has the capability of implementing the modification within a 24-month period after the effective date of the final rule.
Further, we believe the benefits that would be derived from implementing Version F6 and Version 15 (discussed in section III.A.1. of this proposed rule) as soon as possible are significant. Those benefits include mitigating existing inefficient work-arounds, allowing for more robust data exchanges between long-term care providers and payers, improving coordination of benefits information, improving controlled substances reporting, codifying clinical and patient data, harmonizing with related standards, and improving plan benefit transparency. We solicit industry comment on the proposed 24-month compliance date for F6 and Version 15, including any barriers specific to compliance with Version F6 and Version 15 that would require additional time for compliance.
As discussed previously, we are proposing to adopt a Pharmacy subrogation transaction standard that would apply to all health plans, not just state Medicaid agencies. As we discuss in section III.B. of this proposed rule, Version 10 would be a modification for state Medicaid agencies, which would be moving to Version 10 from Version 3.0. For all other health plans, Version 10 would be an initial standard. As previously noted, section 1175(b)(2) of the Act addresses the timeframe for compliance with modified standards. That section requires the Secretary to set the compliance date for a modification at such time as the Secretary determines appropriate, taking into account the time needed to comply due to the nature and extent of the modification, but no sooner than 180 days after the effective date of the final rule in which we adopt that modification. Section 1175(b)(1) of the Act requires that the compliance date for initial standards—which Version 10 would be for covered entities that are not state Medicaid agencies—is no later than 24 months after the date of adoption for all covered entities, except small health plans, which must comply no later than 36 months after adoption.
We are proposing to align the compliance dates for state Medicaid agencies and all other health plans (except small health plans) to comply with Version 10. Should we not to do this, some health plans would need to use Version 10 at the same time as state Medicaid agencies in order to conduct Pharmacy subrogation transactions with those state Medicaid agencies, while other health plans could use different standards. Aligning the compliance timeframes would reduce confusion and administrative burden that would arise were there concurrent standards in effect. Thus, we propose to require all health plans (except small health plans) to comply at the same time. The alignment of compliance dates also makes it more feasible for state Medicaid agencies and non-Medicaid health plans to invest in system upgrades to accommodate one specific standard rather than divide resources to maintain two concurrent transaction standards. Therefore, we propose to revise § 162.1902(b) to reflect that all health plans, except small health plans, would be required to comply with Version 10 for Pharmacy subrogation transactions 24 months after the effective date of the final rule. We would also revise § 162.1902(a) to reflect that state Medicaid agencies would be required to comply with the current standard, Version 3.0, until the compliance date of Version 10.
Small health plans, as defined in 45 CFR 160.103, are those health plans with annual receipts of $5 million or less. In accordance with section 1175(b)(1) of the Act, we are proposing that small health plans, other than small health plans that are state Medicaid agencies, would be required to comply with the new standard 36 months after the effective date of the final rule.
We solicit industry and other stakeholder comments on our proposed compliance dates.
This proposed rule proposes to incorporate by reference: (1) the Telecommunication Standard Implementation Guide Version F6 (Version F6), January 2020; (2) equivalent Batch Standard Implementation Guide, Version 15 (Version 15) October 2017; and (3) the Batch Standard Subrogation Implementation Guide, Version 10 (Version 10), September 2019 National Council for Prescription Drug Programs.
The Telecommunication Standard Implementation Guide, Version 6 contains the formats, billing units, and operating rules used for real-time pharmacy claims submission. The equivalent Batch Standard Implementation Guide, Version 15, provides instructions on the batch file submission standard that is to be used between pharmacies and processors or among pharmacies and processors. Both implementation guides contain the data dictionary, which provides a full reference to fields and values used in telecommunication and its equivalent batch standard.
The Batch Subrogation Implementation Guide, Version 10, is intended to meet business needs when a health plan has paid a claim that is subsequently determined to be the responsibility of another health plan within the pharmacy services sector. This guide provides practical guidelines for software developers throughout the industry as they begin to implement the subrogation transaction, and to ensure a consistent implementation throughout the pharmacy industry.
The materials we propose to incorporate by reference are available to interested parties and can be inspected at the CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD 21244-1850. Copies may be obtained from the National Council for Prescription Drug Programs, 9240 East Raintree Drive, Scottsdale, AZ 85260. Telephone (480) 477-1000; FAX (480) 767-1042. They are also available through the internet at
Under the Paperwork Reduction Act of 1995, we are required to provide 60-day notice in the
• The need for the information collection and its usefulness in carrying out the proper functions of our agency.
• The accuracy of our estimate of the information collection burden.
• The quality, utility, and clarity of the information to be collected.
• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.
In this proposed rule we are soliciting public comment on each of these issues for the following sections of the rule that contain proposed “collection of information” requirements as defined under 5 CFR 1320.3(c) of the PRA's implementing regulations. If regulations impose administrative costs on reviewers, such as the time needed to read and interpret this proposed rule, then we should estimate the cost associated with regulatory review. We estimate there are currently 104 affected entities (which also includes PBMs and vendors), (416 reviewers total). We assume each entity will have four designated staff members who will review the entire proposed rule. The particular staff members involved in this review will vary from entity to entity, but will generally consist of lawyers responsible for compliance activities and individuals familiar with the NCPDP standards at the level of a
In this proposed rule we are soliciting public comment on each of these issues for the following sections of the rule that contain proposed “collection of information” requirements as defined under 5 CFR 1320.3(c) of the PRA's implementing regulations. If regulations impose administrative costs on reviewers, such as the time needed to read and interpret this proposed, then we should estimate the cost associated with regulatory review. We estimate there are 104 affected entities (which also includes PBMs and vendors). We assume each entity will have four designated staff member who would review the entire rule, for a total of 416 reviewers. The particular staff involved in this review will vary from entity to entity, but will generally consist individuals familiar with the NCPDP standards at the level of a computer and information systems manager and lawyers responsible for compliance activities.
Using the wage information from the Bureau of Labor Statistics (BLS) for computer and information systems managers (code 11-3021), we estimate that the labor cost of having two computer and information systems managers reviewing this proposed rule is $95.56 per hour, including fringe benefits and overhead costs (
We are also assuming that an entity would have two lawyers reviewing this proposed rule. Using the wage information from the BLS for lawyers (code 23-1011), we estimate that their cost of reviewing this proposed rule is $113.12 per hour per lawyer, including fringe benefits and overhead costs (
We solicit comments on our assumptions and calculations.
The following requirements and burden associated with the information collection requirements contained in §§ 162.1102, 162.1202, 162.1302, 162.1802, and 162.1902 of this document are subject to the PRA; however, this one-time burden was previously approved and accounted for in the information collection request previously approved under OMB control number 0938-0866 and titled “CMS-R-218: HIPAA Standards for Coding Electronic Transactions.”
OMB has determined that the establishment of standards for electronic transactions under HIPAA (which mandate that the private sector disclose information and do so in a particular format) constitutes an agency-sponsored third-party disclosure as defined under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501
Should our assumptions be incorrect, this information collection request will be revised and reinstated to incorporate any proposed additional transaction standards and proposed modifications to transaction standards that were previously covered in the PRA package associated with OMB approval number 0938-0866.
This rule proposes modifications and an initial adoption to standards for electronic retail pharmacy transactions adopted under the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Under HIPAA, the National Committee on Vital and Health Statistics (NCVHS) recommends standards and operating rules to the Secretary of the Department of Health and Human Services (HHS) following review and approval of standards or updates to standards from the applicable SSO—in this case, the National Council for Prescription Drug Programs (NCPDP). The HHS Secretary must generally promulgate notice and comment rulemaking to adopt new or updated standards before they can be utilized to improve industry processes.
On May 17, 2018, the NCVHS recommended that the Secretary adopt the NCPDP Telecommunications Implementation Guide Version F2 (Version F2) and two related batch standards: Batch Standard Implementation Guide, Version 15, and the Batch Standard Subrogation Implementation Guide, Version 10 (Version 10). On April 22, 2020, the NCVHS recommended that the Secretary adopt NCPDP Telecommunications Implementation Guide Version F6 (Version F6) in lieu of Version F2, as well as the two batch standard recommendations set forth in the May 2018 letter. (For purposes of this analysis, Version F6 and its equivalent Batch Standard Version 15 are collectively referred to as Version F6.) These standards have been developed through consensus-based processes and subjected to public comment which indicated, without opposition, that the updates are required for current and future business processes. Based on informal communication with industry, should the updates to the standards not be adopted, industry will need to continue using NCPDP Version D.0 and the associated work arounds, including manual claims processing and claims splitting for drugs priced at or in excess of $1 million.
We have examined the proposed impacts of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (September
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a rule: (1) having an annual effect on the economy of $100 million or more in any 1 year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local or tribal governments or communities (also referred to as economically significant); (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive order.
A Regulatory Impact Analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). This proposed rule is anticipated to have an annual effect on the economy in costs, benefits, or transfers of $100 million or more. Based on our estimates, OMB's Office of Information and Regulatory Affairs has determined this rulemaking is “economically significant” as measured by the $100 million threshold, and hence also a major rule under Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (also known as the Congressional Review Act).
We have prepared an RIA that, to the best of our ability, presents the costs and benefits of this proposed rulemaking. We anticipate that the adoption of these new versions of the retail pharmacy standard would result in costs that would be outweighed by the benefits.
This portion of the analysis is based in part on industry research conducted in 2019 and 2020 by the CMS Alliance to Modernize Healthcare (CAMH), a Federally Funded Research and Development Center, to assess the costs and benefits associated with the potential adoption of Versions F2 and F6. As part of this effort, CAMH did the following: identified the relevant stakeholders that would be affected by the adoption of a new HIPAA standard for retail pharmacy drug transactions; obtained expert opinion, expressed qualitatively and quantitatively, on impacts on affected stakeholders of moving from the current version to the updated standards; and developed a high-level aggregate estimate of stakeholder impacts, based on available information from public sources and interviews. References to conversations with industry stakeholders in this section of the proposed rule are based on the interviews conducted by CAMH unless otherwise noted.
In conversations with industry stakeholders, we have been informed that entity-specific financial impact analyses of modifications to HIPAA transaction standards are not initiated until formal HHS rulemaking has been initiated, since proposed timing is a critical variable in cost development. For instance, in public comments submitted to the NCVHS,
In lieu of financial cost estimates, industry stakeholders have provided preliminary assessments that the conversion to Version F6 would entail between two to four times the level of effort as the previous HIPAA pharmacy standard conversion from Version 5.1 to Version D.0. But, we do not have reliable baseline data on the actual costs of that previous conversion to which to apply the multipliers because we: (1) are not aware of any available information on the final costs of the conversion to Version D.0; (2) have been told that stakeholders do not track expenditures in this way; and (3) our previous regulatory estimates combined the Version D.0 implementation with the concurrent X12 Version 5010 conversion, and so would be ambiguous at best. Moreover, as discussed in connection with comments received on the 2009 Modifications proposed rule generally, many commenters mentioned underestimated costs or overestimated benefits of transitioning to the new versions, but few provided substantive data to improve the regulatory estimates.
With respect to benefits, we are not aware of any available information or testimony specifically quantifying cost savings or other benefits, although there is ample testimony supporting the business need and benefits of the proposed changes.
Standard economics recognizes cost in several different ways. Marginal cost describes the resources needed to produce one additional unit of a good. Rule-induced costs may include new inputs of labor, materials, capital, etc.; but exclude sunk costs (already invested). The recommended methodology for a RIA considers government intervention to impose costs.
Opportunity cost refers to the benefits forgone by choosing one course of action instead of an alternative. A business that invests in venture X loses the opportunity to use those same funds for venture Y. Based on oral and written NCVHS testimony by the retail pharmacy industry and pharmacy management system vendors, it was suggested that their software development process for a HIPAA standard conversion would represent an opportunity cost. For instance, some large pharmacy chains maintain permanent technical staff to make day-to-day changes in their pharmacy management systems and management adjusts staff assignments according to the organization's needs. HIPAA standard transaction version changes like the proposed Version F6 implementation, would, we believe, shift priorities for these staff, potentially delaying other improvements or projects. In this scenario, the opportunity cost consists of the time-value of delayed projects. Other pharmacy firms have an ongoing relationship with their pharmacy management software vendors. The purchaser generally obtains a hardware and software package with an ongoing agreement that includes periodic payments for maintenance, updates, upgrades, training, installation, financing, etc. Thus, the software is expected to evolve, rather than being just a one-time installation. The balance between upfront charges and monthly maintenance fees more closely resembles a multiyear lease than the one-time sale of an off-the-shelf application to a consumer. Thus, the parties often contemplate an ongoing supplier relationship in which maintenance and upgrades represent an opportunity cost.
Average cost equals total cost divided by the total units of production. Average costs for goods and labor come from industry surveys and public reports. Researchers can determine average cost relatively easily, whereas marginal cost would require complex analyses of a particular industry, firm, or production volume. This RIA uses average costs because of their availability and verifiability.
However, the proposed changes to adopt Version F6 and Version 10 generally do not require new out-of-pocket expenditures, so average cost may not describe the realities of actual budget impacts to firms. We seek comment on these assumptions.
The objective of this RIA is to summarize the costs and benefits of the following proposals:
• Adopting modified real time and batch standards for retail pharmacy transactions for health care claims or equivalent encounter information; eligibility for a health plan; referral certification and authorization; and coordination of benefits, transitioning from Telecommunications Standard Version D.0 to Version F6.
• Adopting a new pharmacy subrogation transaction standard, replacing the Batch Standard Medicaid Subrogation Implementation Guide, Version 3, with the Batch Standard Subrogation Implementation Guide, Version 10, applicable to all prescription drug payers.
Consistent with statutory and regulatory requirements, the NCVHS recommends HIPAA standards, which are developed by Standard Setting Organizations (SSOs), in this case the NCPDP, through an extensive consensus-driven process that is open to all interested stakeholders. The standards development process involves direct participatory input from representatives of the industry stakeholders required to utilize the transactions, including pharmacies (chain and independent), health plans and other payers, PBMs, and other vendors that support related services. We are not aware of any opposition to moving forward with these updates.
We are proposing a 2-year compliance date following the effective date of the final rule. For purposes of this analysis, we assume a 2-year implementation period. The remainder of this section provides details supporting the cost-benefit analysis for each of the proposals referenced previously.
Table 1 is the compilation of the estimated costs for all of the standards being proposed in this rule. To allocate costs over the proposed 2-year implementation period, we assumed a 50-50 percent allocation of IT expenses across the 2-year implementation period and all training expenses in the second year. However, this is just an informed guess, as we did not locate any source information on this assumption. We note again that we are not aware of any data or testimony describing quantifiable benefits or cost savings attributable to these proposals, and have solicited comments on whether there are significant quantifiable benefits or cost savings that should be included in our analysis.
The objective of this portion of the RIA is to summarize the costs and benefits of implementing Version F6. We invite the industry or other interested entities or individuals to comment on all of our assumptions and projected cost estimates, and to provide current data to support alternative theories or viewpoints throughout.
Almost all pharmacies and all intermediaries that transfer and process pharmacy claim-related information already use Version D.0 for eligibility verification, claim and service billing, prior authorization, predetermination of benefits, and information reporting transaction exchanges (the latter two categories are not HIPAA-adopted pharmacy standards). Pharmacies utilize technology referred to as pharmacy management systems that encode Version D.0 to submit these transactions for reimbursement on behalf of patients who have prescription drug benefits through health and/or drug plan insurance coverage (health plans). These submissions are generally routed through two intermediaries: a telecommunication switching vendor (switch) and a specialized third-party administrator for the health plan, generally a PBM. Billing transactions may occur in one of two modes: real time or batch. Pharmacy claims are generally transacted in real time as a prerequisite to dispensing prescription medications. For instance, Medicare Part D rules generally require each claim to be submitted online in real time to permit accumulator balances to be updated after every claim so cost sharing on each subsequent claim will accurately reflect changes in benefit phases. The equivalent batch standard enables transmission of non-real-time transactions. For instance, a batch submission could be sent following a period when real-time response systems were unavailable or following a retrospective change in coverage. Technically, the batch standard uses the same syntax, formatting, data set, and rules as the telecommunications standard, “wraps” the telecommunication standard around a detail record, and then adds a batch header and trailer to form a batch file. The claims processor may then process the batch file either within a real-time system or in a batch-scheduling environment.
Based on the 2017 Census business data, pharmacies have a bimodal size distribution. About 99 percent of firms have a single location, predominantly the traditional independent, owner-operated storefront and the remainder of fewer than 200 large firms operate an average of approximately 150 establishments (locations) each. According to other industry data, the largest five chain pharmacy firms represent over 28,000 locations, and the two largest chains each exceed 9,000 locations.
Pharmacies are typically classified by ownership as either chain or independents. Health data analytics company IQVIA estimated
As noted, pharmacies utilize pharmacy management systems to encode Version D.0 for claim-related data exchanges via telecommunication switches. Pharmacies that do not internally develop and maintain their pharmacy management systems will contract with technology vendors for these services. Based in part on communications with industry representatives, such as the American Society for Automation in Pharmacy, we believe there are approximately 30 technology firms providing computer system design, hosting, and maintenance services in this market. Based on testimony provided to the NCVHS, in 2018 this market represented approximately 180 different software products.
Pharmacies also contract with telecommunication switches for transaction routing. In addition to routing, switches validate the format of pharmacy transactions prior to transmission to the payer and then check the payer response to make sure it is formatted correctly for the pharmacy to interpret. Based on conversations with industry representatives, we believe there are three telecommunication switches in this segment of the market.
Some healthcare providers that dispense medications directly to their patients, known as dispensing physicians, may use Version D.0 to submit these outpatient prescription drug claims on behalf of their patients to health plans via health plans' PBMs. However, we do not believe this practice to be widespread and therefore do not account for it in this RIA.
Health plans generally provide some coverage for outpatient prescription drugs, but do not generally contract and transact with pharmacies directly. Instead, health plans typically contract with PBM firms to receive and process pharmacy claim transactions for their enrollees. We assume even the relatively
As previously noted, in 2017 there were 745 Direct Health and Medical Insurance Carriers and 27 Health Maintenance Organization (HMO) Medical Centers—a total of 772 health plan firms. Comparable data limited specifically to PBMs is not available, but based on Part D experience, we estimate that approximately 40 firms conduct some PBM functions involved with processing some pharmacy claim transactions. Based on testimony provided to the NCVHS, in 2018 these 40 firms represented approximately 700 different payer sheets,
Pharmacies either internally develop or externally purchase pharmacy management information systems to bill and communicate with PBMs. Based on public comments related to Version F6 submitted to the NCHVS, available at
To determine whether our assumptions were reasonable, we met with representatives from IHS. Based on those conversations, we understand that IHS, tribal, and urban (I/T/U) facilities with pharmacies would have multiple Version F6 implementation scenarios. Although these facilities are not legally chain pharmacies, we believe their implementation costs may be roughly similar and, thus, we treat I/T/U facilities with pharmacies under this category for this analysis. IHS manages a significant federal health information technology (HIT) system with a suite of modules, including pharmacy dispensing and billing, that supports IHS pharmacies, as well at least 16 urban entities and 114 tribal entities; however not all of these entities include pharmacies. In contrast to other pharmacy entities treated as chain pharmacies, we understand that additional budget funding may be required for IHS to implement Version F6 within the proposed implementation timeframe. We estimate that IHS would incur implementation costs at a level roughly equivalent to the VA system, and that this expense would be a marginal cost for the IHS. We also understand that approximately another 60 tribal entities and another 25 urban entities do not utilize the federal system, but, rather, contract with commercial vendors for HIT; although again, not all of these entities operate their own pharmacies. As a result, we estimate that about 60 percent of these smaller I/T/U entities (51) would rely on existing maintenance agreements with commercial vendors for implementation and, like smaller chain pharmacies, would incur direct implementation costs to support user training costs. We solicit comments on our assumptions.
In the 2017 Census business data there were 190 firms classified as Pharmacies and Drug Stores with more than 500 employees, representing 27,123 establishments. This classification does not include grocery store pharmacies, which were elsewhere reported to number 9,026 in 2017, and to be decreasingly offered by smaller grocery chains in 2020.
Based on conversations with a variety of industry representatives, we understand that these larger firms retain the technical staff and/or contractors that would undertake the Version F6 conversion efforts as an ongoing business expense. Consequently, in practice the cost estimates developed in this section do not represent new additional expenditures for these firms, but rather opportunity costs for these resources that would otherwise be deployed on other maintenance or enhancement projects.
As previously noted, industry estimates of the costs of a conversion
The 2009 Modifications final rule discussed receiving estimates of $1.5 million and $2 million from two large national pharmacy chains and elected to use an estimate of $1 million for large pharmacy chains and $100,000 for small pharmacy chains in the first implementation year. That rule also discussed a few public comments disputing these large chain estimates,
We believe that Version F6 conversion costs for chain pharmacies would be differentiated in three general categories: (1) the largest firms operating in multiple pharmacy channels; (2) other midsize retail pharmacy chain firms operating primarily in either the open-door retail and/or another single pharmacy channel; and (3) smaller chain pharmacy firms. Starting with the point estimates discussed in the Version D.0 rulemaking and making some upward adjustments to address potential underestimation, we estimate that—
• The two largest chain pharmacy firms incurred a baseline (D.0) cost of $2 million;
• The 23 midsize chain pharmacy firms, the VA and IHS pharmacy operations incurred a baseline cost of $1 million; and
• The 237 smaller chain pharmacy firms incurred a baseline cost of $25,000.
Based on the 2x-4x multiplier estimates described previously, we assume a midpoint 3x multiplier for the estimated 25 larger chain pharmacies and the VA that would finance and manage their system conversion requirements internally; consequently, we estimate that over the 2-year implementation period:
• Two chain pharmacy firms would incur all internal Version F6 conversion costs of (3*2 million), or $6 million each.
• The 25 chain pharmacy-sized firms (23 midsized chains, the VA and IHS) would incur all internal Version F6 conversion costs of (3*1 mil), or $3 million each.
Based on a CAMH environmental scan conducted with industry representatives, we understand that most pharmacy firms rely on their pharmacy management system vendor for conversion planning, development, implementation, testing, and initial (primary) training. CAMH suggested that pharmacies would likely need to make some investments in staff training, but would likely not have an increase in direct upfront software costs because system software updates are usually factored into the ongoing contractual fees for operating and maintenance costs of their pharmacy systems. Thus, we understand that HIPAA modification efforts are generally already priced into vendor maintenance agreements and fee structures, and we assume there would be no increases specifically due to the Version F6 conversion in these ongoing costs to pharmacies. We assume that primary training is developed or purchased at the firm level and may deploy at the establishment level in secondary employee in-service training slots. We assume that this training does not scale along with the conversion costs, but rather with the size of the organization in terms of locations and employees. As summarized in Table 2, using the generally uncontested estimates from the Version D.0 rulemaking adjusted for inflation,
We invite public comments on our general assumptions and request any additional data that would help us determine more accurately the impact on the pricing structures of entities affected by this proposed rule.
As noted previously, the 2019 IQVIA data included 88,181 pharmacies, of which 45 percent (39,985) were independently owned. We recognize that this classification is not identical to the use of the term independent community pharmacy; however, we are not aware of publicly available data to help us segment this market further. We know from Census business data that in 2017 there were 19,044 pharmacy firms with fewer than 500 employees, representing 20,901 establishments. Just as we assume that the firms with more than 500 employees represent chains, we assume that those with fewer than 500 employees represent independently owned open- or closed-door pharmacies.
We understand that these smaller pharmacies predominantly rely on their pharmacy system vendors for upgrades, including HIPAA standard version conversion planning, development, implementation, testing, and primary training. In return, they pay ongoing maintenance and transaction fees. As discussed previously with respect to some chain pharmacies, we understand that Version F6 conversion efforts would already be priced into existing maintenance agreements and fee structures. Therefore, we do not assume increases in these ongoing costs to independent pharmacies as the result of the Version F6 conversion, and we estimate pharmacy direct costs would generally be comprised of training and other miscellaneous expenses. As with chain pharmacies, we assume that primary training is developed or purchased at the firm level and deployed at the establishment level in secondary employee in-service training slots. We further assume that this training does not scale along with the conversion costs, but, rather, with the size of the organization in terms of locations and employees. For this reason, we assume that the few system users in very small pharmacies would be trained directly by the pharmacy management system vendor, and no secondary training costs would be required for such small firms.
As noted previously, a commenter on the 2009 Modification proposed rule
We anticipate that health plans should see minimal changes in their operations and workflows between Version D.0 and Version F6. Health plans contract with processors/PBMs for conducting online eligibility verification, claim and service billing, predetermination of benefits, prior authorization, and information reporting transaction exchange types and transaction record storage. While health plans (or their other vendors) supply PBMs with eligibility records and receive data from PBMs containing data derived from claims, they are not typically parties to the exchange of the HIPAA pharmacy transactions. Based on NCVHS testimony with stakeholders and in development of an environmental scan on the impact of this update to the pharmacy standards, we understand that HIPAA standard conversion costs are already priced into
All PBMs would experience some impacts from the Version F6 conversion, involving IT systems planning and analysis, development, and external testing with switches and trading partners. One PBM commented to the NCVHS that the most significant impact would be the expansion of the financial fields to accommodate very expensive drug products with charges greater than $999,999.99. Another PBM processor representative indicated in a conversation that the impact on payer/processors would depend on the lines of business they support—that entities supporting Medicare Part D processing would have the most work to do, but would also get the most value from the transition. The extent to which these activities would be handled by in-house resources or contracted out may vary by organization. Based on other conversations, we understand that from the PBM perspective, the Version F6 conversion adds fields that increase precision and machine readability; rearranges some things to make processing more efficient and flexible in the long run; implements more efficient ways to accomplish work-arounds that payers already have in place (so the changes in the transactions would map to back-end system fields and logic already in place); and involves relatively few structural changes.
PBMs may manage prescription drug coverage for a variety of lines of business, including commercial health plans, self-insured employer plans, union plans, Medicare Part D plans, the Federal Employees Health Benefits Program, state government employee plans, managed Medicaid plans, and others,
Public commenters to the 2009 Modifications proposed rule regarding the D.0 conversion, self-identifying as large PBMs, estimated that costs for their upgrades would be more than $10 million and $11 million, respectively. As a result of these comments, we revised our estimates up to $10.5 million for each large PBM company and maintained the original assumption of $100,000 in conversion costs for smaller specialty PBMs,
• The largest three PBMs incurred baseline (Version D.0) conversion costs of $10.5 million.
• The 3 next-largest PBMs and the VA PBM incurred baseline conversion costs of $4 million.
• The remaining 33 PBMs incurred baseline costs of $500,000.
As previously noted, industry estimates of the costs of a conversion from Version D.0 to Version F6 have been expressed as multiples of two to four times the costs for the Version 5.1 to Version D.0 conversion. However, several PBM commenters to the NCVHS suggested the lower end of this range. This would be consistent with our understanding that many of the changes involve mapping current back-end work-around systems to newly codified data, as opposed to building substantial new functionality from scratch. However, expansion of all existing financial fields to accommodate larger numbers would involve changes to many interrelated systems. As summarized in Table 4, using a 2x multiplier, we estimate that over the 2-year implementation period:
• The largest 3 PBMs would incur Version F6 conversion costs of (2*10.5 mil), or $21 million each.
• The next 3 midsize PBMs and the VA PBM or four firms, would incur Version F6 conversion costs of (2*4 mil), or $8 million each.
• The remaining 33 PBMs would incur Version F6 conversion costs of (2*500,000), or $1 million each.
As previously discussed, pharmacies that do not internally develop and maintain their pharmacy management systems contract with technology vendors for these services. We believe there are approximately 30 technology firms providing computer system design, hosting, and maintenance services in this market, with different companies serving one or more market segments, such as retail, mail, long-term care, or specialty pharmacy. Software vendors often have commitments to their clients to maintain compliance with the latest adopted pharmacy transaction standards. They must incorporate these standards into their software systems; otherwise, they would not be able to sell their products competitively in the marketplace. These systems cannot properly support their users using outdated standards or missing key functionalities which the industry has identified as essential to business operations. We understand that vendors anticipate upgrades to these standards, and the cost of updating the software is incorporated into the vendor's routine cost of doing business and product support pricing. As discussed in the context of independent pharmacies, based on conversations with a variety of industry representatives, we understand that future HIPAA standard conversion efforts are often already priced into existing maintenance agreements and fee structures for their customers. However, the marginal costs of the conversion would be borne by these vendor entities.
We understand from conversations with industry representatives that system update costs are usually embedded into operating costs, where they represent opportunity costs for vendors that offset the resources to add new features (system enhancements) that their clients may request. Updating systems would take some, but not all, resources currently doing system enhancements and improvements and move them over to ensuring compliance with the new standards. In the 2009 Modifications final rule,
We further estimate that these pharmacy system vendor firms would incur 80 hours of training costs for each pharmacy client firm at a mean hourly wage rate of $28.51 (also from the BLS data), the product rounded to $2,300. Thus, we estimate that in the third year of the 2-year implementation period: 30 pharmacy management system firms would incur Version F6 training costs of $2,300 for 2,265 clients (237 small chain pharmacy and 2,028 independent pharmacy firms), or $5,210,000 in total for this industry segment.
In addition, both pharmacies and PBMs contract with telecommunication switches for transaction validation and routing. Based on conversations with industry representatives, we believe there are three switches in this segment of the market. We are not aware of any data to help us estimate their costs of system upgrades, but believe their costs are less than those of chain pharmacies and PBMs. We estimate that over the 2-year implementation period three telecommunication switching vendors would incur Version F6 conversion costs of $1.5 million each. These other vendor costs are summarized in Table 5.
In summary, total estimated Version F6 conversion costs are summarized in Table 6.
Industry commentary on benefits related to the Version F6 conversion is available in two segments: first, the 2018 NCVHS testimony and industry representative interviews related to the proposed intermediate Version D.0 to Version F2 conversion, and second, the 2020 NCVHS testimony and public comments related to the revised Version F6 proposal. Both sets of evidence portray industry consensus that updating the HIPAA pharmacy standards is necessary for current and future business needs at a significant, but unavoidable, cost. Commentaries describe numerous non-quantifiable benefits, such as to enable compliance with regulatory requirements, to facilitate the transmittal of additional codified and interoperable information between stakeholders that would benefit patient care and care coordination, and to power advanced data analytics and transparency. Some changes would result in operational efficiencies over manual processes, but would also entail greater manual effort to collect information and input data at an offsetting cost. We are not aware of any assertions or estimates of industry cost savings attributable to the Version F6 conversion, and we solicit comment on whether there are significant savings that should be accounted for in our analysis. For pharmacy management system vendors and switches, we assume upgrading existing systems for the Version F6 conversion is a cost of doing business and retaining customers and does not involve cost savings.
Initial automation of pharmacy coordination of benefits transactions was a large part of the previous Version 5.1 to D.0 conversion. Further refinement of this type of information is included in the Version F6 conversion. Additional fields are expected to improve the flow of information between pharmacies and payers and allow for more accurate billing to the correct entity. However, better information does not translate into savings as directly as the initial transition from manual to fully electronic processes. Moreover, commenters to the 2009 Modifications proposed rule suggested that even those minor levels of savings (1.1 percent of pharmacist time) may have been overestimated.
Other changes, such as more structured communication between pharmacies and payers to resolve prescriber-identifier validation activities at the point of sale, or to better enable compliance with federal and state limitations on filling and refilling controlled substance prescriptions, would enable better compliance with Drug Enforcement Administration and CMS rules without PBMs having to resort to claim rejections. In general, many of these changes are expected to support pharmacy efficiency improvements, reduce some manual workflow processes related to Food and Drug Administration mandated Risk Evaluation and Mitigation Strategy (REMS) data collection and use, reduce the time required to resolve claim rejections and transaction attempts, and reduce recoupment risk on audits.
Pharmacy and pharmacy vendor commenters to the NCVHS noted that other types of changes would benefit patients by enhancing pharmacy and payer patient care workflows through the replacement of many clinical free text fields with discrete codified fields. This would enable automation that can trigger real-time workflows that could aid in goals such as combatting the opioid crisis or communicating relevant therapy-related information for at-risk patients. Improvements would support better patient care and safety through more accurate patient identification and enhanced availability and routing of benefit and drug utilization review information. For instance, new response fields for drug utilization review messaging and Formulary Benefit Detail help to convey clinical information such as disease, medical condition, and formulary information on covered drugs. This would enable the pharmacist to have more informative discussions with patients and provide valuable information about alternative drug or therapy solutions. We assume that some of this data exchange would eliminate manual processes and
The benefits that could accrue to health plans and PBMs mirror the improvements that could accrue to pharmacy efficiencies discussed previously. Better information flows and interoperability could enable more efficient benefit adjudication, enhanced communications with trading partners and patients, and better data. Better data could improve payment accuracy, regulatory compliance, and advanced analytics for forecasting, coordination of care, and patient safety. For instance, better information on adjudicated payer types could support more accurately identifying other payers involved in the transaction. Improved information on other payers could result in cost avoidance by avoiding duplication of payment and/or by preventing Medicare from paying primary when it is the secondary payer. However, improved patient and alternative payer identification could also increase the transparency of the identification of payers secondary to Medicare and increase costs from other payers' subrogation in some circumstances. The ability to automate the processing of very expensive drug claims would avoid more cumbersome processes, but the absolute volume of such claims may not be enough to generate significant savings. We are not aware of any studies or estimates of cost savings for health plans or PBMs attributable to the Version F6 conversion, nor are we aware of public comments describing any such cost savings. Furthermore, in testimony to the NCVHS, the NCPDP noted the importance of Version F6 for achieving broader (but difficult-to-quantify) healthcare transformation goals: it improves the structure to support the clinical evaluation of prescription products and planned benefit transparency, which are key components for achieving expected healthcare outcomes related to value-based care, digital therapeutics, social determinants of health, and other areas of health innovation.
Subrogation occurs when one payer has paid a claim that is subsequently determined to be the responsibility of another payer, and the first payer seeks to recover the overpayment directly from the proper payer. Such erroneous payments may occur as the result of retroactive changes in patient coverage or because of the lack of information on other payers or correct payer order at the point of sale. Subrogation avoids putting the pharmacy in the middle of the corrective action by avoiding the alternative burdensome process of the first payer recovering the overpayment from the pharmacy and, thus, forcing the pharmacy to attempt reversing the claim and rebilling the proper payer.
The current HIPAA subrogation transaction standard addresses federal and state requirements for state Medicaid agencies to recover reimbursement from responsible health plans but does not address similar requirements for other payers, such as Medicare Part D, State Pharmaceutical Assistance Programs (SPAPs), state AIDS Drug Assistance Programs (ADAPs), or other private insurers. Replacing this standard with initial adoption of Version 10 would extend the standard to all third-party payers. Insurers, employers, and managed care entities are generally referred to as health and/or drug plan sponsors, or, more generally, as third-party payers. Their health plans generally provide some coverage for outpatient prescription drugs, but do not generally directly manage coordination of pharmacy benefits and subrogation (also known as third-party liability services). Instead, health plans and other third-party payers generally contract with PBMs or with specialized payment integrity/financial recovery vendors for these services. The subrogation technical standard is based on the batch telecommunications standard and may utilize any field in an approved standard.
Medicare Part D requires real-time coordination of benefits, and we understand that these processes, as well as responsibility for managing subrogation (primarily for Medicaid retroactivity), are generally contracted through PBMs. Other payers, such as state Medicaid agencies and commercial insurers, are more likely to contract with payment integrity/financial recovery vendors. As of March 2018, there was evidence that some states managed this activity directly,
Based on a CAMH environmental scan conducted with industry representatives, we understand that the demand for subrogation today differs by third-party line of business. Third-party payers for governmental programs (Medicaid, Medicare Part D, and SPAPs/ADAPs) drive most of the subrogation demand. This is in large part due to their retroactive eligibility rules and potential overlaps in enrollment. Third-party commercial payer contracts are less likely to have a comparable retroactivity-of-coverage issue and, due to the rising cost of health insurance, are increasingly less likely to have enrollees covered under more than one insurance program or policy. For these reasons, we understand that third-party commercial payers are more likely to subrogate with workers' compensation, auto insurance, or other non-healthcare insurance-related parties, rather than with other healthcare payers.
While pharmacies are not users of the subrogation standard, they are potentially affected by any further expansion of the standard from Medicaid to all third-party payers. This is because one alternative to subrogation involves the payer that paid in error recouping funds from pharmacies and transferring the effort and risk of rebilling the appropriate payer to the pharmacy.
The bulk of the work to implement Version 10 for many third-party payers has been previously addressed in costs associated with implementing Version F6, specifically its equivalent batch standard. Based on conversations with industry representatives familiar with the subrogation standards, we understand that the changes in Version 10 have been undertaken to preserve the integrity of the standard for Medicaid purposes while allowing for the collection of a limited number of new data elements to assist with other payer subrogation, particularly for Part D payers. We understand that the changes between Version 3.0 and Version 10 are not extensive, so we believe this change would not have significant effects on state Medicaid agencies or their vendors. However, we are not aware of data or public comments to help us confirm this assumption.
We also assume that payers that desire to pursue prescription drug claim subrogation have already contracted with PBMs or other contractors that have implemented the Batch Standard Medicaid Subrogation Implementation Guide, Version 3.0, or some variation on this standard, on a voluntary basis. However, testimony provided in the March 2018 NCVHS hearing indicated that some payers had not yet implemented the batch processing software, and would have additional IT system, administrative, and training costs to convert to Version 10. We are not aware of the specific payers to which this remark referred, and, thus, several years later, we have no basis on which to estimate the number of additional payers or state Medicaid agencies that could potentially adopt the standard for the first time with Version 10. Nor do we know if any such payers might instead contract with a vendor to manage this function on their behalf during the course of the Version 10 implementation. As with PBM and vendor contractual arrangements discussed previously, we assume that HIPAA standard conversions have been priced into ongoing contractual payment arrangements and would not increase costs to third-party payers as the result of converting to Version 10. We solicit comments to help us understand the impacts of converting to Version 10 on any payers or state Medicaid agencies that have not previously implemented NCPDP batch standards and/or Subrogation Version 3.0. We also solicit comments on our assumptions on the impacts on state Medicaid agency vendors in general, as well as data with which to quantify any additional impacts beyond the Version F6 conversion estimates provided previously.
Based on conversations with industry representatives, we further understand that payers already engaged in subrogation, particularly Part D PBMs, have already, albeit inconsistently, implemented Version 3.0 for other payers. Version 10 provides more requirements for use of the standard and how to populate the fields to increase standardization. Thus, we assume that the incremental effort required to transition to Version 10 largely consists of a mapping exercise from current PBM or vendor operating systems, rather than an initial build and migration from manual to automated processes. We are not aware of any studies or public comments to help us quantify these incremental costs.
As noted previously, state Medicaid agencies, commercial third-party payers, and the VA generally contract with four payment integrity/financial recovery firms for subrogation. We believe, based on conversations with industry representatives, that these firms generally utilize Subrogation Version 3.0 today, and would have to invest in Version F6 batch standard upgrades to implement Version 10 and prepare to potentially accept subrogation from other third-party payers. These firms were not included in the previous vendor estimates. We are not aware of studies or public comments that describe costs related to their activities and requirements. We assume these vendors would incur a minority of the costs associated with the Version F6 conversion and some internal data remapping expense. Therefore, as summarized in Table 7, we estimate that that over the 2-year implementation period:
Four payment integrity/financial recovery vendors would incur Version F6, equivalent Batch Standard, Version 15 and other Version 10 conversion costs of $500,000 each.
The primary benefits for third-party payers are the opportunity to reduce claims costs when another party is also responsible for the claims and the avoidance of cumbersome manual processes. However, we are not aware of studies or public comments that help us estimate the frequency and size of this benefit. Prescription drug claims tend, on average, to be for much smaller amounts than medical claims, such as those for hospital admissions, and we believe many payers may pursue subrogation only on the more expensive claims. Discussion at the March 2018 NCVHS hearing indicated that about 5 percent of patients had multiple insurances. It is estimated that national drug expenditures, the volume of claim reconciliation, and that the savings opportunity could easily exceed a billion dollars (as the subrogation transaction standard proposal was not revised in 2020, we do not have more recent testimony updating this estimate). However, additional testimony at that same hearing
As noted previously, while pharmacies are not users of the subrogation transactions standard, they could potentially benefit from further expansion of the standard from state Medicaid agencies to all third-party payers if additional payers that are currently recouping overpayments from pharmacies instead were to transition to a subrogation approach. However, we are not aware of any studies or public comments that would help us estimate the likelihood or size of a potential change of this nature. We solicit comments to help us understand the extent to which the adoption of Version 10 may have an effect on pharmacies.
We considered a number of alternatives to adopting Version F6 and Version 10, but chose to proceed with the proposals in this in this rule after identifying significant shortcomings with each of the alternatives.
One alternative we considered was to not propose to adopt Version F6 and continue to require the use of Version D.0. We also considered waiting to adopt Version F6 at a later date since we recently published a final rule in 2020 modifying the requirements for the use of Version D.0 by requiring covered entities to use the 460-ET field for retail pharmacy transactions denoting partial fill of Schedule II drugs. We did not proceed with either alternative because we believe that, were we to do so, the industry would continue to use a number of work arounds that increase burden and are contrary to standardization. We also believe that the number of these work arounds, as well as use of the work arounds, would continue to increase if we were not to propose adoption of Version F6 at this time. For example, NCPDP has advised that several new drugs priced at, or in excess of, $1 million are already on the market, and researchers and analysts anticipate that over the next several years, dozens of new drugs and therapies priced similarly or higher may enter the market. As the number of drugs and therapies in the market priced at, or in excess of, $1 million increases, the total burden associated with manual work arounds would also increase.
We invite public comments on these assumptions and request any additional data that would help us to more accurately quantify the time and resource burdens associated with the existing, and, potentially, future work arounds should Version F6 not be adopted. We also chose not to proceed with these alternatives because, as discussed in section III.A. of this proposed rule, we believe adoption of Version F6 would support interoperability and improve patient outcomes.
We considered proposing a compliance date longer than 24 months for covered entities to comply with Version F6. However, as discussed in section III.C. of this proposed rule, we chose to propose a 24-month compliance date because we believe the benefits to be derived from implementing Version F6 as soon as possible are significant. We also considered proposing staggered implementation dates for Version F6, whereby covered entities using the retail pharmacy transactions would have different compliance dates. We believe this alternative would not support standardization since pharmacies, PBMs, and health plans all rely on the information transmitted in the retail pharmacy transactions, and if any one of these three entities would not be using the same standard version at the same time, the information needed to process claims and check eligibility would be deficient. Pharmacies need the most current eligibility data from the plans to determine correct coverage and payment information, and health plans and PBMs need the most current information to be reflected in the claims data to maintain the beneficiaries' most current benefits.
Concerning the proposed adoption of Version 10, we considered not adopting that updated version and continuing to require the use of Version 3.0. Such alternative would continue to permit non-Medicaid health plans that engage in pharmacy subrogation transactions to continue using the proprietary electronic and paper formats currently in use. We chose not to proceed with this alternative because we believe it is important to adopt standards that move the industry toward uniformity among all payers.
One of the costs of compliance with a final rule is the necessity for affected entities to review the rule in order to understand what it requires and what changes the entity will have to make to come into compliance. We assume that 104 affected entities will incur these costs, as they are the entities that will have to implement the proposed changes, that is, those entities that are pharmacy organizations that manage their own systems (27), pharmacy management system vendors (30), PBMs (40), telecommunication switch vendors (3), and payment integrity/financial recovery vendors (4). The particular staff involved in such a review will vary from entity to entity, but will generally consist of lawyers responsible for compliance activities and individuals familiar with the NCPDP standards at the level of a computer and information systems manager. Using the Occupational Employment and Wages for May 2020 from the BLS for lawyers (Code 23-1011) and computer and information system managers (Code 11-3021),
As required by OMB Circular A-4 (available at
The RFA requires agencies to prepare an initial regulatory flexibility analysis that describes the impact of a proposed change on small entities, unless the head of the agency can certify that the rule will not have a significant economic impact on a substantial number of small entities. The RFA generally defines a small entity as (1) a proprietary firm meeting the size standards of the Small Business Administration (SBA); (2) a not-for-profit organization that is not dominant in its field; or (3) a small government jurisdiction with a population of less than 50,000. States and individuals are not included in the definition of a small entity. For the purpose of the proposed rule, we estimate that a change in revenues of more than 3 to 5 percent would constitute the measure of significant economic impact on a substantial number of small entities.
SBA size standards have been established for types of economic activity or industry, generally under the North American Industry Classification System (NAICS). Using the 2019 SBA small business size regulations and Small Business Size Standards by NAICS Industry tables at 13 CFR 121.201, we have determined that the covered entities and their vendors affected by this proposed rule fall primarily in the following industry standards:
This change in retail pharmacy transaction standards would apply to many small covered entities in the Pharmacy and Drug Store segment (NAICS code 446110). However, based on information obtained by CAMH during its conversations with industry experts, we understand that small pharmacies generally rely on ongoing arrangements with certain specialized computer system design services vendors (a subset of NAICS code 541512) to integrate the standards into their pharmacy management software and systems as a routine cost of doing business. Therefore, these covered entities may not bear the bulk of the costs attributable to the proposed changes. Instead, as detailed later in this RIA, generally, the costs applicable to small pharmacies are expected to be a portion of the costs for user training for some firms. The pharmacy management system vendors are not covered entities, and we are not aware of publicly available data to comprehensively identify these entities and, where applicable, parent firm size. Other types of covered entities providing pharmacy services, such as the subset of grocery stores with pharmacies, cannot be clearly identified within NAICS data, as such data are not collected in this detail, but are included in our estimates for larger entities. Conversely, institutions with outpatient pharmacies (for example, hospitals) also cannot be clearly identified by NAICS data but are not included in our analysis, since we believe such institutions are generally part of larger organizations that do not meet the SBA definition. One exception to this assumption are the IHS urban and tribal facilities with pharmacies that bill prescription drug plans, which we address later in this analysis.
For purposes of this RIA, the definition of an entity most closely resembles the federal statistical agencies' concept of a firm.
Based on Census business data records indicating that in 2017 there were a total of 19,234 total pharmacy firms, we estimate that just over 19,000 pharmacy firms qualify as small entities, though communications with industry representatives suggest that figure may overestimate the current industry small entity landscape. Available data does not permit us to clearly distinguish small pharmacy firms from firms that are part of larger parent organizations, but we use employee size as a proxy for the firm size subject to the SBA size standard. For purposes of this analysis, we assume the firms with more than 500 employees (190) represent chain pharmacies and those with fewer than 500 (19,044) employees represent independently owned open- or closed-door pharmacies. The 19,044 firms with fewer than 500 employees represented 20,901 establishments and accounted for total annual receipts of $70.9 billion and average annual receipts of $3.7 million—well below the SBA standard of $30 million. By contrast, the 190 firms with 500 or more employees represented 27,123 establishments and accounted for over $211 billion in annual receipts, and thus, average annual receipts of $1.1 billion. Therefore, we assume 19,044 pharmacy firms qualify as small entities for this analysis.
For 2017, the Census Bureau counts 745 entities designated as Direct Health and Medical Insurance Carriers and 27 as Health Maintenance Organization (HMO) Medical Centers. We assume that these 772 firms represent health plans that sponsor prescription drug benefits. Of the 745 Carriers, those with fewer than 500 employees (564) accounted for $35 billion in total and over $62 million in average annual receipts, exceeding the SBA size standard of $41.5 million. Comparable data on the eight smaller HMO Medical Centers is not available due to small cell size suppression. Although health plan firms may not qualify as small entities under the SBA receipts size standard, they may under non-profit status. However, we are not aware of data that would help us understand the relationship between health plan firm and ownership tax status to quantify the number of such firms. In any case, as explained in more detail later in this RIA, we do not estimate that health plans would generally bear costs associated with the changes in this proposed rule, as their contracted transaction processing vendors (generally PBMs) would be responsible for implementing the changes, and, generally, based on conversations with the industry we do not believe their contractual terms would change as the result. Therefore, although we cannot estimate the number of health plan firms that may meet the small entity definition using non-profit status, generally we do not believe such entities would bear costs attributable to the proposed changes.
In addition to the covered entities, we estimate 30 pharmacy management system vendors, 40 PBM vendors, three telecommunications switching vendors, and four payment integrity/financial recovery firms would be affected by the proposed changes to their clients. We
To determine the impact on small pharmacies, we used Census business data on the number of firms with fewer than 500 employees and user training cost estimates developed using public comments on prior rulemaking and updated for inflation. As discussed earlier in this RIA, we assume that the clear majority of pharmacy firms are small entities that rely on their contracted pharmacy management system vendors to absorb HIPAA standard version conversion costs in return for ongoing maintenance and transaction fees. We assume that pharmacy firms would have direct costs related to Version F6 user training that would vary in relation to employee size; that the vast majority (90 percent) of small pharmacy firms with fewer than 20 employees would receive all necessary user training from vendors; and that the remaining 10 percent of small pharmacy firms (2,028) with 20 or more employees would have additional staff user training expense totaling $30,000 on average in the second year of the implementation period. As displayed in Table 10, the resulting total impact of approximately $61 million represents approximately 0.1 percent of small pharmacy annual revenues. Therefore, we conclude that the financial burden would be less than the 3 percent to 5 percent of revenue threshold for significant economic impact on small entities.
As stated in section V.F. of this proposed rule, we considered various policy alternatives to adopting Version F6. Specific to reducing costs to small entities, we considered staggering the implementation dates for Version F6 among the affected entities that utilize the NCPDP transaction standard. But we chose not to propose this alternative because pharmacies, PBMs, and health plans all rely on the information transmitted though the retail pharmacy transactions, and if any one of these three entities would not be using the same standard version at the same time, the information needed to process claims and check eligibility would be deficient. Pharmacies need the most current eligibility data from the plans to determine correct coverage and payment information. Plans and PBMs would suffer because they would not have the most current information reflected though the claims data to maintain the beneficiaries' most current benefits.
As referenced earlier in this section, we use a baseline threshold of 3 percent to 5 percent of revenues to determine if a rule would have a significant economic impact on affected small entities. The small pharmacy entities do not come close to this threshold. Therefore, the Secretary has certified that this proposed will not have a significant economic impact on a substantial number of small entities. Based on the foregoing analysis, we invite public comments on the analysis and request any additional data that would help us determine more accurately the impact on the various categories of entities affected by the proposed rule.
In addition, section 1102(b) of the Act requires us to prepare a RIA if a rule would have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a metropolitan statistical area and has fewer than 100 beds. This proposed rule would not affect the operations of a substantial number of small rural hospitals because these entities are not involved in the exchange of retail pharmacy transactions. Therefore, the Secretary has certified that this proposed rule would not have a significant impact on the operations of a substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates would require spending more in any 1 year than threshold amounts in 1995 dollars, updated annually for inflation. In 2022, that threshold is approximately $165 million. This proposed rule does not contain mandates that would impose spending costs on state, local, or tribal governments in the aggregate, or by the private sector, in excess of more than $165 million in any 1 year. In general, each state Medicaid agency and other government entity that is considered a covered entity would be required to ensure that its contracted claim processors and payment integrity/financial recovery contractors update software and conduct testing and training to implement the adoption of the modified versions of the previously adopted standards. However, information obtained by CAMH during its conversations with industry experts supports that the costs for these services would not increase as a result of the proposed changes. Our understanding is that HIPAA standard conversion costs are already priced into ongoing contractual payment arrangements between health plans, contracted claim processors, and payment integrity/financial recovery contractors.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or
In accordance with the provisions of Executive Order 12866, this proposed rule was reviewed by the Office of Management and Budget.
Because of the large number of public comments, we normally receive on
Administrative practice and procedures, Electronic transactions, Health facilities, Health insurance, Hospitals, Incorporation by reference, Medicaid, Medicare, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Department of Health and Human Services proposes to amend 45 CFR part 162 as set forth below:
42 U.S.C. 1320d-1320d-9 and secs. 1104 and 10109 of Public Law 111-148, 124 Stat. 146-154 and 915-917.
The revisions and additions read as follows:
Certain material is incorporated by reference into this subpart with the approval of the Director of the Federal Register under
(b) National Council for Prescription Drug Programs (NCPDP), 9240 East Raintree Drive, Scottsdale, AZ 85260; phone: (480) 477-1000; fax: (480) 767-1042; website:
(7) The Telecommunication Standard Implementation Guide Version F6 (Version F6), January 2020; as referenced in § 162.1102; § 162.1202; § 162.1302; § 162.1802.
(8) The Batch Standard Implementation Guide, Version 15 (Version 15), October 2017; as referenced in § 162.1102; § 162.1202; § 162.1302; § 162.1802.
(9) The Batch Standard Subrogation Implementation Guide, Version 10 (Version 10), September 2019, as referenced in § 162.1902.
The addition reads as follows:
(e) For the period on and after [date TBD], the following standards:
(1)
(2)
(3)
(4)
(5)
(ii) The ASC X12 Standards for Electronic Data Interchange Technical Report Type 3-Health Care Claim: Professional (837), May 2006, ASC X12N/005010X222 (incorporated by reference, see § 162.920).
The addition reads as follows:
(d) For the period on and after [date TBD], the following standards:
(1)
(2)
The addition reads as follows:
(e) For the period on and after [date TBD], the following standards:
(1)
(2)
The addition reads as follows:
(e) For the period on and after [date TBD], the following standards:
(1)
(2)
(3)
(4)
The revision and addition read as follows:
(b) The pharmacy subrogation transaction is the transmission of a request for reimbursement of a pharmacy claim from a health plan that paid the claim, for which it did not have payment responsibility, to the health plan responsible for the claim.
(a) The Secretary adopts the following standards for the Medicaid pharmacy subrogation transaction, described in § 162.1901(a), for the period from January 1, 2012, through [date TBD], The Batch Standard Medicaid Subrogation Implementation Guide, Version 3, Release 0 (Version 3.0), July 2007, as referenced in § 162.1902 (incorporated by reference, see § 162.920).
(b) The Secretary adopts the following standard for the pharmacy subrogation transaction, described in § 162.1901(b), The Batch Standard Subrogation Implementation Guide, Version 10 (Version 10), September 2019, as referenced in § 162.1902 (incorporated by reference, see § 162.920).
(1) For the period on and after [date TBD], for covered entities that are not small health plans.
(2) For the period on and after [date TBD], for small health plans.
Federal Communications Commission
Proposed rule.
In this document, the Federal Communications Commission (FCC or Commission) seeks comment on proposals to ensure that mobile carriers continue to implement advanced telecommunications services and that fixed providers have sufficient
Comments are due on or before December 9, 2022, and reply comments are due on or before December 27, 2022.
You may submit comments, identified by WC Docket Nos. 10-90 and 18-143, by any of the following methods:
•
•
• Filings can be sent by hand or messenger delivery, by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail. All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.
• Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9050 Junction Drive, Annapolis Junction, MD 20701. U.S. Postal Service first-class, Express, and Priority mail must be addressed to 45 L Street NE, Washington, DC 20554.
• Effective March 19, 2020, and until further notice, the Commission no longer accepts any hand or messenger delivered filings at its headquarters. This is a temporary measure taken to help protect the health and safety of individuals, and to mitigate the transmission of COVID-19.
Pursuant to §§ 1.415 and 1.419 of the Commission's rules, 47 CFR 1.415, 1.419, interested parties may file comments and reply comments on or before the dates indicated in this document. Comments may be filed using ECFS.
For further information, please contact, Dangkhoa Nguyen, Telecommunications Access Policy Division, Wireline Competition Bureau, at
This is a summary of the Commission's Further Notice of Proposed Rulemaking (FNPRM) in WC Docket Nos. 18-143 and 10-90, adopted on October 27, 2022, and released on October 28, 2022. Due to the COVID-19 pandemic, the Commission's headquarters will be closed to the general public until further notice. The full text of this document is available at the following internet address:
1. According to the United States Department of Agriculture, “the major threat of disaster in Puerto Rico and the U.S. Virgin Islands comes from hurricanes, tropical storms, and drought.” In 2017, two hurricanes battered these Territories, causing extensive damage and loss of life. Although repair of infrastructure was critical, “simply putting vulnerable systems back to the way they were before they collapsed is not enough.” The outages, flooding, and landslides in Puerto Rico caused by the recent Hurricane Fiona demonstrate that infrastructure in areas prone to hurricanes must be built to withstand storm damage and have redundant capabilities.
2. In the aftermath of the 2017 hurricanes, the Commission committed to ensuring the restoration, hardening, and expansion of advanced telecommunications networks in the Territories by creating the Bringing Puerto Rico Together Fund and the Connect USVI Fund. As part of these efforts, the Commission adopted a plan to support state-of-the-art mobile wireless networks, including the 5G services being deployed nationwide. For fixed broadband services, the Commission adopted a new, single-round competitive process to award fixed broadband support tied to defined deployment and public interest obligations over a 10-year period in place of the frozen support carriers were then receiving. With the effects of Hurricane Fiona clearly evident, the Commission now seeks to build on these efforts and ensure that carriers maintain and strengthen existing facilities while network construction and improvement continue toward the goal of bringing more advanced services to the Commonwealth of Puerto Rico and the U.S. Virgin Islands (together “the Territories”). As explained in the following, the Commission seeks comment on proposals to ensure that mobile carriers continue to implement advanced telecommunications services and that fixed providers have sufficient resiliency and redundancy during the
3. The Commission provided a three-year period of support for mobile carriers to rebuild their networks to their pre-hurricane coverage levels. In addition, carriers had the opportunity to accept additional funding dedicated to the expansion of 5G services throughout the Territories. Although substantial progress has been made, this Stage 2 mobile support will end in 2023, and it appears now that more work is needed to ensure that Puerto Rico and the U.S. Virgin Islands enjoy the same levels of service as the mainland. Hurricane Fiona has provided a reminder of the critical nature of mobile services in times of emergency and that carriers must have the resources necessary to prepare for and repair from severe storms. The Commission seeks comment on these issues.
4.
5.
6. The Commission adopted the current Stage 2 three-year support period to allow further development of the procedures and standards for mobile voice and broadband services for possible future application in the Territories. At the time, the Commission anticipated issuing a Further Notice of Proposed Rulemaking to seek comment on the implementation of a long-term support process for high-speed mobile broadband networks through Puerto Rico and the U.S. Virgin Islands before Stage 2 ended. Notwithstanding the Commission's proposal for a transition period of up to two years, it proposes that transitional support will cease once support is authorized under a long-term mobile wireless mechanism for Puerto Rico and the U.S. Virgin Islands. The Commission seeks comment on its proposal for the period of transitional support, including whether to continue transitional support after two years if authorizations under a long-term mechanism have not yet occurred.
7.
8. The Commission required eligible facilities-based mobile carriers to meet interim and final milestones to restore their network coverage to at least their pre-hurricane area, while also meeting public interest and network performance obligations for 4G LTE and 5G network technologies. While the interim milestone reporting deadline date has not been reached, staff analyses based on June 2021 Form 477 data preliminarily indicate that mobile carriers participating in the Bringing Puerto Rico Together Fund and the Connect USVI Fund will have met, or exceeded, their interim milestone to restore network coverages to at least 66% of their pre-hurricane coverages. Similarly, the Commission's review of carriers' publicly available coverage maps reflects significant coverage of the Territories with 4G LTE and 5G capable networks. Do participating carriers require a different amount of transitional support to preserve service following the full restoration of pre-hurricane coverage areas? Should the transitional support for each eligible facilities-based mobile carrier vary depending on any network resilience performance metrics? Should any unused Stage 2 mobile support designated for 5G networks be used to offset a carrier's transitional support? For example, if a carrier was unable to use all of the 25% of total support allocated to 5G networks, should that unused support be deducted from the transitional support the carrier would otherwise receive? Is the amount of proposed transitional support sufficient to permit carriers to further harden advanced telecommunication networks supporting 5G service? The Commission seeks comment on its proposal for transitional support amounts, along with any evidence of why a different support amount or alternative proposals might be necessary.
9.
10.
11.
12.
13.
14. The Commission next addresses the phase-down of frozen support adopted in the
15. To ensure continuity of service throughout the Territories, the Commission proposes to freeze phase-down support to the incumbent LECs that did not win competitive support at
16. While the Commission proposes to extend phase-down support to December 31, 2025, are there other possible circumstances in which it would be appropriate for the Commission to consider extending or shortening the phase-down period? Would a significant delay or substantial failure to meet the final deployment milestone by the winning applicant require an extension of phase-down support? Conversely, should the Commission consider shortening its proposed additional phase-down period if a winning applicant meets its milestones earlier than required? The Commission seeks comment on any additional factors and circumstances it should consider in adjusting the phase-down period. Are there actions the Commission should take to ensure sufficient flexibility in the event that support should be curtailed or extended?
17. The Commission also proposes that an incumbent LEC must limit its use of the phase-down support to resiliency and redundancy measures, consistent with the
18. To provide oversight and accountability and prevent waste, fraud, and abuse, the Commission proposes to subject phase-down support recipients to ongoing oversight by itself and the Universal Service Administrative Company. An incumbent LEC interested in receiving this support would be required to submit a spending plan for its use of phase-down support for redundancy and resiliency measures to the Wireline Competition Bureau (the Bureau) for approval. At the conclusion of each calendar year, the incumbent LEC would be required to provide the Commission with a report of how the phase-down support was spent on resiliency and redundancy measures consistent with the Bureau-approved plan, along with a certification pursuant to section 54.313(n) of the Commission's rules that the support was used only for authorized purposes. The Commission seeks comment on this proposal. Should the Commission require additional oversight and accountability measures specific to the receipt of phase-down support? Are there alternative measures the Commission should consider to ensure oversight and accountability of providers receiving additional phase-down support?
19.
20. The FNPRM may contain proposed modified information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. The Commission, as part of its continuing effort to reduce paperwork burdens, will invite the general public and the Office of Management and Budget to comment on any information collection requirements contained in the document, as required by the PRA. In addition, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198,
21.
22. The FNPRM proposes support to maintain, improve, and expand mobile services in Puerto Rico and the U.S. Virgin Islands. The FNPRM proposes making support available to a facilities-based mobile carrier that currently receives funding and that maintains its ETC designation using a subscriber-based process. Four mobile carriers in the Territories currently receive high-cost support and three carriers in the Territories currently receive phase-down high-cost support discussed in the FNPRM. The FNPRM does not propose that other carriers will obtain an ETC designation to receive part of the additional support proposed by the FNPRM, so the Commission does not anticipate the proposed rule to affect more than seven providers out of the 1,763 providers currently receiving high-cost support. Accordingly, the Commission anticipates that the FNPRM
23. Accordingly,
24.
25.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of availability; request for comments.
The North Pacific Fishery Management Council (Council) submitted Amendment 123 to the Fishery Management Plan (FMP) for Groundfish of the Bering Sea and Aleutian Islands Management Area (BSAI FMP) to the Secretary of Commerce (Secretary) for review. If approved, Amendment 123 would amend regulations governing Pacific halibut (
Comments must be received no later than January 9, 2023.
You may submit comments on this document, identified by NOAA-NMFS-2022-0088, by any of the following methods:
•
Electronic copies of the final Environmental Impact Statement and the Regulatory Impact Review (collectively referred to as the “Analysis”) prepared for this proposed rule may be obtained from
Bridget Mansfield, 907-586-7642.
The Magnuson-Stevens Act requires that each regional fishery management council submit any fishery management plan amendment it prepares to NMFS for review and approval, disapproval, or partial approval by the Secretary. The Magnuson-Stevens Act also requires that NMFS, upon receiving an FMP amendment, immediately publish a notice in the
NMFS manages the U.S. groundfish fisheries in the exclusive economic zone under the BSAI FMP. The Council prepared the BSAI FMP under the authority of the Magnuson-Stevens Act (16 U.S.C. 1801
Pacific halibut is fully utilized in Alaska as a target species in subsistence, personal use, recreational (sport), and commercial halibut fisheries. Halibut has significant social, cultural, and economic importance to fishery participants and fishing communities throughout the geographical range of the resource. Halibut is also incidentally taken as bycatch in commercial groundfish fisheries. In recent years, catch limits for the commercial halibut fishery in the BSAI have declined in response to decreasing halibut spawning biomass although halibut catch limits increased in 2021, while limits on the maximum amount of halibut bycatch allowed in the groundfish fisheries have remained constant since 2015, when they were reduced under BSAI FMP Amendment 111. This BSAI FMP amendment, if approved, would set annual halibut PSC limits in the BSAI Amendment 80 sector groundfish fisheries based on halibut abundance, which is the sector with the largest share of PSC limits. This proposed approach is consistent with the requirements of the Magnuson-Stevens Act to minimize bycatch to the extent practicable while achieving, on a continuing basis, optimum yield from the groundfish fisheries.
Halibut is not a groundfish species under the BSAI FMP and, therefore, is not subject to provisions of the Magnuson-Stevens Act requiring the establishment of an annual overfishing limit (OFL), an acceptable biological catch (ABC), or a total allowable catch (TAC) limit. This is because it is subject to the Halibut Convention. Although halibut is not managed under an OFL, ABC, or TAC, the IPHC has developed a harvest policy to control removals during conditions of declining or poor stock abundance. The IPHC harvest policy includes a harvest control rule that reduces commercial harvest rates if the stock is estimated to have fallen below established thresholds for female spawning biomass. The harvest control rule would severely curtail removals during times of particularly poor stock conditions. The harvest control rule has not been triggered, even during the most recent years of relatively low exploitable biomass (see Section 3.1.1.1 and Section 3.1.2.1 of the Final Environmental Impact Statement and the Regulatory Impact Review (collectively referred to as the “Analysis”)).
The IPHC conducts an annual stock assessment for the coastwide halibut stock. Based on the most recent stock assessment for Pacific halibut, the estimated spawning stock biomass has been stable since 2010. Stock assessment models used by the IPHC in 2020 project a decreasing female spawning biomass over the next few years, assuming current removal rates from all sources. Advice from the most recent stock assessment ensemble is presented annually to the IPHC as a risk-based decision matrix that combines different catch levels and various performance metrics. In 2017, the previous IPHC harvest policy was replaced with an interim harvest strategy policy while a management strategy evaluation process is underway. This approach sets a coastwide commercial catch limit considering mortality from all sources and then distributes the commercial catch limit across IPHC Regulatory Areas using estimates of stock distribution from the IPHC fishery independent setline survey and relative harvest rates.
The commercial halibut fishery in the BSAI is managed by NMFS under the Individual Fishing Quota (IFQ) and Community Development Quota (CDQ) Programs that allocate exclusive harvest privileges. The IFQ Program was implemented in 1995 (58 FR 59375, November 9, 1993). The Council and NMFS designed the IFQ Program to end a wasteful and unsafe “race for fish,” and to maintain the social and economic character of the fixed-gear fisheries and the coastal fishing communities where many of these fisheries are based. The CDQ Program was established in 1992 (57 FR 54936, November 23, 1992) and amended substantially by the Coast Guard and Maritime Transportation Act of 2006 (Pub. L. 109-241)). Under Section 305(i)(1)(D) of the Magnuson-Stevens Act, 65 villages are authorized to participate in the CDQ Program, represented by 6 CDQ groups (16 U.S.C. 1855(i)(1)(D)). CDQ groups manage and administer allocations of crab, groundfish, and halibut, and use the revenue derived from the harvest of CDQ allocations to fund economic development activities and provide employment opportunities on behalf of the villages they represent. The amount of halibut for commercial harvest allocated to the CDQ Program varies by halibut management area and ranges from 20 to 100 percent of the commercial catch limits assigned to Areas 4B, 4C, 4D, and 4E.
The combined CDQ and IFQ halibut fisheries in Area 4 were harvested by an average of approximately 120 vessels from 2015 through 2019. The CDQ and IFQ halibut fisheries provide revenue to vessel owners and crew that harvest halibut. These fisheries also provide economic benefits to shore-based halibut processors and socioeconomic benefits to BSAI fishing communities that provide support services to the halibut harvesting and processing sectors. From 2015 through 2019, Area 4 halibut ex-vessel revenues declined by 32 percent, resulting in negative economic impacts for fishery participants and affected fishing communities due to changing market conditions, while catch of halibut in Area 4 has remained relatively constant.
In Area 4, the specific proportion of halibut removals that are taken as PSC in the groundfish fisheries versus catch in the commercial halibut fishery has shifted over time. From 1990 to 1996, commercial halibut fisheries averaged 37 percent and PSC averaged 60 percent of total halibut removals. From 1997 to 2011, commercial halibut fishery removals increased as a portion of total removals; commercial halibut fisheries averaged 57 percent and PSC averaged 41 percent of total halibut removals. From 2012 through 2014, commercial halibut fishery removals decreased as a portion of total removals; commercial halibut fishery averaged 41 percent and PSC averaged 55 percent of total removals. From 2016 through 2019, commercial halibut fishery averaged 52 percent and PSC averaged 47 percent of total removals.
Halibut PSC is taken by vessels using all gear types, but it occurs primarily in the trawl and hook-and-line groundfish fisheries. NMFS manages halibut bycatch in the BSAI by (1) establishing halibut PSC limits for trawl and non-trawl fisheries; (2) apportioning those halibut PSC limits to groundfish sectors, fishery categories, and seasons; and (3) managing groundfish fisheries to prevent PSC from exceeding established limits.
Current halibut PSC limits for BSAI groundfish fisheries were established by Amendment 111 to the BSAI FMP in 2016 (81 FR 24714, April 27, 2016). The current total annual halibut PSC limit for BSAI groundfish fisheries is 3,515 metric tons (mt). Of that, 1,745 mt are apportioned to the Amendment 80 sector, which is comprised of 27 non-pollock trawl catcher/processors. Of the four BSAI groundfish fishery sectors, the Amendment 80 sector is apportioned the majority of halibut PSC
The Amendment 80 sector halibut PSC limit of 1,745 mt is apportioned between Amendment 80 cooperatives and the Amendment 80 limited access fishery according to the process specified at 50 CFR 679.91. Amendment 80 cooperatives are responsible for coordinating fishing activities to ensure the cooperative halibut PSC allocation is not exceeded. The Amendment 80 groundfish fisheries provide revenue to Amendment 80 vessel owners and crew members that harvest and process groundfish. In addition, the fisheries provide socioeconomic benefits to fishing communities that provide support services for Amendment 80 vessel operations.
The halibut PSC limit established for each BSAI groundfish sector is an upper limit on halibut PSC for that sector for each year. However, the amount of halibut PSC used by a BSAI groundfish sector is almost always less than its halibut PSC limit. Halibut PSC use is less than the halibut PSC limit due to a range of operational factors, including the need to avoid a closure or enforcement action if a PSC allocation is reached. The current halibut PSC limit for the Amendment 80 sector is 1,745 mt, the non-Amendment 80 trawl limited access sector limit is 745 mt, the CDQ limit is 315 mt, and the non-trawl sector limit is 710 mt. From 2010 through 2020, the Amendment 80 sector has accounted for roughly 60 percent of the overall BSAI groundfish trawl PSC mortality. In recent years, catch limits for the commercial halibut fishery in the BSAI have declined, while these limits on the maximum amount of halibut PSC have remained constant, making halibut bycatch a larger proportion of total removal.
Therefore, consistent with the Council's purpose and need statement for this amendment to prevent halibut PSC from becoming a larger proportion of total removals in the BSAI as halibut abundance declines, the Amendment 80 halibut PSC limit should decline in proportion to reduced amounts of halibut available for harvest by all users. The proposed amendment balances the interests of the two largest halibut user groups in the BSAI, the directed commercial halibut fishery and the Amendment 80 sector, as well as other users including subsistence and recreational, by establishing abundance-based halibut PSC limits for the Amendment 80 sector. This abundance-based approach is consistent with the IPHC management approach for the directed commercial halibut fisheries off Alaska, which establishes annual catch limits that vary with halibut abundance.
In any given year, results from the most recent IPHC setline survey index for halibut in Area 4ABCDE would be categorized into one of four ranges including very low, low, medium, and high. Annual results from the NMFS Alaska Fisheries Science Center (AFSC) Eastern Bering Sea (EBS) trawl survey index for halibut would be categorized into a high or low range. Under this proposed amendment, each year the intercept of the most recent survey results in the proposed index table would establish the annual halibut PSC limit for the Amendment 80 sector. Those limits would range from the current Amendment 80 halibut PSC limit when abundance is high in the IPHC setline survey to 35 percent below the current limit when abundance is very low in the IPHC setline survey.
In December 2021, the Council recommended, and NMFS now proposes, Amendment 123 to link the halibut PSC limit for the Amendment 80 commercial groundfish trawl fleet in the BSAI groundfish fisheries to halibut abundance. In recommending Amendment 123, the Council intends to minimize halibut PSC to the extent practicable while achieving optimum yield in the BSAI groundfish fisheries on a continuing basis. The amendment, if approved, would be expected to provide incentives for the Amendment 80 fleet to minimize halibut mortality at all times. Achievement of these objectives could result in additional harvest opportunities in the directed commercial halibut fisheries, helping to provide for the sustained participation of such communities that participate in those directed fisheries and allowing for a fair and equitable allocation of the resource. Based on a review of the scientific information and consideration of the revised National Standard guidelines, the Council and NMFS determined that reducing halibut PSC with declining halibut abundance provides conservation benefits, as defined by the Magnuson-Stevens Act. The Council and NMFS determined that this proposed amendment, if approved, may provide additional harvest opportunities for the commercial halibut fisheries.
Amendment 123 would amend Sections 3.6.2 and 3.7.5 of the BSAI FMP to establish the link between the halibut PSC limit for the Amendment 80 sector in the BSAI groundfish fisheries and halibut abundance. Amendment 123 would allow NMFS to annually set the halibut PSC limit for the Amendment 80 sector according to halibut abundance indices from the most recent annual IPHC setline survey and the NMFS AFSC EBS shelf trawl survey. Section 3.7.5.2 of the BSAI FMP currently apportions the halibut PSC limit in the BSAI between the Amendment 80 sector and the BSAI trawl limited access sector and sets the annual halibut mortality PSC limit for the Amendment 80 sector at 1,745 mt. This static limit would be replaced by instructions indicating that the limit would be set annually. Section 3.6.2.1.4 of the BSAI FMP reiterates the halibut PSC limit in the BSAI for the Amendment 80 sector is set at 1,745 mt. The revision in this section would replace the static limit with the process for setting the annual halibut mortality PSC limit for the Amendment 80 sector. That process would be based on a table with pre-established halibut abundance ranges from the IPHC survey setline index in Area 4ABCDE and the AFSC EBS shelf trawl survey index. The annual Amendment 80 sector halibut PSC limit would be set at the value found at the intercept of the results from the most recent IPHC setline survey in Area 4ABCDE and the most recent AFSC EBS shelf trawl survey.
NMFS is soliciting public comments on proposed Amendment 123 through the end of the comment period (see
Respondents do not need to submit the same comments on Amendment 123 and the proposed rule. All relevant written comments received by the end of the applicable comment period, whether specifically directed to the BSAI FMP amendment or the proposed rule will be considered by NMFS in the approval/disapproval decision for Amendments 123 and addressed in the response to comments in the final decision. Comments received after the end of the applicable comment period will not be considered in the approval/disapproval decision on Amendment 123. To be considered, comments must be received, not just postmarked or otherwise transmitted, by the last day of the comment period (see
Central Intelligence Agency.
Notice of a modified system of records.
Pursuant to the Privacy Act of 1974, as amended, and Office of Management and Budget (OMB) Circular No. A-108, notice is hereby given that the Central Intelligence Agency (CIA or “the Agency”) is modifying one of its system of records notices, CIA-21, Applicant Records, to reflect the Agency's maintenance of records on prospective applicants.
In accordance with 5 U.S.C. 552a(e)(4) and (11), this system of records is effective upon publication.
Kristi Scott, Privacy and Civil Liberties Officer, Central Intelligence Agency, Washington, DC 20505, (571) 280-2700.
On July 22, 2005, the Agency published in the
In accordance with 5 U.S.C. 552a(r), the Agency has provided a report to OMB and Congress on this notice of a modified system of records.
Applicant Records
The classification of records in this system can range from UNCLASSIFIED to TOP SECRET.
Central Intelligence Agency, Washington, DC 20505.
Chief, Recruitment Center, Central Intelligence Agency, Washington, DC 20505.
[Delete existing paragraph and replace with the following:]
Applicants and prospective applicants for employment with the CIA.
[Delete existing paragraph and replace with the following:]
Records concerning the applicant or prospective applicant, including: biographic data, medical and employment history statements, educational transcripts, and personal references; and records relating to employment processing, including: interview reports, test results, correspondence, review comments, and general processing records.
[Delete existing paragraph and replace with the following:]
Records are used by CIA human resources management officials and other authorized personnel: to ensure process integrity; to enable the CIA and the Director of the CIA to carry out their lawful and authorized responsibilities; to review an applicant's or prospective applicant's qualifications; for security background investigations; for suitability determinations; for medical screening; and to determine whether employment with the CIA will be offered.
[Delete existing paragraph and replace with the following:]
CIA applicants or prospective applicants; applicant or prospective applicant references; educational institutions and private organizations; physicians and medical practitioners; CIA employees; and other federal agencies.
70 FR 42417, July 22, 2005.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) is initiating a changed circumstances review (CCR) to determine if Kader Exports Private Limited (Kader Exports) is the successor-in-interest to the Liberty Group in the context of the antidumping duty (AD) order on certain frozen warmwater shrimp (shrimp) from India. We preliminarily determine that Kader Exports is the successor-in-interest to the Liberty Group.
Applicable November 9, 2022.
Adam Simons, AD/CVD Operations, Office II, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401
On February 1, 2005, Commerce published in the
The merchandise subject to the
Pursuant to section 751(b)(1) of the Act, Commerce will conduct a CCR upon receipt of information concerning, or a request from, an interested party for a review of an AD order which shows changed circumstances sufficient to warrant a review of the order. The information submitted by Kader Exports supporting its claim that it is the successor-in-interest to Liberty Group demonstrates changed circumstances sufficient to warrant such a review.
Section 351.221(c)(3)(ii) of Commerce's regulations permits Commerce to combine the notice of initiation of a CCR and the notice of preliminary results if Commerce concludes that expedited action is warranted.
In this CCR, pursuant to section 751(b) of the Act, Commerce conducted a successor-in-interest analysis. In making a successor-in-interest determination, Commerce examines several factors, including, but not limited to, changes in the following: (1) management; (2) production facilities; (3) supplier relationships; and (4) customer base.
In accordance with 19 CFR 351.216, we preliminarily determine that Kader Exports is the successor-in-interest to the Liberty Group. Record evidence, as submitted by Kader Exports, indicates that Kader Exports operates as essentially the same business entity as the Liberty Group with respect to the subject merchandise.
For the complete successor-in-interest analysis, including discussion of business proprietary information, refer to the accompanying Preliminary Decision Memorandum. A list of the topics discussed in the Preliminary Decision Memorandum is included as the appendix to this notice. The Preliminary Decision Memorandum is a public document and is made available to the public via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at
Commerce will issue its final results of the review in accordance with the time limits set forth in 19 CFR 351.216(e).
In accordance with 19 CFR 351.309(c)(1)(ii), interested parties may submit case briefs not later than 30 days after the date of publication of this notice. Rebuttal briefs, limited to issues
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request via ACCESS within 30 days of publication of this notice. Hearing requests should contain: (1) the party's name, address, and telephone number; (2) the number of participants; and (3) a list of issues to be discussed. Oral presentations at the hearing will be limited to issues raised in the briefs. If a request for a hearing is made, parties will be notified of the time and date for the hearing, in accordance with 19 CFR 351.310(d).
Consistent with 19 CFR 351.216(e), we will issue the final results of this CCR no later than 270 days after the date on which this review was initiated, or within 45 days if all parties agree to our preliminary finding. This notice is published in accordance with sections 751(b)(1) and 777(i) of the Act and 19 CFR 351.216(b), 351.221(b) and 351.221(c)(3).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) determines that Jilin Bright Future Chemicals Co., Ltd. (Jilin Bright) sold certain activated carbon from the People's Republic of China (China) at less than normal value during the period of review (POR), April 1, 2020, through March 31, 2021. Commerce also determines that Datong Juqiang Activated Carbon Co., Ltd. (Datong Juqiang) did not make sales of subject merchandise at less than normal value during the POR. Commerce further determines that certain companies made no shipments of the subject merchandise during the POR.
Applicable November 9, 2022.
Jinny Ahn or Zachariah Hall, AD/CVD Operations, Office VIII, Enforcement and Compliance, International Trade Administration, Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-0339 or (202) 482-6261, respectively.
On May 6, 2022, Commerce published the
The merchandise subject to the
All issues raised by interested parties in briefs are addressed in the Issues and Decision Memorandum. A list of the issues addressed in the Issues and Decision Memorandum is provided in Appendix I to this notice. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at
Based on our review of the record and comments received from interested parties regarding our
In the
In our
In the
For companies subject to this review, which established their eligibility for a separate rate, Commerce determines that the following weighted-average dumping margins exist for the period from April 1, 2020, through March 31, 2021:
In the
Pursuant to section 751(a)(2)(C) of the Act and 19 CFR 351.212(b), Commerce has determined, and U.S Customs and Border Protection (CBP) shall assess, ADs on all appropriate entries covered by this review. Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the
For the individually-examined respondent in this review which has a final weighted-average dumping margin that is not zero or
For the respondents which were not selected for individual examination in this administrative review and which qualified for a separate rate, the assessment rate will be equal to the rate assigned to them for the final results (
The following per-unit cash deposit requirements will be effective upon publication of the final results of this administrative review for all shipments of the subject merchandise from China entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided by section 751(a)(2)(C) of the Act: (1) for Datong Juqiang, Jilin Bright, and the non-examined separate rate respondents, the cash deposit rate will be equal to their weighted-average dumping margins established in the final results of this
We intend to disclose the calculations performed to parties in this proceeding within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).
This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping and/or countervailing duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping and/or countervailing duties has occurred and the subsequent assessment of double antidumping duties.
This notice also serves as a reminder to parties subject to an APO of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
We are issuing and publishing these final results of administrative review and notice in accordance with sections 751(a)(1) and 777(i) of the Act.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) finds that Qufu Xinyu Furniture Co., Ltd. (Qufu Xinyu) did not make sales of subject merchandise at less than normal value (NV) during the period of review (POR) October 9, 2019, through March 31, 2021; Shanghai Beautystar Cabinetry Co., Ltd. (Beautystar) is part of the People's Republic of China (China)-wide entity; and Jiang Su Rongxin Wood Industry Co., Ltd. (Rongxin Wood) is the successor-in-interest to Jiangsu Rongxin Cabinets Co., Ltd. (Rongxin Cabinets).
Applicable November 9, 2022.
Jacob Keller, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-4849.
On May 6, 2022, Commerce published the
The products covered by this
All issues raised in the parties' briefs are addressed in the Issues and Decision Memorandum. A list of the issues addressed is included as Appendix I to this notice. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at
Commerce determines that 15 companies, not individually examined, are eligible for separate rates in this administrative review.
Commerce considers all other companies, listed in Appendix II of this notice, for which a review was requested, and which did not demonstrate separate rate eligibility, to be part of the China-wide entity.
As discussed in the Issues Decision Memorandum, Commerce continues to find that the sale made by Dalian Hualing Wood Co., Ltd. (Hualing) serving as the basis for administrative review is not a
Because the non-
In the
Commerce determines that the following weighted-average dumping margin exists for the administrative review covering the period October 9, 2019, through March 31, 2021:
Normally, Commerce discloses to the parties in a proceeding the calculations performed in connection with a final results of review in accordance with 19 CFR 351.224(b). However, because Commerce made no adjustments to the margin calculation methodology used in the
Pursuant to section 751(a)(2)(C) of the Act and 19 CFR 351.212(b), Commerce has determined, and CBP shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with these final results of review. Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of review in the
For Qufu Xinyu, and the respondents which were not selected for individual examination in this administrative review, and which qualified for a separate rate, we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties. For the companies listed in Appendix II, identified as part of the China-wide entity, we will instruct CBP to apply an antidumping duty assessment rate of 251.64 percent (the rate applicable to the China-wide entity) to all entries of subject merchandise during the POR exported by those companies.
The following cash deposit requirements will be effective upon publication of the final results of this review for shipments of the subject merchandise from China entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided by sections 751(a)(2)(C) of the Act: (1) for subject merchandise exported by the companies listed above that have separate rates, the cash deposit rate will be the rate established in these final results of review for each exporter as listed above; (2) for previously investigated or reviewed Chinese and non-Chinese exporters not listed above that received a separate rate in a prior segment of this proceeding, the cash deposit rate will continue to be the existing exporter-specific rate; (3) for all Chinese
This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping and/or countervailing duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping and/or countervailing duties occurred and the subsequent assessment of double antidumping duties.
This notice also serves as a reminder to parties subject to an administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305, which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and terms of an APO is a sanctionable violation.
We are issuing and publishing these final results of review in accordance with sections 751(a)(l), 751(a)(2)(B), and 777(i) of the Act.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of virtual meeting.
The North Pacific Fishery Management Council (Council) Bering Sea and Aleutian Islands (BSAI) Crab Plan Team (CPT) will meet virtually on November 29, 2022.
The meeting will be held on Tuesday, November 29, 2022, from 9 a.m. to 12 p.m., Alaska Time.
The meeting will be a virtual meeting. Participants can join online through the link at:
Sarah Rheinsmith, Council staff; phone: (907) 271-2809; email:
The agenda will include a summary of the snow crab rebuilding plan initial review analysis, and Plan Team discussion. The agenda is subject to change, and the latest version will be posted at
You can attend the meeting online using a computer, tablet, or smart phone, or by phone only. Connection information will be posted online at:
Public comment letters will be accepted and should be submitted electronically to
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; public meetings and request for comments.
NMFS will hold one virtual hearing and accept written comment regarding an action to implement Presidential Proclamations 9496 and 10287, establishing the Northeast Canyons and Seamounts Marine National Monument. Regulations under the Magnuson-Stevens Fishery Conservation and Management Act and the Atlantic Coastal Fisheries Cooperative Management Act require publication of this notice to provide interested parties the opportunity to comment on this upcoming fishery management plan amendment.
The virtual hearing will be held on November 16, 2022. See
You may submit written comments by the following method:
•
Laura Deighan, Fishery Management Specialist, 978-281-9184,
On September 15, 2016, the Northeast Canyons and Seamounts Marine National Monument was designated for waters of the North Atlantic (Presidential Proclamation 9496; 81 FR 65161, September 21, 2016). This Proclamation prohibited commercial fishing within the monument, with a 7-year exemption for the American lobster and Atlantic deep-sea red crab fisheries. In June 2020, monument prohibitions were revised via Proclamation 10049 (85 FR 35793, June 11, 2020) removing commercial fishing from the list of prohibited activities set forth in the 2016 Proclamation. Most recently, in October 2021, Proclamation 10287 (86 FR 57349, October 15, 2021) again modified the activities allowed within the monument. This 2021 proclamation restored commercial fishing to the list of prohibited activities, providing “for the prohibition of all commercial fishing in the monument, except for red crab and American lobster commercial fishing, which may be permitted until September 15, 2023.”
NOAA Fisheries will hold one virtual public hearing and accept written comments regarding an action intended to incorporate the monument area and commercial fishing prohibition into the region's fishery management plans and fishery regulations. A public hearing document with additional details can be found on the NOAA website at
Written comments will be accepted at the hearings or via the submission methods described above, by November 30, 2022.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; receipt of application.
Notice is hereby given that Aaron Lynton, 986 Kupulau Drive, Kihei, HI 96853, has applied in due form for a permit to conduct commercial and educational photography on humpback whales (
Written, telefaxed, or email comments must be received on or before December 9, 2022.
These documents are available upon written request via email to
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
Erin Markin or Carrie Hubard, (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 film humpback whales in the waters off the coast of Maui for a documentary on their social interactions and behaviors in Hawaiian waters. The applicant would film and observe up to 400 adult/juvenile humpback whales and 75 humpback whale calves annually topside from a vessel, using an unmanned aircraft system (UAS), or underwater by diving. Up to 60 Hawaiian spinner dolphins (
It has come to the agency's attention that the 2016 interim final humpback approach rule (50 CFR 216.19; 81 FR 62010, September 8, 2016) does not explicitly exempt permits issued under section 104(c)(6) of the MMPA from its prohibitions. It is not the agency's intent to preclude the issuance of permits or authorizations consistent with the requirements of the MMPA. We interpret the rule to allow issuance of these permits. Consistent with this interpretation, it has been our practice to continue to issue section 104(c)(6) permits that are in compliance with the MMPA's requirements and our review procedures. However, to eliminate any potential ambiguity, we intend to revise the rule to explicitly clarify that photography permits issued under section 104(c)(6) of the MMPA are exempt from the prohibitions on approach.
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 Western Pacific Fishery Management Council (Council) will hold its Hawaii Archipelago Fishery Ecosystem Plan (FEP) Advisory Panel (AP) to discuss and make recommendations on fishery management issues in the Western Pacific Region.
The meeting will be held on Tuesday, November 22, 2022, from 9 a.m. to 1 p.m. (Hawaii Standard Time). For agenda, see
The meeting will be held by web conference via Webex. Instructions for connecting to the web conference and providing oral public comments will be posted on the Council website at
Contact Kitty M. Simonds, Executive Director, Western Pacific Fishery Management Council; phone: (808) 522-8220.
Public Comment periods will be provided in the agendas. The order in which agenda items are addressed may change. The meetings will run as late as necessary to complete scheduled business.
The meeting is accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Kitty M. Simonds, (808) 522-8220 (voice) or (808) 522-8226 (fax), at least 5 days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public hybrid meeting.
The Caribbean Fishery Management Council's (Council) Scientific and Statistical Committee (SSC) will hold a public hybrid meeting to address the items contained in the tentative agenda included in the
The SSC public hybrid meeting will be held on November 29, 30 and December 1, 2022, from 10 a.m. to 5 p.m., Atlantic Standard Time (AST).
The SSC public hybrid meeting will be held at the Courtyard by Marriott Isla Verde Beach Resort, 7012 Boca de Cangrejos Avenue, Carolina, Puerto Rico 00979. You may join the SSC public hybrid meeting via Zoom by entering the following address:
Find your local number:
In case there are problems and we cannot reconnect via Zoom, the meeting will continue via GoToMeeting. You may join from a computer, tablet or smartphone by entering the following address:
You can also dial in using your phone.
Join from a video-conferencing room or system.
Get the app now and be ready when the first meeting starts:
Miguel A. Rolón, Executive Director, Caribbean Fishery Management Council, 270 Muñoz Rivera Avenue, Suite 401, San Juan, Puerto Rico 00918-1903, telephone: (787) 766-5926.
The following items included in the tentative agenda will be discussed:
The order of business may be adjusted as necessary to accommodate the completion of agenda items. The SSC three-day public hybrid meeting will begin on November 29, 2022, at 10 a.m. AST, and will end on December 1, 2022, at 5 p.m. AST. Other than the start time, interested parties should be aware that discussions may start earlier or later than indicated, at the discretion of the Chair. In addition, the meeting may be completed prior to the date established in this notice.
For any additional information on this public hybrid meeting, please contact Dr. Graciela García-Moliner, Caribbean Fishery Management Council, 270 Muñoz Rivera Avenue, Suite 401, San Juan, Puerto Rico, 00918-1903, telephone: (787) 403-8337.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; public meeting.
The Mid-Atlantic Fishery Management Council's (MAFMC's) Summer Flounder, Scup, and Black Sea Bass Advisory Panel will hold a public meeting jointly with the Atlantic States Marine Fisheries Commission's Summer Flounder, Scup, and Black Sea Bass Advisory Panel.
The meeting will be held on Wednesday, November 30, 2022, from 1 p.m. to 5 p.m., EDT. For agenda details, see
The meeting will be held via webinar. Connection information will be posted to the calendar at
Christopher M. Moore, Ph.D., Executive Director, Mid-Atlantic Fishery Management Council, telephone: (302) 526-5255.
The Mid-Atlantic Fishery Management Council's Summer Flounder, Scup, and Black Sea Bass Advisory Panel will meet jointly with the Atlantic States Marine Fisheries Commission's Summer Flounder, Scup and Black Sea Bass Advisory Panel to discuss 2023 recreational management measures for each species. The purpose of this meeting is to review the Monitoring Committee's recommendations for 2023 recreational management for all three species and to provide Advisory Panel input on 2023 recreational management measures.
The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Shelley Spedden, (302) 526-5251 at least 5 days prior to the meeting date.
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system (
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
As announced in the Notices of Technical Conference issued in this
The purpose of this conference is to discuss policy issues related to the reliability and security of the Bulk-Power System.
The conference will be open for the public to attend, and there is no fee for attendance. Information about this technical conference can be found on the Events Calendar on the Commission's website,
Commission conferences are accessible under section 508 of the Rehabilitation Act of 1973. For accessibility accommodations, please send an email to
For more information about this technical conference, please contact Lodie White at
The staff of the Federal Energy Regulatory Commission (FERC or Commission) has prepared a draft environmental impact statement (EIS) for the Wahpeton Expansion Project, proposed by WBI Energy Transmission, Inc. (WBI Energy) in the above-referenced docket. WBI Energy requests authorization to construct and operate the Wahpeton Expansion Project, which would provide an incremental 20,600 equivalent dekatherms per day of firm natural gas transportation capacity from WBI Energy's existing Mapleton Compressor Station to the proposed Montana Dakota Utilities (MDU)-Kindred and MDU-Wahpeton Border Stations to provide natural gas services to the communities of Kindred and Wahpeton, North Dakota.
The draft EIS assesses the potential environmental effects of the construction and operation of the Wahpeton Expansion Project in accordance with the requirements of the National Environmental Policy Act (NEPA). Commission staff concludes that approval of the proposed project, with the mitigation measures recommended in the EIS, would result in some adverse environmental impacts. Most of these impacts would be temporary and occur during construction (
The Wild Rice River Route Alternative—Milepost (MP) 55 would affect landowners that have not been part of the FERC's environmental scoping process, as further discussed on page 4. Therefore, by this letter we are notifying these parties of our evaluation and requesting comments about this route alternative presented in section 3.3.1 of the draft EIS.
The draft EIS addresses the potential environmental effects of the construction and operation of the following project facilities, in Cass and Richland Counties, North Dakota:
• a new 60.5-mile-long, 12-inch-diameter natural gas pipeline;
• minor modifications to WBI Energy's existing Mapleton Compressor Station;
• a new MDU-Wahpeton Border Station;
• a new MDU-Kindred Border Station;
• seven new block valve settings;
• four new pig launcher/receiver settings; and
• ancillary facilities.
The Commission mailed a copy of the
The draft EIS is not a decision document. It presents Commission staff's independent analysis of the environmental issues for the Commission to consider when addressing the merits of all issues in this proceeding. Any person wishing to comment on the draft EIS may do so. Your comments should focus on draft EIS's disclosure and discussion of potential environmental effects, measures to avoid or lessen environmental impacts, and the completeness of the submitted alternatives, information and analyses. To ensure consideration of your comments on the proposal in the final EIS, it is important that the Commission receive your comments on or before 5:00 p.m. Eastern Time on December 27, 2022.
For your convenience, there are four methods you can use to submit your comments to the Commission. The Commission will provide equal consideration to all comments received, whether filed in written form or provided verbally. The Commission encourages electronic filing of comments and has staff available to assist you at (866) 208-3676 or
1. You can file your comments electronically using the eComment feature on the Commission's website (
2. You can file your comments electronically by using the eFiling feature on the Commission's website (
3. You can file a paper copy of your comments by mailing them to the Commission. Be sure to reference the project docket number (CP22-466-000) on your letter. Submissions sent via the U.S. Postal Service must be addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC 20426. Submissions sent via any other carrier must be addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, MD 20852.
4. In lieu of sending written or electronic comments, the Commission invites you to attend one of the public comment sessions its staff will conduct in the project area to receive comments on the draft EIS, scheduled as follows:
The primary goal of these comment sessions is to have you identify the specific environmental issues and concerns with the draft EIS. Individual verbal comments will be taken on a one-on-one basis with a court reporter. This format is designed to receive the maximum amount of verbal comments, in a convenient way during the timeframe allotted.
Each comment session is scheduled from 5:00 p.m. to 7:00 p.m. Central Standard Time. You may arrive at any time after 5:00 p.m. There will not be a formal presentation by Commission staff when the session opens. Comments will be taken until 7:00 p.m. Please see appendix 1 for additional information on the session format and conduct.
Your verbal comments will be recorded by the court reporter (with FERC staff or representative present) and become part of the public record for this proceeding. Transcripts will be publicly available on FERC's eLibrary system (see page 2 for instructions on using eLibrary). If a significant number of people are interested in providing verbal comments in the one-on-one settings, a time limit of 5 minutes may be implemented for each commentor. Although there will not be a formal presentation, Commission staff will be available throughout the comment session to answer your questions about the environmental review process.
It is important to note that the Commission provides equal consideration to all comments received, whether filed in written form or provided orally at a comment session.
Any person seeking to become a party to the proceeding must file a motion to intervene pursuant to Rule 214 of the Commission's Rules of Practice and Procedures (18 CFR part 385.214). Motions to intervene are more fully described at
As indicated on page 1, some landowners are receiving this draft EIS because their property has been identified as potentially being affected by the Wild Rice River Route Alternative—MP 55, which is recommended by FERC staff to avoid or lessen environmental impacts along WBI Energy's proposed pipeline route. Section 3.3.1 of the draft EIS contains our analysis and discussion of this alternative. The Commission staff wants to ensure that all potentially affected landowners have the opportunity to participate in the environmental review process, thus staff is soliciting comments to assist with the environmental analysis of this route alternative, which will be presented in the final EIS.
Additional information about the project is available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC website (
In addition, the Commission offers a free service called eSubscription that allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
Any person desiring to protest in any the above proceedings must file in accordance with Rule 211 of the Commission's Regulations (18 CFR 385.211) on or before 5:00 p.m. Eastern time on the specified comment date.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
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:
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
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Environmental Protection Agency.
Notice.
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), Hazardous Waste Specific Unit Requirements, and Special Waste Processes and Types (EPA ICR Number 1572.13, OMB Control Number 2050-0050) 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 November 30, 2022. Public comments were previously requested via the
Additional comments may be submitted on or before December 9, 2022.
Submit your comments, referencing Docket ID No. EPA-HQ-OLEM-2018-0757, online using
The EPA's policy is that all comments received will be included in the public docket without change, including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI), or other information whose disclosure is restricted by statute.
Submit written comments and recommendations to OMB for the proposed information collection within 30 days of publication of this notice to
Peggy Vyas, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: 202-566-0453; 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
With each information collection covered in this ICR, the EPA is aiding the goal of complying with its statutory mandate under RCRA to develop standards for hazardous waste treatment, storage, and disposal facilities, to protect human health and the environment. Without the information collection, the agency cannot assure that the facilities are designed and operated properly.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections.
Written comments shall be submitted on or before January 9, 2023. If you anticipate that you will be submitting comments but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email:
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: 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; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; 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; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written comments shall be submitted on or before January 9, 2023. If you anticipate that you will be submitting comments but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email:
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
In a December 1998 Report and Order in WT Docket Nos. 98-20 and 96-188, the Commission consolidated, revised and streamlined the Commission's rules governing the licensing application procedures for radio services licensed by the Commission's Wireless Telecommunications Bureau in order to fully implement the Universal Licensing System (ULS). As a result of the ULS rule conversions in connection with this information collection requirements contained in 47 CFR 90.477(a), interconnected systems now file all information (100 percent). Section 90.477(d)(3), interconnected systems were changed to reflect NAD83 coordinates.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: 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; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; 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; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written comments shall be submitted on or before January 9, 2023. If you anticipate that you will be submitting comments but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email:
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
The Commission also received approval from OMB for the information collection requirements contained in FCC 16-55. The amendments contained in the Second Report and Order create additional capacity for wireless broadband by adopting a new approach to spectrum management to facilitate more intensive spectrum sharing between commercial and federal users and among multiple tiers of commercial users. The Spectrum Access System (SAS) will use the information to authorize and coordinate spectrum use for Citizen Broadband Radio Service Devices (CBSDs). The Commission will use the information to coordinate among the spectrum tiers and determine Protection Areas for Priority Access Licensees (PALs).
The following is a description of the information collection requirements for is approved under this collection:
Section 96.25(c)(1)(i) requires PALs to inform the SAS if a CBSD is no longer in use.
Section 96.25(c)(2)(i) creates a default protection contour for any CBSD at the outer limit of the PAL Protection Area, but allows a PAL to self-report a contour smaller than that established by the SAS. These rules which contain information collection requirements are designed to provide for flexible use of this spectrum, while managing three tiers of users in the band, and create a low-cost entry point for a wide array of users. The rules will encourage innovation and investment in mobile broadband use in this spectrum while protecting incumbent users. Without this information, the Commission would not be able to carry out its statutory responsibilities.
Federal Communications Commission.
Notice; extension of temporary application freeze.
In this document, the Federal Communications Commission (Commission) extends the existing, 180-day freeze on filing certain applications pending the outcome of new proceeding, GN Docket No. 22-352.
The temporary, 180-day, application freeze was extended on October 28, 2022.
Simon Banyai, Broadband Division, Wireless Telecommunications Bureau, (202) 418-1443 or
This is a summary of the Commission's Order in GN Docket No. 22-352, FCC 22-80, adopted on October 27, 2022, and released on October 28, 2022. The full text of this document is available on FCC's website at
On October 28, 2022, the Commission released a Notice of Inquiry and Order, GN Docket No. 22-352,
Accordingly,
The Commission hereby gives notice of filing of the following agreements under the Shipping Act of 1984. Interested parties may submit comments, relevant information, or documents regarding the agreements to the Secretary by email at
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The public portions of the applications listed below, as well as other related filings required by the
Comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors, Ann E. Misback, Secretary of the Board, 20th Street and Constitution Avenue NW, Washington, DC 20551-0001, not later than December 9, 2022.
1.
1.
Board of Governors of the Federal Reserve System.
The companies listed in this notice have given notice under section 4 of the Bank Holding Company Act (12 U.S.C. 1843) (BHC Act) and Regulation Y, (12 CFR part 225) to engage de novo, or to acquire or control voting securities or assets of a company, including the companies listed below, that engages either directly or through a subsidiary or other company, in a nonbanking activity that is listed in § 225.28 of Regulation Y (12 CFR 225.28) or that the Board has determined by Order to be closely related to banking and permissible for bank holding companies. Unless otherwise noted, these activities will be conducted throughout the United States.
The public portions of the applications listed below, as well as other related filings required by the Board, if any, are available for immediate inspection at the Federal Reserve Bank(s) indicated below and at the offices of the Board of Governors. This information may also be obtained on an expedited basis, upon request, by contacting the appropriate Federal Reserve Bank and from the Board's Freedom of Information Office at
Unless otherwise noted, comments regarding the applications must be received at the Reserve Bank indicated or the offices of the Board of Governors, Ann E. Misback, Secretary of the Board, 20th Street and Constitution Avenue NW, Washington DC 20551-0001, not later than November 25, 2022.
1.
Board of Governors of the Federal Reserve System.
November 18, 2022 at 10:00 a.m.
Telephonic. Dial-in (listen only) information: Number: 1-202-599-1426, Code: 544 104 083#; or via web:
Kimberly Weaver, Director, Office of External Affairs, (202) 942-1640.
Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).
Notice.
Under the provisions of the Paperwork Reduction Act, the
Submit comments on or before December 9, 2022.
Written comments and recommendations for this information collection should be sent within 30 days of publication of this notice to
Additionally, submit a copy to GSA through
Marissa Ryba, Procurement Analyst, at telephone 314-586-1280, or
9000-0032, Contractor Use of Interagency Fleet Management System Vehicles.
This clearance covers the information that contractors must submit to comply with the following FAR requirements:
FAR 51.202—For the contracting officer to authorize a contractor's use of Interagency Fleet Management System (IFMS) vehicles, this FAR section requires contractors to submit the following information:
(1) A written statement that the contractor will assume, without the right of reimbursement from the Government, the cost or expense of any use of the IFMS vehicles and services not related to the performance of the contract;
(2) Evidence that the contractor has obtained motor vehicle liability insurance covering bodily injury and property damage, with limits of liability as required or approved by the agency, protecting the contractor and the Government against third-party claims arising from the ownership, maintenance, or use of an IFMS vehicle; and
(3) Any recommendations.
FAR 51.203—Once authorized by the contracting officer, this FAR section requires contractors to submit their request for IFMS vehicles and related services in writing to the appropriate GSA point of contact and include the following information:
(1) Two copies of the agency authorization;
(2) The number of vehicles and related services required and period of use;
(3) A list of employees who are authorized to request the vehicles or related services;
(4) A listing of equipment authorized to be serviced; and
(5) Billing instructions and address.
The contracting officer will use the information to determine the contractor's eligibility to obtain IFMS vehicles and related services, and to authorize this use. The GSA will also use this information to determine whether appropriate authorization has been granted by the contracting officer.
A 60-day notice was published in the
General Services Administration (GSA).
Notice of a new system of records.
The purpose of the system of records is to maintain personal contact information of government employees in order to ship home office equipment.
This system of records will go into effect without further notice on December 9, 2022 unless otherwise revised pursuant to comments received.
You may submit comments by any of the following methods:
•
•
Richard Speidel, Chief Privacy Officer, GSA, by email at
The General Services Administration seeks to establish a new system of records for the GSA Advantage! program. GSA Advantage! is an online shopping and ordering system used by government agencies to purchase goods and services. GSA seeks to use GSA Advantage! As a medium for government employees to order home office equipment. This system of records will securely manage users' personal contact information to facilitate shipping this equipment directly to federal employees' personal mailing addresses.
GSA Advantage!—GSA/ADV-1.
Unclassified.
The General Services Administration (GSA) Federal Acquisition Service (FAS) is the owner of the system. The system is hosted, operated, and maintained by GSA staff and contractors. Records are maintained in an electronic form on servers housed at government facilities within the United States. Contact the system manager for additional information.
Director, eCommerce Division GSA IT, Office of Acquisition IT Services, 1800 F St. NW, Washington, DC 20405.
E-Government Act of 2002, Public Law 107-347 Sec. 204 (44 U.S.C. 3501 note); 40 U.S.C. 501; Public Law 104-52 Sec 620; 40 U.S.C. 587(c)(3).
GSA Advantage! is the government's online electronic shopping and ordering system. The purpose for the GSA Advantage! Program collecting Personally Identifiable Information (PII) is to allow the purchase and shipment of home office equipment directly to federal employees.
Individuals covered by the system are federal employees.
The system contains information related to the purchase and shipment of home office equipment through the GSA Advantage! platform. Data elements include the covered individual's:
• full name;
• email address;
• phone number; and
• home address.
Information is obtained from covered individuals ordering home office equipment.
In addition to those disclosures generally permitted under
a. To the on-line ordering fulfillment contractor to allow for the confirmation by email of orders received, fulfilled and closed.
b. To shipping contractors or government agencies responsible for mailing services to ship the equipment to employees.
c. To an expert, consultant, or other contractor of GSA in the performance of a federal duty to which the information is relevant.
d. To an appropriate federal, state, tribal, local, international, or foreign law enforcement agency or other appropriate authority charged with investigating or prosecuting a violation or enforcing or implementing a law, rule, regulation, or order, where a record, either on its face or in conjunction with other information, indicates a violation or potential violation of law, which includes criminal, civil, or regulatory violations.
e. To the Department of Justice (DOJ) or other federal agency conducting litigation or in proceedings before any court, adjudicative or administrative body, when: (a) GSA or any component thereof, or (b) any employee of GSA in his/her official capacity, or (c) any employee of GSA in his/her individual capacity where DOJ or GSA has agreed to represent the employee, or (d) the United States or any agency thereof, is a party to the litigation or has an interest in such litigation, and GSA determines that the records are both relevant and necessary to the litigation.
f. To a court in connection with any litigation or settlement discussions regarding claims by or against GSA, to the extent that GSA determines the disclosure of the information is relevant and necessary to the litigation or discussions.
g. To an appeal, grievance, hearing, or complaints examiner; an equal employment opportunity investigator, arbitrator, or mediator; and an exclusive representative or other person authorized to investigate or settle a grievance, complaint, or appeal filed by an individual who is the subject of the record.
h. To the National Archives and Records Administration (NARA) for records management purposes.
i. To the Office of Personnel Management (OPM), the Office of Management and Budget (OMB), and the Government Accountability Office (GAO) in accordance with their responsibilities for evaluating federal programs.
j. To a Member of Congress or his or her staff on behalf of and at the request of the individual who is the subject of the record.
k. To another federal agency or federal entity, when GSA 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.
l. To appropriate agencies, entities, and persons when (1) GSA suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (2) GSA has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by GSA or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with GSA's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
All records are stored in a secure data center. PII is encrypted in transit, encrypted at rest, and not viewable by other users.
Application administrators can retrieve records by any field search using their administrative login via Multi-Factor authentication (including appropriate background investigation and access approvals). All direct data retrievals are logged for tracking.
System records are retained and disposed of according to GSA records maintenance and disposition schedules, the requirements of the Recovery Board, and the National Archives and Records Administration guidance.
System records are safeguarded in accordance with the requirements of the Privacy Act, the Computer Security Act, and the GSA Advantage! System Security Plan. System roles are assigned with specific permissions to allow or prevent accessing certain information. Records in the system are protected from unauthorized access and misuse through a combination of administrative, technical, and physical security measures. Administrative measures include, but are not limited to, policies that limit system access to individuals within an agency with a legitimate business need, and regular review of security procedures and best practices to enhance security. Technical measures include but are not limited to system design that enforces separation of duties for privileged users including role-based access controls; multi-factor authentication with strong passwords that are frequently changed; FIPS 140-2 compliant database encryption, and FIPS 140-2 compliant encryption in
Requests for access to records should be directed to the system manager. Individuals seeking access to their records in this system of records may submit a request by following the instructions provided in 41 CFR part 105-64.2.
Individuals wishing to contest the content of records about themselves contained in this system of records should contact the system manager at the address above. See 41 CFR part 105-64.4 for full details on what to include in a Privacy Act amendment request.
Individuals seeking notification of any records about themselves contained in this system of records should contact the system manager at the address above. Follow the procedures on accessing records in 41 CFR part 105-64.2 to request such notification.
None.
N/A.
Centers for Medicare & Medicaid Services, Health and Human Services (HHS).
Notice.
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the
Comments must be received by January 9, 2023.
When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways:
1.
2.
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, please access the CMS PRA website by copying and pasting the following web address into your web browser:
William N. Parham at (410) 786-4669.
This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see
Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the
1.
CMS requires that MA and PDP organizations submit a completed PBP and formulary as part of the annual bidding process. During this process, organizations prepare their proposed plan benefit packages for the upcoming contract year and submit them to CMS for review and approval. CMS uses this data to review and approve the benefit packages that the plans will offer to Medicare beneficiaries. This allows CMS to review the benefit packages in a consistent way across all submitted bids during with incredibly tight timeframes. This data is also used to populate data on Medicare Plan Finder,
Administration for Children and Families, HHS.
Notice.
The Administration for Children and Families (ACF) has reorganized the Office of Administration (OA). This reorganization creates a new Office of the Chief Technology Officer (CTO). It will transfer the administration of the Public Assistance Reporting Information System (PARIS) and the coordination of Multi-Program Advance Planning Document (APD) approvals from the Office of Planning, Research, and Evaluation (OPRE) to the new CTO.
Ben Goldhaber, Deputy Assistant Secretary for Administration, Office of Administration, 330 C St. SW, Washington, DC 20201, (202) 795-7790.
This notice amends Part K of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health and Human Services (HHS), Administration for Children and Families (ACF), as follows: Chapter KP, Office of the Deputy Assistant Secretary for Administration (ODASA), as last amended at 83 FR 43585 through 43586 (July 17, 2020) and Chapter KM, OPRE, as last amended 81 FR 41308 through 41310 (June 24, 2016).
I. Under Chapter KP, Office of the Deputy Assistant Secretary for Administration, delete section KP.10 Organization in its entirety and replace with the following:
KP.10 Organization. The Office of the Deputy Assistant Secretary for Administration is headed by the Deputy Assistant Secretary for Administration (DASA) who reports to the Assistant Secretary for Children and Families. The office is organized as follows:
II. Under Chapter KP, Office of the Deputy Assistant Secretary for Administration, delete section KP.20 Functions in its entirety and replace with the following:
A. The Office of the Deputy Assistant Secretary for Administration (ODASA) directs and coordinates all administrative activities for the Administration for Children and Families (ACF). The DASA serves as ACF's Chief Financial Officer; Chief Grants Management Officer; Federal Manager's Financial Integrity Act (FMFIA) Management Control Officer; Deputy Ethics Counselor; Personnel Security Representative; and Reports Clearance Officer. The DASA serves as the ACF liaison to the Office of the General Counsel and, as appropriate, initiates action in securing resolution of legal matters relating to management of the agency and represents the Assistant Secretary on all administrative litigation matters. The DASA represents the Assistant Secretary in HHS and with other federal agencies and task forces in defining objectives and priorities, and in coordinating activities associated with federal reform initiatives. ODASA provides leadership of assigned ACF special initiatives arising from Departmental, federal, and non-federal directives to improve service delivery to customers. The DASA provides day-to-day executive leadership and direction to the Office of the Deputy Assistant Secretary (ODAS), Office of Grants Policy (OGP), Office of Grants Management (OGM), Office of Diversity Management and Equal Employment Opportunity (ODME), Office of the Chief Information Officer (OCIO), and the Office of Government Contracting Services (OGCS). The ODASA consists of the Associate Deputy Assistant Secretary for Administration, who provides executive leadership and direction to the Office of Transformation, Business, and Management, and the Chief of Staff.
B. The Office of Transformation, Business, and Management (TBM) directs and coordinates administrative activities for ACF and the ODASA, as well as provides leadership of special initiatives to improve service delivery to customers. The Office supports the DASA in fulfilling ACF's Chief Financial Officer and FMFIA Management Control Officer responsibilities and conducts Enterprise Risk Management and Program Integrity activities across ACF. The Office provides cross-cutting services to support ACF's human capital management, including organizational and employee development activities; facility, safety, security, and emergency management activities; and activities to support the DASA's role as Deputy Ethics Counselor. TBM carries out cross-cutting activities to improve ACF service delivery, including business process engineering and data analytics. The Office manages operations for the ODASA, including human capital management, travel management, management operations, and administration and budget functions.
C. The Office of Grants Policy (OGP) provides agency-wide guidance to program and regional office staff on grant related issues, including developing and interpreting grants policy, coordinating strategic grants planning, facilitating policy advisory groups, and ensuring consistent grant program announcements. The Office prepares, coordinates, and disseminates action transmittals, information memoranda, and other policy guidance on grants management issues; provides grants administration technical assistance to ACF staff; and directs and/or coordinates management initiatives to improve financial administration of ACF mandatory and discretionary grant programs. OGP develops and administers grants management training for ACF program and grants staff and administers grants management certification for ACF grants staff. The Office serves as the centralized receipt point for grant applications, performs initial application qualification reviews, provides standard guidance and training to ACF staff on recruiting grant reviewers and conducting grant panel reviews, and oversees logistical support for program-led objective reviews.
D. The Office of Grants Management (OGM), led by the Associate Deputy
E. The Office of Government Contracting Services (OGCS) serves as ACF's centralized contracting office. OGCS analyzes ACF's mission needs to determine how best to utilize procured services to achieve the agency's strategic goals. The Office prepares annual acquisition strategies and specific acquisition plans, conducts market research, prepares documentation, and provides centralized coordination and review to support ACF contract awards. OGCS manages ACF's acquisition certification training programs and serves as the central point of contact for the ACF acquisition workforce. OGCS develops guidance and procedures and ensures compliance with applicable regulations, rules, and policies.
F. The Office of the Chief Technology Officer (CTO) serves to provide leadership and strategic direction on technology and innovation delivery at ACF as well as directly oversees ACF Office of the Chief Information Officer to align ACF's forward-leaning technology with its data and technology services. CTO is comprised of the Digital Service at ACF division, the administration of the PARIS, the coordination of Multi-Program APD approvals, and the ACF OCIO.
Digital Service at ACF works to transform and improve the U.S. human services ecosystem by modernizing information technology systems, improving the design and delivery of human services, and delivering value to the government stakeholders, human service providers, grantees, and consumers of ACF's services.
The mission of OCIO is to obtain, procure, or develop cost effective and efficient information technology (IT) solutions that enable ACF's staff and grantees to successfully fulfill programmatic missions that result in the realization of the ACF vision. The OCIO implements IT strategies, policies, and governance frameworks to improve the efficiency and performance of ACF's IT systems that support ACF business processes in a manner that balances risk and cost with required outcomes, while ensuring compliance with all federal statutes and regulations. OCIO has ACF-wide responsibility for the direction and development of ACF's IT acquisition strategy, planning analysis and approval, management of IT investments both pre-award and post-award, and leadership of key technology initiatives. The OCIO provides oversight and guidance on the use of business process reengineering, performance measurement, and continuous process improvement in the development, operation, and application of information systems and infrastructure. The OCIO manages cross-organizational stakeholder relations to maintain a flexible and adaptive IT posture that supports a resilient risk management approach to IT security and privacy. The OCIO creates policies to provide improved management of information resources and technology to more efficiently and effectively service ACF's internal and external clients and ACF employees. The OCIO will identify the appropriate continuing education for staff in the domain of records management, IT security and privacy, and incident response protocols.
III. Under Chapter KM, OPRE, delete in its entirety and replace with the following: KM.00 MISSION. OPRE is the principal advisor to the Assistant Secretary for Children and Families on improving the effectiveness and efficiency of programs designed to make measurable improvements in the economic and social well-being of children and families. OPRE provides guidance, analysis, technical assistance, and oversight to ACF programs and across programs in the agency on strategic planning aimed at measurable results; performance measurement and management; research and evaluation methodologies; demonstration testing and model development; statistical policy and program analysis; synthesis and dissemination of research, evaluation, and demonstration findings; data science; data governance; data use, re-use, and integration; data ethics; data sharing, privacy, and confidentiality; and application of emerging technologies to improve the effectiveness of programs and service delivery.
OPRE, through the Division of Economic Independence, the Division of Child and Family Development, the Division of Family Strengthening, and the Division of Data and Improvement, oversees and manages the research and evaluation programs under sections 413, 429, 511, 1110, and 2008 of the Social Security Act and section 649 of the Head Start Act, as well as other research, evaluation, data, and improvement activities authorized by Congress and related to ACF programs and the populations they serve. These activities include priority setting and analysis; managing and coordinating major cross-cutting, leading-edge studies, and special initiatives; and collaborating with federal partners, states, communities, foundations, professional organizations, and others to promote the safety, well-being, and development of children, families, and communities; parental responsibility; employment; and economic independence.
OPRE also provides coordination and leadership in implementing the Government Performance and Results Act, Modernization Act, the Paperwork Reduction Act, the Information Quality Act, and the Foundations for Evidence-Based Policymaking Act and provides expert advice on matters related to data use and reuse, privacy and confidentiality, and the sharing of information. The Office coordinates mandated OMB information collection
KM.10 Organization. OPRE is headed by a Deputy Assistant Secretary, who reports to the Assistant Secretary for Children and Families. The Office is organized as follows:
A. The Office of the Deputy Assistant Secretary provides direction and executive leadership to OPRE in administering its responsibilities. It serves as principal advisor to the Assistant Secretary for Children and Families on all matters pertaining to improving the effectiveness and efficiency of ACF programs; strategic planning; performance measurement and management; research, evaluation, statistical, and analysis methods; program and policy evaluation; research and demonstrations; state and local innovations and progress; synthesis and dissemination of research and evaluation findings; supports ACF programs in responsibly managing and using data to improve the effectiveness, equity, and efficiency of human services programs; and application of emerging technologies to improve the effectiveness of programs and service delivery. It represents the Assistant Secretary for Children and Families at various planning, research, evaluation, data, and improvement forums and carries out special Departmental and Administration initiatives.
The Office of the Deputy Assistant Secretary manages the formulation and execution of budgets for OPRE programs; manages correspondence; coordinates the provision of staff development and training; provides support for OPRE's personnel administration, including staffing, employee and labor relations, performance management, and employee recognition; manages OPRE space, facilities, and supplies; and overseas travel, time and attendance, and other administrative functions for OPRE.
B. The Division of Economic Independence, in cooperation with ACF income support programs and others, works with federal counterparts, states, community agencies, and the private sector to understand and overcome barriers to economic independence; promotes parental responsibility; and assists in improving the effectiveness of programs that further economic independence. The Division provides guidance, analysis, technical assistance, and oversight in ACF on strategic planning and performance measurement for economic independence; statistical, policy, and program analysis; surveys, research, and evaluation methodologies; demonstration testing and model development; synthesis and dissemination of research and evaluation findings; and application of emerging technologies to programs that promote employment, parental responsibility, and economic independence.
The Division develops policy-relevant research priorities; conducts, manages, and coordinates major cross-program, leading-edge research, demonstrations, and evaluation studies; manages and conducts statistical, policy, and program analyses on trends in employment, child support payments, and other income supports; and works in partnership with states, communities, and the private sector to promote employment, parental responsibility, and family economic independence. Division staff also provides consultation, coordination, direction, and support for research and evaluation activities related to employment, parental responsibility, and family economic independence across ACF programs.
C. The Division of Child and Family Development, in cooperation with ACF programs and others, works with federal counterparts, states, community agencies, and the private sector to improve the effectiveness and efficiency of programs and foster safety and sound growth and development of children and their families. The Division provides guidance, analysis, technical assistance, and oversight in ACF on strategic planning and performance measurement for child and family development; statistical, policy, and program analysis; surveys, research, and evaluation methodologies; demonstration testing and model development; synthesis and dissemination of research and evaluation findings; and application of emerging technologies to improve the effectiveness of programs and service delivery. The Division conducts, manages, and coordinates major cross-programs, leading-edge research, demonstration and evaluation studies; develops policy-relevant research priorities; and manages and conducts statistical, policy, and program analyses related to children and families. Division staff also provides consultation, coordination, direction, and support for research and evaluation activities related to children and families across ACF programs.
D. The Division of Family Strengthening, in cooperation with ACF programs and others, works with federal counterparts, states, community agencies, and the private sector to improve the effectiveness and efficiency of programs; fosters the safety, positive growth and development of children, youth, parents, and vulnerable populations; and strengthens families.
The Division provides guidance, analysis, technical assistance, and oversight in ACF on parent, child, youth and family development and dynamics; child safety; statistical, policy and program analysis; surveys, research, and evaluation methodologies; demonstration testing and model development; synthesis and dissemination of research and evaluation findings; and application of emerging technologies to improve the effectiveness of programs and service delivery.
The Division conducts, manages, and coordinates major cross-program, leading-edge research, demonstration, and evaluation studies; develops policy-relevant research priorities; and manages and conducts statistical, policy, and program analyses related to strengthening families. Division staff also provides consultation, coordination, direction, and support for research and evaluation activities related to strengthening families across ACF programs.
E. The Division of Data and Improvement supports ACF programs in responsibly managing and using data to improve the effectiveness, equity, and efficiency of human services programs. The Division works with ACF programs and, in cooperation with ACF programs and others, works with federal counterparts, states, community agencies, and the private sector to improve the effectiveness, efficiency, and equity of programs through improved management and use of data.
Division staff provide guidance, analysis, technical assistance, and oversight on strategic planning and performance measurement; data governance; data ethics; statistical, policy, and program analysis; continuous improvement; surveys, data collection, and analysis methodologies; application of data analyses to program operations and decision-making; application of emerging technologies to improve the effectiveness of programs and service delivery; data sharing,
The Division coordinates and provides consultation, direction, and support for ACF data governance activities; conducts demonstrations and develops tools, policies, and procedures that support the increased accessibility and reuse of administrative and survey data for statistical purposes; conducts, manages, and coordinates major cross-program, leading-edge research, demonstration, and evaluation studies related to responsible data management and use; develops policy-relevant priorities for data collection and analysis; manages and conducts statistical, policy, and program analyses; and provides consultation, coordination, direction, and support for research and evaluation activities related to responsible data management and use. The Division provides leadership and guidance to interagency work groups in these areas for the Department.
IV. Continuation of Policy. Except as inconsistent with this reorganization, all statements of policy and interpretations with respect to organizational components affected by this notice within ACF, heretofore issued and in effect on this date of this reorganization are continued in full force and effect.
V. Delegation of Authority. All delegations and redelegations of authority made to officials and employees of affected organizational components will continue in them or their successors pending further redelegations, provided they are consistent with this reorganization.
VI. Funds, Personnel, and Equipment. Transfer of organizations and functions affected by this reorganization shall be accompanied in each instance by direct and support funds, positions, personnel, records, equipment, supplies, and other resources.
This reorganization will be effective upon date of signature.
Food and Drug Administration, HHS.
Notice.
The meeting of the Oncologic Drugs Advisory Committee scheduled for November 22, 2022, is canceled. This meeting was announced in the
Joyce Frimpong, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-7973,
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for XCOPRI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Anyone with knowledge that any of the dates as published (see the
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biologic product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product, XCOPRI (cenobamate) indicated for treatment of partial-onset seizures in adult patients. Subsequent to this approval, the USPTO received a patent term restoration application for XCOPRI (U.S. Patent No. 7,598,279) from SK Biopharmaceuticals Co., Ltd., and the USPTO requested FDA's assistance in determining the patent's eligibility for patent term restoration. In a letter dated April 5, 2021, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of XCOPRI represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for XCOPRI is 5,326 days. Of this time, 4,850 days occurred during the testing phase of the regulatory review period, while 476 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 5 years of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TISSUEBLUE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Anyone with knowledge that any of the dates as published (see
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biologic product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical
FDA has approved for marketing the human drug product TISSUEBLUE (Brilliant blue G Ophthalmic Solution). TISSUEBLUE is a disclosing agent indicated to selectively stain the internal limiting membrane. Subsequent to this approval, the USPTO received a patent term restoration application for TISSUEBLUE (U.S. Patent No. 7,731,941) from Kyushu University, National University Corporation, and the USPTO requested FDA's assistance in determining the patent's eligibility for patent term restoration. In a letter dated June 8, 2021, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of TISSUEBLUE represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for TISSUEBLUE is 4,631 days. Of this time, 4,395 days occurred during the testing phase of the regulatory review period, while 236 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,375 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for NEXLETOL and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Anyone with knowledge that any of the dates as published (see
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biologic product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product, NEXLETOL (bempedoic acid). NEXLETOL is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C. Subsequent to this approval, the USPTO received a patent term restoration application for NEXLETOL (U.S. Patent No. 7,335,799) from Esperion Therapeutics, Inc., and the USPTO requested FDA's assistance in determining the patent's eligibility for patent term restoration. In a letter dated December 14, 2020, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of NEXLETOL represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for NEXLETOL is 3,774 days. Of this time, 3,408 days occurred during the testing phase of the regulatory review period, while 366 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Sameness Evaluations in an ANDA—Active Ingredients.” This guidance is intended to assist applicants preparing an abbreviated new drug application (ANDA) by providing recommendations on demonstrating sameness between the active ingredient in a proposed generic drug product and its reference listed drug (RLD).
Submit either electronic or written comments on the draft guidance by January 9, 2023 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
You may submit comments on any guidance at any time as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Susan Levine, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1674, Silver Spring, MD 20993-0002, 240-402-7936.
FDA is announcing the availability of a draft guidance for industry entitled “Sameness Evaluations in an ANDA—Active Ingredients.” This guidance is intended to assist applicants preparing an ANDA by providing recommendations on demonstrating sameness between the active ingredient in a proposed generic drug product and its RLD as required under section 505(j)(2)(ii) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)(2)(ii)) and FDA's regulations at 21 CFR 314.94(a)(3)(i).
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (Hatch-Waxman Amendments) created an approval pathway for generic drug products under which applicants can submit an ANDA under section 505(j) of the FD&C Act. An ANDA relies on the Agency's previous finding of safety and effectiveness for an RLD and, as a result, may be approved without submission of the same type and extent of information that is required for approval of a new drug application to establish the safety and effectiveness of the proposed product. Among other things, an ANDA must contain information to show that the active ingredient of the proposed generic drug product is the “same as” that of the RLD (21 U.S.C. 355(j)(2)(A)(ii); 21 CFR 314.94(a)(5)). FDA may not approve an ANDA unless the ANDA contains sufficient information to show that, among other things, the active ingredient is the same as that of the reference listed drug (21 CFR 314.127(a)(3)). Accordingly, the ANDA applicant is responsible for providing sufficient information to demonstrate that the proposed generic drug product is the “same as” the RLD with respect to the active ingredient. To assist prospective applicants in evaluating and demonstrating sameness, this guidance provides information on active ingredient sameness considerations.
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 “Sameness Evaluations in an ANDA—Active Ingredients.” 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
Persons with access to the internet may obtain the draft guidance at
Health Resources and Services Administration (HRSA), Department of Health and Human Services.
Notice.
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Comments on this ICR should be received no later than January 9, 2023.
Submit your comments to
To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email
When submitting comments or requesting information, please include the information request collection title for reference.
All 50 states, the District of Columbia, Puerto Rico, Guam, the U.S. Virgin Islands, and the five U.S. Pacific Territories or Associated Jurisdictions receive RWHAP Part B grant awards, including funds for RWHAP ADAP. RWHAP Part B reporting requirements include the annual submission of an ADAP Data Report (ADR), including a Recipient Report and a Client Report. The Recipient Report is a collection of basic information about grant recipient characteristics and policies including program administration, purchasing mechanisms, funding, and expenditures. The Client Report is a collection of client-level records (one record for each client enrolled in the RWHAP ADAP), which includes the client's encrypted unique identifier, basic demographic data, enrollment information, services received, and clinical data.
HRSA is proposing two revisions and one re-installment of questions to the ADR Recipient and Client Reports to
• Replacement of the Recertification Date variable with the Last Date of Eligibility Confirmation will remove the previous 6-month recertification requirement, which is no longer required by policy,
• Reinstate a question that was inadvertently removed from the 2021 ADR that is needed to assess the quality of medication data; and
• Change the DUNS number variable to Unique Entity Identifier. On April 4, 2022, the federal government stopped using DUNs numbers, making it less burdensome for entities to do business with the federal government. As a result, Recipients no longer have to report the DUNs number in the ADR.
HRSA does not anticipate these proposed revisions resulting in a change in the reporting burden. New and revised data elements require reporting of information that should already be collected by recipients to meet legislative or programmatic requirements for the proper oversight and administration of the program.
HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
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 on Alcohol Abuse and Alcoholism.
The meeting will be held as a virtual meeting and is open to the public as indicated below. Individuals who plan to view the virtual meeting and need special assistance or other reasonable accommodations to view the meeting, should notify the Contact Person listed below in advance of the meeting. The open session will be videocast and can be accessed from the NIH Videocasting and Podcasting website (
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 intramural programs and projects as well as the grant applications and/or contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with intramural programs and projects as well as the grant applications and/or contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when
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 meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(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 meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Advisory Council on Alcohol Abuse and Alcoholism.
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 meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting.
U.S. Citizenship and Immigration Services, Department of Homeland Security.
60-Day notice.
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) invites the general public and other Federal agencies to comment upon this proposed extension of a currently approved collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the
Comments are encouraged and will be accepted for 60 days until January 9, 2023.
All submissions received must include the OMB Control Number 1615-0121 in the body of the letter, the agency name and Docket ID USCIS-2007-0037. Submit comments via the Federal eRulemaking Portal website at
USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Chief, telephone number (240) 721-3000 (This is not a toll-free number. Comments are not accepted via telephone message). Please note contact information provided here is solely for questions regarding this notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS website at
You may access the information collection instrument with instructions or additional information by visiting the Federal eRulemaking Portal site at:
Written comments and suggestions from the public and affected agencies should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
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U.S. Citizenship and Immigration Services, Department of Homeland Security.
60-Day notice.
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) invites the general public and other Federal agencies to comment upon this proposed extension of a currently approved collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the
Comments are encouraged and will be accepted for 60 days until January 9, 2023.
All submissions received must include the OMB Control Number 1615-0126 in the body of the letter, the agency name and Docket ID USCIS-2012-0004. Submit comments via the Federal eRulemaking Portal website at
USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Chief, telephone number (240) 721-3000 (This is not a toll-free number. Comments are not accepted via telephone message). Please note contact information provided here is solely for questions regarding this notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS website at
You may access the information collection instrument with instructions or additional information by visiting the Federal eRulemaking Portal site at:
Written comments and suggestions from the public and affected agencies should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
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Office of the Secretary, U.S. Department of Housing and Urban Development (HUD).
Notice.
In accordance with the Build America, Buy America Act (“BABA” or “the Act”) this notice advises that HUD is proposing a public interest waiver to further HUD's phased implementation of the Buy America Domestic Content Procurement Preference (“Buy America Preference,” or “BAP”) for recipients of Federal Financial Assistance (“FFA”) provided by HUD. On May 5, 2022, HUD previously issued a separate waiver covering all FFA obligated by HUD on or before November 14, 2022, including Community Development Block Grant (“CDBG”) formula grants. In order to fully focus on the successful implementation of the BAP in CDBG formula grants, one of HUD's largest grant programs, HUD has determined that it is in the public interest to propose a new public interest waiver of the application of the BAP for all other FFA provided by HUD. HUD is proposing that this waiver cover all FFA obligated by HUD during the ninety (90) day period after its effective date except for those funds utilized in connection with the purchase of iron or steel products in infrastructure projects funded by CDBG formula grants obligated by HUD on or after November 15, 2022. In addition, in the case of FFA obligated by HUD on or after November 15, 2022, but prior to the effective date of the final waiver, the waiver will apply to all expenditures incurred on or after the date of the final waiver, except for those funds utilized in connection with the purchase of iron or steel products in infrastructure projects funded by CDBG formula grants obligated by HUD on or after November 15, 2022. HUD is also, through this waiver, soliciting specific comment on the further phased implementation of the BAP in connection with the iron and steel products used in other non-CDBG formula grant FFA provided by HUD and in the full implementation of the BAP in connection with the use of construction materials and manufactured products in all infrastructure projects across HUD's FFA programs.
HUD published this proposed waiver on its website on November 3, 2022. Comments on the waiver proposed in this document are due on or before November 17, 2022. HUD will consider comments received and announce any subsequent changes to this waiver through a subsequent notice. If issued, the waiver would be applicable to awards that are obligated on the effective date of the waiver and eighty-nine (89) days thereafter for a total of ninety (90) days.
Interested persons are invited to submit comments on this public interest, general applicability waiver. Copies of all comments submitted are available for inspection and downloading at
To receive consideration as public comments, comments must be submitted through one of two methods, specified below. All submissions must refer to the above docket number and title.
1.
HUD strongly encourages commenters to submit comments electronically. Electronic submission of comments allows the commenter maximum time to prepare and submit a comment, ensures timely receipt by HUD, and enables HUD to make them immediately available to the public. Comments submitted electronically through the
2.
No Facsimile Comments. Facsimile (FAX) comments will not be accepted.
3.
Joseph Carlile, Department of Housing and Urban Development, 451 Seventh Street SW, Room 10226, Washington, DC 20410-5000, at (202) 402-7082 (this is not a toll-free number). HUD welcomes and is prepared to receive calls from individuals who are deaf or hard of hearing, as well as individuals with speech and communication disabilities. To learn more about how to make an accessible telephone call, please visit
The Build America, Buy America Act (“BABA” or “the Act”) was enacted on November 15, 2021, as part of the Infrastructure Investment and Jobs Act (“IIJA”) (Pub. L. 117-58). The Act establishes a domestic content procurement preference, the BAP, for Federal infrastructure programs. Section 70914(a) of the Act establishes that no later than 180 days after the date of enactment, HUD must ensure that none of the funds made available for infrastructure projects may be obligated by the Department unless it has taken steps to ensure that the iron, steel, manufactured products, and construction materials used in a project are produced in the United States. In section 70912, the Act further defines a project to include “the construction, alteration, maintenance, or repair of infrastructure in the United States” and includes within the definition of infrastructure those items traditionally included along with buildings and real property. Thus, beginning May 14, 2022, new awards of FFA by HUD through a program for infrastructure, and any of those newly obligated funds then obligated by the grantee, are covered under BABA provisions of the Act, 41 U.S.C. 8301 note, unless covered by a waiver.
Since the enactment of the Act, HUD has worked diligently to implement the BAP. Consistent with the requirements
Following the expiration of the “General Applicability Waiver of Build America, Buy America Provisions as Applied to Recipients of HUD Federal Financial Assistance” (87 FR 26219), HUD will fully implement the BAP for purposes of the purchase of iron and steel products used in infrastructure projects funded with Federal Financial Assistance provided by HUD through its CDBG formula grants obligated by HUD on or after November 15, 2022. Additional details on HUD's implementation of the BABA requirements can be found at
Under section 70914(b), HUD and other Federal agencies have authority to waive the application of a domestic content procurement preference when (1) application of the preference would be contrary to the public interest, (2) the materials and products subject to the preference are not produced in the United States at a sufficient and reasonably available quantity or satisfactory quality, or (3) inclusion of domestically produced materials and products would increase the cost of the overall project by more than 25 percent. Section 70914(c) provides that a waiver under 70914(b) must be published by the agency with a detailed written explanation for the proposed determination and provide a public comment period of not less than 15 days.
The Office of Management and Budget's April 18, 2022 memorandum, “Initial Implementation Guidance on Application of Buy America Preference in Federal Financial Assistance Programs for Infrastructure” (M-22-11),
In Fiscal Year 2022, HUD grantees will receive more than $15 billion through the Department's programs where infrastructure is an eligible activity that may be subject to the BAP. For example, Community Development Block Grant (“CDBG”) funds may be used for infrastructure projects (
As HUD's previous Notices advised and as supported by several comments received during the comment period, many of HUD's programs may be subject to the BAP and have previously not required compliance with similar Buy America preferences. Because the potential application of BAP mandated by the Act is new to the majority of HUD's programs and Federal Financial Assistance (“FAA”), HUD is choosing to implement the BAP first with respect to all iron and steel products used in infrastructure projects funded with FFA provided by HUD through its CDBG formula grants on or after November 15, 2022. In order to focus on this implementation, HUD is proposing to waive the application of the BAP in connection with all other FAA. This will provide an additional limited period to allow for further consideration of the most efficient methods of implementation of the BAP across the remaining HUD programs for construction materials and manufactured products more generally. This waiver advances BABA by reducing the administrative burden to potential assistance recipients where the costs of uncertainty in compliance with BABA could distract from the focus on the efficient and effective implementation of BABA in one of HUD's largest FFA programs and allows for broader phased implementation once further clarity and guidance on the implementation is received. Failure to provide recipients such flexibilities could delay the award for infrastructure projects as grantees and funding recipients must exert considerable effort in accounting for the sourcing for miscellaneous, low-cost construction materials without the benefit of complete guidance on the Act's requirements.
HUD believes that better coordination with HUD FAA recipients in the implementation of BABA will avoid unnecessary and undue hardship. Such a waiver will allow grantees and funding recipients to focus their efforts on such critical projects. Proposing this waiver is not an alternative to increasing domestic production. Rather this waiver will allow HUD to focus (particularly in the early phases of BABA implementation) on key products and critical supply chains where increased U.S. manufacturing can best advance our economic and national security. This waiver will also allow grantees and funding recipients to continue with projects in connection with iron and steel products where Made in America requirements have long been contemplated—providing greater ease of implementation for HUD's CDBG formula grantees. Without this waiver, HUD grantee and funding recipient participation could be impacted, such as modification of current plans.
As HUD's previous Notice advised and as supported by several comments received during the comment period, many of the HUD's programs that may be subject to the BAP and have previously not required compliance with similar Buy America preferences. Because the potential application of BAP mandated by the Act is new to the
No funds obligated by HUD or the grantee/funding recipient during the period of the waiver that would be exempted from compliance with BAP as a result of the waiver will be required to apply the BAP.
No funds that have been obligated by HUD before November 14, 2022, or during the pendency of this waiver will require compliance with the BAP, with the exception of iron and steel products used in connection with infrastructure projects funded through CDBG formula grants obligated by HUD on or after November 15, 2022, or unless otherwise required by another FFA award. Where the BAP or other BABA requirements are made applicable to a project of a grantee or funding recipient by another Federal agency, those requirements are not waived by this waiver, nor is the grantee or funding recipient exempt from the application of those requirements in accordance with the requirements of the Federal Agency providing such Federal Financial Assistance.
Under OMB Memorandum M-22-11, “Memorandum for Heads of Executive Departments and Agencies,” published on April 18, 2022, agencies are expected to assess “whether a significant portion of any cost advantage of a foreign-sourced product is the result of the use of dumped steel, iron, or manufactured products or the use of injuriously subsidized steel, iron, or manufactured products” as appropriate before granting a public interest waiver.
As required under section 70914 of the Act, HUD is soliciting comment from the public on the waiver announced in this Notice. In particular, HUD invites comments on the waiver of application of the BAP for iron and steel products in connection with infrastructure projects funded through HUD's FFA programs other than CDBG formula grants. HUD also seeks specific comment on how it may best further phase in the application of the BAP for all construction materials and manufactured products in connection with CDBG formula grants and all other HUD FFA programs. HUD invites comments on what time period would be appropriate for purposes of achieving these various phases of orderly implementation of the Act.
Bureau of Indian Affairs, Interior.
Notice.
This notice announces the extension of the Class III gaming compact between the Rosebud Sioux Tribe of the Rosebud Indian Reservation and the State of South Dakota.
The extension takes effect on November 9, 2022.
Ms. Paula L. Hart, Director, Office of Indian Gaming, Office of the Assistant Secretary—Indian Affairs, Washington, DC 20240, (202) 219-4066.
An extension to an existing Tribal-State Class III gaming compact does not require approval by the Secretary if the extension does not modify any other terms of the compact. 25 CFR 293.5. The Rosebud Sioux Tribe of the Rosebud Indian Reservation and the State of South Dakota have signed an agreement to extend the expiration date of their existing Tribal-State Class III gaming compact to April 12, 2023. This publication provides notice of the new expiration date of the compact.
Office of the Secretary, Office of Acquisition and Property Management, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the Office of the Secretary, Office of Budget, are proposing to renew an information collection.
Interested persons are invited to submit comments on or before December 9, 2022.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
To request additional information about this ICR, contact Laura Walters, Quarters Rental Program Manager, Interior Business Center, 7301 W Mansfield Ave., MS D-2910, Denver, CO 80235, or fax 303-969-6336, or by email to
In accordance with the Paperwork Reduction Act of 1995 (PRA, 44 U.S.C. 3501
A
As part of our continuing effort to reduce paperwork and respondent burdens, we are again soliciting comments from the public and other Federal agencies on the proposed ICR that is described below. We are especially interested in public comment addressing the following:
(1) Whether or not the collection of information is necessary for the proper performance of the functions of the agency, including whether or not the information will have practical utility;
(2) The accuracy of our estimate of the burden for this collection of information, including the validity of the methodology and assumptions used;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) How might the agency minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Comments that you submit in response to this notice are a matter of public record. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
Respondents are typically property management companies or significant property owners in specific communities and are contacted by email or telephone. They may provide the rental unit information requested in OS-2000 and OS-2001 verbally, update rental data collected during a previous survey, enhance/complete rental data gathered from published sources, or provide lists of rental units they manage.
This collection of information provides data that is essential for DOI and the other Federal agencies to manage GFH in accordance with the requirements of OMB Circular A-45 (Revised). If this information were not collected from the public, DOI and the other Federal agencies providing GFH would be required to use professional real estate appraisals of private market rental costs, again, in accordance with OMB Circular A-45, but at an increased cost to the taxpayer.
An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Bureau of Land Management, Interior.
Notice of availability; request for public comment.
In accordance with the National Environmental Policy Act of 1969, as amended (NEPA), and the Federal Land Policy and Management Act of 1976, as amended, the Bureau of Land Management (BLM) has prepared a Draft Resource Management Plan (RMP) Amendment and Environmental Assessment (EA) for the 1995 Florida RMP for the Jupiter Inlet Lighthouse Outstanding Natural Area (ONA). This notice announces a 60-day comment period on the Draft RMP Amendment, EA, unsigned finding of no significant impact (FONSI), and the BLM's proposed area of critical environmental concern (ACEC).
Your comments on the Draft RMP Amendment and EA must be received by the BLM by January 9, 2023 or 15 calendar days after the last public meeting, whichever is later.
Your comments on the BLM's proposed ACEC must be received by the BLM by January 9, 2023.
The BLM will be holding two public meetings on the following dates at the following locations:
• November 29, 2022 6 p.m. EST, Virtual via Zoom. Registration is required. To register in advance for this webinar, visit:
• December 15, 2022 6 p.m. EST, Virtual via Zoom. Registration is required. To register in advance for this webinar, visit:
The Draft RMP Amendment and EA, including information about the proposed ACEC, are available for review on the BLM ePlanning project website at
Written comments related to the Draft RMP Amendment, EA or ACEC proposal for the 1995 Florida RMP may be submitted by any of the following methods:
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Documents pertinent to this proposal may be examined at the Jupiter Inlet Lighthouse Outstanding Natural Area.
Peter DeWitt, Program Manager; telephone: (561) 295-5955; address: Jupiter Inlet Lighthouse Outstanding Natural Area, Bureau of Land Management, 600 State Road 707, Unit B, Jupiter, Florida 33469; email:
This document provides notice that the BLM Eastern States State Director has prepared a Draft RMP Amendment and EA and is announcing the comment period on the Draft RMP Amendment and EA, including BLM's proposed ACEC. The RMP amendment would change the existing 1995 Florida RMP.
The planning area is located in Palm Beach County, Florida, and encompasses approximately 126 acres of public land.
The BLM has prepared the Draft RMP Amendment for the Jupiter Inlet Lighthouse ONA and associated EA to evaluate management strategies for resources, resource uses, and special designations within the Jupiter Inlet Lighthouse ONA. The Draft Florida RMP Amendment for the Jupiter Inlet Lighthouse ONA will determine management for approximately 120 acres of BLM-administered surface land (Lots 15, 17, 19, and 22); lands expected to be returned to the BLM when the United States Coast Guard relinquishes its withdrawal (Lots 16 and 21); land patented to the Town of Jupiter that, if ever returned, would fall under the jurisdiction of the BLM (Lot 20); and a 1.08-acre easement granted to the BLM by the State of Florida.
The BLM, as directed by the Consolidated Natural Resources Act of 2008 (CNRA), manages the ONA in coordination with local partners to protect, preserve, and enhance the unique and nationally important historical, natural, cultural, scientific, educational, scenic, and recreational values at the ONA, with an emphasis on restoring native ecological systems. Issues considered in the Draft Florida RMP Amendment and EA are conserving and protecting ONA resources and objects or values including special status species, native ecosystems, visual and scenic values; maintaining ONA values and settings; and managing for sustainable recreation, visitor growth, and visitor enjoyment. The Draft Florida RMP Amendment and EA also considers decisions regarding a special recreation management area (SRMA) and associated recreation management zones (RMZs), land use authorizations, and an ACEC.
The formal public scoping process for the Draft Florida RMP Amendment and EA began January 21, 2022, with the publication of a Notice of Intent in the
The BLM is seeking to amend the 1995 Florida RMP to provide guidance for the legislatively mandated uses and protections of the Jupiter Inlet Lighthouse ONA. The need for the amendment is to update special designations and provide land use planning-level direction for recreation programs and land within the ONA that the BLM acquired after designation that reflects the evolving long-term management needs for protection, conservation, and enhancement of the unique and nationally important values of the site consistent with the ONA's designating language (CNRA) and Resource Management Planning regulations at 43 CFR 1610. The purpose of the amendment is to establish management direction for BLM-administered land and resources, as described below.
The BLM has analyzed three alternatives in detail, including the No Action Alternative (Alternative A) and two action alternatives (Alternatives B and C). Alternative A continues existing management in the planning area, as reflected in decisions from the 1995 Florida RMP. However, Alternative A does not reflect management direction in the CNRA and does not include decisions for all areas that are currently managed by the BLM. Under Alternative A, Lot 15 would remain designated as the Jupiter Inlet tract ACEC (51.1 acres) and Lots 15 and 20 would be available for conveyance under the Recreation and Public Purposes Act or available for cooperative management with other government and/or private organizations. Alternative B focuses on updating the management objective to include conservation and consideration of the seven core resources and values for which the ONA was designated. In addition, Alternative B would remove the ACEC designation from Lot 15, designate an SRMA and associated RMZs, allow lands acquired to be managed in the same way as adjacent lands, manage temporary land use authorizations, and disallow long-term leasing of the site. Alternative C would expand the Jupiter Inlet tract ACEC to 87.5 acres, limit temporary land use authorizations, and allow long-term leasing. Similar to Alternative B, Alternative C would also set a management objective to include conservation and consideration of the seven core resources and values for which the ONA was designated and designate an SRMA and associated RMZs. The BLM did not identify any additional alternatives needing consideration.
The State Director has identified Alternative B as the preferred alternative. Alternative B was found to best meet the State Director's planning guidance and, therefore, was selected as the preferred alternative because it provides a balanced management approach that meets the intent of the CNRA by addressing public access, recreation, and visitor services, while providing equitable opportunities for the appropriate use of the ONA. In addition, an ACEC designation is not necessary or appropriate because management attention provided under the congressional designation is adequate to protect the resources and values.
The preferred alternative would not propose the following potential ACECs for designation:
• the existing Jupiter Inlet tract ACEC in Lot 15 (51.1 acres)
• the expanded Jupiter Inlet tract ACEC to encompass Lots 15, 16, 17, and 19 (87.5 acres).
Comments may be submitted using any of the methods listed in the
The BLM will provide additional opportunities for public participation consistent with the NEPA and land use planning processes, including a 30-day public protest period and a 60-day Governor's consistency review on the Proposed RMP Amendment. The Proposed RMP Amendment and EA is anticipated to be available for public protest in March 2023 with an Approved RMP Amendment and Decision Record in June 2023.
See the
The BLM will continue to consult with Indian Tribal Nations on a government-to-government basis in accordance with Executive Order 13175, BLM MS 1780, and other Departmental policies. Tribal concerns, including impacts on Indian trust assets and potential impacts to cultural resources, will be given due consideration. Consultation will continue on an individual basis with interested Tribal Nations.
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.
Bureau of Land Management, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, the Bureau of Land Management (BLM) proposes to renew an information collection.
Interested persons are invited to submit comments on or before January 9, 2023.
Send your written comments on this information collection request (ICR) by mail to Darrin King, Information Collection Clearance Officer, U.S. Department of the Interior, Bureau of Land Management, Attention PRA Office, 440 W 200 S #500, Salt Lake City, UT 84101; or by email to
To request additional information about this ICR, contact Sabry Hanna by email at
In accordance with the Paperwork Reduction Act of 1995 (PRA, 44 U.S.C. 3501
As part of our continuing effort to reduce paperwork and respondent burdens, we invite the public and other Federal agencies to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.
We are especially interested in public comment addressing the following:
(1) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) The accuracy of 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 the agency might 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,
Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
An agency may not conduct or sponsor and, notwithstanding any other provision of law, a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
United States International Trade Commission.
November 17, 2022 at 9:30 a.m.
Room 101, 500 E Street SW, Washington, DC 20436, Telephone: (202) 205-2000.
Open to the public.
1. Agendas for future meetings: none.
2. Minutes.
3. Ratification List.
4. Commission vote on Inv. No. 731-TA-1594 (Final)(Superabsorbent Polymers from South Korea). The Commission currently is scheduled to complete and file its determination and views of the Commission on December 5, 2022.
5. Outstanding action jackets: none.
William Bishop, Supervisory Hearings and Information Officer, 202-205-2595.
The Commission is holding the meeting under the Government in the Sunshine Act, 5 U.S.C. 552(b). In accordance with Commission policy, subject matter listed above, not disposed of at the scheduled meeting, may be carried over to the agenda of the following meeting.
By order of the Commission.
Notice is hereby given that, on August 4, 2022, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Also, Medalynx, Thousand Oaks, CA; and Molecular Quantum Solutions, Søborg, DENMARK; have withdrawn as parties to this venture.
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and Pistoia Alliance, Inc. intends to file additional written notifications disclosing all changes in membership.
On May 28, 2009, Pistoia Alliance, Inc. filed its original notification pursuant to section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on May 16, 2022. A notice was published in the
Bureau of Labor Statistics, Department of Labor.
Notice of information collection; request for comment.
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. The Bureau of Labor Statistics (BLS) is soliciting comments concerning the proposed revision of the “Report on Occupational Employment and Wages.” A copy of the proposed information collection request can be obtained by contacting the individual listed below in the Addresses section of this notice.
Written comments must be submitted to the office listed in the Addresses section of this notice on or before January 9, 2023.
Send comments to Carol Rowan, BLS Clearance Officer, Division of Management Systems, Bureau of Labor Statistics, Room G225, 2 Massachusetts Avenue NE, Washington, DC 20212. Written comments also may be transmitted by email to
Carol Rowan, BLS Clearance Officer, at 202-691-7628 (this is not a toll free number). (See
The Occupational Employment and Wage Statistics (OEWS) survey is a Federal/State establishment survey of wage and salary workers designed to produce data on current detailed occupational employment and wages for each Metropolitan Statistical Area and Metropolitan Division as well as by detailed industry classification. OEWS survey data assist in the development of employment and training programs established by the Perkins Vocational Education Act and the Wagner-Peyser Act.
The OEWS program operates a periodic mail survey of a sample of non-farm establishments conducted by all fifty States, the District of Columbia, Guam, Puerto Rico, and the U.S. Virgin Islands. Over three-year periods, data on occupational employment and wages are collected by industry at the four- and five-digit North American Industry Classification System (NAICS) levels. The Department of Labor uses OES data in the administration of the Foreign Labor Certification process under the Immigration Act of 1990.
Office of Management and Budget clearance is being sought for the OEWS program. Occupational employment data obtained by the OEWS survey are used to develop information regarding current and projected employment needs and job opportunities. These data assist in the development of State vocational education plans. OEWS wage data provide a significant source of information to support a number of different Federal, State, and local efforts.
With the release of the May 2021 OEWS estimates in March 2022, the OEWS program implemented a new model-based estimation methodology (MB3). The MB3 methodology uses modeling to predict the staffing pattern and wages for every non-observed establishment on the OEWS population frame using observed OEWS survey response data along with current data from the Quarterly Census of Employment and Wages program. This differs from the older design-based methodology that used weighting and imputation to make the OEWS response data represent the OEWS population frame. Research and testing indicated the accuracy and reliability of the MB3 estimates improved over the former approach.
As part of an ongoing effort to reduce respondent burden, OEWS has several electronic submission options which are available to respondents. Respondents have the ability to submit data by email, or fillable online forms. In many cases, a respondent can submit existing payroll records and would not need to submit a survey form.
The Bureau of Labor Statistics is particularly interested in comments that:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility.
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used.
• Enhance the quality, utility, and clarity of the information to be collected.
• 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 submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget approval of the information collection request; they also will become a matter of public record.
Occupational Safety and Health Administration (OSHA), Labor.
Request for public comments.
OSHA solicits public comments concerning the proposal to extend the Office of Management and Budget's (OMB) approval of the information collection requirements specified in the Standard for Welding, Cutting, and Brazing.
Comments must be submitted (postmarked, sent, or received) by January 9, 2023.
Seleda Perryman or Theda Kenney, Directorate of Standards and Guidance, OSHA, U.S. Department of Labor; telephone (202) 693-2222.
The Department of Labor, as part of the continuing effort to reduce paperwork and respondent (
The following sections describe who uses the information collected under each requirement, as well as how they use it. The purpose of these requirements is to reduce employees' risk of death or serious injury by ensuring that employment has been tested and is in safe operating condition.
Section 1910.255(e) requires that a periodic inspection of resistance welding equipment be made by qualified maintenance personnel, and that a certification record be generated and maintained. The certification shall include the date of the inspection, the signature of the person who performed the inspection and the serial number, or other identifier, for the equipment inspected. The record shall be made available to an OSHA inspector upon request. The maintenance inspection ensures that welding equipment is in safe operating condition while the maintenance record provides evidence to workers and agency compliance officers that employers performed the required inspections.
OSHA has a particular interest in comments on the following issues:
• Whether the proposed information collection requirements are necessary for the proper performance of the agency's functions to protect workers, including whether the information is useful;
• The accuracy of OSHA's estimate of the burden (time and costs) of the information collection requirements, including the validity of the methodology and assumptions used;
• The quality, utility, and clarity of the information collected; and
• Ways to minimize the burden on employers who must comply; for example, by using automated or other technological information collection, and transmission techniques.
The agency requests an adjustment decrease of 187 burden hours (from 5,806 burden hours to 5,619 burden hours) associated with the collections of information in the Welding, Cutting, and Brazing Standard. This adjustment decrease is a result of a decrease in the number of welders, cutters, solders, and brazers in general industry from 21,770 to 21,070 a difference of 700 welders, cutter, solders, and brazers in the previous package. The agency will summarize any comments submitted in response to this notice and will include this summary in its request to OMB.
OSHA will summarize the comments submitted in response to this notice and will include this summary in the request to OMB to extend the approval of the information collection requirements.
You may submit comments in response to this document as follows: (1) electronically at
Due to security procedures, the use of regular mail may cause a significant delay in the receipt of comments.
Comments and submissions are posted without change at
James S. Frederick, Deputy Assistant Secretary of Labor for Occupational Safety and Health, directed the preparation of this notice. The authority for this notice is the Paperwork Reduction Act of 1995 (44 U.S.C. 3506
Wage and Hour Division, Department of Labor.
Notice.
The Department of Labor (the Department) is soliciting comments concerning a proposed extension of the information collection request titled, “The Family and Medical Leave Act of 1993, as Amended.” This comment request is part of continuing Departmental efforts to reduce paperwork and respondent burden in accordance with the Paperwork Reduction Act of 1995 (PRA). The Department proposes to extend the approval of this existing information collection without change to existing requirements. The PRA program helps ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. A copy of the proposed information request can be obtained by contacting the office listed below in the
Written comments must be submitted to the office listed in the
You may submit comments identified by Control Number 1235-0003, by either one of the following methods:
Amy DeBisschop, Division of Regulations, Legislation, and Interpretation, Wage and Hour Division, U.S. Department of Labor, Room S-3502, 200 Constitution Avenue NW, Washington, DC 20210; telephone: (202) 693-0406 (this is not a toll-free number). Alternative formats are available upon request by calling 1-866-487-9243. If you are deaf, hard of hearing, or have a speech disability, please dial 7-1-1 to access telecommunications relay services.
I.
The Wage Hour Division (WHD) created optional use forms for this information collection. The General Notice (WHD Publication 1420) provides information needed to allow employers to satisfy the general notice requirement. See 825.300(a). The Certification of Health Care Provider for Employee's Serious Health Condition (Form WH-380-E) allows an employee requesting FMLA leave for their own serious health condition to satisfy the statutory requirement to furnish, upon the employer's request, appropriate certification (including a second or third opinion and recertification) to support the need for leave for the employee's own serious health condition. See 825.305(a). The Certification of Health Care Provider for Family Member's Serious Health Condition (Form WH-380-F) allows an employee requesting FMLA leave for a qualifying family member's serious health condition to satisfy the statutory requirement to furnish, upon the employer's request, appropriate certification (including a second or third opinion and recertification) to support the need for leave for the family member's serious health condition. See 825.305(a). Notice of Eligibility & Rights and Responsibilities (Form WH-381) allows an employer to satisfy the regulatory requirement to provide an employee who potentially qualifies to take FMLA leave with a notice of whether the employee is eligible as defined in 825.110, and written notice detailing specific expectations and obligations of the employee and explaining any consequences of a failure to meet these obligations. See 825.300(b) and (c). Designation Notice (Form WH-382) provides a format an employer may use to meet its obligation to designate leave as FMLA leave. See 825.301(a). Certification of Military Family Leave for Qualifying Exigency (Form WH-384) allows an employee requesting FMLA leave based on a qualifying exigency to satisfy the statutory requirement to furnish, upon the employer's request, appropriate certification to support leave for a qualifying exigency. See 825.309. Certification for Serious Injury or Illness of a Current Servicemember for Military Caregiver Leave (Form WH-385) allows an employee requesting FMLA leave based on an active duty covered servicemember's serious injury or illness to satisfy the statutory requirement to furnish, upon the employer's request, a medical certification from an authorized health care provider. See 825.310. Finally, Certification for Serious Injury or Illness of a Veteran for Military Caregiver Leave (Form WH-385-V) allows an employee requesting leave based on a veteran's serious injury or illness to satisfy the statutory requirement to furnish, upon the employer's request, a medical certification from an authorized health care provider. See 825.310.
II.
• 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;
• Enhance the quality, utility, and clarity of the information to be collected;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; and
• Provide information that could help 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,
III.
National Endowment for the Humanities, National Foundation on the Arts and the Humanities.
Notice of meeting.
Pursuant to the Federal Advisory Committee Act, notice is hereby given that the National Council on the Humanities will meet to advise the Chair of the National Endowment for the Humanities (NEH) with respect to policies, programs and procedures for carrying out her functions.
The meeting will be held on Thursday, November 17, 2022, from 10:00 a.m. until 10:50 a.m.
The meeting will be held by videoconference originating at Constitution Center, 400 7th Street SW, Washington, DC 20506.
Elizabeth Voyatzis, Committee Management Officer, 400 7th Street SW, 4th Floor, Washington, DC 20506; (202) 606-8322;
The National Council on the Humanities is meeting pursuant to the National Foundation on the Arts and Humanities Act of 1965 (20 U.S.C. 951-960, as amended). The National Council will convene in executive session by videoconference on November 17, 2022, from 10:00 a.m. to 10:50 a.m.
This meeting of the National Council on the Humanities will be closed to the public pursuant to sections 552b(c)(4), 552b(c)(6), and 552b(c)(9)(B) of Title 5 U.S.C., as amended, because it will include review of personal and/or proprietary financial and commercial information given in confidence to the agency by grant applicants, and discussion of certain information, the premature disclosure of which could significantly frustrate implementation of proposed agency action. 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.
The National Science Board's (NSB) Committee on Science and Engineering Policy hereby gives notice of the scheduling of a teleconference for the transaction of National Science Board business pursuant to the National Science Foundation Act and the Government in the Sunshine Act.
Monday, November 14, 2022, from 12:00 p.m.-12:30 p.m. EST.
Friday, November 18, 2022, from 3:30 p.m.-4:00 p.m. EST.
This meeting will be held by video conference through the National Science Foundation.
Open.
Point of contact for this meeting is: (Chris Blair,
This meeting was noticed on October 28. 2022, at 87 FR 65258.
Friday, November 4, 2022, from 2:00-3:00 p.m. EDT.
This meeting is CANCELLED.
Point of contact for this meeting is: Chris Blair,
Nuclear Regulatory Commission.
Notice of meeting.
The U.S. Nuclear Regulatory Commission (NRC) will convene a meeting of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) on December 5-6, 2022. A sample of agenda items to be discussed during the public session includes: an overview of Y-90 medical events; overview of the review of Lu-177-PSMA for the treatment of adult patients with prostate cancer; review of pre-rulemaking documents for the rulemaking to establish requirements for Rb-82 generators and emerging medical technologies; and overview of the status of rulemaking for regulations for decommissioning financial assurance for sealed and unsealed radioactive materials. The agenda is subject to change. The current agenda and any updates will be available on the ACMUI's Meetings and Related Documents web page at
The ACMUI Chair, Darlene F. Metter, M.D., will preside over the meeting. Dr. Metter will conduct the meeting in a manner that will facilitate the orderly conduct of business. The following procedures apply to public participation in the meeting:
1. Persons who wish to provide a written statement should submit an electronic copy to Ms. Gupta Sarma using the contact information listed above. All submittals must be received by the close of business on November 29, 2022 and must only pertain to the topics on the agenda.
2. Questions and comments from members of the public will be permitted during the meeting, at the discretion of the ACMUI Chair.
3. The draft transcript and meeting summary will be available on ACMUI's website
4. Persons who require special services, such as those for the hearing impaired, should notify Ms. Gupta Sarma of their planned participation.
This meeting will be held in accordance with the Atomic Energy Act of 1954, as amended (primarily Section 161a); the Federal Advisory Committee Act (5 U.S.C. App); and the Commission's regulations in Title 10 of the
For the U.S. Nuclear Regulatory Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
The Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to negotiated service agreement(s). The request(s) may propose the addition or removal of a negotiated service agreement from the Market Dominant or the Competitive product list, or the modification of an existing product currently appearing on the Market Dominant or the Competitive product list.
Section II identifies the docket number(s) associated with each Postal Service request, the title of each Postal Service request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 (Public Representative). Section II also establishes comment deadline(s) pertaining to each request.
The public portions of the Postal Service's request(s) can be accessed via the Commission's website (
The Commission invites comments on whether the Postal Service's request(s) in the captioned docket(s) are consistent with the policies of title 39. For request(s) that the Postal Service states concern Market Dominant product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3622, 39 U.S.C. 3642, 39 CFR part 3030, and 39 CFR part 3040, subpart B. For request(s) that the Postal Service states concern Competitive product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3035, and 39 CFR part 3040, subpart B. Comment deadline(s) for each request appear in section II.
1.
2.
This Notice will be published in the
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The proposed rule change consists of amendments to the Clearing Agency Liquidity Risk Management Framework (“Framework”) of NSCC and its affiliates, The Depository Trust Company (“DTC”) and Fixed Income Clearing Corporation (“FICC,” and together with NSCC and DTC, the
In its filing with the Commission, the clearing agency 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 clearing agency has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Clearing Agencies adopted the Framework
The proposed changes to the Framework would (1) add a new section describing the process by which FICC would designate uncommitted liquidity resources as QLR;
The Clearing Agencies would add a new section to the Framework that pertains specifically to FICC's designation of uncommitted liquidity resources as QLR pursuant to the requirements of Rule 17Ad-22(a)(14)(ii)(B) under the Act.
In addition, and consistent with its existing processes, FICC would consider whether any uncommitted liquidity resources, including those that are designated as QLR, would require a proposed rule change with the Commission pursuant to Section 19(b)(1) of the Act,
The proposed new section would explain that, in order to designate an uncommitted liquidity resource as a QLR, FICC would first identify the properties of each financing arrangement, including the underlying collateral and the liquidity providers. Based on the nature of the liquidity resource, FICC would then determine the nature of the rigorous analysis that is appropriate for that resource and would conduct that analysis at least annually.
The proposed new section to the Framework would also state that, following completion of that analysis, both (1) the components of that analysis and (2) the results of that analysis, would be presented to the Board Risk Committee on at least on an annual basis. When considering whether to designate the uncommitted resource as a QLR, the Board Risk Committee would determine if the uncommitted liquid resource is highly reliable under extreme but plausible market conditions consistent with Rule 17Ad-22(a)(14)(ii)(B) under the Act.
The proposed changes to the Framework would also make clear that FICC may have access to liquidity resources that are not designated as QLR. At this time, FICC maintains uncommitted master repurchase agreements (“MRAs”) that can be utilized to finance via the repo market
In addition, the proposed rule changes provide that, at least annually, FICC would conduct counterparty due diligence reviews that would assess each non-QLR liquidity provider's ability to provide liquidity to FICC under current market conditions and would provide a summary of these reviews to the Board Risk Committee.
As a conforming change, the proposed rule change would delete language referring to MRAs as QLR. The proposed rule change would add a sentence stating that FICC may count MRAs as QLR if the procedures for designating them as such (as described above) are followed. As a further conforming change, the proposed rule change would specify that the section of the Framework regarding liquidity resources that are not designated as QLR applies specifically to FICC.
The current Framework contains a stand-alone section (“Stand-Alone Section”) on the due diligence and testing of liquidity providers that the Clearing Agencies perform. The proposed rule changes would delete the Stand-Alone Section and would instead add descriptions of the due diligence and testing performed in connection with each type of liquidity resource in the section of the Framework where each resource is described, as further described below in subsection v. The proposed rule changes also state where testing is not performed, where applicable, as further described below in subsections iv. and v.
More specifically, the Stand-Alone Section currently states that the Counterparty Credit Risk department (“CCR”) reviews the limits, outstanding investments, and collateral held (if applicable) at each investment counterparty. The proposed rule change would (i) restate this language to make clear that CCR's review includes a financial analysis of each counterparty, the Clearing Agencies' investments at each counterparty, and any recommendations for changes in limits to these investments and (ii) place the restated sentence in the section of the Framework related to the specific liquidity resource that CCR is surveilling.
Finally, the Stand-Alone Section references testing. The proposed rule change would move the references to testing where each resource is described in the Framework.
The proposed changes would make clear that each FICC division has its own Clearing Fund that includes deposits of cash. The proposed changes would also delete language regarding the ability of FICC to borrow from the Clearing Fund as that is already covered in the rules of each division. The proposed rule change would clarify the description of FICC's QLR by adding language on same day access to funds regarding deposits of Clearing Fund in creditworthy commercial banks. The proposed changes would also clarify that the rules-based committed Capped Contingency Liquidity Facility programs are determined for each FICC division per the division's respective rules.
In addition, the Framework would make clear that for purposes of making FICC Clearing Fund deposits, Members are not considered “liquidity providers” with reference to Rules 17Ad-22(e)(7)(iv) and (v) under the Act.
The proposed rule change would clarify the description of NSCC's QLR by deleting language regarding the ability of NSCC to borrow from the Clearing Fund as that is already covered in the NSCC Rules. In addition, the proposed changes would replace “medium- and long-term” with “senior” (which covers both medium- and long-term) before “unsecured notes” in the description of NSCC's QLR in order to simplify terminology.
The proposed changes would provide that, because the process for collecting Supplemental Liquidity Deposits (“SLD”), pursuant to NSCC Rule 4A,
The proposed rule change would clarify the descriptions of DTC's and NSCC's QLR by adding language on same day access to funds regarding deposits of DTC Participants Fund and NSCC Clearing Fund in creditworthy commercial banks. In addition, the proposed changes would make clear that for purposes of making DTC Participants Fund deposits and NSCC Clearing Fund deposits, DTC Participants and NSCC Members, respectively, are not considered “liquidity providers” with reference to
The proposed changes would add language to the descriptions of DTC's and NSCC's QLR to reflect DTC's and NSCC's current practices of conducting surveillance of bank lenders to their committed credit facility, and testing the committed credit facility at least annually to confirm that the lenders, agents and respective Clearing Agency are operationally prepared to meet their obligations under the facility and are familiar with the borrowing process.
The proposed rule change would also make a correction to the description of DTC's Collateral Monitor. Currently, the Framework states that the Liquidity Risk Product Unit verifies that the Collateral Monitor will not become negative if the transaction is processed. Because this verification is done automatically, the proposed rule change would correct the sentence to state that DTC performs this verification automatically.
The proposed rule changes include certain technical changes as follows:
• Make conforming and cross-reference changes in the Executive Summary;
• Delete a sentence that may be confusing in that it states that liquidity resources are maintained consistent with risk tolerances, whereas the correct statement is that liquidity resources are maintained consistent with Rule 17Ad-22(e)(7) under the Act,
• Make conforming and cross-reference changes in the general section on “Liquidity Resources;”
• Restate the first sentence in the section describing FICC's QLR so that it reads more clearly;
• Remove cross-references and phrases referencing other sections of the Framework where such references are no longer correct;
• Add the word “FICC” to the end of a sentence where it was inadvertently deleted; and
• Renumber the last three sections of the Framework to account for the deletion of the section on due diligence/testing.
The Clearing Agencies believe that the proposed changes are consistent with Section 17A(b)(3)(F) of the Act,
Section 17A(b)(3)(F) of the Act requires, in part, that the rules of a registered clearing agency be designed to promote the prompt and accurate clearance and settlement of securities transactions, and to assure the safeguarding of securities and funds which are in the custody or control of the clearing agency or for which it is responsible,
The proposed changes described in Items II(A)1.iii. through II(A)1.vi. above would (1) delete the stand-alone section on due diligence and testing of liquidity providers, and instead add due diligence and testing descriptions where each liquidity resource is described; (2) clarify the description of FICC's QLR; (3) clarify the description of NSCC's and DTC's QLR, add language to reflect NSCC's and DTC's current due diligence and testing processes regarding their committed line of credit, and make a correction to the description of DTC's Collateral Monitor; and (4) make technical changes. These proposed changes would improve the clarity of the descriptions of various liquidity management processes of the Clearing Agencies. The improvement in the clarity of the descriptions of liquidity risk management processes within the Framework would assist the Clearing Agencies in carrying out these functions. Therefore, the Clearing Agencies believe the proposed changes are consistent with the requirements of Section 17A(b)(3)(F) of the Act
The Clearing Agencies believe that the proposed changes are consistent with Rule 17Ad-22(e)(7) under the Act,
In addition, the proposed changes are designed to ensure that any uncommitted resource that is designated as QLR would be highly reliable in extreme but plausible market conditions, in accordance with Rule 17Ad-22(a)(14)(ii)(B) under the Act.
The Clearing Agencies do not believe the proposed rule change would have any impact, or impose any burden, on competition. As described above, the
The Clearing Agencies have not received or solicited any written comments relating to this proposal. If any written comments are received, they will be publicly filed as an Exhibit 2 to this filing, as required by Form 19b-4 and the General Instructions thereto.
Persons submitting comments are cautioned that, according to Section IV (Solicitation of Comments) of the Exhibit 1A in the General Instructions to Form 19b-4, the Commission does not edit personal identifying information from comment submissions. Commenters should submit only information that they wish to make available publicly, including their name, email address, and any other identifying information.
All prospective commenters should follow the Commission's instructions on how to submit comments, available at
The Clearing Agencies reserve the right to not respond to any comments received.
Within 45 days of the date of publication of this notice in the
(A) by order approve or disapprove such proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On March 25, 2022, 24X National Exchange LLC (“24X”) filed with the Securities and Exchange Commission (“Commission”) a Form 1 application under the Securities Exchange Act of 1934 (“Act”) seeking registration as a national securities exchange under Section 6 of the Act.
24X proposes to operate a fully automated electronic trading platform for the trading of listed NMS stocks pursuant to unlisted trading privileges.
In Amendment No. 1, 24X proposed several changes to its trading system and corporate governance, and provided additional financial statements. Among other things, Amendment No. 1 revised the corporate documents of 24X and its direct holding company;
The Commission requests that interested persons provide written views and data with respect to 24X's Initial Form 1 Application, as amended by Amendment No. 1. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (“PRA”) (44 U.S.C. 3501
Rule 15b11-1 provides that a broker or dealer may register by notice pursuant to section 15(b)(11)(A) of the Exchange Act (15 U.S.C. 78
The Commission staff estimates that the total annual reporting burden associated with Rule 15b11-1 and Form BD-N is approximately three hours, based on an average of zero initial notice registrations per year that each take approximately 30 minutes to complete, for zero hours, plus an average of eleven amendments per year that each take approximately fifteen minutes to complete, for 2.75 hours,
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.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
Cboe Exchange, Inc. (the “Exchange” or “Cboe Options”) proposes to update its Fees 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 Fees Schedule, effective October 31, 2022.
Currently, pursuant to Footnote 32 of the Fees Schedule, transaction fees for Customer VIX orders executed during the Global Trading Hours (“GTH”) session are waived through December 31, 2022. The waiver was designed to encourage additional customer order flow in VIX options during GTH. However, the Exchange no longer believes the current waiver is having the designed effect and therefore the Exchange proposes to eliminate the current waiver prior to its expiration. Specifically, the proposed waiver will only apply through October 31, 2022 and effective trade date, November 1, 2022, standard Customer transaction fees for VIX orders executed during GTH will apply.
The Exchange believes that the proposed rule change is consistent with the objectives of Section 6 of the Act,
The Exchange believes that the proposed rule change to eliminate the waiver for Customer VIX orders executed during GTH is reasonable as the waiver was meant to be temporary and the Exchange no longer wishes to maintain it, nor is it required to maintain such waiver. As noted above the Exchange no longer believes the waiver is having the desired effect of encouraging additional Customer order flow in VIX options during GTH. The proposed change is also equitable and not unfairly discriminatory as it applies uniformily to all Customers.
The Exchange does not believe that the proposed rule change will impose any burden on intramarket or intermarket competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange does not believe that the proposed rule change will impose any burden on intramarket competition because the proposed change applies uniformly to all Customers. Customers, like all other market participants, will
The Exchange has not solicited, and does not intend to solicit, comments on this proposed rule change. The Exchange has not received any written comments from members or other interested parties.
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.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
Cboe Exchange, Inc. (the “Exchange” or “Cboe Options”) proposes to renew an existing pilot program until May 8, 2023. The text of the proposed rule change is provided below. (additions are
(a)-(d) No change.
(e) Nonstandard Expirations Pilot Program.
(1)-(2) No change.
(3) Duration of Nonstandard Expirations Pilot Program. The Nonstandard Expirations Pilot Program shall be through [November 7, 2022]
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.
On September 14, 2010, the Securities and Exchange Commission (the “Commission”) approved a Cboe Options proposal to establish a pilot program under which the Exchange is permitted to list P.M.-settled options on broad-based indexes to expire on (a) any Friday of the month, other than the third Friday-of-the-month, and (b) the last trading day of the month.
Pursuant to the order approving the establishment of the Program, two months prior to the conclusion of the pilot period, Cboe Options is required to submit an annual report to the Commission, which addresses the following areas: Analysis of Volume & Open Interest; Monthly Analysis of Weekly Expirations & EOM Trading Patterns; Provisional Analysis of Index Price Volatility; and, for SPX and XSP options specifically, certain market quality data.
If, in the future, the Exchange proposes an additional extension of the Program, or should the Exchange propose to make the Program permanent (which the Exchange currently intends to do), the Exchange will submit an annual report (addressing the same areas referenced above and consistent with the order approving the establishment of the Program) to the Commission at least two months prior to the next bi-annual expiration date of the Program.
The Exchange believes there is sufficient investor interest and demand in the Program to warrant its extension. The Exchange believes that the Program has provided investors with additional means of managing their risk exposures and carrying out their investment objectives. Furthermore, the Exchange has not experienced any adverse market effects with respect to the Program.
The Exchange believes that the proposed extension of the Program will not have an adverse impact on capacity.
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
In particular, the Exchange believes that the Program has been successful to date and states that it has not encountered any problems with the Program. The proposed rule change allows for an extension of the Program for the benefit of market participants. Additionally, the Exchange believes that there is demand for the expirations offered under the Program and believes that that Weekly Expirations and EOMs will continue to provide the investing public and other market participants increased opportunities to better manage their risk exposure.
Cboe Options 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. Specifically, the Exchange believes that, by extending the expiration of the Program, the proposed rule change will allow for further analysis of the Program and a determination of how the Program shall be structured in the future. In doing so, the proposed rule change will also serve to promote regulatory clarity and consistency, thereby reducing burdens on the marketplace and facilitating investor protection.
The Exchange neither solicited nor received comments on the proposed rule change.
Because the foregoing proposed rule change does not: (i) significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule change should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange proposes to amend BOX Rule 7240 (Complex Orders) to permit electronic Multi-Leg Orders on BOX. The text of the proposed rule change is available from the principal office of the Exchange, at the Commission's Public Reference Room and also on the Exchange's internet website at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The self-regulatory organization has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.
Currently, only Multi-Leg Orders defined as “Complex Orders” trade electronically on BOX.
The Exchange now proposes BOX Rule 7240(b)(2)(iii) to detail the trading priority requirements for Multi-Leg Orders. Proposed BOX Rule 7240(b)(2)(iii) provides that each component leg of a Multi-Leg Order will be required to trade (A) at or between the NBBO, and (B) at a price that is at least $0.01 better than any Public Customer order on the BOX Book.
The following example illustrates the execution of a Multi-Leg Order:
Example 1—Execution of a Multi-Leg Order
BOX Leg A Book: 6.00—6.60 (no Public Customer interest)
BOX Leg B Book: 3.00—3.30 (no Public Customer interest)
Leg A NBBO: 6.00—6.60
Leg B NBBO: 3.00—3.30
Strategy: Buy 4 A Calls, Sell 1 B Call
The Exchange receives a Multi-Leg Order for the purchase of the strategy at a net price of 22.80, buying 4 A Calls and selling 1 B Call. Since the order can be executed at a price that is at or between the NBBO for each component series, and at a price that is at least $0.01 better than any Public Customer order on the BOX Book, the legs of the Multi-Leg Order will be executed at 6.45 for leg A and 3.00 for leg B to achieve the net price of 22.80 (6.45 times 4 equals 25.80 less 3.00 equals 22.80).
Example 2—Execution of a Multi-Leg Order
BOX Leg A Book: 6.00—6.60 (no Public Customer interest)
BOX Leg B Book: 3.00—3.30 (Public Customer to sell at 3.30)
Leg A NBBO: 6.00—6.60
Leg B NBBO: 3.00—3.30
Strategy: Buy 4 A Calls, Sell 1 B Call
The Exchange receives a Multi-Leg Order for the purchase of the strategy at a net price of 20.70, buying 4 A Calls and selling 1 B Call. Since there is a Public Customer Order on the BOX Book for Leg B to sell at 3.30 and the Multi-Leg Order can only be purchased at a net price of 20.70 if leg A is purchased at 6.00 (6.00 times 4 equals 24.00) and leg B is sold at 3.30 (24.00 less 20.70 equals 3.30), the Multi-Leg Order will be rejected.
The Exchange proposes further, in proposed Rule 7240(b)(1), that the minimum increment for bids and offers on electronic Multi-Leg Orders will be $0.01 and each leg of an electronic Multi-Leg Order may be executed in one cent increments, regardless of the minimum increments otherwise applicable to the individual legs of the order.
The Exchange understands that there may be some concerns that if the ratios of multi-legged strategies, where each component leg is allowed to trade in one cent increments, are too greatly expanded, market participants will, for example, enter multi-legged strategies designed primarily to trade orders in a class in pennies that cannot otherwise execute as simple orders in that class in pennies. The Exchange believes it is highly unlikely that market participants will submit non-bona-fide trading strategies with larger ratios just to trade in penny increments. Adding a single leg to a larger order just to obtain penny pricing may further reduce execution opportunities for such an order because it may be less likely that sufficient contracts in the appropriate ratio would be available and because it is unlikely that other market participants would be willing to execute against an order that is not a bona-fide trading strategy. Further, the Exchange notes that all option series traded on BOX can currently trade in penny increments in the Price Improvement Period (“PIP”) regardless of the minimum increment otherwise applicable.
The Exchange will announce the implementation of Multi-Leg Orders by Informational Circular at least 48 hours prior to deployment of this functionality, as the Exchange believes that 48 hours of notice is adequate for Participants.
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
In particular, the Exchange believes the proposed rule change will remove impediments to and perfect the mechanism of a free and open market and benefit investors because another exchange has established both electronic and open outcry execution of Multi-Leg Orders, regardless of ratio.
The Exchange believes that the proposed change perfects the mechanism of a free and open market and protects investors and the public interest by continuing to protect the priority of Public Customers as evidenced by the requirements detailed in proposed Rule 7240(b)(2)(iii). In particular, the execution of each leg of a Multi-Leg Order (i) will be at a price that is at least $0.01 better than any Public Customer order on the BOX Book; and (ii) will be at or between the NBBO. The Exchange notes that another exchange has established multi-leg electronic trading, regardless of the ratios between the component legs. Therefore, the proposed rules perfect the mechanism of a free and open market and protect investor and the public interest by increasing efficiency and competitive pricing by establishing Multi-Leg Orders on BOX which creates intermarket competition between exchanges.
The Exchange also believes that establishing electronic Multi-Leg Orders benefits investors and provides a means for market participants to execute Multi-Leg Orders outside of the BOX Trading Floor, as multi-leg QOO Orders are currently the only way to execute Multi-Leg Orders on BOX. Participants may find it more convenient and efficient to execute Multi-Leg Orders electronically because they do not require manual handling or the services of a Floor Broker.
Additionally, the Exchange believes that electronic trading of Multi-Leg Orders in one cent increments will remove impediments to and perfect the mechanism of a free and open market and benefit investors, because it will provide Participants with the same pricing flexibility with respect to all of their Multi-Leg Orders on BOX (
The Exchange believes the proposed changes will increase opportunities for execution of Multi-Leg Orders and lead to tighter spreads on BOX, which will benefit investors. The Exchange also believes that the proposed rule change is designed to not permit unfair discrimination among market participants, as all market participants may trade electronic Multi-Leg Orders, and the priority requirements apply to electronic Multi-Leg Orders of all market participants.
Lastly, the Exchange notes that the proposed changes discussed herein are not novel. The trading of multi-leg QOO orders in one cent increments was recently adopted by BOX.
The Exchange does not believe the proposed rule change will impose any burden on intramarket competition, as the proposed rule change will apply in the same manner to all Participants. The Exchange notes that all Participants, regardless of account type, will have the ability to submit electronic Multi-Leg Orders with any ratio in the increments permitted by the proposed rule change. Further, the proposed rule change will provide all Participants with an additional means for trading Multi-Leg Orders on BOX. The Exchange believes the proposed rule change does not impose any undue burden on intermarket competition and may, on the contrary, promote competition, as another exchange currently offers the proposed functionality.
The Exchange has neither solicited nor received comments on the proposed rule change.
Because the foregoing proposed rule change does not (a) significantly affect the protection of investors or the public interest; (b) impose any significant burden on competition; and (c) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section
A proposed rule change filed under Rule 19b-4(f)(6) normally does not become operative prior to 30 days after the date of the filing. However, pursuant to Rule 19b-4(f)(6)(iii),
The Commission finds that waiving the 30-day operative delay is consistent with the protection of investors and the public interest. The proposal will provide investors with an additional venue for electronically trading complex orders with a ratio less than one-to-three or greater than three-to-one. The Commission believes that proposal does not raise new or novel regulatory issues because another options exchange currently provides for the electronic trading of complex orders with a ratio less than one-to-three or greater than three-to-one.
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The principal purpose of the proposed amendments is for ICE Clear Europe to amend the rate of return paid by the Clearing House on Euro (“EUR”) cash margin and Guaranty Fund deposits. The proposed amendments do not involve any changes to the ICE Clear Europe Clearing Rules or Procedures.
In its filing with the Commission, ICE Clear Europe 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. ICE Clear Europe has prepared summaries, set forth in sections (A), (B), and (C) below, of the most significant aspects of such statements.
The purpose of the proposed rule changes is for ICE Clear Europe to its rate of return paid on EUR cash margin and Guaranty Fund deposits applicable to all Clearing Members for house and customer accounts. ICE Clear Europe pays a rate of return on cash deposited by Clearing Members in respect of margin and Guaranty Fund requirements referred to as the ICE Deposit Rate (the “IDR”). The IDR is calculated daily and applied to cash balances held at the close of business on the previous business day in respect of US Dollar (“USD”), EUR and Pound Sterling (“GBP”) deposits. The IDR is calculated as the net income earned on cash deposits in the relevant currency (positive or negative) less a charge or spread.
ICE Clear Europe is proposing to reduce the spread for EUR balances from 25 bps to 15 bps. The spread for USD balances and GBP balances would remain unchanged at 15 bps and 12 bps respectively. ICE Clear Europe has determined that in light of current financial market conditions, including central bank rates for Euro deposits and repo rates available in the market, it is appropriate to increase the net IDR on EUR balances (through a lower spread). ICE Clear Europe believes the change would better align the relative costs and benefits of using EUR to cover margin and Guaranty Fund obligations with otherwise available market rates and facilitate the Clearing House's ability to maintain adequate EUR balances for liquidity management purposes.
ICE Clear Europe believes that the proposed rule changes are consistent with the requirements of the Act, including Section 17A of the Act
The proposed amendments are also consistent with the requirements of Section 17A(b)(3)(F) of the Act
ICE Clear Europe does not believe the proposed rule changes would have any impact, or impose any burden, on competition not necessary or appropriate in furtherance of the purpose of the Act. Although ICE Clear Europe is revising a certain spread applied to the IDR, as set forth herein, it believes such changes are appropriate
Written comments relating to the proposed amendments have not been solicited or received by ICE Clear Europe. ICE Clear Europe will notify the Commission of any comments received with respect to 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.
All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-ICEEU-2022-021 and should be submitted on or before November 30, 2022.
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 Exchange, Inc. (the “Exchange” or “Cboe Options”) proposes to extend the operation of its SPXPM pilot program. The text of the proposed rule change is provided below. (additions are
.01-.12 No change.
.13 In addition to A.M.-settled S&P 500 Stock Index (“SPX”) options approved for trading on the Exchange pursuant to Rule 4.13, the Exchange may also list options on SPX whose exercise settlement value is derived from closing prices on the last trading day prior to expiration (P.M.-settled third Friday-of-the-month SPX options series). The Exchange may also list options on the Mini-SPX Index (“XSP”) and Mini-RUT Index (“MRUT”) whose exercise settlement value is derived from closing prices on the last trading day prior to expiration (“P.M.-settled”). P.M.-settled third Friday-of-the-month SPX options series and P.M.-settled XSP and MRUT options will be
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.
On February 8, 2013, the Securities and Exchange Commission (the “Commission”) approved a rule change that established a Pilot Program that allows the Exchange to list options on the S&P 500 Index whose exercise settlement value is derived from closing prices on the last trading day prior to expiration (“SPXPM”).
During the course of the Pilot Program and in support of the extensions of the Pilot Program, the Exchange submits reports to the Commission regarding the Pilot Program that detail the Exchange's experience with the Pilot Program, pursuant to the SPXPM Approval Order,
The pilot reports both contain the following volume and open interest data:
(1) monthly volume aggregated for all trades;
(2) monthly volume aggregated by expiration date;
(3) monthly volume for each individual series;
(4) month-end open interest aggregated for all series;
(5) month-end open interest for all series aggregated by expiration date; and
(6) month-end open interest for each individual series.
The annual reports also contain (or will contain) the information noted in Items (1) through (6) above for Expiration Friday, A.M.-settled, S&P 500 and RUT index options traded on Cboe Options, as well as the following analysis of trading patterns in the Pilot Products options series in the Pilot Program:
(1) a time series analysis of open interest; and
(2) an analysis of the distribution of trade sizes.
Finally, for series that exceed certain minimum parameters, the annual reports contain the following analysis related to index price changes and underlying share trading volume at the close on Expiration Fridays:
(1) a comparison of index price changes at the close of trading on a given Expiration Friday with comparable price changes from a control sample. The data includes a calculation of percentage price changes for various time intervals and compare that information to the respective control sample. Raw percentage price change data as well as percentage price change data normalized for prevailing market volatility, as measured by the Cboe Volatility Index (VIX), is provided; and
(2) a calculation of share volume for a sample set of the component securities representing an upper limit on share
The minimum open interest parameters, control sample, time intervals, method for randomly selecting the component securities, and sample periods are determined by the Exchange and the Commission. In proposing to extend the Pilot Program, the Exchange will continue to abide by the reporting requirements described herein, as well as in the SPXPM Approval Order, the P.M.-settled XSP Approval Order, and the P.M.-settled MRUT Approval Order.
The Exchange proposes the extension of the Pilot Program in order to continue to give the Commission more time to consider the impact of the Pilot Program. To this point, Cboe Options believes that the Pilot Program has been well-received by its Trading Permit Holders and the investing public, and the Exchange would like to continue to provide investors with the ability to trade SPXPM and P.M.-settled XSP and MRUT options. All terms regarding the trading of the Pilot Products shall continue to operate as described in the SPXPM Approval Order, the P.M.-settled XSP Approval Order, and the P.M.-settled MRUT Approval Order. The Exchange merely proposes herein to extend the term of the Pilot Program to May 8, 2023.
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
In particular, the Exchange believes that the proposed extension of the Pilot Program will continue to provide greater opportunities for investors. Further, the Exchange believes that it has not experienced any adverse effects or meaningful regulatory concerns from the operation of the Pilot Program. As such, the Exchange believes that the extension of the Pilot Program does not raise any unique or prohibitive regulatory concerns. Also, the Exchange believes that such trading has not, and will not, adversely impact fair and orderly markets on Expiration Fridays for the underlying stocks comprising the S&P 500 index and RUT index. The extension of the Pilot Program will continue to provide investors with the opportunity to trade the desirable products of SPXPM and P.M.-settled XSP and MRUT, while also providing the Commission further opportunity to observe such trading of the Pilot Products.
Cboe Options does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange does not believe the continuation of the Pilot Program will impose any unnecessary or inappropriate burden on intramarket competition because it will continue to apply equally to all Cboe Options market participants, and the Pilot Products will be available to all Cboe Options market participants. The Exchange believes there is sufficient investor interest and demand in the Pilot Program to warrant its extension. The Exchange believes that, for the period that the Pilot Program has been in operation, it has provided investors with desirable products with which to trade. Furthermore, the Exchange believes that it has not experienced any adverse market effects or regulatory concerns with respect to the Pilot Program. The Exchange further does not believe that the proposed extension of the Pilot Program will impose any burden on intermarket competition that is not necessary or appropriate in furtherance of the purposes of the Act because it only applies to trading on Cboe Options. To the extent that the continued trading of the Pilot Products may make Cboe Options a more attractive marketplace to market participants at other exchanges, such market participants may elect to become Cboe Options market participants.
The Exchange neither solicited nor received comments on the proposed rule change.
Because the foregoing proposed rule change does not: (i) significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule change should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Securities and Exchange Commission.
Order; correction.
The Securities and Exchange Commission published a document in the
Naomi P. Lewis, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549, (202) 551-5400.
In the
Securities and Exchange Commission (“Commission”).
Notice.
Notice of an application under section 6(c) of the Investment Company Act of 1940 (the “Act”) for an exemption from sections 2(a)(32), 5(a)(1), 22(d) and 22(e) of the Act and rule 22c-1 under the Act
Applicants request an order (“Order”) that permits: (a) The Funds (as defined below) to issue shares (“Shares”) redeemable in large aggregations only (“creation units”); (b) secondary market transactions in Shares to occur at negotiated market prices rather than at net asset value; (c) certain Funds to pay redemption proceeds, under certain circumstances, more than seven days after the tender of Shares for redemption; and (d) certain affiliated persons of a Fund to deposit securities into, and receive securities from, the Fund in connection with the purchase and redemption of creation units. The relief in the Order would incorporate by reference terms and conditions of the same relief of a previous order granting the same relief sought by applicants, as that order may be amended from time to time (“Reference Order”).
J.P. Morgan Exchange-Traded Fund Trust, J.P. Morgan Investment Management Inc. and JPMorgan Distribution Services, Inc.
The application was filed on September 6, 2022 and amended on October 27, 2022.
An order granting the requested relief will be issued unless the Commission orders a hearing. Interested persons may request a hearing on any application by emailing the Commission's Secretary at
The Commission:
Deepak T. Pai, Senior Counsel, or Terri G. Jordan, Branch Chief, at (202) 551-6825 (Chief Counsel's Office, Division of Investment Management).
For Applicants' representations, legal analysis, and conditions, please refer to Applicants' amended and restated application, dated October 27, 2022, which may be obtained via the Commission's website by searching for the file number at the top of this document, or for an Applicant using the Company name search field, on the SEC's EDGAR system. The SEC's EDGAR system may be searched at
For the Commission, by the Division of Investment Management, under delegated authority.
Notice of request for public comment and submission to OMB of proposed collection of information.
The Department of State has submitted the information collection described below to the Office of Management and Budget (OMB) for approval. In accordance with the Paperwork Reduction Act of 1995 we are requesting comments on this collection from all interested individuals and organizations. The purpose of this Notice is to allow 30 days for public comment.
Submit comments up to December 9, 2022.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Direct requests for additional information regarding the collection listed in this notice, including requests for copies of the proposed collection instrument and supporting documents, to Annura N. Murtadha, US Department of State, Office of Risk Analysis and Management, 2401 E St. NW, L408, Washington, DC 20037; who can be reached on 202-657-6020 or at
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We are soliciting public comments to permit the Department to:
• Evaluate whether the proposed information collection is necessary for the proper functions of the Department.
• Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used.
• Enhance the quality, utility, and clarity of the information to be collected.
• Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Please note that comments submitted in response to this Notice are public record. Before including any detailed personal information, you should be aware that your comments as submitted, including your personal information, will be available for public review.
The information collected from individuals and organizations is specifically used to conduct screening to ensure that Foreign Assistance-
The State Department has implemented a Risk Analysis and Management Program to vet potential contractors and grantees seeking funding from the Department of State to mitigate the risk that such funds might benefit entities or individuals who present a national security risk. To conduct this vetting program the Department collects information from contractors, subcontractors, grantees and sub-grantees regarding their directors, officers and/or key employees through mail, fax or electronic submission. The information collected is compared to information gathered from commercial, public, and U.S. government databases to determine the risk that the applying organization, entity or individual might use Department funds or programs in a way that presents a threat to national security. This program is consistent with Section 7034(f) of the Department of State, Foreign Operations, and Related Programs Appropriations Act, 2022 (Div. K, Pub. L. 117-103) and similar provisions in prior appropriations acts.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice of funding opportunity.
The Department of Transportation (DOT), Federal Aviation Administration (FAA), announces the opportunity to apply for $20 million in FY 2023 Airport Infrastructure Grant funds for the FAA Contract Tower (FCT) Competitive Grant Program, made available under the Infrastructure Investment and Jobs Act of 2021, herein referred to as the Bipartisan Infrastructure Law (BIL). The purpose of the FCT Competitive Grant Program is to make annual grants available to eligible airports for airport-owned airport traffic control tower (ATCT) projects that address the aging infrastructure of the nation's airports. In addition, the FCT Competitive Grant Program will align with DOT's Strategic Framework FY2022-2026 at
Airport sponsors that wish to be considered for FY 2023 FCT Competitive Grant Program funding should submit an application that meets the requirements of this NOFO as soon as possible, but no later than 5:00 p.m. Eastern time, December 6, 2022.
Submit applications electronically at
Robin K. Hunt, Manager, BIL Implementation Team, FAA Office of Airports, at (202)267-3263 or our FAA BIL email address:
The FY 2023 FCT Competitive Grant Program will be implemented consistent with law and in alignment with the priorities in Executive Order 14052,
BIL established the FCT Competitive Grant Program, a competitive discretionary grant program, which provides $20 million in grant funding annually for five years (Fiscal Years 2022-2026) to sustain, construct, repair, improve, rehabilitate, modernize, replace, or relocate nonapproach control towers; acquire and install air traffic control, communications, and related equipment to be used in those towers; and construct a remote tower certified by the FAA including acquisition and installation of air traffic control, communications, or related equipment. This program also supports the President's goals to mobilize American ingenuity to build modern infrastructure and an equitable, clean energy future. In support of Executive Order 13985,
The FCT Competitive Grant Program falls under the project grant authority for the Airport Improvement Program (AIP) in 49 United States Code (U.S.C.) § 47104. Per 2 CFR part 200—
Consistent with statutory criteria and Executive Order 14008,
The FAA will also consider projects that advance the goals of the Executive Orders listed under Section E.2.
This NOFO announces up to $20,000,000, subject to availability of funds, for the Fiscal Year 2023 FCT Competitive Grant Program. The FCT Competitive Grant Program is a $100 million grant program, distributed as $20 million annually for five years (Fiscal Years 2022, 2023, 2024, 2025, and 2026).
The FAA will consider projects at an airport-owned Airport Traffic Control Tower (ATCT) that sustain, construct, repair, improve, rehabilitate, modernize, replace, or relocate nonapproach control towers; acquire and install air traffic control, communications, and related equipment to be used in those towers; or construct a remote tower certified by the FAA including acquisition and installation of air traffic control, communications, or related equipment. To date, there are no certified remote tower systems. The FAA is currently evaluating this technology to assess its suitability for use in the National Airspace System. In addition, these projects will also be evaluated based on overall impact on the National Airspace System, including age of facility, operational constraints, nonstandard facilities, or new FCT entrant requirements. This also includes applicable Executive Orders as listed in Section E.2.
The FAA intends to publish a NOFO annually to announce additional funding made available, expected to be $20 million per year, for Fiscal Years 2024-2026.
Eligible applicants are those airport sponsors approved in the FAA's contract tower program or contract tower cost share program as defined in 49 U.S.C. 47124, and normally eligible for Airport Improvement Program (AIP) discretionary grants as defined in 49 U.S.C. 47115. The eligible applicants include a public agency, private entity, state agency, Indian Tribe, or Pueblo owning a public-use National Plan of Integrated Airport Systems (NPIAS) airport, the Secretary of the Interior for Midway Island airport, the Republic of the Marshall Islands, the Federated States of Micronesia, and the Republic of Palau.
No cost sharing or matching is required. The Federal cost share of the FCT Competitive Grant Program is 100 percent for all airports eligible to receive grants.
All projects funded from the FCT Competitive Grant Program must be:
i. Airport-owned ATCT projects that sustain, construct, repair, improve, rehabilitate, modernize, replace, or relocate nonapproach control towers;
ii. Projects that acquire and install air traffic control, communications, and related equipment to be used in those towers; or
iii. Projects to construct a remote tower
An application for FCT Competitive Grant Program projects, FAA Form 5100-144,
Direct all inquiries regarding applications to the appropriate Regional Office (RO) or Airports District Office (ADO), or to the BIL Team. RO/ADO contact information is available at
Applicants are required to submit information contained in FAA Form 5100-144,
All applications must be submitted electronically following the instruction on the form. Once the form is complete, save a copy of the form electronically to your files for future reference. Next, scroll to the bottom of the form and press the “submit” button. This action will generate an email for you to send to the FAA BIL Team for review and evaluation. If the submit button did not automatically generate an email, you can also manually email your saved open field form to:
Applicants selected to receive an FCT Competitive Grant Program grant will then be required to follow AIP grant application procedures prior to award, which include meeting all prerequisites for funding, and submission of Standard Form SF-424,
Airports covered under the FAA's State Block Grant Program or airports in a channeling act state should coordinate with their associated state agency on the process for deciding who should submit an application using the procedures noted above. All applicants, including those requesting full federal share of eligible project costs, should have a plan to address potential cost overruns as part of an overall funding plan.
Applicants must comply with 2 CFR part 25—
Once awarded, the FAA grant recipient must maintain the currency of its information in SAM until the grantee submits the final financial report required under the grant or receives the final payment, whichever is later. A grant recipient must review and update the information at least annually after the initial registration and more frequently if required by changes in information or another award term.
The FAA may not make an award until the applicant has complied with all applicable UEI and SAM requirements. If an applicant has not fully complied with the requirements by the time the FAA is ready to make an
Non-Federal entities that have received a Federal award are required to report certain civil, criminal, or administrative proceedings to SAM (currently the Federal Awardee Performance and Integrity Information System (FAPIIS)
Airports that wish to be considered for FY 2023 FCT Competitive Grant Program funding should submit an application that meets the requirements of this NOFO as soon as possible, but no later than 5:00 p.m. Eastern time on December 6, 2022. Submit applications electronically to
All projects funded from the FCT Competitive Grant Program must be at airports approved in the FAA's contract tower program or contract tower cost share program defined in 49 U.S.C. 47124.
FCT Competitive Grant Program funds may not be used to support or oppose union organizing.
Using Digital Signatures: Form 5100-144 allows digital signatures. To access the digital signature field, save this form to your computer and then reopen it with a PDF reader or editor. The signature field often does not display when Form 5100-144 is viewed within a web browser.
Applications for FY 2023 FCT Competitive Grant Program will be rated using the following criteria:
i. Projects must meet eligibility requirements under the FCT Competitive Grant Program outlined under Sections C.1 and C.3 above.
ii. The FAA will consider timeliness of implementation, with priority given to those projects, including “design only” projects, that can satisfy all statutory and administrative requirements for grant award in July 2023.
iii. ATCT projects will be evaluated based on the overall impact on the National Airspace System, including age of facility, operational constraints, nonstandard facility conditions, or new FCT entrant requirements.
iv. Priority will be given to projects that advance aviation safety or enhance air traffic efficiency.
v. The applicant should describe whether and how project delivery and implementation creates good-paying jobs with the free and fair choice to join a union to the greatest extent possible, the use of demonstrated strong labor standards, practices and policies (including for direct employees, contractors, and sub-contractors, and service workers on airport property); use of project labor agreements; distribution of workplace rights notices; union neutrality agreements; wage and/or benefit standards; the use of Local Hire Provisions;
Federal awarding agency personnel will evaluate applications based on how well the projects meet the criteria in E.1, including project eligibility, justification, readiness, and impact on the National Airspace System. The FAA will also consider how well projects advance the goals of the following Executive Orders: the President's January 20, 2021, Executive Order 13990,
Prior to making a Federal award with a total amount of Federal share greater than the simplified acquisition threshold, the FAA is required to review and consider any information about the applicant that is in the designated integrity and performance system accessible through SAM (currently FAPIIS) (see 41 U.S.C. 2313). An applicant, at its option, may review information in the designated integrity and performance systems accessible through SAM and comment on any information about itself that a Federal awarding agency previously entered. The FAA will consider any comments by the applicant, in addition to the other information in the designated integrity and performance system, in making a judgment about the applicant's integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 2 CFR 200.206.
BIL awards are announced through a Congressional notification process and a DOT Secretary's Notice of Intent to Fund. The FAA RO/ADO representative will contact the airport with further information and instructions. Once all pre-grant actions are complete, the FAA RO/ADO will offer the airport sponsor a grant for the announced project. This offer may be provided through postal mail or by electronic means. Once this offer is signed by the airport sponsor, it becomes a grant agreement. Awards made under this program are subject to conditions and assurances in the grant agreement.
i. Pre-Award Authority
All project costs must be incurred after the grant execution date unless specifically permitted under 49 U.S.C. 47110(c). Certain airport development costs incurred before execution of the grant agreement, but after November 15, 2021, are allowable, only if certain conditions under 49 U.S.C. 47110(c)are met [see Table 3-60 of the AIP
ii. Grant Requirements
All grant recipients are subject to the grant requirements of the AIP, found in 49 U.S.C. Chapter 471. Grant recipients are subject to requirements in the FAA's
Domestic Preference Requirements: As expressed in Executive Order 14005,
Civil Rights and Title VI: Recipients of Federal transportation funding will be required to comply fully with Title VI of the Civil Rights Act of 1964 and implementing regulations, the Americans with Disabilities Act, Section 504 of the Rehabilitation Act of 1973, and all other civil rights requirements. The DOT's and the FAA's Office of Civil Rights will be providing resources and technical assistance to ensure full and sustainable compliance with Federal civil rights requirements.
Critical Infrastructure Security and Resilience: It is the policy of the United States to strengthen the security and resilience of its critical infrastructure against both physical and cyber threats. Each applicant selected for Federal funding under this notice must demonstrate, prior to the signing of the grant agreement, effort to consider and address physical and cyber security risks relevant to the transportation mode and type and scale of the project. Projects that have not appropriately considered and addressed physical and cyber security and resilience in their planning, design, and project oversight, as determined by the Department and the Department of Homeland Security, will be required to do so before receiving funds for construction, consistent with Presidential Policy Directive 21—Critical Infrastructure Security and Resilience and the National Security Presidential Memorandum on Improving Cybersecurity for Critical Infrastructure Control Systems.
Performance and Program Evaluation: As a condition of grant award, grant recipients may be required to participate in an evaluation undertaken by DOT, the FAA, or another agency or partner. The evaluation may take different forms, such as an implementation assessment across grant recipients, an impact and/or outcomes analysis of all or selected sites within or across grant recipients, or a benefit/cost analysis or assessment of return on investment. DOT may require applicants to collect data elements to aid the evaluation. As a part of the evaluation, as a condition of award, grant recipients must agree to: (1) make records available to the evaluation contractor or DOT staff; (2) provide access to program records and any other relevant documents to calculate costs and benefits; (3) in the case of an impact analysis, facilitate the access to relevant information as requested; and (4) follow evaluation procedures as specified by the evaluation contractor or DOT staff. Requested program records or information will be consistent with record requirements outlined 2 CFR 200.334-338 and the grant agreement.
iii. Standard Assurances
Each grant recipient must assure that it will comply with all applicable Federal statutes, regulations, executive orders, directives, FAA circulars, and other federal administrative requirements in carrying out any project supported by the FCT Competitive Grant Program grant. The grant recipient must acknowledge that it is under a continuing obligation to comply with the terms and conditions of the grant agreement issued for its project with the FAA. The grant recipient understands that federal laws, regulations, policies, and administrative practices might be modified from time to time and may affect the implementation of the project. The grant recipient must agree that the most recent Federal requirements will apply to the project unless the FAA issues a written determination otherwise.
The grant recipient must submit the Certifications at the time of grant application and Assurances must be accepted as part of the grant agreement at the time of accepting a grant offer. Grant recipients must also comply with 2 CFR part 200, which “are applicable to all costs related to Federal awards,” and which is cited in the grant assurances of the grant agreements. The Airport Sponsor Assurances are available on the FAA website at:
Grant recipients are subject to financial reporting per 2 CFR 200.328 and performance reporting per 2 CFR 200.329. Under the FCT Competitive Grant Program, the grant recipient is required to comply with all Federal financial reporting requirements and payment requirements, including the submittal of timely and accurate reports. Financial and performance reporting requirements are available in the FAA October 2020 Financial Reporting Policy, which is available at:
The grant recipient must comply with annual audit reporting requirements. The grant recipient and sub-recipients, if applicable, must comply with 2 CFR part 200 subpart F Audit Reporting Requirements. The grant recipient must comply with any requirements outlined in 2 CFR part 180,
For further information concerning this notice, please contact the FAA BIL Implementation Team via email at:
Federal Aviation Administration (FAA), DOT.
Notice of request to release airport property.
The FAA proposes to rule and invite public comment on the release of land at the Monroe Regional Airport under the provisions of Section 125 of the Wendell H. Ford Aviation Investment Reform Act for the 21st Century (AIR 21).
Comments must be received on or before December 9, 2022.
Comments on this application may be mailed or delivered to the FAA at the following address: Mr. Justin Barker, Manager, Federal Aviation Administration, Southwest Region, Airports Division, Louisiana/New Mexico Airports Development Office, ASW-640, Fort Worth, Texas 76177.
In addition, one copy of any comments submitted to the FAA must be mailed or delivered to Mr. Charles Butcher, Airport Director, at the following address: 5400 Operations Rd., Monroe, LA 71203.
Mr. Jean Gamarra, Program Manager, Federal Aviation Administration, Louisiana/New Mexico Airports Development Office, ASW-640, 10101 Hillwood Parkway, Fort Worth, Texas 76177, Telephone: (817) 222-5522, Email:
The FAA invites public comment on the request to release property at the Monroe Regional Airport under the provisions of the AIR 21.
The following is a brief overview of the request:
The City of Monroe requests the release of 2.46 acres of non-aeronautical airport property. The land was acquired by Deed without Warranty from the United States on September 8th, 1949. The property to be released will be sold for the expansion of the Chenault Aviation and Military Museum. Any person may inspect the request in person at the FAA office listed above under
In addition, any person may, upon request, inspect the application, notice and other documents relevant to the application in person at the City of Monroe Legal Department, telephone number (318) 329-2240.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice.
This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion nor omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before November 29, 2022.
Send comments identified by docket number FAA-2022-1256 using any of the following methods:
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Andrew Thai at (202) 267-0175, Office of Rulemaking, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591.
This notice is published pursuant to 14 CFR 11.85.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of final disposition; denial of application for exemption.
FMCSA announces its decision to deny the application from Leland Schmitt, Jr., requesting an exemption from five provisions of the federal hours of service (HOS) regulations. The applicant requests the exemption for a five-year period and believes that his safe driving record and experience demonstrate an equivalent level of safety. FMCSA analyzed the application and public comments and determined that the exemption would not achieve a level of safety that is equivalent to, or greater than, the level that would be achieved absent such exemption.
Mr. Richard Clemente, FMCSA Driver and Carrier Operations Division; Office of Carrier, Driver and Vehicle Safety Standards; Telephone: 202-366-2722. Email:
To view comments, go to
To view documents mentioned in this notice as being available in the docket, go to
If you do not have access to the internet, you may view the docket by visiting Dockets Operations in Room W12-140 on the ground floor of the DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m., ET, Monday through Friday, except Federal holidays. To be sure someone is there to help you, please call (202) 366-9317 or (202) 366-9826 before visiting Dockets Operations.
FMCSA has authority under 49 U.S.C. 31136(e) and 31315 to grant exemptions from certain Federal Motor Carrier Safety Regulations (FMCSRs). FMCSA must publish a notice of each exemption request in the
The Agency reviews safety analyses and public comments submitted, and determines whether granting the exemption would likely achieve a level of safety equivalent to, or greater than, the level that would be achieved by the current regulation (49 CFR 381.305). The decision of the Agency must be published in the
To reduce the possibility of driver fatigue, FMCSA's hours of service (HOS) regulations in 49 CFR part 395 place limits on the amount of time drivers of commercial motor vehicles (CMVs) may drive. The HOS regulations in 49 CFR 395.3(a)(1) prohibit an individuals from driving again after 11 hours driving or 14 hours on duty until they have been off duty for a minimum of 10 consecutive hours, or the equivalent of at least 10 consecutive hours off duty. Under 49 CFR 395.3(a)(2)—commonly referred to as the 14-hour “driving window”— a driver has 14 consecutive hours in which to drive up to 11 hours after being off duty for 10 or more consecutive hours. Section 395.3(a)(3)(ii) mandates that drivers take a 30-minute break when they have driven for a period of 8 cumulative hours without at least a 30-minute interruption. The break may be satisfied by any non-driving period of 30 consecutive minutes (
Leland Schmitt, Jr., requests a five-year exemption from 49 CFR 395.3(a)(1), section 395.3(a)(2), section 395.3(a)(3)(ii), and sections 395.3(b)(1) and (2). The applicant is an owner-operator currently leased to D & E Transport in Clearwater, Minnesota, who has been driving CMVs for 30 years. The requested exemption is solely for Mr. Schmitt. The applicant states that the mandatory 10 hour off-duty break goes against his natural sleep patterns, as his normal nighttime sleep while in the CMV is between 5 and 7 hours.
The applicant believes that his level of safety under this exemption would be better than he could achieve by complying with the HOS regulations because he will receive the proper rest needed when he needs it. He points to his excellent driving record and 30 years of safe driving experience. He states that he has not been involved in any crashes and that he has accumulated over three million safe driving miles during his truck driving career. He further indicates that he is not requesting an exemption from the required 11 hours of total driving time, which will be properly recorded by the electronic logging device (ELD) in the vehicle. In his application for exemption, he also cites a sleep study by the Massachusetts Institute of Technology, which he states finds “no impact from more night sleep, though naps help.”
On June 9, 2022, FMCSA published Mr. Schmitt's application and requested public comment [87 FR 35282]. The Agency received 651 total comments, 647 of which were filed by individual commenters; 350 comments supported the exemption, 68 were opposed, and 229 offered no position either for or against the request. Advocates for Highway and Auto Safety (Advocates) filed comments strongly opposing the request. Advocates stated: “Exempting the Petitioner (or any CMV operator) from these HOS provisions and allowing him to drive as long, frequently and as much as he desires would be utterly reckless and presents a needless threat
Other themes included among the comments were that: (1) safe drivers are leaving the trucking industry because they are “over-regulated;” (2) there are problems relating to loading/unloading delays at shipper and driver detention times; (3) the applicant should use the current sleeper-berth “split” provisions (7/3 “split”); (4) with over three million CMV drivers in the industry, the Agency cannot exempt one individual driver from the HOS rules; (5) numerous commenters would like to be included in the exemption if it is granted, and others said that they would be applying for a similar exemption; (6) the HOS regulations and the mandatory use of ELDs are objectionable; (7) if the exemption is granted, it should apply to all CMV drivers; and (8) the Agency should do a pilot study on the exemption the applicant requests.
FMCSA evaluated Mr. Schmitt's application and public comments and denies the exemption request. Mr. Schmitt failed to establish that he would maintain a level of safety equivalent to, or greater than, the level achieved without the exemption. The Agency established and enforces the HOS regulations to keep fatigued drivers off the public roadways. Research studies demonstrate that long work hours reduce sleep and harm driver health and that crash risk increases with work hours. The HOS regulations impose limits on when and how long an individual may drive, to ensure that drivers stay awake and alert, and to reduce the possibility of cumulative fatigue. The Agency concurs with commenters that if it exempts one individual from the HOS regulations, it could open the door for a huge number of similar exemption requests. Such a result would be inconsistent with a primary goal of the HOS regulations.
For the above reasons, Leland Schmitt, Jr.'s exemption application is denied.
Federal Railroad Administration (FRA), Department of Transportation (DOT).
Notice of availability and request for comments.
This document provides the public with notice that, on October 26, 2022, Central Florida Rail Corridor (CFRC) submitted its Positive Train Control Safety Plan (PTCSP), Version 4.1, dated October 21, 2022, to FRA's Secure Information Repository. CFRC asks FRA to approve its updated PTCSP and certify CFRC's Interoperable Electronic Train Management System (I-ETMS) as a mixed PTC system.
FRA will consider comments received by January 9, 2023 before taking final action on the PTCSP. 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 its PTCSP, CFRC asserts that the I-ETMS it is implementing is a mixed PTC system as defined in Title 49 Code of Federal Regulations (CFR) 236.1015(e). The PTCSP describes CFRC's I-ETMS implementation and the associated I-ETMS safety processes, safety analyses, and test, validation, and verification processes used during the development of I-ETMS. The PTCSP also contains CFRC's operational and support requirements and procedures.
CFRC's PTCSP is available for review online at
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 Transit Administration (FTA), Department of Transportation (DOT).
Notice of calendar year 2023 random drug and alcohol testing rates.
This notice announces the calendar year 2023 drug and alcohol random testing rates for specific recipients of FTA financial assistance. The minimum random drug testing rate will remain at 50 percent, and the random alcohol testing rate will remain at 10 percent.
Applicable Date: January 1, 2023.
Iyon Rosario, Drug and Alcohol Program Manager in the Office of Transit Safety and Oversight, 1200 New Jersey Avenue SE, Washington, DC 20590 (telephone: 202-366-2010 or email:
On January 1, 1995, FTA required large transit employers to begin drug and alcohol testing of employees performing safety-sensitive functions, and to submit annual reports by March 15 of each year beginning in 1996, pursuant to drug and alcohol regulations adopted by FTA at 49 CFR parts 653 and 654 in February 1994. The annual report includes the number of employees who had a verified positive test for the use of prohibited drugs, and the number of employees who tested positive for the misuse of alcohol during the reported year. Small employers commenced the required testing on January 1, 1996, and began reporting the same information as the large employers beginning March 15, 1997.
FTA updated the testing rules by merging them into a new 49 CFR part 655, effective August 1, 2001 (66 FR 42002). The regulation maintained a random testing rate for prohibited drugs at 50 percent and the misuse of alcohol at 10 percent. The Administrator may lower the random testing rate to 25 percent if the violation rates drop below 1.0 percent for drug testing and 0.5 percent for alcohol testing for two consecutive years. Accordingly, in 2007, FTA reduced the random drug testing rate from 50 percent to 25 percent (72 FR 1057). In 2018, however, FTA returned the random drug testing rate to 50 percent for calendar year 2019 based on verified industry data for calendar year 2017, which showed that the rate had exceeded 1 percent (83 FR 63812).
Pursuant to 49 CFR 655.45, the Administrator's decision to determine the minimum annual percentage rate for random drug and alcohol testing is based, in part, on the reported positive drug and alcohol violation rates for the entire public transportation industry. The information used for this determination is drawn from the Drug and Alcohol Management Information System (MIS) reports required by 49 CFR 655.72. To ensure the reliability of the data, the Administrator must consider the quality and completeness of the reported data, may obtain additional information or reports from employers, and may make appropriate modifications in calculating the industry's verified positive results and violation rates.
For calendar year 2023, the Administrator has determined that the minimum random drug testing rate for covered employees will remain at 50 percent based on a verified positive rate for prohibited drug use of 0.99 percent for calendar year 2021 and 1.08 percent for calendar year 2020. Further, the Administrator has determined that the minimum random alcohol testing rate for calendar year 2023 will remain at 10 percent, because the violation rate again was lower than 0.5 percent for calendar years 2020 and 2021. The random alcohol violation rates were 0.17 percent for 2020 and 0.13 for 2021.
Detailed reports on FTA's drug and alcohol testing data collected from transit employers may be obtained from FTA, Office of Transit Safety and Oversight, 1200 New Jersey Avenue SE, Washington, DC 20590, (202) 366-2010, or at:
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
Notice.
PHMSA announces the availability for public review and comment on the Natural Gas Distribution Infrastructure Safety and Modernization (NGDISM) Grant Program Tier 1 Nationwide Environmental Assessment. PHMSA is using a programmatic, tiered environmental analysis to: describe the effects of implementing the NGDISM Grant Program and ensure that implementation of the NGDISM Grant Program at any project site complies with environmental laws and does not result in a significant environmental impact.
Interested persons are invited to submit comments on or before December 9, 2022. To the extent possible, PHMSA will consider late-filed comments.
Comments should reference the Docket number for this notice and may be submitted in the following ways:
Shakira Mack by email at
On November 15, 2021, the Infrastructure Investment and Jobs Act (IIJA) (Pub. L. 117-58) was enacted. Under the heading “Department of Transportation—Pipeline and Hazardous Materials Safety Administration—Natural Gas Distribution Infrastructure Safety and Modernization Grant Program” in title VIII of division J, the Natural Gas Distribution Infrastructure Safety and Modernization Grant Program was established. The stated purpose of the program is to provide grant opportunities to municipality and community-owned utilities (not including for-profit entities) “to repair, rehabilitate, or replace its natural gas distribution pipeline system or portions thereof or to acquire equipment to (1) reduce incidents and fatalities and (2) avoid economic losses.” The statutory requirements for PHMSA's implementation of the program are mandatory, and PHMSA is expected to implement the program as swiftly as possible to reduce incidents, fatalities, and adverse impacts to the public and the environment, particularly in disadvantaged communities.
Under the Federal Pipeline Safety Laws, 49 U.S.C. 60101
PHMSA is publishing this notice, in compliance with the National Environmental Policy Act of 1969 (NEPA), to give stakeholders an opportunity to comment on PHMSA's Tier 1 Nationwide Environmental Assessment.
We invite interested persons to review and provide comment on the Tier 1 Nationwide Environmental Assessment which is included in the docket for this notice. The document is available at
Before issuing the Tier 1 Nationwide Environmental Assessment, PHMSA will evaluate all comments received on or before the comment closing date. Comments received after the closing date will be evaluated if it is possible to do so without incurring additional expense or delay. PHMSA will consider each relevant comment it receives prior to issuing the Tier 1 Nationwide Environmental Assessment as part of the NGDISM Grant Program.
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 the general public and other Federal agencies to take this opportunity to comment on the revision to 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 respondents are 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 the renewal of its information collection titled “Licensing Manual.” The OCC also is giving notice that the collection has been sent to OMB for review.
Comments must be received on or before December 9, 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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Written comments and recommendations for the proposed information collection should also be sent within 30 days of publication of this notice to
On July 1, 2022, the OCC published a 60-day notice for this information collection, (87 FR 39590). You may review comments and other related materials that pertain to this information collection following the close of the 30-day comment period for this notice by the method set forth in the next bullet.
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Shaquita Merritt, Clearance Officer, (202) 649-5490, Chief Counsel's Office, Office of the Comptroller of the Currency, 400 7th Street SW, Suite 3E-218, Washington, DC 20219. If you are deaf, hard of hearing, or have a speech disability, please dial 7-1-1 to access telecommunications relay services.
Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the OMB for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) to include agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. The OCC asks OMB to approve this revised collection.
To reflect revisions to 12 CFR part 5, which was revised effective January 11, 2021,
On July 1, 2022, the OCC published a notice for 60 days of comment concerning this collection (87 FR 39590). No comments were received. Comments continue to be solicited on:
(a) Whether the information collections 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; and
(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.
Office of Foreign Assets Control, Treasury.
Notice.
The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons that have been placed on OFAC's List of Specially Designated Nationals and Blocked Persons (SDN List) based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.
See
OFAC: Andrea Gacki, Director, tel.: 202-622-2490; Associate Director for Global Targeting, tel.: 202-622-2420; Assistant Director for Licensing, tel.: 202-622-2480; Assistant Director for Regulatory Affairs, tel.: 202-622-4855; or the Assistant Director for Sanctions Compliance & Evaluation, tel.: 202-622-2490.
The SDN List and additional information concerning OFAC sanctions programs are available on OFAC's website (
On November 4, 2022, OFAC determined that the property and interests in property subject to U.S. jurisdiction of the following persons are blocked under the relevant sanctions authority listed below.
1. LAMBERT, Joseph, Haiti; DOB 05 Feb 1961; POB Jacmel, Haiti; nationality Haiti; Gender Male (individual) [ILLICIT-DRUGS-EO14059]. Sanctioned pursuant to section 1(a)(i) of Executive Order 14059 (E.O. 14059) of December 15, 2021, “Imposing Sanctions on Foreign Persons Involved in the Global Illicit Drug Trade,” for having engaged in, or attempted to engage in, activities or transactions that have materially contributed to, or pose a significant risk of materially contributing to, the international proliferation of illicit drugs or their means of production.
2. LATORTUE, Youri, Haiti; DOB 13 Nov 1967; POB Gonaives, Artibonite, Haiti; nationality Haiti; Gender Male; National ID No. 05-01-99-1967-11-00001 (Haiti) (individual) [ILLICIT-DRUGS-EO14059]. Sanctioned pursuant to section 1(a)(i) of E.O. 14059 for having engaged in, or attempted to engage in, activities or transactions that have materially contributed to, or pose a significant risk of materially contributing to, the international proliferation of illicit drugs or their means of production.
Office of Foreign Assets Control, Treasury.
Notice.
The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons and vessels that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List (SDN List) based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them. The vessels placed on the SDN List have been identified as property in which a blocked person has an interest.
See
OFAC: Andrea Gacki, Director, tel.: 202-622-2490; Associate Director for Global Targeting, tel.: 202-622-2420; Assistant Director for Licensing, tel.: 202-622-2480; Assistant Director for Regulatory Affairs, tel.: 202-622-4855; or the Assistant Director for Sanctions Compliance & Evaluation, tel.: 202-622-2490.
The Specially Designated Nationals and Blocked Persons List and additional information concerning OFAC sanctions programs are available on OFAC's website (
On November 3, 2022, OFAC determined that the property and interests in property subject to U.S. jurisdiction of the following persons are blocked under the relevant sanctions authorities listed below.
1. ARTEMOV, Viktor Sergiyovich, Chemin Des Princes 2, 1223, Cologny, Switzerland; Geneva, Switzerland; DOB 20 Oct 1975; alt. DOB 31 Dec 1975; POB Donetska Oblast, Ukraine; nationality Ukraine; Gender Male; Secondary sanctions risk: section 1(b) of Executive Order 13224, as amended by Executive Order 13886; Passport FN356229 (Ukraine) expires 17 Apr 2028 (individual) [SDGT] (Linked To: HIZBALLAH; Linked To: ISLAMIC REVOLUTIONARY GUARD CORPS (IRGC)-QODS FORCE).
Designated pursuant to section 1(a)(iii)(C) of Executive Order 13224 of September 23, 2001, “Blocking Property and Prohibiting Transactions With Persons Who Commit, Threaten to Commit, or Support Terrorism,” 66 FR 49079, as amended by Executive Order 13886 of September 9, 2019, “Modernizing Sanctions To Combat Terrorism,” 84 FR 48041 (E.O. 13224, as amended), for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services to or in support of, HIZBALLAH, a person whose property and interests in property are blocked pursuant to E.O. 13224.
Designated pursuant to section 1(a)(iii)(C) of E.O. 13224, as amended, for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services to or in support of, ISLAMIC REVOLUTIONARY GUARD CORPS—QODS FORCE, a person whose property and interests in property are blocked pursuant to E.O. 13224.
2. EL ZEIN, Mohamed (a.k.a. AL-ZAYN, Muhammad; a.k.a. AL-ZAYN, Muhammad 'Ali), Beirut, Lebanon; Tehran, Iran; DOB 17 Feb 1987; nationality Lebanon; Gender Male; Secondary sanctions risk: section 1(b) of Executive Order 13224, as amended by Executive Order 13886; Passport 3090014 (Lebanon) expires 09 Mar 2020 (individual) [SDGT] (Linked To: HIZBALLAH; Linked To: ISLAMIC REVOLUTIONARY GUARD CORPS (IRGC)—QODS FORCE).
Designated pursuant to section 1(a)(iii)(C) of E.O. 13224, as amended, for having materially assisted, sponsored, or provided financial,
Designated pursuant to section 1(a)(iii)(C) of E.O. 13224, as amended, for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services to or in support of, ISLAMIC REVOLUTIONARY GUARD CORPS—QODS FORCE, a person whose property and interests in property are blocked pursuant to E.O. 13224.
3. NAFRIEH, Edman, Iran; DOB 24 Apr 1980; POB Tehran, Iran; nationality Iran; Gender Male; Secondary sanctions risk: section 1(b) of Executive Order 13224, as amended by Executive Order 13886; Passport H13722880 (Iran); alt. Passport RE0061544 (Saint Kitts and Nevis) expires 09 Jul 2027 (individual) [SDGT] (Linked To: HIZBALLAH; Linked To: ISLAMIC REVOLUTIONARY GUARD CORPS (IRGC)—QODS FORCE).
Designated pursuant to section 1(a)(iii)(C) of E.O. 13224, as amended, for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services to or in support of, HIZBALLAH, a person whose property and interests in property are blocked pursuant to E.O. 13224.
Designated pursuant to section 1(a)(iii)(C) of E.O. 13224, as amended, for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services to or in support of, ISLAMIC REVOLUTIONARY GUARD CORPS—QODS FORCE, a person whose property and interests in property are blocked pursuant to E.O. 13224.
4. RYABIKOVA, Tatiana (a.k.a. SURDON, Tatiana Ryabikova), France; DOB 24 Jan 1970; nationality France; Gender Female; Secondary sanctions risk: section 1(b) of Executive Order 13224, as amended by Executive Order 13886; Passport 04KH30561 (France) (individual) [SDGT] (Linked To: ARTEMOV, Viktor Sergiyovich).
Designated pursuant to section 1(a)(iii)(C) of E.O. 13224, as amended, for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services to or in support of, VIKTOR SERGIYOVICH ARTEMOV, a person whose property and interests in property are blocked pursuant to E.O. 13224, as amended.
5. ZAHEDI, Rouzbeh (a.k.a. ZAHEDI, Roozbeh), Iran; DOB 01 Dec 1970; POB Iran; nationality Iran; Gender Male; Secondary sanctions risk: section 1(b) of Executive Order 13224, as amended by Executive Order 13886; (individual) [SDGT] (Linked To: HIZBALLAH; Linked To: ISLAMIC REVOLUTIONARY GUARD CORPS (IRGC)—QODS FORCE).
Designated pursuant to section 1(a)(iii)(C) of E.O. 13224, as amended, for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services to or in support of, HIZBALLAH, a person whose property and interests in property are blocked pursuant to E.O. 13224.
Designated pursuant to section 1(a)(iii)(C) of E.O. 13224, as amended, for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services to or in support of, ISLAMIC REVOLUTIONARY GUARD CORPS—QODS FORCE, a person whose property and interests in property are blocked pursuant to E.O. 13224.
6. FAZZONE, Gregorio, Switzerland; DOB 13 Nov 1959; alt. DOB 31 Dec 1959; nationality Switzerland; Gender Male; Secondary sanctions risk: section 1(b) of Executive Order 13224, as amended by Executive Order 13886; Passport X4818118 (Switzerland) expires 15 Jul 2020 (individual) [SDGT] (Linked To: AVA PETROLEUM SERVICES S.A.).
Designated pursuant to section 1(a)(iii)(E) of E.O. 13224, as amended, for being a leader or official of AVA PETROLEUM SERVICES S.A., a person whose property and interests in property are blocked pursuant to E.O. 13224, as amended.
1. AVA PETROLEUM SERVICES S.A., Rue Rodolphe-Toepffer 8, Geneva 1206, Switzerland; Organization Established Date 20 Jul 2009; Secondary sanctions risk: section 1(b) of Executive Order 13224, as amended by Executive Order 13886; Commercial Registry Number CH-660.1.612.009-4 (Switzerland) [SDGT] (Linked To: ARTEMOV, Viktor Sergiyovich).
Designated pursuant to section 1(a)(iii)(A) of E.O. 13224, as amended, for being owned, controlled, or directed by, directly or indirectly, VIKTOR SERGIYOVICH ARTEMOV, a person whose property and interests in property are blocked pursuant to E.O. 13224, as amended.
2. BLUE BERRI SHIPPING INC., Trust Company Complex, Ajeltake Road, Ajeltake Island, Majuro MH96960, Marshall Islands; Secondary sanctions risk: section 1(b) of Executive Order 13224, as amended by Executive Order 13886; Organization Established Date 04 Mar 2021; Business Number 108160 (Marshall Islands) [SDGT] (Linked To: ARTEMOV, Viktor Sergiyovich).
Designated pursuant to section 1(a)(iii)(C) of E.O. 13224, as amended, for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services to or in support of, VIKTOR SERGIYOVICH ARTEMOV, a person whose property and interests in property are blocked pursuant to E.O. 13224, as amended.
3. CENTRUM MARITIME PTE. LTD., 10 Anson Road, 20-05 International Plaza, 079903, Singapore; Organization Established Date 12 Nov 2020; Secondary sanctions risk: section 1(b) of Executive Order 13224, as amended by Executive Order 13886; Commercial Registry Number 202036616G (Singapore) [SDGT] (Linked To: ARTEMOV, Viktor Sergiyovich).
Designated pursuant to section 1(a)(iii)(A) of E.O. 13224, as amended, for being owned, controlled, or directed by, directly or indirectly, VIKTOR SERGIYOVICH ARTEMOV, a person whose property and interests in property are blocked pursuant to E.O. 13224, as amended.
4. ENERGOTRADE PLUS DMCC, Unit No: 3O-01-BA1417, Jewellery & Gemplex 3, Plot No: DMCC-PH2-J&GPlexS, Jewellery & Gemplex, Dubai, United Arab Emirates; Organization Established Date 31 Mar 2021; Secondary sanctions risk: section 1(b) of Executive Order 13224, as amended by Executive Order 13886; Company Number 11650050 (United Arab Emirates); Business Number DMCC-807753 (United Arab Emirates); Business Registration Number DMCC190145 (United Arab Emirates) [SDGT] (Linked To: ARTEMOV, Viktor Sergiyovich).
Designated pursuant to section 1(a)(iii)(A) of E.O. 13224, as amended, for being owned, controlled, or directed by, directly or indirectly, VIKTOR SERGIYOVICH ARTEMOV, a person whose property and interests in property are blocked pursuant to E.O. 13224, as amended.
5. EXPANSE SHIP MANAGEMENT LIMITED, Office 131, 11th Floor, Ankara Caddesi 145, Kordonboyu Mahallesi, Kartal, Istanbul, Turkey; Trust Company Complex, Ajeltake Road, Ajeltake Island, Majuro MH96960, Marshall Islands; Secondary sanctions risk: section 1(b) of Executive Order 13224, as amended by Executive Order 13886; Organization Established Date 2021; Organization Type: Sea and coastal freight water transport [SDGT] (Linked To: ARTEMOV, Viktor Sergiyovich).
Designated pursuant to section 1(a)(iii)(C) of E.O. 13224, as amended, for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services to or in support of, VIKTOR SERGIYOVICH ARTEMOV, a person whose property and interests in property are blocked pursuant to E.O. 13224, as amended.
6. GILDA TAR KARVAN INTERNATIONAL COMPANY, No 9 6th Alley, Tehran 1514643411, Iran; No. 7 Alvand Street, Argentine Sqr., Tehran 19666, Iran; Secondary sanctions risk: section 1(b) of Executive Order 13224, as amended by Executive Order 13886; National ID No. 10103735379 (Iran) [SDGT] (Linked To: NAFRIEH, Edman).
Designated pursuant to section 1(a)(iii)(A) of E.O. 13224, as amended, for being owned, controlled, or directed by, directly or indirectly, EDMAN NAFRIEH, a person whose property and interests in property are blocked pursuant to E.O. 13224, as amended.
7. HARBOUR SHIP MANAGEMENT LIMITED, Trust Company Complex, Ajeltake Road, Ajeltake Island, Majuro MH96960, Marshall Islands; Ap 22, Carrer de Pallars 193, Barcelona 08018, Spain; Secondary sanctions risk: section 1(b) of Executive Order 13224, as amended by Executive Order 13886; Identification Number IMO 6235071 [SDGT] (Linked To: ARTEMOV, Viktor Sergiyovich).
Designated pursuant to section 1(a)(iii)(C) of E.O. 13224, as amended, for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services to or in support of, VIKTOR SERGIYOVICH ARTEMOV, a person whose property and interests in property are blocked pursuant to E.O. 13224, as amended.
8. INTREPID NAVIGATORS S.A., Trust Company Complex, Ajeltake Road, Ajeltake Island, Majuro MH96960, Marshall Islands; Secondary sanctions risk: section 1(b) of Executive Order 13224, as amended by Executive Order 13886; Organization Established Date 15 Feb 2022; Business Number 113129 (Marshall Islands) [SDGT] (Linked To: ARTEMOV, Viktor Sergiyovich).
Designated pursuant to section 1(a)(iii)(A) of E.O. 13224, as amended, for being owned, controlled, or directed by, directly or indirectly, VIKTOR SERGIYOVICH ARTEMOV, a person whose property and interests in property are blocked pursuant to E.O. 13224, as amended.
9. MONUMONT SHIP MANAGEMENT LIMITED, Trust Company Complex, Ajeltake Road, Ajeltake Island, Majuro MH96960, Marshall Islands; Daire 131, Kat 11, 1st Marina B Blok, Ankara Caddesi 147, Kordonboyu Mahallesi, Kartal, Istanbul, Turkey; Kat 7, Rumeli Plaza, Rumeli Caddesi, Mesrutiyet Mahallesi, Nisantasi, Sisil, Istanbul, Turkey; Secondary sanctions risk: section 1(b) of Executive Order 13224, as amended by Executive Order 13886; Organization Established Date 2021; Identification Number IMO 6207825 [SDGT] (Linked To: ARTEMOV, Viktor Sergiyovich).
Designated pursuant to section 1(a)(iii)(C) of E.O. 13224, as amended, for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services to or in support of, VIKTOR SERGIYOVICH ARTEMOV, a person whose property and interests in property are blocked pursuant to E.O. 13224, as amended.
10. PETRO NAVIERO PTE. LTD., 20 Upper Circular Road, 02-10/12 The Riverwalk, 058416, Singapore; Secondary sanctions risk: section 1(b) of Executive Order 13224, as amended by Executive Order 13886; Organization Established Date 31 Mar 2021; Commercial Registry Number 202111423D (Singapore) [SDGT] (Linked To: ARTEMOV, Viktor Sergiyovich).
Designated pursuant to section 1(a)(iii)(A) of E.O. 13224, as amended, for being owned, controlled, or directed by, directly or indirectly, VIKTOR SERGIYOVICH ARTEMOV, a person whose property and interests in property are blocked pursuant to E.O. 13224, as amended.
11. RISING TIDE SHIPPING CORP., Trust Company Complex, Ajeltake Road, Ajeltake Island, Majuro MH96960, Marshall Islands; Secondary sanctions risk: section 1(b) of Executive Order 13224, as amended by Executive Order 13886; Organization Established Date 22 Mar 2022; Business Number 113667 (Marshall Islands) [SDGT] (Linked To: ARTEMOV, Viktor Sergiyovich).
Designated pursuant to section 1(a)(iii)(A) of E.O. 13224, as amended, for being owned, controlled, or directed by, directly or indirectly, VIKTOR SERGIYOVICH ARTEMOV, a person whose property and interests in property are blocked pursuant to E.O. 13224, as amended.
12. AL HAKEEL AL ASWAD OIL TRADING LLC, Unit No: 1701 Ontario Tower, Business Bay, Dubai, United Arab Emirates; Secondary sanctions risk: section 1(b) of Executive Order 13224, as amended by Executive Order 13886; Organization Established Date 19 Sep 2016; Organization Type: Extraction of crude petroleum [SDGT] (Linked To: ARTEMOV, Viktor Sergiyovich).
Designated pursuant to section 1(a)(iii)(C) of E.O. 13224, as amended, for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services to or in support of, VIKTOR SERGIYOVICH ARTEMOV, a person whose property and interests in property are blocked pursuant to E.O. 13224, as amended.
13. AZUL VISTA SHIPPING CORPORATION, Trust Company Complex, Ajeltake Road, Ajeltake Island, Majuro MH96960, Marshall Islands; Secondary sanctions risk: section 1(b) of Executive Order 13224, as amended by Executive Order 13886; Commercial Registry Number 107790 (Marshall Islands) [SDGT] (Linked To: ARTEMOV, Viktor Sergiyovich).
Designated pursuant to section 1(a)(iii)(C) of E.O. 13224, as amended, for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services to or in support of, VIKTOR SERGIYOVICH ARTEMOV, a person whose property and interests in property are blocked pursuant to E.O. 13224, as amended.
14. PONTUS NAVIGATION CORP., Trust Company Complex, Ajeltake Road, Ajeltake Island, Majuro MH96960, Marshall Islands; Secondary sanctions risk: section 1(b) of Executive Order 13224, as amended by Executive Order 13886; Commercial Registry Number 113562 (Marshall Islands) [SDGT] (Linked To: ARTEMOV, Viktor Sergiyovich).
Designated pursuant to section 1(a)(iii)(C) of E.O. 13224, as amended, for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services to or in support of, VIKTOR SERGIYOVICH ARTEMOV, a person whose property and interests in property are blocked pursuant to E.O. 13224, as amended.
15. TECHNOLOGY BRIGHT INTERNATIONAL LIMITED, Trust Company Complex, Ajeltake Road, Ajeltake Island, Majuro MH96960, Marshall Islands; Secondary sanctions risk: section 1(b) of Executive Order 13224, as amended by Executive Order 13886; Commercial Registry Number 107346 (Marshall Islands) [SDGT] (Linked To: ARTEMOV, Viktor Sergiyovich).
Designated pursuant to section 1(a)(iii)(C) of E.O. 13224, as amended, for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services to or in support of, VIKTOR SERGIYOVICH ARTEMOV, a person whose property and interests in
16. TRITON NAVIGATION CORP., Trust Company Complex, Ajeltake Road, Ajeltake Island, Majuro MH96960, Marshall Islands; Secondary sanctions risk: section 1(b) of Executive Order 13224, as amended by Executive Order 13886; Commercial Registry Number 113453 (Marshall Islands) [SDGT] (Linked To: ARTEMOV, Viktor Sergiyovich).
Designated pursuant to section 1(a)(iii)(C) of E.O. 13224, as amended, for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services to or in support of, VIKTOR SERGIYOVICH ARTEMOV, a person whose property and interests in property are blocked pursuant to E.O. 13224, as amended.
17. VISTA CLARA SHIPPING CORPORATION, Trust Company Complex, Ajeltake Road, Ajeltake Island, Majuro MH96960, Marshall Islands; Secondary sanctions risk: section 1(b) of Executive Order 13224, as amended by Executive Order 13886; Organization Established Date 22 Apr 2021; Commercial Registry Number 108904 (Marshall Islands) [SDGT] (Linked To: ARTEMOV, Viktor Sergiyovich).
Designated pursuant to section 1(a)(iii)(C) of E.O. 13224, as amended, for having materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services to or in support of, VIKTOR SERGIYOVICH ARTEMOV, a person whose property and interests in property are blocked pursuant to E.O. 13224, as amended.
On November 3, 2022, OFAC also identified the following vessels as property in which a blocked person has an interest under the relevant sanctions authority listed below:
1. B LUMINOSA Oil Products Tanker Djibouti flag; Secondary sanctions risk: section 1(b) of Executive Order 13224, as amended by Executive Order 13886; Vessel Registration Identification IMO 9256016; MMSI 621819076 (vessel) [SDGT] (Linked To: HARBOUR SHIP MANAGEMENT LIMITED).
Identified pursuant to E.O. 13224, as amended, as property in which HARBOUR SHIP MANAGEMENT LIMITED, a person whose property and interests in property are blocked pursuant to E.O. 13224, as amended, has an interest.
2. BLUEFINS Oil Products Tanker Djibouti flag; Secondary sanctions risk: section 1(b) of Executive Order 13224, as amended by Executive Order 13886; Vessel Registration Identification IMO 9221657; MMSI 621819069 (vessel) [SDGT] (Linked To: HARBOUR SHIP MANAGEMENT LIMITED).
Identified pursuant to E.O. 13224, as amended, as property in which HARBOUR SHIP MANAGEMENT LIMITED, a person whose property and interests in property are blocked pursuant to E.O. 13224, as amended, has an interest.
3. BOCEANICA Oil Products Tanker Djibouti flag; Former Vessel Flag Palau; Secondary sanctions risk: section 1(b) of Executive Order 13224, as amended by Executive Order 13886; Vessel Registration Identification IMO 9267132; MMSI 621819060 (vessel) [SDGT] (Linked To: ARTEMOV, Viktor Sergiyovich).
Identified pursuant to E.O. 13224, as amended, as property in which VIKTOR SERGIYOVICH ARTEMOV, a person whose property and interests in property are blocked pursuant to E.O. 13224, as amended, has an interest.
4. BUENO Oil Products Tanker Djibouti flag; Secondary sanctions risk: section 1(b) of Executive Order 13224, as amended by Executive Order 13886; Vessel Registration Identification IMO 9282443; MMSI 621819070 (vessel) [SDGT] (Linked To: HARBOUR SHIP MANAGEMENT LIMITED).
Identified pursuant to E.O. 13224, as amended, as property in which HARBOUR SHIP MANAGEMENT LIMITED, a person whose property and interests in property are blocked pursuant to E.O. 13224, as amended, has an interest.
5. RAIN DROP Crude Oil Tanker Cook Islands flag; Secondary sanctions risk: section 1(b) of Executive Order 13224, as amended by Executive Order 13886; Vessel Registration Identification IMO 9233208; MMSI 518998461 (vessel) [SDGT] (Linked To: BLUE BERRI SHIPPING INC.).
Identified pursuant to E.O. 13224, as amended, as property in which BLUE BERRI SHIPPING INC., a person whose property and interests in property are blocked pursuant to E.O. 13224, as amended, has an interest.
6. ZEPHYR I (f.k.a. ZHEN I) Crude Oil Tanker Panama flag; Former Vessel Flag Palau; Secondary sanctions risk: section 1(b) of Executive Order 13224, as amended by Executive Order 13886; Vessel Registration Identification IMO 9255880; MMSI 511100663 (vessel) [SDGT] (Linked To: ARTEMOV, Viktor Sergiyovich).
Identified pursuant to E.O. 13224, as amended, as property in which VIKTOR SERGIYOVICH ARTEMOV, a person whose property and interests in property are blocked pursuant to E.O. 13224, as amended, has an interest.
7. ADISA Oil Products Tanker Panama flag; Secondary sanctions risk: section 1(b) of Executive Order 13224, as amended by Executive Order 13886; Vessel Registration Identification IMO 9304667; MMSI 353024000 (vessel) [SDGT] (Linked To: TRITON NAVIGATION CORP.).
Identified pursuant to E.O. 13224, as amended, as property in which TRITON NAVIGATION CORP., a person whose property and interests in property are blocked pursuant to E.O. 13224, as amended, has an interest.
8. JULIA A (f.k.a. AZUL) Oil Products Tanker Liberia flag; Former Vessel Flag Palau; Secondary sanctions risk: section 1(b) of Executive Order 13224, as amended by Executive Order 13886; Vessel Registration Identification IMO 9236353; MMSI 511100435 (vessel) [SDGT] (Linked To: AZUL VISTA SHIPPING CORPORATION).
Identified pursuant to E.O. 13224, as amended, as property in which AZUL VISTA SHIPPING CORPORATION, a person whose property and interests in property are blocked pursuant to E.O. 13224, as amended, has an interest.
9. LARA I (f.k.a. CLARA) Oil Products Tanker Liberia flag; Former Vessel Flag Palau; Secondary sanctions risk: section 1(b) of Executive Order 13224, as amended by Executive Order 13886; Vessel Registration Identification IMO 9231767; MMSI 511100481 (vessel) [SDGT] (Linked To: VISTA CLARA SHIPPING CORPORATION).
Identified pursuant to E.O. 13224, as amended, as property in which VISTA CLARA SHIPPING CORPORATION, a person whose property and interests in property are blocked pursuant to E.O. 13224, as amended, has an interest.
10. NOLAN (f.k.a. OSLO) Oil Products Tanker Panama flag; Secondary sanctions risk: section 1(b) of Executive Order 13224, as amended by Executive Order 13886; Vessel Registration Identification IMO 9179701; MMSI 354798000 (vessel) [SDGT] (Linked To: PONTUS NAVIGATION CORP.).
Identified pursuant to E.O. 13224, as amended, as property in which PONTUS NAVIGATION CORP., a person whose property and interests in property are blocked pursuant to E.O. 13224, as amended, has an interest.
11. YOUNG YONG Oil Products Tanker Djibouti flag; Secondary sanctions risk: section 1(b) of Executive Order 13224, as amended by Executive Order 13886; Vessel Registration Identification IMO 9194127; MMSI 621819067 (vessel) [SDGT] (Linked To: TECHNOLOGY BRIGHT INTERNATIONAL LIMITED).
Identified pursuant to E.O. 13224, as amended, as property in which TECHNOLOGY BRIGHT INTERNATIONAL LIMITED, a person whose property and interests in property are blocked pursuant to E.O. 13224, as amended, has an interest.
Departmental Offices, Treasury.
Request for comments; extension of comment period.
On September 29, 2022, Treasury published a Notice that invited the public to comment on questions related to cyber insurance and catastrophic cyber incidents in order to inform a joint assessment being conducted by the Department of the Treasury's Federal Insurance Office (FIO) and the Department of Homeland Security's Cybersecurity and Infrastructure Security Agency (CISA) into “the extent to which risks to critical infrastructure from catastrophic cyber incidents and potential financial exposures warrant a federal insurance response.” The purpose of this notice is to extend the comment period for a period of one month until December 14, 2022 and provide more time for interested parties to provide comments.
The comment period for the notice published at 87 FR 59161 on September 29, 2002, is extended. Responses must be received by December 14, 2022 to be assured of consideration.
Please submit comments electronically through the Federal eRulemaking Portal:
Richard Ifft, Senior Insurance Regulatory Policy Analyst, Federal Insurance Office, (202) 622-2922,
On June 21, 2022, the Government Accountability Office (GAO) issued a report,
On September 29, 2022, Treasury published a Notice in the
Departmental Offices, Department of the Treasury.
Notice.
The Department of the Treasury will submit the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on these requests.
Comments should be received on or before December 9, 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
United States Sentencing Commission.
Notice of final priorities.
In October 2022, the Commission published a notice of proposed policy priorities for the amendment cycle ending May 1, 2023. After reviewing public comment received pursuant to the notice of proposed priorities, the Commission has identified its policy priorities for the upcoming amendment cycle and hereby gives notice of these policy priorities.
Jennifer Dukes, Senior Public Affairs Specialist, (202) 502-4500,
The United States Sentencing Commission is an independent agency in the judicial branch of the United States Government. The Commission promulgates sentencing guidelines and policy statements for Federal sentencing courts pursuant to 28 U.S.C. 994(a). The Commission also periodically reviews and revises previously promulgated guidelines pursuant to 28 U.S.C. 994(o) and submits guideline amendments to Congress not later than the first day of May each year pursuant to 28 U.S.C. 994(p).
As part of its statutory authority and responsibility to analyze sentencing issues, including operation of the Federal sentencing guidelines, the Commission has identified its policy priorities for the amendment cycle ending May 1, 2023. Other factors, such as legislation requiring Commission action, may affect the Commission's ability to complete work on any or all identified priorities by May 1, 2023. Accordingly, the Commission may continue work on any or all identified priorities after that date or may decide not to pursue one or more identified priorities.
Pursuant to 28 U.S.C. 994(g), the Commission intends to consider the issue of reducing costs of incarceration and overcapacity of prisons, to the extent it is relevant to any identified priority.
The Commission has identified the following priorities for the amendment cycle ending May 1, 2023:
(1) Consideration of possible amendments to § 1B1.13 (Reduction in Term of Imprisonment Under 18 U.S.C. 3582(c)(1)(A) (Policy Statement)) to (A) implement the First Step Act of 2018 (Pub. L. 115-391); and (B) further describe what should be considered extraordinary and compelling reasons for sentence reductions under 18 U.S.C. 3582(c)(1)(A).
(2) Consideration of possible amendments to section 2D1.1 (Unlawful Manufacturing, Importing, Exporting, or Trafficking (Including Possession with Intent to Commit These Offenses)), section 2D1.11 (Unlawfully Distributing, Importing, Exporting or Possessing a Listed Chemical; Attempt or Conspiracy), section 5C1.2 (Limitation on Applicability of Statutory Minimum Sentences in Certain Cases), and related provisions in the
(3) Consideration of possible amendments to § 2K2.1 (Unlawful Receipt, Possession, or Transportation of Firearms or Ammunition; Prohibited Transactions Involving Firearms or Ammunition) to (A) implement the Bipartisan Safer Communities Act (Pub. L. 117-159); and (B) make any other changes that may be warranted to appropriately address firearms offenses.
(4) Resolution of circuit conflicts as warranted, pursuant to the Commission's authority under 28 U.S.C. 991(b)(1)(B) and
(5) Implementation of any legislation warranting Commission action.
(6) Continuation of its multiyear work on section 4B1.2 (Definitions of Terms Used in Section 4B1.1), including possible amendments to (A) provide an alternative approach to the “categorical approach” in determining whether an offense is a “crime of violence” or a “controlled substance offense”; and (B) address various application issues, including the meaning of “robbery” and “extortion,” and the treatment of inchoate offenses and offenses involving an offer to sell a controlled substance.
(7) In light of Commission studies, consideration of possible amendments to the
(8) Consideration of possible amendments to the
(9) Consideration of possible amendments to the
(10) Consideration of possible amendments to the
(11) Multiyear study of the
(12) Continuation of its multiyear examination of the structure of the guidelines post-
(13) Multiyear study of court-sponsored diversion and alternatives-to-incarceration programs (
(14) Consideration of other miscellaneous issues, including possible amendments to (A) section 2D1.1 (Unlawful Manufacturing, Importing, Exporting, or Trafficking (Including Possession with Intent to Commit These Offenses) to address offenses involving misrepresentation or marketing of a controlled substance as another substance; (B) section 3D1.2 (Grouping of Closely Related Counts) to address
The Department of Veterans Affairs (VA) gives notice under the Federal Advisory Committee Act, 5 U.S.C. App. 2, that the National Research Advisory Council will hold a meeting on Wednesday, December 7, 2022, by MS Teams. The teleconference number is 1-872-701-0185, conference ID 317 213 453# or the meeting link is
The meeting will convene at 11:00 a.m. and end at 2:00 p.m. Eastern daylight time. This meeting is open to the public.
The purpose of the National Research Advisory Council is to advise the Secretary on research conducted by the Veterans Health Administration, including policies and programs targeting the high priority of Veterans' health care needs.
On December 7, 2022, the agenda will include follow up discussion of sensitive species; overview of VA Homelessness Research; discussion of subcommittee activities and updates on the Research Enterprise Initiative. No time will be allocated at this meeting for receiving oral presentations from the public. Members of the public wanting to attend, have questions or presentations to present may contact Rashelle Robinson, Designated Federal Officer, Office of Research and Development (14RD), Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420, at 202-443-5768, or
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
Veterans Benefits Administration, Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Written comments and recommendations on the proposed collection of information should be received on or before January 9, 2023.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Maribel Aponte, Office of Enterprise and Integration, Data Governance Analytics (008), 810 Vermont Ave. NW, Washington, DC 20006, (202) 266-4688 or email
Under the PRA of 1995, Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VBA invites comments on: (1) whether the proposed collection of information is necessary for the proper performance of VBA's functions, including whether the information will have practical utility; (2) the accuracy of VBA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
No changes have been made to this form. The respondent burden has increased due to the estimated number
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
Veterans Benefits Administration, Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Written comments and recommendations on the proposed collection of information should be received on or before January 9, 2023.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Maribel Aponte, Office of Enterprise and Integration, Data Governance Analytics (008), 810 Vermont Ave. NW, Washington, DC 20006, (202) 266-4688 or email
Under the PRA of 1995, Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VBA invites comments on: (1) whether the proposed collection of information is necessary for the proper performance of VBA's functions, including whether the information will have practical utility; (2) the accuracy of VBA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
No changes have been made to this form. The respondent burden has increased due to the estimated number of receivables averaged over the past year.
By direction of the Secretary.